Scientific Objectives

MULTIPLE SCLEROSIS

General Multiple Sclerosis

The following areas of research are currently being considered with a focus on Multiple Sclerosis (MS)

  • The importance of diligent monitoring of patients
    • Markers for disease monitoring, disease prognosis, and/or risk mitigation
    • New or improved quantitative outcome measures in multiple sclerosis, including next-generation technology and patient assessment technologies
  • MS and its treatment in special populations, i.e. geriatric or pediatric patients, family planning, underrepresented populations

Research support is awarded on a highly competitive basis, and submission of research proposals in these areas of interest does not guarantee that support will be awarded.

MS Therapies

Biogen MS therapies include the following products.

  • Disease Modifying Therapies
    Dimethyl fumarate
    Diroximel fumarate
    Natalizumab
    SC and IM Peginterferon beta-1a
    IM Interferon beta-1a
  • Symptomatic Therapies
    Prolonged-release fampridine


The following areas of research are currently being considered with a focus on

Dimethyl Fumarate:

  1. Studies deciphering the MoA of dimethyl fumarate including its neuroprotective potential or how it may cause lymphopenia
     

Diroximel Fumarate:

  1. Comparative effectiveness as assessed by PROs or adherence vs newer DMTs in the treatment of naïve as well as switch patients
  2. Assessment of DRF as it relates to PROs, such as quality of life, workability, or treatment satisfaction
  3. Studies deciphering the MoA of diroximel fumarate including its neuroprotective potential, effects on the gut-brain immune axis and microbiome, how it may cause lymphopenia
     

Peginterferon beta-1a and Interferon beta-1a:

  1. Assessment of underrepresented or underserved patient populations, including older/elderly patients and racial and ethnic minority patients
  2. Real-world effectiveness as assessed by quality of life, cognition, adherence, and treatment satisfaction vs. other platform MS therapies
    • Real-world effectiveness (as detailed above) and safety/tolerability of intramuscular (IM) peginterferon beta-1a
  3. Assessment of pregnancy and family planning-related topics, including MS treatment and disease activity considerations, and infant/child outcomes (e.g., developmental milestones)
  4. Assessment of novel ways to mitigate injection site reactions (ISR) and flu-like symptoms (FLS) or better manage patients who experience these adverse events
  5. Examinations of work productivity, pharmacoeconomics, and health resource utilization

Out of scope:

  1. Biomarker studies to identify specific responder populations among patients treated with peginterferon beta-1a or interferon beta-1a
  2. Studies on interferon beta MoA
     

General MS Therapies:

  1. Real world/comparative effectiveness, switching and sequencing strategies, and adherence to therapies.
  2. Studies on the MoA of Biogen products (except peginterferon beta-1a and interferon beta-1a).
     

Research support is awarded on a highly competitive basis, and submission of research  proposals in these areas of interest does not guarantee that support will be awarded.

Rare Diseases

General SMA

The following areas of research are currently being considered to support studies related to Spinal Muscular Atrophy (SMA) and Nusinersen.

Clinical effectiveness in a multi treatment era

  • Nusinersen effects on domains such as bulbar function (e.g., swallowing, speech, phonation) and respiratory function (e.g., reduced need for ventilation, pulmonary function tests) across the SMA phenotypic spectrum
  • Characterization of new patient phenotypes or trajectories among patients treated with nusinersen 
  • Studies which inform treatment algorithm and patient choices (e.g., definition of suboptimal treatment response, time to response and predictors of response, patient preferences)

Patient experience and health economics

  • Quality of life correlation with patient function to allow for the identification of sensitive tools to measure disease progression and treatment response
  • Digital tools to assess pediatric SMA patients' outcomes with the potential for classification as a medical device

Biomarkers

  • Identification and validation of biomarkers of disease progression or response to nusinersen therapy in SMA (human studies only)

Research support is awarded on a highly competitive basis, and submission of research proposals in these areas of interest does not guarantee that support will be awarded.

Collaborative multicenter proposals are highly encouraged, as they have the potential to include more robust patient populations.

Alzheimer’s Disease

General Alzheimer’s Disease

  • Characterization of AD progression from MCI to severe dementia
  • Development of new screening instruments and cognitive and functional measures of disease progression across disease continuum of MCI due to AD, to AD dementia
  • Characterization of the initial  symptoms and clinical presentation of MCI, MCI due to AD and mild AD dementia in general practice using digital technology/tools
  • Biomarker studies of therapeutic response to aducanumab, concordance studies, novel AD populations, and exploratory studies for novel AD biomarkers*
    • For biomarker studies of therapeutic response to aducanumab – biomarkers should fall within the ATN framework
    • Concordance studies should be evaluating a biomarker in comparison to validated amyloid PET, tau PET or equivalent validated CSF assay for amyloid or tau
    • Studies of novel AD populations should be evaluating therapeutic response to aducanumab, but can be outside the ATN framework
    • Exploratory studies should aim to inform on disease progression biomarkers or novel diagnostics / monitoring biomarkers
    • For studies related to ARIA biomarkers, please contact a Biogen Medical representative at MedicalResearch@biogen.com

*Please submit evidence / data to support the validation of the assay being used or demonstrate that the assay is being run in a GCLP / CLIA accredited lab.

Proposals inclusive of underrepresented populations will take precedence.

Research support is awarded on a highly competitive basis, and submission of research proposals in these areas of interest does not guarantee that support will be awarded.

biosimilars

Etanercept (BENEPALI)

Study proposals are currently being considered for support when related to:

  • Rheumatoid arthritis
  • Psoriatic arthritis
  • Adult axial spondyloarthritis, including ankylosing spondylitis and non-radiographic spondyloarthritis
  • Plaque psoriasis
     

Established areas of research include:

  • Maintenance of response
  • Patient reported outcomes
  • Patient satisfaction
  • Healthcare resource utilization
  • Patient adherence / drug survival
  • Assessing and quantifying the NOCEBO effect
  • Healthcare resource utilization
     

Please note that ONLY proposals from within the EU will be considered by Biogen.

Research support is awarded on a highly competitive basis, and submission of research proposals in these areas of interest does not guarantee that support will be awarded. 

 

Infliximab (FLIXABI)

Study proposals are currently being considered for support when related to:

  • Adult rheumatoid arthritis
  • Adult psoriatic arthritis
  • Adult axial spondyloarthritis, including ankylosing spondylitis and non-radiographic spondyloarthritis
  • Adult plaque psoriasis
  • Adult and paediatric Crohn’s disease
  • Adult and paediatric ulcerative colitis
     

Established areas of research include:

  • Immunogenicity
  • Maintenance of response
  • Prediction and optimization of response
  • Treatment modalities
  • Patient reported outcomes
  • Patient satisfaction
  • Healthcare resource utilisation
     

Please note that ONLY proposals from within the EU will be considered by Biogen.

Research support is awarded on a highly competitive basis, and submission of research proposals in these areas of interest does not guarantee that support will be awarded. 

 

 

 

Submit your research proposal or manage your study today

If you have any questions or would like to get in touch with the Biogen local medical contact in your country/region, please email us at MedicalResearch@biogen.com.