BioHealth Innovation Weekly for November 12, 2024

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November 12, 2024

Updated Save the Date, Mark your calendars now. 11th Annual BioHealth Capital Region Week Rescheduled for September 23-25, 2025!

The 11th Annual BioHealth Capital Region Week has been rescheduled to take place from September 23rd through 25th, 2025, at USP in Rockville, Maryland. Mark your calendars for this premier gathering of industry leaders, innovators, investors, and experts shaping the future of the biohealth industry.

Building on the tremendous success of our 10th Annual Week, the 2025 event will continue to feature hallmark events like the Forum, Crab Trap Competition and the Investment Conference, offering invaluable networking and presentation opportunities for both emerging companies and seasoned investors.

BioTalk Podcast - Connecting Innovation to Opportunity: A Conversation with Rachel Rath, Head of JLABS @ Washington, DC

In this episode of BioTalk, Rich Bendis sits down with Rachel Rath, the Head of JLABS @ Washington, DC, to discuss her journey and insights on building a thriving ecosystem for life sciences innovation. Rachel shares her academic and professional background, from roles at PCORI and BARDA Blue Knight to leading JLABS @ Washington, DC. She offers an in-depth look at JLABS’ national and international footprint, and the significant partnerships with organizations like Children’s National, Virginia Tech, and BARDA that strengthen the innovation landscape across the mid-Atlantic.

Tune in as Rachel shares the current priorities at JLABS, highlighting the diversity of its tenant portfolio, which spans MedTech, Pharma, and Integrated Healthcare Solutions. She also discusses how JLABS companies benefit from the support and resources available through Johnson & Johnson, including access to valuable connections, mentorship, and funding opportunities via JJDC.

Listen now via your favorite podcasting platform:

Apple: https://apple.co/4fybjcO
Spotify: https://spoti.fi/4eenlXO
Amazin Music: https://amzn.to/3NRxK0P
TuneIn: https://bit.ly/4ecryv7

Bethesda's Vitrian Closes on $50M Initial Investment into Biomanufacturing Capacity & Launches Partnership with AmplifyBio

BETHESDA, Md. & WEST JEFFERSON, Ohio--(BUSINESS WIRE)--Vitrian, the leading end-to-end provider of investment capital and capacity building services for biomanufacturing, announced today that it closed a $50 million investment, with ability to scale to $65 million, into AmplifyBio’s Manufacturing Enablement Center (AMEC) in New Albany, Ohio as a first step of a larger commitment to support biomanufacturing in Central Ohio. AmplifyBio is a leading advanced therapy CRO and CDMO offering a full range of drug development and manufacturing services.

Located in the heart of Central Ohio’s advanced manufacturing corridor, adjacent to Intel’s $20B Ohio One semiconductor mega-fab facility and Amgen’s $360 million biomanufacturing plant, the 350,000 square-foot AMEC site is home to AmplifyBio’s multi-modality process development and quality control labs and GMP manufacturing suites.

WBJ: Novavax taps AstraZeneca, Pfizer alum to lead key manufacturing site

Novavax Inc. (NASDAQ: NVAX) has tapped AstraZeneca and Pfizer alum Åsa Manelius to oversee operations at the Swedish lab where it manufactures a key vaccine ingredient that's expected to help drive the Gaithersburg company's growth.

The company said this week it has named Manelius as its new managing director of the Novavax AB site in Uppsala, Sweden — where it makes Matrix-M, the adjuvant for its Covid-19 vaccine and other candidates it’s developing. She will assume the post in Feburary.

Manelius succeeds Magnus Savenhed, a nearly 20-year Novavax executive who held that position since 2018. He became CEO of Swedish biotech TdB Labs AB in September.

Catalyzing Crucial Cross-Border Collaborations and Innovation to Address Unmet Needs in Rare Diseases

The Indo US Bridging RARE Summit 2024 will spotlight the urgent need for cross-border collaborations to address disparities in rare disease treatment by bringing together patient advocates, clinicians, researchers, and policymakers. The summit will focus on expanding access to orphan drugs, facilitating international clinical trials, and streamlining regulatory pathways. By honoring the pioneers of the orphan drug regulatory review process and the development of affordable CAR-T cell therapies, the summit aims to inspire affordable innovation and foster global partnerships for equitable healthcare in rare diseases.

Altimmune Announces Successful Completion of End-of-Phase 2 Meeting with FDA for Pemvidutide in the Treatment of Obesity

GAITHERSBURG, Md., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced the successful completion of its End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) and agreement on the design of a Phase 3 registrational program for its product candidate, pemvidutide, in the treatment of obesity.

U.S. FDA Removes Clinical Hold on Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Phase 3 Trial

GAITHERSBURG, Md., Nov. 11, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The FDA has cleared the Company to begin enrolling the planned Phase 3 trial following the determination that Novavax satisfactorily addressed all clinical hold issues. Novavax will be working with the clinical trial investigators and other partners to resume trial activities as quickly as possible.

Regional startups find support at annual GMU Accelerate Investor Conference

The Accelerate Investor Conference spurs the region’s innovation and startup ecosystem engagement to a new level and showcases the Virginia, Maryland, and metropolitan Washington, D.C., region as a destination for business development, venture investment, and job creation.

Each year the event grows in size and stature. This year Mason Enterprise, which plans the event, reports there were 480 registered attendees, 19 speakers, 48 company pitches, 72 investors judged and participated, and 14 student teams that pitched.

The competition targeted entrepreneurs with early to mid-seed stage, high-growth businesses with the potential to have an immediate and positive impact on our local economy, as well as student concepts with longer-term business viability. After days of networking, engagement, and education, the winners were selected.