A Collaborative Approach to Drug Development

Jeffrey Spaeder, M.D.,

Quintiles

In order for new therapies to meet the needs of all the stakeholders, an increasing emphasis by the biopharmaceutical industry on early collaborations with patients, payers, and physicians will be critical for the success of new drugs and devices.

The obligation and opportunity for the biopharmaceutical industry to engage with patients continues in earnest. In the past, biopharmaceutical companies typically sought patient dialog to the back-end of clinical development — after, or just prior to, the launch of a new drug. However there is considerable value in obtaining input from patients and families at the front-end of clinical development to ensure that the voice of the patient is reflected in a potential product’s overall clinical and commercial strategy.

“…there is considerable value in obtaining input from patients and families at the front-end of clinical development…”

Additionally, it is critical for the industry to foster and nurture collaborative relationships with physicians and payers as well, as all stakeholders within the healthcare ecosystem play an increasingly important role in creating differentiated therapies that reduce the burden of disease and the costs associated in managing them. In this context, collaborative, multi-stakeholder assessment on the value of new or future therapies will become increasingly important.

This process of early engagement with patients need not necessarily be dependent on guidelines from regulatory agencies. Although a formal framework for communicating risk/benefit information to patients regarding medications that are already on the market would be extremely helpful, pursuing a more open dialog with patients would empower patients to not only take a more active role in their own healthcare, but to influence the development of future medications as well. Such an approach takes a pragmatic, long-term view by carefully balancing the needs of all healthcare stakeholders in a sincere effort to improve health outcomes for patients.

The opportunity for more robust conversations is clear. While the concept of collaborating with multiple stakeholders to influence drug development is hardly new, recent data from the Quintiles’ New Health Report suggested that the industry isn’t quite there yet. Despite the value in collaborating with patients early in the drug development process—and the fact that nearly four or five surveyed biopharmaceutical executives felt that they are very- or moderately-effective in understanding the needs of patients—only 48% of patients reported that biopharmaceutical companies understand the needs of patients. Furthermore only 19% of patients think they can be very or extremely influential in influencing which medications are available.

“…it is in biopharma’s best interests to engage paying bodies in the very early stages of a drug’s lifecycle.”

This discrepancy in perceptions between biopharmaceutical executives and patients is unfortunate, as is the limited early interaction between payers and the biopharmaceutical industry, especially in an increasingly cost-conscious environment. With payers demanding demonstrable proof of a new therapeutic’s value as a condition for reimbursement, it is in biopharma’s best interests to engage paying bodies in the very early stages of a drug’s lifecycle.

Despite the increasing influence of payers in treatment decisions, data from The New Health Report indicate that half of managed care executives report that biopharma is ineffective at working with other stakeholders to improve health outcomes. Furthermore, of those managed care executives who reported using outcomes data to evaluate new medicines, only 35% say they use information provided by biopharmaceutical companies, while the vast majority (85%) indicated a preference for measures developed and tracked by their own organizations.

However, while physicians may perceive biopharma as a valuable source of information, 54% say that the industry does a poor- or fair-job in working with physicians to improve patient outcomes. As a consequence while the industry is perceived as a good source of information, physicians do not recognize it as a stakeholder in improving healthcare.

“…half of managed care executives report that biopharma is ineffective at working with other stakeholders to improve health outcomes.”

For the biopharmaceutical industry to be seen as a critical ally in developing valuable new therapies and improving public health, it must solicit input earlier in the development of new therapies from patients, payers and providers. By engaging with, and incorporating the needs of these stakeholders, the industry can more effectively design trials with the requisite clinical, economic and humanistic endpoints to satisfy the needs of these communities.

About the author:

Dr. Jeffrey Spaeder

Dr. Jeffrey Spaeder, M.D., serves as Quintiles’ Chief Medical and Scientific Officer. In this role, Dr. Spaeder acts as Quintiles’ lead medical expert, representing the company’s position on a wide variety of governance, ethical and scientific issues. Further, he provides leadership in the ethical conduct of studies, chairing Quintiles’ Drug Safety Committee and serving as vice-chair of Quintiles’ Council on Research Ethics.

About Quintiles

Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of more than 25,000 engaged professionals in 60 countries works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. For more information, please visit www.quintiles.com.

For full details from Quintiles’ 2011 New Health report visit www.quintiles.com/newhealthreport. Quintiles will release its 2012 New Health Report in May.

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