Welcome to EMD Serono's Investigator Sponsored Trials (ISTs) website for investigator sponsored research. EMD Serono's IST 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:

Oncology:

  • Mechanism of action.
  • Safety or efficacy in special populations under-represented in our absent from existing or planned studies.
  • Proof of concept studies that provide a rational for a clinical development plan for a new use.
  • Unmet medical needs.
  • Exploration of new tools (e.g., diagnostic modalities, screening tools, or quality of life assessment tools).
  • Understanding of disease states.
  • Improvement of patient care.

Multiple Sclerosis, Reproductive Health and Endocrinology:

  • 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.
  • In vitro or animal studies.

Types of Support We Provide

  • Several forms of support may be approved by EMD Serono's Review Committee, including:
    • Funding to pay for expenses based on fair market value that are directly related to the research protocol.
    • Providing drugs or devices for use in the research.
  • Click Here (IST Process Overview) for the specific rules and restrictions on the types of support we provide as well as a list of permissible study costs.

Therapeutic Areas of Interest

Investigator-Sponsored Studies in the area of immuno-oncology are supported by EMD Serono and Pfizer Inc. in connection with their strategic alliance ("Alliance") to co-develop and co-commercialize avelumab (BAVENCIO®), a human anti-PD-L1 IgG1 monoclonal antibody.

In general, the Alliance will give priority to to investigator-sponsored proposals that aim to explore the following:

  • Safety and efficacy of novel combinations with avelumab and/or sequencing based on strong scientific rationale and developing trends in the field (monotherapy trials will be de-prioritized)
  • Use of avelumab in early stage disease
  • Further understanding of the clinical usefulness of engaging the innate immune system with avelumab
  • Adequate management of immune-mediated AEs and infusion-related reactions
  • Combinatorial synergy with avelumab and other checkpoint inhibitors
  • Duration of therapy evaluations
  • Definition/identification of responders in the 'tail of the curve'
  • Understanding of primary, adaptive, and/or acquired resistance to IO therapy
  • Identification of other biomarkers

Preference will also be given to the following tumor types based on the timeline below:

  • Merkel Cell Carcinoma (MCC)
  • Non-Small Cell Lung Cancer (NSCLC)
  • Squamous Cell Carcinoma of the Head & Neck (SCCHN)
  • Ovarian Cancer
  • Gastric Cancer
  • Renal Cell Carcinoma (RCC)
  • Urothelial Carcinoma (UC)

Special Submission and Review Schedule*

The Global Review Committee for the Alliance reviews study proposals at quarterly meetings, with particular tumor types assigned to each quarterly meeting (see schedule below). Study proposals for each tumor type will generally be reviewed twice per year, and not until the assigned quarterly meeting.

Carefully review the submission deadline for the particular tumor type you propose to study with avelumab. If a submission deadline is missed, your study proposal will not be considered until the next designated review.

Focused Area of Interest*

Submission Deadline*

Quarterly Review

NSCLC, Ovarian/Gynecological, UC, and RCC

30 July 2018 Pfizer
02 August 2018 EMD Serono

September 2018

MCC, SCCHN, Gastric, and Other tumor types not covered at other quarterly meetings

30 September 2018 Pfizer
09 November 2018 EMD Serono

December 2018

Lung, Ovarian/Gynecological, UC, and RCC

28 January 2019 Pfizer05 February 2019 EMD Serono

March 2019

*Check back frequently to the web-based submission portal as these areas of interest and/or the submission/review schedule are subject to change.

Please contact your EMD Serono Medical Science Liaison for additional information.

Areas of Interest for Multiple Sclerosis

Preference will be given to study proposals that enhance clinical knowledge and potentially impact patient care in the following broad areas of interest.

  • Clinical outcome studies, such as outcome measures (e.g., advanced MRI, OCT, disability), comparative effectiveness of MS therapeutics, defined patient populations (e.g., gender, race, underlying co-morbid conditions, switch patients), patient reported outcomes (PRO, adherence, QoL), and human immunology (cytokine shifts) on DMDs.
  • Biomarkers (e.g., clinical, pharmacogenomic, metabolomic; including pilot studies) as a predictor of response, correlative markers of clinical response and markers of disease progression.
  • MS symptom management, safety and tolerability including prospective (longitudinal) clinical cohort studies.

Areas of Interest for Reproductive Health

Preference will be given to study proposals that enhance clinical knowledge and potentially impact patient care in the following broad areas of interest.

  • Clinical studies (prospective and retrospective) such as outcome measures (monofollicular/ovulation), multi-follicular response in ART, incremental recombinant FSH dosing options, comparative effectiveness of infertility treatments and regimens, defined patient populations (e.g., gender, race, PCO patients, oocyte donors), and patient reported outcomes (PROs).
  • Biomarkers (e.g., clinical, pharmacogenomic) including novel diagnostic screening tools, predictors of response, correlative markers of clinical response and late stage translational (from bench to bedside).

Areas of Interest for Endocrinology

  • Clinical studies (prospective and retrospective) such as treatment outcome measures, correlation between adherence and responses to treatment, factors that may play the role in patient's response to therapy, patient reported outcomes (PROs) and impact on cost-effectiveness of the rhGH therapy in adherent versus non-adherent patients.
  • Biomarkers (e.g. clinical, pharmacogenomic) including predictors of response to rhGH therapy and correlative markers of clinical response.

How to Apply

  • Investigators may, but are not required to, contact an EMD Serono Medical Science Liaison for a preliminary discussion of the concept and an explanation of EMD Serono's application, review, and approval process. If you do not know your MSL representative, please contact the IST Coordinator by email ist@emdserono.com.
  • An application outlining the research proposal should be submitted to EMD Serono's Review Committee through our IST website. EMD Serono uses a two-step application process. To start the application process new users should register below. Registered users may log in below to start a new application.
  • Submissions are evaluated according to scientific merit, innovation, potential clinical importance/impact, patient safety, reasonableness of budget, and qualifications of the investigator(s).

Questions?

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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