Leaders in Pharmaceutical Business Intelligence (LPBI) Group

This interactive Forum will help attendees understand the FDA and how to achieve maximum success and avoid common pitfalls when working with the agency in early drug development. Our panel of experts, including a former FDA investigator, will cover the following topics:

• Overview of the FDA’s structure and function
• How did we get here? The Evolution of FDA
• Getting into the Clinic: The IND and Case Studies
• Chemistry, Manufacturing and Controls – Why is CMC is so Important to FDA?

Come join the discussion and take away a deeper understanding of FDA expectations and valuable tips for improved communication.

Speaker:

• Drew Barlow, M.P.H., Senior Director, Regulatory, Syner-G Pharma CMC Consulting
• Julia Morteo, Director, Regulatory Affairs, Stealth BioTherapeutics

Moderator:

• David S. Mantus, Ph.D., Vice President Regulatory Affairs & Quality Assurance, BIND Therapeutics

Bios:

Drew Barlow, M.P.H., Senior Director, Regulatory, Syner-G Pharma CMC Consulting

Drew Barlow has over 15 years of experience in CMC regulatory affairs & quality compliance.  After a stint in clinical research at Wake Forest University, Drew began his tenure with the Food and Drug Administration in the Office of Regulatory Affairs.  With the Agency Drew carried out investigations, inspections and other assignments over FDA regulated industries, specializing in pharmaceutical manufacturers and GMP compliance.  Joining Vertex Pharmaceuticals in 2006, Drew established the post approval CMC regulatory group and oversaw numerous small molecule development projects in a variety of disease areas. He then brought his regulatory CMC strategy expertise to Alkermes plc where he led multiple global late phase programs. Drew joined the Syner-G team in January of 2015. His areas of expertise include devising & implementing CMC strategies for worldwide marketing applications, agency meeting planning & facilitating, post approval regulatory reporting, IND and IMPD preparation, GMP inspection readiness, and Quality by Design implementation.  Drew received a B.S in Biology from Mount Saint Mary’s College in Maryland and a Master’s in Public Health from The University of North Carolina at Greensboro.

David S. Mantus, Ph.D., Vice President Regulatory Affairs & Quality Assurance, BIND Therapeutics

Dave Mantus has been working in Regulatory Affairs for 23 years both in industry, as a consultant and as a professor. Dr. Mantus served as Vice President, Regulatory Affairs at Cubist Pharmaceuticals and held various regulatory roles at Sention Inc., Shire Biologics, PAREXEL, the Massachusetts Public Health Laboratory, and Procter and Gamble Pharmaceuticals. He is a co-author of a book on regulatory affairs, “FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics,” that is in its third edition, and has published numerous scientific papers and done presentations around the world. In 2009, Dr. Mantus was named Citizen Schools (www.citizenschools.org) “Citizen Teacher of the Year” for his work teaching at the Edwards Middle School in Charlestown, MA. Dr. Mantus received his B.S. in Chemistry at the College of William and Mary, his M.S. and Ph.D. in Chemistry from Cornell University and was a post-doctoral research fellow in Biomedical Engineering at the University of Washington.

Julia Morteo, Director, Regulatory Affairs, Stealth BioTherapeutics

Julia has nearly 10 years of extensive Regulatory Affairs experience, serving functions in Regulatory Operations, Regulatory-CMC, and Regulatory Strategy.  Julia spent 8 years at Cubist Pharmaceuticals, where she helped bring eCTD submission capabilities in house, was responsible for the CMC content of marketing applications for CUBICIN® in over 50 countries worldwide, and provided Regulatory support on pre- and post-approval programs.  For the past several years, Julia has functioned as the Global Regulatory Strategy lead on more than 10 development programs ranging from pre-clinical to Phase 3 across multiple therapeutic areas.  Julia has led numerous successful IND submissions, IND amendments, and FDA meetings.  Julia has been with Stealth BioTherapeutics since 2014, where she is the Regulatory lead on Stealth’s Phase 2 neurologic rare disease and CV/Renal programs.  Julia graduated from Mount Holyoke College, where she was a double major in Religion and a self-designed major in Science and Medicine in Cultural Perspective.

SOURCE

http://www.massbio.org/events/calendar/3401-roadmap_for_regulatory_success_navigating_the/event_detail

From: MassBio Network <groups-noreply@linkedin.com>

Date: Saturday, September 26, 2015 at 12:42 PM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: Don’t miss “Navigating the FDA and the IND” on 9/29!