-- Arcellx to receive $200M equity investment at $61.68 per share and an $85 million upfront cash payment --

-- Kite exercises option to Arcellx's ARC-SparX program ACLX-001 in multiple myeloma --

-- The companies expand the scope of their existing collaboration for CART-ddBCMA to include lymphomas --

REDWOOD CITY, Calif. and SANTA MONICA, Calif., Nov. 15, 2023 /PRNewswire/ -- Arcellx, Inc. (NASDAQ: ACLX) and Kite, a Gilead Company (NASDAQ: GILD), today announced that the companies have expanded their existing collaboration, which was originally announced in December 2022.

Kite has exercised its option to negotiate a license for Arcellx's ARC-SparX program, ACLX-001, in multiple myeloma, which is comprised of ARC-T cells and SparX proteins that target BCMA. The companies have also expanded the scope of the collaboration for Arcellx's CART-ddBCMA to include lymphomas.   

"Since entering into this strategic collaboration with Kite almost one year ago, we are thrilled with how the partnership is rapidly progressing and the alignment across our teams," said Rami Elghandour, Arcellx's Chairman and Chief Executive Officer. "Helping as many cancer patients as possible serves as the core of our collaboration. With the deep and durable responses demonstrated in our CART-ddBCMA Phase 1 trial in multiple myeloma, we believe that our novel synthetic binder, the D-Domain, underscores the potential to engineer a new class of CAR T therapies. We are excited to deepen our relationship with Kite as they continue to invest in our platform by exercising their rights to our ACLX-001 ARC-SparX program in multiple myeloma and increasing their investment in our company. With this additional investment from Kite, our strengthened cash position is anticipated to extend our runway into 2027, as we advance towards commercializing CART-ddBCMA. Additionally, as our partnership deepens, we continue to identify operational efficiencies and additional opportunities to collaborate which are also reflected in this agreement. Importantly, these efficiencies embody the trust developed with our Kite partners and do not alter the original agreement in principle or economics. We look forward to sharing data from our CART-ddBCMA Phase 1 trial at ASH in December."

WATERTOWN, Mass. and GAITHERSBURG, Md., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Selecta Biosciences, Inc. (NASDAQ: SELB) (the Company) today announced that it has merged with Cartesian Therapeutics, Inc., a clinical-stage biotechnology company pioneering RNA cell therapies for autoimmune diseases. In connection with the merger, Selecta announced a $60.25 million private financing led by Timothy A. Springer, Ph.D., member of the Selecta Board of Directors.

With the cash from both companies at closing and the proceeds of the concurrent private financing, the combined company is expected to have over $110 million on hand to support the development of the Cartesian pipeline through the Phase 3 study of lead product candidate, Descartes-08, a potential first-in-class RNA-engineered chimeric antigen receptor T-cell therapy (rCAR-T) for the treatment of MG, as well as the advancement of additional RNA cell therapy programs.

Concurrent with the merger, the combined company has been renamed Cartesian Therapeutics, Inc. The Company’s Nasdaq ticker symbol will change to “RNAC” effective prior to the opening of trading tomorrow, November 14, 2023.

What are the latest advancements in cancer research and innovation? Join us in this episode of BioTalk with Rich Bendis as we explore the dynamic world of cancer research and technology development with our distinguished guest, Michael Weingarten, Director of the Small Business Innovation Research (SBIR) Development Center at the National Cancer Institute (NCI).

Mr. Weingarten plays a pivotal role in leading a team of Program Directors managing the NCI's SBIR & STTR Programs, overseeing a substantial portfolio of $182 million in grants and contracts annually. These programs are at the forefront of NCI's efforts to drive innovation, fostering the development and commercialization of groundbreaking technologies and products for cancer prevention, diagnosis, and treatment.

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Explore the intersection of the BioHealth Capital Region and the NCI, understanding how collaboration and partnerships are shaping the future of cancer research and innovation. Michael and Rich delve into the goals for the future, highlighting the NCI's vision and commitment to advancing cancer prevention, diagnosis, and treatment through technology and innovation.

The hospital will advocate for the unique needs of children as part of nationwide network working to accelerate transformative health solutions

November 13, 2023 - Children’s National Hospital was selected as a spoke for the Investor Catalyst Hub, a regional hub of ARPANET-H, a nationwide health innovation network launched by the Advanced Research Projects Agency for Health (ARPA-H).

The Investor Catalyst Hub seeks to accelerate the commercialization of groundbreaking and accessible biomedical solutions. It uses an innovative hub-and-spoke model designed to reach a wide range of nonprofit organizations and Minority-Serving Institutions, with the aim of delivering scalable healthcare outcomes for all Americans.

“The needs of children often differ significantly from those of adults. This partnership reflects our commitment to advancing pediatric healthcare through innovation and making sure we’re addressing those needs effectively," said Kolaleh Eskandanian, Ph.D., M.B.A., vice president and chief innovation officer at Children’s National. “Leveraging the strength of this hub-and-spoke model, we anticipate delivering transformative solutions to enhance the health and well-being of the patients and families we serve.”

ROCKVILLE, MARYLAND, November 13, 2023 – BioHealth Innovation, Inc. (BHI), a leading organization dedicated to supporting and advancing the BioHealth industry, is pleased to announce the appointment of Dr. Eric S. Edwards, Co-founder and CEO of Phlow Corporation, to its Board of Directors. In addition, Donna J. Edmonds, CEO of BRAINBox Solutions, Inc., has been appointed as the new Vice Chair of the Board.

“We are incredibly excited to welcome Dr. Eric S. Edwards to our Board of Directors and to appoint Donna J. Edmonds as our new Vice Chair,” said Richard Bendis, BHI President and CEO. “Dr. Edwards' remarkable achievements in pharmaceutical innovation and his dedication to improving healthcare delivery are perfectly aligned with our mission at BHI. Similarly, Donna's extensive experience and proven leadership in the healthcare sector will be invaluable as we continue to drive forward our vision. Their appointments signify BHI's continued journey towards fostering a robust and dynamic BioHealth ecosystem in our region.”

Dr. Eric S. Edwards, currently the Co-founder and CEO of Phlow Corporation, brings a wealth of experience and innovation to BioHealth Innovation, Inc. (BHI). With a remarkable career spanning pharmaceuticals and healthcare, Dr. Edwards is at the forefront of securing the supply chain for critical essential medicines in America. His visionary leadership extends beyond Phlow, as he co-founded Kaléo, Inc., a pharmaceutical company dedicated to novel treatments for chronic and acute-care diseases.

The NHLBI is accepting applications for the I-Corps at NIH™ Program, which provides funding, mentoring, and networking opportunities to current Phase I SBIR/STTR awardees and Fast-Track awardees in the first phase of their award to help commercialize your promising biomedical technology. During this 8-week, hands-on program, you’ll learn how to focus your business plan and get the tools to bring your treatment to the patients who need it most.   

Program benefits include:   

• Funding up to $55,000 to cover total program costs  
• Training from biotech sector experts  
• Expanding your professional network 
• Building the confidence and skills to create a comprehensive business model  
• Gaining years of entrepreneurial skills in a matter of week

All applications must be submitted through PAR-22-073 no later than November 15, 2023. Please note that the updated due dates for the FY2024 I-Corps at NIH™ cohorts may be found at NOT-OD-23-188. This cohort begins in March 2024. The sessions will be held virtually except for the in-person kickoff in Houston, TX, and the in-person closeout session in Bethesda, MD.

 For more information, contact Stephanie Davis, Small Business Program Coordinator (This email address is being protected from spambots. You need JavaScript enabled to view it.) or visit the I-Corps at NIH™ program website.  

US-based biotech company VLP Therapeutics, Inc. (VLPT) and its Tokyo-based group company VLP Therapeutics Japan, Inc. (VLPT Japan) together announced on November 8 the third closing of its financing round, which secured investments from Sumitomo Mitsui Trust Bank, Limited, a new investor headquartered in Tokyo, and Mr. Robert G. Hisaoka, an existing investor in the US.

With this funding the VLPT group plans to: 1) bolster its vaccine research and development underway in the US for cancer treatment and infectious disease prevention, such as malaria and dengue; and 2) establish a manufacturing facility, which is expected to begin operation in 2024–2025 and will enable VLPT Japan to produce investigational vaccines in-house in Fukuoka, Japan.

GAITHERSBURG, Md., November 7, 2023 – Emergent (NYSE: EBS) has recently submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval for the expansion of the indication for ACAM2000®, Smallpox (Vaccinia) Vaccine, Live to include immunization against mpox virus. The sBLA includes data from a well-controlled animal study in which ACAM2000® vaccine has been shown to be effective in protecting against mpox virus exposure.

“Community transmission of mpox continues to be a public health challenge in the U.S.,” said Paul Williams, SVP and Products Business Head, Emergent BioSolutions. “Our sBLA submission for ACAM2000® reflects Emergent’s commitment to expanding our product capabilities and continuously support the U.S. government as we address emerging infectious diseases and strengthen future preparedness.”

Mpox, formerly called monkeypox, is a rare disease caused by infection with the mpox virus. Mpox virus is part of the same family of viruses as variola virus, the virus that causes smallpox. Mpox symptoms are similar to smallpox symptoms, but milder, and mpox is rarely fatal.¹ Since the start of last year, there have been more than 31,000 mpox cases in the U.S. and 55 deaths, according to the CDC, with more than 91,000 cases and 166 confirmed deaths globally.

BALTIMORE, MD, November 7, 2023 –Irazú Oncology, LLC, a biotechnology research company working to develop the next generation of cancer vaccines, and University of Maryland, Baltimore (UMB) are marking the one-year anniversary of their exclusive, worldwide license agreement and continuing partnership for the development of UMB’s novel immunotherapeutic vaccine technology. The Company, founded and led by Marco Chacón, PhD, is a UMB startup pursuing its plans to commercialize UMB’s technology as part of its oncology vaccine platform.

Irazú Oncology’s Membrane Vesicle Platform (MVP) technology utilizes nanosized outer membrane vesicles (OMVs) derived from attenuated bacteria to display and deliver tumor antigens to sites of immune response. The OMV vaccines are designed to stimulate the body’s own immune system to attack and destroy tumor cells. The Company’s lead vaccine candidate, IRZ-CRC-1, is a bivalent colorectal cancer vaccine that has shown excellent efficacy in colorectal cancer preclinical models.

A life sciences accelerator called Blackbird Laboratories has $100 million to spend to turn Baltimore into a biotech hub.A life sciences accelerator called Blackbird Laboratories has $100 million to spend to turn Baltimore into a biotech hub.

Blackbird was founded at the start of this year with the backing of Baltimore Ravens owner Steve Bisciotti’s family foundation. So far, Blackbird has looked at about 80 to 100 proposals and funded five programs, Blackbird CEO Matt Tremblay told Endpoints News.

Baltimore has had a few notable biotech success stories, such as Thrive Earlier Detection (acquired by Exact Sciences in 2020) and Personal Genome Diagnostics (acquired by Labcrop in 20222), but Tremlay said he hopes to support a "Kendall Square-like phenomena." He's looking to back research ideas that ultimately become biotech startups based in Baltimore. 

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OXFORD, United Kingdom, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), formerly Vaccitech plc (NASDAQ: VACC), a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity and cancer will present data from its Phase 2 Hepatitis B trials of VTP-300 at The American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2023, November 10-14 in Boston, MA.

The company also announced today that it has changed its name to Barinthus Biotherapeutics plc to represent the evolution and expansion of its focus beyond vaccines. The company expects to begin trading under its new name and ticker (Nasdaq: BRNS) effective as of November 7, 2023. As part of the rebranding, the company has also updated its website -- learn more at www.barinthusbio.com.

Are you curious about the world of transformative regenerative medicine and stem cell research? Are you eager to understand how Maryland champions researchers and companies in the field of stem cell and regenerative medicine? Do you want to learn more about the Maryland Stem Cell Research Fund (MSCRF)? Listen to the latest episode of BioTalk with Rich Bendis as he welcomes MSCRF Executive Director, Ruchika Nijhara, PhD.

In this enlightening episode, Dr. Nijhara, a forward-thinking leader driven by her passion for advancing scientific innovation, delves into the funding mechanisms that Maryland employs to support research and development at all stages and fosters collaboration and innovation.

• Partnership combines QIAGEN’s QIAseq panels, CLC LightSpeed, and QCI Interpret software to support Element’s AVITI System users in genomic analysis
• Collaboration to accelerate discovery, enhance cost efficiencies, and improve turnaround times for genomic applications in the scientific community
• QIAGEN to present performance data for universal QIAseq library preparation panels running on other sequencing platforms at ASHG Annual Meeting 2023 in Washington, DC

Venlo, the Netherlands, and San Diego, California, Nov. 02, 2023 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and Element Biosciences, Inc. today announced a strategic partnership to offer comprehensive next-generation sequencing (NGS) workflows for the Element AVITI™ System, an innovative sequencing platform.

Element’s AVITI System is a versatile benchtop sequencer offering a combination of performance, cost, and flexibility for a wide range of NGS applications. For customers using the AVITI System, QIAGEN provides Sample to Insight NGS workflows with validated QIAseq panels and integrated bioinformatic solutions, including CLC LightSpeed and QCI Interpret software.

“The collaboration between QIAGEN and Element Biosciences delivers unprecedented insights across various genomic applications to our customers worldwide. Researchers are increasingly searching for complete solutions and workflows from sample to insight, and we are committed to advancing the field together by providing innovative technology and applications that help researchers accelerate discovery,” said Nitin Sood, Senior Vice President, Head of Life Sciences Business Area at QIAGEN.

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the first patient has enrolled in the registration-phase TETON PPFstudy, which will evaluate nebulized Tyvaso® (treprostinil) Inhalation Solution in 698 adult patients with progressive pulmonary fibrosis (PPF). This is in addition to two separate ongoing registration-phase studies, TETON 1 and TETON 2, of nebulized Tyvaso in patients with another type of pulmonary fibrosis (PF) known as idiopathic pulmonary fibrosis (IPF).

By Alex Keown | October 31, 2023 - 

Addimmune, currently American Gene Technologies HIV-focused research, is expected to become a publicly traded company in early 2024 following a merger with 10X Capital Venture Acquisition Corp. III, a special purpose acquisition company (SPAC).

Following the merger with the SPAC company, Addimmune will use the raised funds to support its planned Phase Ib clinical trial assessing the company’s Gag-specific AGT103-T, a genetically modified cell product, CEO Jeff Galvin told BioBuzz. The merger announcement comes months after plans to separate the HIV business were shared by AGT.

Addimmune launched with the goal of building on the success of a Phase I study assessing AGT103-T as a potential therapeutic for HIV that could offer a functional cure of the disease. Trial data revealed that 100% of participants showed active immune responses to HIV after participants ceased taking their antiretroviral therapy. The data showed that several of the seven trial participants achieved significant viral suppression, which signals the possibility that AGT103-T has the potential to deliver a functional cure to HIV patients. The Phase I data was published in November 2022 in Frontiers in Medicine, a peer-reviewed scientific journal focused on medical advancement. 

Six new products that can be used to detect residual host cell genomic DNA (gDNA)

MANASSAS, Va. and ROCKVILLE, Md., Oct. 30, 2023 /PRNewswire/ -- Today, ATCC and U.S. Pharmacopeia (USP), two premier materials management and standards organizations, announced the launch of their first set of joint products to advance the quality control and reduce the risk in the manufacturing of biological therapies and vaccines. This initial set of six products consists of highly characterized and pure genomic DNA (gDNA) from cell lines used in bioproduction that can be used to measure residual host cell DNA in various biotherapeutic products, as required by regulatory authorities. The presence of gDNA is a predominant concern in the development of biological therapies as it can pose a safety risk if it is not removed from the product.

"Developing cutting-edge medicines in the biologics space requires trusted reference materials and standards to ensure quality, consistency and safety," said Amanda Cowley, General Counsel and SVP Legal, Strategy and People of USP. "With increased demands around the globe for new biological medicines on accelerated timelines, it's essential that there are products and solutions that can be used to address and advance quality assessment and bring confidence to the development process. By focusing on the detection of gDNA, this first set of ATCC and USP products is significant for the future of biological development as it addresses a common concern when it comes to quality and mitigating risk."

ROCKVILLE, MARYLAND, October 30, 2023 – BioHealth Innovation Inc. (BHI) proudly welcomes Jon Nelson to its innovative team. Jon joins BHI as a Technical Writer and Program Manager, bringing an impressive nine years of research experience within the biological sciences, further enhancing BHI’s commitment to advancing healthcare technologies.

Jon’s journey in biological sciences began with the pursuit of his master’s degree in biology at the University of North Carolina at Greensboro. During this time, he worked with bioinformatics to predict epigenetic drug efficacy and leverage cutting-edge technology for groundbreaking solutions.

“We are excited to have Jon Nelson join our team. His extensive research experience and innovative mindset align perfectly with BHI’s mission to drive innovation and transformative healthcare solutions,” said Monique Bennett, BHI Life Science Business Strategist.

RICHMOND, Va., Oct. 30, 2023 /PRNewswire/ -- BRAINBox Solutions today announced initial investments into the company's Series B financing to support U.S. regulatory clearance and initial commercialization of its BRAINBox TBI concussion diagnostic/prognostic test in adults and completion of a clinical study in pediatric patients. Genoa Ventures is leading the financing, which includes other current and new investors.

"We have made significant clinical and pre-commercial progress in developing the BRAINBox TBI test," said Donna Edmonds, BRAINBox Solutions' CEO. "We are working with selected platform partners as we determine the fastest path to market for use in both point-of-care and emergency department settings." She noted that in addition to the adult population, the company is developing BRAINBox TBI tests for pediatric patients, and, through a National Institutes of Health grant, for geriatric patients.

"The BRAINBox TBI test is the first to integrate physiologic and functional testing, an approach that is designed to maximize sensitivity and specificity, and provide objective criteria for the diagnosis and prognosis of acute traumatic encephalopathy, commonly known as concussion," said W. Frank Peacock, MD FACEP, FACC, FESC, the study's Principal Investigator and Professor, Vice Chair for Research, Henry JN Taub Department of Emergency Medicine, Baylor College of Medicine.

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WASHINGTON, D.C., Oct. 27, 2023 (GLOBE NEWSWIRE) -- Boys with Duchenne muscular dystrophy (DMD) have a clinically proven, new treatment option with the Food and Drug Administration’s approval Thursday of vamorolone, a steroidal-type, anti-inflammatory drug developed based on research performed at Children’s National Hospital. 

Created by ReveraGen BioPharma Inc., vamorolone has a molecular structure similar to traditional corticosteroids, which are currently used to treat DMD. Yet its structure was found to be chemically different enough to reduce unwanted side effects, including brittle bones and reduced stature. Nearly two decades ago, ReveraGen leaders – President and CEO Eric Hoffman, Ph.D., and Vice President for Research Kanneboyina Nagaraju, D.V.M., Ph.D. – launched research efforts into the drug when they led the Center for Genetic Medicine Research at Children’s National. They worked with then-Chief Academic Officer Mark Batshaw, M.D., on the new clinical option. 

Dive into the world of viral safety with the upcoming 2024 PDA Virus Conference. Set against the picturesque backdrop of Amsterdam, this event promises to be a melting pot of knowledge, innovation, and networking.

📅 Dates to Remember:

• Conference: Jun 26 - Jun 27, 2024
• Abstract Submission Deadline: November 30, 2023

📍 Location: Amsterdam Marriott Hotel, Stadhouderskade 12, Amsterdam, The Netherlands. Nestled amidst iconic attractions, the hotel offers a blend of luxury and convenience.

🔍 Theme: "Viral Safety Reloaded - the Finalized ICH Q5A (R2)"

🌟 Highlights:

• A unique opportunity to attend two conferences in a week, with the Advanced Therapy Medicinal Product Conference preceding this event.
• Engage with a diverse Scientific Program Planning Committee, featuring stalwarts from ViruSure, Eli Lilly, Merck KGaA, U.S. FDA, and more.
• Submit your abstracts! Remember, they should be non-commercial and focus on breakthroughs in Virus Safety.

GAITHERSBURG, Md., Oct. 26, 2023 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its clinical program investigating pemvidutide for the treatment of NASH.

NASH is a serious, potentially life-threatening condition that is a leading cause of liver failure and liver transplantation globally. NASH is a growing public health concern, and there are currently no approved treatments. The Fast Track designation is designed to facilitate the development and expedite the review of new drugs intended to treat serious conditions and address unmet medical needs.

“The FDA’s decision was informed by the results of Altimmune’s studies including its Phase 1b randomized, placebo-controlled study of pemvidutide in subjects with non-alcoholic fatty liver disease (NAFLD), which showed class-leading relative reductions in liver fat and non-invasive markers of hepatic inflammation and a favorable safety and tolerability profile,” said Vipin K. Garg, Ph.D., President and CEO of Altimmune. “The Fast Track designation reflects Altimmune’s commitment to patients with NASH and efforts to find safe and effective treatments for this condition.”

October 25th, 2023 – Johnson & Johnson Innovation, in collaboration with Carilion Clinic Innovation, Verge Alliance (with support from City of Roanoke), and Virginia Tech Corporate Research Center (VTCRC), announced today at the Harnessing the Potential of Antibody Drug Conjugates (ADC) in Oncology event at JLABS @ Washington D.C. that Bacchus Therapeutics, Luminary Therapeutics, and QurCan Therapeutics Inc., have been selected as the awardees in the Advancing Oncology InnoVAtion QuickFire Challenge.

The challenge invited innovators from across the globe with an active interest in the Virginia innovation ecosystem to submit potential solutions aiming to transform patient outcomes in oncology in adult populations with potential applications in pediatric oncology. The awardees hope to nurture Virginia’s outstanding innovation ecosystem and spearhead innovative solutions to enhance the quality of life for cancer patients across the globe.

MCLEAN, Va. & BEDFORD, Mass.--(BUSINESS WIRE)--MITRE announced a new five-year contract with the Centers for Medicare & Medicaid Services (CMS) to operate the CMS Alliance to Modernize Healthcare, a federally funded research and development center, more commonly known as the Health FFRDC.

Established in 2012, the Health FFRDC serves the public interest by tackling complex, cross-cutting challenges affecting health and well-being. As the Health FFRDC operator, MITRE serves as an objective advisor to CMS, the Centers for Disease Control and Prevention, Food and Drug Administration, National Institutes of Health, Health Resources and Services Administration, Administration for Children and Families, and all the operating divisions across HHS, as well as other governmental organizations with health missions.

Maryland Venture Fund Authority advises and consults with TEDCO regarding the administration of the InvestMaryland program

COLUMBIA, Md. (October 24, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced the FY24 Maryland Venture Fund Authority (“Authority”) members, including new appointees Vishal Amin, Ricardo Alvarado and Bei Ma.

“TEDCO is excited to welcome these new members to the Maryland Venture Fund Authority,” said Jack Miner, TEDCO’s chief investment officer. “Through their efforts, we know FY24 will be productive, allowing for the continued growth, development and diversification of Maryland’s economic development.”

Authority officers include:

• Grace Garry, Chair
• Renée Winsky, Vice Chair
• Mike Thielke, Secretary

The Authority consists of nine members, seven appointed by Governor Wes Moore with the advice and consent of the Senate, one member appointed by the president of the Senate and one member appointed by the speaker of the House.

The FDA’s Commissioner, Dr. Robert M. Califf, recently visited India and shared his opinion on India’s Unique Opportunity and Important Responsibility as the Pharmacy to the World. The Inaugural 2-day Indo US Bridging RARE Summit was held on Oct 29 and 30, 2023 at George Mason University in Arlington, VA. The organizing committee led by Dr. Harsha Karur Rajasimha at the Indo US Organization for Rare Diseases (IndoUSrare), a US-based nonprofit committed to combating rare diseases, are aiming to catalyze this potential cooperation and harmonization between the FDA and Indian regulators to create a pathway for biopharmaceutical sponsors to start commercially launching orphan therapies in India. The effect can be far reaching, saving or impacting millions of lives. Dr. Peter Marks, Director of Center for Biologics Evaluation Research (CBER), FDA, keynote speaker at the Summit, announced the Creation of Operation Warp Speed for Rare Diseases, a pilot program called Support for Clinical Trials Advancing Rare Disease Therapeutics (START).

(HERNDON, Va.) October 24, 2023: The launch of Operation Warp Speed in 2020 to develop COVID-19 vaccines was a resounding success, developing and making available the vaccines to the general public in record time and saving an estimated 3.2 million lives and $1.15 trillion in the U.S. alone.1 As a result of that achievement, the U.S. Food and Drug Administration (FDA) is launching a pilot program — Support for Clinical Trials Advancing Rare disease Therapeutics (START) — this year to accelerate the pace of development of therapeutics for very small populations with very high medical need. 1 Globally, rare diseases are defined by The World Health Organization (WHO) as a disorder which affects less than 6.5 to 10 people out of 10,000.2 According to a report by RARE-X, there are over 10,897 known rare diseases affecting over 400 million people worldwide. Since the Orphan Drug Act of 1983, the FDA has approved about 1100 orphan drugs to treat about 5-7% of rare diseases. Hence, a majority of rare diseases remain without treatment options. At the recently concluded Indo US Bridging RARE Summit 2023, Dr. Peter Marks, director at the FDA’s Center for Biologics Evaluation and Research (CBER), spoke about the START program, the India opportunity, and stated, “We have fifteen FDA approved gene therapies till date. We are very committed to working with the rare disease communities for gene therapies and with our colleagues globally. India is an incredible opportunity in terms of capacity and capability. By leveraging them and working together, we can achieve some wonderful things for people with rare diseases.”

As part of the President’s Investing in America agenda, the U.S. Department of Commerce identified regional centers primed for technological innovation and job creation.

WASHINGTON, DC — The Biden-Harris administration, through the U.S. Department of Commerce’s Economic Development Administration (EDA), today announced the designation of 31 Tech Hubs in regions across the country. This is the first phase of the new Tech Hubs program, which is an economic development initiative designed to drive regional innovation and job creation by strengthening a region’s capacity to manufacture, commercialize, and deploy technology that will advance American competitiveness.  The program invests directly in burgeoning, high-potential U.S. regions and aims to transform them into globally competitive innovation centers.