Taking a Drug Asset to Market, focus on Proof of Concept (Phase II)-David Larwood-01/21/2014 - 8:30am

Event Information
Event Topic: 
Taking a Drug Asset to Market, focus on Proof of Concept (Phase II)
Event Date: 
01/21/2014 - 8:30am
Event Location: 
Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyvale, CA
Speaker Information
Event Speaker: 
David Larwood
Event Speaker Title: 
Event Speaker Company: 
Valley Fever Solutions
Event Speaker Bio: 

David Larwood

David has been CEO of Valley Fever Solutions since our founding in 2007. He has been leading our manufacturing process development, now ready for GMP manufacturing. In his PhD studies in Pharmaceutical Chemistry at the University of California San Francisco he helped invent a successful drug delivery system (PEG liposomes). Earlier, he was first to synthesize a commercially important contrast agent.

He is an experienced business executive with 15 years experience as VP or CEO. He was VP and primary attorney of two companies that successfully went public and operated for years. He took Verisity Ltd. public as its General Counsel and remained in that role until the company was acquired in 2005. FormFactor went public in 2003.

Event Details
Event Details: 

Taking a drug to market is a long and expensive process. The steps are well known and can be described on a single page. The journey is much more complex, very asset specific. Very few products make it through the gauntlet, which is why the average cost of each drug new to the market costs $2-3B. The primary asset itself costs at leas $100M and more often about $500M and can be more. The bigger number reflects the great many drugs that do not get to market. Many drugs fail for scientific reasons - some side effect that is not observed until many people have tried the drug at expected dosage levels. Some fail for policy reasons - the reviewers are sometimes very tough, even unreasonably tough. And some fail for financing reasons - the investors simply lose appetite for the tremendous expense and long time.
We will revisit the general path of drug sourcing, evaluation, and approval, with a particular focus on "proof of concept" - clinical evidence that the compound is efficacious in treating sick people. Dave Larwood will share his presentation from January 13, 2014 at the Biotech Showcase (companion to the JP Morgan conference in San Francisco). He will expand that with a broader scope of development generally, with some thoughts about what seems to be working for many Bay Area entrepreneurs.