Paula Brown Stafford, MPH joined Quintiles in 1985 as a biostatistician, and is currently the President of Clinical Development. Her global responsibilities cover all of Quintiles’ Phase I-IV services, including Clinical and Data Operations, Laboratory Services and Functional Resourcing.
Paula has held numerous positions during her 27 years with Quintiles including positions in Project Management in the United States and Europe, Business Development, Scientific Operations and General Management.
In addition to her role at Quintiles, Paula is the Board Chair of CDISC (Clinical Data Interchange Standards Consortium)
Stacie Yonkin leads the Biogen Idec customer account team for Quintiles, providing global operational oversight and management of Biogen Idec’s business portfolio within Quintiles.
In her more than 20 years with Quintiles, Stacie has held a variety of leadership positions across sales, account management as well as contracts and proposals. Throughout her career, Stacie has leveraged her in-depth knowledge of the clinical development process, global operations and business relationship skills to deliver strong growth and performance—from tactical engagements and joint ventures to strategic investment partnerships and internal operations.
Drug development strategies are constantly shifting to help offset current market challenges faced by the pharma and biopharma industry, particularly as they relate to outsourcing. In recent years the number of major partnerships and alliances among CROs and big pharma/biopharma have grown, and are proving to be greater in scale, longer in duration, and more diverse than ever. In addition to clinical R&D services, sponsor companies also look to leverage the latest technologies to help streamline the drug development process with real-time data, as well as lower overall development costs.
Among the major, multivariate partnerships of late, Quintiles and Biogen Idec recently entered a five-year strategic clinical development pact and multi-year collaboration aimed at optimizing Biogen’s clinical development processes. The collaboration will focus on clinical trial efficiency, transparency, quality, innovation and operational excellence. Quintiles will work with Biogen on the design, planning and execution of Biogen’s Phase II-IV studies and select Phase I studies. Biogen will also leverage Quintiles’ technology and systems.
We spoke with Stacie Yonkin, Quintiles senior vice president and managing director, and Paula Brown Stafford, Quintiles president of Clinical Development, to gain additional insight into the dynamics of the deal, its goals, focus, and technology aspects. —KB
Contract Pharma: What do you see as the greatest motivators for outsourcing in today’s market?
Paula Brown Stafford: Increasingly complex clinical trials and the need for specific therapeutic and scientific expertise will continue to drive demand for service providers among biopharmaceutical companies. As sponsors develop more personalized medicines, they will partner with Quintiles to leverage our deep and broad therapeutic and scientific expertise, and our data analytics platforms that provide more sophisticated approaches to managing trial complexity.
Contract Pharma: What were some of the reasons behind the Biogen deal with respect to outsourcing needs?
Stacie Yonkin: While we can’t speak for Biogen Idec, we believe the complementary nature of our organizations, in terms of our commitment to patients, values and ambitions, focus on finding solutions and delivering results, and an understanding of the value of innovation and entrepreneurship were key factors in our selection.
CP: We’re hearing a lot about real-world outcomes in the industry. Is this an area covered under the partnership?
PBS: Yes, the partnership with Biogen Idec includes projects involving our Real-World & Late Phase Research division, an emerging area of our company with a focus on prospective interventional trials and observational studies, database research, and quality and outcomes measurement. The team provides the full spectrum of solutions for real-world and late phase evidence development across the global healthcare ecosystem. Our capabilities with EMR and integrated health system data through our data assets and networks can help our customers better understand real-world treatments and outcomes and increase efficiency of clinical trial planning and design.
CP: How are services evolving to adjust to changing R&D requirements for biopharma?
PBS: We are excited about this relationship as it allows Biogen Idec and Quintiles to collaborate and function as a single clinical development team throughout the drug development process.
While this collaboration will allow Biogen Idec to focus on cultivating its deep scientific expertise and innovation, Quintiles will focus on operational execution and help to advance Biogen Idec’s growing pipeline. As a result, Quintiles will be afforded more decision-making and strategic input into the clinical trial design process, moving to a more dedicated delivery model. With increased autonomy and accountability, Quintiles can optimize the clinical trial delivery process, which is structured to create time and resource efficiencies.
CP: In what areas did technology factor into the alliance?
PBS: The collaboration is structured to leverage the Quintiles Infosario technology platform as well as the company’s processes, systems and scientific expertise across the Biogen Idec portfolio. We believe each of these additions will support Biogen Idec as it continues to grow its pipeline of therapies.
CP: What impact are the latest e-clinical solutions having on clinical trials and services?
PBS: Quintiles is investing in people, processes and technology to help connect insights and improve delivery for better outcomes. The shift from paper to electronic trial master files (eTMF) is one e-clinical solution that Quintiles is actively pursuing, due to the potential for significant improvements in the quality, speed and costs associated with a clinical trial. The new, automated eTMF system provides global visibility to the trial master file, supporting the ability to perform remote audits and quicker submission of the final trial master file at the conclusion of a trial. This e-clinical solution permits delivery of the trial master file in less time and at a lower cost—sometimes up to six months faster.
In addition, the “cloud” presents numerous opportunities in the realm of clinical trial workflow. We are exploring how we can harness this power for investigator site contracting to streamline processes and maximize operational efficiencies. Finally, new e-capabilities are being introduced that make it easier than ever before to communicate to sites and set up data collection virtually—with systematic data collection that minimizes user error and provides close to real-time updates related to clinical research investigation and reporting.
CP: We’re seeing a shift in the dynamics of Sponsor/CRO outsourcing models. Are there any notable areas in this partnership where you see significant change?
PBS: The intent of this agreement with Biogen Idec is to create a seamless collaboration built on mutual trust and respect, and is unique in a number of ways—it’s designed to promote increased transparency to improve predictability and productivity of the clinical development process; it allows for joint decision making to assist in long-term resource planning; it will streamline processes and cross-portfolio standardization to increase efficiency; and we can avoid duplication of efforts through distinction of roles and responsibilities based on each company’s core competencies.
We believe this type of agreement with Biogen Idec exemplifies the future of drug development collaboration and how a biopharmaceutical company and a service provider can best work together. We’re hopeful this announcement is part of a broader shift to an even more collaborative approach to clinical development—one that we believe will help improve our customers’ probability of success.
CP: What are the continued challenges with managing partnerships? How do you approach managing partnerships?
PBS: My advice is to stay diligent, focused and aligned. Communication is critical in any partnership to ensure that everyone understands the goals and objectives and is moving in the same direction. In the first year of any partnership, everyone is enthusiastic about the relationship and getting ready for implementation. The second year is typically when we learn where the plans and implementation may not have been fully aligned and have to re-visit and refine the operational processes to meet the expectations of both partners.
SY: As we grow and scale our collective partnerships, providing effective change management will continue to be a critical component to success and accelerating momentum. In addition, the guiding partnership principles must stay top of mind so that every person working within the collaboration stays true to the shared core values. Both partners can never lose sight of our patients and why the partnership was created.
All partnerships are inherently unique, but I believe there are two major common denominators for a partnership to be truly collaborative—transparency and two-way communication. Both sides must build an open and honest culture for a partnership to succeed. At the end of the day, we have to reach our targets and produce results, so you have to assemble talented people who are true team players and collaborative in every sense of the word.
CP: What’s your outlook on the biopharma industry for the next few years?
PBS: I believe there are three key trends that will most impact the biopharma industry over the next few years. The first is related to increased outsourcing, which is due to the growing demands of increasingly complex clinical trials and the need for specific expertise as biopharmaceutical companies in-license drugs outside of their core areas of expertise.
The second trend is the shifting stakeholder influence—the changing stakeholders are requiring tailored evidence, and biopharma companies will need to go beyond proving safety and efficacy and demonstrate real-world improvement in patient outcomes.
Finally, evolving technologies and approaches to developing medicine, such as genomics, biomarkers, biologics, biosimilars, personalized medicine, and advancing how medicines are discovered, developed and delivered, will continue to impact research and development in a big way.