What prompted Lundbeck to first invest in products targeting rare disease?
Lundbeck is solely focused on advancing innovative therapies for brain diseases and we have been involved in rare central nervous system-related diseases since we began operating in the U.S. more than a decade ago. Brain research is perhaps the most challenging space in drug development, and so we were not intimidated by the daunting challenge of rare and complex diseases.

We see ourselves as an instigator of progress because of our special expertise and a commitment in brain diseases. As a pioneer in rare diseases, we understand that our risk-taking commitment creates opportunity for other companies to enter. When we are successful, it encourages others to enter the space, and that advances research and treatment options for patients.

Lundbeck brought to market a therapy for a rare disorder that affects people with certain autonomic conditions such as Parkinson’s disease and multiple system atrophy. Can you share some background on the need for this treatment option?
Not only was there no available treatment for the disorder, but there was also little understanding of it within the prescriber community, and most healthcare professionals were not trained in how to identify it. We invested in patient and provider education. And now, as our product loses exclusivity, there is enough interest in this space and recognition of the need that there are a number of generics entering the market. 

Lundbeck has developed enduring relationships with rare-disease patient communities, and the company is known to maintain long-term commitments even after you are no longer actively marketing products. Can you give us an example of this ongoing commitment?
Recently, we completed the work needed to enable more patients to gain access to a medicine developed and brought to market by the company back in 2009. This was accomplished by pursuing a two-year effort to get FDA approval for a label expansion for the product, even though the medicine had already lost exclusivity, has generic competition and Lundbeck would reap little to no return from its investment in the label expansion.

The medication is used to treat a type of rare seizure disorder in children and was originally approved for infantile spasms in appropriate patients ages 1 month to 2 years, as well as refractory complex partial seizures in patients 10 years and older with inadequate response to alternative treatments. That meant the medication was not approved for use in children ages 3 to 9, and after the medicine lost exclusivity two years ago, allowing for generic competition, children in this age group were often denied insurance coverage, even if they had used it successfully prior to age 3.

After being informed of the denials by the TS Alliance, a patient group with which we have a long-standing relationship, we committed to expanding the label. Upon evaluating our data, the FDA approved a label that broadened the indication for refractory complex partial seizures in patients down to 2 years of age or older. This label expansion now means there will be no age gap for appropriate patients needing critical access to this medication.

That story is intriguing on several levels, including the fact that the company chose to invest in a product where there may be little, if any, benefit to its business. Why did Lundbeck take this path?
For us, it’s not enough to say we put patients at the center. It’s our actions that matter. And in this case, we enthusiastically took on the expense and effort of the label expansion because it was the right thing to do. It was important to the patient community and would allow more children to be treated, whether or not they were on our therapy or a generic alternative. 

In celebration of Rare Disease Day, what message does Lundbeck have for patients, caregivers and HCPs within the rare disease community?
When you are affected by a rare disease, you can feel stranded and unseen. But with 25 million to 30 million Americans impacted by rare diseases, you are far from alone, and you deserve to be seen. This Day recognizes and celebrates all those in the rare disease community, and we rally around you.

By Jed Weiner
iBIO News Contributor
White Oak Communications

Twenty-first century leaders recognize that diversity of thought results in better business outcomes. In a perfect world, that fact would lead to more diversity in c-suites and board rooms. Unfortunately, unconscious and conscious biases are deeply engrained. The Women in BIO – Chicago 3.8 Initiative (named after International Women’s Day, March 8) is designed to contribute to greater equity and better business outcomes by diversifying startup board rooms.

The 3.8 Initiative enables mid-career women to access the opportunities and benefits that startup board service can lend, while also combatting the perception that qualified women do not exist for those roles. According to Maryam Saleh, 3.8 Initiative co-founder and executive director of the Ed Kaplan Family Institute for Innovation and Tech Entrepreneurship, “This program was built to improve gender diversity at the leadership level for all companies, but more intentionally to connect and bring more women’s perspectives to the startup community. We launched in Chicago where few women currently occupy seats on local healthcare startup boards – our goal is to build a hands-on approach to diversifying the startup board composition.”

During last year’s inaugural, 10-month program, the 3.8 Initiative prepared 10 women for startup board service, built bridges between the talented mid-career women and startups looking for advisors or independent board members, and created a safe space for the first cohort to connect and build their networks. “We are providing one-on-one mentorship, executive coaching, startup board resume consultations and exposure to our strong network of innovation executives, supporters, startups, accelerators, incubators and industry leaders,” said 3.8 Initiative Co-founder Dimitra Georganopoulou.

Personal Perspectives from the Cohort 

Earlier this month, iBIO interviewed three members of the 2020 cohort to obtain participants’ views of the 3.8 Initiative. Below are some of their observations, edited for space considerations.

What motivated you to join the first 3.8 Initiative cohort?

Tina Esposito, Chief Health Information Officer, Advocate Aurora Health:The ability to talk with and learn from true subject matter experts was an incredible opportunity. I recognized and appreciated that the program was designed to do something meaningful around gender gaps and other diversity issues. I couldn’t walk away from that.

Beata Dowling, VP Financial Planning and Analysis, Horizon Therapeutics: As a business leader, you’ll never know everything. I’ve always been a proponent of my own development, always curious to learn and grow. I have encouraged my teams to include learning and development to further their knowledge and experience.  For me, this has allowed me to take on new roles and expand into new areas.

Lilli Zakarija, President & CEO, EdgeOne Medical: I had already spent a lot of time mentoring startups on strategy and product development, so learning how to prepare to be on a board would enable me to contribute to a startup in a more meaningful and sustained way.

What aspects of the 3.8 Initiative did you find to be the most gratifying or enlightening? 

Ms. Zakarija: The program highlighted the importance of finding a personal passion and connecting an opportunity to serve on a board with that passion. Passion is critical to a successful tenure on a board. Getting to know a group of very accomplished businesswomen in the Chicago area was also quite gratifying.

Ms. Dowling: We had the opportunity to hear directly from functional experts, such as attorneys, scientists and CEOs. They all gave honest and transparent guidance, as well as sharing their career progression and experiences as a board member. In addition, this has been a great experience to meet fantastic female leaders who are pursuing this new opportunity.

Ms. Esposito: I learned about areas that I didn’t have experience with, so to get time with experts in these topics was wonderful, as was the ability to talk through the lessons with my cohort peers and to learn from each other.

What would you say to someone who is considering apply for the 2021 cohort?

Ms. Dowling: It’s a great program. You need to want to do it, make time for it  and be committed to it. If being on a startup board is important to you, this is a way to explore it in a very professional matter. 

Ms. Zakarija: If you feel you’ve come to a point in your career where you’ve mastered functional areas and you want to share your expertise for a higher purpose, this program is for you. If you want another opportunity to challenge yourself, to expand network, and to contribute by sitting on a startup board, submit your application.

Ms. Esposito: You’d want to be at point in your career to appreciate where board members can be effective by providing strategic counsel and oversight, rather than tactical recommendations. Make sure you have the time to invest so you can learn. If you’re ready, do it, don’t wait!

At the conclusion of her interview, Tina expressed deep appreciation for the 3.8 Initiative co-founders addressing the diversity gap on startup boards. She felt humbled by their investing their personal time to create a program for the betterment of others.

iBIO shares Tina’s gratitude and embraces the vision articulated by 3.8 Co-founder Holly Copeland, Horizon’s senior director of Corporate Social Responsibility, Sustainability & Impact: “Our hope is that in five or 10 years, we can all look back at this time with a lot of pride, knowing that programs like 3.8 helped to drive systemic change; that the presence of more women in board rooms has led to better business decisions, more economic empowerment, and a shifting perception across communities of how and where women can show up and express agency.”

For more information about the program and to apply for the 2021 cohort before the January 25th deadline, visit https://www.womeninbio.org/page/chicago38.