Small Molecule or Biomolecular Drugs (Biologics) –What’s the Difference?

Wednesday, June 22, 2011
11:30 – 1:30 pm EST

Course Description:
Biomolecular drugs (Biologics – therapeutic proteins and Mabs) have leveled the playing field – a) about as many new biologics being approved each year as new small molecule drugs (NMEs); b) all the big Pharma now have the capacity to develop both types of drugs (note the recent buy-out of Genzyme by Sanofi-Aventis), c) those that had biologics capacity are increasing it., d) the larger biotech companies are developing the capacity to develop small molecules, and e) now with many blockbuster biologics nearing patent expiration biosimilars are on the way. It’s no longer - choose which type – you will need to know how to discover and develop either type of drug. This is a crash course on the differences and similarities between small molecule and biomolecular drugs for everyone who needs to know.

Learning Objectives:

How do small molecule drugs differ from biomolecular drugs? We will compare their properties, how they differ in Discovery and Preclinical, how stage lengths vary, how costs vary, and how biosimilars are not generics.
Where are they not so different? We will see that biologics are now in most therapy areas, discovery and development of both types can be managed with the same milestones and stages, biologics success rates were initially higher but they are becoming like small molecules, so much so that the FDA has them reviewed by the same group, CDER.
Can one company treat them the same way? Because they’re not so different – sure! But the differences can create different issues. So being aware of differences up front can help in project and portfolio planning.

Who Should Attend:
Anyone who has worked in one area and faces the need to work in both areas:

Therapy Area Heads and Group Leaders,
Platform Technology Heads and Group Leaders (protein sciences, assay development, pre-clinical sciences, clinical sciences),
Project Leaders and Portfolio Managers.
Medicinal Chemists ought to know what they are up against.

Instructor Information:
James Samanen, Ph.D. President, James Samanen Consulting; formerly worked at GlaxoSmithKline for 31 years
James is a pharmaceutical consultant with a track record of 30+ years leadership and innovation in drug discovery project & portfolio management, and portfolio data analysis at GlaxoSmithKline. While at GSK James developed and implemented worldwide Portfolio Management for GlaxoSmithKline Discovery and Genetics Research businesses encompassing 2000 staff and $400M budget - involving negotiation and implementation of processes for selection and prioritization of research programs, developing IT systems, mirroring past to present performance with fit-for-purpose benchmarking analysis, modeling future performance, change management and team training. His work enabled an increase in productivity of drug-like leads in GSK by > 50% in 2 years by cross-functional team-working, prioritization and 40% portfolio downsizing. He also enabled strategy changes reducing cycle times by 50%. As a group leader in Medicinal Chemistry he discovered & championed lotrafiban (antithrombotic) to Phase III, and 2 preclinical candidate antithrombotics. He has been a project leader in diverse areas of drug discovery. He established James Samanen Consulting in December, 2008.