Successful Phase 1 Adaptive Trials: Through the Lens of Clinical Operations, Formulation Development, and Regulatory Compliance

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Tuesday, October 11, 2022 at 11am EDT | 10am CDT | 8am PDT Learn how integrated formulation and clinical manufacturing expertise, as well as strategic partnerships between CDMOs and CROs, can help achieve flexible and efficient first-in-human studies, fast development of challenging molecules, and reduced clinical development timelines and costs, all while increasing success rates.

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Event Overview:
Conventional manufacturing of dosage forms for small molecule drugs in centralized facilities is not well-suited to meet the needs of adaptive clinical trials for early-phase dose escalation and confirmatory trials. Current approaches for developing finished dosage forms for adaptive Phase I trials are limited to simple formulations, owing to the limited understanding of drug products and manufacturing processes in early development. While the centralized approach may be suitable for water-soluble compounds, it may not address issues of challenging molecules, which would need to be overcome using advanced drug delivery technologies.
In this webinar, experts from Catalent and HMR will discuss a unique approach that integrates advanced formulation expertise with on-demand Phase I clinical manufacturing, adaptive clinical testing, and regulatory support, to help achieve flexible and efficient first-in-human studies and fast development of challenging molecules.
Participants will discover how a strategic partnership between a contract and development manufacturing organization (CDMO) and contract research organization (CRO) can play a significant role in accelerating clinical trial supply manufacturing in support of an adaptive trial design and reduce clinical development timelines and costs while increasing success rates.

Key Learning Objectives:

  • Identify clinical operational challenges during the adaptive dose-ranging study, and their impact on trial drug supplies
  • Learn how the manufacturing of formulations and dosage forms “on-demand” can accommodate an adaptive dosing protocol
  • Discover how a strategic collaboration between a CDMO and CRO can create a streamlined process between clinical operation and drug supply, which benefits both patients and innovator companies.

Who Should Attend:

  • Formulation development
  • Preclinical development
  • Research and development
  • Analytical development
  • Chemistry, manufacturing, and controls (CMC)
  • Product development
  • Project management
  • Manufacturing and operations management
  • Consultants for drug development

Stephen Tindal
Director, Science and Technology

Stephen Tindal plays an important role within the company’s research and development team by providing advice to clients in Europe and Asia-Pacific on the early phase drug development and delivery technologies to progress their small molecule programs. His work is largely focused on preclinical to phase 1 development and is based on the assessment of preclinical data to help define any challenges to dosage form development. Tindal has more than 30 years of experience at Catalent where he has held roles of increasing responsibility and has demonstrated expertise in root cause investigation, technology innovation and in supporting business development. He holds a bachelor’s in chemistry and analytical science from Loughborough University, Loughborough, U.K.

Sally Dowen
Director of Clinical Science and Regulatory Affairs
Hammersmith Medicines Research

Sally Dowen has over 15 years of experience in early phase clinical pharmacology studies, having first joined Hammersmith Medicines Research (HMR) as a clinical project manager in 2006. In 2021, she became head of HMR’s projects division, with responsibility for clinical project management, medical writing, and regulatory support. Dowen has worked on over 300 early phase clinical studies, including adaptive design, first-in-human, PET, bridging, bioequivalence, drug-drug interaction, and studies involving the administration of vaccines, GMOs, psychedelics, or radioactive compounds. In 2010, she earned a certificate in human pharmacology from the Royal College of Physicians, Faculty of Pharmaceutical Medicine, London, U.K. Prior to joining HMR, she held post-doctoral research associate positions at both Cambridge University and Cancer Research U.K. She is a member of the Health Research Authority Phase 1 Advisory Group.
Dowen holds a master’s in natural sciences and a doctorate in molecular oncology, both from Cambridge University, Cambridge, U.K.

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