The research and development (R&D) journey is inherently a long, complex and costly one. Drug developers large and small are partnering with Contract Research Organizations (CROs) early in the development process to help overcome critical challenges and achieve greater efficiencies across the drug development continuum.
In addition to reducing drug development timelines and costs, there are several pharma and biopharma trends contributing to increased outsourcing of R&D activities. Among them, increasingly complex small molecules and biologics requiring extensive ground work, highly specific drug technologies, and expertise.
Dr. David Shoemaker of Rho discusses R&D trends and challenges, efforts to streamline drug development, and the greatest motivators for outsourcing in today’s market. –KB
Contract Pharma: What are the pharma/biopharma R&D trends impacting CROs and services?
David Shoemaker: The bottom line is that any trends that affect pharma/biopharma affect CROs inasmuch as outsourcing has never been greater than today, with an anticipated outsourcing level reaching greater than 50% of pharma/biopharma outsourced R&D spend by 20241. The major trends occurring currently are the following:
Migration to decentralized clinical trials
Migration to use of real-world data
Migration to use of artificial intelligence in selection of development candidates
These are trends that have been in the works for some time, but the COVID-19 pandemic has thrust these topics into the forefront of everyone’s consciousness. CROs are attempting to make these migrations in double time, and the jury is out on how successful they will be over the course of the next few years as the industry recovers from the impact of the pandemic.
CP: What are the current R&D challenges the industry faces? What areas of expertise are needed to overcome them?
DS: The current R&D challenges the industry faces primarily revolve around the skyrocketing amount of work involved in the development of novel gene transfer, cellular and tissue-based products. As science has improved over the past decade, companies have increased their focus on developing potential therapies to target more specific populations rather than potential blockbuster therapies. This specialty approach to rare diseases was prompted by the high prices that companies have been able to charge in the U.S. for these types of products, and the institution of price controls similar to those present in other regions would be a first step toward reining in this development and refocusing pharma/biopharma on developing medicines for large proportions of the general public. Likewise, when it comes to focusing on targeted specific populations and rare diseases, it is also important for CROs to have the expertise and capabilities to design and execute natural history studies, or to engage with the right patient advocacy groups and entities to access patients and deal with patient-focused development.
CP: What do you see as the greatest motivators for outsourcing in today’s market? Do you see opportunities to further engage existing customers?
DS: The greatest motivator for outsourcing in today’s market is due to an evident shift in development work from big pharma/biopharma companies to smaller biotech companies, academia, private foundations and government agencies. The smaller entities do not have the internal resources of the big pharma/biopharma companies, and this necessitates the smaller entities outsourcing a greater proportion of the development work to CROs. To accommodate this need, large CROs have created divisions specifically targeting these small entities and have outfitted them with individuals skilled in all disciplines of integrated product development – especially as there is no predicting where a small entities’ deficiencies may lie. Of course, this also increases the ability of independent consultants to compete with CROs for these development activities.
CP: What services are you seeing an increased demand from sponsors and from what sectors? Where do you think the biggest opportunities lie?
DS: From our experience, the greatest demand is currently coming from the Quality/Chemistry, Manufacturing, and Controls (CMC) sector. Whether it be at the Pre-IND, IND or NDA/BLA preparation stage, the request for assistance with manufacturing strategy and implementation and data compilation is overwhelming. Rho’s focus is on the small to mid-size pharma/biopharma, which is where we have perceived the biggest opportunities for significant work with the potential for repeat business. Historically, the majority of complete response letters are issued due to CMC deficiencies. Based on these trends, the demand and need for solid CMC support and appropriate focus on pharmaceutical product development will continue to grow.
CP: What efforts are being made to streamline drug development among sponsors/service providers?
DS: The greatest streamlining efforts occur in the integration of the service providers’ team with that of the product sponsor. Big CROs have long advocated “preferred provider” relationships with big pharma, but this has the unwanted effect of leaving the other clients as second-class citizens. Smaller CROs have successfully courted small pharma/biopharma for some time now and several have established reputations that rival big CROs for performance if not revenues. Ultimately, having an experienced, strong program manager on the product sponsor’s team who interfaces with an experienced, strong program manager on the CRO side is the only way to streamline product development, and this only occurs if these two individuals are provided day-to-day decision-making authority and sufficient resources from their respective organizations.
Dr. David Shoemaker has been a trusted regulatory advisor to international clientele for close to 30 years, providing regulatory and scientific expertise for integrated product development programs across a wide range of therapeutic areas. Dr. Shoemaker has extensive experience in all stages of investigational product development, has moderated dozens of regulatory authority meetings, and has managed and contributed to over one hundred INDs, over a dozen IMPDs, and dozens of successful marketing applications across the majority of reviewing divisions at FDA and several international regulatory authorities. At Rho, Dr. Shoemaker serves as an expert scientific and regulatory reviewer for documents destined for regulatory authorities and as an advisor to integrated product development program teams.
