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The ALS Association Investor Conference Request for Applications

Phase I and II Clinical Trials for development of novel, high-potential treatments for people with ALS for presentation to investors


Deadlines

Application due:
Extended to March 13, 2019

Request to attend investor meeting to present business plan:
April 1, 2019

Investor conference presentation materials:
April 20, 2019

Submit via online portal- instructions follow


Point of Contact

Attn: 2019 Investor Conference
Neil Thakur, Ph.D.
EVP, Mission Strategy, The ALS Association
researchgrants@alsa-national.org


Overview
The ALS Association invites companies seeking private investment to support their Phase I or Phase II study of a novel ALS therapy to apply to present to select investors April 29, 2019.


Background
The limited effectiveness of current ALS therapeutics means any new treatment has potential for significant commercial success. However, drug development is a lengthy, expensive, and risky process. The ALS Association has been systematically working to accelerate scientific progress and reduce the risk of financing ALS drug development.

The ALS Association supports research on treatment approaches that have a strong rationale for target choice and pharmacodynamics markers to ensure target engagement. We also support the basic and translational science to develop these approaches, and clinical trial consortia to facilitate their testing.

We have also been working to smooth the regulatory environment and ensure more robust trials. Last summer we held a WorkshopALS: Developing Drugs for Treatment Guidance for Industry – and offered a summary of recommendations to the FDA on their ALS clinical trial guidance. We also supported the development of ALS clinical trial guidelines that will be published in the near future.

With this initiative, we seek to further facilitate private sector investment in ALS research.


Opportunity
This initiative intends to bring additional private capital into ALS drug development. The Association requests applications from companies seeking private investment in their clinical trials, with preference given to current or ready to deploy phase II trials.

Up to 7 promising firms will be offered the chance to present to preselected investors on April 29, 2019 in the Boston, Mass. area. The investors will be apprised of the firms and their product in advance.

Firms will be given the opportunity to present for up to 20 mins, including at least 5 mins for questions. Firms would then be responsible for negotiating their own financing, if they wish, from any of the investors present. Ample time will be provided for networking during the conference.

The Association does not intend to invest in any proposal submitted through this request. It also does not guarantee applicants will receive offers of funding, nor obligate applicants to accept any offers.


Application
The online submission will include the following:

  • Executive summary (500 words max).
  • Public statement conveying study impact - 200 words max, that will be posted to our website if the application is selected for presentation.
  • Business offer, including figures and key data. Applicants should use this section to explain the science and rationale, proposed study, and the investment opportunity offered. No more than 10 pages, not including references. Be sure to address:
      • A brief overview of the applicant firm, with a description of their ALS portfolio.
      • The investment opportunity, type of preferred financing, and description of how the investment will advance their ALS study.
      • The investment that the firm has already received, when, from whom, and under what terms.
      • Current status of relevant intellectual property.
      • Statement of therapeutic safety and prior trial results, if available.
      • Pharmacokinetics of treatment approach including dosing, metabolism, other ADME data, route of administration, and duration of therapeutic intervention.
      • Overview of proposed trial design, including clinical endpoints, potential biomarkers, proposed trial size, duration, and proposed control group composition, etc.
  • Primary applicant’s (Principal Scientist’s) biographical sketch/resume.
  • Additional project personnel/roles/brief background statements.
  • Any documentation noting approvals from FDA for investigational new drug (IND) and IRBs.
  • Letters of support for collaborations or resources should be included.
  • Plans for open label extension and/or expanded access, or a statement that neither will be offered (no more than one page).
  • A bibliography of work arising from key trials for this product (e.g. Phase I, Phase IIA), including links to publications, preprints and/or pre-registered protocols (no more than one page).

  • Except as noted above, all application materials will be kept confidential to Association staff and reviewers.


    Determining Who Will Present at the Conference
    The Association will convene a review panel to evaluate the applications. Reviewers will include representation from both academic and industry experts, ALS clinicians, a person with ALS and/or an ALS caregiver. Reviewers will sign a non-disclosure agreement and will declare any conflicts of interest. Applications will be rated on the following criteria:

    • The speed and likelihood in which this trial will improve ALS treatment and advance science.
    • Innovative trial design – The degree to which the trial proposes efficient and respectful solutions to challenges in neurodegenerative disease trials, including openness to historical and alternative controls, crossover designs that ensure every participating patient gets the drug, mid trial re-randomization of the control group, etc., as well as well as other approaches that shorten trial timelines and reduce burden on participants and caregivers.
    • Clinical trial feasibility – The degree to which the reviewers believe that the trial would be able to move quickly through FDA processes.
    • Investment opportunity – The degree to which the proposal expedites the firm’s ALS program and provides flexibility in accepting investor money in exchange for equity or a share of ownership of the results.


    Online Submission

    Step 1: Register using this link:
    http://alsa.spectrumportal.net/Accounts/Register

    Step 2: Login using this link:
    http://alsa.spectrumportal.net/Accounts/Logon

    Step 3: Complete online application using this link:
    http://alsa.spectrumportal.net/IndividualApplicants/Application/0/31

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