Paul Sieving
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The National Eye Institute's (NEI) budget for fiscal year 2016 was $695 million, which was used to fund research projects, training, clinical trials, and small business innovation grants. Major initiatives included regenerating neurons and neural connections in the eye through the Audacious Goals Initiative, contributions to the BRAIN Initiative and Precision Medicine Initiative. The NEI supports collaborative research projects, small business grants, and conducts intramural research including stem cell therapy and gene therapy clinical trials. Growing the vision research field through training and diversity programs is also a priority.
Paul Sieving
- 1. Ophthalmic Innovation 2015 “A View from the NEI”
- 2. Ophthalmic Innovation 2015: View from the National Eye Institute Paul A. Sieving, MD, PhD Director, NEI, NIH
- 3. 2% 3% 11% 9% 6% 4% 65% FY 2016 Budget Mechanisms Research Training Resrch Mgmt& Support Intramural Research Other Research R&D Contracts Research Centers Research Projects Grants NEI Budget in FY2016: $695 million • NIH budget approximately $30 billion. • NEI Research Project Grants: The biggest part of NEI budget. • Non-diluting funding: Money comes free, and Grantee keeps the IP (Bayh-Dole Act).
- 4. Major Initiatives at NEI & NIH. NEI Audacious Goals Initiative: “Regenerate neurons & neural connections in the eye & visual system.” • Important for AMD, RP, glaucoma & other retinal diseases. • Model for regenerative therapy beyond vision: CNS & spinal cord. NIH BRAIN Initiative - 2014: The vision research community is dominating BRAIN projects. NIH Precision Medicine Initiative – 2015: • Medical treatments of the future. • More than 600 genes can cause eye diseases. • NEI is on course to implement biology to develop novel medical treatments.
- 5. Collaborative research projects – currently budgeting $11M/year Make resources available across disciplines to address scientific and technical questions beyond the capabilities of any one research group. • $2M/yr for 5 yrs • Proof of concept Preclinical development IND/IDE submission possible clinical trial support for trials. • Leber Congenital Amaurosis (LCA) Gene Therapy NEI kicked off this research, using R01/R24 grant funding. Proof of Concept -- Demonstrated restoration of functional vision and improved sensitivity in vision-limited subjects from RPE65 gene mutations 15 years to get to Phase 3 clinical trial for registration. R24 Translational Research Grants Program Director: Neeraj Agarwal, PhD. agarwalnee@nei.nih.gov
- 6. Enable small companies to convert innovative ideas into ophthalmic drugs, medical devices or assistive technologies that help people. • NEI commits nearly $20 M/year in funding about 50 small companies. • Regulatory Assistance Program provides support in seeking FDA approvals. Among projects receiving SBIR support in the past year: • VisionQuest Biomedical, LLC: Low-priced, portable retinal camera for large scale eye screening at sustainable cost. • Photoswitch Biosciences: Small‐molecule therapeutic photo- switch channel to restore vision in retinal degenerative disease. • Novoron Bioscience, Inc: LRP1 antagonist receptor associated protein for therapeutic regeneration of optic nerve after axon injury. Small Business Grants (SBIR & STTR) Program Director: Jerry Wujek, PhD, wujekjer@nei.nih.gov
- 7. Intramural Research at NEI (snippets) iPSC Stem Cell Therapy Development • Use iPS cells to create RPE patch to treat AMD. • A major NEI intramural basic to clinical initiative. • Stem cells into human subjects in 2017/2018. • A leading NIH program for neural transplantation. Human Ocular Gene Therapy X-Linked Retinoschisis (XLRS): Phase I / IIa. • One of first NIH in vivo gene therapy programs. • Clinical trials with XLRS patients ongoing. X-Linked Retinitis Pigmentosa RPGR: Pre-Clinical Phase. • Murine animal model. • AAV-based therapeutic rescue.
- 8. NEI commits nearly $50M in annual clinical trial support Effective Treatment of Diabetic Macular Edema • Trial found that Avastin and Lucentis performed similarly to Eylea for mild vision loss but demonstrated treatment differences for more significant loss. • Conducted by NEI DRCR.Net Extramural Clinical Trial Support Extended daily eye patching effective at treating stubborn amblyopia in children • Trial found that ocular patching can be extended to 6 hours to treat amblyopia otherwise resistant to therapy. • Effective for children up to 17 years old. • Conducted by PEDIG Research Group, supported by NEI grants EY011751 and FY018810.
- 9. Growing the Vision Research Talent Pool NEI trains students, fellows and clinicians in vision research. • Fellowship training in basic science and clinical research engages graduate students, baccalaureate fellows, postdoc fellows and clinicians in vision research. • Diversity in Vision Research and Ophthalmology (DIVRO) recruits students from underrepresented groups for summer internship program.
- 10. End of Slides Ophthalmic Innovation 2015: View from the National Eye Institute. Paul A. Sieving, MD, PhD.