14:00 – 14:05
Janis Bernat, Associate
Director, Biotherapeutics &
Scientific Affairs, IFPMA
14:05 – 14:15
Introduction to Biotherapeutic
& Biosimilar Medicines
Gino Grampp (R&D Policy
Director (Amgen) & IFPMA
Biotherapeutics Group Chair)
14:15 – 15:15
Panel Session Regulatory
HyeNa Kang (Scientist – World
Biologics and Biosimilars
in Mexico: Challenges &
Fernando Fon (Medical Director
& Regulatory Affairs – AMIIF)
Biotherapeutics and patients:
what matters in principle
Alison Lightborne (Policy
Manager – IAPO (the
International Alliance of
15:15 – 15:45
Questions & Answers
15:45 – 16:00
Regulatory Affairs Director at Amgen
Dr. Grampp is a Director of R&D Policy at Amgen, where he leads external affairs related to biosimilars in Latin America and other regions. Prior to this role, he was Director of Regulatory Affairs, supporting regulatory agency interactions, technical strategy and submissions related to Amgen’s biosimilars development program while advocating for science-based implementation of biologics policies.
Before his engagement on biosimilars, Dr. Grampp led technical teams responsible for development and quality oversight of Amgen’s biologics manufacturing processes.
Dr. Grampp earned his bachelor’s degree in Chemical Engineering at the University of Wisconsin and a Ph.D. in Chemical Engineering from the Massachusetts Institute of Technology.
Dr. Grampp is the current Chair of IFPMA’s Biotherapeutics Group.
Medical and Regulatory Affairs Director at AMIIF (Mexican Association of Pharmaceutical Research Industries)
Mr. Fon has more than 17 years of experience on Pharmaceutical Medicine covering areas and positions like Clinical Research, Marketing, Medical Department, Pharmacovigilance and Compliance.
In his current role, he coordinates several multidisciplinary teams; including the biotherapeutics working group, with the commitment to impulse the embracement of best international practices of pharmaceutical sector in Mexico.
Policy Manager, IAPO (the International Alliance of Patients Organizations)
Ms. Alison Lightbourne is a Policy Manager at IAPO (the International Alliance of Patients Organizations), a unique global alliance representing patients of all nationalities across all disease areas and working to promote patient-centred healthcare around the world. She manages and coordinates IAPO’s policy activities including working with members to develop of statements and policy positions, communicating these at the global level and building the capacity of members to advocate within their own countries. She works on collaborative projects with WHO and others at international level, and in regional partnerships on initiatives that help bring patients to the centre of healthcare and health policy-making including on issues that advance patient empowerment and involvement at all levels, improve access, affordability and quality of medicines and treatment for all.
Scientist, Essential Medicines and Health Products (EMP), World Health Organization (WHO)
Dr Kang joined WHO Norms and Standards for Biologicals group in January 2009 and has been in charge of development/implementation of WHO recommendations for regulatory evaluation of biologicals, particularly biotherapeutics including biosimilars. She was a responsible officer to develop several WHO guidelines on regulatory evaluation of biotherapeutics, e.g. evaluation of quality, safety and efficacy of biotherapeutics; biosimilarity evaluation; regulatory assessment of approved biotherapeutics. She has organized many workshops and coordinated the development of case studies to implement the evaluation principles in WHO guidelines into regulatory practices in countries.
Prior to joining WHO, Dr Kang was a scientific officer for twelve years at Korea Ministry of Food and Drug Safety (formerly Korean Food and Drug Administration). In 2004, she worked on the project to develop HCV DNA vaccine at the Vaccine and Infectious Disease Organization-International Vaccine Center in the University of Saskatchewan in Canada.
Dr Kang holds a V.M.D (2007) in Veterinary Immunology and Microbiology from the Konkuk University in Seoul, Republic of Korea and a master degree (1993) in Developmental physiology and a bachelor degree (1991) in Biology from Sungshin Women’s University in Seoul, Republic of Korea.
15th Mar 2016
14:00 to 16:00 UTC±00:00
Vieux-Bois Avenue de la Paix, 12 Geneva, Switzerland