Enabled-First-in-Human™ programs re-engineer the pathway from candidate selection, into clinical development and through to Proof of Concept (PoC). Timelines for early development can be significantly accelerated and the associated costs reduced, supporting pharma development teams in their quest for ever increasing R&D efficiency and productivity.
Enabled-First-in-Human™ programs exploit Quotient’s Translational Pharmaceutics™ platform, which integrates real-time drug product manufacturing with clinical testing. This platform delivers:
- Streamlined expenditure on drug product development and clinical trial manufacturing until the drug candidate has achieved PoC and been validated for full development
- “Real time” modification of dose and formulation composition in response to clinical data (safety, pharmacokinetics, pharmacodynamics) emerging from the program
- Seamless and uninterrupted transition between clinical investigations in healthy volunteers and patients, enabling accelerated PoC read out
This webinar will describe the Translational Pharmaceutics™ platform and present Enabled-First-in-Human case studies to illustrate how it has been applied in early stage drug development programs.
Alyson Connor, Director, Exploratory Clinical Pharmacology, Quotient Clinical
Dr Alyson Connor has over 16 years’ experience in the design and implementation of Phase 1 trials at Quotient Clinical, a company specialising in early drug development. As Director, Exploratory Clinical Pharmacology Alyson leads a cross-functional team responsible for the design, implementation of Phase 1 studies, with particular emphasis on First-in-Human.
After graduating from the University of Newcastle-upon-Tyne, UK with a first class honours degree and PhD, Alyson 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 Principal Scientist at the end of 2005 and Director, Exploratory Clinical Pharmacology in Jan 2013.
Phil Collis, VP, Clinical Development, Biocryst Pharmaceuticals
After completing a PhD and post-doctoral research in London, UK, Phil Collis started his career in clinical development at Glaxo Group Research in 1989. Over the past 25 years he has worked in large pharma, the CRO environment and for the last 8 years has worked at BioCryst Pharmaceuticals, a company that uses structure-guided drug design to discover and develop small molecule inhibitors of key targets involved in infectious and rare diseases.
Who Should Attend?
EVPs, VPs, Directors, Heads, Managers, Principal Scientists from formulation research and development functions, CMC groups and Clinical development / clinical pharmacology.
Quotient Clinical offers a unique range of services, based on its Translational Pharmaceutics™ platform. Translational Pharmaceutics™ integrates formulation development, real-time GMP manufacturing with clinical testing, significantly reducing the time and cost of bringing a drug to market.
For more than 20 years, Quotient Clinical has brought innovation to early drug development programs for Pharmaceutical companies worldwide. At the company’s purpose built facilities, “real-time” manufacturing of all types of dosage forms is co-located with its clinical pharmacology unit to maximise flexibility, speed and cost savings for clients. More than 200 highly trained specialists provide a full range of services from study set-up right through to data analysis and reporting.
For further information, www.quotientclinical.com.