Drug Development Overview: Formulation and Equipment needs for a Small Molecule Therapeutic. How & when to make it happen.-Andrew Nelsen, P.E. & Gail L. Strong, Ph.D.-04/21/2009 - 8:30am

Event Information
Event Topic: 
Drug Development Overview: Formulation and Equipment needs for a Small Molecule Therapeutic. How & when to make it happen.
Event Date: 
04/21/2009 - 8:30am
Event Location: 
Speaker Information
Event Speaker: 
Andrew Nelsen, P.E. & Gail L. Strong, Ph.D.
Event Speaker Company: 
Event Speaker Bio: 

Andrew E. Nelsen, P.E. has over 25 years experience designing and building (or purchasing and installing) pharmaceutical equipment for R&D, Pilot Plant and Production.

Specializing in equipment for a wide range of innovative time-release drug products, his experience included solid-dosage (tablets), extrusion and web handling (calendering, laminating and converting), and packaging. Often he found that unprecedented time-release drug products required the design of new manufacturing equipment (e.g.: laser-based tablet drill) or adaptation of equipment from another industry (food-service kneader-extruder adapted to transdermal manufacture.)

As Senior Director of the Equipment Engineering & Development group of ALZA / Johnson & Johnson, Andy led a team of equipment designers, engineers, and fabricators.

He is co-founder of the Johnson & Johnson Global Engineering Community of Practice, a world-wide innovation-sharing group within Johnson & Johnson. He is active in the Programs Committee of the SF chapter of the ISPE (International Society of Pharmaceutical Engineers).

Gail L Strong, Ph.D. is an expert in pharmaceutical development with over 15 years experience bringing small molecules from discovery to late stage clinical trials. She has played a key role in the discovery team by providing physical chemical characterization, salt selection and hydrate and polymorph screening to the identification of lead compounds for development at the Upjohn Company.

Dr. Strong led the U.S.Pharmaceutics function for the Pharmacia Co. In that capacity the groups provided CMC transition for a molecule from discovery to early clinical trials. At Theravance Inc, Dr. Strong led the Oral Formulation development group which evaluated, developed and outsourced manufacture of oral drug products for clinical trials. She also led the GIPROK project with successfully moved TD-5018 through a Phase 2 proof of concept study and positioned it for Phase 3 evaluation.

Event Details
$0 - Free
Event Details: 

Getting a drug to market is a complex, expensive and time-consuming endeavor. All too frequently, poor planning or lack of foresight results in delays, cost over-runs and missed opportunities. In this presentation we will provide an overview of the general drug development process focusing on drug formulation and equipment needs. We will discuss potential options and their impact on timing and risks that you may find in your project.