Early-stage drug development after academic research is a complex process that often leaves investigators and clinicians in a fog.
PIs have long created products for academia, taking that same product and establishing a biotech company takes understanding the nuances of branding, fundraising, clinical trials, and most importantly, compliance. What happens after preclinical work for cancer therapeutics founders and PIs is what we help demystify.
In planning your path to human trials, there is no trade-off to having access to the knowledge, connections, and personal guidance the TMCi programs provide to demystify this journey and set you on the road to success. The knowledge I’ve developed, the connections I’ve made, and the personal coaching I’ve received through the TMCi Accelerator have been instrumental in “clearing the IND development fog” and creating our start-up’s fast-track plan to human trials.
– Russell Hayward, CEO, etiraRX
The early steps for preclinical research, pre-clinical and pre-IND phase, are integral to building the scientific foundation. The aim of preclinical research is to design and execute studies that generate data to confirm the medicinal drug depicts an anti-tumor effect and is safe to use. Initially, the pre-clinical work is performed by the investigator at the institution’s laboratory.
As the program continues to evolve and confirmatory data is generated, the development of the medicinal product advances from pre-clinical to pre-IND phase.
The aim of the pre-IND studies are to generate additional data to confirm efficacy and safety. These studies are conducted at external laboratories, or Clinical Research Organizations (CROs). CROs must be certified by the FDA in Good Laboratory Practices (GLP), a set of principles adopted to ensure the quality and integrity of laboratory studies. GLP achieves this by governing the processes and conditions under which non-clinical research is conducted, and data collection, including how research facilities are maintained.
One of the areas where we lift the fog for founders is transitioning from academic research to the clinical phase.
As a launch tool kit, we foster an investigator’s evolutionary journey to becoming a therapeutics entrepreneur and better positioning their innovative product for successful commercialization.
– Ahmed AlRawi, Program Manager for Accelerator for cancer therapeutics
Developing impactful investor pitches or looking directly to clinical trials is where many founders think of taking their first steps, but the reality is that compliance with current Good Manufacturing Practices (cGMPs) and completing an Investigational New Drug (IND) Application are two actions that set the foundation therapeutics to reach the clinic.
cGMP is a system set up by the Food and Drug Administration to ensure medicinal drugs for human use are consistently produced and controlled according to quality standards to minimize potential pharmaceutical production risks.
For cancer therapeutics founders this means enabling GMP production for medicinal drugs in support of clinical trials.
Selecting a Contract Development and Manufacturing Organization (CDMO) to manufacture GMP medicinal drugs is s strategic decision, this work is planned usually a year prior to IND filing. Implementing this is crucial not only for the value it adds in protecting product integrity: safety, identity, strength, purity, and quality (SISPQ), but its success resonates throughout the road to the clinic.
The IND Application is the second key step that founders should take when starting on their path to clinic. The FDA must have sufficient information to assess a study’s safety and uses the IND to ensure that subjects will not face undue risk of harm in any clinical investigation that involves the use of the medicinal drug.
Sponsors must comply with the FDA IND process for approving the use of new drugs in humans, and the first step is to file the IND Application. The application is organized so that the applicant provides relevant data, generated during non-clinical research, that can confirm the new drug is safe and efficacious for the intended therapeutic indication. Additionally, the IND Application requires detailed manufacturing information and clinical protocols, where having a medicinal drug already developed and in compliance with cGMPs will come into play.
All new drugs are required to be FDA IND-approved before entry into clinical trials. After a successful application, the current process is the issuance of IND approval from the FDA which verifies that the new drug can advance to being used in a clinical setting for all 3 phases. Additionally, the investigation sites, where the clinical trials will take place, must be FDA-approved and receive Good Clinical Practices (GCP) certification before trials can begin.
It is an intensive process.
TMC Innovation Accelerator for cancer therapeutics supported by the Cancer Prevention and Research Institute of Texas (CPRIT) has the insight, infrastructure, and experience to help you demystify the road ahead.
Our Accelerator is designed to provide guidance on drug development and business development for investigators and early-stage biotechnology company executives, including strategic knowledge for your cGMPs, IND application, impactful investor pitches, and clinical trials. Over the course of 9 months, you will receive all the tools you need to successfully navigate your founder journey.
Applications for our next cohort are open, together, we can continue to push the boundaries of healthcare innovation and ultimately improve patient outcomes worldwide.