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CLSA Events

Life Science Series: Planning Your Drug Development Success

In collaboration with

MPI Research

The discovery and identification of a new molecular entity (NME) and the application of research required to show a proof-of-principle for a therapeutic agent can be rife with pitfalls and it is extremely difficult to qualify a new prospect for venture funding or partnering with another pharmaceutical company. Many times, companies in the early stages of a concept or principle identification fall into the trap of focusing on only the efficacy segment of their prospective therapeutic agent’s potential but have little or no safety data to provide for the initial funding considerations. This often missing safety data is considered to be a critical component by individuals who are responsible for making key venture capital funding and pharmaceutical venture decisions.

We will take the audience from early discovery to the demonstration of efficacy, drug/biologic agent exposure, early candidate selection, and the preclinical safety aspects which may not be considered by startup companies. In addition, we will discuss scaleup and impurity issue considerations for the Active Pharmaceutical Ingredient (API) during the development phases through late stage drug/biologic development, selection of a preclinical safety evaluation partner, API supply, and regulatory filings. The symposium will conclude with a panel discussion to provide attendees with the opportunity for valuable exchanges with experts in the fields of drug development and regulatory toxicology.

Speakers

David Brewster, PhD, DABT
Head Drug Safety Evaluation
Global Exploratory Development
Vertex Pharmaceuticals

Joy Cavagnaro, PhD, DABT, RAC
President
Access BIO

Stephen W. Frantz, PhD, DABT
Senior Director of Business Development Pacific Northwest Region
MPI Research

Richard Slauter, PhD, DABT
Senior Director
Drug Metabolism/Pharmacokinetics and Senior Principal Study Director
MPI Research

Michael Taylor, PhD, DABT
Founder and Principal
NonClinical Safety Assessment

What: Life Science Series: Planning Your Drug Development Success
When: Wednesday, September 19, 2012
Registration & Breakfast: 7:30AM
Speaker Presentations: 8:00AM – 10:00AM
Panel Discussion: 10:00AM – 11:00AM
Where: South San Francisco Conference Center
255 South Airport Blvd.
South San Francisco, CA
Directions
Parking: Multiple Lot Options
Getting There: Public Transportation Information
Cost: Pre-registration through September 17
$20 members
$40 non-members
On-site registration on September 19
$40 members
$75 non-members
Attire: Business attire suggested