IND/CTA/IMD Featured Articles
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Rare Disease Drug Development: A Thriving Business Model
6/1/2012
Orphan drug development is accelerating to an unprecedented level fueled by several factors that make the rare disease business model more attractive than ever. By Chris Garabedian
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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
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Efficient Contracting Processes For Clinical Trials ... From The Legal Perspective
1/27/2012
On Dec. 1, 2011 in Cambridge, MA, law firm Pepper Hamilton’s Timothy Atkins, partner, life sciences, and Jason Reiser, associate, life sciences, gave a presentation as part of the firm’s Life Sciences Speaker Series. By Sara Gambrill
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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
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5 Key Questions & Answers Regarding Pharmacovigilance
9/29/2011
A Q&A with Sanket Agrawal, executive director, global regulatory affairs and safety, at Amgen, and Nagaraja Srivatsan, senior VP, head of life sciences, North America, Cognizant Technology Solutions.
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Janet Woodcock — CDER, Safety, And The Cutting Edge
9/29/2011
Safety and innovation have become the twin poles of a dynamic struggle that both embattles and empowers the FDA’s Center for Drug Evaluation and Research (CDER). By Wayne Koberstein
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C-Path And The Predictive Safety Testing Consortium: Working To Qualify Safety Biomarkers For Preclinical Use
9/29/2011
Safety liabilities are a major cause of attrition during drug development. Adverse drug reactions resulting in post-approval withdrawal of a medicine cost the pharmaceutical industry millions of dollars and affect thousands of people every year. By Mark Camercon
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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.