| |OCTOBER 20238CIOReviewIN MY OPINIONEXPANDING THE PROMISE OF IMMUNOTHERAPY BEYOND THE ONCOLOGY REALMBased on my 25 years of experience working in research ethics and clinical trial oversight, I foresee the next five to 10 years as being one of the most innovative and impactful times for research. Just within the last decade, immunotherapy has gone from pre-clinical pipe dreams to radically transforming what researchers and clinicians envision is even possible. We now have the ability to manipulate a patient's own immune system to attack cancer cells without poisons or radiation, and instead, their own immune cells doing what they were designed to do, with a little help from science. My team at Advarra has the privilege of seeing the latest emerging research involving the most cutting edge of therapies. We see immunotherapy intersecting with gene editing to potentially cure previously incurable conditions and as researchers continue to explore the potential of immunotherapy, we're starting to see innovative applications beyond just the oncology field. According to statistics published by the U.S. Food and Drug Administration (FDA), the number of Investigational New Drug applications involving gene therapy has grown exponentially since 2015, and those early phase projects will be hitting the clinic in the next 10 By James Riddle, MCSE, CIP, CPIA, CRQM, Vice President, Research Services & Strategic Consulting, Advarrayears. What an amazing time to see innovative therapies, like immunotherapies, developed to where they are making a direct and impactful difference in human health. These innovations don't come without challenges, but with some proactive collaboration and preparation, we'll be able to bring many more new immunotherapies and other breakthroughs to patients very soon.Challenges of Immunotherapy ManufacturingTo be certain, moving to personalized, "N-of-1" therapies will be hard for our industry. Manufacturing a genetically engineered, customized product for a specific patient is much more difficult than producing pills in a bottle at a central manufacturing plant. However, many companies are working diligently to solve manufacturing challenges though mobile production facilities and self-contained labs. In such settings, a technician can program the parameters of the patient's condition, cell type, genetic markers, and other information, and the robots can then produce an engineered immunotherapy product specific to that patient. Imagine one of those bespoke bio-manufacturing labs in every hospital, standing ready to produce an N-of-1 therapy exactly when the patient needs it. I believe we will have that capability, or close to it, within the next 10 years.James Riddle
< Page 7 | Page 9 >