Investigator Sponsored Studies for Neurology & Immunology

EMD Serono's ISS Program supports research that can advance scientific, medical, health economic and other knowledge about the products and diseases we study.


Types of Research Eligible for Support

EMD Serono gives higher priority to research that is innovative and has the potential to address specific unmet medical or scientific data needs. Some potential general areas on which research may focus include, without limitation:

Neurology & Immunology

  • Clinical studies involving approved EMD Serono drugs or devices.
  • Observational studies, such as epidemiology studies and certain health outcomes research studies where the primary focus is the scientific understanding of the disease.
  • Other types of research on disease states, including diagnostic screening tools, which involve no EMD Serono drugs or devices.

At the present time, we are only accepting ISS applications in the therapeutic area of Neurology. We are not currently accepting applications in the therapeutic area of Immunology.

Our areas of interest in Neurology are limited currently to studies evaluating the efficacy of investigational cladribine tablets and its mechanism of action.

Types of support we provide

Several forms of support may be approved by EMD Serono's Review Committee, including:

  • Funding to pay for trial-related expenses based on fair market value that are directly
    related to the research protocol.
  • Providing drugs or devices for use in the research.

Study Budget
Our rules and restrictions on permissible and impermissible study expenses are as follows:

  • All expenses associated with the conduct of investigator sponsored research must be identified in the detailed study budget in the application.
  • The amount of all expenses must not exceed fair market value of the expenses associated with the research. Fair market value includes, among other things, consideration of the relevant market and geographic region.
  • Expenses shall only be requested for research-related goods and services that are legitimate, reasonable and necessary for the conduct of the research and that are actually utilized in the conduct of the research.
  • All payments must be milestone-based and not results based. In addition, payment shall not be made in one lump sum prior to the start of research.

Permissible direct study costs include without limitation:

  • Subject-related costs
  • Non-EMD Serono drugs and clinical supplies, while EMD Serono does provide funding for placebo, in general it does not supply the placebo, nor does EMD Serono provide blinded study drug.
  • Study-related personnel costs (for personnel dedicated to the Study), but may not include the cost of any fringe benefits for the personnel
  • Diagnostic fees and services
  • Data management expenses
  • Statistical services - this cost should be limited to $2,500, absent special circumstances that are documented
  • Institutional overhead - in general, the amount of institutional overhead is limited to 25% of the total research budget. An amount in excess of 25% may be approved by the Review committee, in its discretion, upon a factual showing of necessity.

Permissible indirect study costs may include:

  • Publication costs (e.g., medical writing to prepare manuscript, manuscript submission fee, etc.) - this cost should be limited to $2,500, absent special circumstances which must be documented
  • IRB review fees - this cost may include initial IRB submission fee and all applicable renewal fees
  • Costs of reasonable travel, lodging, congress registration (if required to make presentation) and related expenses of the ISS Requestor for the express purpose of presenting the study results at one scientific congress or meeting.

Costs that shall not be included in any ISS Proposal include:

  • Start-up funds to establish new clinical research programs or to expand an existing program
  • Purchase of capital equipment or software
  • Hiring of staff that are not dedicated to the Study
  • Costs of travel, lodging, or related expenses of the Applicant for purposes other than presenting Study results at a scientific congress or meeting
  • Expenses relating to the ISS Requestor’s normal business operations (e.g., electricity, phone, employee fringe benefits)
  • Any "permissible" expenses which exceed fair market value

ISS Process Overview

How to Apply
To apply for a grant for an Investigator Sponsored Study, download the application form below and fully complete it.

Download Application Form (.doc)

The information required for the application form include:

  • Title of proposal
  • Type of support requested (financial, drug or both) and an estimate of amount; include name of drug (if applicable)
  • Study design
  • Study rationale and unmet medical need
  • Study hypothesis
  • Study population
  • Feasibility of enrolling proposed population
  • Description of the unique or novel feature of the Study
  • Study Budget

Send the completed application to:
cladribinetabletsinvestigatorstudies@emdserono.com

All applications must be sent to the above email address.  Applications sent to other emails will not be considered. In addition, hard copy applications will not be accepted.

ISS Review
EMD Serono's Review Committee will review all applications for scientific merit, innovation, clinical importance/potential impact on patients and alignment with our areas of interest. 

The Review Committee may have follow up questions about your application, in which case we will contact you. Applicants will be notified of the Review Committee's decision via email.

Grant Agreement
If your application is approved, you will be sent a written grant agreement which will set forth your obligations with respect to the study.

You will have eight weeks to review, sign and return the grant agreement. If the grant agreement is not returned within eight weeks, the grant may be withdrawn. 

Some of the topics addressed in the Grant Agreement include:

  • Funding: amount and payment schedule (if applicable)
  • Drug - amount (if applicable)
  • Adverse Event Reporting
  • Requirement to submit Monthly Reports to EMD Serono
  • Intellectual Property rights
  • Publication requirement

Conduct of the Study

Legal Compliance

Legal Compliance

EMD Serono requires investigators with ISSs to comply with all applicable laws, rules, regulations and industry codes related to clinical and/or non-clinical research. Investigators may be required by law to file an IND for the Study. Investigators are responsible for making the IND determination and filing for the IND, not EMD Serono.

For those Studies that require IRB/IACUC approval and/or an IND, must submit a copy of the approved IRB/IACUC and/or IND to EMD Serono.

Please note: All IRB/IACUC approvals must be received within four months of when EMD Serono executes the Grant Agreement. If this deadline is not met, EMD Serono reserves the right to rescind approval of the ISS.

Clinical Study Registration

Clinical Study Registration

Investigators with ISSs are required to comply with all applicable laws, rules, regulations and industry codes governing registration of protocols and posting of results. Investigators should be identified as the "sponsor" on such registrations and postings, not EMD Serono. EMD Serono also encourages you and your institution to add your study to the FDA's ClinicalTrials.gov database or another study registry website.

Study Drug

Study Drug

Once a Grant Agreement has been fully executed, the drug approved for the Study may be requested.  EMD Serono will notify you of the procedure to make the drug supply request. Requests for study drug require at least a minimum lead time of five business days, sometimes longer.  Please note: EMD Serono only ships study drug from Monday to Thursday; study Drug is not shipped on Fridays.

It is the responsibility of the Investigator to maintain the study drug and supplies in the appropriate conditions and to account for all study drug and supplies, including its receipt, usage, destruction or return. EMD Serono will notify Investigators about how to return study drug.

Adverse Event Reporting

Adverse Event Reporting

Investigators are responsible for complying with all applicable laws, rules, regulations and industry codes concerning adverse event reporting. The Grant Agreement will include information on how to submit an adverse event to EMD Serono.

Reports

Reports

In order to ensure the appropriate progress of research, EMD Serono requires that you submit an update on your study on a monthly basis. Monthly status reports are due the first business day of each month. EMD Serono will notify you about the procedure for submitting these monthly status reports. Milestone payments will not be made if a monthly status report has not been submitted for the most recent month.

All Investigators must provide EMD Serono with a detailed Final Report which outlines the research findings.

Publications

Publications

EMD Serono expects the results of ISSs to be published or presented, whether the results are positive or negative.

Publications must take the form of either (1) a manuscript submitted to a peer-reviewed journal, or (2) an abstract submitted to a scientific or medical congress. 

IMPORTANT: All publications must be sent to EMD Serono in advance of submission, according to the timeframe set forth in the written agreement. 

All publications should comply with recognized ethical standards concerning publications, authorship and disclosure of funding, including without limitation the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, as revised from time to time, located at www.icmje.org and established by the International Committee of Medical Journal Editors.

All Investigators must provide EMD Serono with a detailed Final Report which outlines the research findings.

Areas of Interest for Neurology & Immunology

We are interested in supporting studies that: 

  • investigate novel medical or scientific issues
  • do not duplicate prior or ongoing global, regional or local studies or another investigator-sponsored study
  • further inform the benefit/risk profile of investigational cladribine tablets in a real-world setting
  • are patient-reported outcome studies with validated tools or robust methodology to enable validation
  • research treatment sequencing
  • investigate special populations
  • inform the understanding of investigational cladribine tablets mechanism of action

No submissions will be officially approved until the FDA’s decision on investigational cladribine tablets.

Financial Disclosure

EMD Serono is required by federal and state law to disclose payments and other transfers of value to healthcare providers, their related entities, and US teaching hospitals.

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