Prioritizing trends and mentorship to powerfully influence the present and shape the future.
By Mark Crawford
With more than 25 years in the biotechnology and pharmaceutical industries, Meena Subramanyam is well-known for her deep expertise in therapeutic drug and diagnostic product development, ranging from early research and development through regulatory approval and commercialization. Her work in translational and biomarker science, combined with her establishment of scientific research teams at Biogen and Takeda Pharmaceuticals, has resulted in the creation of safe and highly effective medicines that have improved the quality of life for millions of people living with debilitating diseases. Her tireless efforts have led to numerous awards and honors, including the American Association of Pharmaceutical Scientists’ Global Leader Award in November 2019.
Some of Subramanyam’s key accomplishments include scientific contributions to the clinical development, regulatory approval, and commercialization of eight first-in-class therapeutics for multiple sclerosis, psoriasis, haemophilia, spinal muscular atrophy, and other diseases. Her teams have established novel methods for measuring the pharmacokinetics and pharmacodynamic effects of therapeutic products, as well as biomarkers of safety and efficacy. She also guided the development of the John Cunningham Virus serology diagnostic tests for the safe use of natalizumab, a humanized monoclonal antibody, for the treatment of multiple sclerosis.
“I hold my work on the immunogenicity test and the JCV serology test for natalizumab as something special for its focus on patient safety,” she says. The test also utilizes the PML [progressive multifocal leukoencephalopathy] risk stratification algorithm, a first for the drug development field. “This accomplishment has allowed the reintroduction of the drug to the market in a way that patients with relapsing remitting forms of multiple sclerosis, and their physicians, can make an informed decision about the risk versus benefit of using the drug,” states Subramanyam.
On a broader level, this work also changed the perception of immunogenicity for monoclonal antibodies. “The natalizumab immunogenicity assessment experience was integral to the development of the immunogenicity assessment guidelines by both the FDA and EMA,” she adds.
Another reason the JCV research is so satisfying for Subramanyam is that it was conducted by the translational sciences group she built at Biogen. The team was responsible for several scientific innovations and technological advancements that were instrumental in developing fit-for-purpose biomarker and bioanalytical strategies to support the clinical development of therapeutics. “It was very rewarding to mentor and support the career development of many talented scientists in my team, some of whom are heads of translational sciences groups across the industry today,” she says.
What It Takes to Lead
Subramanyam is known as an inspirational leader who encourages critical scientific thinking and is not afraid to challenge preconceived notions. She believes that good leaders motivate people to take risks that are grounded in experiential knowledge, “taking evolving scientific and technical data into consideration.” It is also important for leaders to listen to diverse and divergent opinions and examine new perspectives to support a bolder vision.
In addition, effective leaders know how to contextualize tasks to a higher value and purpose—bigger-picture or enterprise thinking. “The ability to inspire and motivate people to be innovative and bold is essential for energizing and maximizing the commitment of people toward a common purpose,” she says. “Being able to build collaborative relationships, communicate effectively, remain resilient to recover from adversity, be courageous to rise above challenges, and feeling confident in one’s own abilities are also traits of successful leaders.”
These capabilities are especially important in leading teams, where different personalities and skills or experience levels are involved. Subramanyam’s goal is always to strike a balance between people and results—that leadership is a process of influence and to be successful the approach needs to be modified or tailored to the people and the situation at hand. “Appreciating and respecting the unique style and perspective of my team members and peers has helped my personal growth as a leader,” says Subramanyam. “Many of my scientific accomplishments would not have been possible without the collaboration and trust of people who believed in my ability to lead.”
Dealing With Change
Perhaps the hardest part of leadership is being able to deal effectively with change.
Drivers for change are diverse, move at different speeds, and often depend on the size of the company and the specific business sector. For example, mergers and acquisitions are commonplace in pharma and such consolidation activities can upset the workforce due to restructuring and layoffs. Individuals must therefore be in constant control of their careers and maintain their professional networks to find their next opportunity. Such “horizontal” consolidations also expect employees to remain nimble and adapt to the evolving vision of the new organization. “It is easy to feel overwhelmed in these circumstances and lose touch with what is critical and meaningful to you,” says Subramanyam. “Staying focused on personal goals and passion has helped me remain in control of my work life and career, regardless of the circumstances.”
As a scientist, Subramanyam will focus her research efforts to improve the speed and efficiency of clinical trial design and execution, as well as to close the gap between data used to gain regulatory approvals needed by the medical community to make healthcare decisions. “I truly believe that future successes in drug development require a fresh and expanded vision to demonstrate differentiated value to patients, providers, and payers and importantly, to reduce cost and time-to-market,” she says.
She intends to accomplish this by integrating data from controlled clinical trials and observational research (real-world data), including biomarker data from wearable devices, to better translate the value of scientific innovation to patient benefit in a streamlined manner. “It has therefore become essential to think broadly about strategies to better utilize real-world data through predictive analytics as well as biomarkers, including digital biomarkers, to define the patient’s disease journey and experience to enhance the understanding of the benefits, risks, and value of therapies,” she continues. “Such an integrated approach is being increasingly used in the industry and I believe the impact of this will become evident in the next five years or so.” Being an active member of AAPS will help her achieve these goals.
The Path of Mentorship
A member since 2005, Subramanyam has established strong and meaningful professional relationships through AAPS that have translated to long-standing friendships.
“AAPS is an important platform and forum for debating the science of drug development among academia, industry, and regulators, and fosters strong collaborations between them to develop and propose solutions. The outstanding partnership between AAPS scientists to share experiential learning to improve the drug development process has resulted in many impactful white paper publications. In addition, AAPS provides an amazing opportunity to build professional networks, find research partners with similar interests, and develop leadership skills.”
On the people front, Subramanyam is enthused to continue mentoring and sponsoring scientists toward leadership roles in the pharmaceutical industry and inspire girls to pursue STEM careers. On a personal and professional level, she notes, she enjoys the opportunity to be a catalyst and guide. “Mentoring is a mutually enriching relationship and extremely rewarding, as it exposes me to diverse thoughts and ideas,” says Subramanyam. “The differences in personality, approach, and culture of those I mentor encourage me to maintain a broad perspective on career options and opportunities. Helping mentees develop their strengths and address gaps in generic skills and knowledge is one of the most important things I do as a mentor—in addition, I am indirectly developing my leadership skills and building a lasting network of talent as well.”
Mark Crawford is a freelance science writer.