Regulatory Hurdles on the Way to Advanced Therapies

SEPTEMBER 30 2020 at 13:00-16:00 Helsinki time, EEST (UTC+3)

Are you on the way to commercialize an advanced therapy? Do you have experience with the process of registration? Do you want to see how it is handled in the US or in Europe? Join our event!

A BIG THANK YOU to all speakers and participants for making our event a great success! Hope to see you at some later TCAF event coming soon!

AGENDA

13:00Introduction and WelcomeAndreas Slama, Tissue Cure Alliance Finland
13:10Company PresentationsTCAF members
13:35Overcoming Challenges in the Development of Advanced TherapiesDavid Morrow,  EATRIS
14:10EvoStem – Challenges in Cell Therapy CommercialisationMinna Kellomäki, Tampere University
14:35Experience with ATMP Commercialization & RegulationAntti Vuolanto, Herantis Pharma
15:00The Role of Finnish Red Cross Blood Service in Cell Therapy DevelopmentSaara Laitinen, Red Cross Blood Service
15:25Advanced Therapies Regulation at the US Food and Drug AdministrationBecky Robinson-Zeigler, ARMI
16:00Q&A 

SPEAKERS

Antti Vuolanto, DSc

Chief Operating Officer, Herantis Pharma Plc

 

Antti Vuolanto, DSc, joined Herantis Pharma Plc in February 2018. He has vast experience in biological drug development, gene therapy, and in-vitro diagnostics. Previously he has served as COO at Valo Therapeutics, as Executive Vice President at Targovax ASA, and COO and co-founder at Oncos Therapeutics Ltd that was merged with Targovax in 2015. He has also held senior management positions at other biotech companies. Dr. Vuolanto graduated as Doctor in Science in Technology at Aalto University, Finland, in 2004 in bioprocess engineering.

Becky Robinson-Zeigler, PhD
Deputy Chief Regulatory Officer, Advanced Regenerative Manufacturing Institute (ARMI)
Principal Consultant, BioFabConsulting


Becky Robinson-Zeigler is a biomedical engineer and the Deputy Chief Regulatory Officer at the Advanced Regenerative Manufacturing Institute (ARMI) where she oversees the regulatory and standards development activities for the BioFabUSA program. Dr. Robinson-Zeigler is also Principal Consultant at BioFabConsulting where she advises members on their regulatory, manufacturing, preclinical, and clinical strategies for their medical device, tissue-engineered, and cell therapy products. Prior to joining ARMI in October of 2017 she spent almost seven years at the US Food and Drug Administration (FDA) reviewing premarket and investigational applications for medical devices at the Center for Devices and Radiological Health (CDRH) and supervising pharmacology/toxicology reviewers regulating advanced therapy biologics at the Center for Biologics Evaluation and Research (CBER). Dr. Robinson-Zeigler received her undergraduate training in biomedical engineering from Columbia University’s Fu Foundation School of Engineering and Applied Science and her graduate training from Yale University, where she received her MS, MPhil, and PhD in biomedical engineering, with a focus on neuroengineering.

Minna Kellomäki Tampere new

Minna Kellomäki, Professor, Biomaterials

Tampere University

Minna Kellomäki is professor of biomaterials and tissue engineering at Tampere University. Scientific research interest area is at large in medical and surgical biomaterials and in body-on-chip materials and designs. Specifically, main focus in research is in developing novel hydrogels as well as hybrid and composite biomaterials, in manufacturing methods and structures for tissue engineering and guided tissue (soft and hard) regeneration applications. The work includes extensive characterization of materials and structures and collaborative in vivo and cell culturing studies. She has been active in university administration and in developing the biomedical engineering education including recent activities for education to regulatory issues. During her career, she has been active in commercialization of research findings (co-founder of three spin off companies, board member of one start up company, consultation of a biomedical company and several inventions transferred to company commercialization). It is close to her heart to support translational research of biomedical engineering and medicine.

David Morrow

David Morrow, PhD

Senior Scientific Programme Manager, EATRIS, The European Research Infrastructure for Translational Medicine

David Morrow is Programme Manager Translational Medicine & Drug Development at EATRIS.

David received a BSc (Hons) in Molecular Biology from University College Dublin in 2001 and a PhD in Vascular Biology from Dublin City University in 2006. This was followed by an American Heart Association Postdoctoral Fellowship at the University of Rochester Medical Center, NY from 2006-08 which resulted in an American Heart Association Young Investigator Award in 2008. From 2009-2015 he was an NIH/American Heart funded Principal investigator heading multiple projects in Cardiovascular disease and Cancer. David also holds an MBA in health science management and has worked as a consultant and in technology transfer in lifesciences.

Saara Laitinen, PhD
R&D manager at FRC Blood Service (FRCBS)

Saara Laitinen has an interest in applied science for the novel therapy development. Having a background in cell biology, biochemistry and lipid membrane from the first start of her scientific carrier she is still fascinated on membrane dynamics and how it can be modified and use as a novel tool of delivering therapies in most challenging disorders of our physiology phases. During current over ten years in FRCBS she has been an elementary part of developing mesenchymal stem cell techniques aiming for better culture methods towards clinical use. Her and her colleagues work in FRCBS has made a foundation to current Cell Therapy Centre in house that is one of the leading cell therapy centres in Finland.