AMBROSUS Partners with TREK THERAPEUTICS to Develop a Blockchain-powered Method to Track Quality in Pharmaceutical Manufacturing

August 11, 2017 – Ambrosus, the world’s first trusted blockchain-based ecosystem for the supply chain, today announced a partnership with pharmaceutical pioneer Trek Therapeutics, PBC (Trek) to apply integrated sensors coupled with blockchain-based technology to pharmaceutical drug manufacturing in Trek’s clinical development program. This announcement comes as blockchain industry heavyweight Jaron Lukasiewicz joins Ambrosus as Strategic Advisor.

AMBROSUS Partners with TREK THERAPEUTICS to Develop a Blockchain-powered Method to Track Quality in Pharmaceutical Manufacturing

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Goals of Phase II Clinical Trials

hepatitis C virus

 

Having previously functioned as an infectious disease consultant at Danbury and New Milford Hospital in Connecticut while teaching at Yale University and New York Medical College, Robert Hindes, MD, serves as the chief medical officer of Trek Therapeutics. In his leadership role with the pharmaceutical developer, Robert Hindes, MD, oversees Phase II clinical trials for a next-generation treatment for hepatitis C virus, with a plan to develop affordable drugs for patients without access to effective therapies..

The primary objective of Phase II clinical trials is to establish the safety and therapeutic efficacy of a drug. Most importantly, companies must use Phase II trials to demonstrate a measurable benefit to the patient. Drugs in Phase II trials must also produce a primary response in the intended target; for example, an anti-cancer drug must actually display anti-cancer properties. Finally, Phase II trials enable researchers to expand the toxicological and pharmacological data collected in Phase I.

In terms of structure, Phase II clinical trials typically recruit approximately 100 to 200 subjects, but this number varies greatly among studies. Due to the relatively small sample sizes, the success of drugs in Phase II trials is assessed by observed differences between the drug(s) being studied and the placebo or active control arm, and generally not by statistical comparisons. Commonly referred to as “pilot” studies or proof-of-concept studies, Phase II trials determine whether a drug is a good candidate for larger, statistically powered Phase III trials in a larger population.

Examining the Causes of Hepatitis C

 

Hepatitis C pic

Hepatitis C
Image: webmd.com

Robert Hindes, MD, served as the group director of virology at Bristol-Myers Squibb, which is based in Wallingford, Connecticut, prior to taking in his role as the chief medical officer of Trek Therapeutics. Focusing on the development of affordable hepatitis C (HCV) drugs that are accessible to the largest possible audience, Robert Hindes, MD, oversees the development of all clinical strategies employed by Trek Therapeutics.

A viral condition, HCV is transmitted when a person comes into contact with the blood or other bodily fluids of somebody who carries the infection. Blood, however, is the main transmitter, as even small traces of it are capable of passing on the infection. Some believe the virus is capable of surviving in blood outside of the human body for a number of weeks in areas that remain at room temperature.

The predominant cause of the infection is the sharing of needles by drug users; for instance, the NHS, the United Kingdom’s public health service, estimates the practice to be the cause of around 90 percent of infections in that country. Less common causes include unprotected sex, particularly amongst people who have other sexually transmitted infections such as genital sores or HIV. There is also the potential for HCV to be passed to others if items that come into contact with blood (such as tattoo equipment, needles, razors, and scissors) have not been properly sterilized before use.

There is also an estimated 5 percent chance that the infection can be passed from mother to child, though it is believed that this cannot occur through breastfeeding.