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CPHI Webinar Series

Common Stumbling Blocks When Outsourcing an Injectable Project to a CMO & How to Avoid Them

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28th June, 2022
4pm CET / 10am EST
What will this webinar address?

With the recent growth in demand for injectables (due to the COVID-19 pandemic and an increased reliance on biologics to treat chronic diseases) and a tightening of the capacity available, many biotech and pharma companies are having to outsource the manufacturing of their drug products. Yet many have limited-to-no experience working with a CMO.

They often do not know what to look for in a vendor or when is the right time to engage with them. They tend to reach out too early before they have the critical information necessary for a CMO to properly define the scope of the project, which can waste valuable time.

This webinar is meant to provide Best Practices on what pharma clients need to have established prior to requesting a proposal from a CMO and how to have an effective kick off meeting to ensure a streamlined transfer.

Why attend:

  • What to look for in a CMO
  • How to prepare your project for tech transfer – key considerations
  • Disposable versus durable equipment – considerations in selecting the best option for your project
  • Component selection & lead times – Are change parts needed?
  • Filter validation – What studies need to be performed prior to RFP
  • Extractables & leachables – Understanding the fluid path at the CMO/selection of tubing
  • How to write an effective Request for Proposal – what needs to be included
  • The CMO Outsourcing Kick-Off: What you should know
    • Alexander Aust
    Senior Project Manager, Parenteral Drug Association (PDA) & founder
    Aust Business Solutions

    Alex has spent the previous ten years working in various roles related to the manufacture of complex parenteral drug products (e.g., lipid nanoparticles, liposomes, suspensions, emulsions, PEG, inorganic nanoparticles, etc.). These roles include working in and with various CDMOs to perform different functions, such as: Business Development, CMC Consulting, Supply Chain, Quality Assurance, Validation, Quality Control, and Regulatory. Alex’s experience includes executing over 30 RNA technology transfers with lipid-based formulations at various stages of the product lifecycle, from Pre-Clinical through Commercial. Currently, Alex leads Aust Business Solutions (ABS), which offers pre-clinical, clinical, and commercial consulting services for drug products utilizing drug delivery systems (DDS).

    Additionally, Alex works for the Parenteral Drug Association (PDA), which is an international nonprofit that is the leading global provider of science, technology, regulatory information, and resources to advance science and regulation through expertise of more than 11,000 members worldwide. Alex earned his M.B.A from Ball State University with a concentration on Manufacturing and Production Management. Previous to this, he obtained an M.S. from Purdue University while studying Molecular and Cellular Biology; his undergraduate studies were completed at the University of Southern Indiana; where he majored in Biology and minored in History. Alex lives in Knoxville, TN with his wife and son.

    Christina Kramer
    VPM Manager - The Americas
    Validation Services, MilliporeSigma

    Christina Kramer manages the project management team for Validation Services at MilliporeSigma, focusing on bacterial retention and physical testing for filter-sterilized pharmaceuticals and biologics..

    She has 12 years of experience working in the pharmaceutical/biotech industry, with 6 years working in the Validation Services project management group.

    Her role encompasses guiding customers with filter-sterilized products through the validation testing process to ensure regulatory compliance.

    Jayna Blake
    Senior Project Manager
    Baxter BioPharma Solutions

    Jayna Blake, Senior Project Manager, Technical Programs at Baxter’s contract manufacturing facility located in Bloomington, Indiana.

    Jayna has over 19 years experience in the pharmaceutical industry and has led over 15 technical transfers as a project manager.

    Jayna is a certified PMP (Project Management Professional) and has earned her bachelor’s degree in education at Indiana University. Jayna is also responsible for the technical review, potential projects evaluation and proposal issuances from the Bloomington site.

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    Overview
    Common Stumbling Blocks When Outsourcing an Injectable Project to a CMO & How to Avoid them
    • 28th June, 2022
    • 4pm CET / 10am EST
    • 60 minutes
    • Free
    Watch Now