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Webinar

Pharmacy Considerations for Early Phase Trials

ET
60 Minutes

From sterile compounding to handling controlled substances, a crucial aspect of conducting successful early phase trials is the careful preparation of both investigational and non-investigational products to be used in a clinical trial setting.

As Phase 1 clinical trials include several different design types with multiple objectives (e.g. First-in-Human, Drug-Drug Interaction, Food Effect, Bioequivalence, etc.), and often require consistent batches of drug product be administered to groups of research participants within a short timeframe, early phase studies present unique challenges for drug developers not typically experienced in later stages of development.

This webinar will present key considerations for successfully planning pharmacy activities in early phase trials including items such as:

  • Evaluating equipment and supply needs, with an emphasis on specialized items needed for the preparation of subject doses
  • Developing a pharmacy manual, which is essential for incorporating the detailed procedural steps not commonly seen in the study protocol
  • Strategies for appropriate blinding across different routes of administration
  • Preparing suitable placebos and ensuring blinding is maintained
  • Selecting comparator or positive control drugs
  • Identifying vendors for drug product sourcing that are dedicated to clinical research
  • Drug product storage, monitoring, handling, transfer, and security protocols
  • Obtaining controlled substances

Join this webinar to receive expert guidance from pharmacy professionals specializing in early clinical development.

Speakers

Todd Janssen

Todd Janssen, RPh

Todd Janssen has been a practicing registered pharmacist (RPh) for over 30 years with the last 12 years focused on phase 1 clinical research. Janssen’s 12+ years of early phase experience have provided invaluable expertise in clinical trial dose preparation including nasal insufflation, powder in capsule, over-encapsulation, aseptic preparation and powder in solution applications. He received training in compounding at the Professional Compounding Centers of America (PCCA).

Donnie Keeney

Donnie Keeney, PharmD

Donnie Keeney has been a licensed pharmacist for nearly a decade. Early in his career, he served as the pharmacist-in-charge (PIC) at several retail pharmacies before joining the clinical research industry. Over the last seven years, Donnie has practiced as a phase I clinical research pharmacist. He has gained extensive experience with a variety of dose preparations, including sterile preparation of large and small molecules, over-encapsulation, non-sterile to sterile formulations, non-sterile compounding and many others.

Sheri Sander

Sheri Sander, PharmD

Sheri Sander has been a pharmacist for over 25 years with well over 15 years focused on early phase clinical research. Additionally, she possesses well over a decade of experience as a hospital clinical pharmacist with extensive knowledge in intravenous compounding, including chemotherapy.  Her expertise has made her an invaluable asset in both hospital and research settings.  Her skills in this area are complemented by her ability to train and mentor other pharmacists in best practices. Sander maintains a strong background in protocol development, regulatory compliance, and extemporaneous compounding. Furthermore, her vast experience includes conducting clinical research for both large and small research organizations, meeting and exceeding client expectations.

Register here!

Date/Time:
ET
Duration:
60 Minutes