Enabling Adaptive Clinical Trials through Integrated Development and Manufacturing Solutions

The adoption of adaptive designs in clinical trials represents a paradigm shift towards a more efficient and flexible approach, overcoming the limitations of traditional fixed designs. Adaptive designs expedite and refine various aspects of the trial design, ultimately safeguarding patients from ineffective treatments. One of the operational challenges limiting the adoption of adaptive designs in clinical development programs is the time it takes to manufacture GMP clinical supplies at trial sites. A viable solution to this challenge is the manufacturing of formulations and dosage forms ‘on-demand’, which not only enhances dosing flexibility but also considerably reduces development timelines and costs. It optimizes the use of active pharmaceutical ingredient (API) and supports decision-making in dose selection with real-time clinical data. In this webinar, industry experts will discuss how manufacturing on demand strategy can enhance your clinical development and improve drug supply utilization. Additionally, the experts will share how to ensure that your adaptive trial is appropriate for regulatory submission.

Key learning objectives:

Gain insight into how an adaptive dosing protocol can be accommodated by a GMP-compliant manufacturing on demand approach, resulting in cost reduction, optimized resource utilization, and reduced API requirements and development time.
Discuss the strategic use of extemporaneous approaches such as API or blend in bottle for reconstitution as a solution or suspension, or liquid or lipid formulations that allow for rapid formula adjustments and accurate dosing in early-stage development.
Learn what regulators look for when evaluating an adaptive trial.

Ariel Dora Stern

Alexander von Humboldt Professor of Digital Health, Economics and Policy, Hasso Plattner Institute & Associate Professor, Harvard Business School

Ariel Dora Stern is the Alexander von Humboldt Professor for Digital Health, Economics and Policy at the Hasso Plattner Institute and an Associate Professor of Business Administration in the Technology and Operations Management Unit at Harvard Business School, where she teaches the course “Transforming Health Care Delivery” in the MBA elective curriculum. Stern's research focuses on technology management and innovation in health care. Her projects consider the regulation, strategy, and economics of health care, with a focus on understanding the drivers of new product development among firms and the determinants of how new medical technologies are adopted and used in practice. She is a faculty member of the Harvard-MIT Center for Regulatory Science, where she was part of the Adaptive Platform Trial coalition. Her research has been cited by Bloomberg, The New York Times, and National Public Radio.

Viral Patel

Director, Product Development, Catalent

Viral Patel is the Director of Product Development at Catalent Pharma Solutions in Nottingham, United Kingdom. With over 17 years of experience in oral drug product development across both industry and academia, he focuses on formulation development, scale-up, and optimization of manufacturing processes. Throughout his career, he has been involved in advancing small molecules through various stages of the drug product approval process, from pre-clinical studies to clinical phases 1-3, including the manufacturing of registration and validation batches. His expertise extends to the development of conventional, enabling, and modified-release formulations, addressing the ever-increasing challenges associated with new modalities such as suboptimal physicochemical and biopharmaceutical characteristics, as well as the development of age-appropriate formulations to deliver patient-centric drug delivery solutions. He is a Pharmacist by training and holds a master's and PhD in Pharmaceutics.

Guillaume Enderlin

Senior Manager, Head, Product Development, Catalent

Guillaume Enderlin is the Senior Manager of Pharmaceutical Development at the Catalent Beinheim site in France. He has worked for 12 years in softgel R&D, from formulation to manufacturing process development, building expertise to spearhead complete Rx Pharmaceutical Development now. Guillaume Enderlin is a Pharmacist (Pharm.D) and holds a Master’s degree in Pharmaceutical Engineering.

moderator

Surani Fernando

Healthcare journalist, writer & podcaster

Surani Fernando is a seasoned healthcare journalist and editor with over 13 years experience covering the biopharma industry. A Sydney native, she started her investigative journalism career in London covering clinical trials, M&A and financing deals for BioPharm Insight, later moving to New York to continue her work as an enterprise journalist and editorial leader for GlobalData and Reorg. She is now based in Madrid working as a freelance journalist, consultant writer and podcast producer. In November 2023, she launched the Raising Biotech podcast.