Written by Brad Geisler
Determining whether to hire a pharmacokineticist or outsource clinical pharmacology work to a consultant can be a difficult decision. Many pharmaceutical companies do not have enough full-time work to support an in house pharmacokineticist, making it more cost effective to partner with a firm that specializes in pharmacokinetics.
In-house pharmacokineticists are one of the last positions to be filled within an R&D group. Often due to the belief that there is a limited need for clinical pharmacology/pharmacokinetic participation within a drug development program.
According to a recent survey, 86% of companies have seen pre-clinical PK/PD analysis impact drug development.
Companies with one or two drugs in their pipeline would benefit greatly from PK/PD support by helping to ensure:
- studies are designed correctly
- dosing information is properly selected
- data is correctly analyzed
- regulatory interactions are handled in a positive and professional manner.
However, most companies do not have the need for a full-time clinical pharmacologist/pharmacokineticist, only on an as needed basis. By choosing to partner with a firm that specializes in these areas, pharmaceutical companies can expect a higher return on investment, and are able to avoid hazards in their drug development program, including unnecessary cost of development, increased time to approval, or in some cases both.
In most cases, it is best to consider partnering with a firm that possesses the expertise in pharmacokinetics, and has a good track record of successful strategy development and interactions with the FDA. With the proper strategy implemented, the monetary price tag, will likely be less than without it. Contact us at to find out how PKPD Bioscience can be an asset to your company’s drug development efforts.
Dr. Martin A Graham is a graduate of Leeds University, England where he earned his BSc in Pharmacology and Microbiology with Joint Honors in 1984. He went on to earn his PhD from the University of London at The Institute of Cancer Research, Royal Marsden Hospital, London UK in 1990. Dr. Graham conducted his post-doctoral research in anti-cancer drug development at the Beatson Institute at University of Glasgow before joining Sterling-Winthrop Pharmaceuticals, which later became Sanofi-Synthelabo, in both the UK and the US. Dr. Graham later served as Director of Pharmacokinetics at Centocor Corporation, a Johnson and Johnson Company; VP of Research and Development at Gemin X biotechnologies; and VP of Development and Regulatory Affairs at TetraLogic Pharmaceuticals.
Dr. Graham founded PKPD Bioscience in 2004 where he currently serves is President and CEO. A decade later he founded KinderPharm in 2014, a pediatric drug development company where Dr. Graham also serves as President and CEO. With his extensive R&D experience with both small molecules and protein therapeutics from IND to NDA/BLA, Dr. Graham has been involved in numerous regulatory filings in the U.S., Japan and Europe for a wide variety of products including Oxaliplatin, Rasburicase, Mitoguazone, Tirapazamine, Alfuzosin, Birinapant, Stelara and Remicade.
Dr. Graham is an Honorary Professor of Pharmacokinetics and Pharmacodynamics at the University of Bradford, Yorkshire, UK and is a specialist in PK/PD modeling clinical trial simulation. He is the author of a text book on the Pharmacokinetics of Cancer Chemotherapy and has substantial publication record in the area of pharmacokinetics, drug metabolism and clinical pharmacology.