A Stagewise Approach to High Potency Drug Product Clinical Development & Commercialization

Life Sciences, Clinical Trials, Pharma Manufacturing & Supply Chain, Drug Discovery & Development, Commercialization & HEOR,
  • Thursday, December 08, 2022

High potency drugs are increasingly prevalent in the drug development pipeline. While highly potent compounds have benefits in treating medical conditions such as cancer, rare diseases etc., companies with promising high potency active pharmaceutical ingredients (HPAPIs) can face significant challenges in developing and bringing these innovative medicines to market. This is specially the case for virtual, small, mid-sized biopharmaceutical companies. Key challenges revolve around phase appropriate containment systems that ensure workers and the environment are protected, along with demonstrable and adequate controls to mitigate cross-contamination risks in a multi-purpose environment.

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Some drug sponsors/developers do not always understand what potency implies or what it means to their proposed processes at a selected CDMO site. They may not know how much or what type of containment is needed and its impact on the development, scale-up and/or commercial manufacturing processes.

This webinar will examine:

  • Selection of level of containment needed for HPAPIs
  • Phase appropriate development to support early and late phase clinical demands at the same site
  • Impacts of using containment for product development activities
  • Strategies to control cross-contamination in multi-purpose facility

Catalent Greenville has developed and implemented a robust new product introduction (NPI) process that utilizes a broad cross-functional approach that brings together EHS, QA, product development and operations to drive consistency and thoroughness in choosing the optimum containment systems that protect people and prevent cross-contamination when introducing an HPAPI onsite.

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Have a containment challenge involving HPAPIs? Wondering how a potent compound will be contained at a contractor site and its impact on the project moving forward?

Join this engaging webinar as featured speakers explore containment issues and provide examples and information from years of real-world experience in handling high potency products.

Speakers

http://Thomas%20B.%20“Brad”%20Gold,%20Catalent

Thomas B. “Brad” Gold, PhD, Head of Pharmaceutical Development, Catalent

As Head of Pharmaceutical Development at Catalent Greenville, Brad Gold is responsible for overseeing all personnel, facilities and services related to formulation development, potent and cytotoxic products, fast-track development and clinical program support through to commercialization. In addition, Brad is responsible for implementing new technology platforms that include advanced drug delivery methods. He holds a doctorate in pharmaceutics/medicinal chemistry from the University of Kentucky, from where he also earned his master’s and bachelor’s degrees in chemistry.

Message Presenter
http://Anshul%20Gupte,%20Catalent

Anshul Gupte, PhD, RAC-Drugs, Senior Director, Scientific and Technical Affairs, Catalent

Anshul Gupte is responsible for technical and scientific oversight of client projects. He works across various functional teams in RFP considerations and scope of work development, proposal delivery, client and prospective client meetings and contributes to the company’s thought leadership agenda. Most recently Anshul served as Senior Director, Drug Product Development for Mayne Pharma in Australia. Previously he worked with Metrics Contract Services in Greenville as Director of Pharmaceutical Development. Anshul holds a Bachelor of Pharmacy from the RGPV University, Bhopal, India, a Master of Science in Pharmaceutical Sciences from Temple University and a Doctorate in Pharmaceutical Sciences from the University of Kentucky.

Message Presenter

Who Should Attend?

  • Pharmaceutical Development Groups
  • Operations and Facility Personnel
  • Quality Engineering and Quality Assurance Teams
  • Environmental, Safety and Health Groups

What You Will Learn

  • FIH containment approaches for high potency active pharmaceutical ingredients (HPAPIs)
  • Formulation, process development and characterization approaches for HPAPIs
  • Scale up and registration approaches of HPAPI projects
  • Impact of containment in product development
  • Cross-contamination control in HPAPI manufacturing

Xtalks Partner

Catalent

Catalent Greenville, part of the Catalent Pharma Solutions network, harnesses complexity and delivers confidence to companies developing novel oral solid dose products. With a 25-year track record, we support pharmaceutical companies from initial concept to global commercialization. Our skilled scientists and expert operators provide pharmaceutical development, analytical testing and commercial manufacturing to customers worldwide from our facility in Greenville, NC — all under a single FDA registration. We specialize in high potency handling and smaller batches, ideal for orphan drug development and niche patient populations. Our strong compliance record and best-in-class equipment make us the ideal partner for your novel oral solid dose product. We’re serious about science and sharply focused on novel drugs that make a difference.

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