Challenging Assumptions

Pharmaceutical Executive, Pharmaceutical Executive-05-01-2022, Volume 42, Issue 5

Motivated by forging new—and needed—pathways in drug development.

Divya Chadha Manek has a dream that no company will ever have to worry about finding patients for their clinical trials. “In clinical development, the biggest problem is recruitment. If we could just take all the stress out of recruitment, it wouldn’t waste multiple years of a program,” says Manek. She believes that the current complex clinical development pathway is, in part, to blame for the lack of innovative therapies, increasing patient and economic burden, and risk of failure.

Manek’s experiences back up her beliefs. Her latest proof point was in April 2020, when she was appointed to the UK government’s Vaccine Taskforce (VTF) as the clinical trials workstream lead, and she witnessed the shortening of the clinical development timeline with COVID-19 vaccines. Given leeway to try new ideas, Manek set up an early centralized COVID-19 vaccine registry for people interested in taking part in the as-yet-not-initiated trials. This registry helped drive faster recruitment into multiple COVID-19 vaccine trials. “As soon as the trials started, we had people virtually at the front door queuing up to take part,” says Manek. She describes her year-long VTF term as a “baptism by fire,” for which she, as taskforce lead, was awarded an Officer of the Order of the British Empire (OBE) by Prince Charles at a Windsor Castle honoring event.

Love of research

Long before this watershed moment, Manek realized research was a passion. Early on, growing up in India, her father was a kidney transplant patient. Manek would research anti-rejection drugs and other elements of his disease to no avail. Surprised at the lack of solutions for people in need, she knew she wanted to help somehow in healthcare. Manek admittedly said she didn’t have the “kind of brain” for medicine or science, so her teacher suggested psychology; Manek worked to get strong grades and a sports scholarship to attend university in the UK. She enjoyed research modules while earning a bachelor’s degree in psychology from Royal Holloway at the University of London. She then moved on to get a master’s degree in clinical research from University of Birmingham, which led to her first job recruiting patients into clinical trials.

For the past 14 years, Manek has held roles of increasing responsibility at the UK’s National Institute for Health Research (NIHR) Clinical Research Network. She set up and recruited to trials, then managed a regional network for mental health studies, which led to increased interactions as an industry liaison manager to ensure smooth clinical operations, working in collaboration with industry partners and National Health Service sites across England. Soon after, the NIHR created a new department for business development, and Manek was appointed industry business development manager. “It wasn’t the traditional pharma [business development], where you need to find assets or the [contract research organization] BD, finding clients for services. It was to bring more commercial clinical research into the UK from pharma, biotech, and medtech,” explains Manek. “I then moved on to being head of the department. The beauty of that role was the ability to create new services that would make clinical research more innovative and more streamlined—and make it more enticing to deliver clinical trials in the UK.”

One of these was a fee-based patient engagement service. “We can offer a service that industry really does need, that no one else can offer. Why don’t we set it up and charge for it?” says Manek, recalling internal planning discussions. “And the responses were ‘we can’t take money from industry,’ ‘we can’t do that.’” She concludes from that experience, “I’ve always wanted to challenge assumptions and not be so bureaucratic.” Manek also had a leading role in creating the National Patient Recruitment Centers, designed to increase the UK’s capacity to deliver large-scale, late-phase commercial clinical trials and make it easier and quicker to deliver commercial research in the NHS.

A natural progression

After serving on the VTF, Manek returned to the NIHR as director of business development and marketing, and in November 2021 took on the role of senior vice president of clinical development at EyeBio, her first private sector role.

Manek always believed she would work in industry at some point, and her colleagues were positive of it. So much so that a few of her managers worked overtime to keep her in the NIHR fold through promotions. One told her, “If I let you go, you’ll move straight into industry.” Another said, “I’m doing this to keep your skills within NIHR.” Harkening back to the fee-based service Manek created, “I would say wherever I worked, I’ve tried to make processes very lean, which is not really in keeping with a large public sector organization,” she acknowledges.

Manek knew the time was right to move to industry, but she needed to weigh her choices: large pharma or biotech? “If I’m taking a risk, I might as well go full hog and join a biotech startup,” says Manek. She knew that in large pharma, roles were often defined and “in a box,” and she wanted to experience the nimbleness of a biotech and the ability to learn all aspects of the business. “I’ve never been responsible for overseeing clinical development and doing it myself from early stage right through to the end,” notes Manek. “The best way of learning is through doing. I want to be able to work sideways in other areas, where being in a larger organization, I wouldn’t be able to.”

For Manek, that now means opportunities at EyeBio to learn and support functions she hasn’t yet experienced hands-on, including regulatory, chemistry, manufacturing, and controls, and preclinical.

“I come to this company with no direct ophthalmology experience, but to know that I will have made a difference to patients, who are potentially going blind, is such a huge passion and motivator,” she says.

EyeBio was founded in August 2021 by David Guyer, MD, and Anthony P. Adamis, MD, working with collaborators at SV Health Investors. Previously, Guyer and Adamis collaborated with SV Health Investors to co-found Eyetech Pharmaceuticals, where they developed and commercialized the first anti-vascular endothelial growth factor (anti-VEGF) drug for the treatment of age-related macular degeneration (AMD) in 2005. In February this year, EyeBio raised $65 million in a Series A funding round, which will be used, in part, to in-license new ophthalmology assets that are not far from the clinic.

Manek is prepared to bring her dreams to bear in her role at EyeBio. These include innovative ideas in areas such as trial design, real-world evidence (RWE)/real-world data (RWD) approaches, and faster recruitment. She looks forward to partnering with organizations to close gaps in the development pathway.

Driven and disciplined

Though facing unknowns now and throughout her career, Manek walks the walk. She has an eye for efficiency, a mindset to accomplish, and a desire to innovate. She sees no reason to do in four weeks what can be done in two. She saw no limitations to managing a £320 million ($417 million) budget without an MBA, pouring over financial reports and asking questions, such as “why are we doing it this way?” “It’s a mindset, rather than a skill set,” she says.

What Manek humbly acknowledges is the luck she has had with colleagues and bosses who have believed in her and challenged her to reach higher. In turn, she is flexible with her reports, believes in them, and communicates clearly, so there is no second-guessing. Manek’s two girls, ages 3 and 6, also benefit from her intertwined life as a working mommy. “I work all times of the day, so they see that I work,” she says. Manek also takes time out to bake and play with her children, and she uses her mornings for exercise and self-reflection.

Recently, she became trustee for Alzheimer’s Research UK, an area she points to as one example of the dearth of innovation in pharma. “You can see the impact [Alzheimer’s] has on patients’ lives, as well as the economy. But look at the pharma pipeline…it’s static,” says Manek. “I think there’s not enough pipeline assets—not because there isn’t great science, but because the clinical development pathway is so complex that it deters good science to progress rapidly.” Manek does believe that during the pandemic, industry was able to embrace new strategies to address ethnic disparities in trials, and to advance trial innovation, such as with adaptive trial designs. But she questions if industry will keep it up.

“If we don’t do something new, it will just be the same, and we will keep getting the same results,” says Manek. 

Lisa Henderson is Pharm Exec's Group Editorial Director. She can be reached at lhenderson@mjhlifesciences.com.