Are We Prepared for the Regulations on Patient-Focused/Patient-Centric Drug Development?
17:00 - 17:45
With the recent first FDA draft Guideline on Patient-Focused Drug Development (PFDD) and three additional guidelines to follow as well as the finalization of the EMA Reflection on pharmaceutical development of medicines for use in the older population”, patient centric drug product development is becoming mandatory for the pharmaceutical industry
What does it mean to the pharmaceutical industry, how do we build a framework of patient centric/focused drug product development
Take an opportunistic view how this can help to create a competitive advantage by adding real value to patients and payers
Debate on how to best take advantage of the emerging regulation and influence its implement
Prof. Dr. Sven Stegemann is director, pharmaceutical business development at Capsugel, and professor of patient centric drug design and manufacturing at the Graz University of Technology, Austria. Over the course of his 21-year career at Capsugel, Dr. Stegemann has worked as an advisor to major pharmaceutical companies on ways to improve the design, development and manufacture of pharmaceutical products so they better address the individual needs of patients. In his academic role, Dr. Stegemann’s focuses his research on the rational development of patient centric drug products and their associated manufacturing technologies, as well as education and training of students and young scientists. Dr. Stegemann is the founder and chair of the AAPS Focus Group on Patient-Centric Drug Development, Product Design, and Manufacturing as well as the founder and President of the Geriatric Medicine Society e.V.. He recently started the industrial-academic collaboration partnership Patient Centric Medicine (PaCeMe) to suitable and meaningful guidance for patient centric drug product design. He is the editor of the book “Developing Drug Products in an Aging Society - From Concept to Prescribing”, a multidisciplinary approach towards patient centric drug development for the older and multimorbid patient populations.
F. Hoffmann-La Roche
Leonie Wagner (born Hattler) studied Pharmacy at Univeristy of Basel. After graduating as a pharmacist she started her PhD thesis in 2014 in Prof. Dr. Jörg Huwyler’s Group in the field of Pharmaceutical Technology. In 2017 she completed the thesis with the title “Oral formulation for children - The microstructure of functionalized calcium carbonate as key characteristic to develop age-appropriate and compliance enhanced formulations”. Since December 2017 she is working as a formulation scientist at F-Hoffmann-La Roche in R&D Oral dosage forms developing formulations for early clinical phases up to market formulation.
W. Moser et al., “Efficacy and safety of oxantel pamoate in school-aged children infected with Trichuris trichiura on Pemba Island, Tanzania: a parallel, randomised, controlled, dose-ranging study,” Lancet Infect. Dis., vol. 16, no. 1, pp. 53–60, Jan. 2016. (mentioned in acknowledgments for developing the tablets)
L. Wagner-Hattler, J. Schoelkopf, J. Huwyler, and M. Puchkov, “Characterization of new functionalized calcium carbonate-polycaprolactone composite material for application in geometry-constrained drug release formulation development,” Drug Dev. Ind. Pharm., vol. 43, no. 10, pp. 1669-1676, Oct. 2017.
L. Wagner-Hattler, K. Wyss, J. Schoelkopf, J. Huwyler, and M. Puchkov, “Mouthfeel Study of Functionalized Calcium Carbonate in Orally Disintegrating Tablets” Int. J. Pharm., vol. 534, no. 1, pp. 50–59, Dec. 2017.
L. Wagner-Hattler, J. Schoelkopf, J. Huwyler, and M. Puchkov. "Stability Investigation of Fcc-Based Tablets for Oral Suspension with Caffeine and Oxantel Pamoate as Model Drugs." Drug Dev. Ind. Pharm., vol. 0, no. 0, pp. 1-9, Oct. 2018.
Head Of Regulatory Affairs and Senior Quality Assurance Consultant
Cambridge Design Partnership
Louise is Head of Regulatory Affairs at Cambridge Design Partnership, a full-service product development consultancy based in Cambridge, UK and Palo Alto, Tx. Originally training as a pharmaceutical scientist at Nottingham University, UK she has over 10 years’ experience in drug delivery and medical device development with a particular focus on device technical management and regulatory strategy for EU and FDA submissions.
With a solid background in developing inhalation and parenteral ‘combination products’ from concept to market through previous experience working at Pfizer Ltd, UK and Oval Medical Technologies, UK, among others, Louise has a proven track record in supporting successful device submissions (and DHF remediations) under FDA, CE and other regulatory authorities.