The fifth module in the Going Global program will provide attendees with a ‘deep-dive’ into the nuances of the European healthcare landscape and how to successfully access and navigate this key global market, with a focus on regulatory strategy, commercialisation and market access for biotech.
This module has three components:
- BioBriefing: Medicines in the EU: What you need to know to get to market (Tue 2 April)
- Workshop: Pathways to Europe: Regulatory, commercial & market access for medicinal products (Wed 3 April)
- Advisory session (Thu 4 or Fri 5 April – individual meeting times to be advised)
BioBriefing: Medicines in the EU: What you need to know to get to market
Tuesday 2 April – Registration at 3.45 pm, presentation & discussion 4.00 pm – 5:00 pm, followed by networking until 6.00 pm
Sweden-based Dr Thomas Lönngren, Strategic Advisor, NDA Group AB and former Executive Director of the European Medicines Agency, will provide an overview of the current European healthcare market and regulatory pathways to get to market. Thomas will explore recent changes in the regulatory landscape; key developments in health technology assessments; and the essentials of payment and pricing in the EU. Learn how your company can develop a robust EU strategy to alleviate risk and drive success in the European biotech market.
If you are unable to participate in the full module, you can register to just attend the module BioBriefing.
Workshop: Pathways to Europe: Regulatory, commercial and market access for medicinal products
Wednesday 3 April, 8.45 am – 5.00 pm
Venue: Cliftons Melbourne, Freshwater Place, Level 18, 2 Southbank Blvd, Southbank
In this workshop, Thomas will be joined by EU experts Jennifer Herz and David Grainger of Biointelect, to explore the European market in depth, enabling an informed approach to global growth for Victorian biotech companies. The workshop will provide practical insights, case studies and actionable information that will assist biotech companies in building successful regulatory, commercial and market access strategies for entry into the EU. Key topics covered will include:
- regulatory strategy and the EMA
- commercialisation and prioritisation of EU geographies
- clinical strategy, guidelines and policy
- value-based market access and pricing requirements
- Health Technology Assessment (HTA).
A 30-minute advisory session with Thomas
Thursday 4 and Friday 5 April
Venue: BioMelbourne Network, 25 Flinders Lane, Melbourne
We will contact you to arrange a suitable time for your 30-minute meeting. You are not required outside of this time on these two days.
Registration for each module includes:
- Up to three attendees at the module BioBriefing
- A full-day intensive workshop for one company representative
- A 30-minute advisory session with the module leader (up to four representatives from your organisation can attend)
- An invitation to attend the exclusive BioMelbourne Network Entrepreneur Roundtable Lunches with local business leaders who have succeeded in taking products to global markets.
The fee is $550 (incl. GST) for your first Going Global module, then $440 (incl. GST) for any subsequent module(s).
Registration confirmation: Please note that places are strictly limited and registration is subject to confirmation by BioMelbourne Network.
Cancellation policy: A full refund is given up to 14 days prior to the module. No refunds within 14 days of the module.
About our speakers
Dr Thomas Lönngren, Strategic Advisor, NDA Group AB and former Executive Director of the European Medicines Agency
Thomas is the former Executive Director of the European Medicines Agency, EMA (Jan 01-Dec 10). He previously served with the Swedish Medical Products Agency (MPA) as Director of Operations (1978-93) and Deputy Director General, (Jan 93 – Dec 00). Thomas established the EMA from a small unknown agency in 2001 to a world-renowned regulatory agency in 2011 and was responsible for all of its operations.
He is currently Director of his own independent consultancy company PharmaExec Consulting AB, Sweden giving strategic advice to the healthcare, pharmaceutical/Biotech and medical device industry in the areas of Drug Development, Regulatory Affairs and Market Access. Through his consultancy his main work is for the NDA Group where he has for the past 4 years been active in Cambridge, Boston US advising biotech companies on getting regulatory approval and market access in EU and he is frequently invited to speak at conferences around the world.
Currently he is a board member of Global Kinetics Corporation in Melbourne Australia, Analytica in Brisbane Australia, and Compass Pathways London, UK. He is a faculty member of Gerson Lehrman Institute (GLG), The Centre for Innovation in Regulatory Science (CIRS), Scientificmed AB, Sweden, Molecular Warehouse, UK and ReNeuron UK. Thomas is an Honorary Member of the Royal Pharmaceutical Society of Great Britain, Honorary Fellow of the Royal College of Physicians of Great Britain, Honorary Doctor of Uppsala University, Sweden and Honorary Doctor of the University of Bath, United Kingdom.
Jennifer Herz, Managing Director, Biointelect
Jennifer Herz founded Biointelect in 2011 to provide strategic commercialisation services to the biopharmaceutical industry.
She has over 20 years of commercial, business development and scientific affairs experience in the biopharmaceutical industry and has held a variety of roles with responsibility for Australia, New Zealand and European markets.
Jennifer was the first Managing Director of Sanofi Pasteur in Australia, which was a start-up company and grew significantly over the six years of her tenure to be an established major provider of vaccines to the public and private market in Australia, New Zealand and the Pacific Region.
She is a member of the Accelerate Commercialisation Expert Network, on the Steering Committee of the NHMRC funded Centre of Research Excellence: Policy relevant infectious disease simulation and mathematical modelling (PRISM) and is a member of the Expert Reference Group of the Australian Partnership for Preparedness Research on Infectious Disease Emergencies (APPRISE).
Biointelect has an extensive international & local network of industry, policy, scientific and clinical experts across many therapeutic areas and healthcare sectors along with global experience in multiple new product launches and start-ups at all stages of development. Since 2012 we have delivered over 130 projects to more than 50 clients supporting the commercialisation of novel health technologies.
David Grainger, Head, Global Health Outcomes and Policy, Biointelect
David Grainger has 40 years of experience in the pharmaceutical industry, spanning Australia, New Zealand, the United States and short assignments in Brussels and London.
He completed his life sciences studies at the University of Auckland with majors in haematology and transfusion science, management studies with the New Zealand Institute of Management and health economics at Monash University in Melbourne.
David is the co-author of numerous publications on health economics and health outcomes research.
David’s industry experience includes a range of roles in sales, marketing, health outcomes research and corporate affairs. This includes ten years as the director of corporate affairs and market access in Eli Lilly’s Australian affiliate, responsible for all health outcomes research, reimbursement dossier development & pricing functions as well as the corporate affairs functions of government relations, advocacy & communications.
More recently, David held a senior role in Lilly’s international public policy group, responsible for developing and supporting the company’s external health care policy positions related to Health Technology Assessment (HTA). David also engaged extensively with governments and thought leaders in a range of markets on policy issues related to universal health coverage, formulary management, HTA, pricing and regulatory affairs.
David has had significant involvement with industry association policy efforts and for six years chaired the HTA Task Force for PhRMA International. For five years he was a member of the Board of Directors of Health Technology Assessment International, a professional society dedicated to HTA. David is also a member of the Policy Research Advisory Committee for the Office of Health Economics in London and a casual lecturer in the Masters of Pharmaceutical Medicine program at the University of New South Wales in Sydney.