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
Valentia Lee-Brotherton, Ph.D., Associate Director
Toxicology and Product Development:
Victoria Tai, M.Sc., DABT
Lois A. Haighton, B.Sc., DABT
Barry Lynch, B.Sc., DABT
Regulatory Affairs:
Katharine Manson, B.Sc., RAC
Business Development:
Chad Yaremko, M.Sc., MBA
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.
Back to Top
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.
Back to Top
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.
Back to Top
Victoria Tai
M.Sc., DABT
Ms. Tai is a Scientist at Ashuren Health Sciences. A toxicologist, whose principal focus is the safety assessment of regulatory products and
toxicology, she combines a thorough scientific understanding of toxicology and pharmacology together with regulatory requirements. She has applied this knowledge, for clients, to the assessment of human risk and the resolution of complex safety and regulatory issues.
Ms. Tai is extensively involved in the development of safety programs for drugs, biopharmaceuticals, medical devices and consumer products. She prepares numerous expert panel reports and FDA white papers for pharmaceutical firms, involving critical
evaluation and interpretation of scientific data on toxicology, carcinogenicity, reproductive toxicity, genotoxicity and metabolism, thereby facilitating and expediting regulatory agency review.
In addition, Ms. Tai is involved in performing gap analysis and program planning(design and critical evaluation of toxicology studies, and study management),
as well as preparation of NDA submissions in CTD format for FDA and European filing.
Ms. Tai received both her Honours B.Sc. in Toxicology and M.Sc. in Pharmacology from the University of Toronto. In addition, she is board certified as a Diplomate of the American Board of Toxicology and is a EUROTOX Registered Toxicologist. Ms. Tai is a member of numerous toxicology and regulatory affairs societies and organizations.
Back to Top
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.
Back to Top
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.
Back to Top
Katharine Manson
B.Sc., RAC
Ms. Manson, a scientist within Ashuren Health Sciences, is responsible for preempting regulatory concerns and questions through previews of data and submissions. Working with numerous clients, she prepares and reviews submissions, from pre-meeting packages and post-marketing changes to complete dossiers for new active substances for regulatory agencies worldwide.
Ms. Manson has successfully advised on and managed the filing of a large number of INDs, CTAs, NDAs, NDSs, and related amendments/supplements. With her strong scientific background, she has assisted in the performance of compliance audits in the United States, Canada, Europe, and Asia.
Ms. Manson received her Honours B.Sc. in Biomedical Science from the University of Guelph and regularly attends a number of educational programmes and conferences including the Society for Quality Assurance and the Canadian Association of Pharmaceutical Regulatory Affairs (CAPRA). Ms. Manson is an active member of the Regulatory Affairs Professional Society and CAPRA. She was also a participating author in the 2006 Fundamentals of Canadian Regulatory Affairs.
Back to Top
Chad Yaremko
M.Sc., MBA
Mr. Yaremko’s primary role at Ashuren Health Sciences is carrying out business development activities via the development of client relationships and the marketing of the group’s scientific acumen and experience. He brings value to client interactions through the continual assessment of evolving industry trends and market evaluations. Additionally, Mr. Yaremko will work with clients to develop solutions to complex drug development and toxicology issues while overseeing projects to ensure accuracy of data and quality of reporting.
Mr. Yaremko has worked in the industry for the last five years managing early stage drug development programs in compliance with both Health Canada and US FDA regulations. Using his strong scientific background and knowledge of various therapeutic areas, he has designed and executed a variety of both clinical and non-clinical studies in the role of project leader.
Mr. Yaremko received both his Honours B.Sc. and M.Sc. in Pharmacology and Toxicology from the University of Western Ontario. Recently, Mr. Yaremko has completed his MBA from the Richard Ivey School of Business with a specialization in the health sciences sector.
Back to Top
