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:

Tracy Brown


Tracey Brown
, is a Principal 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) as well as being a UK/EU Registered Toxicologist.

 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).

Patrizia Nestby Dr

 

Dr Patrizia Nestby, Regulatory Affairs Consultant, Director and Founder of Pioneer Regulatory Limited, is a Principal Consultant to CNS. Patrizia has over 20 years of experience in global strategic and operational regulatory affairs. She has worked within industry as well as consultancy environments and held positions that afforded leadership and operational experience in defining and executing regulatory strategy as well as authoring and review of regulatory and clinical submission documents. Patrizia is an Honorary Fellow and Past-President of The Organisation for Professionals in Regulatory Affairs (TOPRA).

MO MAR JPEG

 

Dr Michael O’Neill, owner and consultant of Nomon Bio Ltd., is a Principal Consultant to CNS. Michael has 30 years’ industry experience with his main area of expertise in nonclinical development strategies. Previously Michael has held senior positions at Merck, Almirall, Eli Lilly and Inflection Bioscience. Michael has authored over 80 papers, book chapters, patents and abstracts. He is also co-authored “The Biotech Manager’s Handbook”.

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.

 M A Zaman

Mustafa A. Zaman is a Principal Consultant in the UK office. Prior to starting his career at the MHRA as a Pharmaceutical Assessor/Reviewer, Mustafa qualified as a Pharmacist after initially gaining a BPharm (Hons) degree and later a PhD in Drug Delivery – both from King’s College London. Mustafa has worked with several international companies including PAREXEL International Consulting (Principal Consultant), GSK (Manager CMC Pre-Approval), GENPACT Pharmalink (Assistant VP), and most recently as VP Regulatory Strategic Operations for Korean company POLUS Inc. Mustafa also holds four academic (honorary) posts at three UK Universities. At CNS, Mustafa acts as a regulatory expert and trusted advisor on strategic, technical and/or process issues (in particular the EU/US), Scientific Advice, IMPD/IND and MAA/BLA to clients working in a wide range of therapeutic areas.  

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 Medical Writing Manager who 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.

Gavin Edwards JPEG

Gavin Edwards is a Director and Senior Consultant in the UK office. Gavin has a BSc Biochemistry and a PhD in Cellular and Molecular Biology. Gavin has worked with a number of international companies including Lonza, ERA Consulting, and PAREXEL. Most recently Gavin served as Senior Director and Global Regulatory Service Line Leader, PAREXEL Consulting. With over 15 years’ experience Gavin possesses a broad spectrum of experience; a particular area of expertise and focus is Chemistry, Manufacturing and Controls (CMC) in respect of recombinant proteins. Notably, Gavin served as CMC-lead author for the first biosimilar monoclonal antibody approved globally.

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 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).

Kelly Burns


Kelly Burns
 is Consultant with over three 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.

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.

Catherine Tabrett

Dr Catherine Tabrett is a Consultant with a PhD in Agricultural Chemistry (1999) and a BScAgr(Hons1) (1995), both from the University of Sydney. Catherine has worked in academic research in Australia and the UK for over a decade and in national and international companies in Clinical Research Associate and Medical Writing roles, across a large range of therapeutic areas. More recently she has worked as a freelance Scientific/Medical Editor, Chemistry Teacher and Laboratory Demonstrator at tertiary institutions. At CNS, Catherine is focused on medical writing for core documents, such as Protocols, Investigator Brochures and Clinical Study Reports. 

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.

 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.

Susanna Mantovani

 Dr Susanna Mantovani is an Associate Consultant with a PhD in Physiology from the University of Milan (Italy). Prior to her role as Project Administrator at   CNS, Susanna worked as a Group leader at the University of Queensland Centre for Clinical Research in the field of neurodegeneration. In addition to   completing a Graduate Certificate in Clinical Trial Research at the University of Sydney, Susanna is a member on the Huntington’s Queensland board of   directors and serves as a molecular biologist on CNS’ Institute Biosafety Committee.

 

 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.