Agenda
Pre-Conference Workshops
March 22, 2027
Day 1 – Main Conference
March 23, 2027
Registration and Breakfast
Rapid shifts since March 2026 have touched expedited programs, clinical development, manufacturing initiatives, and promotional enforcement. At the same time, FDA’s Commissioner’s National Priority Voucher (CNPV) Pilot has moved into implementation, while new initiatives are reshaping regulatory priorities. This year in review separates binding requirements from guidance and proposals to set clear priorities for the conference.
- Monitoring regulatory priority shifts under Trump 2.0, including those arising through HHS and the MAHA agenda
- Distilling what is binding versus what is guidance or proposal and prioritizing 2027 compliance dates
- Assessing the implementation of the CNPV Pilot and new initiatives affecting clinical development and manufacturing
- Reviewing how FDA’s evolving approach to regulatory decision-making and transparency is changing sponsor strategies and expectations
Late pivots on confirmatory evidence, real-world evidence, or cross-center coordination can add months when least expected. This session turns approval fundamentals into a forward plan that designs pivotal evidence with confirmatory needs in mind and choreographs device or diagnostic touchpoints to protect speed and quality.
- Designing pivotal programs while anticipating confirmatory study expectations
- Integrating external controls and real-world evidence without triggering avoidable pushback
- Coordinating drug, device, and diagnostic interfaces and sequencing key FDA meetings
- Evaluating new IND initiatives and opportunities for earlier FDA engagement
Morning Networking Break
Companies can use FDA’s expedited review programs to enhance their regulatory strategies and reduce the time-to-market for their new products. This session covers the expedited review programs for drugs, including the latest developments and early implementation of the Commissioner’s National Priority Voucher (CNPV) program.
- Comparing criteria for the CNPV, Priority Review, Breakthrough Therapy, Accelerated Approval, and Fast Track programs
- Examining early CNPV approvals and their implications for review timelines and sponsor preparation
- Evaluating key considerations for companies before seeking expedited review
Moving a prescription product to nonprescription status broadens reach only if conditions-of-use and self-selection evidence answer real-world risks. This session contrasts ACNU with the Monograph route and outlines a data and labeling path that travels from submission to shelf without surprises.
- Choosing ACNU versus Monograph strategically and scoping fit-for-purpose datasets
- Demonstrating comprehension and self-selection and planning label-comprehension studies
- Monitoring post-market performance and updating labeling responsibly
Networking Luncheon
Enrollment stalls, diversity misalignment, and decentralized-trial hiccups can derail timelines even when the science is sound. This session turns evolving trial design and regulatory expectations into documentable plans that reviewers trust and sites can deliver.
- Evaluating diversity action plan requirements and requesting waivers with defensible rationales
- Selecting sites and networks to achieve representation benchmarks
- Maintaining data integrity and monitoring decentralized and hybrid execution
- Examining new approaches to trial design, including master protocols and FDA’s clinical development modernization initiatives
Afternoon Networking Break
Portfolio gaps, mis-listings, or mistimed exclusivities undercut hard-won approvals. This block frames patent scaffolding, Orange Book positioning, and naming choices so legal and regulatory tracks reinforce each other from IND through launch.
- Summarizing core patent tools for drugs and biologics and structuring durable portfolios
- Listing and delisting Orange Book patents and crafting carve-outs and skinny labels
- Coordinating exclusivities (NCE, orphan, pediatrics, reference product, interchangeability) and timing lifecycle moves to protect entry windows
Getting a follow-on product to market means balancing speed, cost, and the risk of litigation. This session walks through the core requirements for small-molecule and biologic entry, showing how sameness, bioequivalence, biosimilarity, and interchangeability standards drive strategy. It also explains how timing notices, stays, and the “patent dance” can protect a launch window or undermine it.
- Comparing NDA, 505(b)(2), and ANDA routes and evaluating Paragraph IV strategies
- Demonstrating sameness and bioequivalence and addressing complex-generic edge cases
- Defining biosimilarity and interchangeability and examining recent FDA guidance affecting biosimilar development
- Timing notices and stays and deciding how to engage in the patent dance
The label is where approval ends and liability begins. Unclear claims or thin risk language echo through promotion, REMS, pharmacovigilance, and litigation. This session shows how to anchor evidence in the PI, anticipate post-market evolution, and use change control to avoid costly relabeling.
- Surveying labeling requirements and exploring the end-to-end review pathway
- Incorporating clinical data accurately and appreciating downstream post-market effects
- Amending labels after launch and leveraging label strategy in product-liability defense
- Pursuing carve-outs and navigating skinny and narrow labeling where appropriate
Conference Adjourns to Day Two
Day 2 – Main Conference & Post-Conference Workshop
March 24, 2027
Registration and Breakfast
Co-Chairs’ Remarks and Recap of Day One
Quality gaps at scale show up as shortages, findings, and recalls when sampling and validation lag behind modern plants. This session translates evolving in-process expectations and advanced-manufacturing incentives into SOPs, supplier controls, and documentation that survive inspection.
- Applying in-process sampling and testing to qualify continuous and modern processes
- Leveraging advanced-manufacturing tools and designations to accelerate readiness and reliability
- Examining FDA’s PreCheck Pilot and its implications for domestic pharmaceutical manufacturing and supply resilience
Short-form ads, influencers, and dynamic feeds compress risk disclosure and stretch substantiation. This session turns recent actions into practical creative rules, governance models, and audit trails that protect claims without dulling the message.
- Substantiating claims in micro-formats and balancing benefits and risks credibly
- Governing agencies and influencers and allocating responsibility across the chain
- Documenting rationales and archiving materials to withstand review
- Examining recent FDA enforcement involving digital promotion, telehealth marketing, and misleading prescription drug claims
Medical and market access teams must inform without implying. This session delineates scientific exchange, HEOR, and payer communications so field conversations support care and the brand without drifting into misbranding.
- Differentiating scientific-exchange lanes and structuring medical-information responses
- Deploying HEOR and safety communications and maintaining alignment with evidence
- Anticipating attorney-general and plaintiff scrutiny and reducing litigation exposure
Morning Networking Break
Signals escalate fast when intake, investigation, and communication are not synchronized. This session aligns pharmacovigilance, REMS, Dear HCPs, and recall mechanics into a single response stream so safety action protects patients and reduces liability.
- Triaging safety signals and escalating appropriately across safety governance
- Executing Part 7 recall steps and communicating with stakeholders effectively
- Aligning pharmacovigilance actions with labeling and reducing regulatory and legal exposure
Hybrid inspections, cross-agency investigations, and digital advertising cases demand responses that age well on appeal. This session sets out record-building and response strategies that keep findings contained and consent decrees off the table.
- Preparing for routine and for-cause inspections and standardizing response playbooks
- Drafting letters that anticipate secondary review and preserve the administrative record
- Coordinating FDA, DOJ, and state fronts and managing monitors and consent decrees
- Examining recent enforcement actions involving misleading promotional claims and unapproved drug products