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.
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Guest Profile – Sarah Norring, PhD, Co-founder and CEO, Plenitude Pharma
Sarah A. Norring, Ph.D. is co‑founder and CEO of Plenitude Pharma Inc., bringing more than 25 years of cross‑sector experience spanning government, academia, and the pharmaceutical, biotechnology, and medical device industries. She has led scientific design, clinical trials, regulatory strategy, product launches, and U.S. operations, with expertise that includes IND & A/NDA submissions, FDA communications, and global medical device registrations.
A trained medicinal chemist and cardiovascular researcher, Dr. Norring has published peer‑reviewed work across cardiology, neurology, and oncology and has been recognized with honors such as the NIH NINDS Merit Award for Innovation and an American Heart Association fellowship.
She has directed clinical, scientific, and operational teams; collaborated with KOLs and healthcare professionals; and contributed to major product launches and strategic initiatives. Her background spans analytical method development, GMP manufacturing support, regulatory directives, program management for multimillion‑dollar NIH portfolios, and academic appointments at multiple universities.
Dr. Norring is known for her strong communication skills, broad therapeutic knowledge, and ability to bridge science, strategy, and execution to advance innovative healthcare solutions.
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 they are a managed services 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.
We are usually asked about
What are the main causes of drug shortages in the U.S.?
Drug shortages are often caused by manufacturing disruptions, limited numbers of suppliers for older generic drugs, quality issues, and economic disincentives to produce low‑margin medicines. These challenges disproportionately affect injectable, off‑patent, and essential hospital drugs.
How are specialty pharma companies helping solve drug shortages?
Specialty pharmaceutical companies address shortages by reintroducing discontinued or off‑patent medicines and focusing on smaller, high‑need patient populations. By leveraging targeted regulatory strategies and modern manufacturing partners, these firms can restore access to essential therapies.
What role does the FDA play in addressing drug shortages?
The FDA supports drug shortage mitigation through expedited review pathways, guidance for manufacturers, and maintaining a public drug shortage list. These programs are designed to speed approval for critical medicines while maintaining safety and quality standards.
Why are off patent drugs especially vulnerable to shortages?
Off‑patent drugs often face low profitability, leading many manufacturers to exit the market. When only one or two suppliers remain, any disruption can quickly result in nationwide shortages.
Who should listen to the Solving Drug Shortages One Medicine at a Time podcast episode?
This episode is valuable for pharma and biotech executives, clinical operations leaders, investors, and healthcare decision‑makers interested in drug development, regulatory strategy, and supply chain resilience. It provides real‑world insight into how industry leaders are tackling drug shortages through innovation and focused execution.