Day Two - CT (Central Time)
Day Two - CT (Central Time)
- Odalys Caprisecca - Vice President, Managed Markets Finance, Novartis Pharmaceuticals Corporation
With the highly anticipated election on the horizon, join us in a policy overview of different scenarios based on the election outcome. We will model out possibilities with experts in the field on health policy issues, drug pricing and treatment of Pharma.
- Review past initiatives by presidential candidates that impacted the industry and expected shifts
- Landscape for 2025 and beyond
- Implications for both the national and state level
- IRA impact on election and outlook for amendments post-election
- Joel White - Founder and President, Horizon Government Affairs
- Maria Ghazal - President & CEO, Healthcare Leadership Council
- James Stansel - Executive Vice President, General Counsel and Corporate Secretary, PhRMA
- Rujul Desai - Partner, Covington & Burling LLP
- Heidi Ross, MPH - Vice President, Policy and Regulatory Affairs, National Organization for Rare Disorders
- Alice Valder Curran - Partner, Global Regulatory, Hogan Lovells
Hear from expert manufacturers of various size and type on how policy has impacted their commercialized product.
- Appropriate weighting within organization and what it means for pricing long term
- Approaches to compliance and risk-based evaluation
- Tips for communicating updates and downside to senior leadership
- Implications of the IRA on development pipeline
- Jesse Mendelsohn - Senior Vice President, Model N
- Dana Lerro - Healthcare Strategy and Policy Analytics, Market Access, BMS
- J'Amie Conrod, MSPH - Vice President, Government Business & Healthcare Policy, Amneal Pharmaceuticals
- Megan Falkowski - Director, Government Pricing & Government Contracting Policy, Pfizer Inc
- Daniel Yerves - Director, Government Pricing, Contracting, & Trade, scPharmaceuticals
- Insights on process for chosen drugs and timeline, portal challenges
- What do we hypothesize the final MFPs signal about CMS discount justification?
- What to prepare and best practices on process: Documentation and data
- What types of drugs are higher risk for selection based on parameters
- Jeff Baab - Executive Director, Life Sciences, IntegriChain
- Kristin Hicks - Partner, Arnold & Porter
- Chantelle Britton - Director, Office of Pharmacy Affairs, Office of Special Health Initiatives, Health Resources & Services Administration (HRSA)
What keeps YOU up at night? The newest requirements for State Drug Pricing? Is it the circling litigation with 340B and contract pharmacies? IRA and Medicaid negotiations? Smoothing and stacking? PBMs and PDABs? Join this open Q&A with external counsel to get answers to your most challenging questions. We’ll also hear about issues that keep them up at night and how it will impact you. *Pre-Conference we’ll poll the attendees for questions to ask our speakers.
- Odalys Caprisecca - Vice President, Managed Markets Finance, Novartis Pharmaceuticals Corporation
- Meena Datta - Partner, Sidley Austin LLP
- Christopher Schott - Partner, Latham & Watkins
- Information regarding all modifications made to rules, regulations, and calculations over the past year, along with their effects on product and delivery processes
- Examine current litigation surrounding IRA
- IRA rebates impact on accruals, forecasting, and new product launches - how to tailor product launch strategy with rebate accruals in mind
- Felecia Manning - Senior Director, Managed Markets Pricing & Government Programs, United Therapeutics Corporation
- Katie Lapins Trujillo - Executive Director, The Pricing Group
- Funso Olufade, PhD, MBA - Sr. Director – Head, Commercial Finance, Ascendis Pharma
- Jennifer English - Head of Pricing Contracting, Ipsen
Navigating the complex pricing practices in the industry and pulling the curtain back on how the pricing was determined
Mapping out the operationalization of the IRA and how to prep for adjustments
- Jake Keenan - Senior Director, Federal Compliance Solutions
- Current state of litigation on contract pharmacies by manufacturers
- Genesis implications: What do court findings mean for the future of the program and manufacturer approaches?
- 340B confluence with IRA and state regulatory movements
- Insights on policy on patient definition and eligibility
- John Gould - Partner, Arnold & Porter
Review technology that ensures transparency, proper discounts, and compliance among discount programs
Status of 340B growth and reform efforts and continued 340B ramifications
340B Influence on PDABs, state policy and trends
Research and insights gathered from covered entities, policy makers and manufacturers
Explore new models for ensuring compliance, transparency and trust among key stakeholders
- Lisa Scholz, PharmD, MBA, FACHE - Vice President, 340B Enterprise Strategy, Health System and Government Services, Cencora
- Speaker TBA - TBA, Kalderos
- Case study on how to successfully utilize advanced AI for duplicate discount data scrubbing in the biosimilar and ultra rare space
- Leverage AI for data validation and forecasting
- Interfacing with states with the most receptivity possible on duplicate discounts
- Tom Evegan - Principal, Strategy & Management Consulting, RSM US LLP
- If we are trailing the product from manufacturer to final customer, how do we account for those steps and verify the actions?
- Guiding through the steps for reporting back to CMS and the 14-day process
- How do you approach “following the pill” across all channels while addressing all possible discounts?
- Using the 10 products authorized, identify how the data was captured and possibilities for improvement upon the process
- Judd Caulfield - Lead Counsel, Oncology Business Unit, Takeda Pharmaceuticals
- Amanda Tucker - Associate Director, Northridge Insight
Pharma is in the crosshairs of society, media, and the government and there is perceived complication among the community concerning the Best Price Stacking Rule.
- Dissect and elucidate the proposed regulation with intricate detail
- Provide an overview of the burdens for all involved parties and understanding the push and pull of implementing the Best Price Stacking Rule
- Identify solutions for operationalizing the proposed rule
- Chris Weiser - Senior Corporate Counsel, US Market Access Legal, Sanofi
- Lynn Buhl - Senior Director, Riparian
- Douglas Helling - Associate General Counsel, UCB
- How to incorporate policy assessments earlier in the development process
- Working with global and R&D colleagues more closely to mitigate risks created by this program early on
- Best resources for active, streamlined 340B validated customers list
- Noncompliance with 340B program consequences
- Matthew Fornataro - Partner, Arnold & Porter
- Understand the size of the problem
Address underlying challenges with identifiers
Review mitigation strategies and tactics
- Marcella Lynch - Director, Forecasting and Pricing - Market Access, Rare Diseases, Chiesi USA, Inc.
- Pharma perspective on internally evaluating contracts and work stream using AI and predictive analytics
- Resulting learnings, tips and tricks
- Interactive Q&A
- Neelabh Saxena - Principal, ZS
- Nishi Chauhan - Decision Analytics Manager, ZS
Join this anonymous live polling session to reveal bot competencies, uses, challenges, creation processes and more!
- Are you using homegrown bots or from a vendor?
- What capabilities do you look for?
- What setbacks have you had?
- Wishlist for future automation?
- Tracy Zheng - Senior Market Access Operations Director, Exelixis
- Mitesh Ghia - Director, Institutional Contracts, Chargebacks & Rebates, Novartis Pharmaceuticals Corporations
- Speaker TBD, Pearl Management Consulting