The Covid-19 pandemic is having a significant impact on CROs and clinical trials resulting in trial suspensions, terminations and delays. The global crisis has also stressed the need for virtual trials leveraging technology and software solutions. Increased adoption of eClinical solutions, Artificial Intelligence, machine learning-based platforms, and innovative trial designs, is expected to transform the CRO landscape over the next few years.
Pharma and biopharma investments in new and innovative therapies, such as regenerative medicine, is resulting in a flourish of R&D activity, along with higher reliance on outsourcing partners for drug development services.
Sponsors continue to seek out therapy area expertise and services as needed. Speed and cost remain strong motivators for outsourcing in today’s market, along with increasing complexity of trials and higher regulatory hurdles. The uncertainty surrounding the global economy is likely to lead to less in-house hiring and more contracting and outsourcing as pharma and biopharma companies face these challenges.
Serge Bodart, Chief Commercial Officer of IDDI discusses the pharma and biopharma trends impacting CROs, outsourcing in today’s market, advances in clinical research, and what is and isn’t working well in Sponsor/CRO partnership models. –KB
Contract Pharma: What are the significant pharma/biopharma R&D trends impacting CROs?
Serge Bodart: Without a doubt, the Covid-19 pandemic is having a major impact on CROs and clinical trials in general. Companies across the industry have already announced significant trial suspensions, terminations and delays due to the inability to enroll and collect patient data. Going forward, the challenges will continue to impact how clinical trials are done; certainly, the need for randomized clinical trials will remain. Undoubtedly the crisis has shown a need and leads for faster drug development.
Other trends include geopolitical uncertainties, such as providing less H-1B1 visas, as well as legislation on drug pricing, which would impact R&D spending, especially for Big Pharma. However, the focus for the global pharmaceutical industry is shifting to leverage CROs to provide expertise on an "as needed" basis rather than investing in their own resources at the early stages of drug discovery.
Working with external sources of innovation, such as biotech start-ups and academics, has numerous benefits. Pharma and Biopharma R&D companies are looking for partners who have a solid track record in therapeutic indications of interest and focused competences. This trend provides increasing opportunities to functional CROs with real differentiators.
CP: What do you see as the greatest motivators for outsourcing in today’s market?
SB: One of the greatest motivators for Big Pharma is to seek improved quality and reduced time-to-market for outsourcing their business functions to CROs. They are looking to increase therapy area expertise and on-demand services. There is a need for focused expertise in areas where it may be difficult for a client to maintain such an asset in-house (mainly for smaller Biotechs). It is more efficient to outsource, for example, biomarker expertise than to recruit and retain an expert long term. The volatility of today’s global economy, and uncertainty on the horizon will lead to less hiring and more contracting and outsourcing as biotech companies and large pharma companies will not be financially equipped to hire new Full-Time Equivalents (FTEs).
Speed and cost remain strong motivators for outsourcing in today’s market, alongside the increasing complexity of trials, higher regulatory hurdles, flexibility and scalability of resources, a need for advanced technology and the growing global footprint. In general, small and medium Biotechs have a bigger need for outsourcing as they have limited resources, with Big Pharma perhaps choosing to partner rather than outsource.
CP: What digital/technology advances are currently impacting clinical development?
SB: The current Covid-19 pandemic emphasizes the need for effective solutions for remote monitoring and advanced reporting capabilities. There is potential for applied research on big data, risk/benefit methodologies and tools and in-silico trials...
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