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Optimizing Adaptive Trials: The Role of On-Demand Manufacturing and Derisking in Accelerating Early Clinical Trial Success

This event is now available on demand

Event Overview:

Small pharmaceutical companies are constantly seeking innovative solutions to streamline early clinical trials. Adaptive clinical trials offer important benefits to sponsors and patients, both from a commercial and ethical standpoint. These trials offer flexibility and efficiency, especially in the early stages, where trial protocols can be adjusted based on interim data, such as introducing new doses or modifying participant sample size. However, adjusting manufacturing demand during an adaptive trial can be complicated, and strict regulatory requirements present significant challenges. On-demand manufacturing provides a robust solution, allowing for real-time supply and demand adjustments and improved trial flexibility.

This webinar will explore how on-demand manufacturing meets the operational needs of adaptive trials and aligns with regulatory expectations. Attendees will gain insights into the integration of oral small-molecule manufacturing technologies and collaborative strategies necessary to ensure compliance and success in this dynamic environment.

Key Learning Objectives: 
  • Understand the strategic importance of on-demand manufacturing in adaptive trials where early data can guide real-time modifications of dose adjustments.
  • Explore how Catalent’s on-demand manufacturing approach ensures compliant production processes, enabling faster responses to the regulatory requirements of adaptive trials and ensuring seamless compliance across various regions.
  • Discover how implementing on-demand manufacturing reduces timelines and optimizes resource utilization, and how smaller companies can benefit from this approach.

Who Should Attend:
  • C-suite executives
  • R&D personnel
  • Product development staff
  • Certified Management Consultant
  • Consultants
  • Scientists
  • Business Incubator Personnel

Featured Speakers


Stephen Tindal
Stephen Tindal
Director, Scientific Advisory, Oral Small Molecules, Europe
Catalent

Stephen Tindal is the Director, Scientific Advisory, Oral Small Molecules, Europe, Catalent. His work is largely focused on preclinical to phase 1 development and is based on assessing preclinical data to help define any challenges to dosage form development. Tindal has more than 36 years of experience at Catalent, where he has held roles of increasing responsibility and has demonstrated expertise in root cause investigation, technology innovation, and supporting business development. He holds a bachelor’s degree in chemistry and analytical science from Loughborough University in England.

Karen Chalk, BSc
Karen Chalk, BSc
Head of Clinical Project Management and Regulatory Affairs, UK
HMR

Karen Chalk, BSc, rejoined HMR as head of clinical project management and regulatory affairs in 2023. Her first appointment with HMR was as a research technician in 2001. She undertook secondments with our training department and pharmacy before leaving HMR in 2003 to continue her career in clinical research. In the 20 years between her appointments here, Chalk worked for both blue-chip pharma companies and small contract research organizations (CROs). Chalk has written about 70 protocols covering all phases, multiple therapeutic areas, and devices, and has acted as a quality consultant to several small biotech companies. She has also run a large multicenter, multicountry, EU-funded study with more than 1000 participants, and a research project on regulatory requirements in sub-Saharan Africa. As head of clinical project management and regulatory affairs, Chalk now oversees clinical project management, regulatory affairs, and quality functions. She is a visiting lecturer in clinical pharmacology, Barts Hospital Medical College and Queen Mary University, London, England, for the MSc course in early drug development.


Judith Jones
Judith Jones
Director of Global Regulatory Affairs
Catalent

Judith Jones is a director of global regulatory affairs, as part of the Catalent corporate regulatory affairs group. Jones has an honors degree in chemistry and is a Fellow of Royal Society of Chemistry and a member of TOPRA. Jones has over 25 years of experience working at Catalent and has been involved in the pharmaceutical industry for her entire career; she has worked in regulatory affairs for more than 20 years. She has extensive experience of the different Catalent dosage forms and technologies, such soft gelatin capsules, Zydis orally disintegrating tablets, sterile injectables, as well as solid oral dosages and medical devices. Her submission preparation experience includes CTAs/INDs/MAAs/NDAs/ANDAs/WHO applications, as well as full submission management and health authority liaison. Jones can provide regulatory assessment and advice for preapproval development projects and postapproval commercial projects, regulatory strategy at all stages of development, and full support for submission execution.


For any technical questions please contact Nicole Schultz: nschultz@mjhlifesciences.com