With an average of over 10 years' per consultant, BioDesk offers its clients one of the most experienced and cohesive groups of regulatory, CMC and toxicology experts available across three continents.


Click on the position titles below for details on our team:

Dr Bryan Smith BioDesk Principal Medical Consultant


Dr Bryan Smith
is our Principal Medical Consultant and leads the Washington D.C. team. Dr Smith, a Family Medicine Clinician and Clinical Pharmacologist, has most recently served with the US Army Medical Materiel Development Activity (USAMMDA) where he chaired the multidisciplinary Integrated Product Teams and managed the development of products designed to prevent and treat malaria in the US Armed Forces. Previously, Dr Smith was a Fellow with the Walter Reed Army Institute of Research (WRAIR) Experimental Therapeutics, Dept. of Clinical Pharmacology and Assistant Chief, Department of Immunology and Medicine, Armed Forces Institute of Medical Sciences, in Bangkok, Thailand. 

 Erik Doevendans BioDesk

 

Erik Doevendans, Owner and Consultant of BD-Consultancy B.V., is a Principal Consultant to CNS. Erik has 18 years industry experience with expertise in CMC and a background in quality assurance, control, medicinal assessment, regulatory affairs and manufacturing operations. Notably Erik was previously a Pharmaceutical Assessor at the Dutch Regulatory Authorities and an expert to the EMA.

martin Headshot 22Nov17 GIF


Dr Martin Moxham, BioDesk's Principal Consultant,
has over 24 years’ industry experience with particular expertise in EU regulatory strategy, clinical and non-clinical data evaluation and supporting scientific advice meetings. Previously Martin held the position of Director of Regulatory Affairs at Alkermes Pharma Ireland and was Managing Director at iRegulatory. Notably Martin is a TOPRA Fellow (FTOPRA).

Richard Turner


Dr Richard Turner
, BioDesk's Principal Consultant in the UK office, has been working in biopharmaceutical development for over 20 years. Richard is a former Pharmaceutical and Scientific Assessor at the Medicines Control Agency (now known as the UK MHRA) and has worked in senior regulatory positions in a number of biopharmaceutical development companies and consultancies including Daiichi Sankyo, Lonza Biologics, ERA Consulting, Elan and Antisoma.

Tracey Brown


Tracey Brown
, is a Senior Consultant with over 25 years’ experience in preclinical drug development, having worked as a Toxicology Study Director for 10 years and a Project Co-ordinator for over 10 years, responsible for the designing, implementing and interpretation of the toxicology packages required for a variety of clinical indications. Tracey has particular expertise in inhaled products developed while working in a large international pharmaceutical company. Tracey is a member of the British Toxicology Society (BTS) and the US Society of Toxicology (SOT).

Hiram Chipperfield website

 

Dr Hiram Chipperfield is a Senior Consultant with over 10 years of regulatory affairs experience. He has a scientific background with a PhD in cell biology followed by academic and commercial post-doctoral research.  Prior to joining CNS, Hiram held roles in a regulatory affairs consulting firm and a global diagnostics company. With experience in products from diagnostics to cell therapies, he has managed projects ranging from preclinical development, first-in-human clinical trials, product registration, through to post-market reimbursement applications.

Fedora Daye Feb17


Fedora Daye, is a Senior Consultant in the US office.  She has a BSc (Biology/Chemistry) and a MPH (Public Health) and has held a range of positions in research, consultancy and marketing in the health sector.  Since moving into Regulatory Affairs (RA) in 1998, she has held senior positions at Goldbelt Raven, Ioma Corporation and most recently as the Director RA at an International Partnership for Microbicides.  Fedora has extensive experience in program management and strategic advisory both internationally and locally with the US (FDA) regulatory authorities.

Caroline Dobbin website

Dr Caroline Dobbin, is a Senior Consultant and holds a PhD in immunology and parasitology.  She has experience in drug development and clinical trials, gaining over 12 years in the Australian and US biopharmaceutical sector.  Caroline has managed preclinical programs and provided medical writing, project management and scientific support for multiple early phase clinical studies in the therapeutic areas of infectious disease, rheumatology and respiratory medicine.  Her experience has included production of regulatory submissions to US and Australian regulatory authorities and the authoring of clinical protocols, Investigator’s Brochures and Clinical Study Reports in accordance with ICH guidelines.  Caroline joins CNS from the QIMR Berghofer Medical Research Institute where she held the position of Clinical Trials Project Manager and Medical Writer.

Simone Flight


Dr Simone Flight
, a Senior Regulatory Consultant within BioDesk, has worked for seven years in early drug development and eight years in the pharmaceutical industry including six years as a regulatory affairs consultant, consulting on international projects from early proof of concept, facilitating marketing authorisation approvals and coordinating post marketing activities. Simone has also worked for three years in RA and compliance within a multinational pharmaceutical company.

CNS HS 03 Louise

 

Louise Moore, is the Director of BioDesk Australia and has been with CNS for over eight years. Louise has more than 20 years’ experience in regulatory affairs and medical writing including nine years working for multinational pharma companies based in the UK and five years in a small Australian biotech, all involving liaison with US, European and Australian regulatory authorities.

Natalie Thomas


Dr Natalie Thomas
, is a Senior Consultant in the UK office. Natalie holds a PhD in biochemistry and molecular biology and started her career as a Research Scientist in the Australian pharmaceutical industry, prior to moving to the UK to commence work in regulatory affairs and product development. Natalie worked in consultancy and project management roles at ERA Consulting and Voisin Consulting prior to joining CNS, where she now provides EU, US and Australian regulatory support to clients. She currently sits on the Editorial Board of the regulatory professional journal, Regulatory Rapporteur, and has obtained the Regulatory Affairs Certification (EU) from the Regulatory Affairs Professional Society (RAPS).

Rehma Chandaria

 

Dr Rehma Chandaria is a Consultant based in the UK Office and acts as the Project Manager/primary contact for a range of CNS clients as well as working on the full scope of US and EU regulatory and scientific/technical activities. Prior to joining CNS, Rehma was employed as a translational research scientist at a biotechnology company working on CAR-T cells, and she has a PhD in tissue engineering & regenerative medicine.

Amy Cooke

 

Amy Cooke is a Consultant based in the UK office and is responsible for supporting the creation of a range of documents for clients. Amy holds a BSc (Hons) Biomedical Science and MSc Cancer Biology from the University of Kent and is a member of The Organisation for Professionals in Regulatory Affairs (TOPRA) and Royal Society of Biology.

Sara McSweeney

Dr Sara McSweeney is a Consultant based in the UK with three years’ experience in managing drug discovery projects in international teams to deliver high quality solutions for unmet clinical needs. Sara has a PhD in Biological Sciences from the University of Edinburgh/UK and has previously worked as a research scientist at the National Heart & Lung Institute, Imperial College London and headed up the in vivo pharmacology team in the Cardiovascular and Metabolic Medicine (CVM) Group at Takeda Cambridge Ltd. At CNS, Sara is focused on providing product development and regulatory consulting support to clients.

Babaji Yadav


Babaji Yadav
is a Consultant with over six years of academic experience in pre-clinical oncology drug development and three years of industry experience (biotech) in early phase drug development. Babaji has a strong background in pharmaceutical sciences with a PhD in Pharmacology and Toxicology from University of Otago, New Zealand. Previously he has worked as a Research Project Manager to oversee IND enabling toxicological studies for lead oncology drugs and, prior to joining CNS, was a Clinical Project Manager. At CNS, Babaji is focussed on providing technical toxicology advice and product development strategies to facilitate entry of client’s compounds into clinical trials.

Sally Yang


Sally Yang
, is a Consultant with over two years of experience and acts as the Project Manager/primary contact for a wide range of CNS clients. At CNS, Sally works on the full range of US FDA regulatory and scientific/technical activities. Sally has a MS in clinical and regulatory affairs and holds a Regulatory Affairs Certification (US) from the Regulatory Affairs Professional Society.

Kelly Burns Associate Consultant

 

Kelly Burns is an Associate Consultant with two years’ experience on early phase clinical studies in the therapeutic areas of infectious disease, respiratory disease, haematology and immunological disorders.  Kelly started her career as a research scientist in reproductive biology in Newcastle Upon Tyne, UK and worked in skin pathology and histology before joining CNS where she now works as a medical writer. 

 Hannah Lewis

 

Dr Hannah Lewis is an Associate Consultant based in the UK office and is responsible for providing regulatory consulting support. Hannah holds a PhD in Cardiovascular Research from King’s College London and has 5 years’ experience working in an academic research environment. At CNS, Hannah authors and compiles regulatory documentation, and provides regulatory procedural and submission support to clients.

 Harriet Thomasson

 

Harriet Thomasson is an Associate Consultant based in the UK office with 3 years of experience and a Masters’ in Chemistry. Prior to CNS, Harriet was an Associate Scientist for a drug discovery services CRO. In her role at CNS, Harriet provides regulatory consulting support to clients.