For professionals and leaders within the healthcare and associated sectors, the term ‘changing lives’ elicits a profound emotion. Every day their passion and commitment is channeled into finding solutions for patients’ needs.
Through the 10 Most Admirable Women Leaders in Biotech for 2021, the team at Insights Care is seeking these leaders from across the globe and bringing them into the spotlight that they rightfully deserve. In that journey, we crossed paths with Dr. Cornelia Haag-Molkenteller, a seasoned biotechnology professional.
As Executive Vice President and Chief Medical Officer at Urovant Sciences, Inc., Cornelia Haag-Molkenteller, MD, Ph.D., has found a home where she can advance her passion for helping address unmet needs through, as she describes it, “innovation with truly novel approaches.”
Many may not think of overactive bladder (OAB) as an area of unmet need; however, Dr. Haag-Molkenteller, a clinically trained urologist originally from Germany, understands that, even with more products being available to address this condition, the stigma remains. And many patients—both women and men—are reluctant to talk with their healthcare providers about their challenges with bladder issues and OAB.
Therefore, many patients do not seek out effective medical treatments that are available today to help manage many of the bothersome symptoms that have a limiting effect on their daily lives. “People are reluctant to mention OAB to their doctors; it’s embarrassing for them to discuss the topic,” she added. “And it’s not a subject the doctor will always ask about, either.”
Dr. Haag-Molkenteller joined Urovant in April 2018 following stints at both large and mid-size pharmaceutical companies, including 10 years at Allergan where she led the clinical development of OnabotulinumtoxinA (BOTOX™) for OAB and neurogenic detrusor overactivity along with other development programs. Her last position at Allergan was as Therapeutic Area Head of Women’s Health, Urology, and Internal Medicine in Clinical Development.
“Experience in a variety of different company structures is extremely important,” she pointed out. “For me, as a young physician entering a large company, it was about learning processes. By working first for larger companies, I learned how the process of developing and obtaining approvals of new drugs happens,” she said.
“I also learned how to work internationally with the company offices and study sites in the different countries and with all levels of company management. As a physician, I continue to be very passionate about urology, the specialty I trained in. For me, urology was a great choice among the surgical specialties because it combines the practice of diagnosis, medical and surgical treatment, and follow up for patients.”
Dr. Haag-Molkenteller describes her previous experience as ‘a good training ground’ for her current work and how it helped her realize why Urovant is the right fit for her professional goals.
“At Urovant, there are fewer management layers, allowing for faster decision making and higher agility and innovation.” From working at larger companies, Dr. Haag-Molkenteller also believes she learned how to work within a complex organization and how to adapt to a variety of leadership styles. She attributes these experiences to why she appreciates being part of Urovant’s dedicated leadership team.
“Urovant offers a very collaborative and trusting environment. We have a strong leadership team, headed by President and CEO Jim Robinson. Importantly, however, everyone on the team is approachable and open to new ideas,” she added. “We also share a commitment to doing the right thing for patients and healthcare providers, as well as for our employees.”
Successful FDA Approval During a Pandemic
The pandemic could not have struck at a more challenging time for the Irvine, California-based company. The New Drug Application for Urovant’s first commercial offering, vibegron, was in the final stages of review by the U.S. Food & Drug Administration (FDA) for approval of the first new oral branded medication in nearly 10 years for the treatment of OAB. The Urovant team responded to all FDA requests in a timely manner, despite the challenges with the pandemic and the demands of completing most of the work and meetings virtually.
“It is a testament to the dedication of the entire Urovant team, our investigative and development partners and the FDA that we were able to obtain approval during the pandemic,” Dr. Haag-Molkenteller stated. The new drug approved under the brand name GEMTESA™ (vibegron), was approved by the FDA on December 23, 2020.
“For our ongoing clinical studies, the pandemic caused us to implement a temporary pause in new patient enrolments,” Dr. Haag-Molkenteller recalled. “Then, reopening of those study sites was done on a one-by-one basis depending on regional COVID-19 infection rates and making sure each center had appropriate COVID protection measures in place. We followed the FDA’s and other regulatory authority’s guidance on the conduct of clinical studies during the pandemic.”
With patient and staff safety paramount, “the Urovant team engaged with the clinical study sites and development partners to add remote visits to the protocols and other measures to reduce the potential risk to patients and site staff.”
Additionally, Dr. Haag-Molkenteller credits current newer technologies with helping to support the ‘human element’ of teamwork, so that the team could collaborate virtually during the COVID-19 shutdown. “Because of the new virtual conferencing technologies, we were able to see each other, and this offered a huge advantage over what we could have done over the phone,” she expressed.
After working virtually for a few months and as the pandemic continued, the senior management team, led by CEO Jim Robinson, established the parameters for Urovant employees coming back into the offices in alignment with CDC and state guidelines.
Putting Patients First
When asked about how biotech companies can address the ever-changing landscape of patient needs, Dr. Haag-Molkenteller sees tenacity as key. “Focus on innovation and innovative products and technologies to serve patient needs. Really think about what can be done, then keep on pushing forward on how to best achieve it,” she advised.
“The mRNA vaccines are an excellent example. At Urovant, we are focused on new and differentiated medicines for patients, their families and healthcare providers. We are always looking for new solutions and new compounds. We are looking for truly innovative new compounds to address unmet patient needs.”
Dr. Haag-Molkenteller also appreciates that even the most innovative medicines cannot benefit patients unless they have access to it. “We have a dedicated and very experienced market access team for the U.S. to enable insurance coverage of our medicines. That allows our R&D team the ability to focus on novel therapies and technologies,” she adds.
“We keep an open mind to opportunities that make sense for Urovant and the company’s capabilities and structure. It’s always foremost that any new product we pursue be right for the patients and healthcare providers we already serve.”
Encouragement for Aspiring Innovators
Dr. Haag-Molkenteller advises budding biotech entrepreneurs to, “Keep on moving with an eye toward the path forward and be prepared to adjust as needed. The path will not always be straight forward – you need to keep this in mind. It’s important for those of us in the medical development community to remember that the path is not straight most of the time.”
Her advice regarding the design of clinical development programs focuses on the importance of people. “Work collaboratively with the clinicians, always remembering to consider the desired outcome in a clinical trial program from the patient and healthcare providers’ perspective. A ‘cool new thing’ has no relevance if it doesn’t meet patient needs,” she stressed.
“Think ‘outside of the box’ when partnering with regulatory authorities, keeping in mind they are also interested in bringing efficacious and safe new medicines to patients.”
She also charges the industry to “find better ways to manufacture drugs cost effectively while making the best quality medicines for all.”
Some final guidance for women aspiring for positions of leadership in the biotech world: “Lead by example,” Dr. Haag-Molkenteller advised. “Learn from your role models, both men and women. Keep an open mind and don’t be limited to only one role model. Follow all those you admire.”
A Vision for the Future and Future Generations
When asked about her blueprint for scaling Urovant’s operations and offerings, Dr. Haag-Molkenteller says, “Over the next five years, I see Urovant expanding its footprint in urology and possibly other specialties with new, novel products coming into our pipeline.”
“We are indeed fortunate to have a medical professional of Cornelia’s caliber on our leadership team at Urovant,” said Urovant President and CEO, Jim Robinson. “She is an immensely capable leader and has assembled a world-class team of research and development experts at Urovant. Her experience in developing new drugs and concern for people dealing with urologic challenges has been a critical factor in bringing GEMTESA to healthcare providers and their patients, and I am grateful for her many contributions to help drive the success of our company into the future.”
Up next for Urovant and Dr. Haag-Molkenteller are advancing the Urovant clinical pipeline, including the investigation of vibegron in OAB in men with benign prostatic hyperplasia, as well as URO-902, which is currently in early clinical development and has the potential to be the first gene therapy for OAB.