In January, the Alliance for Regenerative Medicine (ARM) released its State of the Industry Briefing which highlighted a record-breaking year for 2021. $23.1B raised for the advanced medicines sector (a 16% increase from 2020), 2,261 ongoing regenerative medicine clinical trials globally, and the evolution from treating and curing rare monogenetic diseases to more prevalent indications. Could we see 10-20 approvals each year by 2025?
This panel, sponsored by Precision ADVANCE, will feature insights from industry leaders on their organization’s pipeline, the advanced therapy investment landscape, and the regulatory, manufacturing, and commercial needs to successfully bring an advanced therapy to market.
David Parker, PhD, is Senior Vice President, Diagnostics Solutions, with Precision for Medicine. He currently leads Precision’s Diagnostics Market Access and Commercialization consulting practice and provides strategic advisory services to the firm’s biopharma and diagnostics clients. David has over 35 years of experience in the healthcare industry, including 24 years of strategy consulting experience centered on the intersection of reimbursement, health economics, clinical science, and marketing strategy. His consulting encompasses all aspects of market access, reimbursement, and evidence development strategy, with a particular focus on personalized medicine, advanced molecular and companion diagnostics, and targeted therapies.
David is a subject matter expert with Precision ADVANCE, a collection of interconnected services and complementary teams uniquely focused on the complexities of clinical, regulatory, manufacturing, and commercial needs to successfully bring cell or gene therapies to market.
Michele Korfin has over 25 years of experience in the biotech/pharma industry, focused on product launches, clinical development, manufacturing, oncology marketing strategy, commercial sales, market access and government affairs. She is experienced at leading cross-functional launch planning for cell therapy and other specialized hematology/oncology therapies.
Ms. Korfin is the Chief Operating Officer and Chief Commercial Officer for Gamida Cell. Gamida Cell is an advanced cell therapy company committed to cures for patients with blood cancers and serious blood diseases. Ms. Korfin is responsible for leading the strategy and execution for operations for the omidubicel BLA and for the commercialization plans, post-FDA approval. She also provides oversight for the operations and commercial strategy for the Natural Killer Cell platform.
Prior to joining Gamida Cell, Ms. Korfin was the Chief Operating Officer of TYME Technologies. Ms. Korfin’s focus at TYME was to advance the pivotal clinical trials for SM-88, an oral therapy and the lead investigational agent for the TYME proprietary cancer metabolism-based therapeutics (CMBTsTM) platform.
Palani Palaniappan currently serves as the Chief Technology Officer of Pioneering Medicines at Flagship Pioneering where he is focused on developing interventions and potential cures for a variety of diseases. He is interested in drug development efficiencies and access to medicine using a right drug for the right tissue approach. Palani has over 25 years of pharmaceutical development backgrounds. He most recently served as the Executive Vice President and Chief Technology Officer at Aruvant Sciences overseeing gene and cell therapy development for rare diseases such as sickle cell disease and hypophosphatasia. His other executive roles included Head of Global Technical Operations at Sarepta Therapeutics overseeing development of RNA and DNA therapies for neuromuscular and musculoskeletal conditions, and Global Head of Biologics and New Modality Development at Takeda Pharmaceuticals for over a decade focusing on oncology, GI and CNS diseases where he led teams based in Japan and the US. His early career included leadership positions at Millennium Pharmaceuticals, Biogen, Nexstar Pharmaceuticals and Par Pharmaceuticals. Throughout his career, Palani participated in all stages of development from research through commercial for portfolios of different modalities including biologics, antibody drug conjugates, RNA and DNA therapies, autologous and allogeneic stem cell therapies, and live microbial products.
Phil Cyr is Senior Vice President of Customer Solutions for Precision Value & Health with responsibility for cell and gene therapy. Phil has over 24 years of health economics, outcomes research, health policy, and payer experience including a strong record of conducting published research, conducting health technology appraisal within a U.S. payer and interacting with global HTAs. Phil and his team have worked on 4 launched cell and gene therapies.
Phil is a subject matter expert with Precision ADVANCE, a collection of interconnected services and complementary teams uniquely focused on the complexities of clinical, regulatory, manufacturing, and commercial needs to successfully bring cell or gene therapies to market.
Rahul Singhvi is a global leader in the Life Sciences industry and serves as the Chief Executive Officer of National Resilience, Inc.
Most recently, Rahul was an Operating Partner at Flagship Pioneering, a Boston-based life sciences innovation firm where he was responsible for founding and operating companies launched from Flagship’s innovation foundry, Flagship labs. Before joining Flagship, Rahul was the Chief Operating Officer of Takeda’s Vaccine Business Unit where he was responsible for worldwide vaccine CMC and manufacturing operations. During his six-year tenure at Takeda, the vaccine business grew to over 500 employees and created an industry leading late-stage pipeline of vaccine candidates against dengue, norovirus, and zika. Before Takeda, Rahul was President and CEO of Novavax, Inc. (Nasdaq: NVAX) where he transformed the company from a specialty pharmaceutical business to a vaccine development company with vaccine candidates against influenza (funded by BARDA) and respiratory syncytial virus (RSV). Rahul’s professional career began at Merck & Co in 1994, where he held several positions in R&D and manufacturing.
Anshul is the President of Project Farma (PF) and Precision ADVANCE. He founded and grew PF into a leading global biologics and advanced therapy engineering consulting firm. In addition, Anshul has served as general counsel and managed all corporate legal transactions. Under Anshul's leadership, PF pioneered the industrialization of advanced therapies including two notable, commercially approved cell and gene therapies and created PF's Advanced Therapy Manufacturing Playbook. This playbook helped develop the largest cell and gene therapy manufacturing footprint in the world. To date, PF has led 20+ facility builds with over $1BB in capital spend, selected and managed 60+ CDMO engagements and partnered with over 40+ advanced therapy organizations.
Project Farma was acquired by Precision Medicine Group in 2020 to be the cornerstone of Precision ADVANCE. ADVANCE is a collection of Precision's interconnected services and complementary teams uniquely focuses on the complexities of clinical, regulatory, manufacturing, and commercial needs to successfully bring a cell or gene therapy to market. Anshul is also dedicated to advancing next-generation medicines through his philanthropic efforts at the Institute for Life Changing Medicines, various patient-advocacy organizations, and the Alliance for Regenerative Medicine.