What is the cost of a failed partnership between a pharma company and its CROs? Is it financial? Research and development time?
Are you a clinical site that finds budget negotiations with a clinical research organization (CRO) or sponsor an uphill battle?
When a pharma or biotech sponsor company engages with a contract research organization (CRO) and other service providers, it develops a list that details which organization is responsible for each task to be conducted. The degree to which a small to midsize sponsor has the expertise and the resources internally to manage a task, as well as budgetary constraints, will dictate which tasks it delegates and which it keeps in-house.
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?
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