Biopharma companies are constantly looking for ways to accelerate time-to-market with minimal operational impact. Yet, when it comes to development, manufacturing and clinical supply of a biologic drug, they face challenges to increase productivity, reduce cost, mitigate risk, and optimize timelines to bring products to market faster. However, having the support of an integrated approach can minimize the impact of these issues, which can become less challenging with the support of an integrated approach. A comprehensive end-to-end solution from biologics development, clinical to commercial-scale manufacturing, and finished product supply has higher quality and improved yield of biopharmaceuticals with reduced cost and time. This event will focus on key considerations for transitioning a molecule from clinical to commercial, beginning with cell line development and biomanufacturing, to formulation and filling and managing clinical trial supply.
Key learning objectives
- Learn the challenge of executing a Drug Substance (DS) to Drug Product (DP) workflow needed to support all the different aspects of development and manufacturing
- Learn how to develop an effective CMC strategy for a biologic product
- Understand how early integration of clinical supply chain services can lead to speed and cost savings
Date: Tuesday, 28th of March, 2023
Time: 8:30 – 11:00 CET
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Meeting room: Auditorium
Program
| 08:30 | Networking, registration and light breakfast |
| 09:00 | Welcome David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance Andrew Watson, Account Director. Biologic Drug Substance, Catalent |
| 09:10 | Development Workflow from DS to DP Wai Lam Ling, Vice President, Scientific Advisory, Science & Technology, Catalent
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| 09:50 | Optimizing Clinical Study Management Gavin Yates, Program Director, CSS and Drug Product Technologies Integrations, Catalent
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| 10:30 | Networking & 1:1 Private Consultancy Appointments All presenters and Catalent experts will be available for private, no-obligation discussions on specific programs and challenges |
| 11:00 | End of Good Morning Meeting |
Speakers
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Wai Lam Ling, Vice President, Scientific Advisory, Science & Technology, Catalent Dr. Ling brings with her more than 25 years of experience in biologics development, including cell and gene therapies. She earned her Bachelor of Science degree in Biochemistry from the University of California, and her Doctorate degree in Pharmacology from the Rutgers University. Dr. Ling also completed her post-doctoral research fellowship at the Albert Einstein College of Medicine, New York. |
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Gavin Yates, Program Director, CSS and Drug Product Technologies Integrations, Catalent Mr. Yates has more than 15 years’ experience in the pharmaceutical industry. His areas of expertise include project management, packaging and labeling, operational activity, supply chain management and key performance indicator (KPI) analysis. He received his bachelor’s degree in biological sciences from University of Birmingham, U.K. |
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