Agenda for Day 1 - Thursday, September 24th, 2026 - ET (Eastern Time, GMT-05:00)
- Adam S. Mostafa - Chief Financial Officer and Head of Business Development, Sitryx Therapeutics
- Explore how to operationalize recent regulatory changes, including practical strategies for adapting to the FASB’s disaggregation standard (DISE), potential impacts on financial reporting and compliance with evolving audit and reporting requirements
- Gain insights into leveraging AI tools and systems to streamline processes, enhance accuracy and efficiency, prepare for commercialization and enable scalability
- Hear lessons learned from transitioning from clinical to commercial operations, including inventory management, government pricing and supply chain complexities
- Discuss approaches to talent development, workload management and fostering adaptability in lean finance teams
CPE Credits Available: 1.2
- Jen Cadigan - Partner & Life Sciences Lead, CrossCountry Consulting
- Sean Godbout - Chief Accounting Officer, Global Controller, Biogen
- Scott Godsoe - Executive Director, Assistant Corporate Controller, Vertex Pharmaceuticals
- Richard Malabre - Senior Vice President & Chief Accounting Officer, Akebia Therapeutics
- Jenni Humes - Chief Accounting Officer, Roivant
- Hear directly from governing bodies as they provide critical updates on SEC and FASB reporting standards
- Understand the significant implications of these changes and how they may impact your organization’s compliance and financial reporting strategies
CPE Credits Available: 1.2
- Ryan Dolan - Senior Managing Partner, Life Sciences Leader, CFGI
- Jennifer Deng - Practice Fellow, FASB
- Richard Correa - Professional Accounting Fellow, Office of the Chief Accountant, U.S. Securities and Exchange Commission
- Gain insights and tools to help navigate evolving market conditions and lead through uncertainty
- Evaluate how inflation, interest rates, and pricing initiatives could affect biotech revenue expectations, margins, capital availability and strategic planning through 2027 and beyond
- Assess how producer prices for U.S. human biologics are changing and identify future pricing trajectories
- Develop a broad view of business cycle changes and sector-level drivers to identify risks and opportunities, aligning strategy, budgeting, and investments while influencing financial reporting decisions with forward-looking economic insight
CPE Credits Available: 1.2
- Jacqueline Green - Consulting Principal and Chief Economist, ITR Economics
- Erin Warner Guill - President and Chief Operating Officer, Auxilius
- Explore strategies to optimize operations and preserve cash runway through automation and cost-effective, scalable systems
- Learn best practices for integrating compliance reporting responsibilities into lean operations while ensuring accurate financial reporting and audit readiness
- Discover approaches to right-size organizations, including strategic cost allocation for ERP systems and audits while building resilient teams
- Gain insights from real-world examples and finance leaders on navigating resource constraints
CPE Credits Available: 1.2
- Kathleen Borthwick - Chief Financial Officer, Passage Bio
- Milton Pires - Controller, Korsana Biosciences
- Amy Garbarino - Senior Director, Accounting & Finance, Bicycle Therapeutics
- Discover how to strategically position your organization to attract investors and secure funding to ensure cash flow in a competitive and evolving financial landscape
- Learn practical approaches to securing partnerships, navigating M&A due diligence costs, and building scalable systems for financial growth
- Gain insights into crafting compelling investment narratives and optimizing investor communication to capitalize on future funding events
CPE Credits Available: 1.2
- Mark LaPre - Vice President of Finance, QurAlis Corporation
- Establish SOX-compliant internal control frameworks over commercial revenue cycles, inventory management and cost accounting to ensure audit readiness
- Navigate the transition from clinical trial accrual accounting to commercial cost structures, including the shift from R&D expense recognition to inventory capitalization and COGS
- Develop cost accounting methodologies for COGS calculation, inventory valuation and variance analysis as operations scale from clinical supply to commercial manufacturing
- Build scalable financial forecasting models incorporating operational metrics, manufacturing costs and supply chain dynamics to support strategic decision-making
- Design audit-ready documentation and reporting processes for commercial operations, addressing critical accounting matters (CAMs) related to inventory, COGS and operational expenses
CPE Credits Available: 1.2
- Learn how to build scalable GTN frameworks by establishing robust controls and teams during clinical trials and pre-commercial phases to ensure a smooth transition to commercialization
- Explore strategies to streamline GTN workflows to address Medicaid, Part D redesign, and commercial contract complexities
- Understand how to ensure compliance with critical audit matters (CAMs) and evolving regulatory requirements
- Discover ways to leverage ERP systems, advanced analytics and AI tools to enhance efficiency and forecasting accuracy
CPE Credits Available: 1.2
- Ryan McNally - Business Process, Risk and Controls Senior Manager, Crowe LLP
- Meagan Caldwell - Senior Director of Technical Accounting, Sumitomo Pharma America, Inc
- Katie Phillips - Senior Director of Accounting, Alnylam Pharmaceuticals, Inc.
- Lydia Wu - Head of Finance, US, PharmaEssentia USA
- Develop robust financial models and forecasting strategies to support the transition from pre-commercial to commercial phases
- Evaluate market opportunities and ROI to assess launch feasibility and financial sustainability
- Prepare for regulatory, supply chain, and operational requirements to meet the demands of a successful product launch
- Gain practical insights into cross-functional alignment and resource optimization to ensure launch excellence
- Learn from real-world case studies on overcoming common pitfalls in commercialization, including managing overhead costs, VAT compliance, and trade regulations
CPE Credits Available: 1.2
- Derek Thomas - Principal, Financial Assurance, Wolf & Company, P.C
- Alaina Ownbey - Vice President, Finance & Accounting, Elicio Therapeutics, Inc.
- Juan Betanzo - Vice President, Strategic Finance, EyePoint
- Develop tailored strategies for successful product launches, addressing unique challenges in supply chain, inventory management, and overhead cost control
- Explore best practices for VAT compliance and trade regulations to ensure smooth market entry and impact on disclosures and reporting
- Learn from real-world case studies on overcoming pitfalls in commercialization, including cross-functional alignment and resource optimization
- Discuss the role of AI and advanced analytics in enhancing forecasting, clinical trial accruals, and post-launch operational efficiency
CPE Credits Available: 1.2
- Maricel Apuli - Chief Accounting Officer, BridgeBio
- Kwame Boateng, Independent
This open forum allows senior-level executives to exchange ideas and best practices for driving internal and organizational success through efficiencies, technology and new innovations.
*Attendees must be Head of/VP/C-Suite-level and currently employed by a life sciences manufacturer. Informa reserves the right to qualify participants for this session.
CPE Credits Available: 1.2
- Maricel Apuli - Chief Accounting Officer, BridgeBio
This dynamic session invites participants from all levels and roles within the biotech industry to engage in open discussions and share diverse perspectives. Through benchmarking and roundtable conversations, attendees will explore innovative strategies, practical solutions and emerging trends that drive operational success and efficiency.
Whether you're navigating challenges in finance, operations, or technology, this session provides a collaborative forum to exchange ideas, learn from peers and uncover actionable insights to enhance your organization's performance and streamline your day-to-day responsibilities.
CPE Credits Available: 1.2
- Meagan Caldwell - Senior Director of Technical Accounting, Sumitomo Pharma America, Inc
- Soufiane Younoussi - Corporate Controller, BPGbio
- Pete Paras - Assistant Controller, Biogen
