Our People

Laurie led multinational teams in over 100 US FDA and EMA/national proceedings, including  FDA milestone meetings, Advisory Committee hearings and EU Scientific Advice and Oral Arguments. She is a recognized global leader in the biopharmaceutical sector for successful product development and regulatory solutions for serious and rare disorders.  Dr. Smaldone Alsup completed her MD and Oncology fellowship at the Yale School of Medicine.

Carol is an independent medical and regulatory consultant who works with PharmApprove providing strategic advice and guidance regarding new drug development and high stakes regulatory meetings, in a broad range of therapeutic areas. Carol is a Board-certified cardiologist with 20+ years of senior executive pharmaceutical experience. She has led strategy and implementation of global development projects, Phase 2b through registration and throughout product lifecycle, in all therapeutic categories, including Cardiovascular, Thrombosis, Diabetes, Osteoporosis, Pulmonary, Immunology, Neuroscience, and Oncology. Prior to entering Industry, Carol was a member of the full time academic medical faculty) at the University of Chicago, and at the Albert Einstein College of Medicine.

Steffen has an extensive clinical background in general internal medicine with a special interest in respiratory medicine combined and an in-depth knowledge of clinical pharmacology and therapeutics. He is a Board-Certified Specialist in Clinical Pharmacology and Therapeutics with the National Board of Health in Denmark. Former Head of Division, Medicines Assessment and Clinical Trials at the Danish Health and Medicines Authority. During his time at the agency, Steffen held several significant roles including CHMP member, a member of the Committee for Advanced Therapies (CAT), Chairman of the CHMP Respiratory Drafting Group and Co-Chair of the EC Working Group on Market Access of Biosimilars under the EU Platform on Market Access of Medicines in EU.

Mark is an expert in infectious diseases and former expert for the Center for Drug Evaluation and Research (CDER) at the FDA, and Medical Director for Emerging and Pandemic Threat Preparedness. Mark was responsible for coordinating drug shortage activities and was the acting Associate Center Director for Quality Assurance in CDER during which time he developed the concept of the Regulatory Briefing. Mark has held senior positions in industry. He is Board Certified in internal medicine and infectious disease and is a fellow of the Infectious Diseases Society of America.

Grant is a Board Certified oncologist and regulatory consultant with 25 years of experience in on oncology drug development, including roles in FDA, industry, and consulting. During his time at the FDA he drafted guidance documents that are now central to the design and interpretation of pivotal studies for cancer drug approval. This included the Cancer Endpoints Guidance which outlines FDA positions on analysis of PFS, a key endpoint in cancer drug approval. Formerly a member of the PhRMA statistical subgroup on PFS and coauthored papers on this topic.

Susan is a trained oncologist, with over two decades of leadership and experience in the Pharmaceutical/Biotechnology industry and the FDA. Susan is an expert in drug and biologic development for hematology and oncology indications, combination product development including companion diagnostics, biosimilars, clinical trial design and regulatory strategy with special emphasis on US FDA requirements.

Margaret is a BoardbCertified rheumatologist with clinical and regulatory expertise in the development of drugs and therapeutic proteins for the treatment of autoimmune and inflammatory diseases. She is a former CBER Deputy Division Director and medical officer at the FDA, and medical director within big pharma. Margaret has extensive experience in developing clinical and regulatory strategies for products at all stages of development, designing clinical trials, analyzing clinical data, submitting marketing applications to regulatory authorities in the U.S and Europe, and preparing clients for meetings with FDA.

Sif is a specialist physician in gastroenterology, hepatology and diabetes. She was a former clinical assessor/senior expert for the Medical Products Agency in Sweden and later moved to the Icelandic Medicines Agency. She was also a member of the CHMP and the SAWP. As a member of the EWP, she coordinated three regulatory guidelines in the field of gastroenterology and became the chair of the Gastroenterology Drafting Group at the EMA in 2010.

Julia is an expert in paediatric drug development, pharmacovigilance and risk management. Formerly Head of Special Populations Unit, Medicines and Healthcare Regulatory products Agency; member of Paediatric Committee and Pharmacovigilance Risk Assessment Committee, European Medicines Agency, secondments to the Office of Pediatric Therapeutics, Food and Drug Administration, and to the Pharmaceuticals Unit, European Commission. Member of CHMP and Committee for Orphan Medicinal Products, European Medicines Agency.

Paul is a Biopharmaceutical development and immunogenicity specialist. He is an expert in the regulatory implications associated with the structure-activity and structure-immunogenicity relationships for diverse types of biopharmaceutical products, including peptides, proteins and advanced therapy medicinal products.

Paula is an expert in biological medicinal products, especially advanced therapy medicinal products and CMC aspects of biopharmaceuticals. A clinical biochemist, with a Ph.D. in muscle cell biology, her main research has been in cell and molecular biology of various inherited diseases. Since 2006, she has been an Adjunct Professor of Biochemistry for the University of Helsinki. She is a former Research Professor at the Finnish Medicines Agency and has served as a member of the EMA Committee for Advanced Therapies (CAT). Paula has also been the Chair of the CAT, EMA CPWP and a member of the BWP.

An expert in statistics, Simon spent 30 years working in Industry. He was also Head of the Statistics Unit, MHRA and vice-Chairman for CHMP Scientific Advice Working Party for five years. He is a Fellow of the Society for Clinical Trials. Simon has also served on a variety of data monitoring committees. He chairs the External Advisory Panel for the Department of Statistics at Oxford University and is an Associate on the faculty at Johns Hopkins University. He is also vice-Chairman of the West London Research Ethics Committee.

Mary has over 28 years of regulatory experience in the pharmaceutical and biotechnology industry, and strategic regulatory experience across all phases of clinical development. She has guided teams in the preparation of global submissions in the US and EU, i.e., US FDA PDUFA meetings and Advisory Committee meetings; EU national and CHMP Scientific Advice meetings, and CHMP Oral Explanation hearings. Mary has broad experience in the development and registration of small molecules as well as biologic products, across major therapeutic areas and regions, including CNS, Dermatology, Immunology, Antivirals, Anti-infectives and Rare diseases.

Carol Marchione has over 30 years of experience in regulatory affairs resulting in multiple drug approvals in oncology, pain, hematology and CNS. She has achieved this by contributing to developmental strategies and successful negotiations with health authorities throughout the lifecycle of drug products, impacting clinical, non-clinical and CMC areas. She has significantly contributed to commercial organizations through her expertise in Promotion Review, Labeling and Risk Management.

Judy Plon has spent over 30 years in the BioPharma Industry, providing strategic regulatory guidance and serving as company representative with health authorities across therapeutic categories that included respiratory, allergy, rheumatology (RA and psoriatic arthritis), metabolic/endocrine (including women’s and men’s health drug products), dermatology, CNS (multiple sclerosis and sleep) and gastrointestinal compounds (IBD). Her experience includes registration submissions and approvals, as well as Health Agency meetings including pre-IND, End-of-Phase 2, pre-registration, Scientific Advice, Advisory Committee meetings and serving on FDA/Industry working panels. Judy also is an expert in nonprescription drug products and has completed 4 Rx-to-OTC switches.

Lisa helps development teams to create and deliver clear, convincing messages to regulators in the US and Europe. Lisa has coached hundreds of individuals and provided presentation, Q&A, negotiation and facilitation training to biotech teams. She has helped 45+ companies prepare to present and defend their positions at FDA Advisory Committees and EMA Oral Explanations. She creates and leads dynamic workshops that empower teams to communicate complex science with clarity. She spent 12 years in Japan in marketing and communications in the legal, financial and hospitality industries.

Michael is a scientific- and leadership-communications expert with over 25 years of experience as a communication strategist, actor, and educator. He helps development teams create compelling messages and present them with clarity and confidence during high-stakes presentations and Q&A sessions.

Neelu has over 25 years of experience in management consulting and industry. She is expert in product development strategies, scientific communication, and cross-functional leadership. Neelu has worked closely with clinical, regulatory and commercial teams across all stages of the product lifecycle in over 35 product categories for over 50 companies. She specializes in leading high-stake meeting preparations, including FDA Advisory Committees, Oral Explanations, Scientific Advisory Groups and Strategic Advisory Boards.

John coaches presenters, moderators and bullpen members on how to present and answer questions with confidence. He employs a hands-on coaching style that elicits almost immediate positive change in those with whom he works. He is particularly skilled at training presenters to deliver material compellingly, working with them on voice, body language, and overall expression while at the podium or bullpen microphone.

Derwin has more than 30 years’ experience as a journalist, communication executive and educator. He helps development teams hone and deliver messages effectively and prepare for FDA and EMA presentations and Q&A sessions. As head of the communication training practice for a global public relations firm, Derwin coached hundreds of Fortune 500 executives, preparing them for high stakes meetings, media interviews and speaking engagements. He helps clients enhance media content, anticipate media coverage and drive national and international media relations campaigns.

Jeff is a former journalist who has provided communications counsel to numerous organizations worldwide over the past two decades. He has helped teams prepare for FDA Advisory Committees in the US, and Oral Explanations and Scientific Advisory Groups in Europe. He has worked with executives across multiple sectors, including technology, telecommunications, management consulting, energy, law, medicine, financial services, philanthropy and academia. Jeff also provides media training and has prepared clients for interviews with Bloomberg News, CNBC, The New York Times, USA Today, The Wall Street Journal and various medical trade outlets.

Sarah has supported over 50 drug and device clients in preparing for Advisory Committees across therapeutic categories including orphan disease, gastroenterology, oncology, women’s health, and endocrinology. Sarah provides client service, project management, logistics support, and KOL management for clients.

Hanne has more than 25 years of experience in Regulatory Affairs focusing on defining European Regulatory Strategies in the context of global development programs and due diligence assessments of potential in-licensing deals. She has been working across several therapeutic areas and has planned and participated in high stake meetings including oral explanations with CHMP and PDCO as well as discussion meetings with the Scientific Advice Working Party.

Bethany contributes project management, client service, KOL management, and logistics support to clients. She has supported over 30 clients preparing for Advisory Committees and Oral Explanations across therapeutic categories including cardiology, oncology, hematology, antimicrobial, neurology, psychiatry, and gene therapy. She has extensive experience aligning and managing the collaborative efforts of cross-functional teams.

As CEO of the NDA Group since 2013 Johan has worked to expand the NDA’s capabilities across the continents working with a team of exceptional skill and expertise. Johan has a background as serial entrepreneur in the IT and technology industry, serving the life science industry for over 20 years. His main focus remains on developing NDA’s unique ability to provide world leading advice and a client experience second to none.

Kim has over 30 years of experience leading development organizations within large and small companies and has demonstrated success in negotiations with worldwide regulatory agencies resulting in multiple regulatory product approvals. She has extensive experience with global clinical and regulatory strategies for medicinal and aesthetic drugs and device products through all phases of development and has also received approval for Orphan Drug and Fast Track designations for rare disease development programs. Kim successfully built and led cross functional teams for development of pharmaceutical products in various therapeutic areas including dermatology, respiratory, cardiovascular, hormone replacement, and autoimmune disorders.

MBA. Executive Director, responsible for business operations at PharmApprove for the past 10 years. Oversees proposals, contracting, and resourcing for client projects and manages our project management group and HR function. Prior to joining PharmApprove she held a variety of marketing positions in the financial services industry.

Chris has over 16 years of Business Development, Pharmaceutical Sales and specialty product training experience working with pharmaceutical companies, CRO’s, and IRB organizations. He has worked closely with clinical, regulatory, and commercial sales teams across the product lifecycle in multiple therapeutic areas such as Respiratory, Dermatology, and Biologic injectables. Chris’ core expertise is managing client relations, navigating contracts, and connecting our clinical experts with pharma and biotechnology companies in order to move research forward.

Nancy has over 30 years of strategic client communication, account management, and business development experience in the pharmaceutical and institutional pharmacy industry. She brings a honed talent to RFPs, contracts, presentations, corporate conferences, and local regulatory events. Her passion also extends to regulation and programs aimed at helping the elderly.

Lena joins us from Diamond Pharma Services where she was Senior Business Development manager for a number of years in support of the groups regulatory, pharmacovigilance and Quality Compliance departments. Prior roles included many years as a Clinical Trials Project Manager and as an Out-licensing Manager and has worked with a number of local and international pharma/healthcare organisations. Lena brings her varied experience and extensive network to her new role at NDA where she will be UK based in support of the UK regulatory team.