National Health Science Foundation - PowerPoint Presentation

Slide1

National Health Science Foundation

Accredited Independent Mark of Efficacy (AIME

TM

)

Session 2

Rationale for Recognition of Clinically Proven Products

“Many stakeholders believe in the need to provide an independent review of products to accredit those which have robust specific evidence to support them”

Options for

Consumer Information Source

Development by the NHSF

Recommended

What is the AIME Service?

It is an independent way of providing consumers with the ability to understand whether the clinical claims made for product they are buying has been supported by clinical evidence

It provides both an on-pack logo and an online support mechanism

There is a limited database of information about the product (containing basic product summary information, but not an extensive database)

Application for inclusion is made by the company marketing the product (and in some cases by the ingredient manufacturer)and is controlled through a strict system linked through bar coding)

The review of the application by an independent panel (the Clinical Advisory Board – which is distinct from the Clinical Round Table)

The service will be revenue neutral or revenue positive for the NHSF

Both the NHSF and member companies will commit to the promotion of the Service to ensure it becomes recognised as a mark of product excellence

The Panel will also be able to offer advice to companies with an interest in improving the quality of the their clinical trials with a view to improved chance of publication in preferred journals

Rationale

The clear identification of the point of differentiation of the well developed products

in the industry will

provide a clear rationale for being a part of the

organisation

It will start to focus consumer awareness on the standard they should be seeking

It will be self funding and provide funds to promote both the service and the organisation in its formative

years

It provides a visible means of highlighting product excellence and is a critical means of raising the bar for all players

The detailed database solutions, either alone or with the ABC continue to be important but given the limited resources of the organisation the early efforts need to focus on the activities that will provide the widest interest.

The next stage of database development should be considered at approximately Year 3-4of the organisations operational life

Initial Recommendation

How does IT Work

The Assessed Independent Mark of Efficacy

What does the AIME Service Do and How does it Work

Administered by the NHSF Secretariat

All product inclusion recommendations are completely at the discretion of the Independent Advisory Board

The Advisory board is made up of Global experts in the development and assessment of clinical evidence

Costs associated with the Advisory Committee are covered by the assessment fees

The NHSF and Member Companies commit to the promotion of the “Tick” and the Clinical Trials Advisory service

Clinical Advisory Board

The Clinical Advisory Board (CAB)is a group of 6 independent experts with global recognition in their area of specialty and with a proven track record in successful clinical trial development and assessment, a strong list of publications, and editorial experience on a range of peer reviewed clinical journals

The role of the CAB is:

To determine the criteria for product inclusion in the AIME

Review all applications for product inclusion into the AIME and approve / reject and assign status

Sign off on final documentation posted on the AIME

CAB Chair to advise the CEO of key issues, opportunities for improvement and concerns pertaining to the AIME; and to provide advice to the Board as required

The CAB Chair is not a member of the Board of Directors

Proposed CAB Membership

Chair Professor John Funder AC MD

BS PhD FRACP FRCP LLD (Hon Monash University),

DMedSci

(Hon University of Melbourne), MD (Hon. University of Sydney

)

Chair of NICM Advisory Board; Member

of NICM Research CommitteeJohn Funder was President of the Australian Society for Medical Research (1979)and the Endocrine Society of Australia (1984), and (1996–2000) Chairman of the International Society for

Endocrinology. In 1990 he resigned as a Senior Research Fellow of the National Health and Medical Research Council to become Director of the Baker Medical Research Institute (1990–2001). He is a Senior Fellow at Prince Henry's Institute of Medical Research at Monash Medical Centre, and a Professorial Fellow at the Centre for Neuroscience at the University of Melbourne. Having published over 500 scientific papers, Funder is an expert in mineralocorticoid receptors and aldosterone biology and serves as a consultant to many pharmaceutical companies engaged in this field.

Dr. Gerry Bodeker researches and advises on international public policy on traditional (indigenous), complementary & alternative medicine and wellness.

Having completed Doctoral studies at Harvard, he has held research and teaching appointments in the Division of Medical Sciences at Oxford University for two decades. Dr.

Bodeker

has been chair of the Commonwealth Working Group on Traditional & Complementary Medicine and done work on medicinal plant conservation for the World Bank, the Global Environment Facility, UNU, and the UN Food & Agriculture Organization. He is co-founder of the WHO-affiliated Research Initiative on Traditional Antimalarial Methods (RITAM). He has written extensively on traditional medicine and is editor-in-chief of the WHO Global Atlas on Traditional and Complementary Medicine and serves on the editorial boards of several journals. He has authored chapters in the

Encyclopedia of Public Health (Elsevier 2008, 2017) on "The health of indigenous peoples" and on "Integrative medicine".. He is a Fellow of the International Union of Pure & Applied Chemistry

Proposed CAB Membership - Continued

Sir Peter David

Gluckman

, ONZ, KNZM, FRS,

FMedSci

, FRSNZ is a New Zealand paediatrician. He is currently the inaugural Chief Science Advisor to the New Zealand Prime Minister.

Associate Professor David Eisenberg -

Associate Professor of Nutrition at Harvard T.H. Chan School of Public Health and Executive Vice President for Health Research and Education at the Samueli Institute.. From 2000-2010, Eisenberg served as the founding Director of the

Osher Research Center at Harvard Medical School and the founding Chief of the Division for Research and Education in Complementary and Integrative Medical Therapies. He simultaneously served as the Director of the Program in Integrative Medicine at the Brigham & Women’s Hospital. His current educational and research interests include: (1) studies to assess the safety, clinical, and cost effectiveness of complementary and integrative medical therapies; (2) the systematic evaluation of herbal medicines using state of the science technologies; and (3) novel multi-disciplinary strategies to optimize lifestyle and self-care

behaviors

(e.g., diet, exercise and stress management) to prevent, treat and manage common medical conditions. Eisenberg is a graduate of Harvard College and Harvard Medical School. He completed his fellowship training in general internal medicine and primary care and is Board Certified in Internal Medicine. Eisenberg has served as an advisor to the National Institutes of Health, the Food and Drug Administration, and the Federation of State Medical Boards with regard to complementary, alternative and integrative medicine research, education, and policy.

Proposed CAB Membership - Continued

Salvador

Cañigueral PhD, Professor of

Pharmacognosy

and

Phytotherapy

in the Faculty of Pharmacy of the University of Barcelona. His research deals with the chemistry and biological activity of medicinal plants.. His research also

dealls with the development of methods for quality control of herbal preparations for medicines, dietary supplements, feed and cosmetics.He is widely published with over 100 research papers, 250

confernce contributions and editorship and contributions to many books. In addition, he is founder and scientific editor of the Spanish Revista de

Fitoterapia and member of the editorial advisory board of the journal Planta Medica.He

is full member of the Royal Academy of Pharmacy of Catalonia, founder member and President of the Spanish Society of Phytotherapy (Sociedad Española de Fitoterapia, SEFIT), and member of the Board of the International Council for Medicinal and Aromatic Plants (ICMAP). He has also been member of the European Scientific Cooperative on

Phytotherapy

(ESCOP) (2003-2016) and the Board of Directors de la Society for Medicinal Plant Research (GA) (2004-2005), and the chairman of the 50th Annual Congress of the Society for Medicinal Plant Research (Barcelona, 2002).

He

has been the chairman (1997-2002) of the Phytotherapy group of the Spanish National Formulary and he is the chairman (1999-) of the Phytochemistry group of the Spanish Pharmacopoeia, as well as member of the Phytochemistry groups 13A (2005-) and 13B (1999-), as well the group on Extracts (2012-), of the European Pharmacopoeia. He is the current president (2011-) of the group 13A of the European Pharmacopoeia. Additionally, he is member of the essential oil committee of the Spanish Agency of Standardisation (AENOR) and the external expert panel of EMA (European Medicines Agency).

Additional Expert to be identified

On-Pack “Tick” for Products with their own Clinical Trials

Early stage of product development, on the market

but with only one promising trial and a commitment

to an ongoing program

Classification valid no longer than 2 years, at which time

new data should be presented for reclassification

Suited to start up companies with 1 0r 2 products

One

RCT showing

non-inferiority published in a peer reviewed journal

Two or more

RCTs published

in well recognised peer reviewed journals showing consistent results

Tick Process for Ingredient Companies

Ingredient Companies may wish to apply for “Tick” status for their specific ingredients if they have invested in clinical

trials showing the effectiveness of their ingredient.

They will follow the standard application process, but will receive an “Ingredient Approval”

An ingredient approval does not provide automatic on-pack access

Products

using these ingredients will then be eligible for a simplified application process if they wish to reference the credentials of the

ingredientEach Product that uses that ingredient must make a separate application to utilise the “Tick” on their packaging and to be listed on the database

The Application for use of an ingredient tick is a simplified process that focuses on the product labelling, the formulation and the recommended dosing to ensure consistency with the original published studiesThe formulation must not include ingredients that were not present in the original studies

If the Advisory Board deem that the use of the ingredient within the product is consistent with the original trials a Linked Master Number will be provided for on pack artwork and the bar code will be linked to the Master Number assigned to the ingredient in the database and the clinical information available will be consistent with that approved from the ingredient application

Tick Process for Ingredient Companies

Product “Tick”

Review Process

&

Responsibilities

“Tick” Approval – Marketed Products

Cost Estimates for Clinical Advisory Board

Core Activity

Guiding Assumptions and details

Total Cost $US

Clinical Advisory

Board

Honoraria

Per diem $US2500.00 and 6 panel members

Assume 1 face to face meeting per year, per diem of 3 days for all delegate,

plus additional 2 days for chair

(19 days)

Assume

2 additional meetings with per diem average of 2 days per meeting including prep time. (The meeting is expected to be

telecon

of about 4 hours) (24 days); Plus 2 additional days through the year for added input by Chair (2 days)

Total 45 days at $US 2500

$112,500

Air travel – Clinical Advisory Board

Assume business class travel for all flights over 6 hours. Meetings

will be held at the most economical location. This assumes a face to face meetings in US or Europe

2 x $10,000 -$15,000 fare from Southern Hemisphere

2 x $5,000 - $7,000 fares

Plus economy fares for other delegates, staff, and any other

adhoc

travel required by the CAB during the year

$60,000

Meeting Costs

Accommodation,

meals, meeting room costs, telecom charges,

courriers

and other administrative costs

$40,000

Contingency

For additional CAB input,

etc

$37,500

Total Allowance

$250,000

Clinical Trials Advisory Service

Pre- Trial Advice

The Advisory Board will provide advice to Member companies on request to review proposed clinical protocols to ensure the best possible chance of meaningful results and publication in a respected journal.

The service will be subject to quote, and will be based on the number of experts involved, and the amount of time required.

It is a service to Member companies and will be priced on a cost recovery basis

Post- Trial Advice

The Advisory board will also offer the service of reviewing the analysis of clinical trials post trial to assist companies present their data in the most appropriate manner to achieve publication is a well rated journal

Members of the Advisory Board are well experienced with publication in peer review journals and are regularly sought after as reviewers

Recommendations

Recommendation 1:

Proceed with the development of the concept of the AIME efficacy mark. Continue to monitor the need for and the optimal timing of the development of a broader Database solution with a target timing of year 3- year 4.

Recommendation 2

: Proceed with the appointment of the CAB and support the first meeting of the group to take place at the earliest convenience post appointment of the CEO.