{"id":39786,"date":"2022-09-13T06:50:30","date_gmt":"2022-09-13T06:50:30","guid":{"rendered":"https:\/\/www.tmc.edu\/?p=39786"},"modified":"2023-05-11T18:58:25","modified_gmt":"2023-05-12T00:58:25","slug":"starting-a-biotech-company","status":"publish","type":"post","link":"https:\/\/www.tmc.edu\/blog\/starting-a-biotech-company\/","title":{"rendered":"Demystifying the Fog of Starting a Biotech Company"},"content":{"rendered":"
Early-stage drug development after academic research is a complex process that often leaves investigators and clinicians in a fog.\u00a0<\/strong><\/p>\n 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. <\/span>\u00a0<\/b>What happens after preclinical work for cancer therapeutics founders and PIs is what we help demystify.<\/span><\/p>\n <\/p>\n 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.\u00a0 The knowledge I\u2019ve developed, the connections I\u2019ve made, and the personal coaching I\u2019ve received through the TMCi Accelerator have been instrumental in \u201cclearing the IND development fog\u201d and creating our start-up\u2019s fast-track plan to human trials.\u00a0<\/span><\/i><\/p><\/blockquote>\n – Russell Hayward, CEO, etiraRX<\/span><\/p><\/blockquote>\n <\/p>\n 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\u2019s laboratory.\u00a0<\/span><\/p>\n 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.\u00a0<\/b><\/p>\n The aim of the pre-IND studies are to generate additional data to confirm efficacy and safety.\u00a0 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.\u00a0<\/span><\/p>\n One of the areas where we lift the fog for founders is transitioning from academic research to the clinical phase.<\/b>\u00a0<\/span><\/p>\n <\/p>\n \u00a0As a launch tool kit, we foster an investigator\u2019s evolutionary journey to becoming a therapeutics entrepreneur and better positioning their innovative product for successful commercialization.<\/span><\/i><\/p>\n – Ahmed AlRawi, Program Manager for Accelerator for cancer therapeutics<\/span><\/p><\/blockquote>\n <\/p>\n Developing impactful <\/span>investor pitches<\/span><\/a> 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.<\/span><\/p>\n 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.\u00a0<\/span><\/p>\n For cancer therapeutics founders this means enabling GMP production for medicinal drugs in support of clinical trials.<\/b>\u00a0<\/span><\/p>\n Selecting a Contract Development and Manufacturing Organization (CDMO) to manufacture GMP medicinal drugs is s <\/span>strategic decision<\/span>, 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.\u00a0<\/span><\/p>\n 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\u2019s 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.<\/span><\/p>\n