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We look forward to receiving your proposal.

Under the Physician Payment Sunshine Act (“Sunshine Act”), Chiesi USA is required to report certain types of payments and transfers of value to certain healthcare professionals and teaching hospitals. By submitting this grant request, you acknowledge that you understand that all or part of this request may be reported under the Sunshine Act and/or certain states' Aggregate Spend laws. If you have specific questions around whether your interactions will be disclosed, please contact Chiesi USA at us.sunshine@chiesi.com prior to submitting your request.

For additional questions regarding the grant submission process please contact us.grants@chiesi.com
For additional question regarding the Expanded Access Program, please contact US.EAP@Chiesi.com.

 

To view our currently active CALL FOR PROPOSALS, please Click Here

Chiesi USA Grants Program Description and What We Support

At Chiesi USA, we are committed to supporting U.S.-based educational efforts of the medical communities we serve. Our grant program funding focuses on the following areas:

  • Independent Medical Education Grants
  • Above Brand Medical Education
  • Investigator-Initiated Research Proposals
  • Collaborative Research Proposals (by Chiesi Invitation Only)
  • Medical Fellowships
  • Patient Education Support
  • Expanded Access Program (EAP)
  • Request for Proposals (RFPs) (by Chiesi Invitation Only)
Note: Grant requests intended or the purpose of which is to influence Healthcare Professional’s purchasing, prescribing or treatment decisions in favor of Chiesi products will not be considered. Funding is contingent upon execution of a mutually satisfactory written agreement by all parties.

Independent Medical Education Grants:

An Educational Grant is funding provided to a third-party for development of an educational activity directed at providing scientific, clinical and medical information with the goal of improving patient care. Educational Grant requests are permissible only if they are independent and free of Chiesi control.

Above Brand Medical Education Grants:


Chiesi may provide Above Brand Medical Education grants for initiatives in alignment which advance the quality of healthcare and the healthcare profession. Initiatives considered for this Grant award will focus on the advancement of the medical community and the challenges faced by the institutions we serve.


Candidate organizations may include healthcare organizations, medical professional societies, advocacy organizations, or similar. Specifically, initiatives may include, but are not limited to the following themes:


Healthcare Professional Development;
Healthcare Policy Research & Initiatives;
Medical resource allocation: (Shortages (ie. staffing, drug et al), Community Challenges, Socioeconomic Status, and Quality et all);
Diversity, Equity & Inclusion; and, Sustainability initiatives as aligned with Chiesi values.


Chiesi can have no say in the faculty, give input, propose topics, etc. Choosing to fund any grant cannot be based on prescribing habits of the requestor or the potential for prescribing our products.

Investigator-Initiated Research Proposals

An investigator-initiated research proposal is an unsolicited request independently developed by an investigator. Such proposal may request drug supply and/or financial funding. Support may include, but is not limited to, drug product, funding for study expenses (based on fair market value), product-related expert advice, or a combination of the foregoing. If approved, the proposing investigator will be responsible for providing periodic study updates (including safety reporting) and a final study report to Chiesi upon study completion or termination.

The proposing investigator, or the institution the investigator is affiliated with, serves as the study sponsor. The sponsor assumes responsibility for initiating and conducting the study, directing the administration of any study drug(s) (if applicable), ensuring compliance with all local laws and regulatory requirements, and analyzing and communicating of all study results.

Indirect Cost: Chiesi USA has determined that an indirect cost of up to thirty percent (30%) of the direct/actual study budget requested in the research grant submission is a reasonable and appropriate amount. In exceptional circumstances, indirect costs exceeding thirty percent (30%) may be evaluated but will require satisfactory rationale in writing from the grant requestor justifying the need for the increased indirect costs, and authorization by Chiesi USA prior to grant approval.

In all circumstances, please note that funding of a research grant is contingent upon full execution of a Research Grant Agreement between Chiesi USA and the Institution.

Collaborative Research Proposals: (By Chiesi Invitation Only)

A collaborative research proposal may be developed independently by an investigator or developed in collaboration with Chiesi. Such proposal may request drug supply and/or financial funding. This proposal may involve, but is not limited to, an invitation for Chiesi to collaborate as a research partner in a larger, ongoing or planned study. Chiesi may provide input to and be involved with the development of the study protocol or data collection form, among other things, depending on the nature of the study or research. Support may include, but is not limited to, drug product, funding for study expenses (based on fair market value), product-related expert advice, or a combination of the foregoing. The proposing investigator is responsible for providing periodic updates (including safety reporting) and a final report to Chiesi upon study completion.

The proposing investigator, or the institution the investigator is affiliated with, serves as the study sponsor. The sponsor assumes responsibility for initiating and conducting the study, directing the administration of any study drug(s) (if applicable), ensuring compliance with all local laws and regulatory requirements, and analyzing and communicating of all study results.

Medical Fellowship Support:

Opportunities for fellowship support include projects or activities involving a specific deliverable. Support is limited to activities or initiatives described below:

  • Funding of fellowship program;
  • Scientific conference solely organized for fellow attendees; and/or
  • Select research initiatives.

Patient Education Support:

Chiesi may provide grants to organizations to support bona fide educational programs, patient-centered activities or educational materials for patients or their caregivers. Grants may not be provided for activities designed to promote the grant requestor’s services or to support patient programs that the grant requestor already provides in its ordinary course of business. This prohibition includes sponsoring and/or providing funding for patient education events, including patient support groups, where the individual healthcare professional delivers lectures to his/her own patients to educate them on disease states and treatment options.

Expanded Access Program (EAP):

For an Expanded Access Program (EAP) request, information should be submitted through this portal.

Expanded Access, sometimes referred to as compassionate use, may be an option for certain individual(s) with serious or life-threatening conditions or diseases that have no available satisfactory or comparable alternative therapy. Chiesi may support EATPs under an open-label treatment protocol.

Please note that patients who qualify for a clinical trial on the underlying investigational product requested are not eligible for Expanded Access or any Chiesi EATP.

Please visit our website www.chiesiusa.com for all requests that fall under FDA Compassionate Use Program or under the 21st Century Cures Act.

Request for Proposals (RFPs): (By Chiesi Invitation Only)

When published, a Request for Proposal (RFP) provides information and details regarding an area of interest in which Chiesi invites organizations or individuals to propose research or educational initiatives in key clinical areas. Submissions in response to RFPs will be considered on the basis of the criteria described in the applicable RFP. Neither submission by an organization or individual nor receipt by Chiesi will be a guarantee of approval.


Grant Submission Process

 

  1. Grant submission
    1. For research and education proposals we are limited to evaluating proposals that are submitted by US healthcare providers (HCPs) or US healthcare organizations (HCOs) and will be managed and coordinated by US healthcare providers or healthcare organizations.
    2. We ask that proposals be submitted to Chiesi through the grant portal at least 90 days prior to the event date to allow for sufficient review time.
    3. Proposals submitted less than 90 days prior to the event date will be subject to Chiesi’s discretion for review priority.
  2. Proposal evaluation
    1. Chiesi USA's Grant Committee meets on a regular basis and reviews proposals based on submission and program date. Chiesi will review your proposal and have a decision returned prior to the start of your program.
  3. Notification of decision
    1. Once the grant is reviewed by Chiesi USA’s Grant Committee, the decision is sent to the email addresses listed as the grant submitter and primary contact.
  4. Award processing
    1. If grant application is approved, you will be sent a Letter of Agreement (LOA) which must be returned and fully executed prior to the program start date. Electronic payment information is also required in order to process granted funds.
    2. If a research grant request is approved for funding, members of our team will be in touch and will facilitate the LOA process.
Areas of Interest



Critical Care

Acute Hypertension
  • Education:
  • Acute hypertensive crisis
  • Acute blood pressure management in cerebrovascular diseases
  • Acute blood pressure variability and clinical outcomes
  • Peri-operative (pre, intra, post) blood pressure management in endovascular and surgical procedures
  • Comparisons of Chiesi's product and other anti-hypertensive agents in blood pressure management
  • Research:

    The following areas of research are currently seen as supporting novel, independent research that advances general knowledge for Chiesi's product within acute hypertension.

  • Prospective evaluation of blood pressure control in acute stroke (ischemic and hemorrhagic) presentations
  • Blood pressure management in hypertensive emergencies/urgencies
  • The impact of acute blood pressure variability in stroke and surgery and the impact on patient outcomes
  • Cost-effectiveness, health resource utilization or quality outcomes
  • Real-world use and evidence in:
    • Cardiac and non-cardiac surgery
    • Neurosurgery
    • Abdominal aortic aneurysm (AAA) or aortic dissection
    • Acute heart failure
    • Pheochromocytoma
    • Vasospasm
    • Pregnancy
    • Pediatrics
    • Pre-hospital (ambulance, mobile-stroke unit, or medevac)

Antiplatelet
  • Education:
  • Antiplatelet selection for complex and high-risk PCI, including cardiogenic shock and cardiac arrest
  • Periprocedural events and thrombus management in patients undergoing complex and/or high-risk PCI
  • Antiplatelet management in patients undergoing surgery after PCI
  • Role of IV antiplatelet therapy in acute neurointerventional procedures
  • Research:

    The following areas of research are currently seen as supporting novel, independent research that advances general knowledge for Chiesi's product.

  • IV antiplatelet use in complex and/or high-risk PCI
  • Angiographic outcomes in patients receiving P2Y12 inhibitors
  • In-hospital thrombotic and bleeding outcomes associated with oral and IV antiplatelet use
  • IV antiplatelet use in neurointerventional procedures
  • IV antiplatelet use in mechanical circulatory support
  • IV antiplatelet use in pediatrics
  • Procedure times, clinical, operational, cost-effectiveness, health resource utilization or quality outcomes associated with antiplatelet use
  • Appropriate dosing of IV anti-platelet agents and conversion to oral therapy



Neonatology

Neonatal Respiratory Distress Syndrome (nRDS)
  • Education:
  • Clinical practices and diagnostic technologies around early identification and early surfactant treatment of nRDS
  • Simulation training for neonatal resuscitation, intubation, and surfactant administration
  • Creation and implementation of nRDS treatment protocols or bundles of care, such as protocols aimed at improving long- and short-term outcomes in patients with or at risk of nRDS
  • Optimal care of preterm infant population subgroups (i.e., late preterm infants, extremely preterm infants) with nRDS
  • Research:
  • Treatment variability in real-world clinical practice, and short- and long-term clinical and economic outcomes in neonates with RDS
  • Studies leveraging innovative methods or real-world data to facilitate early identification of infants with RDS (within first 2 hours of life) and need of surfactant therapy (e.g., using FiO2 as an indicator)
  • Clinical studies or human factor studies of novel and innovative methods to administer surfactant
  • Surfactant therapy in preterm infant population subgroups that are under-represented in clinical trials (such as late preterm infants born 32 wGA and peri-viable preterm infants born 22-25 wGA)
  • Disparity and equity of treatment and outcomes in preterm infants with RDS
  • Studies characterizing bedside practice or protocols before, during and after endotracheal tube surfactant administration in ventilated infants



Rare Disease

Inborn Errors of Metabolism
  • Fabry Disease
  • Education:
    • Early diagnosis for Fabry Disease and recommendations for when to initiate treatment
    • Optimized assessment of disease progression in Fabry patients
    • Unmet needs in the current management of patients with Fabry disease
    • Fabry disease manifestations in female patients
  • Research:
    • Innovative approaches to increasing the diagnosis rate for Fabry Disease
    • Clinical or biomarker evidence supporting shorter time to treatment initiation with the goal of improving long-term patient outcomes
    • Optimized assessment of disease progression in treated patients
    • Validation of new biomarkers of subclinical and clinical disease progression
    • Impact of anti-drug antibodies on clinical outcomes with enzyme replacement therapies

  • Alpha Mannosidosis
  • Education:
    • When to suspect alpha-mannosidosis – clinical and laboratory parameters
    • Current management of alpha-mannosidosis
    • The role of alpha-mannosidase enzyme replacement as a bridging therapy before or after hematopoietic stem-cell transplantation
  • Research:
    • New approaches to alpha mannosidosis screening and diagnosis
    • Characterization of the clinical and immunological profile of patients with alpha mannosidosis
    • Understanding the natural history of alpha mannosidosis
    • Gender differences in the prevalence, age of onset and progression of alpha mannosidosis
    • Genotype, phenotype and biomarker correlates of alpha-mannosidosis
    • Healthcare utilization of alpha-mannosidosis patients
    • Characterization of disease monitoring practices in the real-world setting
    • Biomarkers and clinical monitoring of disease progression and treatment effect
    • Understanding current treatment approaches for alpha mannosidosis
    • The role of alpha-mannosidase enzyme replacement as a bridging therapy before or after hematopoietic stem-cell transplantation

Rare Hematology and Immunology
  • Sickle Cell Diseases (SCD), Beta Thalassemia, and Rare Anemias  
  • Education:
    • General iron overload and damage
    • Iron chelation therapy in thalassemia, SCD, and other rare anemias
  • Research

    The following areas of research are currently seen as supporting novel, independent research that advances general knowledge for Chiesi's product for iron chelation therapy (all studies requiring product are to be done with Twice-A-Day formulation):

    • Use in SCD and/or thalassemia patients
    • Combination therapy with iron chelation therapy
    • Use in other hematological diseases, including rare anemias. Examples include aplastic anemia, myelodysplastic syndrome (MDS), hematochromatosis.
  • Adenosine Deaminase Severe Combined Immunodeficiency (ADA-SCID)  
  • Education:
    • ADA-SCID disease state and available pharmacotherapies
    • Management of primary immunodeficiencies and SCID
  • Research
    • Understanding ADA-SCID: mechanism of disease and complications
    • Clinical outcomes in enzyme replacement therapy treated ADA-SCID patients
    • Biomarkers and clinical monitoring of ADA-SCID
    • Long term outcomes and survival of ADA-SCID patients

Rare Cardio-Metabolic
  • Homozygous Familial Hypercholesterolemia (HoFH)
  • Education:
    • The need for early diagnosis and treatment in HoFH
    • Under detection and undertreatment in HoFH
    • Therapeutic treatment options and lifestyle management
  • Research
    • HoFH patient finding initiatives
    • Long term effectiveness and safety of lomitapide in large real-world studies
    • Effectiveness and safety of lomitapide in patients on high doses of lomitapide
    • The role of a low-fat eating plan to achieve and maintain a normal BMI and healthy lifestyle

Endo-Metabolic
  • Lipodystrophy
  • Education:
    • When to suspect lipodystrophy and early diagnosis using clinical and laboratory parameters
    • Assessment of the impact of metabolic complications and comorbidities of Lipodystrophy beyond HbA1c and triglycerides
    • Treatment of complications of leptin deficiency in lipodystrophy
    • What can metreleptin offer before (GL) and beyond (PL) standard of care (SoC) in lipodystrophy
  • Research:
    • Natural history of Lipodystrophy in pediatric patients
    • Benefits of early vs late treatment on the progression of comorbidities, assessment beyond lab parameters
    • Assessment of the effects on metreleptin in LD sub-types such as AGL, APL, progeroid LD, BMT associated lipodystrophy.
    • Impact of metreleptin on and validation of LD specific PROs such as pain, fatigue, ability to work.
    • Understanding the clinical impact of neutralizing antibodies against metreleptin
    • Development of robust diagnostic criteria for PL
    • Efficacy, short/long term benefits and safety of metreleptin in other leptin deficient states (e.g., congenital leptin deficiency)
    • Utilization of lipodystrophy severity score in clinical practice
  • Acromegaly
  • Education:
    • Early identification and diagnosis of acromegaly
    • Symptoms as a measure of acromegaly disease activity and impact on patient quality of life and productivity
    • Benefits, risks, limitations, and burdens of currently available therapies
  • Research
    • Use in patients without prior exposure to injectable somatostatin receptor ligands
    • Use prior to transsphenoidal surgery
    • Pharmacokinetic exposure with ingestion of different foods or beverage types
    • Titration protocols
    • Combination therapy or higher dose monotherapy in patients achieving partial IGF-I response with prior therapy

Dermatology
  • Epidermolysis Bullosa
  • Education:
    • Awareness of Epidermolysis Bullosa (EB) – disease, diversity and severity of illness
    • Pathophysiology and escalation of disease
    • External wound manifestations
    • Complexity of disease and multidisciplinary team management
    • Inflammation, fibrosis and squamous cell carcinoma
    • Unmet needs in the management of patients with EB and current and future treatment directions
    • Impact of disease on persons living with EB, their family and carers
    • Daily management and quality of life
  • Research:
    • Understanding and documenting the natural history and burden of the severe subtypes of EB
    • Definition and measurement of outcome measures relevant to EB
    • Impact of treatment on cellular activity, biomarkers and cytokines
    • Clinical outcomes in the short and longer term for patients with severe subtypes of EB
    • Wound chronicity, age and size of wound relevance to management and treatment options
    • Healthcare utilization of people living with EB
    • Other EB subtypes and relevant rare and/or dermatological conditions


FAQs

  1. Are you currently accepting grant request applications?
    1. Grant submission process please contact us.grants@chiesi.com
    2. Expanded Access Program, please contact US.EAP@Chiesi.com

    1. Chiesi USA is always accepting grant requests through our grant portal at www.Chiesi.versic.com/login. For additional questions:
  2. To be eligible for grant, must company be an American company (we are an international company, but have offices in the USA).
    1. For research and education proposals, we are limited to evaluating proposals that are submitted by US healthcare providers (HCPs) or US healthcare organizations (HCOs) and will be managed and coordinated by US healthcare providers or healthcare organizations.

  3. Are you accepting grants pertaining to education/research in a particular therapeutic area?
    1. Chiesi USA reviews all submissions received through our grants portal at www.chiesi.versaic.com/login. Please review our Areas of Interest page to find a complete listing of current focus areas. Please note that you may still submit a proposal pertaining to an unlisted focus area for review.

  4. May I submit a grant request for an activity that has already started/occurred?
    1. Chiesi USA is unable to provide funding for events where the program date has already occurred per the ACCME guidelines. We ask that all educational programs seeking support (educational CME, fellowship support, patient education/advocacy) be submitted at least 90 days prior to the event date to allow time for internal review and processing.

  5. When are grants requests reviewed and when should a submitter expect to hear back regarding a decision?
    1. Chiesi USA's Grant Committee meets on a regular basis (typically at least one time per month) and reviews proposals based on submission and program date. We ask that proposals be submitted to Chiesi through the grant portal at least 90 days prior to the event date to allow for sufficient review time. Chiesi will review your proposal and have a decision returned prior to the start of your program.

  6. What if I submit a proposal that requires a funding decision well in advance of the program date?
    1. Should you have a proposal that requires notification of approval well in advance of the program date, please plan accordingly and submit the proposal a minimum 90 days PRIOR to the funding decision deadline. In addition, once the proposal has been submitted, please send an email notification to us.grants@chiesi.com clearly stating the date you need Chiesi's decision by.

  7. Are there certain expenses which you will not provide funding for?
    1. Chiesi USA reviews all grant proposals and awards funding based on the educational merit of the programs. Awarded funding is earmarked to cover the costs of the education components of the program which typically do not include, but are not limited to, the following: lavish meals, travel and lodging costs, purchase of equipment, gifts, registration fees for attendees, and recreational activities.

  8. Must I sign the Chiesi USA grant agreement/LOA? What if I have my own or would like to make changes to the Chiesi template?
    1. In order to receive funding, all organizations must sign the Chiesi USA Letter of Agreement prior to the program start date. We do not accept other institutions LOAs for educational or research programs. Should you wish to request changes to the LOA, please note that this will extend the timeline for execution as all LOA change requests are considered and reviewed by our legal team.
      Any changes to the LOA or program content made by the requestor (agenda, budget, speakers) without Chiesi’s awareness result in a withdrawal of funding.
    2. If the research grant request is approved for funding, members of our team will be in touch and will facilitate the LOA process.

  9. When may I expect to receive the awarded grant funds?
    1. The LOA will be considered executed when signed and returned to Chiesi USA. The LOA must be returned prior to the start of the program. Payment(s) will be made upon Chiesi receipt of a fully executed agreement.
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