Consultants Profile

Carrie KaiYue Wang, M.D.
Drug Development, Project Management

Dr. Wang is a scientist and an experienced surgeon. Dr. Wang has been Pre-Clinical Consultant of RF Therapeutics, Inc. since 2000, where she provides preclinical expertise to product development and efficacy studies in the field of tissue necrosis. Dr. Wang has also been Research Scientist of Angiotech Pharmaceuticals, Inc. since 2000, where she develops animal models of various diseases, provides surgical expertise to clinical trials and preclinical GLP toxicity and efficacy studies in the field of vascular graft failure and intra-articular inflammation, and writes invention disclosures, project proposals, study protocols and reports. She led the early discovery R&D efforts of a then commercialized product. Dr. Wang was Research Associate of Angiotech Pharmaceuticals, Inc. from 1998 to 2000 prior to her promotion as Research Scientist. Dr. Wang has eleven years clinical experience in general and laparoscopic surgery and ten years experience in experimental vascular surgery. She was Research Associate in the Department of Vascular Surgery of the University of British Columbia from 1997 to 1999. She was Attending Surgeon of Second Municipal Hospital in Sichuan, China from 1988 to 1995.

Dr. Wang received her M.D. degree from the Medical School of West China University of Medical Sciences in Sichuan, China. She has filed 2 patents in the USA and Europe and is author of 10 scientific publications and presentations.

Herman Lam, Ph. D.
Compliance and Regulatory, Training

Dr. Lam is very active in the field of instrument qualification, performance verification and method validation. He has a wealth of experiences in a wide range of analytical instrumentation which enable him to solve very challenging analytical and manufacturing issues. Prior to embarking on his own consulting business in 2008, Dr. Lam was Principal Investigator at GlaxoSmithKline (Canada). He joined Glaxo Canada as Research Scientist in 1989 where he managed product development projects to support IND and NDA submissions. He gradually shifted the focus of his work to analytical instrumentation and lab automation and had laid the foundation of lab instrument qualification, performance verification and instrument management program. He was also responsible for the implementation of new analytical technologies and had led the development of a custom designed automated system for nasal spray analysis.

Dr. Lam co-founded the Calibration & Validation Group (CVG) in 1995. CVG is a government registered non-profit professional organization with focus on the calibration, validation and analytical sciences in the pharmaceutical industry. He is currently President of CVG. Dr. Lam was a member of the USP Dissolution Calibrator advisory panel. He is currently a member of the USP reference standard project team.

Dr. Lam has developed instrument qualification and performance verification courses for Agilent Technologies and CVG; and has presented the courses at various organizations and institutions in the North American and Asia. He has been invited to lecture at Health Canada, Shanghai Bureau of Quality and Metrology, and other universities.

Dr. Lam received his Bachelor of Science degree from the University of Toronto and his Ph.D. degree in Chemistry from York University. He is co-editor and co-author of a few books. He is currently working on a new book to be published in 2009 on advanced instrumentation methods and performance verification topics to complement the 2004 volume.

Irene Li, B.Sc.
Project Management, Compliance and Regulatory

Ms. Li is a result-focused quality and regulatory affaires consultant with over 10 years of hands-on experience in the pharmaceutical and biopharmaceutical industry in both Canada and China. Ms. Li was Project Consultant of Alcan Pharm Packaging – PharmEng Technology Inc. for redesigning the renovation of a GMP facility. Ms. Li was Quality and Regulatory Affaires Consultant of Premier Diagnostic/IPET Pharmaceuticals Inc. for the design and validation of a new GMP facility and the respective Establish License application. Ms. Li was Quality Assurance Associate and Project Coordinator of Dragon Pharmaceuticals Inc. where she managed API submission projects in EU and other countries, and developed and implemented QA procedures and the documentation system. Ms. Li was Project Manager and Assistant President of Chongqing BTM Biotechnology Co., Ltd. in Chongqing, China, where she was responsible for ensuring meeting the requirements and regulations of the State Food and Drug Administration (SFDA) in China for a product registration submission project. She also launched and completed a Phase III clinical trial according to GCP requirements. Ms. Li was R&D Manager and Vice President of Chongqing Duotai Pharmaceutical Co., Ltd. in Chongqing, China, where she coordinated the registration submission to SFDA for a new drug license and transferred the products from a pilot to a full production scale. She also completed the GMP certificate application project. Ms. Li was QA Manager of Shenzhen Neptunus Pharmaceutical Co., Ltd. in Shenzhen, China, where she established and implemented a GMP quality system.

Ms. Li received her Bachelor of Sciences degree in Pharmacy Science from Guiyang Medical University in Guiyang, China. Ms Li is a Licensed Pharmacist in China.

Milica Jovanovic, M.Sc.
Project Management, Compliance and Regulatory

Ms. Jovanovic is the founder of MJ Pharm Consulting where she provides a wide range of consulting services to support Pharmaceutical Research & Development, Quality Laboratories, and Contract Research Organizations and help them to align technical solutions to business objectives. Ms. Jovanovic possesses extensive expertise and knowledge of analytical development and regulatory compliance with 25 years of leadership and hands-on experience in the industry and 5 years of teaching experience. In the past 15 years, Ms. Jovanovic has held strategic management roles in major Canadian generic pharmaceutical companies. The most recent positions were Director of Analytical R&D Laboratory at Genpharm Inc. (a subsidiary of Merck KGaA, Darmstadt) and Manager of Analytical Development at Apotex Inc. In addition to Ms. Jovanovic’s core competencies, she has access to a vast network of strategic partners and professionals who can enhance her services by providing a broad range of services in Regulatory Affairs for the global market, Formulation Development and Bio-studies.

Ms. Jovanovic received her Bachelor of Science degree and Master of Science degree in Chemistry with a specialization in Biochemistry from the University of Belgrade in Belgrade. Ms. Jovanovic is a member of the Calibration & Validation Group (CVG) and a member of the American Association of Pharmaceutical Scientists (AAPS) in the USA.