Biohealth Innovation - 543rd Edition, January 24, 2023

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January 24, 2022

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BioHealth Innovation Announces Two New Entrepreneurs-in- Residence at the National Institutes of Health

ROCKVILLE, MARYLAND, January 23, 2021 – BioHealth Innovation Inc. (BHI) announces the addition of Luis Gutiérrez and John K. Hsu, Ph.D., J.D., to the growing Entrepreneurs-in-Residence (EIR) team. Luis will work with the NIH Office of Extramural Research (OER), while John will work with The National Heart, Lung, and Blood Institute (NHLBI).

The OER manages the NIH’s extramural research program, providing guidance and support to staff, grantees, and the public on funding opportunities, policies, and regulations. It also oversees the review, award, and administration of grants and contracts for biomedical and behavioral research conducted outside of the NIH. In addition, the NHLBI conducts and supports research on the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases. It also works to improve the health of individuals and populations through education and public health initiatives.

BioHealth Innovation, Inc. (BHI) and Montgomery County Announce Kevin Heller, MD as a part-time “Executive in Residence”

BioHealth Innovation, Inc. (BHI) and Montgomery County are pleased to announce the selection of Kevin Heller, MD as a part-time “Executive in Residence”—a position dedicated to providing 1:1 technical assistance to Montgomery County-based biotech and medtech startups.

Heller will join two previously announced “MoCo” Executives in Residence, Jen Butler and Luis Guitierrez, who have been working closely with local entrepreneurs since November.

“I am eager to join Jen and Luis as we strengthen our community’s biohealth cluster,” said Heller. “Starting and growing a successful biotech company takes patience, perseverance, and resources. Supporting the next generation of life sciences entrepreneurs is critical from a long-term public health perspective and from a local economic development standpoint.”

Immediate Opening Life Sciences Business Strategist

BioHealth Innovation (BHI) is an innovation intermediary that facilitates the commercialization of emerging technologies in the BioHealth Capital Region (Maryland, DC and Virginia). We are seeking a Life Sciences Business Strategist to join our team remotely.

The right candidate will be an energetic and continuous learner who is passionate about accelerating the adoption of new technologies to improve lives. The position is geared toward an early-career scientist who wants to engage with the biohealth industry in new ways.

Our Strategists support selected growth-stage businesses beyond commercialization plans and federal grant proposals—they cultivate important relationships with client entrepreneurs and innovators. The Strategists’ work also includes collaborating with expert Entrepreneurs-In-Residence from around the country and other professionals in BHI’s network who have built careers at the intersection of business and science.

$100M donor gift to launch U.Va. biotech institute - Virginia Business

The University of Virginia will build a biotechnology institute funded with a $100 million donation from Charlottesville investor Paul Manning and his wife, Diane, the university announced Friday.

Along with the Mannings’ gift, U.Va. will contribute $150 million, and the state has allocated $50 million in initial investments for the institute in its 2022-24 budget, according to the announcement.

Image: Paul Manning. Photo courtesy the University of Virginia

Moore adds nine to Cabinet, including heads of Housing, Environment, Planning and Commerce - Maryland Matters

Ahead of his swearing-in on Wednesday, Gov.-elect Wes Moore’s Cabinet is nearly complete. Moore announced his picks for nine additional cabinet positions on Tuesday, filling out key roles including the heads of the departments of Housing, Environment, Planning and Commerce.

The latest appointments include two Maryland mayors — Jake Day of Salisbury and Emily Keller of Hagerstown — meaning a change of leadership elsewhere in the state.

Image: The Great Seal of the State of Maryland on the front of the Maryland State House. Photo by Danielle E. Gaines.

REGENXBIO Announces Phase I/II Trial of RGX-202, a Novel Gene Therapy Candidate for Duchenne Muscular Dystrophy, is Active and Recruiting Patients

Company has initiated Phase I/II AFFINITY DUCHENNE™ trial of RGX-202
Company also enrolling newly active observational screening study, AFFINITY BEYOND, evaluating AAV8 antibody prevalence in boys with Duchenne
Commercial-scale cGMP material from the REGENXBIO Manufacturing Innovation Center to be used in the clinical trial
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

ROCKVILLE, Md., Jan. 23, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that the Phase I/II AFFINITY DUCHENNE™ trial of RGX-202 for the treatment of Duchenne muscular dystrophy (Duchenne) is now active and recruiting patients. RGX-202 is designed to deliver a transgene for a novel microdystrophin protein that includes the functional elements of the C-Terminal (CT) domain found in naturally occurring dystrophin. RGX-202 uses REGENXBIO's proprietary NAV® AAV8 vector.

AFFINITY DUCHENNE is a multicenter, open-label dose evaluation and dose expansion clinical trial to evaluate the safety, tolerability and clinical efficacy of a one-time intravenous (IV) dose of RGX-202 in patients with Duchenne.

John C. Jacobs New Novavax CEO - President and Chief Executive Officer

John C. Jacobs joined Novavax as president and chief executive officer, and a member of the board of directors, in January 2023. He is a seasoned industry leader who has more than 25 years of commercial, operations, business and leadership experience across multiple therapeutic areas. Previously, Mr. Jacobs served as president and chief executive officer and a member of the board of directors at Harmony Biosciences from June 2018 to January 2023, and executive vice president and chief commercial officer from October 2017 to June 2018, leading the company through a successful IPO and taking its first product through FDA review, approval and commercialization. Prior to joining Harmony, Mr. Jacobs held leadership roles at Teva Pharmaceuticals beginning in 2014, including senior vice president and general manager of the Respiratory Business Unit, senior vice president of Commercial Operations in North America and general manager of Teva in Canada. Mr. Jacobs has also held positions of increasing scope and responsibility at major pharmaceutical companies including Cephalon, Wyeth and Pfizer. Mr. Jacobs has a proven track record in developing market-leading commercial strategies, major product launches and building and leading highly effective teams and organizations. He received bachelor’s degree in business from State University of New York College at Plattsburgh and a master of business administration from The State University of New York at Binghamton.

Department of Defense’s Proposed Rule Would Change SBIR/STTR Data Rights and Markings Rules - Lexology

On December 19, 2022, the Department of Defense ("DOD") issued a proposed rule seeking to amend the Defense Federal Acquisition Regulation Supplement (“DFARS”) to implement the data rights portions of recent Small Business Innovation Research Program and Small Business Technology Transfer Program Policy Directive, which emphasizes the need to protect the intellectual property interests of small businesses. In addition to addressing the small business directives, the proposed rule seeks to update markings requirements related to (1) small business data rights and (2) concerns raised by the Federal Circuit’s decision in The Boeing Co. v. Secretary of the Air Force, 983 F.3d 1321 (Fed. Cir. 2020).

Congress proposes omnibus with $1.8 billion for CHIPS & Science Act and additional innovation funding | SSTI

Federal innovation and entrepreneurship initiatives would receive substantial new funding under the text of the omnibus spending bill shared on the morning of Dec. 20 by the Senate Committee on Appropriations. The legislation, which totals $1.7 trillion and covers both regular FY 2023 appropriations and supplement funding, provides a total of $1.8 billion for programs authorized by this year’s CHIPS and Science Act and increases funding for multiple long-standing efforts — including each of the SSTI Innovation Advocacy Council’s priority programs. The legislation is expected to pass Congress this week, before the current funding agreement expires on Dec. 23.

New TEDCO Study Outlines Critical Steps Needed to Cultivate a Thriving, Inclusive and Growing Innovation Economy | citybiz

TEDCO, Maryland’s economic engine for technology companies, unveiled a legislatively mandated Maryland Innovation Competitiveness Study—one that could lead to a 5-year, $250 million down payment for an Equitech Growth Fund and the establishment of a major Kirwan-type commission. The new commission would map out an in-depth strategic plan focused on ensuring Maryland becomes a national model for a thriving, inclusive tech sector and innovation economy.

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