How Pharmaceutical Companies Are Partnering With Patient Advocates to Ensure Access to Oncology Care

A Conversation With Thomas P. Sellers, MPA

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Thomas P. Sellers, MPA

With the advent and emphasis on patient-focused drug development and through initiatives like 21st Century Cures, patient groups are having more influence across the entire drug development continuum, from discovery and approval to market.

—Thomas P. Sellers, MPA

Thomas P. Sellers, MPA, has been a tireless advocate for patients’ rights for more than 20 years. A 15-year prostate cancer survivor and only child, Mr. Sellers said it was his mother’s death from lung cancer when she was 51, followed by the death of his father from glioblastoma multiforme that led him to a career in patient advocacy. Over the past 2 decades, Mr. Sellers held the positions of Chief Financial Officer for the American Cancer Society New England Division and CEO of the National Coalition for Cancer Survivorship. He is currently Senior Director for Patient Advocacy and Corporate Philanthropy for Millennium, The Takeda Oncology Company.

His overarching goal at Millennium is to ensure that patients have access to the most effective therapies available and that the company develops programs to address the unmet needs of patients with cancer and their caregivers, including giving them a greater role in drug and clinical trial development.

 The ASCO Post talked with Mr. Sellers about the increasing collaboration among patients, patient advocacy groups, and the pharmaceutical industry in the funding of new oncology therapies and in the facilitation of clinical trial design and patient recruitment, and how these relationships are having an impact on drug development and ­approval.

Advocacy Collaborations

How does Millennium collaborate with patient advocates in its drug development process?

We strategize and engage with patient advocacy groups—such as the International Myeloma Foundation (IMF), the Multiple Myeloma Research Foundation (MMRF) and the Leukemia & Lymphoma Society (LLS)—that are very involved in and have a significant amount of knowledge and experience in the design of clinical trial concepts and protocols to consult with our oncology research division about patient concerns. We are also currently looking at additional ways to directly involve patient advocates who are highly trained in the clinical trial process.

In addition, we convene meetings with patient advocacy leaders involved in cancers we do not currently have a lot of drug development in, such as the Ovarian Cancer National Alliance, LUNGevity, Lung Cancer Alliance, and Melanoma Research Foundation, because we want the voices of all active participants in the cancer community around the table.

Several years ago, we formed the Cancer Advocacy Council, which is made up of patient advocates and thought leaders in the patient community, and each year we convene one or two meetings to address a specific topic of concern to patients, with the goal of advancing our knowledge of patient needs—for example, easier access to therapies or patient education about their cancer. We also want to know about patients’ experience with their therapies, such as treatment effectiveness and side effects.

We also have meetings with representatives from the American Cancer Society and the Patient Advocate Foundation to ensure that we are aware of every concern patients have, including their financial concerns. We are really focused on building relationships in which there is mutual value for patients, caregivers, and us.

Greatest Concerns

What are some of patients’ greatest concerns?

Their number 1 concern is having access to drugs, and that access can include everything from getting the drug to transportation to and from the cancer clinic, lodging, and other financial impacts of having cancer, including not being able to work or their caregivers not being able to work.

One of the ways we try to mitigate the financial burden of having cancer is by supporting the patient assistance programs of organizations like the LLS or the Patient Advocate Foundation and CancerCare’s transportation program.

Therapeutic Advances

How is Millennium partnering with patient advocacy groups to advance cancer therapies?

One example is MMRF’s 10-year CoMMpass study in multiple myeloma. Millennium was the first company to collaborate with MMRF to both fund and participate in the study. But our involvement is more than just writing a check. We want to partner with patient advocacy groups and private foundations to be part of the entire process to learn how patients respond to therapies.

Patients and the pharmaceutical industry will greatly benefit from the work that CoMMpass is doing. Millennium’s Translational Medicine Department is involved in that study, but the relationship grew from having a strong patient advocacy function within Millennium.

Another example is our collaboration with the IMF to identify myeloma patient preferences.

Changing Relationship

Please talk about the evolution of patient involvement in drug development. How has the relationship changed between patients and pharmaceutical companies?

It has changed significantly and in multiple ways. Five years ago, the extent of pharmaceutical companies’ involvement with patient groups seemed to be limited to the drugs serving the needs of patients involved in those groups. With the advent and emphasis on patient-focused drug development and through initiatives like the U.S. House of Representatives Committee on Energy and Commerce’s 21st Century Cures, which is studying the gap between the science of cures and drug regulation, patient groups are having more influence across the entire drug development continuum, from discovery and U.S. Food and Drug Administration (FDA) approval to market.

For example, the MMRF’s Multiple Myeloma Research Consortium is serving as an incubator for clinical trials, and the MMRF has invested a lot of money in the development of new myeloma therapies. Other patient organizations such as the LLS are supporting early drug discovery in preclinical and clinical studies. And there are lots of other groups getting involved earlier and earlier in the drug development process.

There is also more patient involvement in government regulatory agencies, including the FDA and the Prescription Drug User Fee Act, which plays an important role in expediting new drug approval. The FDA has started holding a series of public meetings with patient groups on individual diseases to develop a structured approach to evaluating and regulating drugs based on benefit and risk.

Clinical Trial Funding

Is there more emphasis now on patient advocacy groups directly funding specific clinical trials?

Yes. There are many patient groups directly funding clinical trials and engaged in helping with the recruitment or the design and organization of clinical trials. Patient advocacy groups are also involved in key government agencies to present the patient perspective to advance cancer research. For example, the National Cancer Institute has an Office of Advocacy Relations and also includes patient advocates who sit on clinical trial and grant review committees and have helped write patient-friendly templates for clinical trial consent forms, among other things.

Major Accomplishments

What significant accomplishments have you seen as a result of patient involvement in drug development at Millennium?

One of the initiatives that came out of our Cancer Advocacy Council is a more accurate way to measure patient outcomes. We brought a group of prostate cancer advocates in to talk about issues they wanted to address in collecting patient reported outcomes and improved the clarity, appropriateness, validity, and usefulness of survey questions.

Ethical Issues

What are the ethical boundaries pharmaceutical companies have to adhere to when working with patient groups?

Most importantly, we must have transparent and open communication characterized by integrity and mutual respect, with clear expectations about our shared goals and objectives. Also, patient groups independently develop their own content for patient education materials or patient education programs that may have costs offset by unrestricted educational grants we provide.

Another way Millennium operates to preserve the integrity of the process is to rarely be the sole sponsor on a project or program. We prefer to work with other companies to fund work for the benefit of patients in a particular area. ■

Disclosure: Mr. Sellers is Senior Director for Patient Advocacy and Corporate Philanthropy for Millennium, The Takeda Oncology Company.