5 Questions for Vimala Raghavendran, Senior Director and Head of USP’s Pharmaceutical Supply Chain Center BioBuzz

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“5 Questions With…” is a weekly series from BioBuzz where we reach out to interesting people to share a bit about themselves, their work, and maybe something completely independent. This week we welcome Vimala Raghavendran, Senior Director and Head of USP’s Pharmaceutical Supply Chain Center.

Vimala Raghavendran directs the United States Pharmacopeia’s (USP) Center for the Pharmaceutical Supply Chain, which houses the USP Medicine Supply Map, an information system that identifies, characterizes, and quantifies risks in the pharmaceutical supply chain by upstream so that stakeholders can prioritize supply chain investments and prevent medicines. shortages.

Vimala has been with USP for over six years, where prior to her current role, she led a multinational strategy and business analysis team. Prior to USP, Vimala led strategy consulting teams at McKinsey that solved strategic issues for payers, providers, PBMs and pharmaceutical companies within the public and private sector. She has also worked in market research and business development at the non-profit drug development company, the International Partnership for Microbicides.

She holds an MBA from the Wharton School at the University of Pennsylvania and a BA in Economics from Knox College.

1) Please introduce yourself to our audience by discussing your education, training and career.

When I was 19, I moved from Mumbai to attend Knox College in Galesburg, Illinois. I must have always been interested in analysis and storytelling because I majored in economics (with lots of math classes) and edited the student newspaper.

After school, I joined the non-profit drug development company, the International Partnership for Microbicides. The organization used public funds to develop a new HIV prevention device for women. Recognizing that I needed to supplement my skills, I earned an MBA from the Wharton School. I then joined McKinsey as a consultant, where I led teams working on strategic issues in healthcare. Consulting was where I really honed my analytical storytelling skills.

After McKinsey, I was eager to see if I could return to a career in the global nonprofit sector and found USP, which was the perfect fit for me! When our leadership asked me to join the new Digital and Innovation group and build a team focused on solving a big problem – the lack of transparency in the drug supply chain, I jumped on the opportunity.

2) Tell us about your daily life in your current role at USP. What excites you most about the work you do?

Working with my colleagues on the USP Drug Supply Card is great fun. I spend a lot of my time with a team of highly creative data scientists and engineers who have a deep understanding of pharmaceutical data. Often, we bring in colleagues from across the USP with expertise in drug nomenclature, pharmacy, analytical chemistry, and product management to solve specific problems, for example, how to characterize the risk of discontinuation the supply of raw materials. For me, the most rewarding part is when I can combine analysis and storytelling to help demystify the risk factors for a specific drug’s supply chain.

I also frequently speak to external collaborators who help guide our understanding of the problem. USP has an extensive network, given its offices in India, China, Europe and the United States, and the more than 490 USP Convention organizations that span the drug supply chain.

Finally, I spend time with my colleagues in the Digital and Innovation division, who work on a range of exciting topics, including exploring emerging trends and technologies that may impact the industries in which USP works. , the search for how to create over 200 years of USP machine-readable content to reduce errors and improve drug quality, and develop new insights by structuring disparate and unstructured data.

3) Can you tell us more about the USP Drug Supply Card? How did it start, how was it developed, and how can people use it?

Over five years ago, we began building a data warehouse to connect internal USP data to external data sources to build a picture of the pharmaceutical supply chain. At the time, our goal was to better anticipate the needs of our stakeholders.

When COVID-19 was declared a pandemic in early 2020 and the lack of supply chain visibility made headlines, we realized we could help solve the problem using the data we had. already begun to enrich and preserve.

The result is the drug supply map, the first of its kind, which helps people identify, characterize and quantify risks in the upstream drug supply chain. We have over 40 datasets and 250 million data points with 92% coverage of generic prescription drugs.

The information in the USP Drug Supply Map can help governments prioritize investments in improving supply chain resilience for drugs, active ingredients, and raw materials. Manufacturers can use the USP Medicine Supply Map to identify market opportunities and assess ways to reduce risk in their raw material supply chains. Group purchasing organizations, wholesalers, and hospitals can use the drug supply map to anticipate drug shortages and prioritize actions to mitigate their impact.

Currently, USP data scientists are working directly with stakeholders to answer their questions. The best way to contact us is to email us at [email protected]

4) Can you tell us more about the other resources, ideas and products that USP offers to the medical research and healthcare communities?

For those unfamiliar with USP, we are an independent, scientific, not-for-profit organization that has been setting quality standards and building trust in medicines for more than 200 years. The USP has over 7,000 standards for pharmaceuticals, foods, and dietary supplements.

Although our standards are recognized as the official standard for drugs by the Food, Drug and Cosmetic Act (and by the laws of approximately 50 other countries), we are not part of the US government.

Our scientists work with experts from industry, government and academia who volunteer to help develop the quality standards – essentially tests and reference materials that help ensure that a medicinal ingredient or medicine is exactly what it’s supposed to be and doesn’t contain anything it shouldn’t like adulterants or impurities.

USP’s role as a convener provides us with unique insights into the global drug supply chain – the challenges and opportunities to strengthen it.

As drug manufacturing became more global, USP’s footprint became global. For example, USP’s USAID-funded PQM+ program helps manufacturers and regulators around the world improve the supply of quality medicines.

USP has been at the forefront of evolving drug manufacturing techniques, striving to develop best practices, training and standards, to advance continuous pharmaceutical manufacturing, as it is an important tool to enable increased diversification, and therefore resilience, of the drug supply chain.

In addition, our job is to help build public confidence in innovative products such as mRNA therapies. Since the successful application of mRNA technology is relatively new, a common approach to assess mRNA quality would support developers, manufacturers, regulators and national control laboratories worldwide , and would provide tools to help accelerate the development of safe and effective mRNA vaccines and therapies. To address this need, USP and a group of leading mRNA experts are seeking scientific input on the new draft guideline, Analytical Procedures for Quality mRNA Vaccines.

5) If you could dine with just one person, dead or alive, real or fictional, who would that person be and where would you dine?

Judge Thurgood Marshall at Indicates, my favorite Indian restaurant in Washington, DC. I admire his fearlessness and conviction in the context of the times in which he lived. And I suspect he would have liked Indian food!

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