Marc Lajoie, PhD is co-founder and CEO of Outpace Bio, which uses protein design to transform cell therapies into cures. Prior to Outpace, Dr Lajoie co-founded Lyell Immunopharma, where he led a team focused on protein engineering and technology development, playing a key role in developing product candidates and overcoming the mechanisms driving T cell dysfunction. Dr Lajoie completed his postdoctoral studies in David Baker’s lab at the University of Washington, where he helped pioneer the ability to design proteins with moving parts, making it possible to create fundamentally new biological functions. He completed his PhD in George Church’s lab at Harvard University, where he created the first genomically recoded organism with a reassigned genetic code and co-founded GRO Biosciences. Dr Lajoie was named 30 under 30 in science by Forbes Magazine in 2012, 35 Innovators Under 35 by MIT Tech Review in 2019, and Endpoints 20 under 40 in biopharma in 2021. He has authored more than thirty scientific publications and is an inventor on nineteen published patent applications.

Theresa LaVallee, PhD, has more than 25 years of biopharmaceutical and research experience with a broad knowledge in the discovery and development of drugs. She has advanced diagnostics and drugs in oncology, immunology and inflammatory diseases from discovery through late state development. Prior to joining Coherus Biosciences as Chief Development Officer, she was Vice President, Translational Medicine and Regulatory Affairs at the Parker Institute for Cancer Immunotherapy (PICI).   

Before PICI, Dr LaVallee held executive roles in drug development with Celldex Therapeutics and Kolltan Pharmaceuticals and was part of the team that built the immune-oncology (IO) portfolio at Medimmune/AstraZeneca working on the clinical development and regulatory packages for multiple checkpoint inhibitors and PD-L1 diagnostic. Dr LaVallee started her career at EntreMed and worked on the initial clinical development of thalidomide and thalidomide analogs. She has a depth of expertise in regulatory strategy to enable science driven development decisions and quality regulatory packages.   

Dr LaVallee has spent most of her career working on advancing oncology drugs that can improve the survival and quality of life for cancer patients. She has been key in building successful teams, organizations and collaborations.

She is author or co-author of more than 50 publications and abstracts. She received her PhD degree from University of California, Los Angeles and her BA degree from the University of California, Santa Barbara.

As Chief Program Officer at Alliance for Cancer Gene Therapy, Barbara Lavery is responsible for all programmatic initiatives, including leadership of the Academic Research Program, Alliance Partners Program, and the Biotechnology Investment Program, development of ACGT Summits, and Scientific Advisory & Fellows meetings.

Prior to joining ACGT, having spent 18 years leading Zoomedia, a healthcare communications agency, as President and CEO, Ms Lavery joined the non-profit world, leading strategic alliances at GlobalGenes to leverage the resources and capabilities of industry and patient communities to improve health and expedite access to effective therapies for all patients with rare diseases. Ms Lavery served as Chair of the board at Global Genes prior to her role within the organization.

During her career, Ms Lavery has worked with the life science industry providing expertise across issues management, awareness building, internal communications & stakeholder relations, media & investor relations, pre-approval and new product approval support, corporate and brand positioning, events management & meeting support, non-profit community and partnership building, advocacy and KOL relations, and digital and social media strategies.

Ms Lavery has presented at industry conferences and forums including World Medical Innovation Forum, ACGT Summit, RESI, BIO, NIH, Keck Graduate Institute, JLABS, California Life Sciences Association, Xconomy, BioPartnering Europe, Partnering for Cures, C21 Bioventures, New Paradigms. She is a graduate of the Annenberg Foundation Alchemy+ program and holds a BA hons., from Central St Martin’s School of Art, London.

Andy Lee is Senior Vice President and Head, Global Clinical Trial Operations (GCTO). In this role, Mr Lee leads and manages GCTO, with particular focus on global, in-patient clinical trials, designed and executed to meet cost, speed and quality standards. Mr Lee is also responsible for the design and study/data management of clinical protocols in all regions and countries, as well as the tools, systems and processes to conduct Merck clinical trials.

Mr Lee joined Merck in September 2014 from Sanofi, where he served as Senior Vice President and Deputy Head of Clinical Sciences and Operations (CSO) and Head of the CSO Clinical Operations Cluster. In addition to directing the CSO, Mr Lee led the integration of Sanofi with Genzyme, where he was Senior Vice President, Global Clinical Operations. Earlier in his career, he spent more than 16 years in a range of positions of increasing responsibility at Pfizer.

Mr Lee holds leadership positions in a number of professional societies, including the role of Treasurer of TransCelerate Biopharma, Inc, a non-profit organization that comprises the world’s leading pharmaceutical and biotech companies. He also serves as a member of the TransCelerate Operating Committee. Mr Lee received his Masters in Bioenergetics and Physiology from Ball State University in Indiana and two undergraduate degrees from Rhodes University in South Africa.

David Leung, MD, PhD joined RefleXion Medical in December 2021 to strengthen the novel, Biology guidance Radiation Therapy, focusing in developing novel PET fiducials and imaging biomarkers. Before RefleXion, Dr Leung led oncology imaging at Bristol-Myers Squibb since 2015. He is board certified in radiology and nuclear medicine. Prior to joining industry, Dr Leung was a practicing academic radiologist and the modality chief in nuclear medicine specializing in molecular imaging and therapy at Columbia University Medical center, where he maintains an adjunct professorship in radiology. Dr Leung also serves as a board member of the New York State Board for Medical Physics.

Dr Leung received his PhD in chemistry and his MD from the Medical Scientist Training Program at Columbia University. His research interests include synthesis of novel PET radiotracers for oncology and other therapeutic areas. His goal is to become a leader in molecular imaging and therapeutics improving health care outcome.

Bruce Levine, PhD, is the 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 BA (Biology) from Penn and a PhD 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 is co-inventor of the first FDA approved gene therapy (Kymriah), chimeric antigen receptor T cells for leukemia and lymphoma, licensed to Novartis. Dr Levine is co-inventor on 29 issued US patents and co-author of >200 manuscripts and book chapters with a Google Scholar citation h-index of 98. He is a Co-Founder of Tmunity Therapeutics, and of Capstan Therapeutics both spinouts of the University of Pennsylvania. Dr Levine is a recipient of the William Osler Patient Oriented Research Award, the Wallace H. Coulter Award for Healthcare Innovation, the National Marrow Donor Program/Be The Match ONE Forum 2020 Dennis Confer Innovate Award, serves as President of the International Society for Cell and Gene Therapy and serves on the Board of Directors of the Alliance for Regenerative Medicine. He has written for Scientific American and Wired and has been interviewed by the NY Times, Wall Street Journal, Washington Post, NPR, Time Magazine, National Geographic, Bloomberg, Forbes, BBC and other international media outlets.

Elaine Long, PhD, is Scientific Leader for the Immuno-Oncology franchise at GE Healthcare Pharmaceutical Diagnostics. As part of her role, she partners with leading Immuno-Oncology experts and pharmaceutical companies developing immunotherapies, to help GE Healthcare to develop the right diagnostic tools, including PET imaging agents and AI solutions, to address current unmet needs to better select and monitor immunotherapy patients.

Dr Long has a PhD in Molecular Immunology and joined GE Healthcare in 2020 with 15 years clinical research experience. She spent 10 years studying pediatric cancer and immunodeficiency disease at UCL Great Ormond Street Institute of Child Health, London. During her 5 years at Oxford University, Dr Long explored the role of T cells in the balance between immune tolerance and immune activation.

Patrick Lucy has nearly thirty years of experience in the biotechnology industry including corporate development, licensing, partnering, acquisition and financing through his various roles in executive leadership.

As President and CEO of Lykan, Mr Lucy is responsible for driving dynamic growth of the company, developing infrastructure and efficiencies and ensuring successful execution and delivery to our clients.

Prior to joining Lykan, Mr Lucy spent 19 years at Pfenex Inc., which began with the spin out of the novel protein production platform from The Dow Chemical Company into a stand-alone biotechnology company. Mr Lucy played an instrumental role in the development of Pfenex’s initial strategy and evolving that strategy over time to derive greater value from the platform. Pfenex successfully completed an initial public offering in 2014 and received their first FDA product approval in 2019. Mr Lucy and his team built the diverse Pfenex portfolio through licensing, development agreements and partnerships, which ultimately led to the acquisition of the company by Ligand Pharmaceuticals in 2020.

Previously, Mr Lucy held various roles in business development, operations, QC, validation and capital project management at Repligen Corporation, Celltech Biologics, Lonza Biologics and Collaborative BioAlliance.

David Main, MBA is President and Chief Executive Officer of Notch Therapeutics. Previously, as Chairman and CEO of Aquinox Pharmaceuticals, a company he co-founded in 2006, Mr Main oversaw the advancement of the company’s lead product from target validation through Phase 3 clinical trials. He also led the transition of Aquinox from a private company to a NASDAQ-listed public company with approximately $300 million raised in equity capital and then completed the successful merger of Aquinox with Neoleukin Therapeutics. Prior to his leadership of Aquinox, Mr Main served as President and CEO of INEX Pharmaceuticals and as a Vice President of QLT. He formerly served as the Chair of LifeSciences BC (formerly BC Biotech), BIOTECanada, and Accel-Rx as well as a Director of BIO.org. Mr Main began his career as a licensed pharmacist at the Royal Columbian Hospital in New Westminster, BC He holds a BSc (Pharmacy) and an MBA from the University of British Columbia (UBC).

Irina Margine, PhD, is a private equity principal on the Wellington Private Equity Team, where she focuses on private company investing in the area of Biotechnology. Prior to joining Wellington Management in 2019, Dr Margine was on the Equity Research Team at Cowen and Co., covering small and mid-cap biotechnology companies. Previously, she worked in risk management within JPMorgan’s wholesale lending businesses. Dr Margine earned her PhD in microbiology from the Icahn School of Medicine at Mount Sinai in New York and her master of science in biomolecular sciences from Utrecht University in the Netherlands.

Peter Marks, MD, PhD is the director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. The center is responsible for assuring the safety and effectiveness of biological products, including vaccines, allergenic products, blood and blood products, and cellular, tissue, and gene therapies. Dr Marks and center staff are committed to facilitating the development of biological products and providing oversight throughout the product life cycle. Examples of these activities include: reviewing and providing advice during product development evaluating applications and making approval decisions based on safety and effectiveness data monitoring the safety of biological products conducting research that supports product development and characterization “The center regulates and does research on complex biologic products that touch people’s lives on a daily basis,” says Dr Marks. “Many of the products that we regulate are vital for promoting and protecting the public health, including vaccines, blood products, and tissues for transplantation. I’m very proud to lead a team of highly committed individuals whose efforts help to ensure the timely development of safe and effective products to meet important medical needs.” Dr Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University. Following this, he completed an Internal Medicine residency and Hematology/Medical Oncology fellowship at Brigham and Women’s Hospital in Boston, where he subsequently joined the attending staff as a clinician-scientist and eventually served as Clinical Director of Hematology. He then moved on to work for several years in the pharmaceutical industry on the clinical development of hematology and oncology products prior to returning to academic medicine at Yale University where he led the Adult Leukemia Service and served as Chief Clinical Officer of Smilow Cancer Hospital. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in 2016. Dr Marks is board certified in internal medicine, hematology and medical oncology, and is a Fellow of the American College of Physicians.