Topic: Industry Commentary

Rising to the Challenges of Precision Medicine: Onward!

As we enter 2015, Health Decisions’ mission – continuous innovation to reduce risk and time to market, fail unsuccessful products faster, enable cost-effective development of precision medicines and provide earlier and more affordable access to novel therapeutics and medical devices – is more important than ever. The biopharma and medical-device industries face numerous challenges. Foremost… Read more »

New White Paper Heralds 2015 Medical Device Trends

A variety of trends will present opportunities and challenges for the medical device industry in 2015. The role of medical devices in our lives is growing by the day in a variety of settings, including at the point-of-care, in the home, in hospitals and commercial labs. With exploding growth in identification of biomarkers, the need… Read more »

A Strategic Clinical Development Partnership Success Story

This post concludes a three-part series on strategic clinical development partnerships. The first post in the series discussed surveys showing widespread disappointment in existing strategic partnerships. The second post in the series identified success factors in strategic clinical development partnerships. This post provides a deidentified example of a successful strategic partnership. How to Assemble a… Read more »

Strategic Clinical Development Partnerships: Success Factors

We have had enough success in strategic clinical development partnerships to discuss success factors rather than the disappointing results of such partnerships reported in the industry surveys and studies referenced in last week’s post, A Reality Check on Strategic Clinical Development Partnerships. Strategic partnerships can work if structured to include key success factors. In our… Read more »

A Reality Check on Strategic Clinical Development Partnerships

The strategic partnership model in clinical development was supposed to increase efficiency, not just lock pharmaceutical companies into deals with big CROs. However, mounting evidence indicates that strategic partnerships as commonly practiced have failed to deliver the goods. In an October 1 article for Applied Clinical Trials, Ken Getz of the Tufts Center for the… Read more »

New White Paper: Top 10 Clinical Development Trends for 2015

With Q4 2014 upon us, it is time to gear up for 2015. A few things are clear. Clinical development will continue to evolve against a pattern of high-failure rates for products aimed at large populations and higher success rates for targeted therapies. Orphan Drug development will remain an area of intense activity with continued… Read more »

Population and Patient in Clinical Research and Treatment Decisions

Traditional clinical trials are all about defining populations with inclusion/exclusion criteria, drawing inferences about response for the population tested and trying to generalize from there to a larger population in the wild. The physician in the clinic works from the opposite direction. The challenge in patient care is examining an individual patient presenting with a… Read more »

Drug Development: Navigating from Molecule Selection to Market

Life-science VCs are great at vetting molecules and identifying target markets for novel drugs and biologics. If VCs have a weak spot, it is in the area where 80% of novel therapeutics die – clinical development. Like many biotech and pharma executives, VCs tend to think candidate selection largely determines whether new products achieve marketing… Read more »