Ashuren Health Sciences prides itself on providing superior guidance to our international clients. Our clients can be reassured that each piece of advice given to them, has been dissected through a series of scientists and toxicologists that can only be provided by the size of our team. To become better acquainted with our team, please select a name from the list of our designated senior scientists. We have only listed senior staff on the website, additional members of the team have bios that are available upon request.

Management:
Lindsay N. Donald, Vice President
Anna Metcalfe, Vice President
Diane C. Scudiery, Ed.M, M.A., Vice President, US Regulatory Affairs
Valentia Lee-Brotherton, Ph.D., Associate Director

Toxicology and Product Development:
Lois A. Haighton, B.Sc., DABT
Barry Lynch, B.Sc., DABT

 

Lindsay N. Donald
Vice President

Lindsay N. Donald has over 25 years of drug development experience in industry within pharmaceutical, biotechnology companies and contract research organizations. He has been an American Board Certified Toxicologist for over
15 years and has worked in a variety of therapeutic areas including anti-inflammatory, anti-infective, oncology, gastro-intestinal disorders and numerous biological products such as thrombolytics, cytokines, monoclonal antibodies and growth factors.

As Vice President of Ashuren Health Sciences he is intimately involved with the strategic planning, design and implementation of drug development programs for clients. Nonclinical and clinical safety data in support of regulatory filings are critically evaluated and he represents clients with various international regulatory agencies including the Food & Drug Administration and Health Canada.

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Anna Metcalfe
Vice President

Ms. Metcalfe, the Vice President of Regulatory Affairs within Ashuren Health Sciences, oversees regulatory staff in the planning, organization, and co-ordination of nonclinical, clinical, and regulatory submission activities. Her primary responsibility is to provide strategic and operational regulatory expertise and leadership necessary to advance the nonclinical and clinical development of drug products from Phase I to Phase III worldwide, for clients of the Pharmaceutical & Healthcare Group.

With over 25 years experience in various therapeutic areas in International Regulatory Affairs, she has developed skills in Clinical Research, Project Management, Drug Development, Medical Information and Medical Research. Ms. Metcalfe has successfully acted as Project Leader for the development of a number of drug candidates from the nonclinical stage to marketing authorizations in the US, Canada, and EU.

Ms. Metcalfe received an Honours Bachelor of Science degree with a specialty in Pharmacology from the University College London, England and has several publications in the area of regulatory and clinical affairs.

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Diane C. Scudiery, Ed.M, M.A.
Vice President, US Regulatory Affairs

Diane Scudiery has over 30 years of domestic and international experience in the pharmaceutical industry specializing in assisting small to midsize biotechnology companies in regulatory strategy, as well as clinical and regulatory operations. She has held positions of increasing responsibility in regulatory affairs, clinical operations, and data management at leading pharmaceutical and biotechnology companies. She has extensive experience in managing clinical programs for oncology products, and in the development and execution of facilitating regulatory activities with the FDA, EMEA, Health Canada and the TGA (Australia). She previously was part of the Alfacell Corporation senior management team where she held the position of Director, Clinical and Regulatory Operations and led successful efforts to obtain Orphan Drug designations in the US and Europe, as well as NDA orphan drug approvals. Prior to joining Alfacell, Ms. Scudiery served as Director of Clinical Research at Enzon Pharmaceuticals, and was a key member of the team responsible for regulatory approvals of their first two marketed products, ADAGEN® and ONCASPAR®. Prior to Enzon, Ms. Scudiery held regulatory and clinical positions at Aventis and Schering-Plough.

Ms. Scudiery earned a B.A. from William Paterson University, a M.Ed. from Rutgers University and a M.A. from Farleigh Dickinson University.

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Valentia Lee-Brotherton
Associate Director

Since joining the team at Ashuren, Dr. Lee-Brotherton has been involved in the design, implementation, and management of nonclinical testing programs. She has tailored detailed product development strategies for new drugs and biopharmaceuticals for a wide range of products, including drugs with specialized routes of administration, small molecules, proteins and peptides, in a variety of indications, such as cancer, pain, and inflammation. Dr. Lee-Brotherton has been involved in tasks ranging from lead candidate selection to preparation and review of regulatory submissions for a large number of projects. She has specialized in numerous aspects of general toxicology, involving risk assessments and independent third-party reviews of toxicology and safety data.

Dr. Lee-Brotherton’s 11 years of research background in toxicology and chemical carcinogenesis, knowledge of chemical carcinogens, drugs, toxic agents, and biotechnologicals, and her extensive experience with both in vitro and in vivo studies in drug metabolism and mechanisms of toxicity, toxicology, and tumorigenesis, continues to serve our clients well in her capacity as a senior project manager and associate director. Dr. Lee-Brotherton has maintained projects and relationships with many pharmaceutical and biotechnology clients that have spanned over 6 years.

Dr. Lee-Brotherton obtained her B.Sc. and Ph.D. from the University of Toronto, and then completed 3 years of training as a post-doctoral fellow at the London Regional Cancer Centre in London, Ontario, Canada. Dr. Lee-Brotherton is a member of the American Association of Cancer Research and has authored and co-authored a number of publications in the fields of toxicology and carcinogenesis.

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Lois A. Haighton
B.Sc., DABT

Ms. Haighton, a board certified toxicologist with over 15 years experience in product safety evaluations, serves clients by playing an integral role as project manager and senior scientific evaluator on a wide variety of health related projects involving critical evaluation and interpretation of scientific data including carcinogenicity, genotoxicity, toxicology, metabolism, endocrine disruption, environmental fate, epidemiology and mechanistic studies. She also has a great deal of experience in conducting risk assessments of contaminated products including foods and pharmaceuticals, and risk assessments of contaminated environments.

Ms. Haighton has prepared numerous scientific and regulatory reports for both government and industry on a wide variety of issues and products including biotechnology-derived products, as well as third party reviews and structure activity relationship (SAR) analyses. Ms. Haighton is also responsible for toxicological evaluations of consumer product formulations to ensure compliance with the U.S. CPSC Regulations and the Canada Hazardous Products Regulations. She also takes the lead in the toxicological evaluation of impurities, degradants and leachables/extractables and related issues in support of new drug applications.

Ms. Haighton graduated from Queen's University with an honours B.Sc. in Life Sciences. While at Queen’s and immediately following graduation, she assisted with mechanistic research of fetal alcohol syndrome. Ms. Haighton has been a Diplomate of the American Board of Toxicology (DABT) since 2002 and a European Registered Toxicologist since 2006. She is also a member of the Society of Toxicology.

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Barry S. Lynch
B.Sc., DABT

As a Senior Scientist, Mr. Lynch has been involved primarily in the Health Sciences section, specializing in pharmaceutical and food toxicology/ regulatory affairs. With his expertise and strong scientific background he supports clients in general toxicology, mechanisms of toxicity, metabolism, and the pathobiology of chemical carcinogenesis in laboratory animals.

Mr. Lynch serves extensively as a senior scientific advisor and resource person for projects involving complex toxicological issues, preparing countless technical reports for submission to regulatory authorities, on behalf of clients in the food, pharmaceutical, chemical manufacturing, biotechnology, and pesticide industries. These reports involve the detailed assessment of toxicology, carcinogenicity, mechanistic, metabolism, phamacokinetic/pharmacodynamic and other data addressing specific regulatory concerns or as part of comprehensive safety evaluations. Included, is the preparation of the toxicology portions of generally recognized as safe(GRAS) dossiers. With a strong chemistry background, he has been responsible for the assessment of technical data prepared for submission to Environment Canada under the NSN Regulations (CEPA). As part of these responsibilities, Mr. Lynch works with CEPA team members to develop testing and regulatory strategies for products requiring assessment under the NSN Regulations.

Mr. Lynch has authored over 30 scientific publications/abstracts, numerous toxicological monographs, and hundreds of confidential technical reports. His reports have been submitted to international authorities including the US FDA, US EPA, the Canadian HPB, EFSA, JECFA and the Japanese Ministry of Health and Welfare.

Mr. Lynch graduated from York University with an honours B.Sc. in Biochemistry and Toxicology. In 2001, he was certified as a Diplomate of the American Board of Toxicology (DABT) was accepted in 2005 on the UK Register of Toxicologists and becoming a Eurotox Registered Toxicologist. Mr. Lynch is also a member of the Society of Toxicology and of the Society of Toxicologic Pathologists.

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