No therapies or pharmaceuticals get made in a vacuum.
Each drug, each treatment is developed with a specific purpose in mind, whether that is to treat a symptom or completely cure a condition.
Those drugs are tested, they are brought to market, and their impacts on patient outcomes are studied. Those outcomes inform subsequent R&D.
This cycle is as old as pharmacology itself. What’s new, however, are the vast amounts of data we can capture from this cycle. Patient outcomes, especially, can be translated back for R&D purposes in quantities that would have been unimaginable a generation ago.
In 2016, Accenture researchers Nicole Faust Cohen, Kevin K. Julian and Thomas K. Kelly, Jr. argued that accessibility to patient-outcome data had brought pharmacology to a crossroads, after which R&D teams would funnel patient-outcome data back into their work. This would fuel patient-centric drug development, which then would bring more targeted therapies to market, accelerate time-to-market, and increase R&D productivity.
The key to unlocking this potential in R&D isn’t data or digitization, however. It’s medical affairs. These are the people who do the work of translating patient-outcome data back into information that R&D can use to optimize drug development.
The Cyclical Relationship Between Patient Outcomes and R&D
Patient centricity and the digitization of the pharmaceutical industry have grown up together. The scale of the former depends on the maturity of the latter.
Ken Getz at the Tufts Center for the Study of Drug Development wrote in 2015 how this contrasts with old models of drug development, in which companies “vied to innovate in an insular and secretive manner.”
“[...] In this approach, patients are subjects; contract research organizations (CROs) and investigative sites are service providers, and health care payers and providers are consumers of newly launched products.”
Very few companies operate under those assumptions today. Instead, real-world patient outcomes become datasets that inform the development of new drugs.
And this feedback loop is constant. As FasterCures Executive Director Margaret Anderson notes, patients are partners with R&D, and “[t]reatments should be developed in concert with patients.”
To achieve that dynamic, medical affairs must shepherd conversations and knowledge so that R&D takes place in an open ecosystem in which all partners are up to speed.
How Medical Affairs Can Help Close This Loop
Patients have numerous digital tools for collecting data and managing their own health, but the pharmacological R&D system isn’t built to receive that data so easily, Ryan Myers, Casey Korba and Anderson write.
Therefore, a patient-centric model of R&D must have two things, they argue:
- A patient-journey map to identify all the points in which patient-outcome data can be collected, and
- A strategic plan for harnessing all of the data that gets generated.
MA’s role is within this strategic plan. “Providing real-world data, and increasing access to it, creates an opportunity for medical affairs leaders to leverage data while continuing to establish and maintain trust with external stakeholders and the medical community,” writes Daniela Crandall MHS, PA-C.
“Medical affairs professionals who want to lead the change must be involved in various projects across the organization and communicate not only to the medical community but also to colleagues within the organization. This collaboration will only become more critical as therapeutics increase in complexity and as big data is utilized to assess outcomes in a value-based system.”
Again, this demonstrates how patient centricity depends on everyone’s ability to collaborate and share data, an ability that must be facilitated by medical affairs, which contextualizes the data for everyone.
“As digitally generated data continues to play a larger role in all stages of the pharma value chain - from R&D to monitoring post-approval patient experience and outcomes - medical affairs is in a strong position to combine data with scientific and technical expertise to generate insights that inform key decision makers inside and outside the company to help share the design and use of products for optimal outcomes,” Priya Chandran, Ethan Dabbs, Jennifer Fortune, Paul-Alexis Kebabtchieff and Hoan Ly write at In Vivo.
3 Systemic Hurdles That Complicate the MA-R&D Relationship
This data-driven model of R&D isn’t only limited by technological design. A handful of systemic challenges remain, and some of MA’s work will involve tackling these challenges.
1. Patient-Outcome Data Needs a Champion
“[T]he senior leadership in many pharmaceutical companies has invested in and built out centralized [real-world evidence] capabilities around data acquisition, standards, and processes,” Olivia Cavlan, Sastry Chilukuri, Matthias Evers and Ann Westra at McKinsey write.
“Typically, these centralized teams sit in global medical affairs to promote the cultivation of more robust RWE science and support a broader vision for the real-world evidence function [...]. That said, RWE capabilities around study design and management are more likely to remain scattered across the organization.”
The McKinsey researchers argue that the people who use this real-world data need to push for its inclusion up and down the pharma value chain. “[O]rganizations need people with deep knowledge of real-world data and analytics, business leaders with strategic vision, and communication skills to make a case for real-world evidence across the organization and externally,” they write.
2. Regulatory Environments Favor Closed R&D
Sarah Jarvis, the global medical affairs lead at ZS, argues that many organizations have put a rigid border between medical and commercial teams for fear of running afoul of compliance concerns.
It’s this border, however, that MA must be allowed to cross for patient-outcome data to fully integrate into R&D.
The challenge, then, is to ensure compliance doesn’t create unnecessary obstructions.
Alexander Bedenkov, Carmen Moreno, Ryan Bate, Andrey Ipatov, Filip Surmont and Maarten Beekman at AstraZeneca offer one model for mitigating regulatory chill factors. AZ’s iDREAM hubs project, launched in Russia in 2018, specifically seeks out opportunities for researchers, entrepreneurs, pharma companies, government bodies and R&D institutions to partner.
iDREAM looks a lot like startup incubators in which local stakeholders all have an interest in seeing nascent projects take off.
Similar models of collaboration can help MA teams share knowledge across the medical-commercial boundary.
3. The Industry Needs to Reimagine Its Approach to Innovation
Here’s where a bigger-picture perspective is helpful.
As Bristol-Myers Squibb’s Shaji Kalathil points out, MA specifically but the industry in general should consider how transformative innovation can drive business value. An internal culture that rewards risk, experimentation and big ideas can help push that line of thinking, as can initiatives like iDREAM above.
“Driving digital transformation in Medical Affairs also requires a broader enterprise mindset compared to other functions,” Kalathil says. “Since Medical Affairs is very closely connected to R&D and Commercial, it is important to visualize the concepts of digital innovation in healthcare through an enterprise lens and have an ‘outside in’ perspective (such as customer experience alignment with touchpoints beyond Medical Affairs) for solutions targeted for customers and patients.”
Such perspectives, along with the right tools and the right champions for patient-outcome data, can fuel a powerful cycle of understanding that in turn can bring major benefits to R&D.
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