The Changing Environment Around Accelerated Approvals and Regulatory Pathways

Amy Blawas joined NDA Group in 2020 and has over 20 years’ experience in the pharmaceutical and regulatory industry, primarily in biologics and cell therapy. She applies her skills & knowledge to a broad range of therapeutic areas and has successfully helped clients prepare & interact with Health Authorities throughout the stages of drug development. Dr Blawas’s therapeutics areas of expertise include personalized medicine, gene and cell therapy, oncology, rare disease, infectious disease, biomaterials, implants, medical devices, transport theory, kinetics, immunology, and cell biology. She is experienced in planning and development of clinical studies, including preparation of protocols, INDs, and Final Clinical Study Reports, regulatory action plans for post-approval commitments and continuous quality improvement and coordination of multi-disciplinary activities between clinical, nonclinical and CMC development disciplinesBefore NDA, Dr Blawas worked for a vaccine company as Associate Director of Regulatory Affairs working with European and US Regulatory agencies. She has worked for CROs and Biotech companies, primarily with Biologics.Dr Blawas has a PhD in BioMedical Engineering from Duke University and the ability to interconnect across divergent disciplines of drug development with a thorough knowledge of FDA and ICH Regulations in the pharmaceutical business.

Dr Jeffrey Bornstein has served as the Chief Medical Officer of Eledon Pharmaceuticals since April 2021. Prior to joining Eledon, he served as Vice President, Head of Clinical Sciences, Gastroenterology at Takeda Pharmaceuticals, and he has previously led development programs at Biogen, Gilead Sciences, Elan Pharmaceuticals and several early stage biotechs. Dr Bornstein earned his Doctor of Medicine and completed his residency in internal medicine at McGill University. He also completed a fellowship in gastroenterology at Duke University Medical Center where he subsequently served on the faculty as an Assistant Professor of Medicine.

Edith A Perez, MD, Chief Medical Officer, is an internationally recognized translational researcher and cancer specialist known for her strategic vision in innovative and patient-centric clinical trial design. Dr Perez joined Bolt in 2020 and has set direction for the organization’s clinical strategy and development and oversees regulatory affairs, pharmacovigilance, biostatistics and medical affairs for the company’s diverse clinical development and early-stage immuno-oncology pipeline.In addition to her work at Bolt Biotherapeutics, Dr Perez is chair of the Health Equity Committee and vice chairperson of the Scientific Advisory Committee for Stand Up to Cancer, a member of the Puerto Rico Science, Technology & Research Trust and has been involved in diversity leadership and philanthropic initiatives with the American Society of Clinical Oncology, the American Association for Cancer Research and The DONNA Foundation. She also serves on the editorial boards of multiple academic journals and is a member of the Board of Directors and the Clinical Advisory Board for Artiva Biotherapeutics. Dr Perez is a professor emeritus of the Mayo Clinic, where she practiced for more than two decades. Prior to joining Bolt, Dr Perez was vice president and head of the BioOncology-US Medical Affairs unit at Genentech, a member of the Roche Group, where she oversaw all US hematology and oncology medical affairs. In that role, Dr Perez led hundreds of trials and was involved in the launch of six drugs, including Gazyva (obinutuzumab) for patients with lymphoma, Perjeta (pertuzumab) for patients with early-stage HER2+ breast cancer, Alesensa (alectinib) for patients with lung cancer and Tecentriq (atezolizumab) for bladder cancer and non-small cell lung cancer patients.Dr Perez earned her medical degree from the University of Puerto Rico School of Medicine in San Juan and completed her residency in internal medicine at the Loma Linda University Medical Center in California. In addition, Dr Perez completed her fellowship training at the University of California, Davis. She also completed the Executive Development Program at the Harvard Kennedy School and the Executive Leadership and the Management Executive Programs at the Wharton School of the University of Pennsylvania. Dr Perez is board certified in internal medicine, medical oncology, and hematology.