Program description and rules

The following rules apply to all received proposals and grants as part of the Grant for Growth Innovation program. The grant rules and procedures may be changed by EMD Serono* for projects based in the United States and Canada and by Merck KGaA, Darmstadt, Germany* to those based in the rest of the world at any time, without notice, in order to comply with applicable laws, rules, regulations, company policies, or industry codes.

If you have any questions regarding the grant rules, please contact GGI@emdserono.com

1. The aim of the grant

As part of EMD Serono* commitment to advance science and medicine, the Grant for Growth Innovation was launched in 2013. The aim of the grant is to support the advancement of science and medical research in the field of growth and to facilitate new external research to identify potential clinical markers in patients with growth disorders.

We are particularly interested in innovative translational studies that could potentiality improve patients lives.

Relevant topics include:

  • The impact of nutrition on growth
  • The metabolic impact of growth disorders
  • Pathophysiology of growth disorders
  • Techniques in diagnosis and follow-up on growth disorders
  • Extremes in growth disorders
  • Identification of biomarkers in patients with growth disorders
  • Research elucidating the long-term metabolic impact of the “GH-IGF axis” activity.

The research must not involve any products of EMD Serono, a business of Merck KGaA, Darmstadt, Germany, testing of competitor products, or interventional clinical studies.

EMD Serono* and its affiliates believe that medical research and dissemination of scientific and educational information are worthy undertakings deserving support. Support for research, however, must be carried out in an appropriate manner. Research grants awarded by the company must be consistent with all applicable laws, rules, regulations, company policies and industry codes and may not be used as a price concession, reward, or inducement to prescribe or purchase our company products.

2. Award criteria

The following criteria must be met for all Grant for Growth Innovation awards:

a. The research must take the form of impactful short-term research (1–3 years). Some examples of this would include translational research, metabolic impact of growth disorders, the impact of nutrition on growth, pathogenesis, diagnostic techniques, predictive markers for treatment response, etc.
b. The research may only involve products from EMD Serono* or competitors, if used on-label and if the aim(s) of the research is (are) not to evaluate or compare the efficacy and/or safety of the products.
c. The research may involve prospective sampling if the sampling is part of non-interventional studies** and not part of interventional clinical trials***
d. The research must be of legitimate scientific value to the company or the medical/scientific community at large and must be designed to provide meaningful information or conclusions.
e. The research must be innovative, feasible, have a strong scientific rationale, demonstrate clear objectives and have a positive impact on research.
f. The research must not compete with any research and development or clinical projects sponsored by EMD Serono* or any of its global affiliates.
g. No preference will be given to individuals or entities for prescribing or purchasing EMD Serono* products or to induce the prescription or purchase of EMD Serono* products in the future. Grant recipients are not expected or obliged to prescribe or purchase EMD Serono* products.
h. The amount awarded for the research must not exceed the legitimate costs to be incurred in carrying out the research to be funded by the grant, and must be commensurate with and not exceed fair market value for the research activities.
i. All applicable regulatory requirements must be observed, including, as appropriate, regulatory filings and ethics committee/institutional Review Board review and approval.
j. The selected researchers must not be currently excluded, debarred, suspended, or otherwise ineligible to participate in their respective countries of citizenship, residence and/or practice. Any selected U.S.-based researcher must not be currently excluded, debarred, suspended, or otherwise ineligible to participate in any current U.S. Federal health care programs, in Federal procurement or non-procurement programs by the Office of Inspector General or the General Services Administration.
k. The selected researchers must have the appropriate training and expertise to conduct the research, as determined by the Grant for Growth Innovation Scientific Committee.
l. Awarding research grants to an individual researcher not affiliated with an institution, as opposed to an institution or organization with a tax identification number, is discouraged but not prohibited, provided all other requirements of the innovation award are followed.
m. In addition to the rules set forth above, all grants must comply with all applicable laws, rules, or regulations.

3. Audit and monitoring

All research activities carried out in connection with a Grant for Growth Innovation are subject to audit and monitoring by EMD Serono* to help ensure that the research programs comply with law and applicable EMD Serono* policy. In addition, the name of the grant recipient and amount of the grant will be publically disclosed to the extent required by law and applicable EMD Serono* policy.

4. Researcher obligations

Progress Reports
In order to ensure the appropriate progress of innovation award research projects, grant recipients must provide the company with periodic updates on the progress of each project, including updated budget information and substantiation of expenses, before any relevant milestone payments are made. If a research project is not progressing satisfactorily, appropriate action will be taken, including but not limited to withdrawing any remaining funding and terminating the research project.

Final Report and Publication
EMD Serono* desires to ensure that research undertaken as part of the Grant for Growth Innovation program is completed and analyzed. All grant recipients must provide EMD Serono* with final study results in the form of a final report including full and final substantiation of the project expenses.

EMD Serono* supports the exercise of academic freedom by researchers and expects the results of research to be published, whether or not the results are favorable to EMD Serono.

5. Certification

When a research project is completed or terminated, the researcher and/or institution conducting the research must certify to EMD Serono* that: (i) the research was conducted in accordance with the terms of the grant agreement, (ii) any unused funds provided by EMD Serono* have been returned to the company, (iii) all safety reporting obligations were met, and (iv) if required, a manuscript or abstract has been submitted for publication, or the research was terminated early and a publication is not appropriate.

6. Reconciliation

At the end of the research project, reconciliation will take place to ensure that funds were used solely for the purpose stated in the Grant for Growth Innovation application and any unused funds are returned to EMD Serono*.

 

*A business of Merck KGaA, Darmstadt, Germany

**A non-interventional study is defined as a study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorization. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients. Epidemiological methods shall be used for the analysis of collected data and not part of interventional clinical trials.

***An interventional clinical trial is defined as a clinical study in which participants are assigned to receive one or more intervention(s) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.