GLP/GMP is next for Ichor Therapeutics.

In March we signed on a new investor, Roger Bagg (you may have seen our press release over at MedTech, or the Town of Lafayette Newsletter – we’re glad everyone else was as excited as we were!). Roger is an ideal investor for Ichor. He has experience investing in other Biotech firms both in the US and the UK, and philosophically speaking he’s well aligned with our CEO, Kelsey Moody.

From our contract research to our oncology and ophthalmology programs, our incubator program for independent researchers, and our internships for students, we think our work is doing a lot of good already; but now with Roger’s help, we can do even better.

“Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed…”

With the capital from our newest investments we’ve begun work with Scott Campbell, a pharmaceutical quality assurance consultant. From the beginning, we have implemented the same standards for our research that are found in most university laboratories. However, for our results to be admissible to the FDA in the support of eventual human clinical trials, we must apply highly stringent GLP/GMP standards. With Scott’s help we have been working tirelessly to transition into a research firm that operates in compliance with Good Laboratory Practice (GLP) regulations.

Scott’s role has been to consult with us about establishing the necessary guidelines and policies that will ensure we are GLP compliant. Our employees have individually and collectively participated in authoring a new GLP compliant Standard Operating Procedure for just about every aspect of lab life.

 

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Now you probably have a lot of questions about what GLP compliance means. Luckily, in addition to the official guidelines, the FDA provides a 26 [TWENTY SIX] page FAQ guide to the FDA official guidelines. We’ll save you the trouble of having to read the whole document to find out that, yes, “photocopies of raw data, which are dated and verified by signature of the copier” are “considered to be ‘exact’ copies of the raw data.” We know that one has been keeping you up at night!

 

GLP is just the first step in our plan. GLP Guidelines mean we will be able to do preclinical Development. If we want to do Clinical Trials (which we do, eventually), then we’ll have to take the next step…. GCP!

GCP (Good Clinical Practices) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects (we’ll probably have to get bigger cages). These methods provide public assurance that the rights, safety, and well-being of trial subjects are protected.

We’re all excited about the changes and improvements we’re making and look forward to introducing you to the Ichor family and traditions!