John Doyle, Dr.P.H., MPH

John Doyle, Dr.P.H., MPH, is Vice President and Practice Leader for Market Access with Consulting at Quintiles. Previously, he was president and a founder of Analytica International, a global reimbursement, outcomes and market access consulting firm. He previously led the Oncology and Immunology Economics Research Group at Bristol-Myers Squibb.

Since 1993, Dr. Doyle has authored over 50 original research articles and abstracts, in a variety of therapeutic areas. As a health economist and epidemiologist, he has lectured on research methodologies for academic and commercial audiences in the U.S., Canada, Europe and Latin America. He has consulted global pharmaceutical and biotech firms on strategic concerns regarding product development, pricing, reimbursement, market valuation and other commercialization issues.

Dr. Doyle received a Bachelor of Science degree in Applied Economics with a concentration in the Life Sciences from Cornell University. He received a Master of Public Health degree and a Doctor of Public Health degree in Epidemiology from the Mailman School of Public Health at Columbia University.

Selected Publications

Commentary: The Real-world Convergence of Comparative Effectiveness Research and Risk-Benefit Assessment
Concerns about safety, value, and outcomes are driving demand for more robust evidence about biopharmaceuticals and other medical interventions. Data generated by traditional premarket clinical development typically do not provide a comprehensive view of a product’s ultimate performance to allay these stakeholders’ concerns. This de facto data shortfall limits market access. Consequently, a new paradigm of complementing and integrating real world research with RCTs is on the rise to provide a holistic view of biopharmaceuticals.

The Effect of Comparative Effectiveness Research on Drug Development Innovation
The drug development process is in dire need of transformation. Even after achieving regulatory approval, pharmaceutical companies are increasingly seeing their products subjected to health technology assessments (HTAs) by public and private payers. The cornerstone of HTA value appraisal, and thus reimbursability, is comparative effectiveness research (CER), a ‘real-world’ comparison of a new product with the existing standard of care. Burgeoning demand for CER will fundamentally transform drug development by forcing biopharmaceutical manufacturers to view drug innovation from a holistic, 360° perspective. Specifically, drug and device developers must alter their existing approach to R&D by: adapting experimental research design methods to address multiple stakeholder demands; demonstrating real-world value through a suite of post-market observational research methods; and creating a transparent CER evaluation protocol based on standard principles. In the long-term, CER is forecast to propel innovation by focusing R&D on products that deliver real-world value to multiple customers and market stakeholders.

An Integrated Approach to Biosimilar Development & Commercialization
As the market for biosimilar products continues to grow, many biopharmaceutical companies trying to enter the space are struggling to overcome the unique challenges that developing such products presents. From navigating the complex global regulatory landscapes to ensuring optimal access, the development road for biosimilars is riddled with questions:

• How do we ensure speed-to-market while maintaining a high quality of clinical evidence?
• How do we maximize uptake of our biosimilar products to realize a return on our investment?
• How do we ensure physicians and patients are comfortable with using our biosimilar products?

The potential demand for biosimilars certainly creates an enormous opportunity for biopharmaceutical companies. But unlike the development of progenitor biologics—or generic versions of chemical-based medications—biosimilar development and commercialization is a uniquely difficult endeavor requiring precision, stepwise planning to ensure timely regulatory approval and optimal market access.

Rewarding Innovation and Value: What is the Role of Comparative Effectiveness Research?
Recent cases of high-profile failures of products in late-stage pharmaceutical development have clearly highlighted the need for transformational change. Today, new drugs cost as much as $2 billion to develop over eight years or more, with severe attrition at each stage of development. Even those products that gain regulatory approval must often prove their value in health technology assessments (HTAs) or other elements of Comparative Effectiveness Research (CER) by public and private payers.CER is increasingly in the public spotlight as a promising way to help improve the productivity and efficiency of healthcare systems in the United States and abroad.Recent decisions to provide substantial federal funding for CER – $1.1 billion under the 2009 economic stimulus package, and a further $800 million under the 2010 healthcare reform legislation – serve to underline the increasing interest in this approach. In future, CER will change pre-market experimental research design to reflect the requirements of multiple healthcare stakeholders. It will also drive increased investment in post-market observational research on the real-world performance of marketed products.

A Blueprint for Clinical / Commercial Convergence: Constructing a New Development Model with Market Access Insights
The development model for bio pharmaceutical companies must shift from two divergent paths to one that combines clinical and commercial resources with market access strategy, information and capabilities. Traditionally, clinical development of new medicinal products has been driven by the clinical-medical leads in a biopharma development organization. In the New Health landscape, biopharma must converge the clinical-medical foundation with a fact-based understanding of the new constellation of stakeholders who control access to today’s markets – policy-makers, more empowered regulatory entities, payers and provider groups. The post-reform market will demand deep understanding of the root interests, networks and decision drivers of each these stakeholders. And dramatic benefits will be realized by companies who develop a differentiated understanding around the confluence of stakeholder needs early in the development phase and then continuously use this data throughout the lifecycle.

Oncology Drug Development and Value-Based Medicine
The growing voice of stakeholders, from patients to payers, is changing the path of drug development. Nowhere is this trend more evident than in the oncology space. While evidence-based clinical medicine still stands as the prime driver, the additional driver that is emerging is overall treatment value. Value-based medicine is at the heart of a broadening debate on a host of topics, including the quality of cancer care, access to treatments and the differing stakeholder expectations of drug therapy. Quintiles’ experts Brian Huber and John Doyle combine their expertise in commercialization, market access and innovation to outline the critical issues to watch. Their report demonstrates the need to converge clinical and commercial imperatives earlier within the drug development process to meet a future demand for value-based medical practices.