Maha Radhakrishnan, M.D., has been one of the public faces in the maelstrom that followed the FDA’s approval of Aduhelm, the first new Alzheimer’s disease drug in decades. It hasn’t been easy—but nothing to do with this disease has ever been easy.
Radhakrishnan is originally from India but trained in medical school in Moscow through an exchange and scholarship program. She got her degree in internal medicine, but, not satisfied with solely being a medical doctor, also got a master’s degree in Russian language, which allows her to interpret, translate and teach.
“I was in Russia at a time point where the split was happening between the ex-Soviet Union, the USSR, as we call it, and the now Russia,” Radhakrishnan said in an interview. “So it actually made me really start appreciating the importance of what it means to be truly global. What it means to truly appreciate different cultures, but more importantly, what does it mean to really look at population health in general.”
After beginning her clinical practice in cardiovascular health and metabolic diseases, Radhakrishnan quickly realized there was an urgent need to address the overall health of the population. After seven years, she made the jump to the pharmaceutical world around 2003, first with a position at Bristol Myers Squibb, and has never looked back. She worked on launching the atypical antipsychotic drug Abilify, which is now owned by Otsuka America Pharmaceutical.
This was Radhakrishnan’s start in neuropsychiatric conditions, and she was intrigued. The interest pushed her toward R&D medical affairs.
“Joining the pharmaceutical industry for me was another eye-opener in terms of the impact and the value that we will add from a research and development and medical standpoint,” Radhakrishnan said. “To kind of just put it in layman’s words, it is how to bring the bedside to the bench, and how to bring the bench to the bedside.”
Radhakrishnan continued her work in a number of therapeutic areas but always had neuroscience in the back of her mind, staying close to mental health conditions and neurology.
Biogen first entered the picture around 2013 when Radhakrishnan joined the company for the first time as head of U.S. medical and then as head of European medical. Biogen spun off its hematology unit as Bioverativ in 2016, sending Radhakrishnan with it as head of the medical function.
“It was fantastic because it really taught me what it takes to really roll up your sleeves and build a company from scratch and take it to IPO, so that was a phenomenal effort,” she said.
After the 2017 IPO, Bioverativ was picked up by Sanofi for $11.6 billion the next year. Radhakrishnan became head of the French pharma’s primary care medical team. But a year and a half later, Biogen came knocking to get her back.
“I always tell people that I never left Biogen,” she said. “There was no saying no … I tell people Biogen is in my DNA.”
Now, Radhakrishnan is responsible for the global medical organization at Biogen, bridging innovations and science coming from the R&D operations to the medical and healthcare community—and patients who will ultimately use the therapies developed by the company.
“Getting a product through regulatory approval is just the first step,” Radhakrishnan said.
‘First is never easy’
Biogen certainly has some experience with how the path can get even rockier after a drug approval.
Aduhelm was controversially approved by the FDA in June based on biomarker data that suggested the therapy could affect the underlying cause of the disease. The rollout has been bumpy, with sales slower than expected, despite the fact that Biogen has the first approved Alzheimer’s medication in decades.
The company has faced criticism over the efficacy of the medicine and the clinical trials backing the approval. The label has been trimmed to a smaller pool of Alzheimer’s patients. Medical clinics have even refused to offer Aduhelm.
Nevertheless, Radhakrishnan is proud to be on a team that’s finally breaking some new ground. She says Aduhelm has been shown to reduce amyloid plaques in the brain, which are thought to be involved in the underlying pathology of the disease. The FDA used this so-called biomarker to approve the therapy on an accelerated basis, with the assumption that the reduction of plaques is likely to improve cognitive decline.
“I cannot express how fulfilling this is. It is indeed a proud moment,” she said. “But along with the pride also comes a sense of accountability, the sense of responsibility that we really need to keep the patient front and center of everything we do.”
Radhakrishnan is well aware of all the criticism that’s been hurled at Biogen over the biomarker approval.
“As a physician, what I feel is that right now, with all the noise, the voice of the patient is being lost,” she said.
But Radhakrishnan also feels a sense of pride that Biogen’s win has spurred a renewed fervor in investment in Alzheimer’s research among big and small pharmas. She says this moment feels a lot like when HIV or oncology had breakthroughs. One accelerated approval led to an exponential rise in the number of approved medications.
Radhakrishnan knows that Biogen’s work is not done and that Aduhelm’s efficacy must be validated. Her team is planning an FDA-mandated phase 4 confirmatory trial to replicate and confirm the findings of the earlier clinical program.
She defended the use of the accelerated pathway for Aduhelm and said Biogen provided the FDA with data from 3,000 patients—about 2.5 million pages of information.
“[Aduhelm] has gone through extreme levels of rigor and scrutiny,” Radhakrishnan said. “We are doing everything possible to speed up the startup and actually the execution of the study right now.”
The approval was just the first step. To streamline treatment options for Alzheimer’s, Radhakrishnan said we need to build out healthcare infrastructure for a comprehensive care model. Alzheimer’s patients often are first identified through primary care, at which point they need to be connected with a specialist. Imaging is also important to determine the level of plaques and damage in the brain and intervene earlier in the course of the disease.
Radhakrishnan welcomes the efforts of companies that will follow in Biogen’s footsteps to provide more treatment options.
“Being the first is never easy,” Radhakrishnan said. “Biogen is leading this, but soon enough, there will be many more programs and products approved in the space, and I would say the future looks pretty bright for anyone who may end up getting Alzheimer’s.”