BioHealth Innovation Weekly for May 23, 2023

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May 23, 2023

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From Genomic Tests to AI Predictions: Dr. Amrie Grammer, Co-Founder of AMPEL BioSolutions, Joins BioTalk

Can you envision a world where precision medicine transforms healthcare as we know it? Tune in to this exciting episode of BioTalk with Rich Bendis, featuring Dr. Amrie Grammer, Co-Founder of AMPEL BioSolutions. In this enlightening discussion, Dr. Grammer unveils the secrets behind AMPEL's remarkable success in precision medicine, making this episode a must-listen. Learn about the groundbreaking genomic tests developed by AMPEL, providing decision support for autoimmune diseases, and delve into the role of artificial intelligence in predicting potential treatments.

Explore the immense potential for a revolution in healthcare as Dr. Grammer shares insights on understanding the human genome and AMPEL's cutting-edge work in harnessing Big Data and Machine Learning for personalized precision medicine. Don't miss this great episode and gain valuable insights into the future of data-driven health.

Listen now via your favorite podcast platform

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YouTube (Audio) - https://bit.ly/3WodEia

TEDCO Announces Investment into CarrTech Corp.

Maryland medical device company supports patients and medical professionals through safer needle filtration device

COLUMBIA, Md. (May 22, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent Seed Funds investment of $250,000 into CarrTech Corp., a medical device company. TEDCO’s Seed Funds invest in early-stage, technology and life sciences companies and provides access to gap financing.

“The current eight-step process healthcare professionals are required to take to administer certain medicine is inefficient and high-risk of needlestick injuries and glass shard contamination to the patient,” said Sue Carr, founder of CarrTech Corp. “By eliminating the need to attach and detach multiple needles, patients are able to get access to the medication they need faster and safer.”

The most recent round of seed funding came from its Life Science Investment Fund; investments are for companies in the process of developing a technology for a product for human health that requires approval from the United States Food and Drug Administration prior to market.

Virginia Catalyst Announces AMPEL as Grant Round 14 Awardee

RICHMOND, VA – May 18, 2023 – The Virginia Catalyst, also known as the Virginia Biosciences Health Research Corporation (VBHRC), today announced that it has awarded $2 million in grants to four life and bioscience projects in the Commonwealth of Virginia, pending execution of the grant agreements. These grants, which will be met with significant matching funds from partner companies, were awarded through Grant Round 14 of Virginia Catalyst’s ongoing mission to stimulate economic development by promoting collaborative projects that address large, unmet needs for improving human health, and that can create high-paying jobs in the Commonwealth.

TEDCO Announces SSBCI Investment into N5 Sensors

Maryland-based business protecting individuals and businesses from environmental hazards through the use of its innovative sensor technology

COLUMBIA, Md. (May 22, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent State Small Business Credit Initiative (SSBCI) investment of nearly $400,000 into N5 Sensors, Inc. This SSBCI investment was made through TEDCO’s Seed Funds.

“Environmental hazards are not always preventable, but detecting these hazards can support the safety of everyone in the area,” said Abhishek Motayed, Ph.D., CEO of N5 Sensors. “I’m thankful for TEDCO’s interest and support—with this additional funding, we can continue our research and find new ways to help provide safety to everyone.”

N5 Sensors, based in Rockville, Md., is a startup company with a mission to keep people safe form environmental hazards. This process is done using a cloud-connected ecosystem of smart sensors that utilize and leverage the endless possibilities of shared data and artificial intelligence. Through this approach, the company has developed a variety of products and solutions, each with the goal of helping individuals stay safe from various environmental hazards.

Baltimore's Flavocure Biotech Announces FDA Clearance of IND Application for Caflanone (FBL-03G), for Clinical Trials in Pancreatic Cancer Patients.

Baltimore, Maryland--(Newsfile Corp. - May 17, 2023) - Flavocure Biotech, Inc. ("Flavocure"), today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase I, first-in-human clinical study of Caflanone (FBL-03G) for the treatment of pancreatic cancer. Pancreatic Ductal Adenocarcinoma (PDAC) accounts for about 2% of all cancers and is associated with 5% of cancer‐related deaths. Caflanone treatment is combined with radiotherapy (RT) for enhanced efficacy against cancer cells.

"We are thrilled to obtain clearance to advance Caflanone (FBL-03G) into clinical trials and are excited about the prospects of what this new class of therapeutic agent may mean for cancer patients," said Dr. David G. Brooks, MD, Ph.D., Interim Chief Medical Officer of Flavocure Biotech, Inc. "This is an important milestone for our company, representing our first program to receive FDA clearance to proceed into a clinical trial. This new approach combining radiotherapy with our lead drug candidate, caflanone, leverages our groundbreaking science and has broad potential applicability in many therapeutic areas," said Dr. Ngeh J. Toyang, Ph.D., Chief Executive Officer and co-Founder of Flavocure Biotech, Inc.

PQE Group US Earns 2023 Great Place To Work Certification™

PQE Group receives certification in the U.S. as a work environment where “you trust the people you work for, take pride in what you do, and have fun with the people you work with.”

May 18, 2023, Washington DC — PQE Group US is proud to be Certified™ by Great Place To Work® for the second year in a row. This esteemed recognition is solely based on the feedback of our present employees regarding their work experience at PQE Group. This year, a remarkable 91% of our employees expressed their satisfaction with their workplace, which is 34 points higher than the average U.S. Company.

Great Place To Work® is the global authority on workplace culture, employee experience, and the leadership behaviors proven to deliver market-leading revenue, employee retention and increased innovation. "Great Place to Work Certification is a highly coveted achievement that requires consistent and intentional dedication to the overall employee experience," says Sarah Lewis-Kulin, the Vice President of Global Recognition at Great Place To Work. She emphasizes that Certification is the sole official recognition earned by the real-time feedback of employees regarding their company culture. “By successfully earning this recognition, it is evident that PQE Group stands out as one of the top companies to work for, providing a great workplace environment for its employees."

JLL Life Sciences Observations Suburban Maryland Q1 2023

Summary and analysis of Maryland's suburban current economic and office real estate market conditions.

Click here to read the entire report.

REGENXBIO Announces NAV® Technology Platform Will Support Bespoke Gene Therapy Consortium's First Rare Disease Clinical Portfolio

ROCKVILLE, Md., May 16, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that preclinical research in Mucopolysaccharidosis type IVA (MPS IVA), also known as Morquio syndrome, was selected for inclusion in the Foundation for the National Institutes of Health Accelerating Medicines Partnership® Bespoke Gene Therapy Consortium (AMP® BGTC), clinical trial portfolio. The Consortium brings together partners such as NIH and FDA, as well as partners from private and non-profit sectors.

Sponsored by Nemours Children's Hospital, MPS IVA is one of eight programs selected as part of AMP® BGTC's first clinical portfolio to help accelerate the development of bespoke gene therapies, with the goal of streamlining the regulatory approval process. MPS IVA is a metabolic condition that primarily affects the skeleton, and is estimated to impact 1 in 200,000 to 300,000 individuals.

Harsha Rajasimha, PhD, founder and CEO of Jeeva Informatics discusses current challenges leading to clinical trial delays, such as the “valley of death.”

Pharmacy Times® interviewed Harsha Rajasimha, PhD, founder and CEO of Jeeva Informatics, on the potential to accelerate patient recruitment and solve clinical trial delays. Currently, the research, development, and approval process of a new drug by the FDA can take between 12 to 15 years. However, studies have shown patient recruitment issues are the cause of 85% of clinical trial delays.

Pharmacy Times: What are the different phases of the drug approval process by the FDA?

Harsha Rajasimha: Typically, drug approval process involves a preclinical phase, which enables first-in-human clinical trial for a new drug or entity. And that goes through phase 1, phase 2, phase 3 trials, typically. And sometimes there can be phase 1 and 2, or phase 2 and 3 combined, and stuff like that, and different types of trial designs these days, but typically phase 1, phase 2, phase 3, where phase 1 is entirely looking at safety of the drug in humans, because it's only tested in animals. Phase 2, looking at safety and efficacy at very low doses to make sure there is some drug effect. And phase 3 is full-fledged in a larger population, to assess the safety and efficacy profile across the range of doses in a range of patients in the target population. And after that, all of this data gets wrapped into an FDA submission for review. And the whole process from phase 1 to phase 3 and the review process can take about 7 years, typically, sometimes longer. And so, it's a very expensive and time-consuming process. And this process is often called the “Valley of Death,” because only 1 in 9, 1 out of 10 drugs actually make it through the regulatory approval. Most of them will fail at phase 1, or phase 2, or phase 3, about 30% at each phase. So, very few drugs make it to market.