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.
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.
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.
Has among other things worked for the Swedish Medical Products Agency (MPA), ABB Cables AB as Controller, ABB High Voltage Cables as Controller, The Swedish National Audit Bureau as Controller responsible for Systems and Support and as a hired consultant from her own company for Permascand AB (AKZO NOBEL) as Controller for the Business Area Process Equipment and as Local Manager and Controller for Ceramic Powders. Joined NDA in 2001.
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 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.
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.
Robert has over 20 years’ experience in the Life science sector. He worked for 14 years in Neuroscience R&D at AstraZeneca after which he took up the position of CEO in a biotech company focusing on developing drugs for the neurodegenerative disease ALS. His experience also includes leading the Biology section at the Swedish National Forensic Centre/Swedish Police Authority. He joined NDA in August 2019 from the position as Director Analytical Development & Head of QC at Research Institutes of Sweden (RISE).
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.
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.
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.
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.
Joined the pharmaceutical industry in 1983 and has worked in regulatory affairs since 1985. Has held a number of positions within French, Italian, UK and US companies. This includes spending three years as European Director of regulatory affairs with the Medeva Group. Joined NDA in 2003.
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.
Andrea looks back on a long career in the life science industry primarily in Business Development and Customer Relations roles. She joined NDA from SANDOZ, where she was Global Program Manager. Before that, she was heading Business Development in AMW, a small Pharma company specialized in transdermal patches and biodegradable implants, and 4SC Discovery, a Biotech focused on discovery services and part of 4SC group, where she was also Head of Customer Relations for many years.
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.