Our Team

 

C2C is focused on providing expert guidance to help companies strengthen their business and scientific positions dramatically improving their chances of reaching the marketplace.  Our team has a proven track record in execution of drug development from pre-clinical to commercial, submission readiness and repositioning experience.

 

 

 

 

  • Y.C. Lee, Ph.D. - Managing Director

    Dr. Lee is the Managing Director of Concept 2 Clinic Inc. and has more than 22 years of extensive pharmaceutical and business development experiences.  Dr. Lee was a co-founder and the CEO of Xphase Pharmaceuticals Inc. Dr. Lee became Senior Director at PharmEng Technology Inc. in 2006 when it acquired PharmLink Inc., a company co-founded by Dr. Lee in 2005 where he led a group of 20 scientists providing pharmaceutical related services. Prior to focusing his career on strategic corporate development, Dr. Lee was Director of Analytical Development at Patheon Inc. where his laboratories developed more than 40 new chemical entities for global regulatory submissions from 2002 to 2005. Dr. Lee also held several senior managerial positions during his 11 years at Eli Lilly Canada Inc. He is the founder of Calibration & Validation Group, a non-profit organization with more than 1,500 analytical and formulation scientists from the industry, academia and government agencies across Canada.  

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  • Nick Toltl, Ph.D. – Vice President, Research & Development

    Dr. Nick Toltl holds a Ph.D. in Chemistry and brings 13 years of experience in the Pharmaceutical industry.  A creative, diverse scientist with expertise and extensive experience as a pharmaceutical development leader, Dr. Toltl successfully combines theoretical and practical training in analytical as well as physical organic chemistry. 

    Prior to joining the Concept2Clinic team Dr. Toltl had oversight of all R&D activities at SGS Canada Inc., Life Science Services as R&D Manager.  While in that role, he designed hiring strategies, increased internal capabilities, and drove the direction of the group to enable new business development and was the lead technical resource for successful RFP requests for both mid-sized and large pharmaceutical companies.

    His background includes designing and executing complex pharmaceutical product control strategies enabling clinical and toxicological studies in GMP/GLP environment.  He has also served as technical expert and cross functional leader for numerous complex problems driving change and implementing solutions.  Dr. Toltl also held the role of Group Leader/Principal Research Scientist at Eli Lilly and Company for 10 years prior to SGS.

    Dr. Toltl has authored multiple successful IND and CTA regulatory submissions as well as addressed regulatory questions. He has also authored numerous technical reports, led and designed research programs, organizational project work plan development, automation strategies, and technology initiatives to advance research.   In addition, Nick has initiated and facilitated multiple academic collaborations within Canada and is a current member of the Executive Council of the Analytical Chemistry Division, Chemical Institute of Canada.  

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  • Johnathan W Kirkwood, B.Sc. - Regular Affair & Quality

    Mr. Kirkwood, has over 20 years experience serving the healthcare industry in the areas of Regulatory Affairs.  He has held senior management positions in Regulatory Affairs, including Cangene Corporation (2004-2009); Eli Lilly Canada Inc. (2002-2004); Boehringer Ingelheim (Canada) Ltd. (1999- 2002); Pharmacia & Upjohn Inc. (1996 –1999). Mr Kirkwood was responsible for regulatory submissions in Canada , Europe , US, and other countries for many recombinant protein products (rhGH, rhGM-CSF), plasma-derived immunoglobulin (hyperimmune) products, Xigris (activated Protein C), Forteo (teriparatide), and the global regulatory approval of Strattera (atomoxetine) and Cialis (tadalafil).

    His current and past clients include academic institutions with gene or cell therapy projects entering clinical trials, small biotech companies with multiple early-phase candidate products, established pharmaceutical manufacturing firms developing new dosage forms for existing marketed products, and foreign pharmaceutical companies seeking to enter the North American market.

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  • Andy Tallevi, B.Sc.CMC (Formulation/Process Director/Quality Systems Development)

  • Andy Tallevi is a Formulation/Process expert with 28 years of industrial experience assisting the Pharmaceutical and Chemical industries with formulation and process issues. Andy worked as a Senior Pharmaceutics Scientist for GlaxoSmithKline, Canada for 18 years with leading many new chemical entity projects of varying dosage forms. His specialty is solid oral dosage forms and was successful formulating immediate and controlled release tablets, working with conventional matrix approaches as well as proprietary technologies such as Procise® and DiffCORE®.  He has been responsible for production of clinical supplies of NCEs in Canada, Europe and the US. Andy understands material properties required of excipients and actives for successful formulation and for robust processes, is well versed on particle sizing and powder flow and holds a US patent on a novel approach for the assessment of the flow of pharmaceutical powders.  

    Prior to leaving GSK Andy was key in the company-wide effort to strengthen processes by Design for Manufacture through the use of PAT and experimental design. In addition to his technical credentials, Andy has an excellent understanding of the regulatory requirements for pharmaceutical development and has assisted companies in audits by Health Canada and the FDA.  Most recently Andy spent 1 year with Health Canada in the Bureau of Pharmaceutical Sciences reviewing and evaluating generic submissions and making recommendations for approval or refusal of Notice of Compliance for the Bureau. He has gained significant insights to the regulatory requirements and expectations of the drug substance and drug product sections of a submission filing to Health Canada.

    Prior to GlaxoSmithKline Andy worked as a scientist for Unilever developing products in the health, beauty and detergent industries. He graduated from the University of Toronto with a B.Sc. major in Chemistry. 

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  • Mary Mazur-Melnyk, Ph.D. – Quality/Regulatory

  • Dr. Mazur-Melnyk is focused on serving the healthcare industry in the areas of Quality/Regulatory Systems, and Process Transfer and Validation/Scale-Up.  She specializes in the areas of Pharmaceutical and Medical Devices (all Classes in FDA, Canadian, Australian and EU environments), Vaccines, In Vitro Diagnostics, Dental Healthcare Products, Disinfectant Drugs and Non-Clinical and Clinical Operations (Bioanalytical and Analytical Testing).  

    Dr. Mazur-Melnyk also lends her expertise to others as a Professor for AAPS (Academy of Applied Pharmaceutical Sciences – Ontario certified College and University) providing Post Graduate training dedicated to the healthcare industry requirements in areas of clinical trial management and regulatory affairs compliance.  Her past experience includes Custom Biologics (GLP and GCP bio-analytical laboratory) QA support since 2006 and her services have been secured by the Canadian Government Microbiology Laboratory in Winnipeg to establish a gap assessment to OECD and FDA CFR Part 58 GLPs.   

    Prior roles held were Vice President of Corporate Quality Operations and Regulatory Compliance Biovail Corporation, Senior Director of Quality Assurance and Quality Control Biomira, Director of Regulatory Affairs, R&D and Quality Operations (Medical Devices and Drugs) Novartis (CIBA Vision), Quality R&D Head Canada and  Co-Director of Project Control Office Technology Transfer Manager Pharmaceutical Sciences QA for GSK and various Quality positions within Sanofi Pasteur (Pasteur Merieux Connaught) 1990-1996.   

    Dr. Mazur-Melynk received her PhD in Molecular Biology/Biochemistry/Toxicology from York University , her M.Sc. in Medical Sciences from McMaster University Medical Center and her Honors B.Sc. in Biology/Microbiology from the University of Toronto .

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  • Austin Freedman, B. Pharm. (Hons). MRPharmS – CMC & QA Specialist

  • Austin Freedman has extensive and varied experience in Industrial Pharmacy, Pharmaceutics, Pharmaceutical R&D and Technology Transfer project leadership in the UK and Canada through Glaxo, GlaxoWellcome, GlaxoSmithKline, Patheon and Apotex. Austin’s accomplishments in technical project leadership are complemented by his skills in business management with P&L accountability, client relationship management and organizational & operational development.  

    Austin earned his Bachelor’s degree (with honours) in Pharmacy in 1984 from the University of London, UK and is a member of the Royal Pharmaceutical Society.   

    Austin began his career in the pharmaceutical industry by joining the Pharmaceutical Research Department of Glaxo Group Research, UK. During the next 15 years, Austin gained in-depth knowledge and practical understanding in developing a wide range of pharmaceutical solid and liquid (including parenteral) products, spanning the entire drug development process from pre-clinical development to scale up and transfer to commercial production. In 1999, Austin transferred to GlaxoWellcome in Ontario, Canada to contribute his experience to the Pharmaceutical Sciences department, where he had CMC leadership roles on multi-national project teams developing significant products for GlaxoWellcome and GlaxoSmithKline.   

    Seeking an opportunity to contribute to a rapidly growing organization in a business/client service environment, Austin joined Formulation Development, Pharmaceutical Development Services at Patheon’s Toronto Region Operations in 2002. During his 8-year career at Patheon, Austin had a variety of senior roles that combined his technical knowledge and business leadership to enable multidisciplinary pharmaceutical development units to meet the requirements of diverse portfolios of clients’ projects, which included formulation and manufacturing process development to support regulatory submissions, clinical programs and technology transfers.   

    In 2011, Austin joined Apotex as Director, Technical Operations at the site in Etobicoke, Ontario, where he facilitated operational excellence and new product launches in the fast-paced generic pharmaceutical environment. While at Apotex, Austin developed and implemented technology transfer process improvements to enable manufacturing processes for a wide variety of products to be transferred robustly between sites in Canada, Europe and India.   

    As a consultant, Austin combines his extensive experience in the innovator, generic and contract sectors of the pharmaceutical industry with his professional training as a pharmacist to provide CMC and Quality Assurance expertise to meet the needs of clients’ projects, through all stages of development and commercialization.   

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