IND/CTA/IMD Featured Articles

1. Is An FDA Pre-IND Meeting Worth It? How To Decide & How To Prepare 1/11/2017

   If you are considering whether to take the time in advance of your investigational new drug (IND) application submission to meet with FDA for feedback on your development program, here are some thoughts to ponder and reasons not to pass up this valuable opportunity.

2. 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.

3. How Do I Get My Compound Into Phase I? 4/2/2014

   The primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity prior to entering into human clinical trials. By Dr. Scott E. Boley and Greg Ruppert

4. 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.

5. 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

6. The High Cost of Clinical Research – Who’s To Blame And What Can Be Done? 4/8/2013

   The cost of new drug discovery has skyrocketed in recent years, and is something that should have everyone in the drug discovery industry concerned. Sergei Varshavsky, M.D., Ph.D., and senior VP of global strategy for contract research firm Synergy Research Group (SynRG), notes it was not always this way. Some of the greatest medicinal discoveries in the history of mankind were inexpensive to develop and test. “There was the discovery of the smallpox vaccine in 1796, ether anesthesia in 1846, and insulin and penicillin in the early 20th century,” he says. “None of them cost much. In fact, the patent for insulin was sold to the University of Toronto for a half-dollar. Despite the low cost, these drugs have saved billions of lives.” Unfortunately today’s medical community is no longer able to accomplish similar feats for such a low cost.

7. 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.

8. Pfizer Perseveres In Pioneering Virtual Clinical Trials 11/29/2012

   Craig Lipset discusses the lessons learned from Pfizer’s REMOTE clinical trial was conducted with less than stellar patient responses.

9. 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

10. The Only Path To True Innovation In Drug Discovery 9/28/2012

    In drug discovery going against the literature can be an uphill battle, but Philip Haydon, Ph.D.’s work with glia cells prove that payoffs can be huge with conviction and tenacity.