Today’s pharmaceutical and medical device companies are facing rising pressure from healthcare communities with patients needing more personalized care, consumers and policy makers pushing to lower healthcare costs, the drive to reduce time and costs to bring new products to market, and complying with increasingly onerous regulations. Meanwhile, the industry is focused on developing more innovative products that improve patient outcomes while decreasing healthcare costs. How does a pharmaceutical or medical device company even begin to try and achieve all these objectives?
Innovating while simultaneously reducing the time and cost of bringing products to market are critical to the financial stability and growth of life science companies. And achieving these goals, without sacrificing quality and patient safety is a prerequisite that is extremely hard to satisfy. This has prompted companies to develop ways of improving the total product realization by examining the processes of development, preclinical verification and validation (V&V), clinical studies, regulatory compliance, manufacturing, sourcing, and others.
New life-changing and life-saving products are being developed by companies across the globe. In order for the FDA to achieve their mission of bringing innovative and safe therapies to patients, the industry needs to find a balance between the amount and type of testing and the number of patients necessary to evaluate the experimental therapies, as well as rely on other scientific data sources such as computational models.
Recently, some medical device submissions for therapeutic devices have contained data from four types of evaluation models — bench, computational modeling, animal, and human — to demonstrate a reasonable assurance of safety and effectiveness. Today, in silico (computer-based) methods allow multidisciplinary design teams to perform a large number of simulations to test a variety of designs and therapeutics under various conditions prior to costly and time-consuming physical prototype builds and lab testing that would otherwise not be possible with animal studies and human clinical trials.
Join us for our webinar as we demonstrate the power of modeling and simulation for pharma and medical device companies, and why it’s so important in today’s Life Sciences industry.
Sara Dutta, Life Sciences Industry Business Experience Consultant, Dassault Systèmes
Sara Dutta is a Business Consultant for the Life Sciences Industry at Dassault Systèmes. She is based at the US headquarters in Waltham, MA. Her aim is to leverage her expertise and the strength of the 3DEXPERIENCE® platform to enable pharmaceutical and medical device companies to innovate and digitally transform their businesses.
Previously to joining Dassault Systèmes, over the last 7 years, Dutta specialized in computational modelling to investigate arrhythmia mechanisms and drug effects on the heart. She worked for 3 years as an ORISE research fellow at the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), where she led work on developing computational techniques to assess cardiac safety and efficacy for the Comprehensive in Vitro Proarrhythmia Assay (CiPA) initiative. Prior to working at the FDA, she completed her PhD in Professor Blanca Rodriguez’s multi-disciplinary research group, the Computational Cardiovascular Science Team, at the University of Oxford (UK). Feel free to reach out to Dutta by sending her an email at firstname.lastname@example.org.Message Presenter
Who Should Attend?
This webinar will be of interest to those in the biopharmaceutical and medical device industries, with relevant job areas including:
- Quality Assurance
- Product Manufacturing
- R&D Technical Staff
- Clinical Researchers
What You Will Learn
Join this webinar where our featured speaker will show how in-silico methods can:
- Reduce reliance on animal models and human clinical trial data
- Accelerate innovation
- Improve quality design and patient safety
- Expedite time to market
- Lower development and clinical trial costs
Dassault Systèmes, the 3DEXPERIENCE COMPANY, provides business and people with virtual universes to imagine sustainable innovations. The Dassault Systèmes 3DEXPERIENCE® platform solutions provide medical device manufacturers with the ability to effectively and efficiently manage quality issues by improving traceability and QSR/GMP/ISO compliance while eliminating non-value-added activities. This can help companies avoid compliance risk, reduce waste and deliver unmatched quality, safety and efficacy.