Research Collaborations between New Jersey and Indian Companies in the Pharmaceutical Industry

N. Tamil Arasu Ph.D. Principal Scientist, Chemistry PTC Therapeutics April 28th, 2008

About PTC Therapeutics

Biopharmaceutical company Located in South Plainfield, NJ Spinout from UMDNJ Employs nearly 180 people Compounds in clinical trials Partnered with major pharma companies Chemistry and some biology collaborated with Indian CROs

Pharmaceutical Research Outsourcing

Chemistry
Process optimization, Formulations, Custom synthesis, Medicinal chemistry, Analytical chemistry

Biology
Assay development, protein expression and synthesis etc.

Pharmacology
Metabolism, PK studies, efficacy studies, animal model studies, enzyme inhibition studies etc.

Clinical Studies
Phase-1, 2 and 3 studies

The Benefits of Outsourcing

Improving R&D productivity, while reducing costs Focus on core strength Easy expansion Faster project outcome

Current Trends in India

Almost all the major pharmaceutical companies work with Indian CROs (Contract Research Organization) Chemistry collaborations have continued for longer period Biology and pharmacology are in early evaluation stages

Advantage India
Very cost effective Highly skilled English-speaking scientists are plenty Project Managers have experience from US and Europe Several well equipped companies are in the business IP protection strengthened after 2005

Chemistry Research Models

FTE (Full Time Equivalent) Fee for service
Custom Synthesis Combinatorial library synthesis Analytical services

Research Alliance

FTE Model
FTE rates are fixed for specific term Some overhead cost is built within the FTE rate Most FTEs have a Masters Degree Some companies provide a full time Ph.D. manager without additional cost for every ~5 FTEs Most suitable for medicinal chemistry Flexibility in the projects

Selecting the CRO

Credibility Quality of scientists Lab facilities Cost Location

Major Medicinal Chemistry CROs

GVK Biosciences Chembiotek Syngene Jubilant Sai Advantium Advinus

Working with CROs

Regular project reports- weekly or Biweekly Regular Teleconferences- weekly or Biweekly Emails Visits

Challenges in the R&D Outsourced Model

Lack of college level education with hands-on experience Understanding of drug discovery process Reagents receiving time Safety consciousness Building the talent pipeline Retaining the experienced candidates

Summary
FTE model has been more beneficial to advanced discovery projects than early stage projects Outsourced R&D services to India significantly reduces the cost and time Long-term growth potential and sustainability unpredictable