Expert Panel on Immune Globulin Product Supply and Related Impacts in Canada - Biographies, Summary of Expertise, Experiences, Affiliations and Interests

Biographies

Chair: Penny Ballem, MD, FRCP, FCAHS

Dr. Ballem is a haematology specialist, currently a Clinical Professor of Medicine at the University of British Columbia as well as a Professor at the Institute of Health Policy Management and Evaluation, Dalla Lana School of Public Health, University of Toronto. She obtained her MD from the University of British Columbia following an M.Sc. in Immunology from the University of Western Ontario. Dr. Ballem has held a range of senior health consulting / advisory roles for governments, chair and co-chair roles for national and international committees, and six years as Deputy Minister of Health for BC, which included being its Liaison Deputy Minister to the FPT Council of Deputy Ministers of Health regarding Canadian Blood Services. Her awards and achievements include recognition as a Fellow of the Canadian Academy of Health Sciences (CAHS) for outstanding performance in the academic health sciences in Canada.

Deputy Chair: Francine Décary, MD, Ph D, MBA, IAS.A, OC, OQ

Francine Décary has a distinguished record as a haematology research scientist and blood system executive and expert. After studying medicine at l'Université de Montréal, Dr. Décary trained in blood transfusion at the New York Blood Center, and obtained a PhD in immuno-haematology from the University of Amsterdam. In 1996, she completed an Executive MBA at l'Université de Sherbrooke. By 1998, Dr. Décary was leading the Eastern Canada operations of Canadian Red Cross Blood Services, and subsequently founded and led Héma-Québec as Chief Executive Officer until 2011. Dr. Décary's awards for scientific and management excellence include the Prix du Québec's prix Armand-Frappier (2005), Officer of l'Ordre national du Québec (2008), and Officer of the Order of Canada (2012). Dr. Décary's Board experience includes the Canadian Society of Transfusion Medicine (chair), lnternational Society of Blood Transfusion (chair), America's Blood Centers (Council secretary), and l'Institut national de recherche scientifique (INRS) (subcommittee chair).

Special Advisor: Merlyn Sayers, MBBCh, Ph D

Dr. Sayers is President and CEO of Carter BloodCare, the community blood program in Dallas Fort Worth. He also serves on the faculty of the University of Texas Southwestern Medical Center. Dr. Sayers was previously the Medical Director at the Puget Sound Blood Center in Seattle, Washington and a faculty member at the University of Washington, Department of Hematology. Dr. Sayers' degrees were awarded by the University of Witwatersrand, Johannesburg, South Africa. He has previously served as the Vice Chair of the Washington State Board of Health, Chairman of the Food and Drug Administration's Blood Safety and Availability Committee, and President of America's Blood Centers (ABC). He is extensively published on issues that include transfusion safety and donor management. He is the most recent recipient of ABC's Lifetime Achievement Award.

Special Advisor: Patrick Robert, Ph D

Patrick Robert, Ph D is the president of the Marketing Research Bureau, Inc. since 1995, a market research firm specializing in collecting and analyzing data on blood and plasma products markets worldwide. Dr. Robert has thirty years of experience in the non-profit and commercial blood and plasma sectors including: WHO (1972), the French Social Studies Corporation (SEDES) (1975), and the OECD (1976). In 1977 he became the Administrator of the Blood Transfusion Department of the International Federation of Red Cross and Red Crescent Societies in Geneva, Switzerland. In 1987, he joined Bayer Corporation as Marketing Research Manager of Plasma Products Division (now Grifols). Dr. Robert holds a doctorate in Health Economics from University of Aix en Provence, France, and a Master of Public Administration from Cornell University, USA. He also studied in Tübingen, Germany for two years. He has published several articles on health care organization, and numerous market studies in the area of blood and plasma.

Summary of Expertise, Experiences, Affiliations and Interests

The following table summarizes the information about affiliations and interests relevant to the Expert Panel on Immune Globulin Product Supply and related Impacts in Canada ("Panel") mandate declared by Panel members. Health Canada considered these declarations as part of the appointment process.

This summary is available as part of Health Canada's commitment to be transparent about the membership of its advisory bodies. Information about members’ expertise and experience is provided in their biographies.

Questions asked to assess affiliations and interests

  1. Direct financial interests
    1. Do you, your spouse/partner, or dependent minor child have any direct financial interests that are of relevance to the mandate of the advisory body, including current employment, investments in companies, partnerships, equity, royalties, joint ventures, trusts, real property, stocks, shares, or bonds?
  2. Indirect financial interests
    1. Within the past five years, have you or your spouse/partner received payment for work done or being done, or financial support, from a party that has an interest in the mandate of the advisory body? Include past employment, contracts or consulting, research support, personal education grants, contributions, fellowships, sponsorships, and honoraria for teaching, speaking, or writing engagements Footnote 1
    2. Within the past five years, have you or your spouse/partner received materials, discounted products, gifts, or other benefits, or attended conferences or meetings where all or part of the travel and accommodation costs were provided by a party that has an interest in the mandate of the advisory body? Footnote 2
    3. Within the past five years, have any of the organizations where you or your spouse/partner are currently employed or where you or your spouse/partner participate in internal decision making (that is, as a board member or as an executive or non-executive director) received grants or other funding from a party that has an interest in the mandate of the advisory body? Footnote 3
  3. Intellectual interests
    1. Within the past five years, have you provided any formal advice or opinion to industry; a Canadian federal, provincial, or municipal government; a foreign government; or a non-government organization on a matter of relevance to the mandate of the advisory body? Include expert testimony or acting as witness (full or part-time), participation on an advisory body, and so on.
    2. Have you ever made public a statement (speeches, lobbying, and so on) or publicly stated a point of view (including in scientific papers, articles, journals, or other publications, or on websites) on issues of relevance to the advisory body's mandate?
    3. Do you currently have any professional or volunteer affiliations (such as membership in professional/scientific societies, trade associations, lobbying, public interest, or advocacy groups) that may have an interest in the mandate and work of this advisory body?
  4. Other affiliations and interests
    1. Do you or your spouse/partner have any other affiliations and interests or potential circumstances that might give a well-informed member of the public reasonable apprehension or grounds for concern regarding the integrity and objectivity of your participation in this advisory body?
Name and Role Summary of Responses
Dr. Penny Ballem Chair 1a. N 2a.Y 2b. N 2c. N 3a. N 3b. Y 3c.Y 4a. N

2. b) Contracts or consulting: I have provided or will be providing consulting services for 3 Ministries of Health in Canada – Alberta, Ontario, Nova Scotia - none of these contracts involve in any way the issues faced by the Panel however all FPT Ministries of Health have an interest in the mandate of the Panel.

  • Alberta Health: contract value over the next 2 years up to $250,000
  • MOHLTC Ontario: contract value over the next 2 years – not yet determined
  • Department of Health, Nova Scotia: contract value over the next 2 years not yet determined

3. b) I was a Deputy Medical Director of the Canadian Red Cross Blood Transfusion Service, BC and Yukon from 1985-1991. At that time the CRCBTS had a strategic goal to become self-sufficient in the collection of plasma from volunteer Canadian donors to meet the needs of plasma derived products for Canadian patients. This strategic goal of the CRCBTS was directly related to the perception of risk of infection (HIV and Hepatitis) from paid plasma donors in the USA whose plasma was used to make plasma derived products which were used in Canada. I do not have a list of statements by date and never published an article related directly to this.

From 2001 to 2006 I was the Liaison DM for CBS at the FPT Council of Deputy Ministers of Health. In that role I was working with colleagues across the country on various public policy issues related to CBS – all of which were concerned with the safety, sustainability, and cost of the blood supply in Canada.

3. c) I am a Fellow of the Canadian Academy of Health Sciences, a scholarly organization which publishes extensively on issues pertinent to the health and health care of Canadians.

I am a Professor at the Dalla Lana School of Public Health, University of Toronto which would have an interest in the work of this body from a public health perspective.

I am a Clinical Professor in the Department of Medicine, Division of Hematology at the University of British Columbia where colleagues are involved in the transfusion and use of all blood and plasma related products.

Dr. Francine Décary Deputy Chair 1a. N 2a.N 2b. N 2c. N 3a. N 3b. N 3c.N 4a. N

Comments

3. b) Throughout my career (until 2011), I was often media spokesperson for my organization and in that role have commented on a wide range of issues related to blood and plasma products. I have also authored/co-authored numerous research articles on transfusion medicine, including some that refer to IVIG. However, to the best of my recollection, I have not previously made public statements about the current issues to be examined in this Panel.

Dr. Patrick Robert Special Advisor 1a. Y 2a. Y 2b. Y 2c N 3a. N 3b. N 3c. Y 4a. N

Comments

1. I own individual stocks in several plasma companies: CSL Behring, Grifols, and Shire.

2. a) CBS and Héma-Québec both subscribe to our newsletter International Blood/Plasma News.
CBS' subscription costs US$950, and Héma-Québec's, US$425
On August 15, 2015, my colleague Matthew Hotchko and I participation in a one-day "Plasma Market Intelligence Workshop" in Ottawa. During this meeting, Matthew and I made a presentation on plasma products' Supply and Demand and answered a number of questions from the participants. For this consulting job, our company charged CBS US$4,763.65, consisting of US$3,263.65 in travel expenses and US$1,500 in consulting fees. In anticipation to this meeting, CBS purchased several reports from our company, the Marketing Research Bureau (MRB) for a total of approximately US$12,500. CBS has purchased many reports from MRB over the years. Héma-Québec has also purchased various reports from the MRB in recent years, and in 2015, commissioned the MRB to develop a forecast of IVIG demand as a "single client" project, which included various reports, totaling US$8,850.

2. b) See above. The travel expenses to attend the meeting to Ottawa was covered by CBS.

3. a) Our participation to the August 2016 CBS meeting was to provide data and information, not advice and opinion.

3. b) I have made many presentations to various plasma industry meetings. They have invariably aimed at providing data and information, and not at expressing opinions, making policy statements or lobbying.

3. c) I am an individual member of the American Association of Blood Banks, of the International Society of Blood Transfusion, of the World Federation of Hemophilia and my company, the MRB is an associate member of the Plasma Protein Therapeutics Association (PPTA).

Dr. Merlyn Sayers Special Advisor 1a. Y 2a. Y 2b. N 2c N 3a. Y 3b. N 3c. Y 4a. N

Comments

1. I am the President and Chief Executive Officer of Carter BloodCare, the community independent blood program for North Central and East Texas. The population served is in excess of 8 million. Blood products collected annually are in excess of 300,000 units. The blood program's services include: recruitment, collection, processing, testing, storage and distribution to more than 200 medical facilities in over 50 counties.

Carter BloodCare is AABB accredited, certified by the Foundation for the Accreditation of Cellular Therapy, and licensed by the Food and Drug Administration. The blood center is also a member of America's Blood Centers, the trade organization representing community independent blood programs in the USA that are responsible for about half of the nation's blood supply.

2. a) Ending in 2016, I served 11 years on the Business Advisory board for Terumo BCT, a global company specializing in blood component, therapeutic apheresis and cellular technologies. The value during the period of service was approximately $75,000. I no longer hold this position.

3. a) As the President and CEO of Carter BloodCare and as a Professor at the University of Texas Southwestern Medical Center and as former President of America's Blood Centers (2003) I have made numerous statements on recruitment, collection, component preparation, and distribution of blood products. I have never made any formal statements regarding blood products in Canada. I was an invited speaker, with paid travel and accommodation, at the Canadian Society for Transfusion Medicine in Ottawa on April 21st 2017. I spoke on screening blood donors for risks of cardiovascular disease.

3. c) I do not have professional or volunteer affiliations, but I have attended conferences / symposiums organized by:

  1. The International Plasma Fractionation Association
  2. The Plasma Protein Therapeutics Association

There was no reimbursement for travel or accommodation when I attended these meetings.

Footnotes

Footnote 1

other than from present employer.

Return to footnote 1 referrer

Footnote 2

other than from present employer, over $1,000.

Return to footnote 2 referrer

Footnote 3

"participate in internal decision making" as a board member or executive or non-executive director.

Return to footnote 3 referrer

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