In today’s ever-changing healthcare marketplace, the integration of clinical science and commercial strategy is essential for pharma companies striving to succeed in a fiercely competitive market. Companies have begun with these functional areas to recognize the power of breaking down barriers to foster collaboration, innovation, and expertise.
There are three stories I am going to tell you to help illustrate these points in this post:
- Pharma companies need more people who can understand and be strategic across the functional areas of clinical science, market access, and health plan account engagement
- Real change outside of your business begets real change inside your business
- “Begin with the end in mind.” - Stephen Covey
Story 1 — Transforming Silos: Driving Market Access and Collaboration in the Pharmaceutical Industry
In May of 2010, I was Director of Extramural Research (Investigator Initiated Studies) for Janssen Medical Affairs Neuroscience. This was about 4 years before I would assume my position in Health Care Quality in the Johnson & Johnson (J&J) Strategic Customer Group (SCG).
In this role, my primary focus was clinical science, where I was entrusted with the strategic oversight of nationally renowned neuropsychiatric researchers and the publishing of their work. However, while I operated effectively in my role, I was highly functional in a silo, where collaboration and cross-functional engagement were limited.
Once an unexpected research issue arose that had commercial implications, it became my responsibility to equip our home office and field commercial colleagues with the necessary knowledge and expertise to address this matter intelligently. This particular situation served as a catalyst in changing the siloed structure of my thinking to which I was accustomed.
Let me tell you, I was out of my comfort zone big time!
Marketing colleagues that I’d had brief interactions with previously started to visit my office on a regular basis to discuss strategy needed on the commercial side of the business. While I felt confident in my scientific and clinical knowledge with strong support from my Medical Affairs, Biostatistics, and Medical Information colleagues, I was plagued with anxiety and uncertainty when it came to engaging on the commercial side. Despite my fear and hesitation, I was undeterred and forged ahead with what I was charged to lead.
At a key point during these events, my Janssen Neuroscience Marketing home office colleagues informed me that I would be training various groups of SCG colleagues at the National Plan of Action meeting in Philadelphia. While I had heard of the SCG group before, I had little understanding about their role and day-to-day tasks within J&J. When I arrived in Philadelphia and started interacting with the large SCG health system account management team and the even larger health plan account management team, my mind was blown.
Several of the thoughts and questions coming to my mind were:
- I wondered even more about the roles of my J&J colleagues in relation to my own day-to-day job at the Janssen Medical Affairs Neuroscience department.
- Despite working at the same company, I had no idea how my work in Medical Affairs connected with the SCG Market Access division.
- I realized the need to educate myself about our broader J&J business and the biopharma industry that I am so deeply passionate about.
Upon reflection, I realized I was entirely too comfortable within the confines of my functional area silo, even though I knew it was not a good idea to work in isolation and constantly reminded myself to avoid such silos. My philosophy was to always lift my head up and seek opportunities to learn about departments and job functions that both directly and indirectly connected to my own. Through this newfound approach, I gained knowledge about the broader business and a deeper understanding of the context and implications of my current work, both for the company and the outside world. For me, this mindset and approach helped bring greater purpose to my work.
Little did I know that this coincidental engagement with the SCG team would eventually lead me to work in the very same department 4 years later!
During my 4-year tenure working in SCG from 2014 until 2018, the strategic silos continued to breakdown. I gained a deeper understanding of our business and developed effective strategies to engage with our health plan and provider customers towards patient-centered business objectives. New business insights came into focus, but I also appreciated where business firewalls needed to be respected, as well as the importance of understanding the vital role of Legal and Compliance considerations.
Some of the new business insights for me included:
- Recognizing the need for organizational structuring and restructuring to navigate complex market dynamics such as:
- Multiple distinct therapeutic areas, some new and others with a long-standing legacy;
- Varying treatment modalities, including small molecule treatments and large molecule biologic regenerative therapies;
- Different payer channel marketplace realities by therapeutic area;
- Resourcing and organizing scientific, population health, and commercial field teams against the needs of the business, its health plan/payer customers, and the distinct needs of highly varied patient populations.
- Embracing a value-based care strategic lens as a foundation of our understanding about the risk held by prioritized health plans and providers in terms of care processes, outcomes, experiences, and total costs of care. This understanding enabled our SCG Health Care Quality Team to collaborate in new ways with our J&J colleagues to evolve internal business strategy in areas of evidence generation, market access, market development, health policy, health equity, and patient advocacy. This also helped align us with our prioritized customers’ goals which led to us achieving our business objectives.
- The Health Care Quality Team at the time of its founding in 2014 was multidisciplinary. Our team consisted of a clinical scientist, health care professional, a regulatory affairs professional, and a health economics and outcomes expert. We played a crucial role in shaping evidence generation strategies to meet the regulatory standards of FDA and other ex-US regulatory authorities while also importantly seeking to optimize market access potential. We also provided expertise in quality measurement with deep knowledge of the data underpinning the quality measures. Lastly, our understanding of the risk held for measure performance by prioritized health plans helped us make recommendations to clinical development teams on key primary and secondary efficacy measures to collect in our pivotal phase III trials.
Ultimately, breaking down silos was a professionally liberating experience.
A key ingredient to successfully and consistently solving these complex issues in pharma (even after breaking down silos) is that you can’t just focus on what’s important to you. By focusing on understanding what is important to cross-functional business partners, senior leadership, your manager, your customers, and other valuable external stakeholders, you’ll be able to deliver exceptional performance, achieving your own goals and objectives.
The key takeaway is that in this highly complex biopharmaceutical industry environment, there is a need for people who can understand and be strategic across the functional areas of clinical science, market access, and health plan account engagement.
The high complexity within the industry can be illustrated within FDA regulatory science guidance (i.e., CDER Patient-Focused Drug Development, Draft FDA guidance to industry on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials).
These documents hold significant importance to industry and have societal relevance. But do payers consider these evidentiary guidances in health plan market access evaluations for new medications? Similarly, complexities are also found from the market access side of the equation with FDA regulatory implications on the other side of the equation.
A recent example is the Pre-approval Information Exchange (PIE) Act of 2022 signed into law in December 2022 and strongly championed by the Academy of Managed Care Pharmacy (AMCP). This act aims to enhance patient access to emerging pharmaceuticals and devices by authorizing pharmaceutical manufacturers to proactively share certain health care economic and scientific information about products with payers ahead of FDA approval.
These guidance documents and their implications spanning pre-approval drug development to market access enablers reinforce why pharmaceutical manufacturers must increasingly recruit and cultivate talent with strategic understanding across the functional areas of clinical science, market access, and health plan account engagement.
Story 2 — “Real change outside your business begets real change inside your business.”
In 2014, at J&J, we embodied this quote! This story centrally involves Scott White, who is currently the J&J Company Group Chairman, North America Pharmaceuticals. He shared this story with me during a 1:1 introductory conversation in 2014 just before I joined the Health Care Quality team in SCG.
During this conversation, Scott told me that less than a year prior, Alex Gorsky, the Johnson & Johnson CEO, asked Scott to meet with Ron Williams, one of the J&J board members and Chairman and CEO of Aetna (at the time), to explain Johnson & Johnson’s strategy for being well-positioned in the rapidly evolving healthcare landscape in the U.S.
Scott told me that he reassured Alex about his ability to lead the meeting, “No problem at all. I’ve got it.” Then with a demure smile, Scott said, “Norris, I know a lot about this business, but I know my limits, and I did not have the knowledge to successfully handle that meeting with Ron Williams.” So to help him prepare for the corporate visionary meeting with Mr. Williams, Scott secured a full day meeting with two individuals who had the knowledge and insights he needed — John Hoffman, head of SCG Health Policy & Advocacy, and Dave Domann, who would soon become my boss in our SCG Health Care Quality team.
John and Dave successfully relayed to Scott everything he needed to understand so that he could articulate a vision and strategic pathway to Mr. Williams as to how J&J should evolve to be positioned for the rapidly evolving value-based healthcare landscape — largely accelerated by the enactment of the Affordable Care Act (or Obamacare) four years prior.
Not only did Scott have a very successful meeting with Ron Williams, he left the meeting with a newfound understanding of how J&J needed to evolve. One of the most significant immediate steps that Scott undertook as a senior leader was to install Dave Domann as the senior director to lead a newly minted SCG Health Care Quality team.
It was clear to me from this story that one key aspect of the vision for J&J’s business strategy was rooted in the role of health care quality and value-based care in the external health care environment.
I tell this story because it was not lost on me that at the highest levels in the multinational pharmaceutical enterprise of Johnson & Johnson, the strategic directional basis of how we would evolve was rooted in external healthcare landscape drivers of health care quality and value-based care/payment.
Again, the key takeaway from this story is that “real change outside your business begets real change inside your business.”
One of the substantial challenges, in today’s environment, is that when new external changes, such as the Inflation Reduction Act introduce dramatic headwinds to the industry, does the posture of the change that needs to occur inside of pharma companies remain positive towards improving quality and driving value-based change? Or do the harsh business realities promote negativity and pessimism?
Of course, I believe that it should stay positive and hopeful. Being apart of this industry for many years, I hope that is what generally happens — industry-wide optimism and a commitment to positive transformation.
Story 3 — Market Access and Clinical Evidence: Beginning with the End in Mind
This final story emphasizes the importance of the old Stephen Covey adage, “begin with the end in mind” – especially when it comes to Market Access and the kind of clinical evidence needed to generate to support achieving strong medication market access.
In 2013, when the Janssen drug candidate, esketamine (now marketed as SPRAVATO™) for the indication of treatment-resistant depression was in phase 2 clinical development, I led an engagement effort with clinical development. After leading a series of presentations about the evolving external value-based payment landscape, we gained the team’s buy-in to collect patient-reported, depression-related quality measure data in the phase 3 clinical program.
I led the commercial market access quality team in identifying the Patient Health Questionnaire (or PHQ-9), a nine-item patient reported outcome scale. The PHQ-9 is a validated scale also used in quality measures related to depression screening and achievement of treatment response or treatment remission in clinical practice. It is also used for health plan accountability for quality measurement.
As a result of our successful internal influencing, the PHQ-9 was adopted into the phase 3 clinical program as a co-primary efficacy scale in the three pivotal trials, replacing the originally planned patient-reported depression symptom measure (i.e., 16-item Quick Inventory of Depression Symptomatology [QIDS] measure).
While the QIDS was a highly validated scale from research and FDA regulatory affairs perspectives, it would be entirely foreign to the future prescribers and payers of the SPRAVATO™ product. The PHQ-9 was a scale that our R&D Patient-Reported Outcomes team ensured was validated from a FDA Regulatory Affairs perspective. Moreover, it would be easily recognizable by both providers and payers involved in the delivery and payment of care for individuals being screened and/or managed for depression.
The phase 3 clinical trial results using the PHQ-9 demonstrated statistical significance in all three trials. At the time of my departure from Janssen in March 2018, these data were being considered for optimizing the drug’s value proposition and market access positioning with payers.
From these three stories, hopefully, you appreciate the new market access business insights, rooted in evidence and value, that I was able to gain in relation to the payer landscape. But, more importantly, it’s my hope that these stories inspire greater thought on how the biopharmaceutical industry should approach developing internal competencies of its people in ways that reflect and do justice to the highly complex realities in the healthcare marketplace.
My Journey Part 2 Preview
Thanks for reading! In Part 2 of My Personal Journey and Story of Inspiration, I will share about furthering my purpose by leaving the corporate world and the impact of losing my father, all leading me to help promote higher quality in health care through entrepreneurship. But Part 2 will be released in the next few months, so stay tuned!
This month, we took an intentional detour to discuss new market access business insights I gained in relation to the payer landscape. These insights were rooted in evidence and value, but were also powerfully shaped by the road I traveled from Clinical Research to Market Access.
By breaking down functional silos and fostering cross-functional expertise, organizations can unlock new possibilities and maximize the impact of their products.
Reflection Questions for You
- How can pharma companies effectively break down functional silos to foster cross-functional expertise?
- What are some key strategies and approaches that can bridge the gap between clinical science and commercial strategy?
- How can health care quality and value-based care initiatives serve as catalysts for internal transformation within pharma companies?
- How do the principles of clinical science and market access integration covered in this article relate to medical devices? Hint: A lot!
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