With the cost and time involved in developing and gaining marketing approval of a new drug, increasingly the transition from clinical R&D to regulatory approval and commercial growth requires thorough data and strategic expertise that integrates scientific and commercial insights. 
 
PAREXEL recently expanded its evidence-based services for biopharma products with PAREXEL Access, which focuses on clinical research and operations, market access consulting, medical communications, and pharmacovigilance to help companies identify, evaluate, generate evidence of product value needed for market access and to support product lifecycle.
 
Joshua Schultz, corporate vice president and worldwide head of PAREXEL Access discusses the importance of demonstrating a products value beyond safety and efficacy, and integrating the three key service areas of evidence identification and evaluation, evidence generation, and communication  –KB
 
 
Contract Pharma: What were some of the driving factors behind establishing the new service?

Joshua Schultz: Our industry is undergoing a profound shift from an environment where achieving marketing authorization approval was sufficient for patient access and appropriate reimbursement to one in which an additional payer hurdle must be cleared. This requires more and different data focused on value elements like relative cost, patient quality of life and total impact on the health system. 

While PAREXEL has been a provider in late phase for more than 15 years, we have seen a growing gap between our industry’s traditional approaches and the rapidly growing needs of today’s marketplace. We believe that a solution to this problem is much tighter integration between evidence evaluation, evidence generation and evidence communication. These various activities are often siloed within sponsors and CROs – creating lost opportunities. In addition, the last several years has seen an explosion in technology and data assets that enable this integration to take new and better forms which can substantially improve our ability to provide value evidence to a diverse stakeholder community. 

The decision to launch PAREXEL Access was predicated upon the realization that only through tight integration of technology with the various capabilities to evaluate, generate and communicate evidence, would we be able to deliver upon the growing needs of our industry in this critical space. 
 
CP: How have pricing controls and payer oversight in the current healthcare landscape impacted drug development?

JS: Prescription drugs as a percentage of total healthcare spending have increased dramatically over time driven in large part by the enormous cost of innovation in the biopharmaceutical space.

Payers, now more than ever, dictate whether an adequate return will be generated on this investment.  However, payers are under huge pressure to control costs which drives a focus on demonstrating clear value to patients and the healthcare system. While this creates obvious challenges to a pharmaceutical company looking to commercialize a newly approved product, it also represents an opportunity to identify key value drivers early on, generating relevant evidence and demonstrating this value to stakeholders in a compelling manner that supports patient, payer, physician and pharmaceutical company needs. 

CP: In what areas do you expect to see the greatest efficiencies through these services?

JS: PAREXEL Access exists to provide our clients with an integrated solution that generates more value than each of the individual pieces. Our integrated approach benefits clients in the following areas:

·       A cross-functional review process to ensure that study designs are optimized from an operational, market access and communication perspective (inclusive of cost and time impacts of various strategies)
·       Our evidence evaluation and modeling offering is designed to help clients understand what data and pieces of evidence are needed to make the most compelling country- or indication-specific case to payers and other stakeholders.
·       By leveraging our experience across all study types, PAREXEL can apply the right evidence generation modalities to provide cost effective solutions – whether through existing secondary data assets, prospective research (observational or interventional), or via ‘hybrid’ studies that include both electronic medical records and site-based research.
·       Communication considerations are integrated from the beginning with a focus on all key audiences (i.e. payers, providers, patients, and policymakers) as well as operational factors (i.e. date elements and timing/type of outputs)
·       Real world evidence approaches and secondary data assets that are lean, global, accurate and applied to appropriate situations 
·       A suite of integrated late phase-specific technologies to enable physicians to work with PAREXEL Access
·       Late phase-specific partnership approaches focused on a molecule, group (e.g. Medical Affairs) or study type (e.g. EAPs) to generate cost savings while increasing value at a portfolio level
 
CP: How can these services help overcome drug development challenges in today’s healthcare and regulatory environment? 

JS: With a global team, experience and innovative ideas, PAREXEL Access offers services to help clients meet the challenge of positioning their products for market access and commercial success.

In this new world, obtaining regulatory approval is no longer sufficient for drug developers to have a successful and profitable drug in the market. Today, companies must be able to seamlessly demonstrate to payers and other stakeholders that their drug is worthy of being reimbursed at a relevant level and prescribed in the right situations. Being able to demonstrate evidence is essential in a world where access-driven commercial models are replacing the marketing and sales focus of the past.

As Corporate Vice President and Worldwide Head of PAREXEL Access, Mr. Schultz oversees the global Late Phase business which provides clinical research services in the peri- and post approval phases, including IIIb/IV clinical trials, observational research, market access, medical communication and patient safety services. During his time at PAREXEL International, a global biopharmaceutical services provider, Mr. Schultz has held a number of roles including heading the Strategic Partnership group which focused on developing and executing innovative relationships with key pharmaceutical companies.

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Kristin Brooks has been Associate Editor at Contract Pharma since 2004.