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BLOG: The Value of a Treatment Response Software

It’s generally accepted that not all patients respond the same way to a given therapy. This makes a lot of sense because we’re all different. However, what’s less understood, is how each individual lesion within our body responds differently to a specific therapy. With access to better tools, we’re able to capture more information with less invasive techniques in order to visualize what’s truly happening inside a patient as they undergo treatment.

What we’re discovering, is that there is typically not a single response playbook for different sites of the body. This concept of intra-patient heterogeneity is counterintuitive to how we think about individuals responding to therapy today. Let’s take a cancer patient as an example. When an individual undergoes systematic therapy, response to that therapy is typically classified within one of two buckets. “Progressing” (getting worse) or “Responding” (getting better). These terms can be somewhat misleading. As we continue to learn more about intra-patient heterogeneity, we find that lesions within a patient can be both “Progressing” and “Responding” at the same time. So how can this be?

This “double” classification is due to how we currently collect and classify data that measures treatment response. A good example of this is within patients with metastatic cancer. When a patient undergoes therapy, their radiological scans are evaluated by a radiologist who measures and documents lesions from those scans. This process is manual and only requires between 3-5 target lesions to be measured and documented to formulate a classification of Progressing or Responding. The issue with this is that many patients develop more than 3-5 lesions. If those additional non-target lesions aren’t counted or even included in the analysis, it becomes difficult to understand the full picture of a patient’s response to a treatment. This lack of information in turn, leaves treating physicians and clinical study principal investigators using their best judgement rather than comprehensive concrete data to identify a patient’s true response to the therapy.

Research from the University of Wisconsin has discovered that as little as 5% of lesions that are not responding to treatment drive the overall treatment effectiveness. Therefore, it is crucial to accurately quantify total disease burden based on the assessment of every individual lesion. AIQ provides the software tool critically needed to do this. AIQ’s software technologies captures every lesion from a patient’s radiological scans using artificial intelligence and machine learning and then compares the lesion’s response to treatment over time to delivers an accurate response classification to healthcare providers and principal investigators. This “actionable intelligence” is used to understand disease burden and identify responding and non-responding lesions leading to the optimal management of care.

Identifying and collecting information on all lesions is important so that the appropriate next steps can be put in place to maximize the opportunity for the best outcome for that individual patient. This can take the form of pivoting to a different treatment plan, maintaining the same treatment, adding another treatment, or discontinuing unnecessary treatment all together.

AIQ’s response assessment methodology is a large departure from the traditional response methods typically used today. Software that provides more information through artificial intelligence is crucial to support and grow as technology continues to play a larger role in patient care and the medical field as a whole. By using medical device software like the one AIQ has developed, more comprehensive data sets will provide the medical community a greater understanding of the broader clinical picture, leading to more individualized treatment plans, more efficient drug development, and better outcomes for patients.

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Alessandra Cesano, MD, PhD
Chief Medical Officer, ESSA Pharma

Alessandra Cesano, MD, PhD is the Chief Medical Officer at ESSA Pharma since July 2019. Previously she has been the Chief Medical Officer of NanoString Inc from July 2015 until June 2019 where she focused in the development of translational and diagnostic multi-plexed assays for the characterization and measurement of mechanisms of immune response/resistance. Prior to joining NanoString, Dr. Cesano was Chief Medical Officer at Cleave Biosciences, Inc. and before then she served as Chief Medical Officer and Chief Operations Officer at Nodality, Inc., where she built and led the R and D group, while providing the overall clinical vision for the organization. Between 1998 and 2008, Dr. Cesano held various management positions at Amgen, Biogen Idec and SmithKline Beecham Pharmaceuticals, where she helped to advance various oncology drugs through late stage development and FDA approvals. Early in her professional career Dr. Cesano spent 12 years conducting research in tumor immunology, including nine years at the Wistar Institute, an NCI Basic Cancer Center connected with the University of Pennsylvania. She also holds membership in several professional and scientific societies including ASCO, ESMO, ASH, EHA, AACR and SITC. In the latter she serves as co-chair in the SITC Industry Committee, Associate Editor for the Biomarker section of JITC and is an active member of the SITC Biomarker Working Group. Over her careers she has been an author on over 140 publications. Dr. Cesano received an MD summa cum laude, a Board Certification in Oncology and a PhD in Tumor Immunology from the University of Turin.

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Giovanni Selvaggi, PhD
Chief Medical Officer, Xcovery

Dr. Selvaggi held global positions of increasing responsibility in clinical development at various global pharmaceutical companies prior to joining Xcovery in March 2019. Dr. Selvaggi joined the pharmaceutical industry in 2010 as Medical Director in the MAGE-A3 lung cancer vaccine program at GSK. He then played an instrumental role in the successful development and approval of ceritinib (Zykadia) in ALK-translocated NSCLC at Novartis in 2013. Most recently, Dr. Selvaggi was part of the immunotherapy team at Bristol-Myers Squibb, serving as a program lead in thoracic malignancies, with a focus on SCLC and mesothelioma, leading to the approval of nivolumab (Opdivo) in third line SCLC indication with NDA in 2018. Dr. Selvaggi received his medical degree at the University of Torino School of Medicine, in Torino, Italy, in 1992 and served as staff physician of thoracic oncology at the University Hospital in Torino, participating in several clinical trials in lung cancer and mesothelioma over a span of 16 years.

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Eric Horler
President and Chief Executive Officer, AIQ Solutions

Eric Horler joined AIQ Solutions as its first President and CEO in September 2018. He has led AIQ through two rounds of equity financing, team construction, product commercialization, and international expansion. Before joining the AIQ team, Eric was President and CEO of Swallow Solutions LLC, a medical device start-up with both therapeutic devices and functional beverages for dysphagia patients. Before that, Eric was General Manager, Premium Anesthesia and Respiratory Care at GE Healthcare. While at GEHC, Eric was responsible for a $220 million global business and a large team spread over three continents. He has also held a series of marketing and business development roles at Baxter Healthcare, including Director of Renal Products and Services for the Latin America region. Eric has a B.S. in Chemical Engineering from Rice University and both an MBA and Master of Engineering Management degrees from the Kellogg School of Business. He lives in Madison with his wife and two children.

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Information on this page is intended for research use only. Applications and/or claims listed are not currently cleared for use in treatment of patients.