Sy Pretorius, senior vice president and chief scientific officer discusses what is and isn’t working well in partnership models and where the industry can improve, as well as the R&D trends impacting CROs and the services they provide. For Contract Pharma’s comprehensive analysis of the CRO Industry, see the Annual CRO Industry Update: Big Data Drives Drug Development Efforts. 
 
Contract Pharma: How are pharma/biopharma R&D trends impacting CROs and services?
 
Sy Pretorius: Rise of Precision medicine – We are seeing more researchers turn to precision medicine and, as a result, CROs are increasingly designing smaller trials in populations that are often more challenging to find and recruit. Related to this, the importance of understanding genomics, biomarkers and companion diagnostic development has never been more significant for CROs.
 
Patient-centricity – CROs and sponsors are finding new and creative ways of interacting with patients in an effort to make it easier and less burdensome for patients to participate in clinical trials.
 
Flexible development paradigms –Although randomized controlled trials (RCTs) remain the cornerstone of drug development, they have clear and well-known limitations. To this end, there has a been a recent increase in more flexible and adaptive study designs and a blurred line between traditional development phases – particularly in Oncology. Adaptive trials allow for pre-specified modifications of aspects of the study based on the analysis of the data, and when well-executed, can be done without jeopardizing the validity and integrity of the study data. These designs present many potential benefits to sponsors, helping them reduce timelines and costs, and also better execute the increasing number of personalized and targeted medicines trials. Regulatory agencies have also expressed their support of these designs where appropriate.
 
Big Data & Real-World Evidence – Across the industry, there is real interest in the value of real-world evidence and other big data sets in our industry. These types of data are the foundation for discussions with payers. In addition, CROs and sponsors can potentially leverage this data across the entire drug development value chain to reduce costs and timelines, improve quality, and ultimately, improve the probability of success.
 
Geographical trends – As we are seeing considerable growth in China, CROs are beginning to place increasing importance on the APAC region, and evaluating a presence in these markets.
 
CP: What do you see as the greatest motivators for outsourcing in today’s market?
 
SP: There is an immense amount of pressure on researchers to stay on budget and in line with pre-approved timelines throughout the clinical trial process. For this reason, outsourcing various elements of the research and trial process to third parties is a popular and effective way to cut down on costs and deliver on deadlines. Outsourcing continues to grow as these pressures continue to proliferate. Likewise, given their unique perspective in working with many clients across thousands of clinical trials, sponsors are increasingly tapping into the development experience and expertise that some of the more established CROs have.
 
CP: How are collaboration models going beyond traditional outsourcing?
 
SP: More and more CROs are moving towards a direct-to-patient approach when working to promote and conduct clinical trials. For example, we are seeing virtual trials gain popularity for CROs working with patients that fit their profile and criteria yet are not geographically in the same location.
 
We are also seeing an uptick in healthcare convergence, where, for example, healthcare systems, pharmacy providers, labs and data aggregators (etc.) from across the world are consolidating to bring services into a one-stop-shop, holistic service.
 
CP: What is and isn’t working well in partnership models?
 
SP: What’s working well: Efficiencies – CROs are generally very efficient, always measuring against reductions in oversight and development costs
 
Cycle times– Via joint efforts with pharmaceutical customers, CROs have seen continued successes in reducing cycle times across trials
 
Quality– By ensuring a policy of joint ownership and confirming aligned incentives, CROs and sponsors are today in a groove of driving improved quality
 
Where the industry can improve: Change management – There is a resistance to change that is deeply entrenched in the highly regulated drug development industry, with hesitancy to experiment with novel approaches. Part of the challenge is on CROs to demonstrate the value of innovative approaches and techniques and encourage sponsors to overcome their reluctance, to advance the industry as a whole.
 
Interoperability– In today’s CRO industry, there is an absence of cross-industry data and process standards, making it challenging to ensure efficient, accurate and reliable deliverables. As the industry and volume of data continue to grow, this presents an opportunity for CROs to potentially drive or contribute to the creation of data standards, as we collect and interact with much of this data. Examples include the CDISC standards, as well as the work that TransCelerate is doing around a Common Protocol Template.
 
Organizational structure– Many organizations across the drug development industry are working in siloed departments, making it nearly impossible to gain access to the necessary information to make informed decisions and move processes along. Some CROs have found success integrating data-driven services to accelerate protocol design and site activation and achieve faster turnaround times. If we eliminate these silos and become more integrated, the industry would see great benefit with broader access to data and information that can be leveraged to enhance drug development processes.
 
CP: Where do you see opportunities to further engage existing customers?
 
SP: There is significant potential for us to further engage with and add value for our clients in the capture, analysis and application of real world evidence in drug development. Also, there is opportunity to further engage clients through outsourcing of regulatory and pharmacovigilance services as well as commercialization related activities.