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iCell Gene Therapeutics Granted Orphan Drug Designation

iCell Gene Therapeutics, a CFB client company, has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its chimeric antigen receptor engineered T-cells directed against the target protein CD4 (CD4CAR) for the treatment of peripheral T-cell lymphoma (PTCL). The Orphan Drug Designation program provides orphan status, and associated development incentives, to drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. Read more about the designation and company here.

iCell

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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 would 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] => 2024-12-03 15:06:31 [post_modified_gmt] => 2024-12-03 20:06:31 [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] => 3128 [post_author] => 4 [post_date] => 2019-01-11 19:49:30 [post_date_gmt] => 2019-01-11 19:49:30 [post_content] => The Biomedical Advanced Research and Development Authority (BARDA) is leading an interagency group to develop a wearable device to detect, and possibly treat, an opioid overdose. This group, Technology Innovation to Combat Opioids (TICO) is holding a Deep Dive on Feb 12-13, 2019 to review possible technologies being developed in this area. Specifically, they are looking for wearables or software as a medical device that are no larger than the palm of your hand and measure a physiological response indicative of an opioid overdose. Examples of possible markers that could be incorporated into the device include, but are not limited to, respiratory rate, blood carbon dioxide or oxygen content, brain activity and opioid levels. The device should have the ability to alert potential caretakers nearby that the wearer is in distress and, potentially, have the capability to dispense a treatment for the overdose event. The technologies should be at a maturity level capable of undergoing pivotal clinical trials in 2020. TICO invites anyone with an innovative idea in this space to submit a 1-2 page summary of their device that addresses the following items:
  1. Provide a high-level device description including how the device detects possible opioid overdose.
  2. How does the device notify potential caretakers? Does it notify people nearby? If so, how?
  3. Description of the user population and use environment?
  4. What are the performance limitations for the device?
  5. How does the device treat an opioid overdose if that is a feature?
  6. Do you own the intellectual property for this technology?
TICO will review each submission and invite selected participants to present their technology at the Deep Dive on Feb 12-13, 2019. Travel funding is not available, however, this meeting will serve as market research for the solicitation that will be issued by BARDA to fund the clinical study. Accommodations can also be made for a virtual presentation. Submissions and questions can be sent to Kristen Herring Kristen.herring@hhs.gov and should be received no later than Jan. 22nd. [post_title] => BARDA: TICO Deep Dive 2 Announcement [post_excerpt] => The Biomedical Advanced Research and Development Authority (BARDA) is leading an interagency group to develop a wearable device to detect, and possibly treat, an opioid overdose. This group invites anyone with an innovative idea in this space to submit a 1-2 page summary of their device. [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => barda-tico-deep-dive-2 [to_ping] => [pinged] => [post_modified] => 2019-04-09 14:41:18 [post_modified_gmt] => 2019-04-09 14:41:18 [post_content_filtered] => [post_parent] => 0 [guid] => http://centerforbiotechnology.org/?p=3128 [menu_order] => 105 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [2] => WP_Post Object ( [ID] => 3301 [post_author] => 3 [post_date] => 2019-07-22 13:14:41 [post_date_gmt] => 2019-07-22 13:14:41 [post_content] => The NIH and CDC have released the annual SBIR Contract Proposal Solicitation (PHS 2020-1), with a submission date of October 23, 2019, 5:00 PM EDT. Please follow the directions in the solicitation very carefully. You must respond exactly to a topic in the solicitation. A pre-proposal conference, via webinar, will take place on August 7 at 1:00 PM EDT. This informational webinar will discuss the PHS 2020-1 solicitation, electronic contract proposal submission (eCPS) website, clinical trials, and topics. Please register for HHS SBIR PHS 2020-1 Contract Webinar in advance, here: https://attendee.gotowebinar.com/register/7505039171902241027 (After registering, you will receive a confirmation email containing information about joining the webinar.) The following Institutes/Centers have issued research topics in the PHS 2020-1 Solicitation: National Institutes of Health (NIH)
  • National Center for Advancing Translational Sciences (NCATS)
  • National Cancer Institute (NCI)
  • National Heart, Lung and Blood Institute (NHLBI)
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • National Institute of Allergy and Infectious Diseases (NIAID)
Centers for Disease Control and Prevention (CDC)
  • National Center for Chronic Disease and Health Promotion (NCCDPHP)
  • National Center for Environmental Health (NCEH)
  • National Center for Emerging Zoonotic and Infectious Diseases (NCEZID)
  • National Center for Immunization and Respiratory Diseases (NCIRD)
Submission Process: There is an electronic submission process for all proposals. Applicants must use the Contract Proposal Submission (eCPS) website to submit their proposal. No other method of proposal submission is permitted. Instructions for electronic submission are provided in the solicitation. Please check NOT-OD-19-121 for topics, contracting officer contact information and other details. You can also find the SBIR contract solicitation link on theFunding page and FedBizOpps. Those interested in the PHS small business research GRANT programs, where investigator-initiated research ideas are encouraged, should use the Omnibus SBIR and STTR solicitations. You can find solicitation links on the Funding page. To understand better the differences between grants and contracts, view the Apply page. [post_title] => NIH/CDC SBIR Contract Solicitation Now Available [post_excerpt] => [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => nihcdc-sbir-contract-solicitation-now-available [to_ping] => [pinged] => [post_modified] => 2019-07-22 13:14:41 [post_modified_gmt] => 2019-07-22 13:14:41 [post_content_filtered] => [post_parent] => 0 [guid] => https://centerforbiotechnology.org/?p=3301 [menu_order] => 92 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [3] => WP_Post Object ( [ID] => 3794 [post_author] => 3 [post_date] => 2021-06-15 14:59:52 [post_date_gmt] => 2021-06-15 14:59:52 [post_content] =>

Join our team! The Center for Biotechnology is recruiting an Assistant Director for Technology and Business Development. The Asst. Director for Technology and Business Development will develop and help implement milestone driven commercialization strategies, and provide oversight to Commercialization Associates who have primary responsibility for conducting due diligence to guide and support Center for Biotechnology/LIBH “investments".

The incumbent will serve as the primary contact with internal and external parties on issues related to research, technology development and commercialization, and foster new collaborative relationships leading to sponsored research agreements and possible strategic alliances with external partners including bioscience companies and investors. 

Read the full position description and apply via the “stony Brook at work” website: https://stonybrooku.taleo.net/careersection/jobdetail.ftl?job=2101841&lang=en

Questions? Contact Anne DePietri (annette.depietri@stonybrook.edu) at the Center for Biotechnology.

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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 would 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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