In October 2017, an updated version of the FDA’s Technical Conformance Guide (TCG) was released. The TCG has been around for about 4 years and provides recommendations on how to submit clinical trial study data to the FDA. Although, this guide is non-binding the FDA emphasizes that adherence to this protocol facilitates drug review and (potential) approval. On a regular basis, usually every six months, a team of medical professionals, statistics/data reviewers and technical staff meet to discuss recent clinical trial study data submissions and associated problems. These discussions lead to an implementation of necessary updates to the TCG that will help guide those interested in a seamless FDA drug approval process.
The Navy Yard – a Life Science Hub (pictured)
As mentioned in our previous post, Philadelphia is positioning itself as a top life science biotech hub. One of the top reasons are the incentives available for real estate purchases in the region. Specifically, the City of Philadelphia and Commonwealth of Pennsylvania now offer numerous tax advantages to life science companies setting up shop in the historic ‘Navy Yard’.
This year, Philadelphia jumped up two spots and ranked #5 for a thriving biotech hub, according to a study by the research firm, JLL. This came as no surprise to us, since we’ve seen many new biotech companies calling Philly home and we also boast branches of big pharma giants including Merck and Pfizer. Also, the US Chamber of Commerce ranked Philadelphia #3 as a start-up leader. This ranking was based on numerous metrics, including talent, capital investments, and connectivity. So why all the buzz around Philadelphia for biotech startups specifically? Here are some advantages, in our opinion, that are positioning the region to be the next leading biotech cluster in the US.
As most biopharmaceutical groups are aware, the 21st Century Cures Act of 2016 mandates a number of powerful core changes to drug and medical device development timelines. Thanks to the new legislation, breakthrough medical device and biologic therapeutics will have drastically expedited development and clinical trial pipelines.
Good quality clinical trial study data that comes through the FDA could potentially avoid delay in data extraction, review and verification that will help drive your product to market faster. In order to do all these tasks quickly and consistently, the submission of your study data needs to be standardized to help the FDA streamline the review process and enable consistent use of analysis tools throughout all clinical trials. Time and time again, we see inconsistencies and irregularities in documentation of study data.
Conducting a First In Man (FIM) clinical trial with a novel drug product is a complicated process that requires an abundance of caution.
Also known as Phase 0 trials, FIM trials crucial tests of a drug product’s ability to enter the trial pipeline and make it toward the market. In real terms, FIM trials are basic PK/PD tests that justify future trials by not harming the trial subjects.
But what factors are the most important to pay attention to before moving into Phase 0, and what does preclinical research contribute?
Generally speaking, if the intent of a clinical trial is to determine the safety and efficacy of a new drug, or changes to an existing drug, then IND submission is required. Filing an IND is quite complex and time consuming, so before starting the process of submission, you’ll want to ensure that it is absolutely necessary. Here we simplified the guidelines to help you determine if you are required to file an IND for your clinical trial and also provide some additional resources for follow-up on more details.
There’s never been a more optimistic time in the history of cancer clinical trials than the present, thanks to immunooncology. Through only a couple of many potential therapeutic modalities, immunooncology’s impact in clinical trials has palpably changed the research and clinical landscape.
The FDA’s Center for Drug Evaluation and Research (CDER) offers an all-encompassing bundle of information that is of interest to the pharmaceutical industry to help get their drug on the market. If you are interested in general educational resources related to this field, you should take a look at the CDER Small Business and Industry Assistance (SBIA) Learn portal that offers a series of presentations and webinars on topics such as regulatory issues, generics development, etc.
We thought the presentation provided earlier this year by the Director of CDER, Dr. Janet Woodcock, entitled the “The Future of Drug Development” was quite interesting, so we wanted to share some of the highlights.
Pictured: A schematic of how immunotherapy could be used against respiratory allergies. Published by Sari Sabban in “Development of an in vitro model system for studying the interaction of Equus caballus IgE with its high-affinity Fc epsilon RI receptor.” [Licensed under CC BY-SA 3.0], via Wikimedia Commons.