This week's Lab Notes has items on a Big Pharma company's new business launch, a contract research organization's expanding service line, a Wayne biopharma firm's key Food and Drug Administration designation, and more.
Here's the roundup:
AstraZeneca
The United Kingdom-headquartered Big Pharma company, which has its North American commercial business headquarters in Wilmington, this week launched a digital health services provider that will support clinical research globally.
Evinova's clients will include pharmaceutical manufacturers, biotechnology firms and contract research organizations. Its focus will be on bringing to market established and scaled digital technology already used by AstraZeneca (NYSE: AZN) to enhance clinical trial design and delivery.
Evinova already has partnerships with Parexel and Fortea, contract research organizations based in Massachusetts and North Carolina, respectively, which will offer Evinova's services to their customers.
"We believe Evinova’s combination of scientific expertise and track record in developing AI-enabled digital technologies provides a real opportunity to fundamentally improve patient care, drive healthcare transformation and reduce carbon emissions," said Pascal Soriot, CEO of AstraZeneca, in a statement.
Cristina Duran, who has been with AstraZeneca for 14 years including four as chief digital officer, will head Evinova.
The new business launched with a staff of 300 from AstraZeneca operations in nine countries.
Incite Health
The Doylestown contract research organization founded by former Johnson & Johnson researcher Renold Capocasale expanded its service line with the launch of its pharmacogenomics platform to support drug development initiatives of pharmaceutical and biotechnology companies.
Pharmacogenomics, also known as PGx, is a specialized type of genetic testing that examines how an individual’s genetic makeup influences their response to medications.
Capocasale said Incite Health's PGx service was designed to help pharmaceutical and biotech companies improve patient recruitment efficiency, accelerate clinical trial timelines, and reduce overall drug development costs.
Drug developers, he said, will be able to improve the safety of clinical trials by identifying those potential participants who, based on their unique genetic profile, may have an increased chance of experiencing a negative reaction to a new drug. Additionally, researchers will be able to tailor dosages, formulations and treatment plans based on genetic responses and identify patients with specific genetic profiles that match their drug’s mechanism of action.
Palvella Therapeutics
The Wayne biopharmaceutical company’s lead new drug candidate, Qtorin rapamycin, received breakthrough therapy designation from the Food and Drug Administration.
Palvella is developing Qtorin as a treatment for microcystic lymphatic malformations, a chronically debilitating and lifelong genetic skin disease affecting an estimated more than 30,000 patients in the U.S. There are currently no FDA-approved treatments for the rare condition, characterized by localized masses of malformed lymphatic vessels that protrude through the skin barrier and persistently leak lymph fluid and bleed.
Palvella is preparing late-stage clinical testing for Qtorin involving 50 patients following its successful phase 2 clinical trials.
“We believe Qtorin rapamycin can fulfill an urgent unmet need for patients suffering from microcystic lymphatic malformations who from a very young age endure significant morbidity as a result of this lifelong disease,” said Wes Kaupinen, Palvella’s founder and CEO.
Breakthrough therapy designation is intended to expedite the development and review of experimental therapies for serious or life-threatening conditions where preliminary clinical study data provides an indication that the drug may demonstrate substantial improvement over existing therapies. Under the designation, the FDA provides intensive guidance, organizational commitment involving senior managers, and eligibility for rolling and priority reviews.
Innovation Space
The Delaware-based "innovation ecosystem" was awarded a $750,000 grant from the U.S. Department of Commerce for its First Fund.
First Fund is Innovation Space's seed-stage investment program for early stage life sciences startups.
Innovation Space was one of just 20 organizations in the country chosen for an EDA Capital Challenge grant and received the top tier of funding awarded.
Bill Provine, founder and CEO of the Innovation Space, said the grant will enable the program to increase staffing and expand its mentorship activities and its geographic reach, as well as to attract private co-investors.
Since its inception in 2017, Innovation Space — which comprises 130,000 square feet of lab and office space on Dupont's Experimental Station campus in Wilmington — has supported more than 100 startups which collectively have gone on to raise more than $1 billion in investments.
Quick Hits
Children’s Hospital of Philadelphia received a $6.4 million gift from the family of Connor Boyle, a Central Bucks East High School graduate who died at the age of 18 from osteosarcoma. The three-year gift is called "The Connor Initiative: Precision Therapeutics for Osteosarcoma & Rare Cancers" and will support research into the disease that is the most common malignant bone tumor in children and young adults. … Madrigal Pharmaceuticals (NASDAQ: MDGL) of Conshohocken appointed Ronald Filippo as its chief information officer. Filippo was previously senior vice president for digital technology at Moderna.
