Regulatory

The Evolution of Gap Assessments, Remote Audits, Inspection Readiness and Remediation during the Covid 19 Pandemic

The Covid 19 pandemic created immense challenges for the Pharmaceutical, Biopharmaceutical and Medical Device Industries, and for companies researching, developing, and manufacturing Rx products around the world. In 2020 and 2021 (and to some degree, continuing today) all processes were dramatically impacted by the pandemic as many employees, consultants, and others were restricted from physically working in the office or manufacturing facility, resulting in skeleton crews and largely remote workers.

 

Transform the Future of Health ARPA H

Transform the Future of Health If you have a bold, ambitious idea and feel you would be a good fit for ARPA-H, please complete the form below and submit your cover letter, CV, and idea or concept that addresses the ARPA-(H)eilmeier Questions.

ARPA-H will support concepts brought to life directly from Program Managers that have not only identified a key problem in health today, but are also passionate about a vision to bring forward revolutionary solutions to solve the problem, and do so in an equitable way. ARPA-H embraces a culture of open innovation and empowers its program managers to fearlessly pursue health breakthroughs that cannot readily be accomplished through traditional research or commercial activity.

 

Blueprint Medtech banner

The Center for Innovative NeuroTech Advancement (CINTA) & NeuroTech Harbor (NTH) announce the 2023 Spring Award Competition supported by the NIH Blueprint MedTech Program

Seeking collaborative projects aimed at developing emerging technologies into commercially viable, clinically focused solutions for disorders of the nervous system that are aligned with the mission and interests of the participating institutes and centers

The current solicitation is open and accepting pre-proposals until March 16th, the next solicitation is expected to be announced in July 2023

 

BIO 2023 Delegation Application

The Maryland Department of Commerce is seeking companies to join the Maryland delegation at the BIO International Convention in Boston, MA, June 5-8, 2023.  Our goal is to identify companies that would benefit the most from participation.  If selected, your company will receive one complimentary Premier Access pass, including access to One-on-One Partnering in the Business Forum and Exhibitor Booths, educational content, and networking receptions, as well as inclusion in promotional content.  Selected companies must be registered to do business in Maryland.

 

science.org

I walked into the conference room, eager to hear a presentation on the same topic as my ongoing Ph.D. project. But my enthusiasm didn’t last long. As a scientist with attention-deficit/hyperactivity disorder (ADHD), the text-laden slides were difficult for me to process while I simultaneously tried to listen to what the presenter had to say. My mind began to wander, only to snap back to the talk when I heard the sound of clapping. Afterward, I was faced with awkward conversations during the coffee break as colleagues asked for my opinion on the research and I had no real answer to give them. The experience was frustrating, but it also helped me think about how I can craft my own presentations to interest all scientists—including audience members with ADHD.

Image: https://www.science.org/

Angela Detweiler, a scientist in the genome sequencing laboratory at the Chan Zuckerberg Biohub in San Francisco, briefs Mark Zuckerberg and Priscilla Chan, cofounders and co-CEOs of the Chan Zuckerberg Initiative (CZI), on the lab’s instruments.CODY PICKENS FOR FORBES

Six and a half years ago, Facebook founder and CEO Mark Zuckerberg and his wife, Dr. Priscilla Chan, announced a $3 billion commitment to basic science research over a decade, including $600 million to create a biomedical research hub in San Francisco in collaboration with researchers from the University of California at San Francisco, the University of California at Berkeley and Stanford University. In late 2021 they promised another $3.4 billion toward science.

Image: Angela Detweiler, a scientist in the genome sequencing laboratory at the Chan Zuckerberg Biohub in San Francisco, briefs Mark Zuckerberg and Priscilla Chan, cofounders and co-CEOs of the Chan Zuckerberg Initiative (CZI), on the lab’s instruments.CODY PICKENS FOR FORBES

Regulatory Trends in Computer Systems Validation and Data Integrity

The Covid 19 pandemic created immense challenges for the Pharmaceutical, Biopharmaceutical and Medical Device Industries, and for companies researching, developing, and manufacturing Rx products around the world. In 2020 and 2021 (and to some degree, continuing today) all processes were dramatically impacted by the pandemic as many employees, consultants, and others were restricted from physically working in the office or manufacturing facility, resulting in skeleton crews and largely remote workers.

 

Image001

Theradaptive, a Frederick-based biotechnology company specializing in therapeutic delivery platforms, Wednesday announced a $4 million Technology & Therapeutic Development Award (TTDA) from the Department of Defense through the Peer Reviewed Medical Research Program (PRMRP) of the Congressionally Directed Medical Research Programs (CDMRP).

The contract will fund its OsteoAdapt regenerative therapeutic product for spine and trauma repair to first in human clinical studies.

Theradaptive’s OsteoAdapt product was granted three breakthrough medical device designations by the U.S. Food and Drug Administration (FDA) in 2021 and 2022 for various spinal indications. OsteoAdapt is created by combining AMP2 protein, a novel bone regenerative biologic, with ReBOSSIS, a 510K-approved implant material. OsteoAdapt has the capability to precisely direct bone regrowth where it is needed in the body.

The funds from the DOD contract will enable Theradaptive to continue its work to meet regulatory requirements and scale up Good Manufacturing Practices-compliant manufacturing of the OsteoAdapt product in preparation for clinical studies. After a request for an Investigational Device Exemption (IDE) is submitted to the FDA for approval, Theradaptive will initiate human clinical trials.

Click here to read more via The Daily Record

Cursor and Perman Portrait Unveiled in Presidents Hall UMB News

“I told Bruce Jarrell, I had told Jennifer [Litchman], please don't do this. You know, don't put me on the wall yet!” pleaded University System of Maryland (USM) Chancellor Jay A. Perman, MD, to the laughter of nearly 100 friends, colleagues, and former colleagues at a Feb. 23 ceremony held to unveil his official portrait as a past president of the University of Maryland, Baltimore (UMB). “For God's sakes, I'm an active faculty member here. I'm not done,” he continued to more laughter.

After Perman and current UMB President Bruce E. Jarrell, MD, FACS, unveiled the portrait together, Perman agreed artist Jacqueline Jasper’s work was “beautiful” and thanked her, still appearing very self-conscious.

 

Thomas Hartung with brain organoids in his lab at the Johns Hopkins Bloomberg School of Public Health.

CREDIT:WILL KIRK/JOHNS HOPKINS UNIVERSITY

A "biocomputer" powered by human brain cells could be developed within our lifetime, according to Johns Hopkins University researchers who expect such technology to exponentially expand the capabilities of modern computing and create novel fields of study.

The team outlines their plan for "organoid intelligence" today in the journal Frontiers in Science.

Image: Thomas Hartung with brain organoids in his lab at the Johns Hopkins Bloomberg School of Public Health. CREDIT:WILL KIRK/JOHNS HOPKINS UNIVERSITY

Transform the Future of Health ARPA H

If you have a bold, ambitious idea and feel you would be a good fit for ARPA-H, please complete the form below and submit your cover letter, CV, and idea or concept that addresses the ARPA-(H)eilmeier Questions.

ARPA-H will support concepts brought to life directly from Program Managers that have not only identified a key problem in health today, but are also passionate about a vision to bring forward revolutionary solutions to solve the problem, and do so in an equitable way. ARPA-H embraces a culture of open innovation and empowers its program managers to fearlessly pursue health breakthroughs that cannot readily be accomplished through traditional research or commercial activity.

Program managers at ARPA-H will serve a term-limited appointment of three years, and no more than six years total, to ensure a constant rotation of new ideas and diverse perspectives.

 

DoD seal logo 2624965220

MARYLAND - February 22 2023 – Today, Theradaptive, a leading biotechnology company specializing in therapeutic delivery platforms, announces a Technology & Therapeutic Development Award (TTDA) of $4 million from the U.S. Department of Defense (DOD) awarded through the Peer Reviewed Medical Research Program (PRMRP) of the Congressionally Directed Medical Research Programs (CDMRP). The contract will fund its OsteoAdapt regenerative therapeutic product for spine and trauma repair to first in human clinical studies.

Theradaptive’s OsteoAdapt product was granted three breakthrough medical device designations by the U.S. Food and Drug Administration (FDA) in 2021 and 2022 for various spinal indications. OsteoAdapt is created by combining AMP2 protein, a novel bone regenerative biologic, with ReBOSSIS, a 510K-approved implant material. OsteoAdapt has the capability to precisely direct bone regrowth where it is needed in the body.

Nasaclip logo

COLUMBIA, Md. (February 28, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent $250,000 investment in NasaClip, a woman- and minority-led startup which created a new device to assist in a painless, hands-free method for stopping nosebleeds. This investment came from TEDCO’s State Small Business Credit Initiative (SSBCI).

“Oftentimes, nosebleeds are non-life threatening, but patients will still go to the emergency department for them,” said Elizabeth Clayborne, MD, CEO and founder of NasaClip. “Unfortunately, the care for nosebleeds can be invasive, painful, and costly; that’s why we created NasaClip. Using NasaClip, patients can treat themselves while remaining in the comfort of their own home. TEDCO’s financial investment will help advance this much needed medical device. ”

 

Ampel Biosolutions Logo

CHARLOTTESVILLE, Va., February 28, 2023 -- AMPEL BioSolutions today announced a genomic precision medicine test for chronic kidney diseases, such as Lupus Nephritis, that could save lives by predicting kidney damage before it is irreversible and providing decision support for prophylactic therapies.  Genes that drive the inflammatory pathways characteristic of different stages of kidney damage are revealed in the peer-reviewed journal Frontiers in Immunology.  AMPEL's breakthrough approach identified markers in kidney biopsy samples that drive pathways that can be targeted by drugs.  The NephroGENE® lab test, only a concept for the last few years, is now ready for development for practical use as a decision support biomarker test to manage kidney disease.

AMPEL's innovation is crucial to provide decision support for day-to-day patient care as well as effective drug development.  Currently, physicians rely on microscopic examination of kidney biopsies to assess the severity of disease and there is no current way to predict drug options.  Today's publication identifies the molecular pathways at every stage of damage leading to end stage renal disease as well as targets of medications to slow down the immune driven damage.  And translation of key genes in animal models used for Lupus Nephritis drug development with human patients is essential to increase the success rate of clinical trials and provide earlier confirmation of the applicability of pre-clinical work to human disease.

Georgetown VP

I write today to announce that Dr. Tatiana Litvin-Vechnyak, currently Associate Vice President for Innovation Ventures at Rutgers University, will serve as Georgetown University’s new Vice President for Technology Commercialization starting February 1, 2023.

Dr. Litvin-Vechnyak brings significant experience and expertise to this critical role, having led the Rutgers Innovation Ventures team’s management of approximately 1,260 technologies, 2,600 patent assets, 800 licenses and 90 startup companies. She holds a Ph.D. in Pharmacology from Cornell University Weill Graduate School of Medical Sciences and a B.A. in Biochemistry and Molecular Biology from Clark University. She has done Postdoctoral Research at Rutgers Cancer Institute of New Jersey where she was a recipient of the Gallo Award for Outstanding Cancer Research. Dr. Litvin-Vechnyak is a Registered Patent Agent; has served on a number of boards over the years, including the Research & Development Council of New Jersey; and was recently elected to the Board of Directors of AUTM -the Association of University Technology Managers.