Guadalupe Hayes-Mota was just 12 years old when he almost died. And although that’s a young age to decide what you want to do for the rest of your life, that experience set the course for Hayes-Mota’s career mission.
Born with a rare form of hemophilia in a small town in Mexico, where the availability of medications was a constant challenge, Hayes-Mota knows personally how supply chain issues can impact a patient’s life. As a child, he and his family would take an eight-hour bus ride to his hematologist, and often the medication he needed would not be available once he got there.
His near-death incident was caused by appendicitis with extreme bleeding from his hemophilia that couldn’t be stopped. Doctors told his parents he might not survive the night.
But he did, and shortly after, his family moved to California in search of better healthcare for their son. Transitioning from Mexico to English-speaking California was a difficult time for Hayes-Mota and his family — but today, people all over the world have benefited from that move.
In his professional career, Hayes-Mota has become a driving force for improving the supply chain system, not just in the U.S., but globally, with the ultimate aim of boosting health outcomes for patients. The goal, he says, is to “build a world where no one is without the medical treatment they need to survive and thrive.”
He got his start in public health by running the most extensive free healthcare system in the U.S. at UCLA Health, which provided over 30,000 underserved patients with care every year. He also worked with the U.S. government in developing and implementing the Affordable Care Act while working at the RAND Corporation.
Next, he entered biotech, where for several years, he led global supply chain departments at Ultragenyx, Biogen, Amgen and GlaxoSmithKline, overseeing the effective distribution of medication to at least 98 countries.
Last year, smack in the middle of COVID, he took another step toward reaching his goal and launched Healr Solutions, a technology and consulting firm aimed at leveraging leading-edge solutions to connect biopharma and healthcare supply chains. As CEO of the new company, Hayes-Mota has discovered a new “recipe” for success in addressing pharma’s ongoing supply chain challenges.
The impact of COVID on supply chains
“When Covid came around, there was a huge disruption within all supply chains,” Hayes-Mota says. Citing a report by Accenture, he adds, “Ninety-four percent of Fortune 1000 companies are seeing supply chain disruptions from COVID-19. Seventy-five percent of companies have had negative or strongly negative impacts on their businesses.”
The pandemic highlighted problems in the supply chain that already existed. For example, in 2021, 88% of the manufacturing facilities that provide active pharmaceutical ingredients (APIs) to the U.S. were overseas, creating long and complex pharmaceutical supply chains, according to the FDA.
The situation created an opportune time to strike a match on an idea Hayes-Mota had for some time.
“I've been thinking about this idea for a while, even before COVID,” he says. “Once I started managing my team and my department during COVID, I saw just how big of a problem this really is. Everyone is facing it and it just keeps multiplying. It is the right time to focus on that problem and create a solution that will alleviate this.”
Hayes-Mota now aims to help solve supply chains issues through Healr Solutions. In his current role, Hayes-Mota says he can provide solutions to a wider, more global field of players, creating a larger impact on patient access to medication than working for just one manufacturer.
Hayes-Mota will focus first on two problems: ensuring supply chains are robust enough in biopharma to make sure patients get their medicines and setting standards of connectivity within the supply chain network. His strategy is to use technology that will help build better-connected supply chains. To that end, Healr has developed a proprietary network that allows interactions between multiple nodes.
“We're unifying the connectivity by using blockchain to connect the specific components together, and we're utilizing machine learning to understand the demand side,” Hayes-Mota says. “These two technologies are much more effective and make it much easier to react to the demand and to communicate with those nodes. That’s our recipe.”
Supply chain challenges in rare disease
The biggest challenge within the supply chain in the U.S. is in securing enough API to meet the nation’s medication needs, as highlighted in a June 2021 White House report, Supply Chain Resiliency, which examines national drug shortages before and after COVID.
The report states that more than 80% of APIs for essential medicines across key therapeutic areas have no U.S. manufacturing source and less than 5% of large-scale API sites, globally, are located in the U.S. Most sites are in India and China. The reason for this weakness in the U.S. system is it’s cheaper to manufacture APIs in other countries.
According to the report, national drug shortages peaked in 2011, and most of the 267 drugs listed in shortage were chemotherapy medicines. The FDA’s analysis of drug shortages, updated in 2020, highlights three main causes: low profitability, low value for quality, and complex, global supply chains.
This lays the foundation for the overall problem for drug manufacturing, and in rare disease the stakes become much higher. Rare disease products are made in smaller batches for a smaller patient target base, which can require more specialized touchpoints or more last-minute customizations than a drug for a larger patient group. In addition, rare disease products are often stored or transported at a specific temperature or in other very specific ways.
To be cost-effective, a rare disease manufacturer needs to forecast the right amount to produce — not too much, and not too little — making agility key to maintaining the supply chain. This is where machine learning can help.
“Rare diseases products tend to be more biologics, gene therapies, which tend to be much more difficult to manage in the supply chain,” Hayes-Mota says. “If you frame that forecast within the machine learning component and create connectivity to flow the goods faster, you're able to move the correct number of products faster to get the medicines to the patient.”
While the demand for rare disease treatment is lower in numbers, the need for speed to market is much higher. It is also vital for rare disease treatments to be manufactured in perfect alignment with demand, because overproducing can be costly in terms of unused inventory and underproducing leaves gaps in patient need.
“What a lot of rare diseases companies do, because they want to make sure they are producing enough product to help the patient, is over-produce it,” Hayes-Mota says. “And inventory is money that could have been invested into development or another component. The key is making sure production is calculated in the most optimized and effective way.”
Using the “recipe” of innovative proprietary technology and machine learning, Hayes-Mota hopes to create a way for rare disease manufacturers to move components and products faster through the pipeline so that treatments can get to patients in less time.
One year into his entrepreneur venture, Hayes-Mota is still active in advocating for others and pursuing his mission inside and outside his company’s walls. As a person living with a rare disease and a healthcare advocate, Hayes-Mota has been appointed by Governor Charlie Baker to the Massachusetts Rare Disease Advisory Council to provide direction for the governor, the legislature, and the department of Public Health on addressing rare disease policy and actions in Massachusetts.
He also serves on several boards, including Fenway Health, a leading health center for the LBGT+ community and HIV patients in New England; and nationally on Save One Life, which provides 30 developing countries with free medicine and financial support.
But for Hayes-Mota, it all comes back to the lessons he learned as a young patient and the motivation it gave him to drive meaningful changes in healthcare. Imagine how many people would not have been helped if that little boy in Mexico had not survived that night.