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ReneeConf

BHI EIR Renée JG Arnold Shares Expertise at the 28th Annual International ISPOR Meeting

By News Archive

ReneeConfRenée JG Arnold, PharmD, RPh, who serves as an Entrepreneur-in-Residence at BHI NHLBI EIR, recently moderated and participated in a panel discussion at the 28th Annual International meeting of ISPOR, which was held on May 8, 2023 in Boston. The panel, titled “Blazing the Trail for Digital Health Innovation: Resources and an Example Based on a Digital Health Application for Dementia Family Caregivers,” was attended by 75 delegates and focused on various aspects of digital health application development. Topics included the challenges and opportunities associated with the development of digital health applications, available NIH grants and product development resources, real-world experience in developing digital health solutions, and emerging regulations in the US for digital health.

After the panel discussion, Arnold and the other panelists continued the conversation with 15 attendees in a separate venue, where they further explored various aspects of digital health applications. Other panelists included Kathleen Rousche, PhD, Director of the Innovation & Commercialization Office at NHLBI; Eric Jutkowitz, PhD, an Associate Professor at Brown University; and Anindita (Annie) Saha, the Assistant Director of the Digital Health Center of Excellence at the US Food and Drug Administration.

GinaFord250

Women In Bio announces appointment of Gina Ford as Executive Director

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GinaFord250Women In Bio is proud to announce that Gina Ford has joined our team as Executive Director. Gina brings a wealth of experience, having worked in the life science and non-profit industries for years. She is a champion of women in the sciences, and we are thrilled to have her guide WIB into the future. 

As WIB nears the conclusion of its latest 3-year Strategic Plan and looks ahead to the future, we are thrilled to have Gina at the helm. Her leadership will continue to drive positive changes that will elevate our operational excellence, enrich our existing programming, and reinforce WIB’s position as a premier organization for women impacting the life sciences and beyond.

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AURPCaucus

Join AURP in Boston for a Deep Dive into Building Communities of “Biotech Innovation”!

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AURPCaucusJoin AURP in Boston for a Deep Dive into Building Communities of Biotech Innovation!

Before the 2023 BIO International Conference begins in Boston, the AURP Bio Health Caucus will focus on building research space supporting communities of bio innovations. 
Developers, A/E firms, researchers, economic development reps, VC firms, and bio innovation district managers will want to attend.

https://www.aurp.net/bio-health-caucus

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Harsha and Rich 250

Navigating the Challenges of Rare Disease Research with Dr. Harsha Rajasimha on BioTalk

By News Archive

 Harsha and Rich 250
Join us for an enlightening episode of BioTalk with Rich Bendis as we explore the pivotal role of patient registries in rare disease research and treatment. Our guest, Harsha Rajasimha, MS, Ph.D., CEO of Jeeva Informatics Solutions and Founder and Executive Chairman of IndoUSrare, shares his extensive experience in clinical genomics data science and precision medicine.

In this episode, Dr. Rajasimha introduces Jeeva Informatics Solutions and IndoUSrare, his non-profit organization. He discusses the importance of patient registries in accelerating rare disease research, the current obstacles in the field, and the potential solutions.

We discuss the role of governments in rare disease research and treatment and the potential for collaboration with non-profits in clinical trials. Finally, Dr. Rajasimha shares the goals of the upcoming Indo-US Rare Summit at the GMU Campus in Arlington, VA.

Tune in for valuable insights from a leader in rare disease research and patient advocacy.

Listen now via your favorite podcast platform

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IndoUS

Raising Awareness: Indo US Bridging RARE Summit 2023 to Shine a Spotlight on Rare Diseases

By News Archive

IndoUSScheduled for October 29-30, 2023, at the George Mason University Campus in Arlington, VA, the Indo US Bridging RARE Summit 2023 aims to unite the global rare disease community and raise awareness about these conditions. While rare diseases are increasingly understood in the United States and Europe, there remains a lack of awareness in other parts of the world, including India. By addressing this gap, the summit aims to make a positive impact on the lives of 1.5 billion people in India and the global population of 8 billion.

Bringing together leaders representing diverse stakeholders in rare diseases, the summit serves as a platform for knowledge-sharing, exchanging experiences, and fostering collaborations to address the challenges faced by rare disease patients and their families. The event covers crucial themes such as cross-border patient engagement, care pathways encompassing screening, diagnosis, and treatment options, digitization of rare diseases including registries and emerging markets, diversity, equity, and inclusion in the globalization of orphan drugs, orphan drug clinical trials, and regulatory pathways.

IndoUSrare, the organizing body behind the summit, is committed to connecting rare disease patients worldwide and prioritizing education, research, and engagement to enhance their quality of life.

For sponsorship opportunities and event information, interested individuals can contact summit@indousrare.or and visit https://www.indousrare.org/summit/. The Indo US Bridging RARE Summit 2023 is an important platform for collaboration and knowledge exchange to make a positive impact on the rare disease community worldwide.

The summit planning committee includes prominent individuals representing various organizations and institutions involved in rare disease research and advocacy. Some of the committee

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Rockville’s MaximBio Inks Contract with National Institutes of Health (RADx) Centered on a new Rapid Platform

By News Archive

maximbio logo Logo

ROCKVILLE, Md. May 9, 2023 /PRNewswire/ — MaximBio® is proud to announce it has signed a new agreement with the National Institutes of Health (NIH) through the Rapid Acceleration of Diagnostics (RADx® ) initiative, continuing a relationship fostered during the height of the COVID-19 pandemic. Building on their previous collaboration which resulted in the successful launch of the MaximBio ClearDetect® COVID-19 Antigen Home Test, the new partnership is centered around development of a COVID-19 and Influenza A/B combo test employing novel Lateral-Flow Technology. This technology, paired with the innovative FiarFly™ analyzer platform, and MaximBio’s proprietary manufacturing techniques, results in class-leading assay performance.

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TEDCO Announces Investment into Rise Therapeutics

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Rise Therapeutics Logo

Biotech company receives follow-on funding to accelerate ongoing clinical development efforts

COLUMBIA, Md. (May 8, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent Seed Funds investment of $200,000 into Rise Therapeutics, a Maryland-based biotechnology company. TEDCO’s Seed Funds invest in early-stage, technology and life sciences companies and provides access to gap financing.

“We are thrilled to receive this follow-on investment from TEDCO,” said Gary Fanger, Ph.D, president and CEO of Rise Therapeutics. “This funding will allow us to accelerate our ongoing clinical development efforts and move closer to bringing our synthetic biology-based immunotherapy drugs to market; we are grateful to TEDCO for their support.”

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Maxcyte 250

MaxCyte Signs Strategic Platform License with Walking Fish Therapeutics to Support the Development of its Innovative B Cell Platform

By News Archive

Maxcyte 250Walking Fish to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to engineer novel B-cell based medicines for the treatment of serious diseases

ROCKVILLE, Md., May 04, 2023 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and to support innovative, cell-based research, today announced the signing of a strategic platform license (SPL) with Walking Fish Therapeutics, Inc. a biotechnology company that is rapidly advancing B cell-based therapeutics.

Under the terms of the agreement, Walking Fish obtains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive platform licensing fees, clinical milestone payments and sales-based payments.

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GSK 250

US FDA approves GSK’s Arexvy, the world’s first respiratory syncytial virus (RSV) vaccine for older adults

By News Archive
  • GSK 250Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time
  • The approval is based on data from the positive pivotal AReSVi-006 phase III trial that showed exceptional efficacy in older adults, including those with underlying medical conditions, and in those with severe RSV disease
  • US launch is planned before the 2023/24 RSV season

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. This is the first RSV vaccine for older adults to be approved anywhere in the world.

Tony Wood, Chief Scientific Officer, GSK, said: “Today marks a turning point in our effort to reduce the significant burden of RSV. Arexvy is the first approved RSV vaccine for older adults, expanding GSK’s industry-leading vaccine portfolio, which protects millions of people from infectious diseases each year. Our focus now is to ensure eligible older adults in the US can access the vaccine as quickly as possible and to progress regulatory review in other countries.”

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Gain 250

Gain Therapeutics Awarded CHF 2.5 million Innosuisse Grant to Advance Lead Program in GBA1 Parkinson’s Disease

By News Archive

Gain 250BETHESDA, Md., May 03, 2023 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (Nasdaq: GANX), a biotechnology company leading the discovery and development of allosteric small molecule therapies, today announced that Innosuisse, the Swiss Innovation Agency, supports GT Gain Therapeutics SA with the amount of CHF 2.5 million (~$2.8 million) to develop GT-02287, Gain’s lead program for GBA1 Parkinson’s disease.

The Company’s Swiss Accelerator innovation project supported by Innosuisse entitled “Harnessing Structurally Targeted Allosteric Regulators to treat Parkinson’s Disease” includes clinical pharmacology and preclinical studies with the Company’s drug candidate GT-02287, which will be conducted as the lead program progresses through Phase 1 and Phase 2 clinical studies in GBA1 Parkinson’s disease.

GBA1 mutations are the major genetic risk factor for Parkinson’s disease and are associated with earlier onset of the disease, faster disease progression and increased rates of cognitive decline. Mutations of the GBA1 gene cause misfolding and dysfunction of the enzyme beta-glucocerebrosidase (GCase). Preclinical models of GT-02287 have shown the ability of this orally bioavailable and brain-penetrant molecule to target and bind to GCase, prevent its degradation and allow its transport to the lysosomes where the enzyme can carry out its biological function. Furthermore, the data from preclinical models demonstrate that enhancement of lysosomal GCase activity by GT-02287 protects against key pathological features of Parkinson’s disease, including alpha-synuclein related pathology and an increase in the survival of dopaminergic neurons. These findings support the potential of GT-02287 to slow or halt disease progression in GBA1 Parkinson’s disease.

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