Pharmaceutical Technology - November 2018

Pharmaceutical Technology - eBook

Issue link: https://www.e-digitaleditions.com/i/1052795

Contents of this Issue

Navigation

Page 23 of 45

24 Pharmaceutical Technology LABORATORY BEST PRACTICES 2018 P h a r mTe c h . c o m ANGELLODECO\STOCK.ADOBE.COM Outsourcing C ontract research, development, and manufacturing organiza- tions (CRO/CDMOs) are well established in the drug develop- ment lifecycle and are often used for dedicated activities along the drug discovery and preclinical development process. Each of these main areas (discovery and development) of the drug develop- ment process breaks into specific areas. These areas can include target identification, target validation, lead identification, early pharmacology, high throughput screening (HTS), adsorption, distribution, metabolism, and excretion (ADME), drug metabolism and pharmacokinetics (DMPK), bioanalysis, formulations, safety/toxicity, process development, and scale up, etc. Domain specialist CROs have emerged in this space as well as larger "platform" CROs who offer full "end-to-end" service. The reliance on CROs as service providers is becoming crucial; many large pharmaceutical companies increasingly look toward CROs for spe- cialist capabilities while streamlining their internal operations. Outsourc- ing has obvious business benefits in certain areas as it helps reduce over- heads and potentially speeds up the process. One major industry driver forcing engagement of CROs is the movement of the pharmaceutical in- dustry toward biologics and biosimilars. The shift to large molecule/biologics as drug candidates has been oc- curring for the past 10–15 years (1)—the trend often attributed to the success of Herceptin, Genentech's blockbuster treatment for certain types of breast cancer. Many pharma and biotech companies have looked to mimic this success, as evidenced by the increase in new drug applications for biologic-based drugs, year-on-year for 10 years. As companies rapidly change their focus, they may lack the laboratory space, instrumentation, and often, the scientific domain knowledge to support biologics research without a huge resource investment. Barriers and Solutions to Effective External Collaboration in Biopharma As biopharma companies rapidly change their focus, they may lack the laboratory space, instrumentation, and the scientific knowledge to support biologics research. Paul Denny-Gouldson is Vice President of Strategic Solutions at IDBS. Paul Denny-Gouldson

Articles in this issue

Links on this page

Archives of this issue

view archives of Pharmaceutical Technology - November 2018 - Pharmaceutical Technology - eBook