Talking Trials

Our leadership team’s perspective on the latest in CRO and clinical research breakthroughs.

Phase I pharmacy
By Sherilyn Adcock, Ph.D., Executive Vice President, Worldwide Clinical Trials Early Phase Services,

Following on from part 1 of our series on the role of pharmacy in clinical research units (CRUs) this post provides valuable insights into the role of manufacturing and compounding, investigational drug blinding and dispending and dosing.

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Phase I pharmacy
By Sherilyn Adcock, Ph.D., Executive Vice President, Worldwide Clinical Trials Early Phase Services,

Phase I clinical trials form an important foundation for drug development and eventual approval of life-saving therapies. This two-part blog will review the role of the pharmacy in a state-of-the-art Phase I clinical research unit (CRU) and discuss best practices. Part 1 will consider the importance of pharmacy staff, the novel role of protocol review and drug accountability, with the next installment discussing manufacturing and compounding, investigational drug blinding and dispending and dosing.

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Leaders in pharmacovigilance in drug safety
By Steve Unger, Laboratory Director, Worldwide Clinical Trials Early Phase Services,

Drug candidate selection includes perspectives from numerous disciplines (drug discovery, drug safety, drug metabolism and pharmacokinetics (DMPK), pharmaceutics, clinical pharmacology and biostatistics).  Many organizations use the fail fast model by integrating development functions into discovery to minimize failures in preclinical Good Laboratory Practice (GLP) studies.  More forward testing allows organizations to select better compounds and to build better, long-term development plans.

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By By Tomislav Babic, MD, PhD, Vice President, Neuroscience Franchise, Worldwide Clinical Trials,

The FDA approved Newron Pharmaceuticals, Zambon and US WorldMeds’ Xadago (safinamide) as an add-on therapy to levodopa/carbidopa for patients with Parkinson’s disease, the companies announced Tuesday, March 21, 2017.

The new drug received European marketing authorization in February 2015 for the treatment of Parkinson’s disease (PD). The approval covers the indication “safinamide as add-on therapy to levodopa alone or in combination with other Parkinson’s disease treatments” in mid-to late stage Parkinson’s disease patients.

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By Toni Bransford, M.D., FACC Senior Medical Director, Medical & Scientific Affairs, Cardiovascular Disease, Worldwide Clinical Trials,

While CVD has been the leading killer of Americans for decades, advances in biomedical research, improved emergency response systems and treatment and prevention efforts helped improve morbidity and mortality in recent years, although without eradicating the disease or the downstream morbidity and mortality. Between 2000 and 2011, the national heart-related mortality rate declined at an average of 3.7 percent per year, while stroke mortality declined at 4.5 percent per year. The bad news is that since then, further progress has stalled.

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By Toni Bransford, M.D., FACC Senior Medical Director, Medical & Scientific Affairs, Cardiovascular Disease, Worldwide Clinical Trials,

The rate of disease progression is dependent both on the primary pathology and the activity of the compensatory processes, the most important of these being neural, endocrine, renal and morphological. Most of these chronic compensatory processes, such as activation of the renin-angiotensin-aldosterone system (RAAS) and sympathetic nervous system, are believed to be harmful, although the increase in natriuretic peptides is believed to be a beneficial compensatory response.

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