They say there are two certainties in life: death and taxes. If we were to add a third certainty to that list, it might be that we generally have inflation as well. But if rising prices on consumer goods are a fact of life, why are some people surprised when the cost of prescription drugs increase as well?
Anyone involved in clinical work knows investigator engagement is not an easy task. Gathering real-time feedback during a trial, selecting the right investigators, and effectively engaging with sites and investigators can be a monumental challenge.
Earlier this year Invesco Perpetual, an investment firm with holdings in Big Pharma companies including Pfizer, Merck, and GSK, announced a $50 million investment in DrugDev, a data sharing platform for clinical trial doctors with an online network of more than 80,000 clinical trial doctors in 93 countries. DrugDev stated at the time that the money would be used to enhance its clinical trial technology as well as acquire companies with complementary technologies. The first of those companies is CFS Clinical. DrugDev announced it has acquired the company, a provider of business and financial management activities for trials, as part of its plan to help companies control the spiraling cost of clinical trials.
When choosing a partner to participate in your human clinical trial, does it matter if you select a state- or federally chartered clinical facility versus a privately operated clinic or hospital? David Shuey, North America life sciences practice leader for insurance brokerage firm Willis Group Holdings plc., believes it does. In fact, if you are not aware of the differences, it could cost you dearly should a problem arise. The issue is sovereign immunity, an ancient carryover from England that is designed to protect the government from lawsuits.
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.
Leslie Williams is President, CEO, and founder of ImmusanT, Inc., an early stage company focused on peptide treatments for auto-immune diseases. Williams has over 20 years of industry experience in healthcare, management, commercial product development and marketing. Williams took time out from her managerial duties to share her perceptions on outsourcing and working with CROs.
Investigator grant payments are typically the single greatest expense in a clinical trial budget, often accounting for 40 to 60 per cent of the total budget. By Kevin Williams, CFS Clinical
The Sunshine Act requires manufacturers of drugs, devices, biologicals, and medical supplies to begin recording all physician payments—including payments made for clinical trial research
The European Commission announced in July this year that it proposed to ease the administrative burdens of clinical trials conducted in the European Union (EU), particularly those taking place in several countries. By John Blakeley, Chief Commercial Officer, Greenphire
As a CRO you will be hearing more and more about the Physician’s Payment Sunshine Act or PPSA in the next few months. By James Neal, Endign
Confusion exists over the definition of fair market value (FMV) when you ask any biopharmaceutical sponsor or investigative site and this article attempts to demystify some
basic factors related to FMV principles, with the goal of fostering improved understanding and dialogue on FMV issues.
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