Webinar: Proven Quality - Preventing quality issues during drug development

A growing number of drug launches have faltered at the final hour because manufacturing processes weren’t up to FDA standards. Some went through that disappointment more than once. How can drug developers properly monitor quality throughout the clinical production process and fix any issues that arise—before the FDA brings out the red flags?

For all of their drug development brilliance, biotech founders often underestimate the essential need to have manufacturing & process development professionals whose resumes and skills match their own. As drugs are getting more complex, so is drug manufacturing, and an MPD professional not only experienced but current with evolving techniques and standards is a key investment, even if developers are using contract manufacturing.

Too often, drug developers think conversations with the FDA start when they file their application. Not so, particularly if new manufacturing methods are needed. If the process is new or complex, it is better to educate FDA reviewers in advance.

Many drug developers naturally turn to contract manufacturers, but even with the best, they need to stay deeply involved, and aware of what is happening with their CDMO. A manufacturing plant that runs into FDA concerns, even for something unrelated to your efforts, can still delay years of work and the rewards of a drug approval.

We’ll look at the diverse set of tactics companies can use to forestall manufacturing disappointments, from recruitment to partnerships to regulatory communication and more.

Mike McCormick

Vice President of Quality and Regulatory

The Center for Breakthrough Medicines

Mike McCormick is the Vice President of Quality and Regulatory at the Center for Breakthrough Medicines. Mike has over 20 years of experience in quality management within the biotechnology, cell and gene therapy and pharmaceutical industry with a proven track record of success maximizing performance, scaling quality commercial operations and streamlining quality systems, while maintaining the highest levels of compliance with global regulations over multi-site operations. Prior to joining CBM, Mike spent 7 years as the V.P of Quality Assurance and Regulatory Affairs at WuXi Advanced Therapies and was responsible for supporting the capacity expansion at the Navy Yard for cell and gene therapy manufacturing and testing operations. He has his MBA with an emphasis in Biotechnology and Health Industry from Penn State University and attended the University of the Sciences in Philadelphia where his field of study was Pharmacology and Toxicology.

Brian Tomkowicz

Senior Director of Vector Engineering

The Center for Breakthrough Medicines

Brian is currently the Senior Director of vector engineering at the Center for Breakthrough Medicines leading the efforts for LV, AAV, and Ad, as well as manufacturability assessment / platform development to support commercial manufacturing. Brian worked for close to a decade at Janssen Pharmaceuticals where he established Janssen’s internal gene therapy program and viral production capabilities (LV and AAV). He was a member of Janssen’s acquisition team that led to the purchase of 4 clinical-stage (Ph1/Ph2) ocular disease gene therapy programs. He completed two academic post-docs at the University of Pennsylvania focused on viral-induced chemokine and integrin receptor signaling. From there he took a position at a biotech start-up, Morphotek, where he rose to the level of Group Leader leading several early-stage clinical development programs for cancer antibody therapeutics. Brian has dozens of peer-reviewed publications along with multiple issued patents pertaining to novel inventions in antibody and gene therapy areas. Brian has a BS in Microbiology from The Pennsylvania State University and a PhD in Molecular Virology from Thomas Jefferson University.


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