Monday, April 18, 2016
The Pulse on Site Success by Christophe Berthoux
As important as the “business” of clinical research is to success, attention to the culture of a research site and the importance of the values that make a site more than a physical structure is a much greater proposition. Why do we have values? The aim of values is multifaceted and the creation of values does not happen overnight. The metamorphosis of values over time can provide meaning, guidance and color to your operation. Organizational change takes time (on average three years) and resources, but the value system you create can impact every facet of the business from resource allocation to hiring processes to the delivery of quality.
IPOs in the CRO market remain steady
InVentiv Health has filed paperwork for an initial public offering (IPO) worth up to $100 million, following in the footsteps of three other large private equity-backed CROs that have gone public in recent years. Analysts see strong financial activity on the horizon for the CRO industry. Healthcare investment experts anticipate other private equity firms, specifically those that have purchased CROs in the past six to eight years, will look for a return on those investments in the near term, primarily through M&A activity or public stock options.
Overseas FDA data integrity warnings: Combating a surge
A surge in the number of FDA-issued data integrity violations to overseas drug manufacturers is prompting concerns about ramifications and conversations about solutions. A recent PricewaterhouseCoopers (PwC) report stated the number of warning letters by regulators has risen from five in 2010-2012 to 24 in 2013-2015—and all but one were issued to facilities located outside of the U.S.
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Cydan Development, an orphan drug accelerator dedicated to creating therapies that improves the lives of people living with rare genetic diseases, has launched Imara. This is the second orphan drug company launched by Cydan since 2015. Imara will develop IMR-687, a disease-modifying therapeutic selected specifically for the treatment of sickle cell disease and other hemoglobinopathies. IMR-687 was discovered by H. Lundbeck.
Pharmaceutical and medical device teams plan to increasingly involve CROs in their clinical trial planning processes. The largest projected change is the level of vendor involvement in trial design activities, according to a recent report issued by pharmaceutical intelligence provider Cutting Edge Information.
The U.S. ranks 1st in how its domestic policies support worldwide life sciences innovation, according to an analysis released by the Information Technology and Innovation Foundation (ITIF), a global technology policy think tank. Released on World Health Day, the findings come in a new report assessing 56 countries—which together comprise close to 90% of the world’s economy—on the extent to which their scientific research, drug pricing, and intellectual property policies contribute to global biopharmaceutical innovation.
Certara, a global biosimulation technology-enabled drug development company, has launched the Simcyp In Vitro (Data) Analysis (SIVA) Toolkit 2.0 to assist drug development researchers with the analysis of complex in vitro studies. These studies are used to assess candidate drugs’ metabolism, transport and formulation properties.
Abpro, an integrated life science company at the forefront of synthetic biology, has partnered with Essex Bio, a China-based biopharmaceutical company. Abpro and Essex will co-develop multiple monoclonal antibodies in immuno-oncology and ophthalmology by leveraging Abpro’s DiversImmune platform. Abpro received a $3.5M equity investment from Essex Bio and an undisclosed amount from affiliates, as part of the agreement.
The global treatment market for non-hematological cancers, which includes breast, colorectal, lung and prostate cancers, among others, will almost double from $72.9 billion in 2014 to $140.8 billion in 2021, at a compound annual growth rate (CAGR) of 9.9%, according to business intelligence provider GBI Research.