Proof-Of-Concept (POC) is a pivotal milestone in the drug development process. Analysis of attrition data from the pharma industry indicates that around 80% of drug candidates continue to fail at, or prior to, POC and do not progress into the later stages of development. Consequently, the early development processes must be re-engineered to improve R&D productivity and shorten project timelines, whilst at the same time allowing a more flexible and interrogative investigation of a drug candidates unique potential.
The Enabled-FIH approach was designed specifically to address these requirements. This webinar will present a set of case studies that will illustrate:
- Integrated and adaptive clinical protocols combining healthy volunteer and POC investigations
- Inclusion of POC either at Quotient, or at other sites globally within a single clinical protocol
- Real time adjustment of drug dose and product composition in response to emerging clinical data
- Continuity of drug product supply to global clinical sites
Dr Hazel Hunt, Corcept Therapeutics, will present the design and results of an early development program focused on a new molecule CORT125134, which is in development for the treatment of Cushing’s syndrome and certain cancers.
Dr Alyson Connor, Quotient Clinical, will present further cases studies illustrating the applications and benefits of Enabled-FIH.
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.
Hazel Hunt, VP of Research, Corcept Therapeutics
Dr. Hunt joined Corcept in 2011, bringing with her more than 23 years of experience in the Pharmaceutical and biotechnology industries. From 2002 to 2011 she was Director of Chemistry and Operations at Argenta, where she worked closely with Corcept and played an integral role in the discovery of Corcept’s portfolio of next-generation selective GR II antagonists. From 1994 to 2002 she worked for Celltech, initially as a Group Leader in Medicinal Chemistry and ultimately as Section Leader, Project Chemistry. From 1992 to 1994 she served as a Research Fellow at The Centre for Drug Design and Development. Before that Dr. Hunt worked at Glaxo Group Research as a Senior Chemist in Medicinal Chemistry. Dr. Hunt received a first class honors degree in chemistry from the Australian National University and a PhD in synthetic organic chemistry from the University of Southampton, UK. She also carried out post-doctoral work at Oxford University and the University of California at Irvine.
Who Should Attend?
EVPs, VPs, Directors, Heads, Managers, Principal Scientists from Clinical Development / Clinical Pharmacology, Formulation Research and Development functions, and CMC groups.
Quotient Clinical offers unique services – based on its Translational Pharmaceutics® – that integrate formulation development, real-time drug product manufacturing and 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 drug product development programs for Pharmaceutical and biotechnology customers worldwide. The company is based in purpose-built, fully integrated facilities in Nottingham, UK, where formulation development, real-time GMP manufacturing and early clinical trials are performed in the same facility. It employs over 250 staff, offering a full range of support services, from study set-up right through to data analysis and reporting.