Forums and Workshops (September 11) - ET (Eastern Time, GMT-05:00)
Successful medtech companies prioritize early planning, incorporating key milestones for regulatory compliance, market access, risk management, and stakeholder engagement. By doing so, they position themselves for growth and innovation in the dynamic healthcare landscape.
Join IQVIA's team of clinical development experts for a discussion on innovative pathways to bring your medtech product to market.
Agenda topics include:
• Regulatory Landscape: Explore current and emerging legislative and regulatory dynamics impacting your medtech products
• Evidence Generation: Prioritize planning for pre- and post-market evidence generation to facilitate smooth market entry
• Stakeholder Engagement: Learn how to effectively understand each stakeholder’s perspective and needs, including regulators, payers, and healthcare providers
• Innovative Case Studies: Share success stories that demonstrate strategies to de-risk medtech pathways, achieve regulatory approval, and optimize market access through data-driven differentiation
Chaired private and exclusive roundtable series.
11am (1hr 40mins) Roundtable One
- M&A, deal environment, anti-trust landscape analysis, general discussion and peer commentary from BD heads
11am 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
1.40pm - Welcome and Introductions
1.45pm - Navigating Raising a Series A to Support Auto-Immune Disease Research
Diana Abdueva, CEO & Founder, Aqtual
1.55pm – How to Start a Startup and Funding Options for Early-Stage Biotechs
- Common pitfalls and mistakes in early-stage founders and entrepreneurs
- Science vs Business and opportunity assessment
- Importance of a strong IP, team, and market opportunity
Stephanie Marrus, Managing Director, Entrepreneurship, UCSF
2.15pm – Getting Your Intellectual Property Right – Right from the Start
- Types of problems often seen in the patent portfolios of start-ups
- How these problems can be avoided including getting the right people involved at the company and communicating effectively with outside counsel
- How to save money through strategic investments that increase the value of your patent portfolio
Anita Meiklejohn, Principal, Fish & Richardson
2.45pm – Group Discussion, Q&A
3pm - End of Forum
- Anita Meiklejohn - Principal, Fish & Richardson
- Diana Abdueva - CEO, Aqtual
- Stephanie Marrus - Managing Director, Entrepreneurship, UCSF
13.40pm (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
3.50pm - Welcome and Introductions
3.55pm – – Strategies for Maximizing Asset Value Throughout Drug Development
- What are the benefits of establishing a market entry and commercialization strategy early on in development?
- What are the key launch and commercialization questions which impact value? When are they most significant to consider in the drug development cycle?
- How do I answer these questions best and “fill the data room” (i.e., determine factors like gross and net price, target audience, messaging on differentiation, what it would take to launch, etc.)
- How do I maintain exit optionality throughout drug development and best prepare for a successful exit (launch, out-license, co-partner, etc.)?
- How does exit optionality allow me to better weather evolving market conditions?
Lee Taurman, Executive Vice President, Head of Commercial Strategy and Solutions, Syneos Health
4.25pm – Preparing to IPO
- Key milestones and timing for an Initial Public Offering (IPO)
- Factors to consider before going public
- Advantages of taking your company public
- Trends and outlook for IPOs in 2024 and beyond
Marc Recht, Partner and Global Life Sciences Dept Co-Chair, Cooley
Evan Leitner, Senior Associate, Cooley
4.55pm – Group Discussion and Q&A
5.30pm - End of Forum
- Marc Recht - Partner and Global Life Sciences Dept Co-Chair, Cooley
- Lee Taurman - Executive Vice President, Syneos Health
- Evan Leitner - Senior Associate, Cooley