First-in-Human to Proof-Of-Concept: Addressing Development Challenges and Accelerating Timelines

Increasing pressure on R&D budgets means the design, speed and precision of early phase clinical programs is critical for success. The traditional staged approach to drug development has involved discrete clinical studies in Phase I and Phase II, separated by decision steps. However, increasingly protocols are being combined or interleaved to accelerate the pathway to POC.

In addition to optimizing the clinical plan, pharmaceutical project teams now also demand more data than ever before to answer key “developability” questions in Phase I. Can we assess the impact of formulation and formulation performance? How can we rapidly manufacture GMP product for Phase I? What drug product will we use for Phase II? Is there a valid biomarker to establish an early pharmacodynamics response? Are there any metabolism or bioavailability issues that need to be addressed?

During this webinar, the speakers will describe how Enabled-First-in-Human® programs integrate real-time GMP drug product manufacturing with healthy volunteer and patient clinical testing into a seamless early development plan. The effect is to significantly reduce time to proof-of-concept, minimize up-front investment and simplify supply chains.

This webinar will present a set of case studies on:

• Integrated single and multiple ascending dose studies combining healthy volunteer and POC investigations
• Real-time adaptive GMP manufacturing to enable dose, formulation and product changes within a clinical protocol in response to emerging clinical data
• Continuous supply of clinical trial material (CTM) to global clinical sites post-Phase I, avoiding the need for tech transfer and scale up prior to Phase II

Dr Ofir Moreno, MEI Pharma, Inc will present the design and results of an early development program of a new molecule ME-401, which is in development for the treatment of lymphoid malignancies.

Dr Alyson Connor, Quotient Clinical, will present further cases studies illustrating the applications and benefits of Enabled-FIH.

Speakers

Alyson Connor, Executive Director, Exploratory Clinical Pharmacology, Quotient Clinical

Alyson is an Executive Director, Exploratory Clinical Pharmacology at Quotient Clinical, with responsibility for the global portfolio of First-in-Human (FIH) and Proof-of-Concept (POC) studies. She has over 15 years’ experience in the design and conduct of clinical programs, with particular emphasis on the use of adaptive and umbrella protocols to streamline the transition to POC. Her responsibilities at Quotient Clinical include coordinating the Quotient team to design integrated Pharmaceutical and clinical development programs, utilizing Quotient’s ability to manufacture drug products in real-time in response to arising human data. After received her PhD from the University of Newcastle, UK, she joined Quotient Clinical (then Pharmaceutical Profiles) in 1997 as a Project Manager. After fulfilling roles in the Project Management, Operational and Scientific departments, Alyson was appointed as Director, Exploratory Clinical Pharmacology in 2013. Alyson is also an acknowledged expert in the visualization of oral dosage form performance in the gastrointestinal tract and regularly publishes on this subject.

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Ofir Moreno, Vice President of R&D, MEI Pharma, Inc.

Dr. Moreno joined MEI Pharma as Vice President, Pre-Clinical Research in September 2010 and was appointed Vice President, Research & Development in July 2012. He was instrumental in advancing pracinostat though Phase 2 trials, and advancing ME-143, ME-344 and ME-401 through investigational new drug-enabling studies and into first-in-human clinical trials. Dr. Moreno has over 20 years of drug discovery and development experience in the Pharmaceutical industry, including positions of increasing responsibility at Merck, Amgen and Corvas International (acquired by Dendreon). Dr. Moreno earned his bachelor’s degree in Biology and Chemistry from Cornell University and his Ph.D. in Organic Chemistry from Harvard University.

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