High-Stakes Meetings

Driving Success in Pivotal FDA and EMA Interactions

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When the stakes are highest—whether you’re facing an FDA Advisory Committee, an EMA Oral Explanation, an Application Orientation meeting, or a major investor pitch—you need more than raw data. You need crisp, strategic storytelling that moves experts to action.  

That’s where PharmApprove comes in. As SSI Strategy’s high-stakes communications practice, we translate complex science into hard-hitting messages that command attention and drive decisions. 

FDA Advisory Committee Preparation

When an FDA Advisory Committee convenes, it holds the keys to your product’s fate: studies show that FDA follows positive committee recommendations in 97% of cases and aligns with panel advice overall 88% of the time. There’s no second chance to make your case—every slide, statistic, and statement must reinforce your benefit–risk story under the brightest scientific spotlight.

At PharmApprove, we partner with you to craft a narrative that resonates with independent experts, turning complex trial data into a compelling argument for approval. 

EMA Oral Explanations

In Europe, you get exactly 20 minutes to resolve CHMP’s toughest objections, with only two working days to submit slides in advance. Those twenty minutes can accelerate approval or leave critical questions unanswered.

Our experts—many former EMA reviewers and scientific advisors—shape your top-line messages and rehearse precise, bottom-line-first delivery so you nail every time frame, every question, and every technical nuance.  

Prepare to win with Pharmapprove

Why Choose PharmApprove?

When you only have one chance to get it right, turn to a partner who never leaves success to luck.

Over 25+ years of experience. We’ve steered sponsors through landmark FDA Advisory Committees and high-pressure EMA Oral Explanations, consistently turning “Go or No-Go” moments into victories.

Our all-star team—from former regulators and KOLs to patient advocates and communications coaches—becomes an extension of your organization, ensuring every message carries credibility.

We deliver end-to-end support, from in-depth gap analysis and narrative workshops to immersive mock sessions, final-hour rehearsals, slide-recall hardware and flawless on-site execution.

Our battle-tested methodology transforms dense data into clear, confidence-inspiring presentations—so you walk into the room ready to win.

Investor & Partner Presentations

Your investors and partners hold the purse strings, and their trust hinges on clarity, confidence, and credibility. Best practices call for 10–15 slides that tell a crisp problem–solution story, spotlight market opportunity, and pre-empt tough questions about risk and scalability.

We help you distill scientific depth into a persuasive investment thesis—complete with data-rich appendices for due diligence—so you command every meeting room, pitch contest, or board briefing. 

Strategic Advisory Boards & Workshops

Advisory boards turn external expertise into your roadmap for success—fuelling smarter trial designs, regulatory strategies, and commercial launches. Studies show that focused KOL workshops drive measurable improvements in protocol acceptability and stakeholder alignment.

We curate tailored panels of KOLs, ex-regulators, and patient advocates, then facilitate high-yield sessions that surface actionable insights and translate them into clear next steps—so you stay ahead of shifting scientific and market demands. 

SERVICE LEADERSHIP

Ellen Connolly

Principal Consultant

Ellen Connolly

Principal Consultant

Ellen Connolly is a seasoned regulatory executive with over 20 years experience in pharmaceutical industry, specializing in FDA-focused strategy. She brings deep expertise in regulatory strategy and development for both ANDA and NDA programs, including extensive experience with the 505(b)(2) pathway. Ellen has successfully guided numerous FDA interactions across pre-IND, IND, NDA, ANDA, and post-approval stages, providing creative regulatory solutions to accelerate market access and optimize product life-cycle management.  

Ellen is talented in navigating current regulations, identification of regulatory trends and surveillance of FDA initiatives to leverage regulatory opportunities. Her experience spans multiple therapeutic areas and dosage forms, and she is known for her collaborative leadership, strategic foresight, and ability to navigate complex regulatory challenges with innovation, ultimately delivering high-quality, timely submissions that achieve successful outcomes. 

Key areas of expertise

  • ANDAs and NDAs, specializing in 505(b)(2) pathways  
  • FDA regulatory strategy 
  • Leadership and submissions across all stages of drug development
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Laurie Smaldone Alsup

SVP Regulatory Science

Laurie Smaldone Alsup

SVP Regulatory Science

Laurie Smaldone Alsup, MD, is an expert in global clinical development and regulatory strategy with a focus on accelerating innovative therapies to patients. A physician executive trained in Internal Medicine and Medical Oncology at the Yale School of Medicine, Laurie brings more than 30 years of global experience in pharmaceutical and biotechnology leadership including biotechnology board experience She advises companies on regulatory and clinical strategies to support product approvals in the U.S. ,Europe and globally with a successful track record across numerous disease indications, including oncology, infectious diseases, immunology, neurology and rare genetic disorders. Laurie previously held senior executive roles at Bristol-Myers Squibb PharmApprove, NDA Group and Phytomedics, guiding numerous products through development, approval, and commercialization worldwide. She currently sits on the board of two biotechnology companies. 

Key areas of expertise

  • Global Clinical Development & Regulatory Strategy 
  • Benefit–Risk Assessment & Product Lifecycle Management 
  • Leadership in Oncology, Immunology, Infectious disease, and Rare Disease Programs 
  • Corporate affairs, risk management and communications 
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Kim Forbes McKean

SVP

Kim Forbes McKean

SVP

Kim Forbes-McKean, PhD is a highly accomplished biotech and pharmaceutical executive with over 35 years of experience in global drug, device and drug-device combination product development. She currently serves as Senior Vice President, Regulatory & Strategy as part of the Regulatory Leadership Team at SSI Strategy. Throughout her career, she has combined deep scientific expertise with strong commercial acumen, successfully converting business units into profitable enterprises. Her leadership spans all phases of development for small molecules, biologics, and combination products, with regulatory successes in oncology, dermatology, inflammatory, auto-immune and rare diseases. Known for building operational infrastructure and high-performing R&D teams, Kim combines strategic vision with executional excellence to deliver transformative healthcare solutions aligned with client and project goals. 

Key areas of expertise

  • Global clinical/regulatory strategy and agency negotiations to secure expedited approvals 
  • Leadership in building cross-functional pharmaceutical development organizations for growth 
  • Drug and drug-device combination product development 
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