Conference Day One

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

9:00 am Presentation: Managing Global Regulatory Complexity to Ensure Compliance & Market Expansion

  • Gregory Montalbano Formerly Associate General Counsel & Head, Compliance, Assertio Therapeutics

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

10:15 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.

10:45 am Morning Break & Networking

Exploring Alternative Financing Strategies to Accelerate Biopharma Growth

11:00 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

11:30 am 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

12:00 pm Networking Lunch

Navigating Legal Complexities in Finance and M&A to Help Biopharma Thrive Amid Market Shifts

1:00 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

1:45 pm Mastermind: 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 administrative laws
  • How legal teams can stay ahead of evolving regulatory changes to ensure successful acquisitions

2:15 pm Afternoon Break & Networking

2:45 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

Capitalizing on Biopharma M&A Opportunities to Maximize Deal Readiness & Corporate Growth

3:15 pm Panel Discussion: Preparing for the M&A & Deal 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

4:15 pm Chair’s Closing Remarks

4:30 pm End of Day One