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. The global crisis has also highlighted the need for virtual trials. As these become more prevalent there will be a significant increase in the technology needed to cope with virtual visits, such as the use of ePRO (diaries, Fitbits etc.) as well as eClinical Solution software supporting Remote, Centralized and Risked Based Monitoring. Innovative Trial Designs will require more advanced technical solutions and integration will be key (RTSM talking to EDC, TMF, ePRO systems, Corelabs, including the use of videos for virtual trials and AI for analysis).
Other digital advances include "Big data analytics" and real-world data collection, such as the use of electronic health records, electronic medical records and artificial intelligence (EHR/EMR/AI). Organizations from outside of health care will continue to enter the clinical development space e.g. cloud storage and cloud computing combined with AI, cognitive analytics, and machine learning. These outside organizations, and our target clients, will need expert guidance on maintaining data quality and suitability as specific to the clinical trial space.
CP: What are some of the biggest advances in clinical research today?
SB: Precision medicine, including therapies that target specific biomarkers, offers some of the biggest advances in clinical research today. In addition, Gene and Cell Therapies, specifically allogenic therapies will ramp up manufacturing and commercialization. Active use of personal monitoring devices e.g. fitness, health metrics trackers, blood glucose monitors, have the potential to truly improve clinical research but the crux lies in having the expertise to take that data and make it both meaningful and acceptable to regulatory authorities.
There is also a shift towards "patient centric" trials and a growing investment in patient engagement solutions. While patient centricity is the current buzz word of the moment the industry as a whole is not there yet. Precision medicine can open the door to it, and with companies leading the way with innovative projects new advances are possible. IDDI is particularly well positioned in the Personalized Medicine area with the development of technologies around the concept of Generalized Pairwise Comparisons (GPC), a statistical method enabling patient preferences when assessing treatment effect.
CP: Are there any new areas sponsors are engaging CROs?
SB: Complex data science requirements, especially within Big Pharma companies, has and will even more so, increase the need for contracting all professionals including Data Managers, Biostatisticians, programming specialists for more study specific needs that will benefit niche CROs and functional service providers (FSPs).
One crucial area where benefits can be achieved is by integrating more technologies together for better clinical trial oversight. Other key opportunities for CRO engagement include biomarker and CDx validation, overall development support, innovative study design, translational research and process standardization.
CP: What is and isn’t working well in partnership models?
SB: The "right" partnerships are working well by providing focused support, clear lines of communication, accountability and familiarity across teams and programs. This generally leads to efficiencies, both operational and budgetary. Partnerships that are not focused tend to result in challenges, including problems with lack of clarity in roles and responsibilities, which leads to more oversight and additional costs. Long term "preferred provider" contracts have proven to be inefficient for several sponsors. In addition, saturation in the CRO space has led to smaller margins for all companies and the top ten CROs are becoming more deleveraged.
Sourcing partnerships with CROs can realize benefits, including volume commitments, pricing, and study design. However, partnerships can only work if effective and proven added value can be demonstrated to clinical development programs, offering agility and stability of dedicated teams, with effective governance in place and mutual commitment of management.
Ultimately, there are pros and cons in each model and a biotech needs a different partnership model than a big pharma. Companies are not selecting partners for life anymore; it is for limited programs, needs and time. Culture and cost-benefit analysis determine the best partnership model. Often the most successful partnerships combine passion, science, and experience with a steadfast focus on ensuring clinical data is ready for submission – that is after all the ultimate goal.