DATE/TIME
September 21, 1:30 – 2:00 PM EST
TITLE
Innovation & Advanced Manufacturing Techniques for Drug Manufacturing: Prospects & Challenges
SPEAKER
Mayank Nagar
Vice President & Head of Technical Services and New Product Launches (North America)
Dr. Reddy’s Laboratories Inc.
ABSTRACT
The COVID-19 pandemic revealed vulnerabilities in the Pharma supply chain that led to drug shortages. FDA and other regulatory bodies have highlighted advanced manufacturing and innovative technologies that improve product quality and process performance to enhance supply chain resiliency.
Advanced manufacturing techniques, including continuous manufacturing, have been gaining traction in research publications and conferences demonstrating their advantages. However, the number of approved filings using these techniques remains quite low, both for drug substances and drug products. This could be due to several reasons: sunken capital into conventional manufacturing technologies, business objectives, technological expertise, change management, and regulatory challenges.
Mayank’s discussion will focus on key aspects of advanced manufacturing for drug products, technologies under evaluation, and some of the barriers and challenges that the industry foresees in implementing this initiative. He will also bring specific insights from a generic pharma perspective and what Industry and global regulators can do to facilitate the adoption of innovation and advanced manufacturing technologies.
Major themes:
• What one means by advanced manufacturing techniques in pharma operations?
• Why the need?
• Some examples where industry has leveraged advanced manufacturing techniques in manufacturing operations.
• What are some of the barriers to implementation?
• What regulators (FDA) can do to encourage innovation?
BIO
Mayank Nagar is a Pharma professional with over 25 years of global leadership experience in pharma operations, consulting, compliance and quality management systems. He has been employed with pharma corporates and advisory companies and provided services and solutions to a broad range of companies/clients including innovators, generic manufacturers, biopharmaceutical companies, startups, and global health organizations. His contributions include enabling new product launches, analyzing technical and business risks, developing operational strategies, and helping to overcome regulatory crisis to achieve business targets.
Mayank is an accomplished professional in liaison and analytical skills with the ability to work in a multi-cultural environment. He has successfully handled several cross cultural/international responsibilities at various locations in India, the U.S., Ireland, Romania, Brazil, South Africa and Malaysia.
Mayank brings a unique combination of technical expertise and business acumen to his role. He is well versed with global quality regulations and successfully guided teams for several U.S. FDA and EU inspections. He has handled a diverse range of pharmaceutical dosage forms including drug-device combination products, sterile liquids and dry powders, complex solid dosage forms, liquid preparations and semisolids, sublingual films, patches, and inhalations. He has expertise in business due diligence, having conducted audits to support several mergers and acquisitions.
