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Event info
Date:28 Mar
Time:08:30 - 11:00
Venue:Medicon Valley Alliance, Copenhagen
Contact person
Mette Bach Dyremose

Mette Bach Dyremose

Head of Communication & Industry Outreach, HALRIC

+45 4029 1009

Accelerating Biologics Through the Clinic: A Seamless Development-to-Manufacture Approach

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





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

  • What to expect during the drug substance and drug product process development?
  • Ensuring a consistent, high-quality biologic during drug product process development
  • Approaches to drug product fill-finish process
09:50 Optimizing Clinical Study Management
Gavin Yates, Program Director, CSS and Drug Product Technologies Integrations, Catalent

  • Assessing risks and developing mitigation plans
  • Efficient coordination of clinical supplies
  • Clinical manufacturing, packaging, storage, and distribution
  • Integrated approach from development to clinical and benefits to using one vendor
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



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.
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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