MULTIPLE SCLEROSIS
General Multiple Sclerosis
The following areas of research are currently being considered with a focus on Multiple Sclerosis (MS)
- The importance of clinical decision-making when starting and transitioning disease modifying therapies
- MS and its treatment in special populations, i.e. geriatric or pediatric patients, family planning, LGBTQ+ patients, 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 (ex-USA)
The following areas of research are currently being considered with a focus on
Dimethyl Fumarate:
- Studies deciphering the neuroprotective potential of dimethyl fumarate or how it may cause lymphopenia
Diroximel Fumarate:
- Comparative effectiveness as assessed by PROs, quality of life, workability, treatment satisfaction or adherence vs newer DMTs in the treatment of naïve as well as switch patients
- Studies evaluating efficacy, safety and/or tolerability when transitioning from antiCD20
- Studies deciphering how diroximel fumarate may cause lymphopenia
Natalizumab
- Examination of long-term outcomes
Peginterferon beta-1a and Interferon beta-1a:
- 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 - Assessment of pregnancy and family planning-related topics, including MS treatment and disease activity considerations, and infant/child outcomes (e.g., developmental milestones)
General MS Therapies:
- Real world/comparative effectiveness, switching and sequencing strategies, and adherence to therapies.
Out of scope:
- Biomarker studies to identify specific responder populations among patients treated with MS therapies
- Studies on MS therapy MoA
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.
Neuromuscular
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.
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.