NDA/BLA/MAA 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. 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

3. MedImmune’s Blueprint For Building A Biologics R&D Engine 5/30/2013

   Bahija Jallal, VP of translational science for MedImmune, has some insights on how to successfully focus your biologics R&D operation to encourage, not kill the entrepreneurial spirit on which it was built.

4. Repurposing And Rescuing Pharmaceutical Drugs 4/26/2013

   Repurposing marketed drugs or rescuing compounds that failed in clinical trials offers entrepreneurs the potential to replenish pipelines with reduced risk and time.

5. 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.

6. ADC: The Next Big Opportunity For Oncology Drugs 2/27/2013

   The commercial success of mAb products such as Rituxan, Erbitux, and Herceptin has catapulted mAbs to the forefront of molecular medicine.

7. 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.

8. Life Science Venture Funding Drops 9/28/2012

   The economic recession made its impact on life science investments and until there is a change in the economy investment and venture capital firms will remain cautious and conservative.

9. Considerations In Using Foreign Trial Data In U.S. NDA Submissions 8/3/2012

   More and more drug companies are finding it financially advantageous to conduct clinical trials in foreign countries and to include data from these trials in NDA submissions. When offshore trials are properly conducted and the data is properly handled, this strategy can accelerate approval and lower the cost of drug development. By Ken Phelps, Camargo Pharmaceutical Services

10. Expert Insight Into ePRO Industry Trends 6/7/2012

    As technologically savvy as we think we have become, there are still plenty of studies being conducted via pen and paper. By Rob Wright