President of R&D
Dr. Richard Gaynor joined Neon Therapeutics in 2016 as President of Research and Development. Prior to joining Neon, Dr. Gaynor was Senior Vice President of global product development and medical affairs at Eli Lilly & Company. Dr. Gaynor began his career in academia, serving on the faculty at UCLA School of Medicine, then joining the faculty at the University of Texas Southwestern Medical School, including serving as the Chief of the Division of Hematology-Oncology and Director of the Simmons Cancer Center.
Friday November 16, 2018
09.00 | Neoantigen Approaches as Personal and Precision Cancer Therapeutics
Chief Executive Officer
Andrew Allen is co-founder of Gritstone Oncology, and President, CEO and a member of the BoD since August 2015. Previously he co-founded and was CMO at Clovis Oncology (NASDAQ: CLVS), and prior to that was CMO at Pharmion (acquired by Celgene in 2008 for $2.9B). He trained in Medicine at Oxford University, obtained a PhD in Immunology at Imperial College, and worked for several years at McKinsey & Company. He serves on the BoD of Epizyme (NASDAQ:EPZM), Sierra Oncology (NASDAQ:SRRA) and Revitope (private). He served on the BoD of Cell Design Labs, Inc until acquisition by Gilead in Dec 2017.
Thursday November 15, 2018
09.30 | Public vs Private Neoantigens – Can Both Be Used Therapeutically?
Director of Bloomberg-Kimmel Institute for Cancer Immunotherapy
Johns Hopkins Medicine
Dr. Pardoll is an Abeloff Professor of Oncology, Medicine, Pathology and Molecular Biology and Genetics at the Johns Hopkins University, School of Medicine. He is the Director of the Bloomberg~Kimmel Institute for Cancer Immunotherapy and Director of the Cancer Immunology Program at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Dr. Pardoll attended Johns Hopkins University, where he earned his M.D., Ph.D., in 1982 and completed his Medical Residency and Oncology Fellowship in 1985. He then worked for three years at the National Institutes of Health as a Medical Staff Fellow. Dr. Pardoll joined the departments of oncology and medicine in 1988. Dr. Pardoll has published over 300 papers as well as over 20 book chapters on the subject of T cell immunology and cancer vaccines. He has served on the editorial board of the Journal of the National Cancer Institute and Cancer Cell, and has served as a member of scientific advisory boards for the Cancer Research Institute, the University of Pennsylvania Human Gene Therapy Gene Institute, Biologic Resources Branch of the National Cancer Institute, Harvard-Dana Farber Cancer Center, Cerus Corporation, Global Medical Products Corporation, Genencor Corporation, CellGenesys Corporation, Mojave Therapeutics, the American Association of Clinical Oncology and the American Association of Cancer Research. Dr. Pardoll has made a number of basic advances in Cellular Immunology, including the discovery of gamma - delta T cells, NKT cells and interferon-producing killer dendritic cells. Over the past two decades, Dr. Pardoll has studied molecular aspects of dendritic cell biology and immune regulation, particularly related to mechanisms by which cancer cells evade elimination by the immune system. He is an inventor of a number of immunotherapies, including GVAX cancer vaccines and Listeria monocytogenes based cancer vaccines. Dr. Pardoll’s basic immunology discoveries include the identification of gd-T cells, NKT cells and IKDC. He elucidated the role of Stat3 signaling in tumor immune evasion and in Th17 development, leading to the discovery that Stat3-driven Th17 responses promote carcinogenesis. Dr. Pardoll discovered one of the two ligands for the PD-1 inhibitory receptor and leads the Hopkins cancer immunology program that developed PD-1 pathway-targeted antibodies, demonstrating their clinical activity in multiple cancer types. His more than 300 articles cover cancer vaccines, gene therapies, cancer prevention technologies, recombinant immune modulatory agents for specific pathways that regulate immunity to cancer and infectious diseases.
Vice President of Research
Parker Institute for Cancer Immunotherapy
Fred Ramsdell currently leads the development of collaborative research programs at the Parker Institute for Cancer Immunotherapy as Vice President of Research. After an NIH fellowship, Fred joined Immunex, cloning and characterizing various tumor necrosis factors and their receptors. He later joined Darwin Molecular (subsequently acquired by Celltech) where his team’s efforts included the discovery of FOXP3, the key factor for regulatory T cells. The discovery was awarded the 2017 Crafoord Prize. Fred has held positions at ZymoGenetics and Novo Nordisk and currently sits on various SABs
Medical Officer, Office of Tissues & Advanced Therapies
Dr. Laronna Colbert is a board certified Medical Oncologist and a clinical reviewer in the Oncology Branch, Division of Clinical Evaluation and Pharmacology/Toxicology, in the Office of Tissues and Advanced Therapies (OTAT) at the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA). While at the FDA Dr. Colbert has participated in the Oncology Center of Excellence (OCE) Multidisciplinary Breast Cancer Working Group, the NCI Cancer Prevention Steering Committee and OTAT’s “Design, Analysis and Review of Clinical Trials” (DART) seminar committee. She currently holds clinical privileges at the Washington DC Veterans Administration Medical Center.
Thursday November 15, 2018
17.00 | Clinical Considerations for Neoantigen-based Cancer Therapy - A Regulatory Perspective
Senior Quality Assessor, MHRA,
Dr Christiane Niederlaender, MHRA Christiane Niederlaender is a Senior Quality Assessor and Deputy Unit Manager of the Biologicals Unit of the MHRA Licensing Division, where she has worked since 2011. She has experience in all classes of biological medicinal products, but her work has a particular focus on advanced therapy medicinal products. She is the UK representative at EMA CAT. Prior to joining the MHRA, Christiane worked for the UK Human Tissue Authority and has extensive regulatory and scientific experience with in tissue and cell therapies. Christiane received a Ph.D. in molecular developmental neurobiology from Kings College London and has spent several years researching and publishing in the area of cancer, development and neurobiology before taking a law degree and joining the regulatory profession.
Head of Vaccine Adjuvant Research
Statens Serum Institute
Prof. Christensen is heading the vaccine adjuvant research at Statens Serum institute and in addition visiting Professor at University of Strathclyde. He has for the last 14 years been working with pharmaceutical and immunological aspects of adjuvant delivery systems including targeted delivery of vaccines. In this period he has played a key role in the development of the two adjuvants that Statens Serum Institut has taken into clinical evaluation: 1) CAF01, five phase 1 evaluations and 2) CAF09, phase 1 evaluation ongoing. He is an acknowledged scientist and key opinion leader in the vaccine adjuvant field.
Director, Process Development & CMC, Personalized Vaccines Unit
Dave is Director of Process Development and CMC for Moderna’s Personalized Vaccines Unit. Previously, he was Associate Director of PD and Tech Transfer at WuXi AppTec in Philadelphia, where he focused on the manufacturing readiness of cell therapy and AAV processes. Prior to 2014, Dave held multiple roles within MS&T and PD at Merck and Company in West Point, PA. His experience spans from early development to commercial support of licensed vaccine products, and crosses cell culture and purification of mRNA, VLP and live virus vaccines, gene therapy vectors, and cell therapies. Dave holds a Doctorate in Biological Engineering from the University of Pennsylvania, and obtained his Bachelors of Chemical Engineering from the University of Delaware.
Project Leader, Personalized Vaccines,
Kaidre is the project leader for Theragnostics and Biomarkers at Transgene. He is responsible for:
- Development of biomarkers strategies for product differentiation and positioning of new cancer immune therapies at clinical stage
- Design and implementation of translational research programs onto clinical development studies
- Acting as subject matter expert in the regulatory registration of a companion IVD test
- Coordination of internal and external stakeholders for the implementation of the biomarker strategy
Bioinformatics Data Scientist, University of California
Rachel Marty has been analyzing proprietary basketball shot data as a Noah Basketball data scientist since 2015. She has presented her research on 3-point shooting at the MIT Sloan Sports Analytics Conference for the past two years and won the best poster award in 2017. In addition to her work with Noah Basketball, Rachel is a PhD candidate in Bioinformatics at UCSD, where she received a NSF Graduate Research Fellowship to fund her computational cancer immunology research. Her research focuses on algorithmic classification of genomic, immune-coding regions that impact cancer progression. Prior to graduate school, she graduated with a bachelor’s degree in Computer Science from UCSD, where she also lettered on the NCAA basketball team.
Chief Scientific Officer
Dr. Flechtner joined Genocea in 2007, soon after the company was founded, and currently serves as Chief Scientific Officer. She is widely recognized as a pioneer in the development of novel vaccines directed toward T cell immunity and has more than 20 years of experience in immunology, cancer, infectious disease, and vaccine development. She leads Genocea’s efforts to develop T cell-directed vaccines and immunotherapies against cancer using the company’s proprietary ATLAS platform to identify and characterize both common and personalized antigens. Prior to joining Genocea, Dr. Flechtner served in a variety of roles developing vaccines and immunotherapies for cancer, infectious disease, autoimmunity, and allergy at companies including Mojave Therapeutics and Antigenics (now Agenus). She received a B.S. in Animal Science and a Ph.D. in Cellular Immunology from Cornell University, and performed her post-doctoral work at Dana Farber Cancer Institute and Harvard Medical School. Dr. Flechtner is a member of Women in Bio, the American Association of Immunologists, American Association for Cancer Research, Society for Immunotherapy of Cancer, President’s Council of Cornell Women, and American Society for Microbiology. She is also an inventor on numerous pending and issued patents and is the author of multiple peer-reviewed scientific publications.
Chief Technology Officer
Dr. Roman Yelensky is Gritstone’s first employee and serves as chief technology officer, with responsibility for the genomics and informatics program. 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.
Professor & Director of Dodson Interdisciplinary Immunotherapy Institute at Miller School of Medicine,
University of Miami
Dr. Gilboa is the Joe Enloe Dodson professor in the Department of Microbiology & Immunology, and Director of the Dodson Interdisciplinary Immunotherapy Institute at the Miller School of Medicine, University of Miami, USA. Dr. Gilboa is known for his pioneering work in gene therapy for genetic disorders, HIV/AIDS, and cancer. The current research in the Gilboa lab is focusing on the development of multi-pronged approaches to cancer immunotherapy using novel drug and drug delivery platforms of oligonucleotide aptamer-targeted RNA therapeutics, and has introduced new concepts in cancer immunotherapy such as inducing neoantigens in disseminated tumor lesions, promoting immune memory, and targeting immune modulation to the tumor lesion.
Chief Scientific Officer
Dr. Franzusoff joined PACT Pharma in 2017 to develop personalized adoptive T cell therapies using precision genome-engineered patient T cells that target confirmed tumor neoepitopes. Alex has actively contributed to significant advances in immuno-oncology (I-O). As SVP R&D at Bavarian Nordic, his team’s work on cancer immunotherapy was key to the $1B deal with BMS in 2015. Dr. Franzusoff earlier co-founded GlobeImmune, where he served as VP R&D, developing immunotherapy against cancer & infectious diseases. In Boston, Alex was CEO & Director for AZTherapies, developing Alzheimer’s combination drug therapies for Phase 3 studies. He previously led the venture-backed Permeon Biologics developing intracellular biologics. Alex was tenured faculty at the Univ. of Colorado Medical School until 2004. Dr. Franzusoff received his PhD in Biochemistry from SUNY Stony Brook, NY. Dr. Franzusoff trained as a postdoctoral fellow with the Nobel Laureate, Dr. Randy Schekman, at UC Berkeley.
Chief Medical Officer
Chief Scientific Officer
Elisa Scarselli (MD), is currently CSO of Nouscom, a biotech dedicated to the development of novel vaccination strategies for cancer immunotherapy. She has a long standing experience in immunology and molecular biology and she has been working for more than ten years in the field of cancer immunotherapy. Elisa, in her previous role of clinical director at Okairos, stengthened her expertice in clinical development of viral vectored vaccines to obtain regulatory approval in different countries of several Phase I and II trials.
Founder & CEO
Dr. Antonella Vitiello founded PersImmune in 2010. Presently, PersImmune is conducting a clinical trial (NCT03258359) of personalized adoptive T cell therapy targeting MDS stem cell neoantigens (PACTN). Prior to PersImmune, Dr. Vitiello’s scientific activities have been mainly focused on the study of the T cell antigenic repertoire and the requirements for in vitro and in vivo induction of cytotoxic T lymphocytes (CTL). Highlights of her scientific career include the discovery of antigen selection by the MHC, the development of HLA-transgenic mice to study the human HLA-restricted CTL repertoire, the relationship between epitope immunodominance and peptide binding affinity to HLA, the demonstration that adoptive transfer of memory and naïve T cells can prevent cancer in a transgenic mouse model of orthotopic prostate cancer. In the human system, Dr. Vitiello has been responsible for the development and testing (Phase I) of the first peptide vaccine to induce a CTL immune response, and development of a procedure to induce a primary CTL response in vitro against myeloid blasts. These T cells can then be adoptively transferred into patients. Dr. Vitiello obtained her doctorate in Pharmacy at the University of Pavia in Italy.
Co-Founder & Chief Scientific Officer
Alex Karlsson-Parra, MD, PhD is associate professor in clinical immunology at Uppsala University, Uppsala, Sweden, with special expertise in transplantation immunology and cancer immunotherapy. He is co-founder and CSO of the clinical-stage biopharmaceutical company Immunicum AB advancing allogeneic cell-based, off-the-shelf, anti-tumor immune primers against a range of solid tumors
Vice President of Molecular & Information Systems
As VP of Molecular Immunology and Information sciences Agenus Inc, Dennis leads the core functions of Research Biochemistry, Molecular and Structural Biology, Visualization Information Systems and IT. He has over 25 years of leadership experience in life sciences including pharma, biotech and Health IT. Before joining Agenus, Dennis was CEO and a founder of Praxeon, Inc., a healthcare informatics company with novel technology that enhanced medical care by providing highly specific, on-target, health information to clinicians and patients. Prior to that, he pioneered the use of Pattern Discovery, a data mining technology, for clinical diagnostics with Cira Discovery Sciences. Dennis has extensive R&D experience in major pharmaceutical and biotechnology environments at Merck, DuPont Pharmaceuticals, BMS and Infinity Pharmaceuticals and has worked on a broad range of therapeutic areas. While at Merck he developed his core interests in applying structural information to understanding biological function that led to identification of the nuances that drive the pharmacology of GPCR signaling mechanisms. This led to the identification of novel GPCR ligands across a range of therapeutic targets. Dennis has also developed key computational methods that underpin some of the most important big data approaches utilized today in drug discovery. He did his Ph.D. in Physical Organic Chemistry from his Adelaide University in his native Australia and post-doctoral fellowships at Rockefeller and Cornell University.
Chief Executive Officer
Bill is a scientist-entrepreneur and CEO of EpiThany. He completed a Doctorate in Pharmacology at the University of Washington (UW) and 3 postdocs at the FHCRC and the UW Depts. of Biochemistry and Bioengineering. He has published work on GPCR pharmacology and drug design, pulmonary physiology, sensory neuroplasticity, neurodegenerative disease, and epitope-based vaccines. He played key business and operational roles in innovative companies including GNI Ltd. (Tokyo), iPierian (San Francisco), and Kineta (Seattle). In 2014 Bill co-founded EpiThany Inc., financing the company personally and helping draft the foundational IP. He has worked in Japan and Korea and speaks both languages.
Chief Technical Officer
Dr. Husbyn completed her PhD at University of Oslo, Norway within the area of peptide synthesis and the testing of complex peptide domains and derivatives as anticoagulants. She has worked within R&D of the Pharmaceutical and Biotech industry for 20 years and has extensive experience within CMC from early discovery until filing of NDA/MAA. For 15 years she held a variety of positions at GEHC ranging from scientist and project manager to department manager, before she joined a small Norwegian Cancer Immunotherapy company in 2012. There she took on the role as Head of CMC. In October 2017 she started at Vaccibody as CTO and was introduced to the area of individualized therapeutic pDNA cancer vaccines.
Tumor Immunology & Immunotherapy
Senior Director Research Biochemistry
Mark A. Findeis is Senior Director of Research Biochemistry at Agenus Inc. He has over 25 years of drug discovery and development experience across a broad range of small to large molecule programs including gene therapy, and a variety of indications including neurodegeneration, infectious diseases, inflammation, and oncology. He has previously held positions at Harvard Medical School, TargeTech, PRAECIS, and was the founding scientist of Satori Pharmaceuticals. He has also consulted for a number of additional large and small pharma organizations. He did his academic training at MIT, Harvard and The Rockefeller University.
Research & Early Development Scientist
Dr Mahesh Yadav is currently a scientist in Oncology Biomarker Development at Genentech. The research projects in his lab focus on characterizing role of tumor mutations in driving anti-tumor responses in cancer immunotherapy. He is developing neoantigen based personalized cancer vaccine and his group is responsible for immune monitoring to validate PCV activity in clinic. Previously his research focused on identification of neoantigens in mouse tumor models and further validating their potential as cancer vaccine (published in Nature 2014). Prior to joining Genentech, he completed his postdoctoral training at UCSF with Dr. Jeff Bluestone where he investigated role of regulatory T cells in autoimmunity and immune homeostasis.
Chief Executive Officer
Stephen Albert Johnston directs the Center for Innovations in Medicine (CIM) at the Biodesign Institute. CIM is unique in its focus on inventing disruptive technologies in biomedicine. The mission is to contribute to the transformation of medicine through technologies that allow prevention, early detection and new therapeutic treatment of disease. Johnston largely focuses on invention. He was inventor/co-inventor of pathogen derived resistance, mitochondrial transformation, TEV protease system, the gene gun, gene immunization, expression library immunization, linear expression elements, synbodies and immunosignaturing. He was professor and director of the Center for Biomedical Inventions at UT-Southwestern Medical Center and Professor of Biology and Biomedical Engineering at Duke University before moving to ASU. Johnston was co-founder of Eliance (now Macrogenics) and HealthTell. He is currently CEO of Calviri, Inc. Calviri is focused on development of novel preventative and therapeutic cancer vaccines and platforms for the early detection of cancer.
Chief Executive Officer
Jeff Roix is CEO of NeoPhore and a company founder. Jeff was previously Chief Operating Officer at Cambridge-based PhoreMost Limited, where he was responsible for launching company operations and building the company’s scientific and portfolio strategy. Jeff has over 15 years experience across biotech, pharma and venture settings, having contributed to preclinical research and clinical development of first-in-man trials for multiple novel cancer drugs, as well as innovative research in diabetes genetics and pharmacology. Jeff obtained his degree from the Harvard Extension School, and previously worked at BioMed Valley Discoveries, Constellation Pharmaceuticals, and MIT.
Professor & Director of UCSF Brain Tumor Immunotherapy Program
University of California, San Francisco
As a physician–scientist, Dr. Okada has been dedicated to development of effective immunotherapy for brain tumor patients for over 20 years. His team was one of very first to discover cytotoxic T lymphocyte (CTL) epitopes in glioma-associated and glioma-specific antigens. Dr. Okada has translated these discoveries into a number of innovative immunotherapy clinical studies. Dr. Okada’s team recently identified a novel neoantigen epitope in Histone variant 3 K27M, and and cloned a high affinity T-cell receptor against the epitope. Based on these studies, Dr. Okada is currently developing the first-in-human TCR-transduced T-cell therapy for patients with H3.3K27M+ glioma.
Vice President of Technical Operations
Marc Wolfgang is the Vice President of Technical Operations at Neon Therapeutics, overseeing manufacture and quality control of neoantigen cancer vaccine and T-cell therapies. Marc has 25 years of biotech/pharma experience, holding various positions in CMC, quality and regulatory affairs at Cerulean Pharma, Momenta Pharmaceuticals, Millennium Pharmaceuticals, Biogen and Boehringer Ingelheim Pharmaceuticals. Marc has a B.S. degree in Biology and a M.S. degree in chemistry. He is the former Chairman of the Nanomedicines Alliance and a former steering committee member for AAPS’s Nanotechnology Focus Group.
Erin E. Jones
Senior Vice President and Global Head of Regulatory Affairs and Quality Assurance
Erin Jones is senior vice president and global head of regulatory affairs and quality assurance at Gritstone Oncology. Previously, he oversaw BLA submissions and ODAC preparations for Nerlynx™, Kadcyla™ and Perjeta™ in HER2-positive breast cancer, and approvals for Herceptin™ in breast and gastric cancers. He has directed regulatory development of dozens of small molecules, monoclonal antibodies, antibody-drug conjugates, plasmids, adenoviral gene therapies, and companion diagnostics in oncology and hematology at Genentech, BioMarin, Cephalon and Centocor. He received his M.S. in computer systems at Pennsylvania State University.
Professor of Immunology
Keith L. Knutson, Ph.D., is a consultant in the Department of Immunology, Mayo Clinic in Florida, where he also serves as director of the Discovery and Translation Lab’s Cancer Research Program. Dr. Knutson joined the staff of Mayo Clinic in 2005 and holds the academic rank of Professor of Immunology, Mayo Clinic College of Medicine and Science. Dr. Knutson is also Director of the Mayo Clinic Cancer Center’s Cancer Immunology and Immunotherapy Program. Dr. Knutson received his B.S. in Microbiology at the University of Washington. He earned his Ph.D. in Physiology and Pharmacology from the University of Georgia and completed two postdoctoral fellowships in immunology, one at the University of British Columbia and the other at the University of Washington. Dr. Knutson received his B.S. in Microbiology at the University of Washington. He earned his Ph.D. in Physiology and Pharmacology from the University of Georgia and completed two postdoctoral fellowships in immunology, one at the University of British Columbia and the other at the University of Washington. Dr. Knutson is internationally recognized in the field of cancer immunology. His research focuses on the immunology and immunotherapy of breast and ovarian cancers, both the basic immunobiology and clinical translation, including clinical trials. His contributions to science include clinical development and testing of self-tumor antigen-specific vaccines in patients with breast and ovarian cancers. He currently has three FDA-approved vaccine trials underway and is principal investigator of 3 Department of Defense grants to test vaccines aimed at preventing recurrence breast cancer, including triple negative breast cancer for which there are no targeted therapies. Dr. Knutson is frequently invited to give presentations on his research both domestically and internationally, and he has authored numerous journal articles, abstracts and other written publications, consistently publishing in high-impact scientific journals. Additionally he holds reviewer responsibilities for several prominent publications. In recognition of his work, Dr. Knutson has received many awards and honors, including the Young Investigator Award-Pharmingen, conferred by the American Association for Cancer Research, and the prestigious Howard Temin Award, conferred by the National Institutes of Health, National Cancer Institute. He is also recognized as the 2017 Investigator of the Year at the Mayo Clinic campus in Florida. In addition to his research activities, Dr. Knutson is active in education and has mentored postdoctoral fellows, research associates and medical students, among others. He holds full faculty privileges in Immunology in Mayo Clinic Graduate School of Biomedical Sciences. Dr. Knutson’s has several current and past memberships with professional organizations which include the Breast Cancer Research Program and the Ovarian Cancer Research Program of the United States Department of Defense, the Tumor Microenvironment Study Section of the U.S. National Institutes of Health Center for Scientific Review, and the Education and Training Committee for the Society for the Immunotherapy of Cancer. He is a Principal Investigator of the Artemis Project, National Breast Cancer Coalition, where he is leading efforts to produce prevention vaccines for breast cancer.
Professor & Director of Center for Inflammation & Epigenetics
Director Bioinformatics Applications
Thursday November 15, 2018
16.30 | From Sample to Neoantigens for Vaccines: Key Challenges and Solutions
Chief Scientific Officer
Co-Founder & CSO