Call for Perspectives on Strategies to Better Align Investments in Innovations for Therapeutic Development with Disease Burden and Unmet Needs

The National Academies of Sciences, Engineering, and Medicine Committee on Strategies to Better Align Investments in Innovations for Therapeutic Development with Disease Burden and Unmet Needs is inviting patients and patient groups, clinicians, investors, scientists, innovators, individuals in government, academic, and industry space, and other stakeholders to share their perspectives on unmet therapeutic needs, investment in innovation, aligning investment in innovative therapeutics with disease burden and unmet need.

For more information about the study, including the statement of task, please visit the project website.

NOTE: In order to share your submission with the Committee, the National Academies is required to include this material in a public access file. These submissions will be made available to the public upon request. Your email address will not be made publicly available or retained by the National Academies. You may also decline to have your submission included in the public access file.

1. Email Address *This question is required. This question requires a valid email address.

2. May we contact you at the e-mail address you provided for more information? *This question is required.

3. For patients and patient groups:

What is your experience with unmet therapeutic needs?

What improvement is most important to you?

Have you addressed your concerns with your health care provider? If so, what was the response?

Is there something else you’d like to share?

4. For clinicians:

What are your primary concerns for unmet needs with your patients and disease burden?

Where are innovative therapeutics lacking, and where could they help the most?

What are the primary impediments to utilizing innovative therapeutics to address patient needs?

Is there something else you’d like to share?

5. For investors:

What are the primary challenges to investing in innovative therapeutics to address unmet patient needs?

What are the challenges for investing to address disease burden in the United States?

What guides your decision-making on where to invest?

Where does public knowledge fall short in understanding the dynamics of investment decisions in innovative therapeutics?

Is there something else you’d like to share?

6. For regulators, policy makers, federal agencies:

What are challenges you see or experience in the approval processes for innovative therapeutics?

How can clinical trial requirements be improved to facilitate the approval of safe and effective innovative therapeutics?

How can policies or programs better incentivize high-value innovation?

What specific policy or regulation changes could be made to ensure the development and delivery of innovative therapeutics to address specific unmet therapeutic needs in the United States?

What current policies or regulations around the development of innovative therapeutics are exacerbating health disparities, or threaten to do so for the future?

Is there something else you’d like to share?

7. For entrepreneurs, inventors, innovators:

What draws you to innovate in a specific disease or therapeutic area?

What are the greatest challenges to overcome in the different stages of development for specific types of therapeutics?

What are the greatest challenges to overcome in developing and innovating in different disease areas?

What existing policies support innovative therapeutic development?

What policies or regulations hinder innovative therapeutic development?

Is there something else you’d like to share?

8. For researchers:

What are the greatest challenges to overcome in different stages of development for innovative therapeutics, in either a specific type of therapeutic or a specific disease area?

What are the challenges of obtaining public funding for specific types of therapeutics or specific disease areas?

What are the challenges of obtaining private funding to advance innovative therapeutics in certain disease areas or types of therapeutics?

What changes in policy or regulation in the United States would facilitate better research for innovative therapeutics to address disease burden and unmet needs?

What public-private partnerships currently exist that succeed at facilitating research in innovative therapeutics?

What types of partnerships could exist to better facilitate high impact therapeutic research?

Is there something else you’d like to share?

9. Your submission may be shared with the Committee and potentially quoted in the final study report. Please select the identifying information you would like included with your submission and enter that information in the corresponding box. If you would not like for your submission to be shared, select that below. Nonetheless, we value all submissions and greatly appreciate the time taken to complete the Strategies to Better Align Investments in Innovations for Therapeutic Development with Disease Burden and Unmet Needs Call for Perspectives.

General characteristics (example: investor, patient advocacy group representative, industry scientist, clinician)

Your name and affiliation

Location (city and state)

Other (please specify)

I prefer not to be identified or my submission shared publicly.

I prefer not to be identified or my submission shared publicly.

Disclaimer: This form information is being collected via Alchemer. Alchemer and Widgix, LLC are not affiliated in any way with, or endorsed by, the National Academies of Sciences, Engineering, and Medicine, and your submission via the Alchemer website is subject to Alchemer's privacy policy and terms of use. Any data you provide to Swoogo that is shared back with the National Academies of Sciences, Engineering, and Medicine will be treated in accordance with the National Academy of Sciences' Privacy Statement as if the data had been provided by you to the National Academies.