Susan Abu-Absi, Ph.D. is Senior Vice President, Pharmaceutical Development & Technology at bluebird bio, a clinical stage gene therapy company located in Cambridge, MA. The integrated product platforms at bluebird bio encompass gene therapy, cancer immunotherapy and gene editing – providing the potential to treat a broad range of serious diseases. She leads the teams that develop the CMC strategy and deliver and support the manufacturing processes and analytical methods required to advance therapies through clinical stages to commercial products and throughout the lifecycle. Susan has over 20 years of experience in biologics process development and manufacturing. Prior to joining bluebird bio, she spent more than ten years in the Manufacturing Sciences & Technology organization at Bristol-Myers Squibb. As a leader at BMS, she contributed to the successful development and commercial supply of several products, including the launches of Opdivo®, Empliciti™, Yervoy®, and Nulojix®. Susan earned a Ph.D. in Chemical Engineering from the University of Minnesota.

Peter Marks, M.D., Ph.D. 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. 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.

Dr. Scott McMillan joined uniQure as Chief Operating Officer in August 2017. Dr. McMillan served most recently as Senior Vice President of Quality and Technical Operations at AMAG Pharmaceuticals where he also was a member of its Executive Management Team. Before joining AMAG Pharmaceuticals, Dr. McMillan held similar positions at AVANT Immunotherapeutics, Inc., and with Johnson Matthey Pharmaceutical Materials, Inc. Dr. McMillan has over 25 years of biotechnology experience in quality, process development, scale-up, technology transfer from bench to commercial scale as well as manufacturing operations. Dr. McMillan holds a Ph.D. in Chemical Engineering from Georgia Institute of Technology, a Master’s degree in Economics and Bachelor’s degree in Chemical Engineering from the University of Delaware.

Dr. Rod Rietze is the past Director of Strategic Development and Innovation at Novartis Pharmaceuticals (Cambridge, MA), where he supported the development of novel bioprocesses, analytics and other enabling technologies for next generation cell and gene therapies, as well as the global manufacture of Kymriah™, the first FDA-approved personalized CAR-T cell therapy. This role was a continuation of his work at Novartis’s Cell and Gene Therapy Unit, where he led the Automation Network that was responsible for transforming a portfolio of small-scale manufacturing processes into scalable platforms sufficient for late stage clinical and commercial scale production. Prior to joining Novartis, Rod led research teams in the discovery and early clinical development of both small molecule and cell-based therapeutics for neural, cardiovascular and auto-immune indications at Pfizer Regenerative Medicine (Cambridge, UK). Preceding his transition to Industry, Rod was a co-founder and faculty member of the Queensland Brain Institute (Brisbane, Australia), where his lab focused on understanding the biology and harnessing the regenerative capacity of resident neural stem cells to slow age-related cognitive decline. His seminal discoveries were featured on the covers of Nature and Science, and received numerous awards including Science Magazine’s “Breakthrough of the Year”. Dr. Rietze has nearly two decades of technical, operational and strategic leadership experience in the development of novel therapeutics and is passionate about delivering innovative technologies and medicines to transform the treatment of disease. He holds a BSc and MSc from the University of Calgary, and a PhD from The Walter and Eliza Hall Institute (University of Melbourne, Australia).

Kelley Rogers is the Technical Program Manager for the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) at the National Institute of Standards and Technology (NIST) Office of Advanced Manufacturing (OAM). In this role, Kelley provides oversight to ensure mission alignment and effectiveness of the technical activities within NIIMBL, a NIST-sponsored Manufacturing USA institute focused on the acceleration of biopharmaceutical manufacturing innovation in the United States. In addition to her responsibilities with NIIMBL, Kelley is the Technical Program Director for Biosciences for NIST's Material Measurement Laboratory. In this role, she works to develop NIST’s technical portfolio to meet current and future measurement sciences needs for the industrial and clinical applications of biotechnology. Kelley received a Ph.D. in Molecular Biophysics and Biochemistry from Yale University and a B.A. in Chemistry from Hendrix College, and was a post-doctoral and staff fellow in the National Institute of Digestive, Diabetes, and Kidney Diseases, at the National Institutes of Health. Her research expertise is in bacterial protein synthesis and cell signaling pathways. After completing her fellowship at NIDDK, and prior to joining NIST, Kelley worked as a Principal Investigator in the biopharmaceutical industry, identifying novel targets for antimicrobial drugs.

Kevin is President and Founder of ThinkQuality, LLC – an innovative consulting firm providing clients across the life science ecosystem with practical strategies, solutions and coaching to address a wide array of quality and regulatory compliance-related challenges and opportunities from early stage discovery through critical CMC development milestones to product approval/launch and beyond. He has over 25 years of real world boots-on-the-ground experience/insights into the complex and global rigors of small and large organizations and draws on over 10 regulatory product approvals (from Lipitor® to Linzess®) and many more investigational and commercial products from numerous therapeutic categories and delivery systems. He earned a B.S. in Chemistry at Tufts University and a Ph.D. in Analytical Chemistry from the University of Massachusetts at Amherst – beginning his career as a scientist/analytical chemist in the consumer products industry. Kevin transitioned into a broader Quality role while at Warner-Lambert/Parke Davis (now Pfizer). Since then, he served in senior, global Quality leadership roles at Purdue Pharma (Director, Research Quality Assurance), AstraZeneca (Global Head, R&D GMP Quality Assurance), Nektar Therapeutics (Vice President and Head, Quality) and Ironwood Pharmaceuticals (Vice President and Head, Global Quality). Kevin is an active and engaged member of MassBio, including co-chair for the DRUGMAN & SUPPLY working group and MassConnect mentor, and is very passionate about working with industry, academia and regulators to advance Quality Practices in education, innovation and new technologies across the life sciences. He is a contributor to IPQ (International Pharmaceutical Quality) – the publication that provides in depth coverage on CMC/GMP regulatory policy.