Genomics

On 14 September 2017, the Committee for Human Medicinal Products (“CHMP”) of the European Medicines Agency adopted ICH Guideline E18 (the “Guideline”) on genomic sampling and the management of genomic data.  The Guideline takes effect on 28 February 2018.

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) developed the Guideline in acknowledgement of the growing awareness of, and interest in, genomic data generated from clinical studies.  The ICH suggested that the absence of a harmonized guideline made it more difficult to conduct genomic research consistently in global studies.  The fact that the CHMP has adopted the Guideline means that EU guidance on this subject is now aligned with the ICH standard.

The Guideline provides general principles for the collection and handling of genomic samples and management of genomic data.  It also affirms broader principles, such as the need for informed consent and the protection of subjects’ privacy etc.  The Guideline applies to both interventional and non-interventional clinical studies, irrespective of when the genomic research is carried out and whether it was envisaged in the study protocol.  The ICH/CHMP intend the Guideline to be interpreted in accordance with the law and policies in each jurisdiction where genomic research takes place.
Continue Reading CHMP Adopts Guideline on Genomic Sampling and Management of Genomic Data

On August 30, the UK government published a report by Professor Sir John Bell of Oxford University providing a number of recommendations to government to ensure the long term success of the life sciences sector in the UK (Life Sciences Industry Strategy).  This blog post summarises the key recommendations and observations made from

As we described in an a post last month, in the State of the Union the President announced a new “Precision Medicine Initiative” to foster the development and delivery of personalized treatments for illnesses such as cancer and diabetes.  The FY 2016 budget released by the President yesterday includes $215 million in funding to launch the Precision Medicine initiative.
Continue Reading President’s Budget Includes Funding for Precision Medicine Initiative

This year’s State of the Union address included little explicit discussion of health IT, but did highlight two areas that could have significant implications for health IT: the President announced a new “Precision Medicine Initiative” and also urged Congress to pass legislation to combat cyber attacks and prevent identity theft.

While the address was scant

The excitement around eHealth innovations was palpable throughout San Francisco this week as the annual JP Morgan healthcare conference flooded the city.  JP Morgan itself offered panels and presentations from industry leaders and emerging companies, while simultaneously occurring conferences, speaker programs, and networking events throughout San Francisco featured discussions on the changing face of healthcare in today’s world of increasing digitization, economic transformation and regulatory oversight.

Major deal announcements were also triggered by the “Superbowl of Healthcare” buzz this week, including scores of new eHealth initiatives and start-ups.  We’ve highlighted a few of the big deals of the week below.

Complex Cross-Disciplinary Approaches: Roche and Foundation Medicine Announce New Partnership

In an approximately $1.2 billion deal, Roche agreed to acquire a majority stake in cancer diagnostic maker Foundation Medicine.  The companies simultaneously entered into a series of commercial arrangements in which Foundation’s tumor analysis and cancer genetics capabilities will be incorporated into Roche’s clinical development platform.  The companies will also collaborate to co-develop novel cancer diagnostics as well as to educate physicians about genetic informatics-based cancer care. 
Continue Reading JP Morgan Conference Highlights eHealth Technologies, Data-Driven Therapeutics