PDA New England: Building a Roadmap for the CMC Portion of Your BLA Submission

PDA New England Chapter is pleased to announce Building a Roadmap for the CMC Portion of Your BLA Submission webinar.

Navigating all of the required elements for a robust CMC BLA section can be overwhelming!

• What are the major milestones?
• Who needs to be involved?
• How do I best assess and mitigate risk to my submission?

NEPDA is offering this webinar to help navigate this process. This webinar will break down the elements of a strong roadmap for the CMC portion of your BLA submission. Included in a strong road map are: the required major initiatives, the sequence of activities, key dependencies and decision points, critical timing milestones, budgeting and headcount requirements, and typical areas of risk. Industry leaders can use this information to proactively prepare for submissions that pass on first try. Two speakers will provide real-world experience and perspective.

This webinar is relevant for:

• CMC Teams
• Regulatory
• Technical Operations
• Quality
• And Anyone contributing to a regulatory CMC submission

Todd Applebaum is the Managing Director of Converge Consulting LLC and has expertise in business strategy, operations, manufacturing, and supply chain management, working throughout the Life Sciences spectrum, including the pharmaceutical, biologics, advanced therapies, and medical device sectors. As Managing Director, he not only leads Converge, but also provides senior leadership for many of the firm’s complex projects.

Prior to founding Converge, Todd served as VP, Technical Operations at Ovascience and VP of Research, Healthcare and Life Science at Gartner. Earlier in his career, Todd co-founded Maxiom Consulting Group, leading an award-winning management consulting practice.

Todd holds an MBA from Carnegie Mellon University and a BS in Industrial Engineering from General Motors Institute.

Vijay Chhajlani has over 25 years experience in the pharmaceutical industry and extensive knowledge of discovery and development for small molecule and protein therapeutics. Vijay was previously VP of Product Development & Technical Operations for Jounce Therapeutics and has held leadership positions at Shire Pharmaceuticals and Bristol-Myers Squibb, and AstraZeneca.

Vijay earned his Ph.D. in Biochemistry from the Cancer Research Institute at India’s Bombay University, completed his Pharmacology Fellowship at Johns Hopkins University and conducted independent research while serving as Associate Professor at Sweden’s Uppsala University. He is credited with more than 50 peer-reviewed scientific publications and several patents, including the discovery of the Melanocortin 1 receptor gene.