Early Drug Development – Failure is Not an Option
Maximizing Proof of Concept
With more and more drugs able to pass the toxicology hurdle and enter into man, early clinical drug trials are now the arena in which key development decisions are made. For large Pharma companies this may mean the difference between developing one drug or another but, for smaller companies, this may be the one opportunity to demonstrate success to fund further development or to provide enough interest for a potential licensing partner. Whilst it is said that all trial work has scientific merit whether it is positive or negative in the world of drug development, for most companies, failure is really not an option. The majority of development compounds fail due to lack of efficacy and this place serious limitations on the industry’s ability to effectively translate biomedical research into marketed therapies.

This workshop will explore ways in which Proof of Concept can be achieved and by discussing optimization of non-clinical models and the importance of early clinical trial planning to maximize the chance of successful outcome.
 
Representatives from late Research to early Clinical Development with a desire to improve their compound success will benefit from participating in this workshop.

The participants will be able to get insight into:

1. Pre-clinical models and predictive efficacy

  • Optimizing the use of appropriate and predictive non-clinical models
  • Can we increase the ability to translate biomedical research into marketed therapies?

The merits of different models will be discussed with the view of optimizing their use

2. Arriving at a reliable Proof of Concept

  • Proof of Principle
    - Can proof of mechanism be demonstrated?
    - Does it matter?
  • What can be gained from normal volunteer studies
  • Proof of concept
    - Therapeutics target
    - Indication selection
    - Patient Population

Efficiency toward a successful proof of concept

To register, simply send an email to fulcrumpharmaevents@fulcrumpharma.com
with your contact information and the Workshop location you will be attending

Joining us will be
Dr Robert M Miller FRCS MBBS FFPM, Chief Medical Officer
Ian Chapman, PhD, FBPharmacolS., Development Director
Fulcrum Pharma Developments Ltd.

Robert Miller is the Chief Medical Officer and a Founder of Fulcrum Pharma Developments which is an independent company specializing in drug development strategy and implementation. Dr Miller trained as a cardiac surgeon and joined the pharmaceutical industry as a medical adviser with ICI in 1988. He moved into the international division in 1990 taking responsibility for the global development of products in three therapeutic areas. In 1996 he joined Protodigm Limited, the virtual company set up by Roche, as a founder member and was Director of Clinical Development.

Dr Miller is a Fellow of the Royal College of Surgeons, The Royal Society of Medicine, and is a Fellow of the Faculty of Pharmaceutical Medicine. He qualified as a physician in 1975 from The London Hospital (England) and has medical degrees from the University of London as well as the Royal Colleges of Surgeons and Physicians of England.

 

Dr Chapman joined Fulcrum Pharma as Development Director in 2006 having worked previously for Quintiles where he held various positions including Scientific Director, Department of Pharmacology, Product Specialist in Business Development and Head of Respiratory and Inflammation Pharmacology.Prior to joining Quintiles in 1995, Ian was Head of Respiratory Pharmacology at Syntex Pharmaceuticals (1994 -1995) having moved from the Respiratory Research group as Senior Scientist at Sandoz Pharma in Basel, Switzerland (1986-1994) where he was involved in the discovery and development of several novel drug candidates including PDE inhibitors, Potassium Channel Openers and Immunosuppressive agents.

Dr Chapman has a wide experience of in vivo and in vitro techniques within pharmacology. He is a Fellow of the British Pharmacological Society and a member of the British Inflammation Research Association, having served on the committees of both. He is an author of over fourty full publications in international journals and books.


For further questions, you can also contact Samuel Gosselin at:samuel.gosselin@fulcrumpharma.com