Drug Solutions Podcast: Novel Excipients in Drug Development

In this episode of the Drug Solutions podcast, Felicity Thomas, European/Senior Editor, talks to Ana Ladino, Ashland’s Global Director—Regulatory Affairs, about the role of novel excipients in drug development. Ana highlights the importance of novel excipients in the advancing drug development pipeline, gives an overview of CDER’s pilot review program, discusses potential changes to regulatory approaches in other regions, and provides an overview of best practices for companies to follow when dealing with novel excipients.

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About the speakers

Ana L. Ladino is Ashland’s Global Director-Regulatory Affairs.

As senior leader of the regulatory affairs function, she manages strategic direction and operational oversight for the regulatory activities for all Ashland’s Life Sciences products: excipients and other oral solid dosage ingredients and coatings, injectables, nutrition, nutraceuticals, agrochemicals, and medical devices. She oversees all FDA and other global regulatory authority interactions for Ashland’s products while ensuring a high level of integrity in regulatory and quality compliance. With 25 years of experience in the healthcare industry, she has extensive experience in drugs, combination products, medical devices, excipients, and API regulatory requirements. She has been involved in industry organizations such as RAPS, IPEC, AAM, ISO, NEMA, authored many global regulatory-related papers, and presents worldwide on various regulatory topics. She served on the Healthcare Businesswomen’s Association (HBA)—West Chester Board.

Ana holds a bachelor’s degree in electrical engineering and a master’s degree in biomedical engineering from Autonomous University of the West (UAO), in Cali, Colombia. In the past, she has worked for West Pharmaceuticals, Accellent, Siemens, GE Medical, and as a university professor.

About the Drug Solutions Podcast

Pharmaceutical Technology presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

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