IND/CTA/IMD Featured Articles

1. Speeding Research With Data Mining Expertise 4/26/2016

   According to The STM Report (2015), more than 2.5 million peer-reviewed articles are published in scholarly journals each year. PubMed alone contains more than 25 million citations for biomedical journal articles from MEDLINE. The amount and availability of content for clinical researchers has never been greater – but finding the right articles to use is becoming more difficult.

2. A Chief Scientific Officer's Opinion On Clinical Outsourcing 4/16/2013

   Dr. Kenneth Burhop is the chief scientific officer of Sangart Inc., a biopharmaceutical company that engages in the research, development, and commercialization of oxygen therapeutics. He joined Sangart in January 2011, after serving as the global scientific lead/CSO for Baxter Healthcare’s Medication Delivery division and VP of R&D for Baxter's Biopharmaceutical Technologies business, including the company’s second generation recombinant hemoglobin program. He has authored over forty publications, more than seventy abstracts, several book chapters, and has been invited to speak at various international meetings and symposia, and is a recognized international expert in the field of hemoglobin therapeutics. Burhop shares his opinions on clinical outsourcing.

3. Pharmacovigilance Trends: Getting To Know The DSUR 4/15/2013

   In 2010, the International Conference on Harmonization (ICH) rolled out its E2F Development Safety Update Report (DSUR) guideline. The DSUR is similar to the US’s Investigational New Drug Annual Report (IND-AR) and the EU’s Annual Safety Report (ASR) in that its purpose is to provide a brief overview of safety for a project on an annual basis. By Malarkodi S. Moorthy, M.Sc., M.Phil., Medical Writer

4. Start Planning Your Clinical Trials NOW 2/13/2013

   Most entrepreneurs new to drug development are focused on demonstrating the pharmacology of their compound, and rightfully so. There is no point in spending years and millions of dollars in the development of something that does not have a chance of demonstrating efficacy in a clinical trial. Often, however, too little planning is done to position the investigational compound as an actual drug for the treatment of human disease.

5. Increased Adoption Of iPSC-Derived Human Cells For Use In Drug Discovery And Toxicity Testing 10/1/2012

   Traditionally, discovering a pharmacological therapy for a disease involves first investigating the underlying biological processes of that condition and then identifying drug candidates that interfere with those processes.  From here, the most promising compounds are advanced to pre-clinical and clinical development. The goal of this “bench to bedside” approach is to translate bench research to point-of-care patient outcomes as quickly and safely as possible. With dwindling drug pipelines, pharmaceutical companies need new approaches that can re-energize their discovery efforts. By Chris Parker, Vice President and Chief Commercial Officer, Cellular Dynamics International

6. Drug Approval Process A Challenge To Manage 2/6/2012
   In the United States, the drug submission approval, and review process is very complicated, with many facets, including manufacturing, preclinical, clinical, and safety. Dr. Paul Chew should know, as he is the chief science officer (CSO) and chief medical officer (CMO) for Sanofi U.S. By Rob Wright, Chief Editor, Life Science Leader magazine
7. Insights And A Peek Into The Future For PRO & ePRO 12/12/2011

   PHT Corporation’s U.S. PRO & ePRO Congress, held in Boston Nov. 9-10, shared electronic patient reported outcome (ePRO) adoption growth numbers, discussions of new regulatory guidance, actionable information that can ease site and study subject burden from ePRO, PRO and ePRO in post-approval, and lingering reasons for sponsor reluctance to adopt ePRO. By Sara Gambrill

8. Disruptive Innovation In Clinical Trials 7/19/2011
   I recently interviewed Dr. John Hubbard, sr. VP and worldwide head of development operations for Pfizer (NYSE: PFE). One of his current favorite subjects is disruptive innovation. I have heard this buzzword a lot lately from people such as Bernard Munos with InnoThink; Paul Hastings, CEO of OncoMed Pharmaceuticals; and Tomasz Sablinski, MD, Ph.D. with Celtic Therapeutics. Being that Hubbard manages more than 700 clinical development projects for Pfizer, I thought I should learn more about the origin of this concept and what it means for the future of drug development.