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Speakers

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Sadik Kassim
Executive Director
Kite, a Gilead Company

Dr. Sadik Kassim is Executive Director at Kite Pharma, where he oversees the CMC activities for all next generation immune cell therapies for cancer.   Previously, Sadik was Chief Scientific Officer of Mustang Bio. Prior to Mustang, Sadik was Head of Analytical Development for Novartis’ Cell and Gene Therapies Unit in Cambridge, MA where he contributed the BLA and MAA filings for Kymriah™.  Earlier in his career, Dr. Kassim was a research biologist in the Surgery Branch at the National Cancer Institute, where he was involved in early research and CMC work that led to the development of Kite’s Yescarta™ (CD19 CAR T) for lymphoma.  Sadik was a research fellow in the University of Pennsylvania’s (Penn) Gene Therapy Program where he led the initial discovery efforts and pre-clinical studies for an AAV8 gene therapy for familial hypercholesteromia.  This program is now in the clinic as part of RegenexBio’s RGX-501 program.

Mark Perrott
Senior Director
Huron

Mark has 20+ years of business process improvement and change management expertise across multiple areas of pharmaceutical R&D. He works to improve processes and assures lasting change in clients and employers from the largest pharmacos to small biotech start-ups.

Dan Maziasz
Vice President & Head of Business Development & Strategic Alliances
Atara Biotherapeutics

Mr. Maziasz leads Atara’s global business development and alliance management activities.  Prior to Atara, Mr. Maziasz served as VP, Corporate Strategy & Business Development at Gilead Sciences following its acquisition of Kite Pharma.  In this role, he led various strategy and business development initiatives focused on new technologies and was responsible for Kite’s Joint Venture in China and strategic partnership in Japan.  Prior to joining Kite, he held roles of increasing responsibility at Amgen in the U.S. and Europe across Business Development, Corporate Strategy, Finance and Commercial.  Mr. Maziasz received a B.S. in Business Administration and Economics from Saint Mary’s College of California and a M.B.A. degree from Loyola Marymount University.

Michael Lehmicke
Director, Science & Industry Affairs
Alliance for Regenerative Medicine

A seasoned leader with over 20 years of R&D experience in biomaterials, medical devices, and regenerative medicine. I have led product development teams for class II devices, human cell and tissue based products, and drug/device combination products. I am a creator and an inventor with multiple US patents to my name.

Slavoljub Milosevic
Head of Technology & Innovation,
Medigene

Yuhong Qiu
Vice President of Global Regulatory Affairs
Legend Biotech

Yuhong Qiu received her PhD degree and completed her post-doctoral training from the Baylor College of Medicine. She has over 20 years of experience in pharmaceutical industry including 12 years in Regulatory Affairs at Novartis Oncology with increasing responsibilities. Yuhong has broad regulatory expertise spanning across both small and biologics development. She led numerous successful global regulatory filings from INDs/CTAs to marketing authorization applications. Currently, Yuhong serves as Vice President of Global Regulatory Affairs in Legend Biotech.

Dan Maziasz
Vice President & Head of Business Development & Strategic Alliances
Atara Biotherapeutics

Mr. Maziasz leads Atara’s global business development and alliance management activities.  Prior to Atara, Mr. Maziasz served as VP, Corporate Strategy & Business Development at Gilead Sciences following its acquisition of Kite Pharma.  In this role, he led various strategy and business development initiatives focused on new technologies and was responsible for Kite’s Joint Venture in China and strategic partnership in Japan.  Prior to joining Kite, he held roles of increasing responsibility at Amgen in the U.S. and Europe across Business Development, Corporate Strategy, Finance and Commercial.  Mr. Maziasz received a B.S. in Business Administration and Economics from Saint Mary’s College of California and a M.B.A. degree from Loyola Marymount University.

James Noble
Chief Executive Officer
Adaptimmune

James Noble has served as our full-time Chief Executive Officer since March 2014, and part-time CEO from July 2008 to March 2014, and is one of our co-founders. From July 2008 until March 2014, Mr. Noble was also CEO of Immunocore. Mr. Noble has 28 years of experience in the biotech industry. He has held numerous non-executive director positions, including at CuraGen Corporation, PowderJect Pharmaceuticals plc, Oxford GlycoSciences plc, MediGene AG, and Advanced Medical Solutions plc. Mr. Noble is also Deputy Chairman of GW Pharmaceuticals plc (NASDAQ: GWPH). Mr. Noble qualified as a chartered accountant with Price Waterhouse and spent seven years at the investment bank Kleinwort Benson Limited, where he became a director in 1990. He then joined British Biotech plc as Chief Financial Officer from 1990 to 1997. Mr. Noble was previously Chief Executive Officer of Avidex Limited, a privately held biotechnology company that was our predecessor, from 2000 to 2006. Mr. Noble holds an M.A. from the University of Oxford.

Day One

Thursday 13th December 2018

9:00 am | Industry Leader’s Fireside Chat

Bob Valamehr
Chief Development Officer & Vice President - Cancer Immunotherapy
Fate Therapeutics

Bahram (Bob) Valamehr is the Chief Development Officer at Fate Therapeutics, overseeing the company’s early development activities including “off-the-shelf” cell therapy products derived from the company’s induced pluripotent stem cell platform. Previously, Dr. Valamehr was the Vice President of Cancer Immunotherapy at Fate and prior to that played key scientific roles at Amgen, the Center for Cell Control (a NIH Nanomedicine Development Center) and the Broad Stem Cell Research Center developing novel methods to control pluripotency, to modulate stem cell fate including hematopoiesis and to better understand cellular signaling pathways associated with cancer. He has co-authored numerous studies and patents related to stem cell biology, oncology and materials science. Dr. Valamehr received his Ph.D. from the Department of Molecular and Medical Pharmacology at UCLA, his M.B.A. from Pepperdine University and his B.S. from the Department of Chemistry and Biochemistry at UCLA.

Barbra Sasu
Chief Scientific Officer
Allogene

Barbra Sasu is currently the CSO of Allogene, a newly-formed allogeneic CAR T company which is an amalgam of the successful Kite management team who delivered regulatory approval of Yescarta,with the technical team who developed the Pfizer CAR T pipeline.Barbra received her PhD from the Paterson Institute for Cancer Research in Manchester, UK in the laboratory of T. Michael Dexter, FRS and conducted her postdoctoral research at Harvard in the laboratory of T Keith Blackwell.  She joined Amgen in 2001 working on normal and malignant hematology initially, transferring to broader cancer biology and finally to immuno-oncology (IO) with a large emphasis on T cell redirective therapies;specifically BiTE molecules.  In 2013 she joined Pfizer to become involved with large molecule IO including the Pfizer T cell redirection programs and led diligence to look for a CAR T collaboration partner.

Adrian Bot
Vice President of Translation
Kite, a Gilead Company

Adrian Bot, M.D., Ph.D. is the Vice President of Translational Medicine at Kite, a Gilead Company, developing genetically engineered cell products for oncology indications. Dr. Bot obtained his M.D. in Romania in 1993 and his Ph.D. in Biomedical Sciences at Mount Sinai School of Medicine in New York in 1998.  Subsequently, he was a Guest Scientist at the Scripps Research Institute in La Jolla. Prior to his appointment as Chief Scientific Officer at Kite Pharma in 2011 and then Vice President of Translational Medicine, Dr. Bot served in various senior R&D management positions at MannKind Corp and Alliance Pharmaceutical Corp.

Aiman Shalabi
Vice President R&D
GlaxoSmithKline

Aiman Shalabi is a global executive with over 20 years’ experience in developing and commercializing new medicines for patients with cancer.  He currently leads the global development program for an adoptive cell therapy targeting solid tumors at GSK (NY-ESO TCR-T) that has achieved FDA Breakthrough and EMA PRIME designations.    Previously Aiman was the Global Vice President at AstraZeneca leading the development team for durvalumab (anti-PDL1) from pre-clinical through phase III and then led the global medical affairs program to support the pre-launch of durvalumab.  At MedImmune he led other IO programs such as the in-licensing and development of Tremelimumab (CTLA-4 from Pfizer) and OX40.  Aiman is a leading advocate for external clinical/academic collaborations, and previously contracted with the Cancer Research Institute (CRI), the Canadian Cancer Trials group and the Harvard Business school to drive philanthropic support of academic clinical innovations. Aiman entered the pharmaceutical industry after a successful career at the US National Institute of Health, National Cancer Institute (CTEP, PMB) where he managed a portfolio of 26 agents and led the NCI compassionate use program.  He received a national award for providing patients with access to breakthrough medicines for leukemia (Gleevec) and breast cancer (Herceptin) prior to FDA approval. Aiman has five university degrees including a Doctor of Pharmacy (USC) and an MBA (Johns Hopkins University).

Alfonso Quintas-Cardama
Chief Medical Officer
TCR2 Therapeutics

Dr. Quintás joined TCR2 in 2017 as Chief Medical Officer. He brings nearly two decades of experience leading clinical strategy and regulatory filings for multiple oncology therapeutics resulting in market approval. Dr. Quintás was the clinical development head of the Cell & Gene Therapies Unit at GlaxoSmithKline where he was responsible for the full clinical development strategy, execution and collaboration with Adaptimmune on affinity enhanced T-cell therapies. Previously, he served as Global Clinical Leader of Novartis’ now approved Kymriah™ (tisagenlecleucel) CTL019 program and was an Assistant Professor in the Department of Leukemia at MD Anderson Cancer Center. Dr. Quintás earned his MD from the Universidad de Santiago de Compostela School of Medicine in Spain. He completed an internship and residency in the Department of Medicine, Albert Einstein College of Medicine in New York and a Hematology and Oncology fellowship at The University of Texas, MD Anderson Cancer Center.

Ali Mohamed
Vice President of CMC
Immatics

Ali Mohamed, PhD, Vice President, CMC, Immatics US Inc. Formerly the senior director of manufacturing operations/ manufacturing development at Caladrius PCT (Now Hitachi Chemical Advanced Therapeutics Solutions). Dr. Mohamed has nearly 20 years of experience in process development and GMP manufacturing of regenerative medicine, cell and gene therapy products at various CMOs and clinical stage companies including Lonza, Osiris Therapeutics, and AlloCure. The speaker holds a PhD in Molecular Pharmacology from Medical College of Ohio and postdoctoral fellowship in neuroscience and neurobiology from the Georgetown University.

Andrea Moore
Director of Analytical Development
Tmunity Therapeutics

Andrea Moore is the Director of Analytical Development at Tmunity Therapeutics.  After joining the team in July 2018, Andrea has been leading the development of all core analytical functions for Tmunity including product characterization and functional assessment strategies.  Previously, Andrea was the Associate Director of the Analytical Development group at WuXi Advanced Therapies, where she led an integrated team to develop novel assays for a wide variety of cell and gene therapies. 

Andrea earned her bachelor’s in Biology from King’s College in Wilkes Barre, PA and her Ph.D. in Microbiology and Immunology from Temple University.

Angela Scott
Chief Operating Officer
TCBiopharm

Angela Scott has 40 years’ hands on experience in cancer research and commercial cell/gene therapy. Originally with the Imperial Cancer Research Fund (Edinburgh), Angela became a key member of the ground-breaking team that cloned ‘Dolly the Sheep’. More recently Angela had a major role at AngelBio, establishing its reputation in the field of innovative cellular therapies. During her tenure, Angela contributed to clinical transition of several cell therapy products from the bench to bedside. As founder, Chief Operating Officer and Board member of TC BioPharm, Angela has wide ranging responsibilities – directing new product development, GMP manufacture of clinical product (to treat cancer patients), QA/QC; clinical, regulatory, business development and finance functions. Angela has advised the UK Government on stem cell policy and practice and is regarded as a KOL cell-based product translation.

Ann Ranger
Senior Director of Translational Medicine
Unum Therapeutics

Dr. Ann Ranger is Senior Director of Translational Medicine at Unum Therapeutics, where she is responsible for the development and execution of biomarker strategies across clinical studies. Prior to joining Unum, Ann was with Biogen for 12 years, where she led multiple programs spanning from early drug discovery to translational research and biomarker development for clinical studies. She received her PhD in Immunology from Harvard University and post-doctoral training at the Dana-Farber Cancer Institute. Her work has resulted in 29 publications and 5 patents.

Andrew Hobbs
Managing Director
Huron

Andrew is a managing director in Life Sciences, which specializes in developing integrated thinking and innovative solutions across market access, commercial strategy, safety, and digital areas. He has a broad understanding of most aspects of the pharma business model with a particular interest in global value strategy, market access, and customer centricity in the delivery of improved patient outcomes.

Blake Aftab
Vice President of Translational Science
Atara Biotherapeutics

Blake T. Aftab, PhD is Vice President and Head of Preclinical Science and Translational Medicine at Atara Biotherapeutics. Dr. Aftab leads cell therapy discovery, research, and translational evaluation for off-the-shelf cell therapies covering oncology, infectious disease, and autoimmune conditions. Dr. Aftab has over 15 years experience in academic, biotech and pharmaceutical industries developing multiple therapeutic modalities including small molecule, biologics, antibody-drug conjugates and cell therapies. Dr. Aftab conducted his doctoral training in Pharmacology and Drug Development at The Johns Hopkins University School of Medicine and received his Bachelors in Pharmacology and Drug Discovery from The University of California, Santa Barbara.

Bradley Wolff
Head of West Coast Life Sciences
Citi Corporate and Investment Banking

Bradley Wolff is a Managing Director, Head of West Coast Life Sciences, at Citigroup and is primarily focused on the Life Sciences Sector. Mr. Wolff joined Citigroup from Bank of America Merrill Lynch where he was also Head of West Coast Life Sciences. Mr. Wolff’s investment banking career spans over two decades; he began his career in the 1990’s as an M&A advisor and subsequently joined Merrill Lynch’s Global Healthcare Group in 2003. In 2009 he spent one and a half years at Leerink Partners before rejoining Bank of America Merrill Lynch in 2011. Mr. Wolff advised and executed over 100 transactions across the pharmaceutical and biotechnology industries. These transactions covered the full spectrum of strategic advisory assignments including mergers & acquisitions, partnering, divestitures, spin-offs, and restructurings as well as debt and equity financings. Mr. Wolff received a BA from University of Minnesota and an MBA from UCLA Anderson School of Management.

Brian Burke
Head of Strategy
Horizon Discovery Group

Brian joined Horizon in 2012 during which time he has led various functions including Sales, Business Development and Product Management.  Much of his career has been focused in driving both the NGS and gene editing revolutions, most notably in the fields of diagnostics and bioprocessing.  In 2018 he was promoted to the Global Head of Strategy and now leads Horizon’s Corporate Development efforts including strategy development and M&A.

Bruce Levine
Founding Director - Clinical Cell, Vaccine Production Facility
University of Pennsylvania

Dr. Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, is the Founding Director of the Clinical Cell and Vaccine Production Facility (CVPF) in the Department of Pathology and Laboratory Medicine and the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania. He received a B.A. (Biology) from Penn and a Ph.D. in Immunology and Infectious Diseases from Johns Hopkins. First-in-human adoptive immunotherapy trials include the first use of a lentiviral vector, the first infusions of gene edited cells, and the first use of lentivirally-modified cells to treat cancer. Dr. Levine has overseen the production, testing and release of 3,000 cellular products administered to >1,100 patients in clinical trials since 1996. T lymphocytes from HIV+ subjects have been rendered resistant to HIV infection and reinfused. T lymphocytes from cancer patients have been redirected with chimeric antigen receptors (CAR's) to hunt and destroy their malignancies. This therapy, developed by the CVPF and licensed by Novartis, recently became the first FDA approved gene therapy (Kymriah). Dr. Levine is co-inventor on 23 issued US patents and co-author of 140 publications with a Google Scholar citation h-index of 71. He is a Co-Founder of Tmunity Therapeutics, a spinout of the University of Pennsylvania. He has been interviewed by the NY Times, Wall Street Journal, Time Magazine, National Geographic, Forbes, BBC, and other international media outlets.

Cheng Liu
Founder and CEO
Eureka Therapeutics

Dr. Cheng Liu is our founder and CEO. Prior to founding Eureka, Dr. Liu was a Principal Scientist in antibody drug discovery at Chiron (now Novartis), where he championed anti-CSF1 antibody program for treatment of bone metastasis to human clinical trials. He is the inventor of multiple issued US patents in drug discovery. In 2007, he was awarded Special US Congressional Recognition for his contributions to improving human health. Dr. Liu received his B.S. in Cell Biology and Genetics from Beijing University and a PhD in Molecular Cell Biology from the University of California, Berkeley.

Day Two

Thursday 13th December 2018

10:00 am | Late Breaking Abstracts- Update on Eureka’s Ongoing Liver Cancer Solid Tumor Study

Chris Baldwin
Director, Supply Chain, Cell and Gene Therapy
GlaxoSmithKline

Chris Baldwin is the Supply Chain Director for Cell & Gene Therapy Products at GSK and is accountable for the vein to vein supply chain for T-Cell Immuno-Oncology products covering a network of apheresis collection centers, manufacturing sites and treatment centers. His team covers managing inventory, logistics, labelling, tracking, site on-boarding and coordinating the cellular supply chain across sites. In previous roles, he has lead teams to design and build supply chains for complex biological products including mRNA vaccines, Biosimilars and Antibody Drug Conjugates. Chris holds a PhD from University of Cambridge and a Masters from University College, London.

June Lu
Director of Translational Research
Endocyte

June Lu has a PhD degree in Chemistry from Purdue University under Dr. Philip Low, Ralph C. Corley Distinguished Professor of Chemistry.  Dr. Lu joined Endocyte in 2000 and has been diligently working in the area of cancer immunotherapy, targeted drug delivery, autoimmune/inflammatory diseases, immuno-oncology, CAR T-cell therapy, and translational research.  Her multi-disciplinary project leadership experiences in IND-enabling drug development earned her 25+ publications (17 first-author, 2 clinical) and multiple patents/patent applications.  Dr. Lu has been an active member of the AACR since 2006 and currently holds the position of Director of Translational Research at Endocyte, a AAA/Novartis company.

Christopher Wiwi
Senior Director, CAR T Technical Commercialization Lead
Celgene Corporation

Chris Wiwi currently serves as the Technical Commercialization Team lead for bb2121, Celgene’s 1st in class anti-BCMA CAR T product for patients with relapsed refractory multiple myeloma. His team is responsible for ensuring a successful global launch of bb2121, in collaboration with Celgene’s partner, bluebird bio. Chris has worked on the bb2121 program since its inception, in both functional leadership and team leadership roles. Most recently, he served as the CMC team lead, where he was responsible for all CMC aspects of bb2121 from IND phase to global registration. Under Chris’ leadership, the bb2121 team initiated clinical development in the United States, Europe, Canada and Japan, and recently completed enrollment for bb2121’s global registration study, KarMMa-1. Previously, Chris was head of Analytical Research & Development for Celgene’s cell therapy organization, where he built and led the analytical development, validation and QC teams that were responsible for the advancement of multiple novel cellular therapy and biomaterials candidates from research to clinical manufacturing. Chris is a recognized leader in the cell therapy field internally and externally. He is a graduate of Celgene’s accelerated leadership program (Catalyst) reserved for top talent across the organization. Chris is very active in coaching and mentoring staff and was recently nominated for Celgene’s Mentor of the Year award. Chris is regularly invited to speak at external conferences, serves on the board of directors for the Standards Coordinating Body and has been active in the Alliance for Regenerative Medicine. Prior to joining Celgene, Chris worked in biologics at Schering-Plough and Merck as a leader in large molecule analytics. Chris received his B.S. in Biology from the University of Notre Dame, his Ph.D. in Cell and Molecular Biology from Boston University, and carried out postdoctoral work at Johnson & Johnson.

Claire White
Nurse Navigator for the Cancer Immunotherapy Program
The Children’s Hospital of Philadelphia

After working as a clinical oncology nurse for 5 years, Claire accepted and subsequently developed the role of a Pediatric Oncology Nurse Navigator within the Cancer Immunotherapy Program at The Children’s Hospital of Philadelphia (CHOP). She’s passionate about her role which focuses on all aspects of ensuring that patients around the globe are able to access both the experimental and commercially available chimeric antigen receptor T-cell therapies that are available at CHOP. She completed her Master of Science in Nursing with a focus in health leadership and nursing education from the University of Pennsylvania in May 2019. She is particularly interested in improving the way that patients access care and navigate the health system when managing their complex health issues. She is a member of the Academy of Oncology Nurse and Patient Navigators and currently serves on the clinical trials committee.  

Clark Eid
Director of Project Management, Therapeutics Production
St. Jude Children’s Research Hospital

Dr. Clark Eid is the Director of Project Management for the Department of Therapeutics Production & Quality at St. Jude Children’s Research Hospital in Memphis, Tennessee.  His department interfaces directly with Children’s GMP, LLC for the manufacture of biologic and Cellular and Gene Therapy (CGT) products.  Dr. Eid has over 25 years of drug development experience and utilizes project management, regulatory affairs skills, and cGMP/cGTP knowledge to help bring clarity to complex problems.

Colleen Dansereau
Director of Clinical Operations, Gene Therapy Program
Dana Farber Boston Children's Center for Cancer and Blood Disorders

Ms. Dansereau is an experienced pediatric hematology oncology registered nurse with an extensive background and experience in both clinical research and clinical operations, specifically in the area of gene and cellular therapies. She has developed an extensive research infrastructure that supports over 14+ gene therapy clinical trials using in vivo, ex vivo and gene editing strategies at Boston Children’s Hospital. She is responsible for providing leadership for development of operational strategies, planning and readiness for introducing newly FDA approved commercial gene therapies into the clinical setting at Boston Children’s Hospital.

David Barrett
Pediatric Oncologist
The Children’s Hospital of Philadelphia

Dr. Barrett graduated from Princeton University with a BA in Ecology and Evolutionary Biology in 1995. He first completed a Master of Science in Biomedical Engineering in 1997 before going on to complete his combined MD/PhD (Molecular Biology and Genetics) at Virginia Commonwealth University in 2004.  He moved to the Children’s Hospital of Philadelphia for his residency in pediatrics (2007) and his fellowship in pediatric hematology/oncology (2010). He is currently an Assistant Professor in Pediatrics at the University of Pennsylvania and an attending physician in the Children’s Hospital of Philadelphia Division of Oncology, Cellular Therapy and Transplant Section.

David Sourdive
Executive Vice President, Technical Operations & Co-founder

David Sourdive, Ph.D., is a co-founder of Cellectis and joined the Board of Directors in 2000. Dr. Sourdive holds the position of Executive Vice President, Technical Operations, with the mission to develop the Company’s industrial and technological basis as well as to deploy its operations in the pharmaceutical arena. Dr. Sourdive combines a strong scientific expertise with experience in managing industrial programs bringing innovative technologies to industrial fruition. He served as Executive Vice President, Corporate Development, from 2008 to 2016. In addition to his role at Cellectis, Dr. Sourdive has also served on the board of directors of the Mediterranean Institute for Life Sciences. David Sourdive graduated from École Polytechnique, received his Ph.D. in molecular virology at Institut Pasteur and completed a research fellowship in the Emory University Department of Microbiology and Immunology. His management training is from the HEC (Challenge +) and his decade-long experience in industrial program management was acquired at the French Department of Defense (DGA) prior to Cellectis’ inception.

Deborah Liben
Executive Director
Celgene

Deborah Liben began her career as outside counsel at Kaye Scholer LLP (now Arnold and Porter LLP) representing pharmaceutical companies in litigation involving off-label promotion and kickbacks allegations.  After nearly a decade, Deborah joined the in-house legal team at Novartis Pharmaceuticals Corporation where she served as a strategic legal advisor for multiple hematology and oncology products and led the U.S. legal support for the first FDA-approved CAR T cell therapy.  Deborah is currently Executive Director, Senior Corporate Counsel at Celgene Corporation, where she is the lead lawyer for Celgene’s CAR T cell therapy programs with bluebird bio and drives the legal strategy for various unique projects in preparation for commercialization.

Devon Shedlock
Vice President - Preclinical Development
Poseida Therapeutics

Dr. Shedlock has extensive experience in the field of T-cell immunology and was formerly associate director of the T-Cell Engineering Laboratory and adjunct assistant professor and at the University of Pennsylvania. Prior to this work he developed numerous vaccines from the preclinic to clinical trials, including those targeting herpes viruses and Ebola. His work also focused on developing vaccine animal models, molecular adjuvants, genetic optimization strategies and advanced delivery technologies. Previously, he studied antibody-mediated neutralization of Ebola as a postdoc at the Vaccine Research Center at NIH. He received his Ph.D. from UPenn investigating the role of T-cells in the generation of immunity.

Derrell Porter
SVP, Global Commercial Head
Atara Biotherapeutics

Derrell D. Porter, M.D. serves as SVP, Global Commercial Head at Atara Biotherapeutics, with responsibility for worldwide commercial operations. Previously Dr. Porter was Vice President with Gilead Sciences, where he led launch preparation for eight global brands including Sovaldi, Harvoni, Zydelig, and Genvoya, and enhanced the company’s overall commercial strategy and planning capabilities, including construction of a global pricing and market access function as well as developed cross-TA competitive intelligence capabilities. He holds a B.S. from UCLA, an M.D. from University of Pennsylvania's Perelman School of Medicine where he was a Gamble Scholar, and an M.B.A. from The Wharton School.

Dong Geng
Senior Director of Non-clinical Development
Legend Biotech

Dong Geng got her Ph.D. in Biochemistry from Boston College. She has 20 years of drug development experiences in biotech and pharmaceutical companies such as J&J, BMS, ImClone and Merck. She has supported 7 successful BLA and numerous IND submissions as functional lead. She has worked with various modalities including mAb, bispecific biologics, vaccines and cell therapies. Currently she is the senior director of Legend Biotech, and responsible for preclinical safety assessment as well as translational bioanalytical and biomarker.

Doug Danison
Vice President - Market Access, Value & Evidence Strategy
bluebird bio

Doug has more than 18 years of Pricing & Market Access experience including roles with Eli Lilly & Company, AMGEN, Millennium/Takeda Oncology and now bluebird bio.  In that time, he has led or overseen the preparation of market access strategies for products in early development, pivotal study planning, launch, and post launch lifecycle management.  He’s addressed market access challenges from a variety of vantage points including Global, European Regional, and US roles.  He’s built teams, processes, and a knowledgebase to help firms execute market access strategies that anticipate and meet the needs of access decision makers. Doug joined bluebird bio in July 2015 to establish the global pricing, market access, and health economics team known as Access Value & Evidence Strategy (AVES).  He leads bluebird’s pricing, market access and value demonstration efforts including oversight of the Global, US, and European teams.

Elena Spanjaard
Global Head of Regulatory Affairs
Celyad

Elena Spanjaard is the Global Head of Regulatory Affairs at Celyad.  Elena is responsible for the global regulatory strategies for Celyad’s autologous and allogeneic CAR-T product pipeline in development for hematological malignancies and solid tumors.  Trained in immunology, she earned her PhD from Boston University School of Medicine and completed her post-doctoral training at Dana-Farber Cancer Institute.  Elena has developed regulatory strategies for cell and gene therapies, biologics, and small molecules in a wide range of disease indications with a special focus in immuno-oncology and T cell therapies.

Elizabeth Olson Hexner
Associate Professor Of Medicine
The University Of Pennsylvania

Dr. Hexner is an Associate Professor of Medicine at the University of Pennsylvania. She is a physician in hematologic malignancies and cellular therapies/transplantation, and she serves as Medical Director of the Center for Cellular Immunotherapies, involved in protocol development across engineered T cell products from Penn and oversight of safety. She went to medical school and did her medical training at Columbia University, and fellowship training at Penn. She is also the Director of the Penn MPN program and Associate Director of the Masters in Translational Research program.

Eric von Hofe
President
AffyImmune Therapeutics

Dr. von Hofe has over 25 years of experience in biotechnology, focused primarily on cancer, immunotherapy and technology development. Prior to joining AffyImmune Therapeutics, he held positions at Antigen Express, advancing an immunotherapeutic for breast and prostate cancer, and at Millennium Pharmaceuticals developing novel therapeutics and disruptive technologies. Previously he was Assistant Professor of Pharmacology at the University of Massachusetts Medical School and was a postdoctoral fellow at the University of Zurich and

Frederic Lehmann
Vice President Clinical Development & Medical Affairs
Celyad

Dr. Lehmann has more than 20 years of industry and academic leadership experience in early clinical development of cancer vaccines and engineered T cell therapies, and highly experienced with enabling translational technologies. Before leading the clinical development program of CAR-T cell therapies at Celyad, Dr. Lehmann served as Vice President, Head R&D and early clinical development cancer vaccines at GSK Vaccines, where he established a global team focused on integrating translational science into drug and biomarkers discovery with early clinical development to improve the speed and probability of success of novel cancer immunotherapies in alignment with GSK business strategy.
He went on to lead the company’s approximately 70-person research organization. During his biotech industry career, he oversaw the opening of multiple INDs for first-i- class CAR-T cell therapy (autologous and allogeneic) and cancer vaccines products. Prior to GSK Vaccines, Dr. Lehmann was acting as lead medical oncologist at the Phase I Unit of the Institute Jules Bordet (Brussels) and earned his postgraduate training at the Ludwig Institute for Cancer Research (Brussels) with Pr. Thierry Boon to further advance the characterization on genes coding for tumor antigens recognized by human cytolytic T lymphocytes and targets for cancer vaccines. Dr. Lehmann earned his medical internship, oncology master degree and postgraduate training in cancer immunology from the Catholic University of Louvain.

Gwendolyn Binder
EVP of Science & Technology
Cabaletta Bio

Dr. Binder is an accomplished leader in the development of engineered T-cell therapies. Before Cabaletta, she served as CTO for Adaptimmune, developing TCR-engineered T-cells for oncology, where she led research and in prior roles established and led the manufacturing and quality teams, and the translational research group.  As the Director of Translational Research Operations at UPenn, she oversaw multiple IND submissions for novel engineered T-cell therapies in HIV and oncology.  As Director of Scientific Affairs at VIRxSYS, she supported the development of the first clinical lentiviral vector.  Dr. Binder earned her Ph.D. from Johns Hopkins in Cellular and Molecular Medicine.

Hans-Peter Gerber
Senior Vice President & Chief Scientific Officer
3T Biosciences

Hans-Peter has over 20 years of research and development experience in oncology, including antibody-drug conjugates (ADCs), redirected T-cell targeting compounds and adoptive T-cell therapies. He has been leading Pfizer’s Bioconjugates division as CSO, overseeing Pfizer’ s efforts in ADC sand, redirected T-cell targeting and nanoparticle development. He previously held senior leadership positions at Seattle Genetics and Genentech. Hans-Peter is currently CSO and Senior Vice President at 3T Biosciences, where he is overseeing platform- and therapeutic program development of TCR-T and cancer vaccine therapeutics. He is a recognized leader in oncology drug development, spanning from target identification and validation, development of novel therapeutic modalities and companion diagnostics, regulatory filings and translational support for early clinical development. He has a proven track record in making initial contacts and to successfully execute external collaborations and licensing deals with academia and corporate partners. Hans-Peter is an internationally recognized leader in Oncology drug discovery and development, with a strong record of accomplishments in the field of targeted therapeutics. His work has led to more than eight IND filings for ADCs and bi-specifics, and contributions to BLA submissions of therapeutic antibodies (Avastin) and two ADCs (Mylotarg, Besponsa) in Oncology. He is an author on over 100 peer-reviewed published papers and inventor on over 15 patents in the field of Oncology drug discovery. Dr. Gerber is also a member of the board at NBE Therapeutics, an early stage ADC company located in Basel, Switzerland, developing ADCs with a unique and novel mechanism of action. Hans-Peter Gerber received an MS in Biochemistry and a PhD in Molecular Biology from the University of Zurich, Switzerland.

James Noble
Chief Executive Officer
Adaptimmune

James Noble has served as our full-time Chief Executive Officer since March 2014, and part-time CEO from July 2008 to March 2014, and is one of our co-founders. From July 2008 until March 2014, Mr. Noble was also CEO of Immunocore. Mr. Noble has 28 years of experience in the biotech industry.

He has held numerous non-executive director positions, including at CuraGen Corporation, PowderJect Pharmaceuticals plc, Oxford GlycoSciences plc, MediGene AG, and Advanced Medical Solutions plc. Mr. Noble is also Deputy Chairman of GW Pharmaceuticals plc (NASDAQ: GWPH).

Mr. Noble qualified as a chartered accountant with Price Waterhouse and spent seven years at the investment bank Kleinwort Benson Limited, where he became a director in 1990. He then joined British Biotech plc as Chief Financial Officer from 1990 to 1997. Mr. Noble was previously Chief Executive Officer of Avidex Limited, a privately held biotechnology company that was our predecessor, from 2000 to 2006. Mr. Noble holds an M.A. from the University of Oxford.

Janet Lynch Lambert
Chief Executive Officer
Alliance for Regenerative Medicine

Janet Lynch Lambert joined ARM in 2017 as the organization’s first CEO. With more than 25 years in public and private sector management, Janet most recently served as the Acting Head of Engagement for the All of Us Research Program at the National Institutes of Health and as head of the Outreach Office in the Office of the NIH Director. Prior to joining NIH, she was Vice President of Government Relations and head of the Washington office of Life Technologies, aiding the company in its growth from $300 million in annual sales to more than $3 billion.

Jamie Margolis
Director of Cell and Gene Therapy Operations
Be The Match BioTherapies

Jamie is the director of Cell and Gene Therapy Operations for Be The Match BioTherapies, and has more than nine years of experience managing the complexities of cellular therapies. Jamie and her team are responsible for ensuring the smooth operational delivery of products and services to cell and gene therapy clients, including supply chain management, development and management of collection networks, identifying and sourcing allogeneic donor cells, and regulatory compliance. She spent six years in patient case management supporting the operational needs of health care providers for stem cell transplant and troubleshooting unexpected disruptions that occur throughout the complex product delivery process. Jamie holds her Ph.D. in Molecular Biology and Genetics from the University of Minnesota.

Jason Krentz
Chief Technology Officer
Tmunity Therapeutics

Mr. Krentz has extensive technical leadership experience in the development and manufacturing of biologic and cell-based products at established and emerging pharmaceutical and biotech companies.  Most recently, Mr. Krentz was Vice President of Manufacturing Operations at Endo Pharmaceuticals where he was responsible for biologic and specialty implant manufacturing, supply chain and process development operations. Prior to Endo, he was Vice President of Technical Operations and Head of CMC Project Management at Auxilium Pharmaceuticals, responsible for global manufacturing and supply chain, technical development and alliance management activities. Prior to joining Auxilium, Mr. Krentz was Head of Technical Operations at Tengion, a clinical stage developer of autologous regenerative medicine therapies.

 

Earlier in his career, Mr. Krentz worked at Centocor/Johnson & Johnson where he held positions of increasing responsibility in process technical support roles and was head of upstream manufacturing operations at a large-scale mammalian cell culture facility. He holds an MBA from St. Joseph’s University and a BS in Materials Science and Engineering from the University of Michigan. 

Jean-Pierre Latere
Chief Operations Officer
Celyad

Jean-Pierre joined Celyad in January 2016 and is responsible for strengthening the organization and key processes in manufacturing, quality, program management, clinical operations and regulatory affairs. He started his career as a Research Associate at the Michigan State University in the US. Following that assignment, he moved to the Johnson & Johnson group where he held various positions, from Scientist to Senior Scientist. He then joined Cardio3 BioSciences in 2008 as Project Manager Delivery System and left the company in 2012 in the position of Senior Director Business Development. Prior to joining Celyad, Jean-Pierre served as Beauty Care and Healthcare Market Global Leader at Dow Corning. Jean-Pierre holds a PhD in Chemistry from the University of Liège, Belgium.

Jian Irish
Global Head of Manufacturing
Kite Pharma

Jian Irish has held various leadership roles over 25 years in the biopharma industry with the responsibilities for product development, launch, supply, and lifecycle management. Jian has served executive leadership roles in launching the cell therapy at Kite Pharma as the Global Head of Manufacturing and Senior Vice President of Supply Chain. Prior to Kite Pharma, she held Vice President Responsibility for Biologics Supply, Sourcing, Partnerships and Biologics Product Development at Sanofi. Jian also served executive leadership roles at Amgen in the JAPAC regional operations, Supply Chain, Manufacturing, and oncology CMC development.

Jian Irish earned her BS in Chemical Engineering from East China University of Science and Technology in China, MS and Ph.D. in Pharmaceutical Sciences from Chiba University in Japan, and MBA from the Anderson School of Management at University of California, Los Angeles.

Jim Beitel
Senior Vice President- Corporate Development
Fate Therapeutics

Mr. Beitel is SVP, Corporate Development, at Fate Therapeutics and is responsible for strategic growth initiatives including expanding the company’s induced pluripotent stem cell (iPSC)-derived cell therapy pipeline through corporate partnerships. Mr. Beitel has more than 20 years of experience in corporate development, strategy, sales and marketing, and finance in the life science industry.  Prior to Fate, Mr. Beitel held various leadership roles at Avanir Pharmaceuticals, Amgen, La Jolla Pharmaceutical Company, and Zacharon. Mr. Beitel holds a MBA from Harvard Business School and a BS in Engineering from the University of Kansas.

John Rossi
Director, Translational Medicine
Kite, a Gilead Company

John Rossi is currently a Director in the Department of Translational Medicine and leads all biomarker activities related to clinical development of Kite’s CAR T-cell pipeline. John joined Kite in February 2015, after spending 12 years at Amgen. At Amgen, John oversaw global biomarker development for a Phase III registrational trial in oncology (trebananib, AMG386) and other studies. At Kite, John has led the development of a biomarker strategy and has also built an effective translational team to support the clinical development of axicabtagene ciloleucel. John’s translational team has contributed directly to the US and European approval of this product.

Joseph Fraietta
Director, Solid Tumor Immunotherapy Research Laboratory
University of Pennsylvania

Dr. Joseph Fraietta is T cell biologist with expertise in tumor immunology. He has developed novel approaches for the treatment of cancer through genetic modification of T cells that contributed to the initiation of multiple clinical trials. Dr. Fraietta’s research efforts have been directed towards enhancing the specificity, persistence and efficacy of CAR T cells, developing mechanisms to render T cells resistant to the tumor microenvironment and improving the processes of engineering lymphocytes. His laboratory has been leading initiatives to interrogate cellular products for mechanisms of potency with the objective of predicting clinical responses to these therapies.

Joseph McGuirk
Division Director, Hematologic Malignancies and Cellular Therapeutics
University of Kansas Medical Center

Dr. McGuirk completed his residency at Yale, fellowship at Memorial Sloan Kettering Cancer Center and subsequently served as Associate Director of the Yale Stem Cell Transplant Program. He currently serves as Director for the Division of Hematologic Malignancies and Cellular Therapeutics at the University of Kansas Cancer Center and holds the endowed Schutte-Speas Professorship in Hematology-Oncology. Dr. McGuirk is currently a member of the ASBMT Board of Directors and Chairs the AACI National CAR-T initiative. He has worked in the field of hematologic malignancies for over 29 years and has published extensively in the areas of stem cell transplantation and cellular therapeutics. Additionally, Dr. McGuirk serves as the principal investigator of numerous clinical trials in both areas, and currently oversees 12 cellular therapy clinical trials, including two investigator initiated trials for which he holds an FDA IND.

Junxia Wang
Director of Analytical Development
Mustang Bio

Junxia Wang, is a Director of Analytical Development at Mustang Bio, a Fortress biotech for the development of CAR T cell therapy for oncology and stem cell therapy for rare diseases. She is responsible for strategic planning and execution of analytical activities for all clinical programs. She and her team are responsible for technology transfer and the development of lot release and characterization assays for clinical manufacturing of CAR T cell and stem cell products. Prior to Mustang Bio, she is an Associate Director of Immunosafety and Bioanalytical Development at Editas Medicine, responsible for the development and implementation of strategies for safety evaluation CRISPR/Cas9 programs across portfolio with a focus on immunogenicity. Prior to Editas, Junxia worked at Novartis, where she was a Fellow in Cell and Gene Therapy, Oncology Business Unit, a project leader in Technical Research and Development spearheaded exploratory analytical activities for biomarker discovery and led functional assay design and development to support process development, manufacturing and clinical development of CAR T-Cell immunotherapy. Before Novartis, Junxia was an Instructor at Harvard Medical School and an Associate Immunologist in Division of Rheumatology, Immunology and Allergy at Brigham and Women’s Hospital, where she conducted research on biomarkers/targets for Inflammatory Arthritis in human using CyTOF, human T cell immuno-phenotyping, classification of T cell effector and memory subsets with PD1 expression. Junxia received her Ph.D. in Pharmacology at Shanghai Institute of Materia Medica, Chinese Academy of Sciences.

Katy Rezvani
Professor - Melanoma Medical Oncology, Chief of Section Cellular Therapy
MD Anderson Cancer Center

Dr. Rezvani is Professor of Medicine, Director of Translational Research, Medical Director of the MD Anderson GMP and Cell Therapy Laboratory and Chief, Section of Cellular Therapy, Department of Stem Cell Transplant and Cellular Therapy, MD Anderson Cancer Center. Dr. Rezvani joined the faculty at the MDACC in 2012 from the Hammersmith Hospital in London, where she was Director of the allogeneic adult stem cell transplant program, Medical Director of the GMP facility and Director of the Transplant Immunology Research Laboratory. Dr. Rezvani has an active research laboratory program in transplantation immunology where the focus of her research group is to study the role of natural killer cells (NK) cells in mediating immunity against leukemia, and to understand the mechanisms of tumor-induced NK cell dysfunction. The goal of these studies is to develop strategies to enhance NK cell effector function against tumors by genetically engineering the cells to enhance their in vivo antileukemic activity and persistence. Dr. Rezvani has extensive laboratory experience in higher-order flow cytometry, CyTOF, various molecular biology techniques and xenograft NSG mouse models of NK immunotherapy. Her laboratory program in transplant immunology has led to the approval and funding of a number of Phase I/II studies of immunotherapy in patients with leukemia and lymphoma.

Kimberley Freeman
Vice-President, Commercial Planning
Adaptimmune

Kimberly Freeman is Vice President of Commercial Strategy and Planning at Adaptimmune LLC, a clinical stage biopharmaceutical company focused on development of T-cell receptor based adoptive T-cell gene therapy to treat cancer. She joined Adaptimmune in 2016 to lead global commercial strategy and market preparation for the successful development and launch of these novel therapeutics. She has specialized in oncology for over 25 years, working within the pharmaceutical industry in disciplines across research, clinical development, new product planning, marketing, market access and sales. Previously, she served as head of Oncology National Accounts at Boehringer Ingelheim Pharmaceuticals, where she launched their first oncology product and companion diagnostic. Prior to that, she spent 17 years at GlaxoSmithKline where she launched five unique oncology products, including treatments for solid tumors and hematologic malignancies, as well as supportive care agents. During her tenure at GlaxoSmithKline, she developed an expertise with respect to oral oncology therapies and the access, distribution and reimbursement of these products. Kimberly holds a Masters in Biology from Cornell University.

Kirstin Powel
Director – Product Quality
Novartis

Kirstin is currently global head of external quality operations for the Novartis Cell and Gene Therapy Unit, including quality responsibility for the overall supply chain from apheresis sites back to prescribing institutions as well as quality oversight for the CGT global contract manufacturing network. Kirstin joined Novartis in February, 2015. Prior to joining Novartis, Kirstin was employed by Lonza, AG in the Global Quality organization, with global quality oversight for biologics as well as cell and gene therapy products. Kirstin has had direct responsibility for cell therapy manufacturing and quality for over twenty years.

Knut Niss
Chief Technology Officer
Mustang Bio, Inc.

Dr. Knut Niss, Ph.D. has been Chief Technology Officer at Mustang Bio, Inc. since March 2018. He joined Mustang in March 2017 as Vice President of Operations, where he initiated and oversees the establishment of Mustang’s cell therapy manufacturing facility. Prior to Mustang, Dr. Niss was Cell Therapy Asset Leader at Biogen, where he oversaw CMC-related activities for gene-edited hematopoietic stem cell and lentiviral gene therapy programs for sickle cell disease and hemophilia, respectively. Earlier in his career, Dr. Niss was Senior Technical Project Leader at Novartis’ cell therapy manufacturing facility in Morris Plains, New Jersey, where he directed the transfer and implementation of the CTL019 process from Penn to Novartis. He also served as Senior R&D Program Manager at EMD Millipore, where he established processes for the large-scale expansion of adult and pluripotent stem cells. Dr. Niss began his career in senior research positions in Pfizer’s Regenerative Medicine and Immunology groups. He holds a Ph.D. in molecular biology from Humboldt University of Berlin, and an M.S. in microbiology from the University of Göttingen in Germany. Dr. Niss completed his postdoctoral research at Boston Children’s Hospital and the Dana-Farber Cancer Institute.

Kristen Sudol
Director - Vein to Vein Supply Chain & Chimeric Antigen Receptor
The Janssen Pharmaceutical Companies of Johnson & Johnson

Kristen Sudol is currently the Director of Vein to Vein Supply Chain for CAR-T within Janssen Supply Chain.  She joined the CAR-T team in April 2018 as the organization was being formed and is working on securing the logistics (transportation & material flow) as well as implementing the CoC / CoI system to support integrity of our material during the V2V process.  Kristen is also responsible to ensure that the Clinical Supply Chain is smoothly transitioned to support the movement of materials and patient experience in the Commercial setting for Janssen’s CAR-T.  She received her MBA from Rutgers University, focusing on Marketing & Strategic Management.  Her undergraduate degree is in Engineering from The College of New Jersey.

Laurence Cooper
Chief Executive Officer
Ziopharm Oncology

Laurence joined Ziopharm Oncology as chief executive officer in 2015 after Ziopharm and Intrexon Corporation together licensed technology for a non-viral approach for genetically modifying T cells from MD Anderson Cancer and the University of Minnesota. This technology is designed to reduce the cost and complexity of genetically modified T cells. Prior to joining Ziopharm, Laurence was a tenured Professor at MD Anderson with joint appointments in the Division of Pediatrics and Department of Immunology. There, he served as Section Chief of Cell Therapy at the Children’s Cancer Hospital and helped lead scientific efforts to develop new treatment approaches which pair genetic engineering with immunotherapies. He remains a visiting scientist at MD Anderson. Laurence has coauthored dozens of peer-reviewed journal articles, abstracts, and book chapters. He has initiated multiple trials under INDs infusing T cells and NK cells. He obtained his M.D. and Ph.D. degrees at Case Western Reserve University in Cleveland and he completed his training in Pediatric Oncology and Bone Marrow Transplantation at the Fred Hutchinson Cancer Research Center in Seattle.

Day One

Thursday 13th December 2018

9:00 am | Industry Leader’s Fireside Chat

Lawrence Lamb
Chief Scientific Officer
Incysus Therapeutics

Dr. Lamb was first to describe the association between relapse-free survival and gdT cell recovery in bone marrow transplant patients. For 26 years, most recently as Professor of Medicine and Director of the Cell Therapy Laboratory at the University of Alabama at Birmingham, Dr. Lamb developed the scientific support for gdT cell-based immunotherapies. Today, this work has brought us to the first clinical trials for allogeneic gdT cell therapy in leukemia patients undergoing haploidentical stem cell transplants and the first gene-modified gdT cell therapy for glioblastoma. Dr. Lamb currently directs clinical and translational research strategy and operations for Incysus Therapeutics.

Li Ren
Director - Chimeric Antigen Receptors T Cell, Chemistry, Manufacturing, Control & Technology Development
Celgene

Dr. Li Ren is a director in Celgene Cell Therapy Development and Operations. She oversees technology transfer of new cell therapy pipeline products to the GMP facility and provides technical support to GMP manufacturing & QC to enable clinical trials.  Dr. Ren has 13 years of experience building and leading cell therapy CMC teams, spanning process development, technology transfer, MSAT, and CMC leadership. She also led the development of multiple cell therapy products including mesenchymal-like stem cells, natural killer cells, HPV-specific T cells, and CAR-T cells.

Loren Wagner
Head, CAR-T Manufacturing Operations
Celgene Corporation

Loren joined Celgene in May 2018 as the Head of CAR T Manufacturing Operations.  In this role, Loren is responsible for the commercialization of Celgene’s CAR T assets, including the startup of their new commercial manufacturing facility in Summit, NJ.  Prior to Celgene, Loren was the Associate VP of Manufacturing Sciences at Allergan, where he was responsible for clinical manufacturing and quality assurance globally from 2006 to 2018.

Maksim Mamonkin
Assistant Professor
Baylor College of Medicine

Dr. Mamonkin is a faculty member at the Center for Cell and Gene Therapy, Baylor College of Medicine. The main research focus of his laboratory is studying the immunobiology of CAR-engineered T cells and developing adoptive cell therapies for hematologic malignancies. Dr. Mamonkin has developed and optimized for clinical evaluation CAR T cell platforms for T-cell malignancies and AML and serves as a PI on several clinical trials of CAR T cells at Baylor.

Mario Marcondes
Senior Director - Clinical Development
Nektar Therapeutics

Mario Marcondes M.D. Ph.D., is a global medical lead for NKTR-255 (IL15) and NKTR-262 (TLR7/8) at Nektar Therapeutics. NKTR-255 is being developed to address long-term effects and insure stem-like capacity of CAR-T’s. Prior to joining Nektar, he held several clinical development roles at Gilead. Preceding Gilead, he held appointments as Assistant Professor at the University of Washington (UW) and Associate Member in Clinical Research at the Fred Hutchinson Cancer Research (FHCRC) in Seattle, WA. Mario completed his dual PhD training in Experimental Pathology at UW/FHCRC.  Dr. Marcondes obtained his Medical Degree at University of Taubate, School of Medicine, Sao Paolo, Brazil.

Mark W. Sawicki
Chief Commercial Officer
Cryoport

Mark Sawicki brings 15 years of business development and sales management experience, having consistently delivered on corporate revenue and market share goals in the pharmaceutical and biotechnology industries. Sawicki was most recently the chief business officer at AAIPharma Services Corporation/Cambridge Major Laboratories Inc. Additionally, he has served in senior business development roles at CMC Biologics and Albany Molecular Research Inc. (AMRI), where he increased revenue at rates far outpacing industry standards. Sawicki holds a bachelor’s in biochemistry from the State University of New York at Buffalo and a Ph.D. in biochemistry from the State University of New York at Buffalo, School of Medicine and Biomedical Sciences. He also received graduate training at the Hauptman Woodard Medical Research Institute. Sawicki has authored a dozen scientific publications in drug discovery with a focus on oncology and immunology.

Martin Lachs
VP Project Management Oncology
ICON PLC

Dr Lachs heads up ICON’s Oncology and Hematology Project Management Group, lending operational and indication expertise across a group of nearly 40 international project management staff, dedicated to oncology drug development. After completing a PhD researching the role of extracellular matrix and cell motility factors related to breast cancer at the University of Manchester (UK), Dr Lachs worked in a post-doctoral position before embarking upon a career in the Bioscience and Clinical Development Industry. Dr Lachs managed a laboratory research team at Unilever Research Laboratories and for the last 18 years has held positions in the CRO industry both at larger full-service (including BRI international and Quintiles Inc.) focused on oncology clinical trials. Dr Lachs also headed the operational group at a London based Medical Imaging Core Lab., IXICO Ltd.

Michael DeRidder
VP, Medicine Commercialization Leader, Oncology Cell Therapy
GlaxoSmithKline

Dr. DeRidder is Global Head of Commercial Strategy for Oncology Cell Therapy, leading the commercial planning for GSK3377794, a TCR therapy against NY-ESO-1.  He also oversees commercial strategy for early internal and partnered programs, and contributes to the identification and evaluation of potential future partners.  Dr. DeRidder took on this role in early 2016, with the formal creation of the Oncology Cell Therapy Unit within the Oncology Therapy Area.  Prior to this, he led commercial strategy for various programs in oncology as well as other therapy areas.  Dr. DeRidder joined GSK in 2011 following 6 years as an Engagement Manager at LEK Consulting.  He holds a Ph.D. in Biomedical Engineering from the University of Pennsylvania and a BSE from Tulane University.

Matthew Spear
Chief Medical Officer
Poseida Therapeutics

Dr. Spear has been working in research and development for over 25 years. He received a B.A. degree from the Johns Hopkins University and an M.D. degree from Stanford University. Post-graduate training was in the Massachusetts General Hospital / Harvard University program. He has served as an Associate Professor on the faculty of the USC Keck School of Medicine, and the UCSD Medical School / UCSD Cancer Center where he managed a clinical practice, drug discovery/gene therapy research, and clinical trial programs for cancer. Dr. Spear led multiple oncology clinical development programs at Pfizer. He subsequently served as Chief Medical Officer and Senior Vice-President at Nereus Pharmaceuticals, followed by Head of Oncology and Head of Biotherapeutics at Sunovion Pharmaceuticals, then as a Vice-President at Incyte. He is currently Chief Medical Officer at Poseida Therapeutics developing multiple CAR-T cell and gene therapy products, and a CIRM CAR-T cell principal investigator. He has also served on NIH / NCI study section, CPRIT grant review panel, biotechnology and pharmaceutical advisory boards, IRB/SRC, and scientific journal editorial review committees related to cancer and gene therapy, as well as authoring numerous scientific papers and patent applications.

Michael Klichinsky
Co-Founder & VP, Discovery Research
Carisma Therapeutics

Michael developed CAR-macrophages for his doctoral thesis under the co-mentorship of Dr. Saar Gill and Dr. Carl June in the Center for Cellular Immunotherapies at the University of Pennsylvania. Michael’s expertise is in the intersection of immunology, synthetic biology, cancer immunotherapy, and translational pharmacology. Michael co-founded Carisma Therapeutics Inc in 2016. In his current role as VP of Discovery, he oversees the research efforts of the company. Michael previously earned a Doctor of Pharmacy degree from the University of Sciences in Philadelphia, and a PhD in Pharmacology from the University of Pennsylvania.  

Michael Werner
ARM Founder and Senior Policy Counsel
Alliance for Regenerative Medicine

Michael Werner is the co-founder & senior policy counsel of ARM as well as a Partner at Holland & Knight LLP. In these roles, Michael focuses on issues affecting biotechnology and pharmaceutical companies, medical research and research institutions, physicians and patients. Before joining Holland & Knight and founding ARM, Michael was president of The Werner Group, a Washington, D.C.-based firm that provided lobbying, regulatory, and bioethics consulting services for biotechnology and pharmaceutical companies, physicians, health plans, investors, and patient advocacy groups. Prior to founding The Werner Group, he was chief of policy for the Biotechnology Industry Organization (BIO), representing over 1000 biotechnology companies.

Miguel Forte
Chief Executive Officer
Zelluna Immunotherapy

Currently the CEO of Zelluna Immunotherapy and visiting Professor at the Lisbon and Aveiro Universities in Portugal. Currently also serving as Chief Commercialization Officer and Chair of the Commercialization Committee of the International Society of Cellular Therapy (ISCT). From February 2006 to January 2010 was VP of Global Medical Affairs at UCB. In 2004, joined Nabi Pharmaceuticals as the VP of Clinical, Medical and Regulatory Affairs in Europe. After several clinical, academic and regulatory positions in the public sector in Portugal and at the EMA, spent six years with Bristol-Myers Squibb in various positions including Country Medical Director, Executive Director of Infectious Diseases, Immunology and Dermatology and VP of International Medical Organization in Portugal and Belgium. Holds an M.D. from the Faculty of Medicine of the University of Lisbon, Portugal, and a Ph.D. in Immunology from the University of Birmingham, UK, an accreditation as Specialist in Infectious Diseases and a certificate on Health Economics of Pharmaceuticals and Medical Technologies (HEP). He is Fellow of the Faculty of Pharmaceutical Medicine of the RCP in the UK.

Paul Rennert
Chief Scientific Officer
Aleta Biotherapeutics

Paul Rennert is President & CSO of Aleta Biotherapeutics Inc., based in Natick MA. Aleta is developing transformative technologies for use in cellular therapeutics directed to the treatment of cancer. Paul's industry expertise covers bench to IND and clinical trial development of biological and small molecule drugs for oncology, autoimmunity, chronic inflammation and fibrosis, notably at Repligen Corp. and Biogen Inc. Since 2012 he has focused on building novel biotechnology companies and worked on the genesis of CoStim Pharmaceuticals with MPM Capital, joined with X-Chem Inc to spin out the asset-centric company X-Rx, founded Sugarcone Biotech LLC, and most recently, co-founded Aleta Biotherapeutics and Encipher Biotechnology. He is well known to the immuno-oncology community through his work with diverse biotech companies, academic centers and investors. His views on IO drug development strategy are widely followed on the sugarconebiotech.com blog, and through numerous invited talks. He has published and patented extensively; his most recent publication is the book "Novel Immunotherapeutic Approaches to the Treatment of Cancer".

Peter Hoang
CEO
Marker Therapeutics

Peter L. Hoang brings over twenty years of immuno-oncology, investment banking, venture capital, and public company executive management experience to Marker Therapeutics, Inc., serving most recently as President & CEO of TapImmune Inc. (Nasdaq: TPIV), one of the predecessor companies that merged to form Marker Therapeutics. He has also served as Senior Vice President of Business Development & Strategy at Bellicum Pharmaceuticals (Nasdaq: BLCM). Previously, as the Managing Director of Innovations at The University of Texas MD Anderson Cancer Center, he headed the new venture formation and development effort for the institution. There, he led the commercialization of MD Anderson’s Sleeping Beauty transposon-based CAR-T program, resulting in the largest public company-to-academic research institution upfront deal in history. Before joining MD Anderson, Mr. Hoang was a Managing Director and head of healthcare mergers & acquisitions advisory for CIT Group (NYSE: CIT). He also served as a senior investment banker in the M&A departments at Oppenheimer, J.P. Morgan, Merrill Lynch, and Deutsche Bank. He earned an M.B.A. with high honors distinction from the Anderson School of Management at UCLA and a B.A. from Yale University.

Peter Olagunju
Vice President of Patient Operations
bluebird bio

Peter is the Vice President of Global Patient Operations with bluebird bio. The Patient Operations function is the primary point of contact within CMC at bluebird bio for Centers of Excellence (COE) interfaces including the collection of patient cells, manufacture of drug product, and operational execution of patient treatments. Creating an optimized point of care experience for patients, providers, and stakeholders related to the treatment process. Prior to bluebird bio, Peter most recently served as Senior Director, Global Technical Operations at Valeant (through the acquisition of Dendreon).  He was at Dendreon for roughly 5 years where he managed the US and EU manufacturing operations and supply chain, including contract manufacturers, external testing sites, and the apheresis network for those regions. Prior to Dendreon, Peter had leadership positions within the quality function at a monoclonal antibody organization (ZymoGenetics) that was acquired by BMS in 2011. Peter did his undergraduate studies at the University of Illinois and completed an MBA program at the Foster school of Business (University of Washington).

Qiong Wang
Senior Director of R&D
Legend Biotech

Dr. Qiong Wang has joined Legend Biotech in July 2018 and is leading US R&D to broaden and strengthen Legend’s pipelines in cell-based immunotherapy. Qiong got her medical degree in China and then came to United States pursuing PhD degree in Infectious Diseases and Microbiology at University of Pittsburgh, in which she had mainly focused on human T cell immunity against Kaposi’s sarcoma in HIV-infected patients. After graduation, she followed her passion in immunology and oncology, became a postdoctoral fellow and subsequently held a permanent scientist position in Surgery Branch, NCI, one of the prestigious institutes in the field of cell-based immunotherapy. During her years at Surgery Branch, she had led and involved studies in understanding T cell immunity against clear cell renal cell carcinoma, pancreatic adenocarcinoma, and melanoma. She had identified T cells, isolated and generated TCRs/CARs against these malignancies using different technologies that eventually were tested in clinical trials. She has published multiple peer-reviewed articles and been granted several patents with her work at NCI. She then went to Astrazeneca/MedImmune and led the effort in building cell therapy platform before joining Legend Biotech.

Rajkumar Ganesan
Director of Antibody Engineering and Bispecifics
Janssen

Raj Ganesan received his Ph.D. at the University of Zurich, Switzerland.  Raj is a Protein/Antibody engineer with extensive industry experience (Genentech, MedImmune and Boehringer Ingelheim) in the Design, Development and Characterization of Monoclonal Antibodies, Multi-Specific Biologics and CAR-T. Since 2017, Raj is leading the pre-clinical discovery of biotherapeutics at Janssen R&D (Johnson and Johnson).

Rick Morgan
Senior Vice President of Immunogenetics
Editas Medicine

Currently I am Senior Vice President Immunogenetics, Editas Medicine, Cambridge, MA and serve on the Board of Directors of the American Society of Gene and Cell Therapy.  The majority of my career was spent in various role at the National Institutes of Health, Bethesda MD.  In 2013, I made the switch from academia to industry to lead the immunotherapy efforts at bluebird bio and recently moved to Editas Medicine to focus on gene editing applications in immunotherapy.  At Editas Medicine, my goal is to develop cellular treatments that go beyond standard TCR/CAR-based antigen targeting, to produce gene edited effector cells designed to function within the hostile tumor microenvironment.

Robert Ott
Director Quality Assurance and Regulatory
Children’s GMP, LLC

Dr. Robert Ott is the Director for Quality Assurance and Regulatory at Children’s GMP, LLC located on the campus of St. Jude Children’s Research Hospital in Memphis, Tennessee.  Dr. Ott has over 15 years of experience in biologics manufacturing and is responsible for oversight of the Quality Management Program.  Under his leadership, the Cellular and Gene Therapy (CGT) program was awarded accreditation from Foundation for the Accreditation of Cellular Therapy (FACT) as an independent processing facility.  

Sadik Kassim
CSO
Mustang Bio

Saul Priceman
Assistant Professor, Dept. of Hematology and Hematopoietic Cell Transplantation
City of Hope National Medical Center

Dr. Priceman is a tumor immunologist with expertise in T cell biology and cancer immunotherapy. He is deeply committed to rapidly advancing innovative immunotherapy approaches on behalf of patients with cancer, in part because of personal experience with family and friends who have struggled with the disease. As an Assistant Professor in the Beckman Research Institute of the City of Hope, Dr. Priceman is developing Chimeric Antigen Receptor (CAR)-based T cell immunotherapy for solid cancers, with a strong focus on metastatic disease in prostate, breast, and ovarian cancer. His current laboratory research focuses on clinically relevant metastatic cancer models to develop combination therapy strategies to improve the durability and potency of CAR T cells, and ultimately the overall immunotherapy response in solid tumors.

Sabine Chlosta
Chief Medical Officer
Triumvera Immunologics

Dr. Sabine Chlosta joined Triumvira as Chief Medical Officer in January 2018 and works on therapies with genetically modified T-cells for patients with liquid and solid tumors. Prior to Triumvira, Dr. Chlosta consulted for Aurora BioPharma, a start-up company developing CAR-T cells in solid tumors, and was previously Senior Medical Director at Merck & Co. where she played a key role in the development of their PD-1 inhibitor Keytruda® in Non-Hodgkin's Lymphoma and also oversaw trials in other indications. Earlier in her career, Dr. Chlosta was a Medical Director at Glycomimetics where she helped launch the company’s first trial in cancer. Dr. Chlosta started her career in industry as a Fellow in oncology drug development at Novartis overseeing clinical pharmacology trials with a small molecule and helped launch the CAR-T lymphoma program with Kymriah®. Dr. Chlosta is board-certified in pediatric hematology-oncology and in pediatrics. She completed post-graduate training in hematology-oncology at the combined program of Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College and in pediatrics at State University of New York at Downstate. Prior to entering clinical training in the United States, Dr. Chlosta was a visiting research Fellow in immunology at Harvard. Dr. Chlosta received her PhD degree in Immunology and Infectious Diseases and her MD degree from Charité Medical School Berlin.  

Scott Shoemaker
Senior Director of Operations
bluebird bio

Scott Shoemaker has 17 years of experience across the range of product life cycle from process development through in-line commercial supply including non-sterile and biologics processes.  In his current role as Senior Director of Manufacturing Operations, Scott has accountability for all external Lentiviral Vector manufacturing for the bluebirdbio product portfolio.  Previous roles with Merck Research Labs / Merck Manufacturing Division as well as Takeda’s Vaccines Business Unit included technical oversight of commercial processes, tech transfers and commercial launches, and new product filings.  Scott holds a bachelor’s (Drexel University) and PhD (Princeton University) in Chemical Engineering.

Shon Green
Director of Clinical Translation
Alitus Institute for Biomedical Sciences

Dr. Green received her training as a cancer biologist at UCSF where she developed and employed preclinical models of cancer to study therapeutic combinations. She utilized these expertise to drive the preclinical development of T cell-based immunotherapies at Eureka Therapeutics Inc., where she successfully guided two novel programs through preclinical proof-of-concept and safety studies to support investigational new drug applications and clinical testing. Currently the Director of Clinical Translation at Altius Institute for Biomedical Sciences, she leads the development of novel genetic and epigenetic editing tools to enhance cellular therapies for cancer and other unmet needs.

Sean Kevlahan
Senior Director, Cell and Gene Therapy
Bio-Techne

Sean Kevlahan, Ph.D. is the Senior Director of Cell and Gene Therapy at Bio-Techne. He is a product driven entrepreneur, specialist in cell biology, and domain leader in cell/gene therapy bioprocessing. Prior to his role at Bio-Techne, he was the CEO and co-founder of Quad Technologies, which was recently acquired by Bio-Techne. Dr. Kevlahan is a lead inventor of many patents and authored numerous publications utilizing Bio-Techne’s core QuickGel™ technology. Dr. Kevlahan holds a B.S in biochemistry from Hofstra University and received his Ph.D. in chemical engineering from Northeastern University.

Stefanos Theoharis
Senior Vice President, Corporate Development and Partnering
Cell Medica

Stefanos joined Cell Medica to lead our partnering activities, bringing a combination of academic, business development, project management and finance skills. Following his PhD, Stefanos worked as a post-doctoral researcher at Imperial College, whilst also worksing for six years in parellel as a paid consultant to the London Technology Network, a government-funded organization bridging the gap between industry and academia. Subsequently, Stefanos joined Lazard, the investment bank, as a member of the Life science M&A team and then Roche Partnering, as Director of Emerging Technologies, where he participated in multiple licensing deals, with a focus on novel innovative technologies. He then joined Antisense Pharma as Head of BD. Prior to joining Cell Medica, Stefanos was CBO for apceth in Munich, where he was responsible for business development on the company’s first-in-man engineered cell therapy platform and its GMP manufacturing business, as well as project management, and communications.

Stephanie Astrow
Senior Director, Translational Medicine
Kite, a Gilead Company

Dr. Astrow has served as Senior Director in Translational Medicine at Kite, a Gilead Company since April 2015, and has led the translational strategy for the company’s first two solid tumor programs in the clinic. She has over 15 years’ experience supporting oncology clinical programs with particular expertise in companion diagnostic development including tests for crizotinib, trastuzumab and cetuximab. Prior to Kite, she was Vice President of R&D at Response Genetics. Dr. Astrow received her PhD from the University of California, Berkeley followed by a Postdoctoral Fellowship at the University of Texas, Austin. She holds an MBA from Pepperdine University.

Steve Shamah
Head of Research
Obsidian Therapeutics

Dr. Steven Shamah joined Obsidian Therapeutics in September 2016 as Senior Vice President and Head of Research where he leads a dynamic team towards the discovery and development of next generation cell and gene therapeutics.  Previously, Steve served as Head of Scientific Operations for the Cell and Protein Sciences group at Juno Therapeutics and, prior to that, as VP of Cell Biology at X-Body Biosciences.  In addition, Steve has served in various management and scientific leadership roles at SRU Biosystems, Archemix, Hydra Biosciences and Phylos, with a particular focus on biologics discovery using in vitro display technologies.

Steve Kanner
Chief Scientific Officer
Caribou Bio

Steve is the Chief Scientific Officer of Caribou Biosciences responsible for R&D activities related to therapeutic discovery and development.  Before joining Caribou, Steve served in positons of increasing responsibility in both oncology and immunology/inflammation drug discovery at Bristol-Myers Squibb, Agensys, and Astex Pharmaceuticals, and was most recently VP, Head of Biology at Arrowhead Pharmaceuticals leading a department in discovery of RNAi therapeutics for oncology, genetic diseases and other indications.  Steve has authored over 80 publications in both peer-reviewed journals and books, and is an inventor on multiple patents and patent applications.  Steve earned his undergraduate degree in Genetics from the University of California, Berkeley, his Ph.D. in Immunology and Microbiology from the University of Miami’s Miller School of Medicine, and did post-doctoral work in oncology at the University of Virginia.

Steven Feldman
Director, Manufacturing and Development
Stanford School of Medicine

Dr. Steven A. Feldman was a Staff Scientist and Director of the Vector Production Facility at Surgery Branch, NCI for the past twelve years.  Dr. Feldman’s group was responsible for the development, characterization, and manufacturing of the viral vectors used in gene therapy clinical trials at the Surgery Branch.  Recently, Dr. Feldman joined the Stanford Center for Cancer Cell Therapy as Director of Manufacturing and Process Science where he will take a lead role in the development and manufacture of viral vectors and novel cell therapies for the treatment of cancer.

Thomas Andresen
Chief Scientific Officer
Torque Therapeutics

Dr. Andresen is Chief Scientific Officer and a co-founder at Torque. Prior to joining Torque, he held positions at the prestigious Technology University of Denmark (DTU), including Professor and Head of Department at DTU Nanotech and Head of the DTU Center for Nanomedicine and Theranostics. Dr. Andresen has founded several cancer medical technology and biotechnology companies in Europe focused on chemotherapy and radiation therapy and has pioneered multiple technologies that are in ongoing clinical trials. Dr. Andresen has more than 20 years of research and development experience in the fields of organic chemistry, biophysics, advanced materials engineering, and cancer biology and is an author on more than 100 research or review articles and multiple patent applications.

Tim Lu
Chief Executive Officer
Senti Biosciences

Dr. Lu is a pioneer in synthetic biology, and  an Associate Professor at MIT and received his MD/PhD from MIT and Harvard. He is a co-founder of Synlogic (NASDAQ: SYBX), Tango Therapeutics, Sample6, Eligo, BiomX, and Engine Biosciences. He has received the NIH New Innovator Award, the US President Early Career Award for Scientists and Engineers, MIT Technology Review’s TR35, Navy and Army Young Investigator Prizes, and others.

Tony Ho
Executive Vice President, Head of Research & Development
CRISPR Therapeutics

Dr. Tony Ho is Executive Vice President, Head of Research and Development at CRISPR Therapeutics over seeing development of allogenic CAR-T, hemoglobinopathy and regeneration medicine.  He was previously Senior Vice President and Head of Oncology Integration and Innovation at AstraZeneca. During his tenure at AstraZeneca, he oversaw both development and commercialization of the two key drugs – Lynparza, a first-in-class PARP inhibitor and Imfinizi (anti-PD-L1), AstraZeneca’s first immuno-oncology drug. Prior to joining AstraZeneca, Tony was the Neurology and Ophthalmology Clinical Section Head at Merck Research Laboratories, Merck & Co., Inc. and led multiple development programs including the approval of Maxalt for pediatric migraine and Zioptan for glaucoma. Prior to joining Merck, Tony was the Co-Founder and Chief Scientific Officer of Neuronyx, Inc., a regenerative medicine company. Tony completed his B.S. in Electrical Engineering at the University of California, Los Angeles, and received his M.D. from the Johns Hopkins University School of Medicine. After an internship in Internal Medicine at the Massachusetts General Hospital, Tony completed his residency and neurophysiology fellowship in the Department of Neurology at the Johns Hopkins Hospital. He was Assistant Professor at Johns Hopkins Hospital in the areas of neuropathy and neuromuscular diseases. Tony describing and elucidating the pathogenesis of a new disease called "acute motor axonal neuropathy (AMAN)". He has published widely in several fields with over 80 papers and is co-inventor of 14 patents. He is currently adjunct Associate Professor of Neurology at University of Pennsylvania and Assistant Professor (Part-time) of Neurology at Johns Hopkins University.

Vita Golubovskaya
Director R&D and Business Development
Promab Biotechnologies

Dr. Vita Golubovskaya is a Director of Research and Business Development at Promab Biotechnologies leading research on novel anti-cancer immunotherapies including CAR-T cell therapy. She has more than 20 years of experience in cancer research, oncology and immunology. Dr. Golubovskaya is an Adjunct Clinical Associate Professor, Department of Medicine, University of Oklahoma Health sciences Center, and previously was an Associate Professor at Roswell Park Cancer Institute and University of Buffalo, SUNY, Buffalo, NY. She holds Ph.D in Cell Biology and authored more than 80 publications, 20 patents and several book chapters.

William Ho
Chief Executive Officer
Incysus Therapeutics

William has 18 years of experience in the biotechnology and healthcare industries. He founded Incysus Therapeutics from AlephPoint Capital, a private healthcare focused investment manager which he launched in 2014. Prior to AlephPoint, Will launched the public investments and cross-over portfolio at New Leaf Venture Partners, a leading healthcare venture capital firm. He was a Senior Equity Research Analyst at Bank of America and an Analyst at Piper Jaffray & Company covering the biotechnology and life-science tools sectors. He was Institutional Investor's All-America Research Team Best Up-and-Comer in 2008. Earlier in his career, he led operational and financial analysis at CuraGen Corporation, one of the leading genomics era companies, where he restructured the company and was an Associate on the Healthcare Investment banking team at Cowen & Co. Will holds an MBA from the University of Notre Dame and a BS in Biochemistry, with honors from McMaster University in Canada.  

Yannick Bulliard
Director Translational Development
Immatics

In 2016, Yannick Bulliard joined Immatics US, Inc. as Director Product Science, where he established the Department’s core activities in process development, development of immunoassays and quality control. Since 2017, Dr. Bulliard is leading the translational development of ACTallo®, Immatics’ allogeneic cellular therapy platform based on γδ T cells. Prior to Immatics, Dr. Bulliard was a project lead for several preclinical assets in Immuno-Oncology at Amgen, CA. He obtained his Ph.D. from the EPFL, Switzerland and went on to pursue a postdoctoral fellowship at Novartis in Cambridge, MA.

Alireza Abazari
MSc, PhD, Scientific Applications Director
BioLife Solutions, Inc.

Dr. Abazari has a Ph.D. in Chemical Engineering from University of Alberta, Canada with further postdoctoral training at Massachusetts General Hospital and Harvard Medical School. He joined BioLife Solutions, Inc. in 2015, and is currently active in the International Society for Cell and Gene Therapy (ISCT), Parenteral Drug Association (PDA), American Association of Blood Banks (AABB), and the Society for Cryobiology, to name a few. He has also been a guest lecturer at Rutgers University and University of Washington bioengineering courses, and an invited member of the PDA Task Force for defining Cryopreservation Standards.

Amy Emmert
Vice President HSCT & Cellular Therapy Service Line Operations
Dana-Farber Cancer Institute

Amy Emmert manages the cellular therapies service line at Dana-Farber Cancer Institute, responsible for business development leadership and continuing advancement of Dana-Farber's stem cell transplantation and cellular therapeutics programs.  Ms. Emmert plays a global role in ensuring that quality and operational improvements, financial performance and regulatory support systems are implemented and coordinated across the sites of care.  Ms. Emmert has extensive experience in healthcare and medical research organizational development; introduction, implementation and socialization of new therapies; resource utilization and cost management in complex clinical service environments; and developing rational workflows to support effective resource management.

Claudia Zylberberg
Chief Executive Officer
Akron Biotech

Dr. Zylberberg is a biotech leader with more than 30 years in the field. She is the founder and CEO of Akron Biotechnology, a manufacturer of novel cGMP-grade products for the gene and cell therapy industries. She also co-founded AssureImmune, an adult stem cell bank, for personalized medicine. She holds numerous patents and peer-reviewed publication records. She has developed products to support the industry growth, like cryomedias and others. Dr. Zylberberg has several patent-pending technologies and grants through NIH and the Department of Defense. In early years, Dr. Zylberberg worked at Nabi Biopharmaceuticals, specializing in human plasma derived products. She is a board member of ISCT, the Alliance for Regenerative Medicine ARM, and the National Academy of Sciences (Regenerative Medicine Forum). Other advisory positions include ISO US TAG, BioFlorida, ISSCR, and Cord Blood Association.

Katherine B. Szarama
Evidence Development Division, Coverage and Analysis Group, Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services

Dr. Szarama joined CMS in 2016 as Social Science Research Analyst in the Coverage and Analysis Group of CCSQ. She led FDA-CMS Parallel Review of the National Coverage Determination for Next Generation Sequencing and leads the National Coverage Analysis on Chimeric Antigen Receptor (CAR) T-cell therapy. She also writes regulations implementing the Medicare Appropriate Use Criteria Program for advanced diagnostic imaging services and previously served the Center for Medicare and Medicaid Innovation (CMMI) designing payment models. Dr. Szarama is a recipient of the Hartwell Foundation Fellowship at St. Jude Children’s Research Hospital where she received post-doctoral training in cancer research.

Sanjay Srivastava
Senior Manager
Deloitte Consulting LLP

Sanjay Srivastava, Ph.D., is a senior manager and the lead for Deloitte's NextGen consulting practice, helping biopharma and biotech companies define and implement fundamentally new and transformative capabilities to develop, produce, and commercialize next-generation therapies. His project work centers around defining and implementing innovative R&D and commercial strategies to design value-added activities that optimize operations and deliver therapies to the market. Srivastava earned his Ph.D. in bio-organic chemistry from the University of Maryland with post-doctoral training at Johns Hopkins University and Cornell University with a focus on neurodegenerative diseases, such as Parkinson’s Disease.

Hussain Mooraj
Next Gen Therapy Practice Lead, Principal
Deloitte Consulting LLP

Hussain brings more than 25 years of experience in manufacturing, supply chain, enterprise technology, sales and marketing, and strategy consulting to his role. Hussain works closely with senior executives from global life sciences firms helping them transform their end-to-end businesses and build start-up organizations to be able to launch life-saving new therapies, especially on the CAR-T and gene therapy side. Hussain leads the Next Gen Therapy practice and is the New England regional lead for life sciences.

Jenna Balestrini
Cell Bioprocessing & Program Manager
Draper

I am equal parts research scientist and engineer. My specialties include the development of technologies to produce cell or cell-based therapies, engineering of artificial organs and disease models, programming cellular response, pathobiology of fibroblasts, mechanobiology and mechanotransduction, and cell-cell and cell-matrix interactions.

Nina Bauer
Chief Commercial Officer
FloDesign Sonics Inc

With more than 15 years’ experience in the Regenerative Medicine sector, Nina has held Business Development roles at the Cell Therapy Catapult (UK), and the University of Edinburgh, and worked as a Life Science Consultant for a wide range of Regenerative Medicine businesses. Most recently, she was the Head of Lonza’s Autologous Cell Therapy business, with manufacturing sites in the US and Europe. As part of this role, she was also in charge of leading the partnership with Octane Biotech, with the aim of establishing the Cocoon™ as a novel manufacturing technology to remove bottlenecks and enable commercially viable services for patient-scale therapies.

Steven Lynum
Executive Director
PHC Corporation

Steven’s work focuses on OEM relations, medical device management, pharmacy automation, BioPharm, stem cell, and regenerative medicine fields. He works closely with world renowned key opinion leaders and pharmaceutical company senior management to find new market opportunities for Panasonic Healthcare. Concurrent with this role, he serves as a corporate officer, as Corporate Secretary and Member of the Board of Directors for Panasonic Healthcare Corporation of North America, and from October 2015 concurrently as Vice President & Officer of Ascensia Diabetes Care US, Inc.

Day Two

Thursday 13th December 2018

11:00 am | Technology (and) Innovation to Support the Global Scale-up Challenges on the Horizon

Kent Thorup
Regional Vice President
Quick Group of Companies

Kent Thorup, Regional Vice President of Business Development for the Quick Group of Companies, has over 38 years of experience in global logistics planning for time-critical, temperature-sensitive and urgent materials. He focuses on developing customized solutions for his clients in the life science and healthcare communities, ensuring product integrity and patient safety. With the advent of Cell and Gene Therapy and Immunotherapy, precision logistics has become a key consideration as pharmaceutical and biotechnology companies carefully design their clinical and commercial manufacturing processes. Kent provides leading companies throughout the world with logistics expertise, supply chain planning and turn-key logistics solutions.

Jim Freeth
Co-managing Director
Retrogenix

Dr Jim Freeth is Co-managing Director of Retrogenix having jointly founded the company in 2008. Prior to this, Jim spent 10+ years in management within the biotech (Oxford BioMedica) and pharmaceutical industry (AstraZeneca). A biologist by training, Jim obtained his PhD at Manchester University, UK, in 1997. Jim has a thorough understanding of the drug discovery process and its key challenges and has had a long-standing involvement in phenotypic drug discovery and target deconvolution. He has contributed to several high impact peer-reviewed scientific publications and is regularly invited to speak at international conferences.

Debiprasad Roy
Head of R&D Systems, Analytics and Programming
Allogene Therapeutics

Debiprasad (Debi) Roy is an innovation leader and influencer with extensive expertise in data analytics, digital platforms and technical operations for life sciences' research including data science, process improvement, product strategy, validation, governance, budgeting, systems implementation, clinical data standards, data management and bioinformatics. He has served as Business Process Owner and implementation lead for Clinical Data Lakes, Big Data platform, Digital Solutions, Veeva Product Suite, LIMS systems, Electronic Notebook integrations, CTMS, Safety Database (Argus), Spotfire, Analytics applications, and Biometrics Applications. He is currently involved in the exploration, business strategy and implementation of emerging technology including AI, BlockChain, and IoTs.

Dobri Kiprov
Medical Director & Senior Vice President
Fresenius Medical Care North America

Dr. Kiprov is the Medical Director and Senior Vice President of Fresenius Apheresis Services . Dr. Kiprov is the first physician to be Board Certified in Hemapheresis. He served two terms on the Board of Directors for the American Society for Apheresis (ASFA) and he received the ASFA Presidential Award and the ASFA Lecturer’s Award for his pioneering work and educational efforts in the field of therapeutic apheresis. Dr. Kiprov has written more than 100 scientific papers on the subject.

Elsy Boglioli
Chief Operating Officer
Cellectis

Elsy Boglioli joined Cellectis in December 2017 as Executive Vice President, Strategy and Corporate Development. Elsy has been named Chief Operating Officer in March 2018. Prior to joining Cellectis, Elsy worked at the Boston Consulting Group (BCG) where she served as Partner and Managing Director, and leader of BCG’s biotech-focused business in Europe. Ms. Boglioli has far-reaching expertise within the pharma and medtech industries, focusing on everything from corporate strategy and M&A to research. At BCG, she was also a member of the global biopharma leadership team and global strategy practice management team and served as regional head of the strategy practice for Europe. Ms. Boglioli graduated from Ecole Polytechnique in Paris, France and holds a master’s degree in economy and management from Pompeu Fabra University in Barcelona, Spain.

Franco Marincola
Chief Science Officer
Refuge Biotechnologies

Dr. Marincola is Chief Scientific Officer at Refuge Biotechnologies, Menlo Park, California. He was previously Distinguished Research Fellow at AbbVie Corporation; Chief Research Officer at Sidra Research, Qatar; Tenured Investigator at the National Institutes of Health, Maryland. Dr. Marincola founded in 2003 the Journal of Translational Medicine and is the Editor-in-Chief. He is also Editor-in-Chief of Translational Medicine Communications and Clinical and Translational Medicine. He is past-president of the Society for the Immunotherapy of Cancer (SITC) and the International Society for Translational Medicine. He edited several books including the SITC-affiliated Cancer Immunotherapy Principles and Practice Textbook. Dr. Marincola is an award winning author of The Wise Men of Pizzo and Cat Behind the Window.

John Lunger
Senior Vice President, Manufacturing & Supply Chain
Adaptimmune

Lead the global manufacturing and supply chain organization. Scope of responsibility includesinternal and external manufacturing of autologous engineered T-Cells and lentiviral vectors, supplychain, sourcing, procurement, and Vector MS&T (manufacturing science and technology).

Zonghai Li
Founder, CEO and CSO
CARsgen Therapeutics,

Dr. Li is a professor in Shanghai Cancer Institute, Renji Hospital, Shanghai Jiaotong University School of Medicine. Dr. Li got his M.D. and Ph.D. from Hunan Medical University and Fudan University respectively. Dr. Li is dedicated to developing innovative immune therapeutics to fight cancer. He has advanced several first-in-class CAR-T cell therapeutics for the treatment of patients with pancreatic, gastric, liver cancer and other cancer types.

Kathleen McDermott
Research Nurse
Dana-Farber Cancer Institute

Kathleen McDermott is a staff nurse with 37 years of oncology experience in the Dana-Farber / Brigham and Women’s Cancer Care Program. In 1981 she started as a new graduate on a general medical floor where she found her calling by caring for the hematology patients and their families on night shift:  newly diagnosed, febrile, neutropenia and scared. In 1984 she moved to the stem cell transplant unit where she realized the impact she could make on patients and families by following them through their transplant inpatient course.  Kathleen move to the ambulatory chemotherapy clinic in 1991 and was able to follow patients and families from diagnosis to cure or to palliative care.   In 1998 she transitioned to the lymphoma population as a clinical program/ research nurse coordinator in the autologous stem cell transplant program. In 2015 the Dana-Farber Cancer Institute started participating in CAR T clinical trials and she assumed the role as the research nurse on these trials. For the past year, since CAR T products have become commercially available in the U.S., Kathleen has collaborated in the  development of the Dana-Farber / Brigham and Women’s Cancer Care CAR T commercial program and has navigated more than 80 patients and their families through CAR T treatment.

Sarah Nikiforow
Assistant Medical Director, Cell Manipulation Core Facility
Dana-Farber Cancer Institute

Dr. Sarah Nikiforow is an oncologist in Boston, Massachusetts and is affiliated with Dana-Farber Cancer Institute. She received her medical degree from Yale University School of Medicine and has been in practice between 11-20 years. She is one of 225 doctors at Dana-Farber Cancer Institute who specialize in Oncology.

Xiao Lei
Chief Executive Officer
Innovative Cellular Therapeutics

Lei Xiao, PhD has over 15 years' experience studying CAR-T, stem cells and cell therapy.  He has served as Professor and Doctoral supervisor at Institute of Biochemistry and Cell Biology, Shanghai Institutes for Biological Sciences of CAS, and Zhejiang University.  Dr. Xiao completed postdoctoral training at The Johns Hopkins University; holds a Ph.D. from Ludwig-Maximilians Universität München.  During his 10-year tenure in biotech R&D, he has been the winner of The National Science Fund for Distinguished Young Scholars, a member of "Shanghai 1,000 Talents Plan" and an expert group member of "Major Research Programs in Stem Cells" sponsored by Ministry of Science and Technology of the P.R.C.

Sean Mackay
Chief Executive Officer
IsoPlexis

Sean is an experienced entrepreneur at the convergence of life sciences and healthcare delivery. He co-founded and leads IsoPlexis, a venture-backed life science startup developing a diagnostic system to measure cellular immune response in patients. Sean led IsoPlexis through foundational licensing and capital raising, while building the team and developing applications and product. Previously, Sean advanced business development at Kleiner Perkins-backed and incubated Lifesquare, which connected patients, payers, and providers through sharing essential healthcare information. While at Lifesquare, Sean generated strategic initiatives related to partnerships across the healthcare ecosystem. Through work at Lazard and several early-stage ventures, he developed deep experience in structuring and financing life sciences companies. Sean advised multiple biotechnology and medical technology companies on how to manage times of strategic change. He founded life science-focused debt advisory business line at Lazard, helping grow revenues ten-fold for the group and establishing infrastructure and hiring required to sustain the business. Sean graduated with a BS in Economics from the University of Pennsylvania’s Wharton School and an MBA from the Yale School of Management.

Matthew Hewitt
Head of Clinical Development, Personalized Medicine
Lonza

Recruited to lead Personalized Medicine's clinical development with potential and current partners to identify promising cell therapies and technology along with understanding and addressing regulatory agency concerns. Assist with the Cocoon platform roll-out as an automated GMP-in-a-box concept for cell/gene therapy manufacturing. The overarching goal is to provide scalable and cost-efficient solutions to current cell/gene therapy manufacturing bottlenecks.

Matthew Frigault
Instructor in Medicine
Massachusetts General Hospital

Dr. Frigault is a medical oncologist in the Hematologic Malignancy Program at the Massachusetts General Hospital Cancer Center, as well as Administrative Director of the Cellular Therapy Service.  In addition, he serves as an instructor at Harvard Medical School. Dr. Frigault recently completed his oncology fellowship at the combined MGH/Dana Farber Cancer Institute training program where he worked with Dr. Marcela Maus, head of the Cellular Immunotherapy Program at MGH. Dr. Frigault’s prior research experience includes pre-clinical development and correlative studies relevant to T-cell immunotherapy in the lab of Dr. Carl June while in graduate school at the University of Pennsylvania. During his post-graduate training at Johns Hopkins, he focused on cellular therapies utilizing marrow infiltrating lymphocytes and chimeric switch receptors in the lab of Dr. Ivan Borrelo.

Peter Emtage
Senior Vice President & Global Head of Cell Therapy Research
Kite, a Gilead Company

Peter Emtage serves as the Global Head of Cell Therapy Research at Kite, a Gilead company.  He most recently served as the Chief Scientific Officer at Cell Design Labs. He previously held senior positions at Intrexon, MedImmune and Femta Pharmaceuticals. Peter is an immunologist by training and over the past 20 years has focused on developing drugs to modulate the immune response in humans. His work in oncology, autoimmunity and infectious disease has included the utilization of viral and non-viral delivery systems, chimeric antigen receptors and TCR adoptive T cell modalities, and monoclonal antibodies in checkpoint blockade and immuno-oncology.  His career started with a post-doctoral fellowship at the National Institutes of Health followed by his role as Research Scientist at Aventis Pasteur and then Instructor in Medicine at Harvard Medical School.

Day One

Thursday 13th December 2018

9:00 am | Industry Leader’s Fireside Chat

Boro Dropulic
Chief Scientific Officer
Lentigen, a Miltenyi Company

Dr. Boro DropuliC, Ph.D., M.B.A is the Chief Science Officer and General Manager of Lentigen Technology Inc (LTI), a wholly owned subsidiary of Miltenyi Biotec GmbH. Prior to LTI, Dr Dropulic founded Lentigen Corporation in December 2004 and served as its Chief Scientific Officer and President. Previously, he was the Founder and Chief Scientific Officer at VIRxSYS Corporation, where he successfully led a multidisciplinary team to initiate and complete the first lentiviral vector clinical trial in humans. Prior to that, Dr. Dropulic was an Instructor and Adjunct Assistant Professor at The Johns Hopkins University School of Medicine, where he was the first to develop an HIV-based vector targeted to inhibit the replication of the HIV/AIDS virus.

George O’Sullivan
Head of Supply Chain
Rubius Therapeutics

George leads the Supply Chain organization at Rubius Therapeutics, an innovative company developing a new class of cellular medicines called Red Cell Therapeutics. His responsibilities include including Supply/Demand Planning, Strategic Sourcing, Apheresis Network, Logistics, and External Manufacturing. Prior to Rubius, he was Executive Director of Global Cell Therapy Supply Chain at Celgene. Before that at Kite Pharma, he designed and built the autologous supply chain to launch one of the first 2 CAR-T therapies to ever reach the market. Prior to joining Kite, he held roles of increasing responsibility at Amgen and Merck, KGaA in Operations and Supply Chain. George holds a bachelor’s in international relations from University of Colorado Boulder and an MBA in finance and operations from the University of Texas Austin.

Qiong Xue
Associate Director, Analytical Development & Cell Therapies
Takeda

Chelsea is currently Head of Analytical Development for Cell Therapies in Takeda. She is building the analytical capabilities and developing an integrated analytical package to enable product quality control, drive product understanding and next-generation design. In her previous role at Novartis, Chelsea contributed significantly on CMC analytics and CQA discovery for CTL019 which was later approved for ALL as Kymriah. She later led a group focused on clinical biomarker development. Chelsea received her Ph.D from Texas A&M Health Science Center and competed postdoc training in Yale University.

Heidi Hagen
Chief Strategy Officer
Vineti

A seasoned Biotechnology and Operations executive. Successfully built organizations and programs within both established and start up environments, commercialized innovative operations, designed and built commercial manufacturing facilities, and streamlined complicated logistics and production systems. Demonstrated results in product development and operational leadership within the biopharmaceutical and medical device industries. Successfully delivered the first operation that manufactures and distributes live autologous cellular products within an 18 hour time window to oncology patients in the US and EU commercial markets.

Alexandre Juillerat
US Laboratory Head
Cellectis

Dr. Alexandre Juillerat, Ph.D., graduated in Chemistry from the University of Lausanne, Switzerland. After receiving in 2006 his Ph.D. in protein engineering from the École Polytechnique Fédérale de Lausanne (EPFL, Switzerland), he moved to the Institut Pasteur in Paris, France for a Postdoctoral fellowship in the laboratory of Structural Immunology.  In 2010, he joined the R&D department of Cellectis in Paris, France, as Project Leader, developing the TALEN® gene editing platform and CAR T-cell projects until 2015, when he joined Cellectis facility based in New York, NY, now leading R&D cell engineering projects.

Jeff Mayhew
Founder & Chief Development Officer
LabConnect Inc.

David Smith
Head of Innovation and Engineering
Hitachi Chemical Advanced Therapeutics Solutions

At HCATS I continue to combine my engineering background with the skills and techniques I have acquired from the Regenerative Medicine field to advance process development for the manufacture of cell therapy products. Currently, there is a deficit in the progression of cell therapies from the bench-side to successful manufacture, with many bottlenecks still to overcome. I have gained valuable skills in design of experiments and the quality by design approach which is required along with my multi-discipline approach to translate these processes to a manufacturing setting for cost effective, high quality cellular products.

Thomas Fellner
Head of Business Development and Account Management, Cell and Gene Technologies
Lonza

Srujana Cherukuri
Chief Executive Officer
Noble Life Sciences, Inc

Srujana Cherukuir, Ph.D. currently serves as chief Executive Officer of Noble Life Sciences. Before becoming CEO, Dr. Cherukuri served in multiple roles at Noble Life Sciences including Chief Operations Officer, Chief Scientific Officer, Vice President of Product Development and Operations, and Director of Scientific Affairs. Prior to joining Noble, Dr. Cherukuri held positions at the Cleveland Clinic Foundation, National Cancer Institute and University of Maryland where she led projects focused on understanding the basic biology and mechanistic actions in cancer cells.

Roman Yelensky
Chief Technology Officer
Gritstone Oncology

Roman Yelensky is Gritstone Oncology’s first employee and serves as chief technology officer, with responsibility for the EDGETM tumor antigen identification platform. Previously, Dr. Yelensky was vice president at Foundation Medicine, which he joined at its inception. At Foundation Medicine, he co-led sequence data analysis for FoundationOne™ and led validation studies supporting clinical laboratory accreditation and testing of more than 100,000 patients. Dr. Yelensky established Foundation Medicine’s FDA-regulated products program, leading to FDA approval of the first NGS-based companion diagnostic. He holds a Ph.D. in bioinformatics and genomics from the Massachusetts Institute of Technology and has co-authored more than 75 manuscripts, including most recently on EDGE in Nature Biotechnology.

John Sweetenham
Associate Director for Clinical Affairs
Harold C Simmons Comprehensive Cancer Center, UT Southwestern

John Sweetenham MD, FRCP, FACP, FASCO is Professor of Medicine and Associate Director for Clinical Affairs at the Harold C Simmons Comprehensive Cancer Center at UT Southwestern in Dallas, TX. He attended medical school at St Bartholomew’s Hospital in London, and trained in Oncology at the University of Southampton, UK, where he was subsequently a Senior Lecturer in Medical Oncology. He moved to the University of Colorado in 2000. He joined the Cleveland Clinic Taussig Cancer Institute and Lerner College of Medicine in November 2005. Prior to moving to UT Southwestern in April 2019, he spent 6 years as Senior Director of Clinical Affairs at the Huntsman Cancer Institute, University of Utah. Dr Sweetenham is internationally renowned for his clinical research in malignant lymphomas and the use of stem cell transplantation. He has authored more than 200 original articles, chapters and books in this area of investigation.

Lan Cao
Senior Director & Head of Product Development, Clinical Manufacturing, Cell Therapy & Pharmaceutical Science
Takeda

Lan Cao is currently the Senior Director, Head of Product Development in the Translational Engine, Cell Therapy group at Takeda, focusing on product development for various cell therapy products, including CAR-T, iPSC-derived T cells, gamma-delta T cells, and CRSIPR gene editing. Lan has more than 10 years’ experience in the cell therapy field in pharmaceutical and biotech companies with increasing roles and responsibilities. Lan has been the key CMC leader in filing multiple INDs and BLAs for cell therapy products. Prior to joining Takeda, Lan was the Executive Director of Technical Operations at CRISPR Therapeutics (CRSP) overseeing the development and manufacturing of CRISPR edited cellular products. His time at CRSP was preceded by Unum Therapeutics (UMRX) and Battersea Biotech, both are clinical stage cell therapy biotech companies in which he was leading the process and analytical development of both viral vectors and T cell products. Prior to that, Lan worked as an Associate Director in Novartis, leading the process development of the first FDA approved CAR-T product, Kymriah. Lan received his Ph.D. in Chemical Engineering from the University of Washington, and postdoctoral training at Harvard University, Bioengineering.  

Isabelle Rivière
Director, Michael G. Harris Cell Therapy and Cell Engineering Facility
Memorial Sloan Kettering Cancer Center

Dr. Rivière received her Ph.D. in Cellular and Molecular Biology from the University of Paris, France.  She initiated her graduate studies at the Institut Curie in Paris and completed her thesis in the laboratory of Dr.Mulligan at the Whitehead Institute in Cambridge, MA. She focuses on developing novel strategies for cell therapies and immunotherapies. Her laboratory investigates genetic approaches to enhance various cell types including T lymphocytes and stem cells for the treatment of cancer and genetic blood disorders.  Over the past 20 years, she has developed cell manufacturing processes for several Phase I/II clinical trials under current Good Manufacturing Practices in the academic setting. Her lab currently supports multiple CAR-T cell based clinical trials for the treatment of hematological malignancies and solid tumors. She also investigates immunological functions of CAR T cells in clinical trials and animal models. She is a member of the Board of Directors of the American Society of Gene and Cell Therapy (ASGCT), the Alliance for Regenerative Medicine (ARM) and the Center for Commercialization of Cancer Immunotherapy C3i (Canada).

Mark Dudley
Senior Vice President, Product Development
Adaptimmune Therapeutics

Dr. Mark Dudley is a Senior Vice President of Product Development at Adaptimmune Therapeutics where he oversees cell and vector process development, cell product characterization, and technical innovation. Previous roles include Director of New Cell Products in the Cell and Gene Therapies Division of Novartis, and Director of the Cell Manufacturing Facility at the Surgery Branch of the US National Cancer Institute. Dr. Dudley has experience in Chemistry, Manufacturing and Controls (CMC) for both early and late stage cell and gene therapies. He helped established scalable, GMP-compliant production strategies for the first approved CAR-T cell product in the US and facilitated globalization of CAR-T products and manufacturing platforms. His experience with research and development of T-cell therapies includes exploratory clinical trial design; regulatory filings; risk assessment; and manufacturing process innovation and has resulted in more than 100 peer-reviewed publications. Dr Dudley pioneered the use of lymphodepleting conditioning with Adoptive Cell Transfer (ACT) and contributed to establishing the tumor eradicating potential of this combination. Dr. Dudley earned a Ph.D. in Biological Sciences at Stanford University, and had post-doctoral fellowships at The University of Pennsylvania in Philadelphia, PA and at the Jackson Laboratory in Bar Harbor, ME

Santanu Das
Managing Director
Huron

Santanu has over 20 years of professional experience in the healthcare industry having both commercial and consulting experience across both industry and agency fields.

Prior to joining Huron, Santanu was Vice President GfK Pricing & Market Access based in London and provided advice and insights to global pharmaceutical, biotechnology and medical device clients on pricing and access strategy across the lifecycle including asset evaluation, pre-launch planning, clinical decision support, launch planning and post launch LOE.

Santanu ran his own healthcare consulting company for over 10 years advising global healthcare clients on due diligence and product commercialization strategy Santanu has also worked in Sales & Marketing at Wyeth Labs and SmithKline Beecham before joining IMS Global Services and then taking up an Account Director role at NFO Migliara Kaplan Europe (now Kantar), running global quantitative and qualitative research programs for global pharmaceutical and biotechnology companies.

Allison Matthews
Allison Matthews, Service Designer
Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery

Trained both in medicine and as an architect, Allison Matthews is a lead service design researcher on the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery Innovation and Design team where she utilizes her experience in healthcare along with her human centered design training to innovate around the delivery and experience of health care.  Allison is passionate about designing for a sustainable health care future, looking at the system and reimagining what the future can bring to patients in need.

Ariane Hamaide
Vice President Corporate Development
Cellectis

Ariane Hamaide is a Vice President Corporate Development at Cellectis. Among other topics, Ariane is in charge of piloting the build-up of Cellectis’ new state of the art manufacturing facility IMPACT (Innovative Manufacturing Plant for Allogeneic Cell Therapies) in Raleigh, North Carolina; as well as early commercial readiness preparation. Prior to joining Cellectis, Ariane worked as a Project Leader at the Boston Consulting Group in the United States and in France, where she specialized on commercial launch preparation and organizational transformation projects for international pharmaceutical companies. Ariane is based in New York.

Zoey Ni
Technical Leader—Asia
Cell & Gene Therapy Enterprise Solution

Dr. Zoey Ni is the Cell & Gene Therapy Enterprise Solution Technical Leader for GE Asia, leading offering in customized process development, HW/SW applications, and facility related services.  Dr. Ni obtained her Ph.D. from Cornell University, and has 15+ years of experience in translational research, drug discovery, diagnosis, and cell therapy.

Kristian Elverum
Senior Vice President of Business Development and Strategy
Rubius Therapeutics

Kris Elverum is a biotechnology and pharmaceutical executive with leadership success at multiple biotech companies and Novartis, and strategy experience at McKinsey & Co, and is a published thought leader on delivering gene and cell therapies to all patients. Kris is currently the SVP of Corporate Development for Turnstone Biologics, a viral immunotherapy company, and previously was the Chief Business Officer of SQZ Biotech, a cell therapy company. Previously, Kris led the U.S. commercial model for CTL019, Novartis’ breakthrough CAR-T cell therapy, and other CAR-T cell immunotherapies, and was the Global Head of Strategy for Novartis’ Sandoz division.

Kimberly Lounds Foster
Corporate Vice President, Global Supply
Celgene

Kimberly Lounds Foster is Corporate Vice President, Global Supply at Celgene, where she oversees the Celgene’s Clinical and Commercial Supply Chain along with Commercial Manufacturing Operations.  Celgene develops and manufactures products on multiple technology platforms, including small molecules, biologics and cell therapies. Prior to Celgene, Ms. Foster was Head of Global Supply Chain at Novartis’ Cell & Gene Therapy unit, where she was responsible for building out the commercial and clinical autologous supply chain for KYMRIAHTM (tisagenlecleucel), the first FDA approved CAR T cell therapy.  Ms. Foster held various positions at Sandoz a Novartis company where she built the External Supply Operations functions for the Americas and managed Sandoz US supply chain for in-line products, new products launches and managed the warehouse and distributions network.

George White
Product Strategy Manager, Cell & Gene Therapy
GE Healthcare

George has 15 years’ experience in the cell and gene therapy industry, predominantly in commercial roles supporting academic research through to industrial scale up and manufacturing.  George joined GE Healthcare in 2013, during which he has had active involvement in the integrations of the Biosafe and Asymptote businesses.  George recently moved from his role as Commercial GM for EMEA, to Global Product Strategy Manager to further support the development of GE’s products and services into the Cell and Gene Therapy space.

Day Two

Thursday 13th December 2018

9:30 am | Maximize Your PD and Manufacturing Capabilities

Wei (William) Cao
Chief Executive Officer
Gracell Biotechnologies

Dr. Wei (William) CAO is the Founder, Chairman and CEO of Gracell. Together with an industry veteran team, Dr. Cao has created Gracell to capture special opportunity of cell therapy for global market. Through external partnership and in-house R&D effort, Gracell has been rapidly progressing with novel CAR-T programs to address the industry’s key issues.   He is a seasoned front runner with over three decades of experience in biotech and R&D. Before conception of Gracell today, he was the co-founder and CEO of Nasdaq listed cell therapy company; served as senior scientific management positions at Chiron (Novartis and Bayer) and Affymetrix (ThermoFisher). William also has over 70 issued patents and applications for advanced cell therapies.   Dr. Cao earned a Bachelor’s degree in Medicine from Fudan University / Shanghai Medical College, China and a PhD degree in Pharmacology from Medical College of Virginia, USA. He has extensive research experience in immune-pharmacology field at Harvard Medical School and Stanford University Medical Center. He is director of International Chinese Stem Cell Foundation (ICSCF), and served as Venture Partner of 6 Dimensions Capital. Dr. Cao received prestigious White Magnolia Award from Shanghai City.

Luca Alberici
Chief Business Officer
MolMed

Luca Alberici is Chief Business Officer since April 2015. He joined MolMed in 2006 and worked with growing responsibilities in R&D, contributing to the development of the Company’s “core” products and scouting and validation of potential drug candidates to enrich the portfolio. After a Master in Business Administration, he joined Bain & Company, a leading management consulting firm, where he was involved in strategic business planning, portfolio effectiveness, organization and process reengineering, due diligence and post-merger integration in healthcare and consumer good practices. Luca holds a Master degree in Medical, Molecular and Cellular Biotechnology from Vita-Salute San Raffaele University, a PhD in Cellular and Molecular Biology from the same institution and a Master in Business Administration from SDA Bocconi Milan.

Richard Koya
Associate Director of the Center for Immunotherapy, Director of the Vector Development & Production Facility
Roswell Park Comprehensive Cancer Center

Dr. Richard Koya, M.D., PhD. is the Director of the Vector Development and Production Facility and the Associate Director of the Center for Immunotherapy at Roswell Park Comprehensive Cancer Center;  Associate Professor of Oncology and member of the Tumor Immunology and Immunotherapy CCSG Program at RPCI.  Dr. Koya was previously an assistant professor in the Department of Surgery, Division of Surgical Oncology,  UCLA, with research focus in cancer gene therapy and immunology. Dr. Koya maintains an active research program focused on finding new and efficacious therapies for cancer based on immunotherapy and gene therapy. Dr. Koya is author of many high-impact publications in the field of cancer research, and he currently leads a National Institutes of Health (NIH) prospective clinical trials program based on  immune modulator/enhancer, T Cell Receptor-engineered T cell transfer for metastatic cancer patients. He also serves as a peer reviewer for various scientific journals in the field of cancer research and immunology and as reviewer for grants in scientific review study sections of the NIH and National Cancer Institute (NCI). Dr. Koya has received many awards; among them are the Scholar Award from the Ministry of Education and Culture of Japan, the Ito Foundation Award, the Nickel-V Foundation Award, and the STOP CANCER Award.

Day Two

Thursday 13th December 2018

10:30 am | Enhancing Engineered T Cell Adoptive Transfer Therapies to Beat Cancer

Maria Whitman
Principal
ZS

Maria Whitman is a principal in ZS’s Philadelphia office. She is a founding leader in ZS’s strategy and transformation practice, working with healthcare clients particularly in the biopharma space and addressing a range of issues from development to commercialization. Maria previously led ZS’s global specialty therapeutics and oncology practice, where she was also accountable for several centers of excellence including rare disease, cell and gene therapy, biosimilars, biomarkers and specialty data. She has served as the managing partner of the Philadelphia office and is part of ZS’s healthcare leadership team. In 2015, Maria was named one of Consulting magazine’s top 12 women consultants globally.

Emilie Viey
Chief Executive Officer
Ovizio Imaging Systems

Emilie Viey is a cellular Biologist, graduated with a PhD in Immunology, University Paris XI, for her work on the role of Gamma Delta T cells in immune response against renal cell carcinoma. She pursued her scientific learning at Innate Pharma, Marseille (France) and gives a twist to her career by joining Roche Diagnostics France. Then, she became a national expert for cell analysis instruments and oversaw the launch of the xCELLigence®, real-time cell analyzer, from ACEA Biosciences Inc. In 2013, she stepped up into the Commercial path and grow up til leading the European business and team for ACEA Biosciences Inc. In 2018, with her undying curiosity for science and new technologies ; she accepted the CEO position within Ovizio Imaging Systems. Ovizio Imaging Systems develops and commercializes a quantitative microscopic imaging platform technology, enabling automation of current manual processes. With cell therapy as main area of focus, Ovizio Imaging Systems offers, through an in-line connection to the bioreactor, and in a closed system; the real-time monitoring of cell viability, counting and phenotyping.

Mark Jones
Senior Manufacturing Engineer
Terumo BCT, Inc.

Laboratory Scientist in the Quantum System Lab, I&D Department at Terumo BCT, Inc. (USA).  Focused on translating manual cell culture processes into automated protocols with various mammalian cell types.  Previous pharmaceutical experience in the antineoplastic development of paclitaxel analogs and targeting conjugates, DNA repair gene transfection studies, RSV cell culture vaccine process development.  Co-inventor of multiple bioreactor development patents and co-author of various cell expansion process related publications.  B.S. from the University of Oregon, M.S. from M.S.U.-Bozeman.

Weifei (Frank) Zhang
VP for GMP Manufacturing
GenScript

Weifeng “Frank” Zhang, has a Master of Engineering degree from McMaster University and he has been working in the pharmaceutical and biotechnology industry for 20 years. He worked 12 years in Medarex/Bristol Myers Squibb (BMS), where he was the validation manager of a clinical manufacturing facility in New Jersey for Monoclonal antibodies (mAb). Then quality engineering manager in Devens Massachusetts, responsible for the approval of all process validation documents, BLA prepration and major CAPA projects for ORENCIA (abatacept), a therapeutic protein (CHO) manufacturing. Frank worked in Shire as MPO (manufacturing product owner) then the head of process development & technical services (PDTS) and SLT member at Milford site, where, OBIZUR, a recombinant porcine sequence factor, was BLA approved and manufactured. In 2018, Frank joined LakePharma as the MSAT director and Business Unit leader for GMP productions.  He was leading the design of GMP processes for plasmid DNA and mammalian drug substance, the business development, creation of clients groups, establishing partnership with industrial leader for LakePharma’s CDMO Biomanufacturing center. In 2019, Frank joined GenScript as the Vice President of BDBU Manufacturing.  He currently oversees Process Development, Manufacturing, MSAT, and Engineering groups.  Responsible for process development and manufacturing activities at Antibody, Plasmid and Viral Vector facilities in Nanjing and Zhenjiang locations.

Amanda Trent
Director of Assay Migration & Development
Accellix

Amanda is the Director of Assay Migration and Development at Accellix, where she is responsible for developing customer-specific cytometry assays and integrating the assays onto the Accellix platform. Working at multiple in vitro diagnostic start-ups in Silicon Valley has given Amanda extensive experience with flow and image-based cytometry, assay verification and validation, systems integration, and in leading and collaborating with highly cross-functional R&D and manufacturing teams.  Her doctoral work prior to that centered on the design and application of biomaterials as immuno-therapeutics.

Xi Zhang
Director, Chief Physician, and Doctoral Supervisor
Xinqiao Hospital of AMU

Professor Xi Zhang is the Director, Chief Physician, and Doctoral Supervisor of Hematological Medical Center of Xinqiao Hospital of Army Medical University. He is the Distinguished Professor of Changjiang Scholar of China. Professor Xi Zhang has deep attainments on hematological stem cell transplantation, he and his team also set foot in the clinical and basic researches of CAR-T, Single Cell Technology and so on. Professor Xi Zhang is the standing committee member of hematology branch of Chinese Medical Association, the chairman of hematology branch of Chongqing Medical Association, the standing committee member of hematology branch of Chinese Medical Doctor Association, the standing committee member of hematological malignancies branch of Chinese Anti-Cancer Association. Professor Xi Zhang presided over 26 national and provincial scientific research subjects. He has published 52 papers as first author or corresponding author in SCI journal (the highest impact factor is 24.008). He also owned 12 national patent invention. Professor Xi Zhang won many price in China, such as the first prize of Chinese Medical Science Prize, the first prize of Chongqing Scientific and Technological Progress.

Dolores Schendel
Chief Executive Officer & Chief Scientific Officer
Medigene

Prof. Dolores J. Schendel holds the positions of CEO/CSO of Medigene AG, a publicly listed (Frankfurt: MDG1, prime standard) biotechnology company headquartered in Martinsried, Germany. In addition, she is Managing Director of Medigene Immunotherapies GmbH, a subsidiary of Medigene that she and coworkers founded as a spin-off of the Helmholtz Center Munich in 2013, and was acquired by Medigene in January 2014. Prof. Schendel served from 1998-2014 as Director of the Institute of Molecular Immunology of the Helmholtz-Center Munich - German Research Center for Environmental Health. She also holds a professorship in immunology at the Ludwig Maximilian University of Munich since 1986.

Christina Coughlin
Chief Medical Officer
Tmunity Therapeutics

Day One

Thursday 13th December 2018

9:00 am | Industry Leader’s Fireside Chat

Yihong Yao
Chief Scientific Officer
Cellular Biomedicine Group

Former MedImmune/AstraZeneca Director B.S. degree Biochemistry, Department of Biochemistry, Fu Dan University, Shanghai, China Master’s Degree bioinformatics, Boston University Ph.D. Molecular Biology & Biochemistry, Department of Biochemistry, University of Kansas, Postdoctoral Fellowship, Johns Hopkins University, School of Medicine, Baltimore, Maryland Dr. Yao has nearly twenty years of experience in the life sciences industry and academia with strong expertise in clinical biomarker discovery and development, strategy and personalized medicine. Dr. Yao received his B.S. degree in Biochemistry from the Department of Biochemistry, Fu Dan University, Shanghai, China, a Master’s Degree in bioinformatics from Boston University and his Ph.D. in Molecular Biology & Biochemistry from the Department of Biochemistry, University of Kansas, Lawrence, Kansas, USA.

Pippa Gledhill
Beacon Analyst
Beacon Targeted Therapies

Derek Lenz
Biopharma Specialist
Beckman Coulter Life Sciences

Charles Mooney
Vice President, Bio-Development & QM
Oklahoma Blood Institute, Member of Blood Centers of America

Jason Martin
Executive Director, Site Head of Warren Manufacturing
Celgene

Dee Anna Smith
Chief Executive Officer
Sarah Cannon Cancer Institute

Chris Mach
Director, Cell and Gene Therapy
Corning

Chris has over 20 years of experience in the Life Sciences and Medical Device industry and joined the Corning Life Sciences team in 2013 as the head of the Bioprocess business. He is now responsible for developing and executing the long-term global strategic plan to drive significant growth for the Cell and Gene Therapy program at Corning. Chris has a long history of successfully managing high growth businesses and accelerating development of new product platforms to address unmet needs. Chris earned his MBA from Washington State University; MSc in Organic Chemistry from Sacred Heart University; BA in Chemistry from SUNY Stony Brook; and BSc in Health Sciences from the University of Delaware.

Cameron Durrant
Chief Executive Officer
Humanigen

Cameron Durrant, MD, MBA, is chairman and chief executive officer of Humanigen, a biopharmaceutical company developing cutting-edge CAR-T optimization and oncology treatments.  Dr. Durrant has led transformations, for brands, business units, and biotech companies, including roles as executive chairman, CEO and chief financial officer. A practicing physician by training, he has expertise in oncology, pediatrics and anti-infectives. He is a prior regional winner of the Ernst and Young ‘Entrepreneur of the Year’ award and an M&A Advisor Turnaround Award Winner 2017.

Don Healey
Senior Vice President Operations
KBI Biopharma

Don has over 30 years experience in cellular immunology and immune regulation in both academic and biotech environments. Prior to joining KBI Biopharma, Don was Chief Scientific Officer at Opexa Therapeutics, developing autologous T-cell immunotherapies for the treatment of autoimmune disease. Previously, he held the position of Director of Immunology at Argos Therapeutics, and was responsible for the development of novel autologous dendritic cell therapies for the treatment of renal carcinoma and HIV. He is a former lecturer in immunology at the University of Leicester, UK, and held post-doctoral positions in the Department of Pathology, Cambridge University, UK, conducting studies on immunoregulation of autoimmune disease. Dr. Healey obtained his Ph.D. at the Hunterian Institute at the University of London, UK, and obtained his BSc in the Department of Pathology, Bristol University, UK.

Julia Tarasenko
Senior Director, US Strategic Accounts
Marken

Rama Shivakumar
Research Scientist
MaxCyte, Inc.

Rama Shivakumar is a Research Scientist and Customer Application Specialist at MaxCyte Inc., a clinical stage biotechnology company that specializes in a flow electroporation platform. As the company’s knowledge manager, Rama coordinates the training and data generation used by the company’s Sales, Marketing, R&D and Engineering teams to expand the adoption of MaxCyte’s technology and is responsible for developing technical notes and other customer facing materials. With over 17 years of experience in biotech, she has extensive hands on knowledge of Electroporation, Protein Production, Process Development of Viral Vector Production and Protocol Development. Rama received her graduate training in Molecular Biology from Indiana University School of Medicine at Indianapolis.

Ian Johnston
Industrial and Academic Cooperations Manager, Senior Project Manager
Miltenyi Biotec GmbH

Dr. Johnston is responsible for the development of cutting edge technologies to enable cell and gene therapies to be applied routinely in the clinic. Since joining Miltenyi Biotec in 1999, Dr. Johnston has developed a number of reagents and procedures to improve the efficiency of genetic modification of primary cells such as human T and stem cells. A number of these procedures have been fully automated on a functionally closed cell processing platform – the CliniMACS® Prodigy. In addition, Dr. Johnston has lead development of numerous products for magnetic isolation of cells, molecules, organelles and for use in the field of HIV research. He has been Principle Investigator on a number of European consortium grants focused on the genetic modification of stem cells, most recently Cell-PID and SCIDNET. His group is also investigating new targets for Chimeric Antigen Receptors (CAR) to be used in T cell cancer immunotherapies.  

Day One

Thursday 13th December 2018

10:00 am | Routine Automated Manufacture of CAR-T Cell Products in a Closed System

Srujana Cherukuri
Chief Executive Officer
Noble Life Sciences, Inc

Surajit Sen
Partner
Strategy&

Surajit Sen is a Partner with Strategy&, the strategy consulting arm of PwC.  Surajit focuses on the Life Sciences sector, with a client base spanning pharmaceutical companies, biotechs, CROs, and private equity investors.  He specializes in helping clients address complex issues related to corporate strategy, growth and innovation, new product commercialization, franchise and brand strategy, market access, R&D strategy, and performance improvement.  Surajit is a member of PwC's Oncology Center of Excellence and leads the firm's work in the cellular therapy space.

Karen Chagin
Vice President, Clinical Development
Tmunity Therapeutics

Prior to joining Tmunity, Dr. Chagin was Vice President of Clinical Development at Adaptimmune LLC, where she was responsible for the strategy and execution of global clinical development programs studying novel engineered T-cell receptor therapies in solid tumors. Prior to that she served as a Scientific Director in Oncology Early Development at Janssen leading development activities for Phase 1 assets. Dr. Chagin began her career in the pharmaceutical industry at GSK where she spent four years in Safety and Pharmacovigilance taking on roles of increasing responsibility before transitioning to Oncology clinical development as a Medical Director.  

Gavin MacBeath
Chief Scientific Officer
TScan

Gavin joins TScan after two decades of experience in academia and industry, founding companies and driving research from early-stage discovery through drug approval. Prior to joining TScan, Gavin served as the CSO at Abpro, where he advanced T cell-engaging bispecific antibodies through pre-clinical development. Previously, Dr. MacBeath served as Co-founder and SVP of Discovery at Merrimack Pharmaceuticals where he advanced several biologics from IND through Phase 2 clinical development. Dr. MacBeath began his career in academia, where he served as Associate Professor in the Department of Chemistry & Chemical Biology at Harvard University, and as Lecturer and Principal Investigator at Harvard Medical School. Dr. MacBeath received his undergraduate degree from the University of Manitoba, his Ph.D. from The Scripps Research Institute, and postdoctoral training with Dr. Stuart Schreiber at Harvard University.

Benjamin Pieritz
Executive Vice President & General Manager
Werum IT Solutions

Vimal Vaidya
Senior Associate Scientist II, Downstream Vector Process Development
bluebird bio

Jelle Kijlstra
Senior Medical Director, Oncology
Covance, Inc

As senior director at Covance, Dr. Kijlstra leads the North American Oncology Therapy Area, and acts as the medical monitor for oncology studies primarily involving hematologic malignancies. In his 28 years-plus of industry experience, including working for Zeneca, Dendreon, Spectrum and several other U.S. biotech firms, he successfully led nine oncology and cellular immunology drugs, as well as two interventional oncology surgical devices to FDA and EMA approval.  He has broad experience in oncology clinical trials (Phases I-III) in solid tumors, hematologic malignancy, immuno-oncology and tumor targeted surgical devices. He is also the patent holding co-inventor of Provenge™, an immunotherapy drug for prostate cancer (FDA approved, 2010). Dr. Kijlstra has presented for FDA advisory boards, and has published several dozen peer-reviewed papers and abstracts.

Seth Gordan
General Manager
Eversana

Seth’s deep understanding of the healthcare industry comes from more than 27 years of experience on both sides of the industry––pharmaceuticals and agency work. He has extensive product marketing and launch experience on both the U.S. and global side. His knowledge of market-access reinforces and informs EVERSANA’s value-based care and patient-centric approach. Seth holds a master’s degree in business administration from Columbia University and a bachelor’s degree from Skidmore College.

Bryan Zimdahl
Clinical Scientist III
Eureka Therapeutics

Bryan Zimdahl, Ph.D. is a Clinical Scientist III at Eureka Therapeutics, Inc. in Emeryville, CA. At Eureka, Dr. Zimdahl has guided several programs through late-stage pre-clinical development and into the clinic. Dr. Zimdahl received his Ph.D. in Molecular Cancer Biology from Duke University and completed post-doctoral training at the University of California, San Diego and Stanford University School of Medicine. Dr. Zimdahl has also participated in the UCSF-Stanford Center for Excellence in Regulatory Sciences and Innovation program and completed the Tufts University School of Medicine course in clinical, pharmacology, drug development and regulation.

Allison Montalvo
Director, Technical Operations, CMC Project Management
Tmunity Therapeutics

Bethany Mancilla
Vice President, Corporate Development
Kite, a Gilead Company

Bethany Mancilla has nearly 30 years of corporate development experience.  She is currently the Vice President of Corporate Development at Kite Pharma.  Bethany joined Kite in April of 2019 and oversees search and evaluation, licensing, collaborations, equity investments and M&A.  Prior to her role at Kite, Ms Mancilla was the Chief Business Officer for Cue Biopharma a Cambridge based, biotech company developing proprietary biologics to selectively modulate antigen specific T cells to treat cancer and autoimmune diseases.  At Cue she was responsible for corporate strategy, financing, and business development including spear-heading a multi-target co-development and co-commercialization agreement with LG Chem Life Sciences.  From April 2012 to August 2018, Ms. Mancilla held increasing roles of responsibility at Amgen most recently as Vice President of Business Development.  During her tenure at Amgen she led the execution of a number of partnerships including immuno-oncology collaborations with Merck, neuroscience collaborations with Novartis and a multi-product cardiovascular collaboration with Servier.  In 2015, she was selected as a top woman at Amgen who helped build the company’s history and is impacting the world of science, technology, and business.

Avery Posey
Assistant Professor & Level Faculty Instructor
University of Pennsylvania

Avery D. Posey, Jr., Ph.D. is an Assistant Professor in the Department of Systems Pharmacology and Translational Therapeutics at the University of Pennsylvania Perelman School of Medicine, a member of the Parker Institute for Cancer Immunotherapy, and a Principal Investigator at the Philadelphia VAMC. Dr. Posey develops and investigates novel CAR-T cell targets and CAR signaling components in pre-clinical solid tumor models in mice and in clinical models with dogs. His laboratory is interested in the anti-tumor potential of targeting cancer-specific glycans and glycopeptides, develops CAR modifications to enhance T cell persistence in vivo, and studies how surface glycosylation of T cells affects cancer immunotherapy efficacy. Dr. Posey is most well known as the inventor of CAR-T cells targeting Tn-MUC1.

Bryan Choi
Clinical Fellow in Neurosurgery
Massachusetts General Hospital

Bruce McCormick
President
Savsu Technologies

Bruce McCormick is an inventor and researcher who has been the recipient of a number of US and foreign patents. His commercial  products have included an FDA approved medical device for Cardio/Pulmonary indications as well as insulated insoles which were featured in the USPTO museum exhibit on footwear technology. His other work includes sports medicine inventions relating to  measuring hidden motion as well as a Garment Fitting System. Bruce has given presentations at many conferences including the IEEE Engineering in Medicine and Biology Society International Conference and the International Conference on Hypertension. Directed research presented at the International Conference on Hypertension as well as research that has been presented to the IOC in Sports Medicine. Delivered TedX presentation on  Preventing the Spread of Global Disease with off grid based refrigeration systems.   Currently he is one of the Founders and President and Chief Technology Officer of Savsu Technologies. On the board of directors of Himed.

Raghu Tadagavadi
Associate Director of Nonclinical Safety
Legend Biotech

Raghu received his PhD in Biochemistry and Molecular Biology from Pennsylvania State University, and postdoctoral fellowship in Immunology from Emory University. He also holds training in Veterinary Medicine and a masters in Veterinary Immunology. Prior to Legend Biotech, Raghu held various positions of increasing responsibilities in Immunology and Toxicology at Pennsylvania State University, WIL Research, Charles River Laboratories, and Johnson and Johnson, and has also practiced veterinary medicine before pursuing his PhD. Raghu is board certified in Toxicology, and regulatory affairs of US, Europe and Canada. Currently, Raghu supports cell therapy development and nonclinical safety at Legend Biotech.

Vinny Subramonian
Executive Director, Oncology CGT, Global Commercial Lead on NY-ESO
GSK

Senior Commercial Leader with more than 15 years of pharmaceutical industry experience in positions of progressive responsibility in early commercialization, global marketing, regional marketing, and enterprise initiatives. Currently, at GlaxoSmithKline as Executive Director, Global Commercial Lead for NY-ESO-1 a T-Cell Receptor investigated in various solid and hematological settings.

Mark White
Senior Director, Scientific Affairs
Berkeley Lights

Mark White started at Berkeley Lights Inc. in 2013 as the first molecular biologist. Since joining BLI, he has played a key role in the initial development of many of the core technology capabilities and assays alongside a multidisciplinary team of biologists and engineers. Mark obtained his Ph.D. in Biomedical Sciences at the University of California, San Francisco and is currently the Sr. Director of Scientific Affairs at Berkeley Lights.

Christopher Heery
Chief Medical Officer
Precision BioSciences

 Christoper Heery, MD, is the Chief Medical Officer at Precision BioSciences. Prior to joining Precision, Dr. Heery served as Chief Medical Officer of Bavarian Nordic where he oversaw clinical development programs for its immune-oncology and infectious diseases portfolios. Prior to this, he was Head of the Clinical Trials Group of the Laboratory of Tumor Immunology and Biology at NCI. He joined the NCI Medical Oncology Branch as a Medical Oncology Fellow in 2009 and also held an Adjunct Appointment in the Genitourinary Malignancies Branch. At NCI, Dr. Heery was part of the larger effort of the Laboratory of Tumor Immunology and Biology to create new immunotherapies for the treatment of cancer. He is board certified in Medical Oncology and Internal Medicine and completed his internal medicine residency at the University of Illinois at Chicago after receiving his M.D. from East Carolina University Brody School of Medicine. Dr. Heery also holds a B.A. in English Literature from Duke University.

Dianna Maar
Application Development Scientist
Bio-Rad Laboratories

Craig Beasley
Vice President - Cell Therapy Supply Chain
Juno Therapeutics, A Celgene Company

Craig Beasley is currently Vice President - Cell Therapy Supply Chain at Juno Therapeutics, A Celgene Company.  He currently oversees supply chain for Celgene’s cell therapy assets (clinical and commercial stage).  This includes demand and supply planning, strategic sourcing, external manufacturing oversight, and supply chain process and systems. Craig joined Juno Therapeutics in 2016 as head of manufacturing & supply chain.  Prior to joining Juno Therapeutics, Craig was Vice President of Next Generation Manufacturing at Biogen.  During his 17 years with Biogen, Craig also held leadership positions throughout the technical operations group (Engineering, Manufacturing, Quality, and Supply Chain).  Four highlights of Craig’s tenure with Biogen included serving as Biogen’s Sr Director of Operations / General Manager of their Denmark biologics manufacturing facility,  Leading the clinical supply chain organization, head of supply chain quality, and serving 2 years as Vice President of Financial Planning and Analysis.  

Don McCahon
Patient Advocate
Emily Whitehead Foundation

Day Two

Thursday 13th December 2018

5:10 pm | Putting Patients First: How Has the Face of Cancer Therapy Changed

Sharon Benzeno
Senior Vice President, Drug Discovery
Adaptive Biotechnologies

Dr. Sharon Benzeno is Senior Vice President leading Drug Discovery at Adaptive Biotechnologies. Before this, Dr. Benzeno held business development roles of ascending responsibility at Adaptive since September 2014. Dr. Benzeno has more than 15 years of experience in cancer biology, R&D, operations and business development. Prior to joining Adaptive, Sharon worked at AstraZeneca for seven years and co-led the oncology business unit at Capgemini Consulting. Dr. Benzeno holds a Ph.D. in Biomedical Sciences from New York University School of Medicine, an MBA in Finance and Leadership from New York University Stern School of Business and a B.A. in Biochemistry from New York University. Dr. Benzeno completed a postdoctoral fellowship in cancer biology at the University of Pennsylvania Abramson Cancer Center.

Amirah Al Idrus
Editor
FierceBiotech

Amirah Al Idrus is an editor with the Life Sciences group covering biotech, medtech and biotech research. She started her career at The Center for Public Integrity, where she was on a team that earned an Al Neuharth Innovation in Investigative Award for their work covering how companies profit from the privatization of prisons. When she’s not working, Amirah spends her time playing rugby, trying to keep her plants alive and baking (and eating) pies.

Day One

Thursday 13th December 2018

9:00 am | Industry Leader’s Fireside Chat

Yanyan Han
R&D Director
HRYZ Biotech

Dr. Yanyan did her Ph.D project in the institute of molecular immunology, Helmholtz Zentrum München - German Research Center for Environmental Health, Munich, Germany from 2006 to 2009, and obtained her PhD degree from medical school of University of Munich in 2010. After that, she received her postdoctoral training in Klinikum rechts der Isar, Technical University Munich, Germany. The research major of her Ph.D and postdoctoral project were cancer immunology and immunotherapy. Since March 2013, she started to work in the research and development department of HRYZ Biotech Co., Shenzhen, China, focusing on cell-based cancer immunotherapy including TCR-T, adoptive T cell transfer, therapeutic cancer vaccine, and neoantigens. Multiple-Antigens Stimulating Cellular Therapy (MASCT), which is a combination of multiple tumor antigen peptides loaded dendritic cells (DCs) and autologous T cells stimulated by these DCs is the first production of HRYZ and has been already approved for IND application in China.

Day Two

Thursday 13th December 2018

10:15 am | Late Breaking Abstracts - The Making of Tumor Specific TCR-T by Reverse Genetic Engineering