In the contract development and manufacturing organization (CDMO)–Sponsor relationship, the quality agreement serves to outline expectations, ensure compliance and protect both parties throughout the life of the contract. With advanced medicines such as cell and gene therapies, the living nature of the product increases the potential for the unexpected to occur. When this happens, even the slightest adversity can create contention, risking not only the program but the partnership itself. A well-written quality agreement, complete with a detailed understanding of governance, can both prevent conflict and prepare to address it should it arise.
In this webinar, the expert speakers will discuss the necessity of aligning objectives, quality standards and compliance frameworks to establish a solid foundation for a collaborative partnership. Noting the evolving regulatory landscape, they will emphasize how a quality agreement that incorporates governance policy and conflict resolution measures can help developers navigate the intricacies of compliance and adapt to regulatory changes, ultimately enhancing the agility of the partnership.
In addition to case studies that illustrate successful governance models that contribute to efficient and successful CDMO relationships, the speakers will share their experiences and best practices as well as offer an experienced perspective on effective governance and conflict resolution strategies.
Register for this webinar today to understand how a well-written quality agreement can help build efficient and successful CDMO relationships.
Speakers
Jo Anne Valentino, VP of Quality Assurance and Regulatory Affairs at Comprehensive Cell Solutions, NYBC
Jo Anne Valentino joined New York Blood Center Enterprises in 2023 as the Vice President of Quality and Regulatory Affairs. She is responsible for the quality oversight of the Comprehensive Cell Solutions (CCS) division. Jo Anne joins with more than 25 years of experience in pharmaceutical operations and quality assurance. Most recently, Jo Anne served as Chief Operating Officer of Minaris Regenerative Medicine, LLC, a US-based CDMO for the cell therapy industry. In this role, she was responsible for oversight of all US development and manufacturing operations. Prior to serving as COO, Jo Anne served as Global Head of Quality for the company’s Regenerative Medicines Business Sector.
Prior to joining Minaris Regenerative Medicine, Jo Anne worked at Novartis Pharmaceuticals Corporation in quality positions of increasing responsibility, including Executive Director, Quality Head and External Supply Operations, Americas region. In that role, she ensured robust quality oversight for a large portfolio of external suppliers. Prior to Novartis, Jo Anne was in leadership positions at Merck and Schering-Plough in operations and quality, as well as product and process development at Reckitt Benckiser.
Jo Anne holds an MS in Management from Stevens Institute of Technology and a BS in Chemical Engineering from Manhattan College.
Message Presenter
Andi Baggarley, Director, Project Management at Comprehensive Cell Solutions, NYBC
Andi Baggarley, MLS(ASCP), joined Comprehensive Cell Solutions (CCS) in 2023 as the Director of Project Management. She is responsible for leading and managing project teams at CCS. Andi has a combined total of more than 20 years of experience that spans across clinical laboratory and pharmaceutical industry. She has contributed to multiple CMC activities supporting cell-based therapeutic products in phase II and III clinical trials, including aseptic manufacturing, supply chain and logistics, as well as supporting GMP contract manufacturing for small molecule and regulatory submissions. She has extensive experience training and managing Manufacturing, MSAT and Environmental Control departments; and developing systems and procedures needed to support GMP manufacturing operations. Her prior experience has led to comprehensive knowledge and understanding of Operations, Project Management, Supply Chain, and Quality Systems.
Andi holds an MS in Healthcare Administration from the University of Louisville and a BS in Biology from Murray State University.
Message PresenterWho Should Attend?
This webinar will appeal to the following professionals within companies that are developing advanced therapeutics:
- Founder/Co-Founder
- Chief Scientific Officer
- Outsource Manager/Director
- Manufacturing Manager/Director
- Quality Manager/Director
- In-house Counsel
What You Will Learn
Attendees will learn about:
- The essential elements of outlining a governance policy in the quality agreement
- Effective strategies to create transparency and accountability within the CDMO–Sponsor partnership
- Approaches to resolving conflict in the business and/or scientific/collaborative relationship
Xtalks Partner
Comprehensive Cell Solutions
Founded in 2003 as a business unit of New York Blood Center Enterprises, CCS offers its deep expertise in the development and manufacture of cell and gene therapies, using its GMP and GTP facilities. CCS provides a true vein-to-vein solution, spanning fresh cellular collections and cord blood-derived stem cells as source material, to cell isolation, manipulation and cryopreservation capabilities for preclinical to commercial stage products. CCS boasts a client roster comprised of the world’s leading pharmaceutical companies, innovative biotechnology organizations, and academic medical centers. CCS maintains its headquarters in New York City, where it offers its full service CDMO capabilities from cellular collections and clinical apheresis through manufacturing and cryopreservation. Additional collection suites, apheresis services, and development and manufacturing operations are offered at sites in Providence, RI, Kansas City, MO, St. Paul, MN, Houston, TX and Louisville, KY.
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