CWWeekly presents this feature as a way to put the spotlight on issues faced by executives in the clinical trials space. Wendy K.D. Selig is founder and CEO of WSCollaborative, a consulting firm that advises patient advocacy groups and other health-sector clients in defining and implementing strategies for collaborations with industry and government.

Q: As the former leader of the Melanoma Research Alliance, how do you think cancer-patient advocacy groups have evolved?

A: Working in the cancer-patient advocacy space for 16 years, first with the American Cancer Society and more recently with the Mela­noma Research Alliance, I have seen significant evolution in the sophistication and strategic approach of patient-focused, nonprofit organizations.

Today, patient advocacy organizations are creating and embracing opportunities to accelerate scientific progress, launched by investments from the NIH and the activities of industry players. Recognizing the opportunities made possible as a result of such breakthroughs as the sequencing of the human genome and other landmark developments in basic science, patient organizations are structur­ing their staff resources, program priorities and funding activities to leverage their impact on behalf of the patients they serve.

By building innovative collaborations across the sectors, patient organizations are becom­ing true partners in the ecosystem of therapy development. They are effectively enhancing awareness and understanding of their specific disease, plus funding research to answer key clini­cal research questions. Patient advocacy groups also help in the design of effective clinical trials.

Increasingly, disease foundations are engaging in variations of “venture philanthropy,” providing critical funding and scientific exper­tise to advance drug development, expanding their reach from working with more traditional academic research grant models to direct part­nerships with industry. Bringing the issue of patient centricity to the forefront of the regulatory system, patient organizations now are leading the charge by implementing Patient-Focused Drug Development, which includes conducting patient preference studies to define novel clinical trial designs and qualify alternative study endpoints.

Q: As a consultant working with rare diseases and other patient groups, how do you see sponsors adjusting to the more active role of nonprofit patient advocacy organizations?

A: Static definitions of “patient advocacy,” and traditional interactions between nonprofits and industry, have become less relevant. Organi­zations and biopharmaceutical companies must innovate in their approach with one another, and develop new types of programs and processes to maximize opportunities for collaboration.

Leaders within the pharmaceutical, biotech­nology and device industries are beginning to embrace this change, redesigning their strategies, structures, processes and programs to develop true partnerships with patient groups through­out the clinical development process. In recent months, several large, legacy pharmaceutical companies have responded to the changing land­scape by empowering high-level chief patient officers to shift company cultures toward a more holistic approach to engage patients and patient groups. More companies are moving away from transactional models of engagement with patient organizations, such as buying a table at a gala event, or one-time grants, and toward a relation­ship focused on developing synergistic programs.

The paternalistic view of patient organiza­tions—as focusing solely on outreach and education with little scientific expertise—is giving way to a realization that many patient groups actually have a great deal of scientific and medical knowledge to bring to the table. Industry is seeking-out patient groups for collaboration to leverage the groups’ focus on specific diseases and connect with select patient populations. They want to access their professional, scientific and medical staffs and advisory groups’ knowledge of the latest research opportunities, clinical advances and strong relationships with key government agencies. For biopharmaceutical companies seek­ing competitive advantage, building an effective alliance development program to tap into the growing expertise of patient groups increasingly is a top priority.

Q: What’s ahead for patient ad­vocacy groups in developing better working relationships with biopharmaceutical companies to meet patients’ needs and improve perceptions of patient-centric clinical trials?

A: Scientific progress is creating opportunities for new therapies and cures for serious dis­eases. Patients have found their voice, embracing new technology and models of collaboration, and leveraging their power through sophisticated advocacy organizations with enormous scientific and “voice of the patient” credibility.

Well-respected entities like the Clinical Trials Transformation Initiative (CTTI), FasterCures, National Health Council and BIO are working with policymakers leading the 21st Century Cures Initiative and regulators implementing Patient- Focused Drug Development to catalogue best practices and policy tools to propel this move­ment forward. With a range of entrepreneurial organizations and companies entering the mar­ketplace, we should see even more innovation. It’s all good news for patients.

Email comments to Ronald at ronald.rosenberg@centerwatch.com. Follow @RonRCW

This article was reprinted from Volume 19, Issue 32, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »