Don’t Just Pass the Baton: Comprehensive Capabilities and Parallel Processes Accelerate Biologic Development Timelines

Biologic drug development from DNA to commercialization involves many moving parts, which can be difficult for companies to coordinate. For example, there are often new expert stakeholders introduced during each stage of development, leading to inefficiencies and confusion. However, with deep expertise and effective communication between teams, companies can reduce risk and shorten time to clinic and, subsequently, to market.

In this webinar series, three biologics subject matter experts will discuss critical considerations in their respective areas of expertise: drug substance, drug product and clinical supply. They will share available tools and strategies that can be implemented to reduce risk and timelines.

Watch now on-demand – Biologic drug substance development and biomanufacturing is a critical step in the long, complex pathway to approval. There are many considerations to be made around cell line and process development, analytical testing and late stage activities such as process characterization and validation. In this “Enabling Success in Biologic Drug Substance Development & Biomanufacturing by Leveraging Expertise and Collaboration”, Steven Perry, PE, Sr. Director of Manufacturing Sciences at Catalent will discuss:

  • Critical drug substance resource needs of sponsor companies
  • How expertise and collaboration amongst the key stakeholders enables successful development and scale up
  • Thinking ahead to what will be needed for successful Drug Product development and fill/finish

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January 16, 2019 – There are many challenges to conduct thorough drug product formulation development at early stage drug substance process development. Those challenges include material limitation, suitable analytical method, time and labor cost. Sufficient development of the right formulation and dosage form for biologics products early on helps to avoid formulation redevelopment and change during the later stage of product development, which leads to additional analytical, pharmacokinetics or even clinical comparability studies. In the presentation “Integrated Solutions for Biologics Formulation and Drug Product Development,” Yunsong (Frank) Li, Director of Process Development at Catalent will discuss:

  • How the use of a high throughput analytical platform and automated plate-based format for formulation screening can enable 96 formulations in only six weeks
  • How to move the molecular candidate quickly to the drug product manufacturing stage using a process based on platform container closure systems and platform manufacturing technology
  • How the integration of these platforms enabled a fast track pathway for a biologic molecule from discovery through drug product fill/finish to the clinic

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February 13, 2019 – Biologic clinical trials can be complex with many factors to consider. Understanding your specific needs and developing a plan early on during drug development can reduce delays and missteps during clinical trials. In the presentation “Shortening Timelines and Reducing Headaches by Developing a Clinical Trial Strategy Earlier During Drug Development,” Kristen DeVito, Global Director of Clinical Supply Services Business Solutions will discuss:

  • How protocol design can impact clinical supply strategy
  • Which clinical supply variables are most likely to be on the critical path
  • Proactive steps to ensure continuity of supply and reduce the risk of study delays and budget overruns

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