Solving Drug Shortages One Medicine at a Time

In this episode of the Driving the Business of Science podcast, host Keith Parent, CEO of Court Square Group, discusses the challenges of drug development and shortages with Sarah Norring, Ph.D., Co‑founder and CEO of Plenitude Pharma Inc. Sarah highlights the critical need to address drug shortages and discontinuations, emphasizing the importance of having multiple manufacturers for essential medicines. She shares her background in medical science and her company's focus on bringing back critical drugs, particularly in women's health and oncology. Sarah mentions the FDA's expedited review process for off-patent drugs on the FDA’s drug shortage list, and her aims to bring one to two products to market within the first three years. The conversation also touches on the challenges of fundraising in this niche pharma sector.

Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.

Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.

In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.

Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

Transcript

Introduction and Purpose of the Podcast

• Keith Parent introduces himself as the CEO of Court Square Group and explains the purpose of the podcast, which is to highlight the stories of people involved in drug development.
• Keith mentions the importance of understanding the economics and logistics behind drug development.
• Keith introduces Sarah Norring, Co-founder and CEO of Plenitude Pharma Inc, and explains the focus of the podcast on drug shortages.
• Keith provides an overview of Court Square Group, mentioning their managed service firm for IT infrastructure and their clinical repository, RegDocs365™.

Sarah Norring's Background and Plenitude Pharma's Mission

• Sarah Norring expresses her excitement about being on the podcast and shares her background, including her PhD in medical science and experience in cardiovascular work and chemistry.
• Sarah explains the gap in healthcare that Plenitude Pharma aims to address: drug shortages and discontinuations.
• Sarah highlights the critical need for essential medicines and the challenges of supply issues and companies discontinuing products.
• Keith asks Sarah about her motivation for focusing on drug shortages, and Sarah explains her extensive experience in healthcare and the need for smaller companies to address these issues.

Reasons for Drug Discontinuation

• Sarah discusses various reasons for drug discontinuation, including economic factors, mergers, supply chain issues, and changes in testing standards.
• Sarah emphasizes the complexity of drug manufacturing and the impact of these factors on the availability of essential medicines.
• Keith inquires about the duration of Plenitude Pharma's operations, and Sarah mentions they are almost at two years and are in the early stages of development.
• Sarah shares her focus on specific therapeutic areas, such as women's health products and oncology, and mentions the current number of drugs on the FDA drug shortage list.

Challenges in Funding and Market Positioning

• Sarah talks about the difficulty of finding investors for niche pharma companies and the challenges of working with generics, which have smaller profit margins.
• Keith shares a personal story about a client who was a foreign-owned company and the challenges they faced during bankruptcy.
• Sarah explains the concept of off-patent, off-exclusivity (OPOE) drugs and the pathway for bringing these drugs to the US market.
• Sarah discusses the importance of having multiple manufacturers for essential medicines to ensure a resilient drug supply chain.

Strategies for Drug Development and Market Entry

• Sarah outlines her strategy for drug development, focusing on women's health and oncology products, and mentions specific drugs like BCG for bladder cancer.
• Sarah highlights the challenges of having only one manufacturer for essential medicines and the need for more competition in the generics market.
• Keith asks about Sarah's fundraising strategies, and Sarah mentions attending various shows and networking to find the right investors.
• Sarah emphasizes the importance of finding investors who understand the mission of Plenitude Pharma and the critical need for addressing drug shortages.

Future Plans and Final Thoughts

• Sarah shares her goal of solving the drug shortage crisis one medicine at a time and her plan to bring one to two products to market in the first three years.
• Keith inquires about any special support from the FDA, and Sarah explains the expedited pathway for drugs on the shortage list.
• Sarah discusses the process of prioritizing drugs on the shortage list based on clinical demand, feasibility, and market impact.
• Keith encourages listeners to invest in companies like Plenitude Pharma and wishes Sarah the best in finding investors and bringing products to market.