BioHealth Innovation Weekly for April 18, 2023

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April 18, 2023

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USP to Host the 2023 BioHealth Capital Region Forum, Investment Conference, and Crab Trap Competition

BioHealth Innovation, Inc. (BHI) is proud to announce that US Pharmacopeia (USP) will be hosting the 9th Annual BioHealth Capital Region Forum for the second year in a row on September 19th and 20th, 2023. In addition to this flagship event, USP will also host the 8th Annual BioHealth Capital Region Crab Trap Competition on September 20th and the 6th Annual BioHealth Capital Region Investment Conference on September 21st.

"We are looking forward to once again hosting the BioHealth Capital Region Forum. As an integral part of this dynamic region, USP is deeply committed to fostering innovation and collaboration across the BioHealth space. USP eagerly anticipates bringing together leading minds and stakeholders to advance our shared vision for the future." said Anthony Lakavage, J.D., SVP of Global External Affairs at USP.

BHI Entrepreneur-in-Residence with NIH/NHLBI, Renée Arnold, Leads Trailblazing Discussion on Digital Health Innovation and Regulation for Dementia Caregiver Apps at ISPOR 2023 Conference

BioHealth Innovation's Renée Arnold is set to lead an insightful panel discussion at the upcoming ISPOR 2023 conference, which will take place on May 8, 2023, one at 12:45 and the other at 3:15 pm. The session, "Blazing The Trail for Digital Health Innovation: Resources and Examples Based on a Digital Health Application for Dementia Family Caregivers," aims to shed light on digital health technologies' research and development pathway. It will also cover the evolving US regulations framing evidence requirements for the approval of digital health applications.

Charlotte’s Tanner Pharma Group and Rockville’s ExeGi Pharma Announce Partnership to Distribute High Potency Probiotic

Partnership Announced to Distribute High Potency Probiotic in Mexico to Support Patients with Gut Microbiome Imbalance

Rockville, M.D., and Charlotte, N.C., April 12, 2023 – ExeGi Pharma LLC (“ExeGi”), a leading developer of live biotherapeutic drugs and probiotics, has announced a partnership with TannerLAC, Inc. (“TannerLAC”), a division of Tanner Pharma Group, to distribute Visbiome® in Mexico. Visbiome® is a high-potency probiotic medical food that helps manage dysbiosis associated with medical conditions like irritable bowel syndrome and ulcerative colitis. With eight probiotic strains delivered in high potency, Visbiome® is one of the most extensively researched probiotics on the market, with over 80 human clinical trials performed over the last 20 years. The formulation is available in more than 40 countries.

Altimmune Completes Enrollment In Phase 2 Clinical Trial Of HepTcell™, An Immunotherapeutic For Chronic Hepatitis B

April 11, 2023 at 7:30 AM EDT

GAITHERSBURG, Md., April 11, 2023 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company (the Company), today announced that it has completed enrollment in its Phase 2 clinical trial of HepTcell, an immunotherapeutic for the treatment of chronic hepatitis B (CHB). With the achievement of this milestone, data readout is planned for the first quarter of 2024.

The multicenter clinical trial, which is being conducted at 26 sites in North America, Europe and Southeast Asia, enrolled approximately 80 subjects with inactive CHB and low levels of hepatitis B surface antigen (HBsAg). Subjects were randomized 1:1 to HepTcell or placebo. The primary endpoint of the trial is clinical response, defined as a 1-log or greater reduction in HBsAg. Secondary endpoints include changes in the levels of hepatitis B virus (HBV) DNA, pre-genomic RNA and other markers of virologic response.

REGENXBIO Receives FDA Fast Track Designation for RGX-202, a Novel Gene Therapy Candidate for the Treatment of Duchenne Muscular Dystrophy

RGX-202 is a potential one-time AAV Therapeutic for the treatment of Duchenne and includes an optimized transgene for a novel microdystrophin and REGENXBIO's proprietary NAV® AAV8 vector
Commercial-scale cGMP material from the REGENXBIO Manufacturing Innovation Center to be used in the clinical trial
AFFINITY DUCHENNE™ Phase I/II trial of RGX-202 is active and recruiting patients; anticipated to report initial trial data in the second half of 2023

ROCKVILLE, Md., April 11, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for RGX-202, a potential one-time gene therapy for the treatment of Duchenne muscular dystrophy (Duchenne).

Maryland Industrial Partnerships (MIPS) - Proposals are due May 1!

Proposals are due May 1!

Grants for Technology Product Development Market-driven new technology and innovation leads to new products and new jobs. Creating jobs in innovative Maryland companies is what the Maryland Industrial Partnerships (MIPS) program has been doing for 32 years: bringing the inventive minds and extensive laboratory resources of the University System of Maryland (USM) to bear on creating the new products that feed the growth of Maryland businesses. Since the program’s inception in 1987, MIPS–enabled products have generated sales of $40 B. MIPS is nationally recognized by the U.S. Small Business Administration as a model program for best practices in transferring technology and is a proven program that contributes significantly to job creation and high tech product development in Maryland.

BizJournals - Baltimore digital health startup Scene Health raises $17.7 million in funding

A Baltimore startup that helps get patients to take their medications has raised one of the largest funding rounds in Baltimore so far this year.

Scene Health announced Wednesday the closure of a $17.7 million series B round led by ABS Capital Partners with participation from Claritas Health Ventures, Healthworx, the innovation arm of CareFirst BlueCross BlueShield, PTX Capital and Kapor Capital. The company is planning to move into an office in North Baltimore this year after it closed its Mount Vernon office during the pandemic.

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BioBuzz: Here Are Several BioHealth Capital Region Life Science Companies Hiring Right Now: Q2 2023

By Alex Keown
April 13, 2023

Companies within the BioHealth Capital Region hub are hiring for multiple positions in Maryland, Virginia and Washington, D.C.

BioBuzz rounds up some of the leading companies in the region seeking top talent, with examples of a few of the jobs for which they are currently hiring.

Kite Pharma

A business division of Gilead Sciences, Kite Pharma is developing innovative cancer immunotherapies. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system’s ability to recognize and kill tumors. The company currently has 28 open positions in the BHCR. You can find their open positions here.

Sr. Director, Head of Quality Control

The senior director, head of quality control will be responsible for leading a commercial manufacturing site Quality Control organization, including analytical, microbial, technical services and sample management groups and activities for cell therapy products. The position also calls for the director to advance technology integration in the labs and methods to cultivate COGM reduction. A qualified candidate will possess an advanced scientific degree, such as an MD, PhD or PharmD, and 12+ years’ experience in Quality Control Biopharmaceuticals or a master’s degree and 12+ years’ experience in Quality Control Biopharmaceuticals.

White House amps up COVID vaccine development with Project NextGen

he Biden administration has announced a $5 billion program to accelerate the development of next-generation COVID-19 vaccines and treatments.

Like Operation Warp Speed, which developed and distributed vaccines in the early days of the pandemic, Project NextGen will cut across government agencies and involve public-private collaborations, a senior Biden official told USA TODAY.

Image: https://www.usatoday.com - From Video

TRUiC: 19 Best Angel Investor Groups for Startups

Angel investors are a great way to obtain startup funding for your business. Typically, angel investors for startups fund early and seed-stage companies that show promise for high growth and scalability. However, the location and industry of your startup can also affect the angel investment opportunities available to you.

These are the top angel investor groups based on industry, stage, and accessibility for entrepreneurs to secure capital to launch their startups.

Top Angel Investor Groups

The decision to seek angel investment to launch your startup is the first step, the second step is finding the top angel investors to secure startup capital from. Fortunately, we have a list of the best angel investor groups for startups here.

1. Tech Coast Angels

About

One of the most popular angel investment groups for startups, Southern California-based Tech Coast Angels provides startup capital in addition to mentoring, connections, and business assistance for entrepreneurs. TCA has over 400 accredited investors across five networks, and invests in a variety of industries including medtech, SaaS, IoT, and more.

Best For

Seed-stage and early-stage startups
Tech startups (fintech, medtech, martech, etc.)
Life sciences startup

Montgomery County Economic Development Corporation Adds New Board Members

Joining Experienced Business Executives Across Industries, Education and Government to Enhance Economic Development in Montgomery County

Rockville, MD — Under the leadership of Board Chair Kevin Beverly, Montgomery County Economic Development Corporation has added new Board Members to its roster, bringing a broad spectrum of experience, knowledge and ideas. The board reflects the diversity and wide range of talent of Montgomery County residents and businesses—working in coordination with the MCEDC team to fulfill its mission of helping businesses start, grow and relocate to Montgomery County, Maryland.

“I am pleased to welcome Dr. Anne Khadamian, Silvana Nani, and Devang Shah to the MCEDC Board, and appreciate their confirmation from the County Council,” said County Executive Marc Elrich. “The skills, experience, and relationships that these individuals have in education, workforce development, technology, communications, and other areas will help MCEDC continue their focus on attracting, retaining, recruiting, and convening in our strategic industries.”

“The impressive range of talent and expertise within our board provides a strong complement to the work we do at MCEDC,” said Bill Tompkins, President & CEO. “The board reflects the diversity that is a hallmark of Montgomery County—drawing in a wide range of business executives from healthcare and manufacturing to life sciences, finance and the nonprofit communities.”