- How are biology and patient needs influencing risk-based investment and networking structure in the manufacturing space?
- Discussing route and location of administration, including MDCP considerations, components and suppliers, design standards
- Exploring flexible facilities, integrated clinical launches, and capital risk avoidance in the quest to get fast to clinical and fast to respond
- Understanding the need for early investment in platform changes. How is the emergence of ADCs, modality blurring, and market
- How do we ensure quality, risk management and compliance processes are in lock step as our technology and platforms evolve
Anil Sawant
SVP Global Quality Compliance
Merck
Anil Sawant is Senior Vice President, Global Quality Compliance at Merck. He is a healthcare Executive with over 35 years of operations experience in Quality Operations, Ethics & Compliance, Research Integrity and Auditing functions. A strategic thinker experienced in development and deployment of management controls, governance processes, and quality and compliance systems in diverse business environments and cultures. Anil leads groups managing branded and generic products, small molecules, vaccines, bio-pharmaceutical, medical devices and consumer products. He was part of the teams that commercialized the first antibody-drug conjugate product and first photoactive drug. Expertise in interpretation of GMPs, GLPs, and GCPs. Good understanding of SOX, Anti-Kickback, Anti-Trust, Privacy and FCPA. Skilled crisis manager and pragmatic thinker with excellent understanding of regulatory requirements, global pharmaceutical supply chain and R&D operations. Extensive experience in resolving compliance matters with US FDA and international regulatory agencies. Subject matter expert in pharmaceutical microbiology and aseptic processing.
