12/16/2024 | Press release | Distributed by Public on 12/16/2024 12:45
$98 Million Manufacturing Facility Will Support Research and Development of Life-Saving Technologies Including Cancer-Fighting Cell Therapies
New Hub Advances New York's Vision for Leadership in Cell and Gene Therapy and is Expected To Attract Leading Life Science Companies and New Jobs
Governor Kathy Hochul today celebrated the opening of the Roswell Park GMP Engineering and Cell Manufacturing Facility, New York's first cell and gene therapy hub, located at Roswell Park Comprehensive Cancer Center in Buffalo. The $98 million facility will create new jobs, help to support the research and development of life-saving cell and gene therapies at Roswell, significantly grow its well-established research capabilities, and establish Roswell as one of the premier cell therapy discovery and development institutions in the nation. The expansion also realizes Governor Hochul's 2023 State of the State commitment to bolster the state's leadership in the fast-growing CGT sector through establishment of an Upstate cell and gene therapy hub to catalyze its growth in western NY. The GEM facility meets U.S. FDA Good Manufacturing Practice standards for manufacture of clinical cell therapy products, positioning the Roswell Park team to be a multifaceted resource for patients, care teams, researchers, and industry collaborators. See pictures of the Roswell GEM here.
"Given cell and gene therapy's potential to be the most transformative therapeutic advance in decades, New York's investment in this fast-growing sector solidifies our state's future as a leader and highly desired partner in cell therapy research, development and manufacturing," Governor Hochul said. "This opening of the first of two CGT hubs in New York State will attract life science companies, accelerate CGT research in life science companies and our premier academic institutions, and create 21st century jobs, while offering hope to generations of New Yorkers and others who rely on the creation of these cutting-edge treatments."
Roswell Park President, CEO and M&T Bank Presidential Chair in Leadership Candace S. Johnson, PhD, said, "We proudly celebrate today the opening of the nation's largest academic facility dedicated to making cell and gene cancer therapies more accessible for cancer patients, for researchers and for companies working to advance this next-generation cancer therapy. Cell and gene therapies are redefining expectations of what is possible through cancer treatment, and through the support of Governor Hochul and Empire State Development, we look eagerly to a future where even the most hard-to-treat cancers can be successfully treated and cured."
Roswell Park Board of Directors Chair Leecia Eve, Esq., said, "Roswell Park exists to be a resource for cancer patients around the corner and around the world. We have one of the most incredible cancer teams anywhere, and now, thanks to visionary leadership and collaboration between Roswell Park and New York State, brilliant innovators who pioneered some of the first cell therapies for cancer now have the facilities and resources they need to reach the promise and potential they see ahead."
Empire State Development invested $30 million to assist in expanding the CGT research capacity at Roswell's Therapeutic Cell Production Facility from six to 20 specialized clean rooms, making it the largest academic cell and gene therapy research and manufacturing facility in the United States. The new facility streamlines every step of the cell therapy development process, shortening the path from research to production. It will encourage the growth of startup companies commercializing these therapies, grow private investment, strengthen the state's innovation-focused talent pool, and attract partnerships with biopharma companies.
GEM's focus includes developing cell and gene therapies to treat solid-tumor cancers. Existing cancer-fighting cell therapies have shown effectiveness only against cancers known as liquid tumors, such as leukemia and lymphoma. While cell therapy is a still-emerging field of cancer therapy, early successes have shown that this approach can lead to durable responses for patients with certain types of blood-based malignancies - cancers that were previously considered untreatable. The development of cell therapies targeting solid tumors like those of the breast, colon, and lung - which are much more common - is an important goal for cancer researchers.
Roswell Park's cell therapy team includes pioneers in the field whose contributions helped lead to five FDA-approved cell and gene therapies. Their expertise covers not only chimeric antigen receptor T-cell (CAR T) therapies but also tumor-infiltrating lymphocytes (TILs), adoptive cell therapies, stem cell transplant and stem cell gene engineering, as well as dendritic-cell and virus-based approaches.
Empire State Development President, CEO, and Commissioner Hope Knight said, "With ESD's investment and the unparalleled experience of Roswell behind its expanded GMP engineering and cell manufacturing facility, New York State is at the forefront of cell and gene therapy in the fight against cancer. Governor Hochul's commitment to grow cell and gene therapy offers tremendous potential to increase intellectual property, create and attract companies to commercialize these products, attract private investment, and form partnerships with biopharma companies."
State Health Department Commissioner Dr. James McDonald said, "New York's first cell and gene therapy hub will offer innovative treatments for cancer which can improve the quality of life for survivors and create more jobs in health care. I congratulate Governor Hochul and Roswell Park on a successful collaboration that will enhance the health of New Yorkers and offer hope."
New York's investment in this fast-growing sector solidifies our state's future as a leader and highly desired partner in cell therapy research, development and manufacturing."
The new Roswell Park facility is a critical component of the statewide Cell and Gene Therapy initiative announced in Governor Hochul's 2023 State of the State address. With the $430 million New York BioGenesis Park on Long Island and the $98 million expansion at Roswell Park, these projects represent a combined total investment of more than half a billion dollars in CGT innovation across New York.
Cell and gene therapies are revolutionary treatments that modify a patient's cells or genes to combat diseases at their source. Offering hope for previously incurable conditions - including cancers, genetic disorders, and autoimmune diseases - these approaches target illnesses at the cellular and genetic levels. They have the potential to provide more effective, longer-lasting treatments with fewer side effects than traditional methods. Advancements in these therapies could revolutionize healthcare, paving the way for personalized medicine and new possibilities for patients who have exhausted other treatment options.
In October, Governor Hochul unveiled plans for New York BioGenesis Park, a groundbreaking $430 million CGT innovation hub in Nassau County on Long Island 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. The project would be developed in multiple phases, with Phase One comprising a 331,000-square-foot facility on Northwell Health's campus in Lake Success, including the first Cell and Gene Therapy Tower (including the CGT business incubator with wet lab and core resources) and Contract Development and Manufacturing Organizations (CDMO) Tower (including GMP manufacturing). Phase One is already poised to advance, with conditional commitments from two anchor tenants; one would operate the CDMO, the other would operate an incubator.
The expansion at Roswell is part of New York State's $620 million Life Science Initiative. Aimed at establishing the state as a national leader in the broader life sciences industry - including biotechnology, pharmaceuticals, and medical technology - the initiative includes $320 million for strategic programs to attract new technologies, promote investment in emerging fields, and stimulate life science business growth and employment statewide. This multifaceted approach seeks to spur the development of a world-class research cluster, enhance the state's ability to commercialize groundbreaking research, and drive economic growth. By solidifying New York's position in life sciences innovation, the initiative advances Cell and Gene Therapy development and strengthens the state's global competitiveness.
Read New York State's Life Science Initiative Strategic Plan.
Assembly Majority Leader Crystal D. Peoples-Stokes said, "With the new Cell and Gene Therapy Hub, the first of its kind in New York State, the state and Roswell Park continue to innovate while providing top of the line support and treatment to patients."
Erie County Executive Mark C. Poloncarz said, "Roswell Park is internationally known as the place for cutting-edge cancer treatment and care, and this investment continues to build that reputation. I thank Governor Hochul for her vision in pursuing this new hub at Roswell Park, keeping Erie County at the forefront of new cancer-fighting technology."
Buffalo Mayor Christopher P. Scanlon said, "Buffalo is proud to play a key role in advancing groundbreaking medical research and creating life-saving solutions for patients. As New York State's first cell and gene therapy hub, this facility not only strengthens Roswell Park's global leadership in cancer treatment but also reinforces Buffalo's position as a regional hub for life sciences and the healthcare industry. Thanks to the leadership of Governor Hochul and our partnership with Roswell Park, Buffalo is at the forefront of leading-edge advancements in healthcare, bringing new jobs and economic growth opportunities to our city."