Charles Koon, M.S.
DATE/TIME September 22, 8:30 – 9:00 PM EST TITLE FDA Watch: Inspection Trends Update SPEAKER Charles Koon, M.S. Vice President Lachman Consultants ABSTRACT *Coming Soon* BIO Charles E. Koon, M.S. is an Executive Director at Lachman Consultants with 30 years of experience in the pharmaceutical industry. His broad background encompasses all aspects of Quality along […]
Melissa Joseph, PhD
DATE/TIME September 22, 9:30 – 10:00 AM EST TITLE Best Practices for Concurrent Compilation of Module 3 CMC Data in Collaboration With the CMO SPEAKER Melissa Joseph, PhD Principal Consultant and Owner Chymesis, LLC ABSTRACT When preparing for an IND/IMPD, it’s inevitable that there will be gaps in understanding on both the client and CMO […]
Tracy Nasarenko
DATE/TIME September 22, 9:00 – 9:30 AM EST TITLE Drug Supply Chain Security Act (DSCSA) Overview: Are You Ready? SPEAKER Tracy Nasarenko Senior Director of Community Engagement, Healthcare GS1 ABSTRACT 66 Days to the final DSCSA deadline, November 27th of this year. In 2013, the United States Congress passed the Drug Supply Chain Security Act […]
Melissa Joseph
Firelli Alonso
DATE/TIME September 21, 11:20 – 12:00 PM EST TITLE Supply Chain for Complex Biologics: Not Mission Impossible SPEAKER Firelli Alonso, Ph.D. Senior Director Biotherapeutics and Vaccines Outsourcing BioTherapeutics Pharmaceutical Sciences Pfizer, Inc. ABSTRACT The complex nature of novel biotherapeutic products, like gene therapy and mRNA vaccines has created significant challenges for an outsourced development approach. […]
Frank Chrzanowski, Ph.D.
Frank Chrzanowski is a semi-retired Pharmaceutical Scientist with over 40 years’ experience in the development of Pharmaceuticals. His experience includes 20 years supporting solid dosage form development heading the Preformulation / Physical Pharmacy Laboratories at McNeil Pharmaceutical and the RW Johnson Pharmaceutical Research Institute, and over 20 years as a Consultant and Expert/Expert Witness The […]
Lisa Cozza
DATE/TIME September 21, 2:00 – 2:30 PM EST TITLE How to Maximize Contract Relationships SPEAKERS Lisa Cozza, Principal Consultant, Tunnell Consulting ABSTRACT This session will explore how to maximize contract relationships from the selection phase all the way through maintenance and contract termination. Lisa will address post-contract challenges in managing partner relationships, including overpromising, performance […]
Ben Locwin
DATE/TIME September 21, 9:20 – 10:00 AM EST TITLE Looking Around Corners: Planning for the Industry’s Next Big Things SPEAKER Ben Locwin • VP Project Solutions, Black Diamond Networks • Science & Public Health Task Force • Professor of Public Health and Healthcare Economics • Healthcare Futurist ABSTRACT “Prediction is difficult, especially about the future.” […]
Mayank Nagar
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 […]
Gautam Ranade
DATE/TIME September 22, 10:15 – 10:45 AM EST TITLE Cell & Gene Therapy Development: Ecosystem Challenges for CDMOs SPEAKER Gautam Ranade Founder and Principal Consultant PharmaFalcon Consulting ABSTRACT In the rapidly advancing realm of Cell and Gene Therapy (CGT) development, pharmaceutical contract development and manufacturing organizations (CDMOs) stand at the forefront of innovation. This presentation […]
