Purpose of the summary

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1 Summary of Expertise, Experience, and Affiliations and Interests Scientific Advisory Committee on Sciences and Clinical Pharmacology (SAC-PSCP) Purpose of the summary The following table summarizes the information about expertise or experience, affiliations and interests relevant to the Scientific Advisory Committee on Sciences and Clinical Pharmacology mandate declared by committee members. Health Canada considered these declarations as part of the selection process. The Health Products and Food Branch has made this summary available as part of its commitment to be transparent about the membership of its advisory bodies. Assessment of affiliations and interests prior to each meeting Prior to each committee meeting, the Health Products and Food Branch assesses members affiliations and interests, including direct financial interests, as they may apply to agenda items for discussion. Depending on the nature of the member's affiliations or interests, the Branch, or the chair of the committee in consultation with the Branch, may limit the participation of a member in the meeting or ask himher to make a verbal statement of affiliations and interests at the beginning of the meeting. Members affiliations and interests are reviewed on an annual basis and updated as required based on changes in the status of their affiliations and interests. In accordance with the Health Products and Food Branch Review of Regulated Products: Policy on Public Input and Guidance on Advisory Bodies, a person with a direct financial interest in the outcome of a review of a regulated product may be a member of an advisory body whose broader mandate encompasses matters of policy, management, or program development. However, such a member would not be asked to participate in any discussion, formulation of advice, or recommendations to the Branch relating to that review. Indicated SectorPerspective and Expertise Sectorperspective: Health professional Industry Research Non-government agencies Expertiseexperience: Bioequivalence Biostatistics Pharmacology Laboratory analytical techniques Medicinal chemistry Medicine 1

2 Pharmacy manufacturing product formulation Pharmacokinetics Physical pharmacy 1. Direct financial interests a. Current employment, investments in companies, partnerships, equity, royalties, joint ventures, trusts, real property, stocks, shares or bonds, with the regulated industry 2. Indirect financial interests a. Within the past five years, payment from regulated industry for work done or being done, including past employment, contracts or consulting; or financial support including research support, personal education grants, contributions, fellowships, sponsorships, and honoraria 1 b. Within the past five years, materials, discounted products, gifts, or other benefits, or attendance at meetings where all or part of the travel and accommodation costs were provided by the regulated industry 2 c. Within the last three years, grants or other funding from the regulated industry to any of the organizations where you are currently employed or participate in internal decision making 3 3. Intellectual interests a. Within the last five years, any formal advice or opinion to industry, a government organization or a non-government organization on a matter of relevance to the SAC-PSCP. b. Within the last five years, any published or publicly stated point of view on issues of relevance to the SAC-PSCP mandate. c. Current professional or volunteer affiliations such as membership of professional societies, lobbying, public interest or advocacy groups, of relevance to the SAC- PSCP. 4. Other a. Any other affiliations and interests or potential circumstances that might give a well-informed member of the public reasonable grounds for concern regarding the integrity and objectivity of your participation other than from present employer other than from present employer, over $1,000 participate in internal decision making means as a board member, or as an executive or nonexecutive director 2

3 Name and Indicated SectorPerspective and ExpertiseExperience Summary of Responses Jake Thiessen (Chair) Kwok Chow Pharmacokinetics manufacturing 1a. no 2a. yes 2b. no 2c. no 3a. yes 3b. yes 3c. yes 4a. no Consultant in scientific, business and regulatory issues for various pharmaceutical companies. Since 2005, has been the Chair for Health Canada's Scientific Advisory Committee on Bioequivalence and Bioavailability. Provided expert testimony to the Tax Court of Canada. Has published numerous articles on Bioequivalence and Bioavailability. Member of the Canadian Society of Scientists and the American Association of Scientists. 1a. yes 2a. yes 2b. no 2c. no 3a. no 3b. no 3c. yes 4a. no Senior Director, Global PDS Technology and Alliances, Patheon Inc. ( ). Stock and healthcare mutual funds. Invited presentations for not-for-profit professional organizations. One day training course on drug delivery systems for Health Canada. One day expert panel discussion for a pharmaceutical company in the United States to improve the bioavailability of a poorly soluble drug. Technology assessment for a consulting company in Canada on a drug delivery technology. Research grant proposal review including review applications for the United States Food and Drug Administration (FDA) grants on behalf of the National Institute for Technology and Education, USA. Member of the American Association of Sciences. 3

4 Eugenia Palylyk- Colwell B.Sc. Pharm, product formulation Registered Pharmacist - Ontario College of Pharmacists (plan B status). Registered Pharmacist - California State Board of Pharmacy (1981 to 2012). Industry 1a. no 2a. yes 2b. yes 2c. no 3a. yes 3b. no 3c. no 4a. no April 2008 to present - occasionally has been asked by the brand name pharmaceutical industry to participate in panel or advisory board meetings on reimbursement issues for brand name products that have been approved or are in clinical development. Sept to Feb contracted to write a clinical study report on a product under development. Feb to March contracted to review, edit, discuss andor write clinical summaries and other provincial submission-related documents pertaining to brand name products. May 2006 to present - in , contracted to write a clinical summary and to review, edit andor write various documents and correspondence pertaining to provincial submissions. In 2011, contracted to provide consultation and to assist with on-going reimbursement issues for provincial drug program payers. In Sept and February 2012, attended reimbursement advisory meeting pertaining to new products which have not yet been approved. Has received contracts in 2012 for the preparation of clinical summaries and an executive summaries for future submissions to the Common Drug Review (CDR) and provincial payers. Feb to present - contracted to review, edit andor write clinical summaries and other submission-related documents pertaining to various brand name products. In March, July and October 2011, wrote clinical summaries with new data for the treatment of chronic diseases. Received reimbursement on travel and accommodations expenses by the respective pharmaceutical manufacturers when asked to participate on advisory panels. Since 2006 she has worked as a consultant for Alberta Blue CrossAlberta Health and Wellness and the Common Drug Review, Canadian Agency for Drugs and Technologies in Health. She has provided comments or advice on clinical data, pharmacokinetic matters and issues pertaining to bioequivalenceinterchangeability and reimbursement issues. 4

5 Allan Donner, FRSC Murray Ducharme PharmD, FCCP, FCP Robert Herman M.D., FRCPC Biostatistic Industry Bioequivalence Pharmacy Pharmacokinetics Pharmacokinetics Laboratory analytical techniques Bioequivalence Pharmacy Medicine Since 2010, contract reviewer for the Division of Biopharmaceutical Evaluation 1, Bureau of Sciences and in 2012 for the Bureau of Cardiology, Allergy and Neurological Sciences and has reviewed Abbreviated New Drug Submissions (ANDS) and Supplement to a New Drug Submissions (SNDS). Involved in the steering committee for a Canadian Society of Sciences symposium on bioequivalence from and presented at the symposium in 2001 on the provincial perspective on interchangeability. 1a. no 2a. no 2b. no 2c. no 3a. no 3b. no 3c. no 4a. no None 1a. yes 2a. no 2b. no 2c. no 3a. yes 3b. yes 3c. yes 4a. no President of a consultancy firm that helps pharmaceutical companies worldwide with their drug development and with their needs in terms of advanced Pharmacokinetic (PK)Pharmacodynamics (PD) modeling and simulations. Consultations to pharmaceutical companies on behalf of a contract research organization. Has made numerous publications and presentations. Member of the Scientific Committee of the Canadian Society of Sciences (CSPS) for the June 2012 meeting. 1a. no 2a. no 2b. no 2c. no 3a. yes 3b. no 3c. yes 4a. no Has provided advice for the Alberta Blue Cross Alberta Health and Wellness, Minister s Expert Advisory Committee on Drugs and Therapeutics, for a legal challenge against a pharmaceutical company, and was a member of Health Canada s Scientific Advisor Committee on Bioavailability and Bioequivalence. Member of the Canadian Hypertension Society Canadian Hypertenstion Education Program (CHEP) Guidelines Taskforce, Chair of the SubCommittee on Treatment of Df Hypertension in Adults Without Confounding Indications For Specific Agents. 5

6 Isadore Kanfer B.Sc. (Pharm),, FPS, MRPharmS Ping Lee Mitchell Levine B.SC., M.Sc., M.D., FRCPC, FISPE Bioequivalence Pharmacy Pharmacokinetics Medicinal chemistry manufacturing product formulation 1a. no 2a. no 2b. no 2c. no 3a. yes 3b. yes 3c. yes 4a. no Comments : Served on Expert Committees of the South Africa Medicines Control Council. Served as a paid per hour pharmaceutical consultant to patent lawyers in November 2007, May 2009 and July Has many publications and speaking engagements and is the co-editor for 4 books in the series Generic Drug Product Development. Member of Canadian Society of Sciences (CSPS), American Association of Sciences (AAPS) and Chairman of the AAPS Bioequivalence Focus Group 1a. yes 2a. yes 2b. no 2c. no 3a. yes 3b. no 3c. yes 4a. no Stocks various pharmaceutical companies. Principal investigator (non-clinical) for two pharmaceutical companies. Technical Presentations provided for various pharmaceutical companies. Paid expert witness in patent cases for various pharmaceutical companies Member of the Canadian Society for Sciences (CSPS) and the American Association of Scientists (AAPS) 1a. no 2a. yes 2b. yes 2c. no 3a. yes 3b. no 3c. yes 4a. no In 2010, reviewed a protocol for a post marketing study and provided feedback to the manufacturer. In 2011 gave a presentation about the Canadian formulary decision making process to a group of pharmacists from across the middle east. The meeting took place in Cairo. The sponsoring company provided my travel to Egypt. In March appointed as the Vice-Chair for the Patented Medicine Prices Review Board (PMPRB). Prior to March 2011, he was a member of the Human Drug Advisory Panel for PMPRB. 6

7 Raimar Löbenberg Christopher Loomis Pharmacology, Medicine Laboratory analytical techniques manufacturing product formulation Pharmacology Currently provide consultative advice to the Ontario Ministry of Health regarding drug benefit reimbursement decisions for individual patients on a case by case basis. Has provided testimony as an expert witness for who pharmaceutical companies, each involved in litigation occurring in the USA. Member of the Canadian Association of Pharmacology and Therapeutics, Canadian Association for Population Therapeutics, International Society for Pharmacoepidemiology. 1a. no 2a. yes 2b. no 2c. yes 3a. yes 3b. yes 3c. yes 4a. no Comments : Was an expert witness in patent cases and a member of reconsideration panels for Health Canada. Currently, Director of the Drug development and Innovation Centre at the University of Alberta, the center received different contracts to develop dosage forms. He had a collaborative research grant with a pharmaceutical company and Natural Sciences and Engineering Research Council of Canada (NSERC). Publishes pharmaceutically relevant research. Member of the United States Pharmacopeial (USP) expert committee for Dietary Supplement and is president elect of the Canadian Society for Sciences (CSPS). 1a. no 2a. yes 2b. no 2c. yes 3a. yes 3b. no 3c. no 4a. no In 2007, he received an honorarium since he served as a member of a Science Advisory Group for a pharmaceutical company in the USA. Member of the Science Advisory Board of Health Canada and member of the Canadian Institutes of Health Research (CIHR) Governing Council. 7

8 Gordon Mckay Elizabeth Vadas Laboratory analytical techniques Industry Medicinal chemistry 1a. no 2a. no 2b. no 2c. yes 3a. no 3b. no 3c. yes 4a. no Chief Executive Officer of Pharmalytics Ltd. but will be closed as of March 31, The company has worked with a variety of sponsor within the last 3 years (Canadian and American). Board member of the Saskatchewan Health Research Foundation, member of the American Society of Mass Spectrometry, member of the Canadian Society of Mass Spectrometry, member of the Canadian Society of Scientists, member of American Association of Sciences and also a fellow in the same society, member of the International Federation (FIP), Chair of the Lake Louise Workshop on Tandem Mass Spectrometry. 1a. yes 2a. yes 2b. no 2c. no 3a. yes 3b. yes 3c. yes 4a. no Ownership of common stocks in pharmaceutical companies. Following retirement from Merck Frosst, she established her own consulting company, InSciTech Inc. She consults for several drug discovery companies in USA and Europe. Reconsideration Panel Member for Health Canada Invited speaker at Scientific Conferences, Universities, Symposia in the area of solid state characterization of drug molecules, from selection, polymorphism and related matters. Member of the American Association of Sciences (AAPS), Canadian Society for Sciences (CSPS) and American Chemical Society (ACS). 8