C-Path, CDISC Develop Standard to Represent Data for Animal Rule Studies

TUCSON, Ariz. and AUSTIN, Texas, October 15, 2019 — The Critical Path Institute (C-Path) and CDISC are pleased to announce the release of a global Foundational Standard that describes how to represent data for the natural history and efficacy studies conducted in animals submitted to applications under the U.S. Food and Drug Administration (FDA) regulations commonly known as the Animal Rule. The Animal Rule provides a regulatory mechanism for the approval of drugs and licensure of biological products when human efficacy studies are not ethical or feasible.Continue reading

HTG Announces the Launch of its New Autoimmune Profiling Assay

TUCSON, Ariz., Oct. 15, 2019 (GLOBE NEWSWIRE) — HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a diagnostic company whose mission is to advance precision medicine, today announced it will begin taking orders for its new 2,002-gene HTG EdgeSeq Autoimmune Panel, which is expected to be commercially available for purchase in kit form or as a service in HTG’s VERI/O laboratory at the end of October 2019. The HTG EdgeSeq Autoimmune Panel provides a comprehensive look into immune system dysfunction, discovery of new biomarkers and the discovery of predictive signatures of drug response in the autoimmune space. The panel is designed to address many questions around autoimmune disorders, which are chronic and often difficult to accurately diagnose. Autoimmune disorders represent a large and growing market, with annual direct U.S. healthcare costs for the treatment of autoimmune disorders being nearly double the direct U.S. healthcare costs for the treatment of cancer, and several of the largest selling pharmaceutical products are targeted towards autoimmune diseases.Continue reading

When we all come together, we can do amazing things

“Leading Women – Biotech and Beyond” has gained a reputation as a smart and sassy way to kick off Arizona Biosciences Week. Gathered high in the penthouse boardroom of Perkins Coie, an international law firm, some 40 women – and a few brave men – come together to share support and stories.

“I love to come to this event,” said one attendee. “When smart, savvy and successful woman come together, they are able to be truly authentic. The storytelling and laughter make for exhilarating evening.”Continue reading

Phoenix embarks on $3B bioscience capital projects, creating 7,000 jobs

“The city of Phoenix has made smart investments into building its bioscience infrastructure and it is paying off in economic impact, new company attraction, exciting job opportunities for residents and most importantly, medical insights that benefit people with health challenges who need help today.” said Joan Koerber-Walker, president and CEO of the Arizona Bioindustry Association.

“One visible example of the impact of these investments is the Phoenix Biomedical Campus, which includes eight facilities and spans 30 acres in the city center. It is a place were we’re training medical professionals, treating patients with life threatening diseases, and creating a home for companies that are working to develop new cures.”Continue reading

ASU Biodesign Institute executive director urges health care forces to ‘go beyond discovery’ at Arizona Wellbeing Commons conference

With organizations the caliber of Mayo Clinic, TGen, the Flinn Foundation, Arizona BioIndustry Association and the state’s universities, Arizona boasts a multitude of talented scientists, health professionals, life science entrepreneurs, nonprofits and government leaders committed to contributing to the quality of life in our state. Arizona’s bioscience sector is adding jobs at a rate that outpaces the nation. And its public universities are seeing increases in bioscience research funding, expenditures and tech transfer.Continue reading