Drug developers partner with contract service providers to help overcome critical challenges and achieve greater efficiencies across the research and development continuum, and increasingly to address the impact of the COVID pandemic on the industry and clinical trials.

Nick Lakin, Senior Managing Director at Syneos Health Consulting, discusses pharma/biopharma R&D trends, some of the challenges the industry faces, and motivating factors for outsourcing. –KB
 
Contract Pharma: What are the pharma/biopharma trends impacting R&D and outsourcing?
 
Nick Lakin: COVID-19 has accelerated the demand for decentralized clinical trials (DCTs). Nearly all pharmaceutical companies are establishing (or accelerating) their DCT capabilities across areas such as mobile nursing, direct-to-patient and site-to-patient supply, mobile health technologies and new patient/site engagement models.
 
In terms of therapy area focus, many pharmaceutical companies have changed their strategies to target immuno-oncology. For those with vaccine portfolios, COVID-19 has placed a massive emphasis on next generation treatments. As a result, for Outsourcers, therapy area expertise has become even more in demand across these areas, and it has become increasingly important for sponsors to make sure they are getting access to CROs who can serve as a strategic partner in these efforts.
 
Lastly, the industry has experienced an overlap between outsourcing and new platform investments, specifically between CROs and technology platform providers who continue to provide overlapping business cases for programs to transform clinical, regulatory and safety operational productivity. Alignments between CROs and technology vendors, as well as the move by many large CROs to invest in their own platforms, makes this an area of shifting sands where sponsors need to make strategic choices.
 
CP: What are some of the R&D challenges the industry faces? 
 
NL: The increased emphasis on DCTs has led to many pharmaceutical companies looking to build capabilities in new areas, such as mobile health, or to accelerate their use of existing technologies (e.g., ePRO/eCOA). One big challenge has been to sift genuine capability from hyperbole in the mass of vendors claiming to have something to contribute. Additionally, the operating models and ownership for incubating and then deploying these capabilities are still areas of change for most pharmaceutical companies. This has led to challenges with embedding new ways of working, competition for talent and establishing the right leadership models with appropriate oversight.
 
The industry is also trying to maintain compliance during this time of operating in both hybrid and virtual models. To date, we’ve seen several regulations move toward becoming mandates in 2022 (e.g., EU CTR). Pharmaceutical companies need to continue the pace of their own internal initiatives to ensure compliance, while working remotely. The next phase for many will be the shift from readiness to performing compliant operations; this will likely result in adjustments to outsourcing strategies. In parallel, compliance in a virtual model has become a critical R&D objective over the last two years, with an increased focus in areas such as data integrity.
 
CP: What areas are being outsourced and what are the motivating factors for outsourcing these areas?
 
NL: As many sponsors are moving to hybrid models where they can leverage internal captive teams in collaboration/competition with strategic CRO and FSP suppliers, the need for rapid responses in COVID-19 trials has led to both sponsors and CROs forming more agile, blended teams across areas such as data management.
 
We’re also seeing new resource demands emerge. For example, DCTs are creating a demand for project managers who have the capability to advise study groups on the right combination of DCT capabilities to assemble for a study. These roles are being sourced both internally and externally by sponsors.
 
Lastly, we have seen monitoring resurface as a focus area. Many companies are exploring new models for centralized monitoring to address issues of increased demand; provision of sites with preferred single points of contact for improved communication between in-house and field CRAs; and reduced cost for administrative activities, such as data entry into tools such as the Shared Investigator Platform.
 
CP: What services are you seeing an increased demand from sponsors and from what sectors?
 
NL: We’re seeing an increased demand in Functional Service Provision (FSP) solutions in both Big Pharma and the mid-sized segment as companies are looking to address increased workloads, as well as access innovation and therapy area expertise.
 
There has also been an increased demand for mobile research nursing, especially in Big Pharma, as well as an increased need for platform-based services (e.g., ePRO and patient concierge services).
 
As a fully integrated biopharmaceutical solutions organization, Syneos Health has in-house FSP solutions designed to provide the broadest range of traditional and non-traditional capabilities through a unique and dynamic approach — customizing solutions to successfully meet the individual needs and goals of customers across their entire asset portfolio.