A New Era in Risk-Based Monitoring

REUTERS/Caren Firouz

Historically, a feet-on-the-street approach has been the gold standard for risk-based monitoring (RBM) of clinical trials. Sponsors have relied heavily on intensive source data verification (SDV) and on-site monitoring, however, as the cost of drug development rises, this method is beginning to lose its luster. Soaring technology and the draw of big data have given industry food for thought – why not benefit from real time electronic data capture by routing clinical trial information to a centralized repository and conduct monitoring from there? The advantages of off-site monitoring are compelling – a reduction in travel costs and carbon footprint, the ability to assess and prioritize risks for maximum safety and data quality, and source data errors caught before they sully the trial. That is not to say that centralized statistical monitoring (CSM) is without its limitations – industry experts agree that the best approach is a personalized one, and will likely include a comprehensive methodology. (more…)

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Merck’s Melanoma Label Perplexes, Disappoints

Keytruda

Merck & Co. Inc.’s FDA clearance, almost two months earlier than expected, of PD-1-targeting Keytruda (pembrolizumab) for melanoma holds the title for gaining the first U.S. approval of a drug in the class, but restrictions in the label have meant “a lot of head-scratching,” said Robert Pierce, director in biologics at Merck and member of the PD-1 development team. (more…)

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Quartet of Players Stake Claim in Robotic Exoskeleton Space

exoskeleton

Seeing a paralyzed patient regaining the ability to walk can be both powerful and emotional. For some physicians and clinicians it’s an everyday occurrence. But no matter how many times it happens, onlookers are often awestruck with the sight. (more…)

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Parkinson’s Disease in the Limelight

parkinson's disease

Parkinson’s disease (PD) is a common, progressive, multicentric neurodegenerative disorder of insidious onset whose main features are bradykinesia, rigidity, tremor at rest, shuffling gait and postural instability. It the second most prevalent neurodegenerative disorder after Alzheimer’s disease, affecting between four and six million people worldwide. The prevalence of Parkinson’s disease in industrialized countries has been estimated at approximately 0.3% of the general population, including 1% of the population aged over 60 years and older and 4-5% of those over age 85. (more…)

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Partnering 2.0 from Adimab: How to do it right

Adimab

Everyone wants tips on how to improve their partnering efforts and prospects. Adimab now has dozens of programs across 20+ partnerships. Tillman Gerngross, co-founder and CEO of well-funded Adimab LLC, chatted with BioWorld about what it takes to rack up so many alliances. (more…)

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Sourcing API – Eastern Europe Potential

API manufacturing

Emerging markets are constantly being evaluated for their potential as alternate locations in all facets of the drug development process, from clinical trials through to drug launch. Active pharmaceutical ingredient (API) manufacturing holds one of the major portions of the generic development cycle that has been continuously outsourced to major locales like India and China, which are deeply intertwined with the supply of medications into Europe and the United States. Discussions around the opportunities and individual characteristics of countries like Brazil, Russia, India, China and South Korean (BRICK) markets often take place; although the overall volume of API manufacturers is far less than India and China, Eastern Europe does provide established companies with defined distribution channels in Western Europe and surrounding countries that can be invaluable. (more…)

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Update on the PCSK9 Inhibitors Race to be the Next Cholesterol Blockbuster

PCSK9

Ulrike Jahnke, Editor at Thomson Reuters, provides an update on the PCSK9 inhibitor race to become the next cholesterol blockbuster, with analysts forecasting multibillion dollar sales for Amgen’s evolocumab and Regeneron and Sanofi’s alirocumab, the most advanced PCSK9 inhibitors in the field. (more…)

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ReWalk’s Clearance puts Exoskeleton Technology in Forefront of Med-tech

exoskeleton

Prior to 2009, exoskeletons and therapies for paralyzed patients were probably the last things on Stephanie Souza’s mind. That changed suddenly and the California resident’s life was turned upside down, when she discovered she was suffering from transverse myelitis, a neurological condition consisting of an inflammatory process of the spinal cord. (more…)

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Patient Stratification: Pathway and Network Based Discovery of Gene Signatures

patient stratification

There is now a general appreciation that most drugs don’t work in all patients and only a relatively small proportion (approximately 10%) of drugs actually go on to become approved. Not all patients will respond favorably to drugs and may even develop adverse events. With this in mind we are seeing a trend by pharmaceutical companies to move toward a more personalized medicine approach; that is using molecular profiling technologies (generating ‘big data’) to identify biomarkers (biological characteristics linked to a disease or condition) that assist in stratifying patients into groups depending on their likely therapeutic response via some shared biological characteristics (e.g. the expression of DNA, RNA and protein). Stratification of patients in complex diseases based on these types of data is however, far from trivial. (more…)

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Medimmune Talks Immunotherapy and Checkpoint Inhibitors

immunotherapy

Bahija Jallal, executive VP of MedImmune, part of Astrazeneca plc, shared with BioWorld why immunotherapy is the focal point of cancer therapy these days. She also described Medimmune’s pact with Incyte Corp. and how the companies are testing anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with oral indoleamine dioxygenase-1 inhibitor, INCB24360. (more…)

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