Pharmaceutical companies are experiencing a significant change because of the shift in drug development toward more complex and expensive cell therapies with a focus on rare diseases.
Over the holiday season, I took the time to reflect on the whirlwind and craziness of the past year. I don’t know about you, but I was ready for some comic relief, so I indulged in one of my favorite pastimes -- attending an improv comedy show. It’s been 10 years since the original Whose Line Is It Anyway ended its successful run as a TV show (much to my chagrin), but Saturday Night Live is alive and well after 40 years.
If you are involved with clinical trials, you are aware of the shortage of qualified CRAs. Numerous reports have noted the continuous increase in turnover and salaries for these clinical professionals. We know the problem exists, but is there anything we can do about it?
In 2017, clinical development services did not witness any significant changes in terms of price index, input cost, and supply-demand gap in comparison to 2016. However, market competition increased, with the supply market seeing continuous mergers and acquisitions, resulting in consolidation and CROs competing for market share in terms of enhanced therapeutic area expertise, geographic reach, full-service capability, technology, and increased functional capability.
Clinical research is incredibly complex, and most pharma/biotech companies outsource a lot of the trial oversight responsibilities to contract research organizations (CROs). The increasingly level of complexity and global nature of clinical research has led to poor communication within pharma and between sponsors and their CROs.
Maria Fardis, CEO of Iovance Biotherapeutics, has spent 18 years working in the pharma industry. Although most of her experience has been in small molecules and proteins, she now works in the cell therapy space and notes these treatments are a new and exciting space with meaningful differences in how clinical trials are conducted.
Large pharma companies have a variety of outsourcing models they can use, from strategic partnerships to functional service provider models. But if you are a small biotech company, does the size of your firm limit your outsourcing options? And how big a role should cost and therapeutic expertise play in that decision?
For a small biotech company, making the transition from discovery to clinical is where the rubber meets the road. This is where all your endless hours of planning pay off and where you will be challenged to put your risk and mitigation plans to the test. During this time, no position will be more important than your director of clinical development.
Clinical laboratory services are the most outsourced services by pharmaceutical, biopharmaceutical, and medical device companies. Trending in the central or core laboratory services market is consolidation and integration of services through acquisitions and collaborations inorganically to expand beyond core services. Through horizontal integration suppliers increase their market share.
Two issues continue to be a headache for those working in the clinical space: patient recruitment and communication. New technologies, including social media, seem to offer a glimmer of hope to getting more patients involved in trials. Unfortunately, the problem of poor communication between sponsors, CROs, and sites is an issue still in need of novel solutions. In this Q&A, Mary Rose Keller, VP of clinical operations for Heron Therapeutics, shares her insights.
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