Forums and Workshops (April 29) - GMT (Greenwich Mean Time, GMTZ)
Forums and Workshops (April 29) - GMT (Greenwich Mean Time, GMTZ)
11:10 - Welcome and Introductions
11:15 - Crossing Borders: Navigating Medical Device Innovation Stateside
This discussion will delve into the challenges of moving from the European market, to the U.S, addressing regulatory and business hurdles encountered along the way. SurePulse Medical, a UK-based company known for its innovative approach to neonatal care, has made significant strides since inception. James Carpenter, CEO, will share experiences in device approval, FDA 510(k) clearance, whilst dealing with cyber-security requirements as well as business difficulties and opportunities whilst launching in the United States. This is an opportunity for entrepreneurs, healthcare professionals, and investors to understand the challenges and opportunities in bringing a medical innovation to a new market.
Moderated by; William Garvin, Shareholder, Buchanan Ingersoll & Rooney PC, Tina Hu-Rodgers, Shareholder & Life Sciences Industry Group Co-Leader, Buchanan Ingersoll & Rooney PC, Adam Wicks, Shareholder and Private Equity & Venture Capital Practice Group Leader, Buchanan Ingersoll & Rooney
Speaker: James Carpenter, CEO, SurePulse Medical
11:50 - Death by a 1000 cuts
Join us for a dynamic discussion on the challenges faced in product development, from navigating unclear target customer/application without thorough vetting, to managing delayed design direction changes, and balancing the pursuit of market trends with leveraging core strengths/IP. We'll delve into strategies for handling premature regulatory hurdles, navigating the balance between MVP product development and FDA requirements, and the importance of timely selection of engineering partners and contract manufacturers.
Moderated by; Bryant Grigsby, CEO, Phoenix DeVentures
12:25 -General Discussion (suggested topics to include but not limited to)
- Fundraising challenges and opportunities
- Overcoming barriers to market and regulatory approval
- Creating the right deals and partnerships to move your business forward
- Internationalising and company growth
12.40 - End of Forum
Chaired private and exclusive roundtable series.
11.10am (1hr 40mins) Roundtable One
- M&A, deal environment, anti-trust landscape analysis, general discussion and peer commentary from BD heads
11.10 Introductions
11.15 Current and Impending Anti-trust and Regulatory Threats
General Discussion and Peer Perspectives
- Perceptions and perspectives on current deal making environment: what are BD heads observing and how are they responding?
- How should big pharma M&A strategies evolve given the regulatory and anti-trust context?
For further information regarding the Pharma BD Leaders Forum, please contact:
Matthew Pullan, Managing Director, LSX
16:10 - Welcome and Introductions
Moderator: Fiona McFarlane, Legal Director, Bird & Bird
16:15 - CEO-Led Case Study - Successful Adaptation of Fundraising Strategy in the Life Sciences/Biotech Sector
- Initially funded to Phase 1 for lead asset, planned Series A for Phase 2 study
- Market shift led to investor demand for more de-risking data before committing to larger funding
- Adapted strategy by advancing FDA "IND" opening, a significant value inflection point
- Successfully opened pre-Series A convertible note for smaller Phase 2a study, paving the way for larger funding round with a leading VC partner
John Boghossian, CEO, Kanna Health; Co-Founder, Pangea Bio
16:30 - Early Considerations for Life Sciences Companies – Funding and beyond
This will be a session for executives of early-stage life sciences and healthcare companies to share their experiences of running a start-up. There will be a short introduction to venture capital financing and other foundational issues, followed by a panel discussion and Q&A session where the attendees can ask questions of company representatives who have successfully navigated the early stage funding arena and investor-side representatives who provide funding to early-stage companies. The session will be operated under the Chatham House Rule to promote a free-flowing exchange of ideas in a confidential and productive environment and to encourage open and honest discussions.
Fiona McFarlane, Legal Director, Bird & Bird
Mario Subramaniam, Partner, Bird & Bird
17.00 - Biotech Breakthroughs: Navigating the Journey from Concept to Commercialization for Early-Stage Pioneers
- Building long-term ecosystem partnerships from the start
- Get it right first time and become attractive to investors and the global market
- Ensure quality methods are developed through each phase and confidently move through key inflection points
Jette Cowan, Head of Commercial, Pharmaceutical, RSSL
17:30 - Final Discussion, Q&A
17.40 - End of Forum
- Fiona McFarlane - Legal Director, Bird & Bird
- Mario Subramaniam - Partner, Bird & Bird
- Jette Cowan - Head of Commercial, Pharmaceutical, UK
- John Boghossian - CEO and Co-Founder, Kanna Health
2pm (2hrs) Roundtable Two – Global BD Heads only
Pier discussion and exploration of solutions to presented challenges.
Potential topics to include:
- IRA developments
- M&A landscape
- Current challenges and success stories
- Anti-trust
- Regulatory update
- AI and relevance, impact on dealmaking
For further information regarding the Pharma BD Leaders Forum, please contact:
Matthew Pullan, Managing Director, LSX
The forum will be bringing together pharma execs who are leading digital strategy, digital transformation & digital innovation within their companies, for benchmarking, peer advice and networking.
16:20 - Welcome and Introductions
Richard Cassidy, SVP Rx+ Business Accelerator, Astellas Pharma
16:25 - Learnings from a Phase V Study: Digital RWE Generation for Migraines
Beth Wolff, Director Digital Health Solutions, Global Corporate Strategy & BD, Lundbeck
16:45 – Building Sustainable, Value-Based Strategic Digital Health Partnerships
Gregoire Guillet, Chief Business and Value Officer, WeHealth Digital Medicine, Servier
17:05 - AI Enabled Prediction of Clinical Trial Success
Christian Hein, Former VP, Global Head of Digital Transformation & Innovation Execution, Novartis
17:25 – Group Discussion
Themes/ topics the group will be looking to discuss;
- How are companies continuing to build their digital strategy and capabilities?
- What are the persisting challenges in scaling digital and analytics?
- Recruiting & retaining talent in the digital space
- Effective partnerships – what has been successful?
- AI use in Pharma (analytics, leveraging RWE, AI modelling & increasing efficiency & effectiveness) – How well is this working?
17.40 - End of Forum
Join us and meet fellow women leaders and supporters of progressing diversity in life sciences in person, make lifelong connections, and enjoy a drink or two to discuss the how we can come together to support female leaders in life sciences and stimulate investment.