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Event info
Date:08 Apr
Time:14:30 - 18:30
Venue:Medicon Valley Alliance, Copenhagen

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Contact person
Katrine Brems Olsen

Katrine Brems Olsen

Network & Event Manager

kbo@mva.org

+45 2337 0040

How to bring your product to market

In the dynamic landscape of microbiome research and development, the journey from concept to market success is often complex and multifaceted. This meeting aims to provide valuable insights and strategies for navigating this pathway successfully.

The successful translation of innovative microbiome-based solutions into tangible products holds significant potential for positively impacting healthcare. Whether you are a researcher or an industry professional, this meeting will share relevant best practices.

Throughout this session, we will explore key considerations such as regulatory challenges, market trends, and effective commercialization strategies. Our speakers bring experience and expertise, promising engaging and informative knowledge sharing.

Thank you for joining us, and let’s make this meeting a collaborative platform for enhancing our understanding and capabilities in bringing microbiome products to market successfully.

Date: Monday, 8th April, 2024
Time: 14:30 – 18:30
Venue: Medicon Valley Alliance, HUB2, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Auditorium

 

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Program

14:30 Arrival, registration & networking
15:00
Welcome
Anette Steenberg, CEO, Medicon Valley Alliance
15:10 Scientific and commercial progress in the microbiome field: future opportunities and investment trends
Denise Kelly, Seventure Partners
15:30 Definitions for a microbiome derived medicinal product and the required documentation for a clinical trial application
Lotte Kanna Dahl Nissen, Non-clinical Assessor, Danish Medicines Agency
15:50 Ferring’s journey towards approval of a novel microbiota-based live biotherapeutic
Brian Clark, Senior Director of Bioethics and
Anette Gemal, Senior Director, Global Regulatory Affairs, Ferring
16:10 Coffee, cake and networking
16:40
How to accelerate commercial manufacturing of Live Biotherapeutic Products
Felix Faupel, Chief Commercial Officer, Bacthera
17:00 Navigating the interplay between Microbiome stakeholders as part of a global development
Henrik Dörge, Voisin Consulting Life Sciences
17:20 Q&A with speakers
17:40 Networking and light snack
18:30 End of meeting

 

Speakers

Professor Denise Kelly joined Seventure Partners in 2015 as an Investment Advisor, focusing on Human Microbiome investments in Europe and the USA. Before that, she led a research team at the University of Aberdeen’s Rowett Institute for over 20 years, specializing in gut microbiology and immunology. Denise also founded GT Biologics Ltd, pioneering Microbiome-based Therapies. She holds a BSc and PhD from Queen’s University, Belfast, and is an Emeritus Professor at the University of Aberdeen, with numerous patents and collaborative projects in her portfolio.
Lotte Dahl Nissen M.Sc., PhD. is a non-clinical assessor at the Danish Medicines Agency in the Clinical Trial Department. She has international research- (immunology) and regulatory experience (CMC and non-clinical) from Denmark and Germany at The Federal Institute for Vaccines and Biomedicines; The Paul-Ehrlich-Institut. She has particular experience in the early regulatory support of medicinal products with special interest in innovative and advanced therapies.
Brian J Clark BSc (Hons), MBChB, FRCPath is senior director and head of Global Bioethics at Ferring Pharmaceuticals A/S. Brian trained as a physician in Glasgow, and initially undertook specialist training in ophthalmology before completing higher specialist training in pathology. He is a registered specialist doctor in the UK, authorised as a specialist doctor in Denmark, a Fellow of the Royal College of Pathologists and a Fellow of the Royal Society of Medicine in the UK. His career has been varied, international and across a wide range of disease and therapeutic domains, spanning healthcare, academia, not-for-profit, biotech and the pharmaceuticals industry. During his broad career, Brian has advised governments, international agencies, regulatory bodies and quality standards organisations on clinical and laboratory research. At Ferring, Brian is part of the team supporting regulatory approval of FE 999322/RBX 2660 in the USA and other countries.
Anette Gemal M.Sc., PhD is senior director at Ferring Pharmaceuticals heading up the Global Regulatory Affairs, Microbiome and Gastro team. She has a long background within drug development, having worked in research and nonclinical development before joining regulatory affairs within different pharmaceutical companies in Denmark. At Ferring Anette was part of the regulatory team supporting the FDA approval of FE 999322/RBX2660 in the USA and is currently the regulatory lead driving the submissions in other markets.
Felix Faupel was appointed as Chief Commercial Officer of Bacthera in September 2020. Before he was leading the Contract Manufacturing business of the generics company Acino International AG. He initially joined Acino as Global Key Account Manager in 2016. Before, he was working as a Business Development Manager for the tech-consulting company Altran (now part of Capgemini) and for the peptide API CDMO Bachem. Felix studied at the University of Zurich (UZH) and holds a Master of Science in Chemistry and Business Studies.
Henrik Dörge has worked in Leadership positions within Pharma, Medical Device, Diagnostics, VC, and Consultancy for more than 25 years. He has experience amongst other from Medtronic, Thermo Fisher Scientific, Guerbet, Innocoll, Eusa Pharma, and Glaukos. Henrik is Managing the Nordics Operations at VCLS and has the past 3 years gained experience from VCLS interacting with various microbiome stakeholders across the Atlantic.

Deadline for registration is 3rd April

The Network

The MVA Microbiome Network is a professional network for Medicon Valley Alliance members from industry, academia and health care sector with interest in the Microbiome field, including drug discovery, nutrition and probiotic development. Joining the network is free of charge but is limited to Medicon Valley Alliance members. However, non-member organizations and companies are welcome to attend one network event to evaluate if joining the network is relevant. If so, becoming a member of Medicon Valley Alliance will automatically allow you to join the microbiome network.

For more information please contact Katrine Brems Olsen kbo@mva.org

 

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