Biopharmaceutical companies developing innovative products must build a stage-appropriate quality system (QS) that ensures the right controls are in place. By doing this, they ensure patient safety and compliance while enhancing operational efficiency. The challenge is in establishing an appropriate level of rigor and controls for the particular stage of the development lifecycle.
From the identification of critical characteristics to the development of methods and procedures, flexibility and discretion early in development give way to more rigorous controls for commercial GMP operations.
The QS journey begins with steps leading to IND submission. As companies progress through Phase 2 clinical trials and are preparing for a Phase 3 trial, BLA/NDA submission, PAI readiness and ultimately commercialization, they need to progressively enhance their quality system. After product approval, companies continue improving their QS for operational efficiency, as well as to avoid costly product failures and regulatory sanctions.
They must design and transition to a commercial quality system to support the new operations involved in scaling production, often via outsourcing, while continuing to manufacture clinical material.
Unpacking the Phases of QS Development
Participants will hear expert discussion focused on three main phases of QS development:
- Creating a quality system suitable for IND submission and clinical trials
- Incremental development of a GMP quality system to prepare for Phase 3 and commercial
- How to adjust a QS to business needs after product approval
This webinar is appropriate for CXOs, Quality, Development, Regulatory, Clinical Operations, Manufacturing, Supply Chain, Technical Operations, and other functional leads engaged with or interested in the stage-appropriate quality system for companies in preclinical development to commercial operations.
Event Details
Date: Wednesday, September 30, 2020 @ 11a – 12p EDT, 3p GMT
Agenda:
- 11:00a – Opening & Introductions
- 11:05a – Overview of The Quality System (QS) Lifecycle
- 11:10a – Expert Interview & Discussion
- 11:40a – Q&A with the Experts
Speakers
Melanie Cerullo
Vice President of Quality & Regulatory, Arranta Bio
Melanie Cerullo has deep experience in quality assurance and regulatory affairs. Previously, Melanie was Vice President of CMC & Quality at Wave Life Sciences. She has a BS in Chemistry and an MBA in Quality Assurance & Regulatory from Temple University.
Todd Applebaum
Managing Director, Converge Consulting
Todd Applebaum has supported many clients transitioning from clinical development to commercial production of Biologics, Pharmaceuticals, and Cell Therapies. Todd consults on business strategy, manufacturing, technical operations, the quality system, process development, operational strategy & execution, supply chain management, business process/workflow automation and IT enterprise solutions. Prior to starting Converge Consulting, he served as VP, Technical Operations at Ovascience, Inc., helping transition the company from research to commercial operations. Todd also held the role of VP, Research for the Healthcare and Life Science industries at Gartner, Inc. where his research focused on building patient outcomes-focused operations, the impact of personalized and precision medicines, global operations and network planning, track & trace technologies and operational & performance excellence. He has a BS in Industrial Engineering from General Motors Institute and an MBA from Carnegie Mellon University.
Dr. James Blackwell
Delivery Partner, CMC & Manufacturing Services, Converge Consulting
Dr. James Blackwell is a leading life science consultant with broad CMC and manufacturing experience spanning early process development through commercial operations. James brings extensive product experience with antibodies, vaccines, recombinant proteins, small molecules, peptides, cell therapy, and medical devices to clients ranging from virtual startups to leading multinational companies. His regulatory experience includes INDs, PAIs, DMFs, and leading NDA CMC submissions. James also has extensive experience evaluating and selecting CMOs, as well as providing oversight and management of external operations. He has been involved with 3rd party consent decree monitoring, quality system remediation, and organizational mentoring.
James was on the formative management team and led manufacturing and technical operations for Shore Therapeutics’ successful recommercialization of Fenoglide. His accomplishments include providing due diligence support for over 40 product, company, and technology strategic initiatives that have involved product analysis and CMC risk assessments for investors, facility and site operations assessment, and evaluation of both new business opportunities and novel product or process technologies. James is a member of ISPE, PDA, AAPS and RAPS. He holds a PhD in Chemical Engineering from Northeastern University, a MS in Microbiology from the Ohio State University, and a MBA/MS in Business/Technology Management from the University of Maryland.