Thursday, September 24th - ET (Eastern Time, GMT-05:00)
- 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 ERP systems to streamline processes, enhance accuracy and prepare for commercialization
- 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
- Sean Godbout - Chief Accounting Officer, Corporate Controller, Biogen
- Scott Godsoe - Executive Director, Assistant Corporate Controller, Vertex Pharmaceuticals
- Richard Malabre - Senior Vice President & Chief Accounting Officer, Akebia Therapeutics
- 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
- Explore the financial implications of Most Favored Nation (MFN) policies and develop response strategies to mitigate risks and optimize pricing structures
- Quantify the impact of tariffs and trade barriers on clinical supply chains, inventory management, and cost of goods sold (COGS), and learn strategies to minimize disruptions
- Understand the influence of evolving regulations on operations, financial planning and disclosures and compliance, including climate change reporting requirements and other legislative changes
- Examine the evolving landscape of global biotech research and licensing opportunities, and assess how international competition is reshaping market dynamics
CPE Credits Available: 1.2
- 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
- Soufiane Younoussi - Corporate Controller, BPG Bio
- Milton Pires - Controller, Korsana Biosciences
- 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
- Adam Mostafa - Chief Financial Officer, Sitryx Therapeutics
- Bill Steinkrauss - Chief Financial Officer, ILiAD Biotechnologies
- Evaluate the financial impact of Maximum Fair Prices (MFP) under the Inflation Reduction Act, including revenue recognition, ASC 606 and compliance reporting requirements
- Analyze MFN pricing pathways, addressing legal uncertainties and operational challenges related to forecasting, budgeting, financial planning, accounting, and reporting
- Implement strategies to integrate pricing changes into financial systems and processes, ensuring SOX compliance and audit readiness
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
- Meagan Caldwell - Senior Director of Technical Accounting, Sumitomo Pharma America, Inc
- Katie Phillips - Senior Director of Accounting, Alnylam Pharmaceuticals, Inc.
- 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
- Alaina Ownbey - Vice President, Finance & Accounting, Elicio Therapeutics, Inc.
- Hikmete O'Brien - Controller, Laxxon Medical
- Juan Betanzo - Vice President, Strategic Finance, EyePoint Pharmaceuticals
- 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
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 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
This dynamic and inclusive 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 platform to exchange ideas, learn from peers, and uncover actionable insights to enhance your organization's performance.
CPE Credits Available: 1.2
- Meagan Caldwell - Senior Director of Technical Accounting, Sumitomo Pharma America, Inc
- Soufiane Younoussi - Corporate Controller, BPG Bio
- Pete Paras - Assistant Controller, Biogen
