NDA's Leadership Team comes from a variety of backgrounds, joined by the ambition to create services and solutions that meet the needs of clients and solves complex problems. Collectively the team represents over 150 years' experience within the pharmaceutical industry, working for some of the world's leading companies and regulatory agencies.
Together NDA's Leadership Team lead a team of over 150 consultants covering the areas of regulatory affairs, pharmacovigilance, health technology assessment and scientific communication.
Laurie has over 25 years of global leadership experience in the pharmaceutical and biotechnology industries in drug development, regulatory strategy and regulatory approvals across all major therapeutic areas. She has led the development and commercialization of drugs for oncology, HIV/AIDS, cardiovascular, metabolics, immunology, infectious diseases, neuroscience, dermatology, inflammatory and immune-based diseases.
Laurie has led numerous multidisciplinary teams in over 50 US FDA and European EMA proceedings, including preparations for numerous key FDA meetings, Advisory Committee hearings and EU Scientific Advice and Oral Arguments.
Andrew holds a PhD in Biochemistry and has extensive industry experience across research, development, approval, and life-cycle management of new medicines. He has held various roles during his career spanning clinical project management, global regulatory affairs, global study and data management and pharmacovigilance. Andrew has 28 years’ experience as a global leader at Pfizer and Roche/Genentech, and has worked across all major therapeutic areas. In addition to this, Andrew has regulatory experience in France and the US leading multiple interactions with FDA.
Eva has more than 30 years in the industry and brings considerable experience in global product development across US, Europe, Canada and other markets. She has expertise in multiple therapy areas notably in diabetes, obesity, cardiovascular, respiratory, oncology and inflammation with experience in market access and its importance in clinical development.
She brings broad regulatory and development experience leading international cross functional teams. In her role, as independent consultant Eva has supported many development companies, driving their development programs for US and EU and preparing them for scientific advice. Before that, Eva served as Executive Director New Products at Merck, Sharp & Dohme (MSD).
Barbara is a sales management professional with extensive experience in the scientific, life science, healthcare, and clinical services industries. She joins NDA from BIOCLINICA a leading provider of specialty outsourced clinical services for the Pharmaceutical, and Biotech industry, where she was Director of Business Development, eHealth Solutions. Prior to this she was BD Director at Meeting Protocol worldwide and Sales Director at Quorum Review IRB.
Cathleen has been responsible for project management and overall business operations at PharmApprove for the past 13 years. She has helped to grow the business from a staff of three to over 30 and has led the efforts to establish advisory committee preparation best practices and optimizing marketing messages of the HSM value proposition to clients. In addition Cathleen has operationalized application of methods and techniques to optimize preparedness for EU high stakes meetings such as SAG, OE and payer negotiations value communication.
Has worked as CEO and entrepreneur in the IT service industry. Has supported for the pharmaceutical industry since the 1990s. Focuses on developing NDA as the undisputed global leader of strategic development advice, taking into account all critical commercial and regulatory considerations to successfully bring good medicines to patients in need. Took over as CEO of NDA in 2013 after many years in the company as both Head of IT and Head of Marketing.
Werner is a specialist physician in pharmaceutical medicine and has extensive international pharmaceutical experience, holding senior positions within Chemo – Exeltis, GE Healthcare, Abbott and Solvay Pharmaceuticals.
Dr. Van den Eynde is managing the operations, strategy and development of the NDA Advisory Board, including business development, sales, marketing and service development.
Kim has extensive pharmaceutical and biotech leadership experience in drug development, regulatory affairs and product commercialization. She has led teams across all phases of development advancing drugs and devices with increasing scope and responsibility and resulting in multiple product approvals. Most recently Kim was Senior Vice President of drug development for Aclaris Therapeutics, responsible for expanding their team to support all development activities for new drug candidates.
Former Executive Director of the European Medicines Agency (EMA). Served with the Swedish Board of Health and Welfare and then as Director of Operations and later Deputy Director General at the Swedish Medical Products Agency (MPA).
Honorary Member of the Royal Pharmaceutical Society of Great Britain. Honorary Fellow of the Royal College of Physicians. Honorary Doctor of Uppsala University, Sweden. Honorary Doctor of the University of Bath, United Kingdom.
Former Head of Section and Senior Medical Officer, Marketing Authorization Department in the National Agency for Medicines, Finland; Committee for Human Medicinal Products (previously CPMP) member; chairman of Committee for Human Medicinal Products, Scientific Advice Working Party, and CPMP ad hoc group on pre-clinical/clinical comparability of biotech products; CPMP Blood Products Working Group member.
Markku is a NDA expert in clinical development and clinical strategies.
Former Head of Division, Medicines Assessment and Clinical Trials, Danish Health and Medicines Authority; Committee for Human Medicinal Products member; Committee for Advanced Therapies member; Chairman of the Committee for Human Medicinal Products Respiratory Drafting Group and Co-Chair of the European Commission Working Group on Market Access of Biosimilars under the EU Platform on Market Access of Medicines in EU.
Steffen is a NDA expert in clinical development and regulatory strategies.
Joined the pharmaceutical industry in 1987. Held senior positions in European and International Regulatory Affairs at GSK, Abbott, UCB and Medeva, where she led groups responsible for Regulatory Strategy for products in a variety of Therapeutic Areas. This resulted in successful product approvals via Centralised and Mutual Recognition procedures in the EU and in the International region. Joined NDA in 2010.
Shelley is an experienced and highly motivated pharmacovigilance and risk management expert, with an international reputation in her field, specialising in delivering global safety solutions. Former senior manager at the MHRA for over 19 years, representing the UK at the EMA on EudraVigilance projects, Shelley now supports clients with implementation requirements of the EU pharmacovigilance legislation, developing NDA’s pharmacovigilance and Audit/inspection readiness services, as well as training Client safety team’s on all aspects pharmacovigilance.
Joined the pharmaceutical industry in 1982 and has worked in regulatory affairs since 1985, including 8 years at the Swedish Medical Products Agency (MPA). Previously worked within global regulatory affairs organisations both at drug and medical device companies, and as a regulatory affairs consultant. Joined NDA in 2009.
Joined the pharmaceutical industry in 1992 and worked in various positions for an American and later a Japanese company. Worked as Director European regulatory affairs for Fujisawa and Astellas from 1999 to 2007 with her team being responsible for the set up and management of several centralised procedures and EU referral procedures. Joined NDA in 2008.
Joined the pharmaceutical industry in 2002. Held senior positions in European, US and International Regulatory Affairs at Roche and Cytos Biotechnology AG across several therapeutic areas Metabolic, Inflammation and Oncology. Served as consultant for a venture capital company and was on secondment in Roche's BD&L / M&A department. Founded her own regulatory consultancy company before joining NDA in 2015.