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Grant for Multiple Sclerosis Innovation

 

Introduction

 

The following rules apply to all received proposals and grants as part of the Grant for Multiple Sclerosis 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 for 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 gmsi@emdserono.com.

 

1. Aim of the grant

 

As part of EMD Serono's* commitment to advance science and medicine, the Grant for Multiple Sclerosis Innovation was launched in 2012. The aim of the grant is to support translational research projects by academic researchers to improve understanding of multiple sclerosis for the ultimate benefit of patients. Potential research topics which could be funded through the Grant for Multiple Sclerosis Innovation include MS pathogenesis, predictive markers for treatment response and potential new treatment. The research must not involve any products of EMD Serono*, 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 Multiple Sclerosis Innovation awards:

 

a. The research must take the form of impactful short-term translational research projects (1–3 years) by academic researchers with relevance to clinical practice. Some examples of this would include MS pathogenesis, predictive markers for treatment response and potential new therapies.

 

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 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 Multiple Sclerosis 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.

 

Research proposals involving stem cells

 

EMD Serono* allows research with human stem cells with careful consideration of ethical and legal standards.  For this purpose, EMD Serono* has developed the company Principle on Stem Cell Research.

 

Pursuant to its Principle on Stem Cell Research and the German Embryo Protection Act (Embryonenschutzgesetz - ESchG) of 13 December 1990, Bundesgesetzblatt 1990 Part I pp. 2746-2748, amended by Article 1 of the Act of 21 November 2011 (Bundesgesetzblatt 2011 Part I p. 2228) (see link: http://www.drze.de/in-focus/stem-cell-research/modules/the-german-embryo-protection-act?set_language=en), EMD Serono* will not support or fund projects proposed in the framework of the Grant for Multiple Sclerosis Innovation which involve the creation of human embryos, the cloning of human beings or any activity of deriving human embryonic stem cells (hESCs).  Also research on the creation and use of human artificial gametes for reproductive purposes will not be supported/funded by EMD Serono*.

 

As a guideline, EMD Serono* complies with the following framework:

 

  • Wherever possible, EMD Serono* supports the use of animal stem cells, human induced pluripotent stem cells (iPSCs) or human adult stem cells rather than hESCs (see above link).
  • EMD Serono* supports the use of hESC cell lines compliant with the German legal framework and of the respective country regulations in which the research is conducted.
  • EMD Serono* opposes reproductive cloning of human beings and does not contribute to such activities in any way.

 

An internal Stem Cell Research Oversight Committee (SCROC) at EMD Serono* ensures the internal assessment and constant review of the company’s position on stem cell research, according to latest scientific, legal and ethical insights. EMD Serono’s SCROC is working under the guidance of the EMD Serono’s Bioethics Advisory Panel (MBAP) to help ensure alignment with EMD Serono’s* overall bioethical guidelines and principles.

 

The SCROC will review research proposals involving the use of human stem cells. Also proposed projects involving any stem cell research with animals must adhere to EMD Serono’s Policy on Animal Welfare.

 

This review process by the SCROC is mandatory for research proposals involving stem cells.

 

Research proposals involving genome editing

 

EMD Serono* is open to supporting innovative research in the field of genome editing which might lead to novel approaches for disease treatment and prevention. However, in accordance with the German Embryo Protection Act (Embryonenschutzgesetz - ESchG) of 13 December 1990, Bundesgesetzblatt 1990 Part I pp. 2746-2748, amended by Article 1 of the Act of 21 November 2011 (Bundesgesetzblatt 2011 Part I p. 2228) (see link: http://www.drze.de/in-focus/stem-cell-research/modules/the-german-embryo-protection-act?set_language=en), EMD Serono does not support the use of genome editing in human embryos and clinical applications of germline interventions in humans. EMD Serono* is also not engaged in nor supports the creation and use of human artificial gametes - gene-edited or otherwise modified - for reproductive purposes.

 

Because EMD Serono* recognizes the many potential benefits of genome editing to correct genetic diseases, research involving genome editing may be supported with careful consideration of ethical and legal standards.

 

EMD Serono* is actively committed to a thoughtful discussion on genome editing issues via the ongoing work of the EMD Serono’s Bioethics Advisory Panel (MBAP). The MBAP advises regularly on issues involving genome editing as well as stem cell research (see above section on stem cell research). Also proposed projects involving any genome editing with animals must adhere to Merck’s Policy on Animal Welfare.

 

Research proposals involving genome editing and submitted for consideration to receive a Grant for Multiple Sclerosis Innovation will be reviewed by the EMD Serono’s Genome Editing Committee which will screen for compliance with the above-mentioned company Principle on Genome Editing.

 

This review process by the EMD Serono’s Genome Editing Committee is mandatory for research proposals involving genome editing.

 

3. Audit and monitoring

 

All research activities carried out in connection with a Grant Multiple Sclerosis Innovation are subject to audit and monitoring by EMD Serono* to help ensure that the research programs comply with the 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 Multiple Sclerosis 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 Multiple Sclerosis Innovation application and any unused funds are returned to EMD Serono*.

 

 

*The biopharma 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.