Webinar:

Accelerating molecules through to Proof-of-Concept, with an integrated early development program

Sponsored by: Quotient Sciences

Focused on:

  • Accelerating Molecules

Date: 3 June

9

Time: 10AM London/ 11AM Paris

In today’s pharmaceutical R&D pipeline there are more molecules in development than ever before, but the attrition rates of drug candidates reaching Phase II remains high and an increasing number of molecules have challenging drug properties.

To keep costs under control, biotech and pharma companies need to transition molecules through early development as quickly as possible, to reach Proof-of-Concept (POC) and select the "winners" for late stage development. To achieve this, there is a need to better understand drug properties and the developability of a molecule, while exploring novel and integrated approaches to early drug development. This, in turn, will enable molecules to reach patients faster by shortening development times.

This webinar will highlight how a fully integrated development plan can bring together the needs of the drug product team and the clinical development team.

Presented by

John McDermott,

Executive Drug Development Consultant

John has over 15 years industry experience in roles in pharmaceutical sciences with Rhone Poulenc Rorer, Covance and Quotient Sciences, which he joined in 2001. He has been central to the development of Quotient's integrated pharmaceutical and clinical development programs, utilizing our ability to manufacture drug products in real-time in response to arising human data. John's responsibilities at Quotient Sciences include the design and implementation of integrated pharmaceutical and clinical development programs. In addition, John has a significant body of experience in scintigraphic imaging studies for oral and inhaled dosage forms, including the development and validation of radiolabelling methods.

Chris Roe,

Senior Research Fellow

Chris joined Quotient in 2015 as a Research Fellow, bringing over 20 years’ experience across pharmaceutical sciences and biopharmaceutics through a series of previous technical and leadership roles at Sanofi, Pfizer, AstraZeneca and Walgreens Boots Alliance. His expertise ranges from early pre‑formulation and biopharmaceutical assessments ensuring appropriate new chemical entity selection, through development of a wide range of dosage forms including preclinical and early clinical inhalation, topical, oral immediate release and modified release formulations, to maintenance and life-cycle management of existing marketed products. Chris’ role at Quotient involves designing science­-­led, robust, clinical study programs which maximise output for clients, in addition to providing scientific support throughout study delivery. Chris holds a Bachelor of Science degree in Medicinal Chemistry from Newcastle University and Postgraduate Certificate in Education from Nottingham Trent University.

Key Learning Objectives

  • Discover how you could potentially shorten your time to POC by over 12 months, with industry case studies
  • Understand how it is possible to screen and evaluate multiple formulation technologies for poorly soluble molecules in a single clinical protocol
  • Hear how it is possible to bridge from 'fit-for-purpose' FIH formulations to 'patient ready' dosage forms without losing time in the development program.
  • Explore strategies for managing CMC investments and creating time savings, including the use of pharmacy preparations and real-time GMP manufacturing
  • Assess the value of streamlining your outsourcing partners and the importance of end-to-end project management.

Audience

  • Heads of Pharmaceutical Development
  • Heads of Formulation Development
  • Formulation Scientist
  • Manufacturing Scientist
  • CMC Scientist
  • Heads of Clinical Manufacturing
  • Heads of R&D
  • Heads of Outsourcing
  • Chief Scientific Officer