Find out how MedTech start-ups can win big in BioPharma
This workshop is focused on answering the critical legal and regulatory challenges that MedTech start-ups face when entering the biopharma market.
Use promo code OneHealthTech to get 20% off your tickets!
The legal and regulatory framework that MedTech companies are required to navigate is out of date and hasn’t kept pace with advances in digital health.
By attending this workshop, MedTech start-ups and Biopharma will gain valuable knowledge and insight as to how to get regulatory approval for digital healthcare products which could offer Biopharma Patent/SPC extension by adding a digital tool.
- Our regulatory and legal experts will provide MedTech start-ups with the essential advice they need to launch a digital health tool and bring it to market.
- We will also show start-ups how to build successful partnerships within the industry and how these partnerships can be critical for long-term success, in particular with Biopharma.
What topics are going to be covered?
- Is every digital tool a medical device?
- Do I need to file a regulatory approval (e.g. CE mark, FDA)?
- Questions about patient privacy and data security since a lot of sensitive patient data is involved, this can present significant risks.
- Digital strategy: digital tools assessment, risk assessment, risk mitigation.
- Law interpretation and practical guidance for MedTech start-ups (around data).
Case studies and Panel discussions on:
- When a drug’s patent expires, offering a digital tool alongside the product may be a way to prolong its life cycle further if there are a large number of active users; It may also prevent patients from shifting from the originator product to a generic. Generic products aren’t likely to offer these digital tools because they are costly to develop and maintain.
- How physicians or biopharma professionals now can see whether a product or drug is working.
Alexander Belcredi / Founder and Managing Director atPhagoMed Biopharma GmbH, Austria
Alexander is a seasoned MedTech and Biopharma executive. During his 9-year tenure at The Boston Consulting Group, he advised multinational MedTech and Pharma companies on strategic topics incl. digitalization and new digital business models. Amongst his projects, Alexander led several incubations of new digital MedTech ventures for Top 15 MedTech companies. Currently, he is the co-founder and CEO of PhagoMed Biopharma GmbH, an Austrian based biotech venture developing bacteriophage-based antibiotics alternatives.
Throughout his career, Alexander has experienced the need for a sound legal and regulatory strategy from multiple angles – while advising multinational companies on product innovation, while incubating digital MedTech businesses and now in his role as CEO of a biotech venture.
More info on Alexander Belcredi: PhagoMed Website
Chris Freer / Regulatory consultant at Global Regulatory Services (GRS), UK
Chris is a senior regulatory consultant with a wealth of knowledge and experience build on a strong manufacturing background in the medical devices and pharmaceutical industry. Chris provides expertise on MedTech regulatory strategy and adopts a logical and methodical approach to problem-‐solving, achieving tasks and objectives.
The Global Regulatory Services (GRS) won the 2017 Biotechnology Award for ‘Best for Global Life Science Regulatory Affairs’ and ‘Best Medical Device Outsourcing Company – UK’
More info on GRS: GRS Website
Shoshana Bloom / CEO and Founder at Innova Health, UK
Shoshana has 16 years of commercial healthcare experience spanning NHS, the Department of Health and commercial healthcare sectors; spent largely in management and commercial roles and leading technology programmes and marketing innovative propositions to the NHS and the Pharmaceutical Industry. Shoshana led the growth in ‘high-tech’ clinical homecare and patient support services for Walgreens Boots Alliance and has previously worked for Healthcare at Home, Lloyds Pharmacy and Superdrug.
Throughout her career, she has been driven to deliver more effective and safer care for patients, making the systems, infrastructure and experience of healthcare safer, efficient and enriching through technology, appropriately deployed, to drive change and deliver greater value. She believes that a fundamental part of this is ‘humanising’ technology design; considering emotional, physical and environmental experiences to ensure its relevance, effectiveness and use.
Innova Health is an integrated, multi-source AI-driven data platform that creates a longitudinal health record, risk-stratifying patients and visualising to care providers overall improvement or a worsening disease state.
More info on Innova Health: Innova Health Website
Anthony Monckton / Chief Operating Officer at ViennEast Consulting GmbH, Austria
Anthony has 37 years’ experience of working for the British government mainly in the Diplomatic Service. His focus was on national security and managing cross-border collaboration and investigation.
Anthony has spoken to the legal and insurance sectors on GDPR and Cyber Security and the Oil and Gas Sector on enterprise risk management. He believes strongly that properly managed risks are opportunities and that for the growing bio-pharma sector the management of personnel, operational, regulatory and reputational risk requires an open but joined up approach.
ViennEast is a boutique business intelligence, corporate investigations and risk management company with a global focus, advising companies across all business sectors on taking a holistic approach to risk from cybersecurity basics, to insider risk, to geopolitical threats.
More info on Anthony Monckton: ViennEast Website
More speakers to be announced
Q: How to find the Governors’ Hall Suite in the hospital?
A: Here is a link to a map of the hospital interior: Venue Map
Q: If I am an NHS employee can I get a discount?
A: If you are NHS employee, you can apply 'NHS'promotion code to get a 15% discount. Please use your NHS email account to verify the eligibility.