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Important SBIR/STTR Information Update from NIH

Update courtesy of BBC Entrepreneurial Training and Consulting

NIH is strongly encouraging small businesses to contact the appropriate Institute or Center early in their application planning to ensure their technology is a priority for the Institute/Center.

An updated SBIR/STTR Application Guide with additional instructions for SBIR Direct Phase II application preparation and submission will be posted by November 26, 2018. The following sections of each FOA are changed:

Part 2, Section I. Funding Opportunity Description The following has been added at the end of the section for each FOA:

PA-18-573 The following Components will not accept an SBIR Direct-to-Phase II submission:
– National Institute of Nursing Research (NINR)
– National Center for Complementary and Integrative Health (NCCIH)

PA-18-574 The following Components will not accept an SBIR Direct-to-Phase II submission:
– National Institute of Environmental Health Sciences (NIEHS )
– National Institute of Nursing Research (NINR)
– National Center for Complementary and Integrative Health (NCCIH)
– Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)
– Centers for Disease Control and Prevention (CDC) (All Components of CDC)
– U.S. Food and Drug Administration (FDA) (All Components of FDA)

Part 2, Section II. Award Information for both PA-18-573 and PA-18-574. Application types now allowed are:
– New (Phase I, Fast-Track)
– New (Direct Phase II)
– Renewal (Phase II)
– Resubmission (all phases)
– Phase IIB Competing Renewal (Phase IIB)
– Revision

The OER Glossary and the SF424 (R&R) SBIR/STTR Application Guide provide details on these application types.

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                    [post_content] => 

Governor Kathy Hochul has unveiled plans for New York BioGenesis Park, a groundbreaking $430 million Cell and Gene Therapy (CGT) Innovation Hub in Nassau County, Long Island. To be developed by The Albanese Organization, Inc., this state-of-the-art facility would catalyze CGT research, development, clinical manufacturing, and commercialization across New York State. With a historic $150 million state investment—the largest nationwide for a cell and gene therapy hub—NYBGP would accelerate the delivery of new therapies from lab to patient in New York's diverse communities. This transformative hub aims to establish New York as the leading global destination for CGT innovation, driving economic growth, attracting top talent, and revolutionizing patient care statewide and beyond.

The Center for Biotechnology is thrilled to be counted as a partner in this effort, and is looking forward to working with our colleagues in the initiative to help catalyze and accelerate life-changing therapies.

New York BioGenesis Park is envisioned as a cutting-edge, full-service campus dedicated to advancing cell and gene therapies and accelerating their commercialization. At full build-out, the 700,000-square-foot park would create an end-to-end Cell and Gene Therapy innovation and supply center, featuring interconnected areas for public engagement, research, manufacturing, and collaboration.

A cornerstone of New York BioGenesis Park is its incubator, supported by a $50 million investment from ESD's Long Island Investment Fund. This facility will empower early-stage therapeutic developers by offering state-of-the-art wet lab space, shared equipment, office space, and other essential resources. This nurturing environment will provide Cell and Gene Therapy companies with access to specialized equipment, mentoring, and stage-appropriate financial guidance. As a critical component of New York BioGenesis Park, the incubator is poised to catalyze the growth of promising Cell and Gene Therapy companies by providing them with resources and support, unlocking their potential for innovation and success.

New York BioGenesis Park would foster strong ties with academic and medical institutions throughout New York, creating a robust ecosystem for Cell and Gene Therapy innovation. Collaborating with the Empire State Cellular Therapy Consortium and world-class institutions like Cold Spring Harbor Laboratory, the Feinstein Institutes, Northwell Health, Roswell Park, Stony Brook University, Weill Cornell, Columbia University and others around the state, New York BioGenesis Park would enhance research synergies and accelerate medical breakthroughs. This ecosystem would bring together experts in advanced Cell and Gene Therapy therapies, offering specialized facilities, services, and resources to both tenants and collaborating institutions. By facilitating cutting-edge science, innovative technology development and novel approaches to clinical trials, New York BioGenesis Park would ensure New York's institutions remain globally competitive in groundbreaking Cell and Gene Therapy research and commercialization.

Read the press release of Governor Hochul's announcement here:
https://www.governor.ny.gov/news/governor-hochul-launches-next-phase-long-islands-nation-leading-cell-and-gene-therapy

[post_title] => Long Island to be location for Nation-Leading Cell and Gene Therapy Innovation Hub: New York BioGenesis Park. [post_excerpt] => [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => long-island-to-be-location-for-nation-leading-cell-and-gene-therapy-innovation-hub-new-york-biogenesis-park [to_ping] => [pinged] => [post_modified] => 2025-02-26 16:35:20 [post_modified_gmt] => 2025-02-26 21:35:20 [post_content_filtered] => [post_parent] => 0 [guid] => https://centerforbiotechnology.org/?p=4488 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [1] => WP_Post Object ( [ID] => 2275 [post_author] => 3 [post_date] => 2016-06-22 14:40:28 [post_date_gmt] => 2016-06-22 14:40:28 [post_content] => bio2016c The Center for Biotechnology team recently ventured out to San Francisco for BIO’s annual International Convention. Through the support of Empire State Development and the Long Island Bioscience Hub, the Center for Biotechnology was able to support six Long Island emerging biotech companies to attend the meeting: Alpha-1 Biologics Corporation, Codagenix, Inc., DepYMed, Inc., iCell Gene Therapeutics, PhD Skin Care LLC and Vela Therapeutics. These companies were joined in the New York Pavilion by more than two dozen other companies and entities representing New York State. Long Island and New York City regional companies Alpha-1 Biologics, Vela Therapeutics, Intrommune Therapeutics, PainQX, Serendipity Biotech, ENB Therapeutics, and QuickSilver Biosystems all were recipients of grants from Empire State Development and NewYorkBio which also assisted their participation in the event. These companies were tapped to present in the New York Pavilion along with six other companies from upstate New York. Envisagenics, ENB Therapeutics, PainQx, QuickSilver and Abcombi BioSciences, all New York State Companies, were invited to participate in the BIO 2016 “Start-Up Stadium” which provide start-up companies with the opportunity to pitch to key members of the investment community, venture philanthropy groups, and BIO attendees. The participating investors provided live feedback and judged the sessions. In addition, six Long Island Bioscience Hub faculty members were invited to participate in the meeting for the first time. These NIH-REACH program supported faculty attended with the goal to learn more about the commercialization process, how it applies to their translational research, and to engage in the partnering process and meet with potential strategic contacts. Center staff met with over 40 strategic partners over the course of the meeting and follow up is underway. bio2016b [post_title] => BIO 2016 [post_excerpt] => The Center for Biotechnology team recently attended the BIO International Convention in San Francisco and supported the participation of emerging companies and faculty entrepreneurs in the event. [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => bio-international-convention-2016 [to_ping] => [pinged] => [post_modified] => 2016-07-14 13:50:46 [post_modified_gmt] => 2016-07-14 13:50:46 [post_content_filtered] => [post_parent] => 0 [guid] => http://centerforbiotechnology.org/?p=2275 [menu_order] => 175 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [2] => WP_Post Object ( [ID] => 2253 [post_author] => 3 [post_date] => 2016-06-16 16:15:26 [post_date_gmt] => 2016-06-16 16:15:26 [post_content] => regenix_web1Rgenix, a cancer therapeutics company developing first-in-class drugs targeting novel cancer pathways, announced a $33 million Series B financing led by Novo A/S and Sofinnova Partners, with participation from existing investors including Partnership Fund for New York City, Alexandria Venture Investments, and Conegliano Ventures LP. The financing will support clinical development of Rgenix’s lead drug candidates, RGX-104 and RGX-202, as well as further development of its therapeutics pipeline. In connection with the financing, Nilesh Kumar of Novo Ventures and Antoine Papiernik of Sofinnova Partners will join the Rgenix Board of Directors together with existing members, including Executive Chairman Eric Rowinsky, M.D., Masoud Tavazoie, M.D. Ph.D., Nancy Chang, Ph.D., and Saeed Tavazoie, Ph.D. Read the full press release about Rgenix’s financing here. [post_title] => Rgenix Announces $33M Series B Financing [post_excerpt] => Rgenix, a cancer therapeutics company developing first-in-class drugs targeting novel cancer pathways, announced a $33 million Series B financing led by Novo A/S and Sofinnova Partners, with participation from existing investors including Partnership Fund for New York City, Alexandria Venture Investments, and Conegliano Ventures LP. The financing will support clinical development of Rgenix’s lead drug candidates, RGX-104 and RGX-202, as well as further development of its therapeutics pipeline. [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => rgenix-announces-33m-series-b-financing [to_ping] => [pinged] => [post_modified] => 2016-06-16 16:17:16 [post_modified_gmt] => 2016-06-16 16:17:16 [post_content_filtered] => [post_parent] => 0 [guid] => http://centerforbiotechnology.org/?p=2253 [menu_order] => 176 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [3] => WP_Post Object ( [ID] => 2237 [post_author] => 3 [post_date] => 2016-06-07 15:14:28 [post_date_gmt] => 2016-06-07 15:14:28 [post_content] => Traverse Biosciences has announced that it has secured $500,000 in convertible debt financing to support operations and advance product development efforts. The seed financing was led by Excell Partners, with matching funds from a number of individual accredited angel investors. The Research Foundation for the State of New York (RF/SUNY) also participated in the financing, as part of an exclusive license and option agreement executed last year that gave Traverse Biosciences access to the relevant intellectual property for use in animal and human health. Traverse Biosciences, which began when CEO Joseph Scaduto was serving as a BioEntrepreneur-in-Residence for the Center for Biotechnology, is working to commercialize its proprietary library of Stony Brook University invented chemically-modified curcumins for the treatment of chronic inflammatory conditions and cancers affecting humans and animals. Read more about Traverse and the recent financing:     [post_title] => Traverse Biosciences Secures $500k Seed Financing [post_excerpt] => Traverse Biosciences announced that it has secured $500,000 in convertible debt financing to support operations and advance product development efforts. The seed financing was led by Excell Partners, with matching funds from a number of individual accredited angel investors. 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Governor Kathy Hochul has unveiled plans for New York BioGenesis Park, a groundbreaking $430 million Cell and Gene Therapy (CGT) Innovation Hub in Nassau County, Long Island. To be developed by The Albanese Organization, Inc., this state-of-the-art facility would catalyze CGT research, development, clinical manufacturing, and commercialization across New York State. With a historic $150 million state investment—the largest nationwide for a cell and gene therapy hub—NYBGP would accelerate the delivery of new therapies from lab to patient in New York's diverse communities. This transformative hub aims to establish New York as the leading global destination for CGT innovation, driving economic growth, attracting top talent, and revolutionizing patient care statewide and beyond.

The Center for Biotechnology is thrilled to be counted as a partner in this effort, and is looking forward to working with our colleagues in the initiative to help catalyze and accelerate life-changing therapies.

New York BioGenesis Park is envisioned as a cutting-edge, full-service campus dedicated to advancing cell and gene therapies and accelerating their commercialization. At full build-out, the 700,000-square-foot park would create an end-to-end Cell and Gene Therapy innovation and supply center, featuring interconnected areas for public engagement, research, manufacturing, and collaboration.

A cornerstone of New York BioGenesis Park is its incubator, supported by a $50 million investment from ESD's Long Island Investment Fund. This facility will empower early-stage therapeutic developers by offering state-of-the-art wet lab space, shared equipment, office space, and other essential resources. This nurturing environment will provide Cell and Gene Therapy companies with access to specialized equipment, mentoring, and stage-appropriate financial guidance. As a critical component of New York BioGenesis Park, the incubator is poised to catalyze the growth of promising Cell and Gene Therapy companies by providing them with resources and support, unlocking their potential for innovation and success.

New York BioGenesis Park would foster strong ties with academic and medical institutions throughout New York, creating a robust ecosystem for Cell and Gene Therapy innovation. Collaborating with the Empire State Cellular Therapy Consortium and world-class institutions like Cold Spring Harbor Laboratory, the Feinstein Institutes, Northwell Health, Roswell Park, Stony Brook University, Weill Cornell, Columbia University and others around the state, New York BioGenesis Park would enhance research synergies and accelerate medical breakthroughs. This ecosystem would bring together experts in advanced Cell and Gene Therapy therapies, offering specialized facilities, services, and resources to both tenants and collaborating institutions. By facilitating cutting-edge science, innovative technology development and novel approaches to clinical trials, New York BioGenesis Park would ensure New York's institutions remain globally competitive in groundbreaking Cell and Gene Therapy research and commercialization.

Read the press release of Governor Hochul's announcement here:
https://www.governor.ny.gov/news/governor-hochul-launches-next-phase-long-islands-nation-leading-cell-and-gene-therapy

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Long Island to be location for Nation-Leading Cell and Gene Therapy Innovation Hub: New York BioGenesis Park.

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