With a BS in Biochemistry, and an MBA, Karen Wurster has spent her career dedicated to developing, launching, and commercializing products to treat diabetes. The core of Karen’s career was spent at Eli Lilly where she contributed to launching multiple blockbuster drugs. After leaving big pharma, Karen consulted on product launches at multiple pharmaceutical companies. In 2020, Karen decided to jump into the world of entrepreneurship and start up in biotech by leading Adipo Therapeutics!
Tell us about Adipo Therapeutics.
Adipo Therapeutics was started at Purdue University by Meng Deng, PhD, to develop a new breakthrough approach to treating type 2 diabetes and other obesity-related diseases. This new treatment works by converting energy storing white fat into energy burning brown fat, leading to weight loss and improved blood glucose with no change in calorie intake. This means a person may be able to lose weight and control their diabetes without changing their diet and exercise.
At the beginning of 2020, when Dr. Deng decided he was ready to start moving his technology from the bench to the market, the Purdue Foundry connected us. Meng and I agreed that I would bring my leadership, product development, and launch experience to lead the company as CEO. Since that time, Meng and I have worked together to raise seed funding, recruit a team, and open our own lab space at IBRI 16 Tech.
How will this product change the lives of those affected by Diabetes?
The promise of the Adipo treatment is to help patients more successfully manage their weight and blood glucose on their own terms. When people are diagnosed with type 2 diabetes, they are told by their healthcare team that they need to lose weight, eat less, and exercise more. They often feel the disease is their fault, because they struggle to lose enough weight on their own to impact their diabetes.
While products are on the market that can reduce a patient’s hunger level and the amount of food they eat, there is nothing on the market that helps them burn more calories, addressing their core body composition and metabolism. Adipo’s treatment would be the first to recognize and treat the core issue of having too much white fat, and not enough brown fat, and the metabolic impact of that imbalance.
You had a lot of choices. What drew you to leading this company?
There are three things that drew me to leading Adipo Therapeutics: high respect for the founder; belief in this new technology that can transform diabetes treatment; and a good fit with my own experiences. In a startup company, the working relationship of the leaders in the small environment is absolutely critical to the success of the business. Beyond his scientific expertise, Adipo’s founder, Meng Deng, brings an understanding of the startup world through his involvement with the Purdue Foundry. Even more importantly, he brings a respectful, collaborative approach to everyone he works with, which gave me the confidence that we could work together to build a team and build a company.
The technology being developed is a treatment that I’m excited about and believe can truly make a difference in the lives of people with obesity related diseases like diabetes. I felt like my experience in building cross functional teams, developing new pharmaceuticals, and knowledge of the diabetes market were the skills needed at this point in the company development.
You rose up within the ranks of a major pharmaceutical company. How did that prepare you for the role of CEO?
My experience at Eli Lilly and partnerships with Amylin and Boehringer Mannheim, gave me the opportunity to learn the critical skills needed to bring a new product from bench to market. I was able to develop and demonstrate both the hard skills and soft skills needed to lead a diverse, cross-functional team of technical experts.
The hard skills included: an understanding of the product development, regulatory, and launch pathway for a new product including budget management, project planning, and the pharmaceutical business model. The soft skills included: identifying, recruiting, and respecting the vast diversity in skills, expertise and perspective needed to optimize your product and company. Finally, working in big pharma has given me a good understanding of what they look for when in-licensing a new treatment, allowing our company to “start with the end in mind”.
As CEO, what do you spend most of your time doing?
Being the CEO at a startup company is great if you love having variety in your week! In leading a small company, you are accountable for everything from accounting, to IT, to patent filings, to HR contracts, to building a website. The key becomes knowing where to focus your time and where and when you can lean on other experts.
My focus has evolved as Adipo has grown from a founder with a proven concept in the beginning of 2020, to a functioning company with lab and office space, a highly functioning team and a detailed project plan for the preclinical development in 2021. My time in 2020 was focused on fundraising, recruiting a team, and developing the preclinical plan, while ensuring all the wheels were turning for key functional areas. By bringing together the right team of experts, in 2121 I’ve been able to shift to spending more time fundraising (never ends!), executing the plan, and developing the long-term strategy. One thing that has not changed is the important time spent on building a support network of other entrepreneurs and investors.
What’s the path to getting FDA approval?
The path to approval includes 3 key steps.
1 - The first step is proof of efficacy and safety in appropriate preclinical animal models to
support approval of an Investigational New Drug (IND) application. An IND gives a company
approval to study their product in people.
2 - The second key phase is proof of safety and dose determination in people (Clinical Trial
Phase 1/2). Phase 1/2 clinical trials usually include treating several hundred people.
3 - The final stage is the proof of efficacy and safety in people (Clinical Trial Phase 3). Phase 3
trials include several thousand people over a longer period of time. It is the data from these
Phase 3 trials that the FDA reviews to determine if the product should be approved. The typical
time from the start of preclinical animal models to product launch is 5-7 years.
What obstacles have you faced because you’re a woman that you wish would change?
The most difficult part of being a woman CEO in life science is that there are few women who have tread this path before you and few VC investors with significant female leadership. This can lead to an unconscious bias towards investments in male led companies. We hear repeatedly that the investors are investing in the team and the leadership.
Questions they ask themselves about the team include “can I see this CEO leading the company to a successful exit?” If their only experience has been with investing in male led companies, unconsciously it may be difficult for them to “see” a woman in that role because they haven’t had that experience.
I would like to see more VCs set specific goals for a percentage of their investments to go to companies led by underrepresented groups. With just 2.3% of VC investment in 2020 going to female led companies, increasing the number would not be hard and they will not be disappointed in the results.
When women-led startups do get funded, they’re more likely to be successful. They “ultimately deliver higher revenue — more than twice as much per dollar invested,” according to a Boston Consulting Group analysis.
What are your fundraising challenges?
The biggest fund-raising challenge I’ve experienced is identifying and cultivating investors with the right fit. The path to exit in the pharmaceutical space is high reward, high risk, and a long path. In addition, many VCs limit their investments to some specific disease areas. It is critical to find investors who value the promise of a new diabetes treatment approach and understand the path to get there.
How have The Startup Ladies helped you grow?
Startup Ladies have been invaluable in providing the practical and emotional support needed to help stay confident and excited about my role. This has been a year of ups and downs, with a steep learning curve, remote work environment, changes in family demands, and delays due to COVID. The Startup Ladies have been there every step of the way, with valuable opportunities to learn new skills, connections with investors, and a supportive environment of strong, smart, ambitious women.
What’s next for you?
2021 is an important year for Adipo Therapeutics. By the end of this year, Adipo plans to have demonstrated preclinical efficacy, had their first discussion with the FDA, and secured funding to support the completion of required preclinical studies. Personally, I’m looking forward to another year full of learning and growth, and being able to offer guidance and support to other women who are entering the entrepreneurial world!
Outside of work, where do you spend your time?
As an “empty nester”, I’ve been able to spend more free time supporting community nonprofits. I’m passionate about serving people who are experiencing homelessness and those who were previously incarcerated. I’m proud to serve on the boards of Public Advocates in Community Re-entry (PACE) and Constructing Our Future (COF), and volunteer locally and globally with Habitat for Humanity.