Life sciences companies are rethinking and revising R&D. To avoid wasting years on drugs and other innovations with poor or no return on investment, they are placing greater emphasis on understanding a product—and its potential for sustained market success—earlier in its lifecycle.
The key to this strategy is incorporating the “voice of the patient” during the early stages of development, says Lisa Flavin, consultant in Witt/Kieffer’s Life Sciences practice. This shift is partly the result of broader healthcare reform, she notes—as healthcare strives to become more patient-centric, so do life sciences companies.
One by-product of the patient-centric approach within life sciences companies is an executive role known as the Chief Patient Officer (CPO). Recently, Sanofi became the first major manufacturer to create this position, hiring pediatrician and public health expert Dr. Anne Beal, whose role will be to heighten the attention on the patient in all that the company does.
Variations of this position and title (for example, Senior Director of Patient Advocacy) have cropped up in some smaller firms, and we can expect to see more Chief Patient Officers hired in the future, Flavin says. In the interview below, she discusses why the role is gaining traction, and how it may impact life sciences firms’ approach to development.
Pharma and biotech companies are just beginning to create Chief Patient Officer and similar executive roles. Why is this happening?
Flavin: With the cost of drugs exceeding what payers are willing to reimburse for, and the pricing pressures only increasing, biotech and biopharma companies realize they need to operate differently than in the past, especially in regards to drug development. They also recognize they have an incredibly strong ally in the patient. The Chief Patient Officer is someone who can help companies connect with and truly understand patients’ needs and preferences.
Is this representative of a sea change, that “approval” is no longer the end-all and be-all of drug development efforts?
Flavin: Absolutely. Getting a drug to market is a long, arduous process fraught with pitfalls. Previously, approval was the culmination of all those efforts and considered the last hurdle to overcome—the goal was getting innovative drugs (or devices and diagnostics) in the hands of patients. Approval often was considered the most recognized measure of success.
What the past few years have shown is that approval is no longer the finish line. Drugs and other products, especially those that have high price tags or don’t provide new or additional patient benefit, are heavily scrutinized in an era of healthcare reform, by patients, physicians, payers, regulators, and so on. Getting products to market does not guarantee that there will be a viable and sustainable demand. This has always been a concern, but it is especially so today.
Where did this CPO trend start, and where is it headed?
Flavin: Orphan drug-focused biotech companies have a long-standing tradition of working hand-in-hand with advocacy groups and specific disease populations. They have been able to illustrate the benefit of engaging the patient at a very early stage in the clinical development cycle while working to tailor a drug profile for a specific and finite population. This method has gotten the attention of other companies, which see a scalable approach to drug development, even for big pharma products.
What’s different now is the level of visibility and investment these “patient executive” roles are gaining within companies. In the past, you would often see an Associate Director or Senior Director of Patient Advocacy. Now, the role is being elevated to VP or C-suite level, as recently evidenced by the appointment of Sanofi’s Chief Patient Officer, as well as with the biotech firm Intarcia’s naming of a Head of Customer Experience & Outcomes (CXO). These cases are both newly created roles that set precedent in two very different cultures.
What are the core responsibilities of the position, or is it really company-dependent at this point?
Flavin: It does depend on the company, but there are some key themes emerging for positions with titles related to patients, patient experience and outcomes. This person will be a leading voice throughout the organization, articulating the need for and ensuring the engagement of patients early in the clinical development process. This person will also be highly attuned to what payers will reimburse for—and he or she will be responsible for bringing that knowledge to the table early on in the formulation of R&D strategy. And finally, the individual in this role will have an understanding of what kind of investment and advocacy the target patient population will be willing to provide, and will have developed models to gauge the level of influence they will have with key opinion leaders and payers.
What type of executive can best fill a role like the CPO? Are there any standard prerequisites? Is an MD required or strongly preferred?
Flavin: Distinctive profiles are emerging for the first class of CPO leaders. An MD is helpful, of course, but there seem to be different routes that executives are taking to ascend to these positions. A CPO or the like can come from outside the corporate world, as is the case with Dr. Beal, an MD who most recently came from the Patient Centered Outcomes Research Institute (PCORI), a non-profit think tank. She is someone who brings instant credibility to the role because of her background.
These executives could also be leaders who have spearheaded well-organized/well-funded advocacy groups, or those who have grown up in a biopharm commercial organization and have an ability to connect and measure patient satisfaction and how it will impact outcomes. An example is Intarcia’s CXO, Jay Smith.
So there is no “one size fits all” profile of the person who should carry the flag for companies in this regard. Over the next few years, we will see if firms coalesce around a clear, distinct profile as these kinds of positions gain in influence and as their contributions to the enterprise, especially overall success in driving innovations to market, is more closely scrutinized, measured and valued.
Ultimately, is a position like the CPO something you can see all major life sciences firms needing? If so, why?
Flavin: Yes, it will become increasingly prominent. Emphasis will continue to tilt toward winning over patients, payers, and key physician opinion leaders, and engaging payers by at least phase II of product development. A strategic, patient-focused role is especially critical for firms introducing any form of disruptive medicine or technology.
Patient advocacy groups are better funded and mobilized than in the past, and increasingly influential with the FDA and other regulators. Led by a Chief Patient Officer, biotech and pharma companies can partner effectively with these organizations to speed up and increase the likelihood of regulatory approval.
So most firms will want to create a role like the Chief Patient Officer, though the jury is definitely still out about what these executives will do within different companies.
By Paul Thomas, Senior Writer (@PaulWThomas)