8:00 am Registration, Networking & Light Breakfast
8:50 am Chair’s Opening Remarks
Adapting to Federal & Global Policy Shifts to Strengthen
Compliance & Business Stability
Compliance & Business Stability
9:00 am Presentation: Managing Global Regulatory Complexity to Ensure Compliance & Market Expansion
Synopsis
- Balance FDA, EMA, and international regulatory expectations for streamlined approvals
- Adapt to evolving global data privacy and cross-border compliance requirements
- How shifting trade policies and geopolitical risks are impacting international operations
9:30 am Panel Discussion: Addressing Concerns Over Cuts to FDA, NIH, CDC & CMS: What it Means for Innovation, Compliance & Talent Retention
Synopsis
- How cuts to agencies like FDA, NIH, CMS, and CDC may delay approvals, complicate drug development, and hinder access to government-supported programs
- How uncertainty fuels tension between legal teams and commercial functions
- Navigate a shifting regulatory environment amid “brain drain,” reassignment, and ambiguity around enforcement priorities at agencies including DOJ
10:00 am Audience Discussion: Navigating Evolving Trade & Tariff Pressures in Biopharma Supply Chains
Synopsis
- Explore how recent and potential U.S. trade actions, including tariffs and legislation like the BIOSECURE Act, may affect sourcing and manufacturing decisions
- Share insights on how tariff changes could influence raw material costs, drug pricing, and access to key markets
- Discuss adaptable legal, regulatory, and operational approaches to strengthen supply chain resilience in a shifting global landscape
10:30 am Speed Networking
Synopsis
Elevate your networking experience by joining the speed networking session tailored for in-house experts, like yourselves, to connect with industry peers & facilitating rapid yet meaningful exchanges of insights & expertise.
11:10 am Morning Break & Networking
Reframing Drug Pricing & Financing Strategy to Drive Policy Readiness & Market Access Success
11:30 am Fireside Chat: Moving Beyond IPOs & Exploring Alternative Financing Strategies to Secure Biopharma Growth
Synopsis
- Why more biopharma companies are reconsidering IPOs amid 2025’s market volatility and political uncertainty
- Understand alternative models: private equity, venture debt, royalty financing, and strategic partnerships
- Legal and operational challenges in structuring non-IPO financing to drive sustainable long-term growth
12:00 pm Mastermind: Reimagining Drug Pricing Strategy to Navigate Policy, Compliance, & Access in a Post-IRA World
Synopsis
- Explore how the IRA and Medicare negotiations impact pricing strategy from pre-launch to blockbuster drugs
- Share legal, financial, and compliance approaches for navigating evolving regulatory pressures
- Discuss how to balance innovation and affordability in real-world access and value decisions
12:30 pm Networking Lunch
Strengthening Biopharma’s Legal & Strategic Readiness Amid Market & Policy Shifts
1:30 pm Presentation: Innovative Funding Models for Capital-Intensive Biopharma Ventures
Synopsis
- How can biopharma companies secure funding beyond traditional equity markets?
- Understand venture capital, private equity, and non-dilutive financing strategies
- Manage regulatory and contractual challenges in alternative financing agreements
2:00 pm Panel Discussion: What Legal Teams Need to Know About Raising Capital in an Uncertain Market
Synopsis
- How are investors evaluating biopharma opportunities in today’s economic climate?
- Legal risks and compliance challenges in securing funding amid financial uncertainty
- Practical strategies for legal teams to support successful fundraising efforts
2:45 pm Afternoon Break & Networking
Capitalizing on Biopharma M&A Opportunities to Maximize Deal Readiness & Corporate Growth
3:15 pm Presentation: Exploring Antitrust Shifts to Understand New Biopharma M&A Opportunities
Synopsis
- The impact of shifting antitrust regulations on biopharma M&A activity in 2025
- New deal-making opportunities that could arise from changes in competition laws
- How legal teams can stay ahead of evolving regulatory changes to ensure successful acquisitions
3:45 pm Presentation: Structuring Acquisitions to Strengthen Legal & Financial Readiness
Synopsis
- Best practices for preparing emerging biotech companies for potential acquisitions
- Structuring deals to minimize risks and maximize financial stability
- Legal frameworks and strategies to ensure smooth and successful acquisition outcomes
4:15 pm Panel Discussion: Preparing for the M&A Surge to Maximize Biopharma Growth & Survival
Synopsis
- Insights on how large pharma companies are targeting acquisitions to fuel growth
- Structuring deals to protect biotech’s and enhance appeal during M&A prep
- How legal teams can balance the needs of both parties to ensure a successful deal and navigate post-merger integration