Eric Langer
DATE/TIME September 26, 1:30 – 2:00 PM EST TOPIC Critical Trends and Growth in Biopharma Contract Manufacturing: Returning to Near Normal SPEAKER Eric Langer Managing Partner, BioPlan Associates, Inc. ABSTRACT This session will discuss critical trends and growth in biopharma contract manufacturing by exploring study results from 250 biopharma manufacturers and their CDMOs. BIO Eric […]
Charles Koon
DATE/TIME September 27, 8:30 – 9:00 PM EST TITLE FDA Watch: Navigating the Latest Inspection Trends SPEAKER Charles Koon Executive Director Lachman Consultants 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 with extensive […]
Zachary Smith
DATE/TIME September 26, 2:00 – 2:30 PM EST TITLE Cost of a Delay Day in Drug Development SPEAKER Zachary Smith Project Manager and Data Scientist Tufts CSDD ABSTRACT The Tufts Center for the Study of Drug Development will share new benchmark data on…. BIO Zachary (Zak) Smith, MA, works on a variety of Tufts CSDD […]
Subba Reddy Inta
DATE/TIME September 26, 11:20 – 12:00 PM EST TITLE The Future of Pharma Operations & Quality SPEAKERS Subba Reddy Inta Vice President & Head of Quality, North America Dr. Reddy’s Laboratories ABSTRACT Pharma business is facing a multitude of forces that will test the pharmaceutical industry’s resilience in the years ahead. These challenges range from […]
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 […]
