By: Dr. Shaina Cahill, Ph.D. (Director Medical Communications & Affairs)
At Novel Biome, one of our driving forces is to continuously improve to ensure we are providing the best products and treatment possible! Over the last year, we have been working in consultation with parents from past treatment retreats, diving into the research and growing as a company to best support patients and gather valuable data. We want to share some of our new improvements based on our goal to have the highest quality product, patient support and long-term positive health outcomes.Increased support throughout the treatment process:
Individualized pre-treatment is a critical component of a successful Fecal Microbiota Transplants (FMT) treatment. Previously we had patients work with their own healthcare providers to get the necessary medications or supplements; however, this was often a significant stressor.
To address this, we recently brought Marie Mvogo, a physician’s assistant, onto our team, who can review each patient’s medical history and labs to put together a thorough and individualized pre-treatment plan. Additionally, Marie plays a role in providing support throughout treatment with a total of 3 consultations.More robust data capture strategy:
Although FMT treatments have been around for hundreds of years, there is still much that should be researched, especially in the context of FMT for children with autism spectrum disorder (ASD). In our commitment to improving patient outcomes and getting broader acceptance of FMT for indications such as ASD, we recognize the critical importance of collecting and reporting clinical outcomes.
In addition to our original assessments, which included the Autism Treatment Evaluation Checklist, we have added the Childhood Autism Rating Scale (CARS-2). The CARS-2 assessment is a validated and widely used diagnostic tool to identify where children are on the autism severity scale using quantifiable ratings. The CARS assessment is administered by a certified professional, Cindy Leparski, both pre-and post-FMT treatment.
Further, we have check-in forms throughout the FMT treatment to help us better understand at what time points specific improvements are reported and what challenges children face. In addition, to better understand changes in quality of life for both parents and children, we have recently added the Quality of Life in Autism Questionnaire (QoLA), giving us a broader understanding of the impacts of FMT treatment.Improved accessibility with three new treatment locations:
We have expanded our treatment locations to address increased demand and our desire to provide accessible treatment for families worldwide. We recognize the importance of offering multiple global treatment destinations to reduce the distance families must travel, reducing stress and hassle. To address this, we have added 3 new locations in Australia, Hungary, and Panama in addition to our original location in Mexico.Our new custom-built lab facility:
At Novel Biome, we strive to provide high-quality, safe, and consistent FMT products, placing the highest standards of Good Laboratory Practice and manufacturing in a pharmaceutical-grade laboratory. Building and maintaining a lab to this standard has been a massive undertaking but consistent with our values of quality and safety! As part of this expansion, we have brought on our new lab manager, Amarjeet Kahlon, who has decades of manufacturing experience and brings a wealth of knowledge in creating comprehensive documentation for manufacturing processes. These enhancements come with a robust adverse events reporting system.
At Novel Biome, we believe strongly that continuous improvement allows us to provide the best products and treatment possible! Our aim is to constantly look for ways to improve our treatment offering through data capture, feedback and advancements in FMT and ASD research. Each and every decision we undertake with regard to treatment is through the lens of improving patient safety, increasing efficacy and demonstrating clinical results. We want to thank all the parents from past treatment retreats for their valuable inputs, insights and support.
Our focus at Novel Biome is on supporting autistic children who suffer from digestive symptoms and significant microbiome imbalance to restore their microbiome through Fecal Microbiota Transplantation (FMT).
Team Novel Biome