The Coronavirus Aid, Relief, and Economic Security (“CARES”) Act, signed in March 2020, provides emergency assistance and health care response for individuals, families, and businesses affected by the 2020 coronavirus pandemic. Our focus will be on understanding the impact of the CARES Act on the life sciences and the pharmaceutical industry with respect to:
- Ensuring the availability of lifesaving drugs by addressing supply chain security risk management and supply shortages of critical drugs and medical products.
- Supply Chain and manufacturing countermeasures and risk management/ supplier redundancy strategies, as well as other preparedness and response activities to mitigate drug shortages.
- Requirement for emerging Biopharmaceutical companies to develop a supply chain risk management and redundancy plan in accordance with the provisions of the CARES Act, which can now be audited by the FDA.
Speakers
Chris Silva
VP Procurement, Supply Chain at Akebia Therapeutics
Chris Silva will be participating as a CARES Act and Supply Chain Resilience/Risk Management discussion panel member, sharing over 20 years of biopharmaceutical supply chain, sourcing and procurement experience. Throughout his career, Chris has improved Operations organizational performance by facilitating suppliers to improve their own performance, created effective supply chains, and supported new product introductions while fostering collaboration and use of appropriate processes to develop productive supplier relationships. Chris began his career at Transkaryotic Therapies (later Shire HGT) and progressed through a number of critical roles as the organization established their global supply chain. Chris later went on to various Strategic Sourcing and Procurement leadership roles at Alkermes, Synageva, and Radius Health before joining Akebia Therapeutics, a leader in the development and commercialization of drugs for the treatment of renal and metabolic disorders. Chris holds a BA from Suffolk University and an MBA from Boston University.
Todd Applebaum
Managing Director, Converge Consulting
Todd Applebaum has supported many clients transitioning from clinical development to commercial production of Biologics, Pharmaceuticals, and Cell Therapies. Todd consults on business strategy, manufacturing, technical operations, the quality system, process development, operational strategy & execution, supply chain management, business process/workflow automation and IT enterprise solutions. Prior to starting Converge Consulting, he served as VP, Technical Operations at Ovascience, Inc., helping transition the company from research to commercial operations. Todd also held the role of VP, Research for the Healthcare and Life Science industries at Gartner, Inc. where his research focused on building patient outcomes-focused operations, the impact of personalized and precision medicines, global operations and network planning, track & trace technologies and operational & performance excellence. He has a BS in Industrial Engineering from General Motors Institute and an MBA from Carnegie Mellon University.
Jeremy Friedler
Senior Consultant, Converge Consulting
Jeremy Friedler is an experienced biotechnology and pharmaceutical operations consultant with over 15 years of strategy and operations experience in the life sciences industry. He brings deep knowledge and expertise in biopharmaceutical Clinical and Commercial Supply Chain Management, Operations Strategic and Long Range Planning, Supplier/CMO Management, Small and Large Molecule Manufacturing/CMC and cGMP Quality. Jeremy’s work with both emerging and established biopharma companies has given him a unique and well-rounded perspective, with biopharmaceutical Operations experience addressing a wide range of challenges faced by emerging and established biopharma clients. Prior to his work with Converge, Jeremy was a Senior Manager in the Pharmaceutical and Life Sciences practice at PricewaterhouseCoopers (PwC), providing Operations advisory services for select corporate strategic initiatives to a broad spectrum of clients, from mid-sized to global biopharmaceutical companies. In earlier roles, Jeremy honed his Operations planning skills in the Strategy & Operations practice of Maxiom Consulting Group. He began his career in Manufacturing, CMC, Clinical Supply Chain, and Commercial Launch Planning at both ARIAD Pharmaceuticals and Alnylam Pharmaceuticals.