The Elixir Factor

When the COVID-19 pandemic hit, it changed the way we operate across countless areas of our lives. Now, many people are assessing what changes should remain moving forward. At Lilly, where we’re focused on developing medicines that will make life better for people around the world, we’re harnessing what we’ve learned to advance our work and asking ourselves: What lessons from the pandemic can we apply to improve clinical trials? The answer: Quite a few.

On this episode of The Elixir Factor, guest host Phyllis Ferrell, global head of Alzheimer’s disease external engagement at Lilly, explores how the disruptions caused by the COVID-19 pandemic are providing new ways for us to think about clinical trials and our work to discover breakthrough medicines. Janelle Sabo, PharmD, vice president of Clinical Research Capabilities at Lilly, shares her perspective on how Lilly’s approach to clinical trials started shifting pre-pandemic and how COVID-19 impacted that work. Jessica Langbaum, PhD, director of Alzheimer’s Prevention Initiative led by Banner Alzheimer’s Institute and Jared Brosch, MD, Indiana University School of Medicine, also join the conversation to talk about how a decentralized approach to clinical trials can advance the science and increase patient access, specifically to cutting-edge Alzheimer’s disease clinical trials.

The group explores how key learnings from the last two years, coupled with recent clinical trial innovations, give us a new path forward to make trials more accessible and expansive, so more people have access to innovative, life-changing new medicines.

Medical innovation happens through clinical trials—but many minority or marginalized communities are not as likely to participate, for a number of reasons. Low participation contributes to this health inequality as clinical trials can help give patients the opportunity to participate in and benefit from new medicine development. This week, guest host Brandy Matthews, associate vice president of global and U.S. medical affairs at Lilly, talks with Ralph and Mollie Richards, and Natalie Cheung Rotelli, senior director of diversity in clinical trials at Lilly. Ralph and Mollie are members of the Alzheimer's Association Greater Indiana Chapter Board of Directors and Indiana Alzheimer’s Disease Research Center Community Advisory Board and work with Black American communities in the Indianapolis metro area and other parts of the country. The group discusses the importance of diversity in clinical trials, the systemic barriers, how sponsors can engage, and Lilly’s role in this work.

Imagine one day if there was a way to treat or even cure a genetic disease with a single injection? Genome-editing technologies provide the possibility to correct genetic problems at their source by precisely editing the DNA of a living organism. These methods have the potential to transform how a variety of diseases are treated, including a group of genetic disorders characterized by muscle weakness also called muscular dystrophies. Duchenne is the most common and severe form, caused by loss of dystrophin, beneath the sarcolemma. The molecular mechanisms of the disease have been extensively investigated since the discovery of the gene in 1986. Joe talks with Hawken Miller and Debra Miller about their own experience with DMD, the factors that inspired Debra to start CureDuchenne, and their goal to remove any barriers to finding a cure. Joe also talks with Lilly scientists, Ruth Gimeno and Tom Hopkins, and the Chief Scientific Officer of Precision BioSciences Derek Jantz, about the promise of gene editing, how it works, and the collaborative research being done to find a cure for one of the most devastating diseases.

Lilly has brought its scientific and medical expertise front and center to attack the coronavirus pandemic around the world. External collaboration, speed, and expertise are key to driving solutions that help our scientists and researchers uncover new way to measure, understand, and treat diseases, especially COVID-19. The experience gained fighting a pandemic will change the way we work forever. Joe talks with Dan Skovronsky, chief scientific officer and President of Lilly Research Laboratories, about monoclonal antibodies and their role as a potential treatment for Covid. Joe also talks to Dr. Mike Cohen, co-principal investigator and director of the Institute for Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill, and Dr. Alexander Stemer, infectious disease expert and co-chair of Symphony Care Network's COVID-19 task force, about the FACTORS that inspired Lilly to “bring the study to the patients” and develop the Blaze-2 COVID-19 trial which enrolled a unique patient population that is rarely targeted for clinical research.

Kids have a ton of insight and the healthcare industry has a lot to learn from them. For starters, their situations are so unique, ranging from specialized peer dynamics to school activities to autonomy differences, etc. Pediatric research takes collaboration from many stakeholders including regulators, clinicians, industry experts, payers. Let’s not forget parents, caregivers and the patients for it to be successful. iCAN, International Children’s Advisory Network, is empowering pediatric patients worldwide by creating a better understanding about the importance of the pediatric patient and caregiver voice in healthcare, clinical trials, and research. Joe talks with Olivia Ohmer and Kyan Sherman Cervati, two amazing kids with type one diabetes, about the factors that inspired them to become advocates for pediatric research. Joe also talks to Amy Ohmer, executive director of iCAN and Courtney Tait, principal research scientist in pediatric capabilities at Lilly about why raising awareness for this research is critical to improve pediatric healthcare, medicine, and innovation around the world.

There were more than 2 million cases of breast cancer diagnosed in 2018 worldwide. While there are more than 3.8 million survivors in the U.S., which is more than any other group of cancer survivors, breast cancer is actually a very complex disease with many different subsets. Often times, it is informed decisions that allow patients to feel more confident about their treatment. Awareness is crucial to better outcomes, but the messaging should be broad and informative as a breast cancer diagnosis can be different for each patient. Joe talks with Michelle Bazer, oncology nurse, mother, and now breast cancer survivor, and Dr. Maura Dicker, VP of Late Phase Oncology Development at Lilly, about the factors that influence treatment decisions, the approaches our scientists are considering to “outsmart” breast cancer, and the significance of friendships during challenging times.

Good science drives innovation. One of the most critical ingredients for an innovation-friendly environment is a strong intellectual property (IP) framework. It allows for collaboration, partnership and larger investments that provide an opportunity to scale research, which in turn can provide a great opportunity for success, and hopefully advance the development of medicines for patients. The U.S. is the global leader of biopharmaceutical innovation because its IP system promotes competition, ensuring each player excels at their role and is incentivized to take risks and share information throughout the process. Joe talks to Dr. John Stewart IV, professor of surgery and physician executive for oncology sciences at University of Illinois College of Medicine at Chicago, about the factors that have influenced his oncology research and how he has been able to continue this research through partnerships and policies that support IP. Joe also talks to Tonya Combs, vice president and deputy general patent counsel of IP procurement at Lilly, about the drug discovery process, the Bayh-Dole Act and the biopharmaceutical research ecosystem during the COVID-19 pandemic.

Dominantly Inherited Alzheimer’s Disease (DIAD) is a rare form of Alzheimer’s disease that causes memory loss and dementia in people typically in their 30s to 50s. The disease affects less than 1 percent of the total population and is devastating to those who are impacted by it, including their families. Joe talks to Dr. Randy Bateman, the Charles F. and Joanne Knight Distinguished Professor of Neurology, director and principal investigator of DIAN-TU and Dr. Roy Yaari, senior medical advisor of neurodegeneration at Lilly, about DIAD, the factors that were considered in the design of the DIAN-TU Study, and AD research in clinical trials. Joe also talks to patient advocate Daisy Duarte about her family experience with DIAD and why she advocates for LatinosAgainst Alzheimer’s.

Health literacy is about a person’s ability to not just read, but to understand and act on health information to help optimize health outcomes. Patients are more responsible for their own health education than ever before. Clear health communication is one of the easiest ways to help those with limited health literacy. During this global COVID-19 pandemic, there has been an overflow of conflicting health information. Joe talks to Dr. Linda Neuhauser, Clinical Professor of Community Health and Human Development at UC Berkeley, School of Public Health, and Co-Principal Investigator of Health Research for Action, and Lori Hall, Advisor of Global Health Literacy at Lilly, about the factors that contribute to the complexity of health information, health care, concepts that have been used by scientists and the media in describing our understanding of the pandemic, and their hope in science to lead us to answers.

The promise of science to change people’s lives has never been greater. Recent progress in understanding biology, including the sequencing of the human genome, has led to new insights — allowing scientists more power and precision to treat disease, including cancer. As the understanding of cancer grows, scientists have found that it’s actually not a single disease but a collection of diseases that are driven by various causes or genetic breakdowns. Joe talks to Pete Nicholas, co-founder of Boston Scientific about his diagnosis of a very aggressive form of non-small cell lung cancer. Joe also talks to Anne White, President of Lilly Oncology, about the factors that came into play to redesign a traditional oncology research and development organization into a biotech and how this new mindset has the potential to develop more medicines for people living with cancer.