The Charter of the Prix Galien USA Committee

The Prix Galien rewards excellence and novelty, and awards additional honors to those who show great promise in the fields of innovative therapeutics, and who have served humanity at large. The pharmaceutical, biotechnology, diagnostics and medical device products considered for the Prix Galien USAAward shall have been based on innovative science, developed by synthetic chemistry or molecular biology, manufactured to precise specifications, tested in controlled clinical trials and marketed by ethical pharmaceutical companies. To be eligible, products must have received marketing approval in the USA by December 31 of the year preceding the award, but not more than five years earlier than December 31 of that year, unless the award is for a new and innovative indication, which must have been added within the previous five years.

The committee will award three prizes for therapeutics: the Best Pharmaceutical Agent (i.e. small molecule), the Best Biotechnology Product, and the Best Medical Device or Diagnostic approved in the USA in the past five years. As to the science, candidates will be chosen from among all therapeutic categories– and each will be judged against all of the others.

The prizes will be awarded for pharmaceutical science that improves the human condition, principally based on two criteria:

One: What was innovative in the course of this product’s scientific development, application or clinical utility?

Two: What was learned for the future of biomedical science from this product’s introduction to the clinic?

Criteria that will not be considered are the size of the market, the size of the company, the cost of development or the contingencies of distribution.

In addition, at the discretion of the committee and the Board of the Galien Foundation, the Prix Galien USA will award a special Pro Bono Humanum award to an individual, a company, an academic institution, or a non- governmental agency that has helped to improve the human condition through the application of biopharmaceutical science to problems of developing or underserved populations worldwide. Other new awards, consistent with the mission of the Galien Foundation, are planned. At the discretion of the committee, these awards will be judged by the committee members.

The awards committee will be composed of up to thirteen individuals and an honorary member chosen by the Board of the Galien Foundation. Except at the onset, committee members will generally serve for one, or a maximum of two, three-year terms. Membership duration will be staggered. Members will be highly distinguished individuals from the scientific and research communities, primarily from the US, but with at least one international member. In addition to outstanding academic credentials, committee members must have demonstrated expertise and understanding of human therapeutics, and must be familiar with healthcare issues. The Board, in consultation with the committee, will choose a Chair, who will serve for two years. The Board will entertain nominations for the committee from current committee members, former committee members, the academic and research communities, and from the scientific divisions of companies engaged in the development of human therapeutics.

The decisions of the independent committee with respect to the choice of winners for awards will be final and wholly the decision of the committee. The committee deliberations will be conducted in private, and without any input whatsoever from the Board of the Foundation, or from Member organizations or other sponsors.