In clinical research and development, comparison to a control is highly recommended by regulatory agencies for the purpose of demonstrating evidence of clinical efficacy of a drug or device. The control could be a placebo, a known standard-of-care or an available market-approved drug or device. With some diseases or certain classes of devices, a viable control (prospective or retrospective) may not be feasible for ethical or pragmatic reasons. In addition, this problem is not uncommon in the biotech and medtech industries.
This creates the need for alternative approaches for carrying out comparative evaluation. Computational Modeling and Simulation (CM&S) has been identified by the US Food and Drug Administration (FDA) as a necessary component for developing in silico trial designs, in which the comparator arm is generated using CM&S techniques. The FDA encourages the use of in silico clinical trials in which a drug or device is tested against a cohort of virtual patients, therefore providing an empirical basis for appropriate comparative assessment.
Understanding clinical outcomes, safety, effectiveness and developmental challenges early can impact the investment sponsors put forth towards a new compound or device. Innovative trial designs are needed to maximize existing outcomes data and to leverage advanced computational techniques for making increasingly better decisions, accelerate product development and decision making, while reducing overall R&D costs.
Join Premier Research and InSilicoTrials Technologies for this joint webinar and explore the potential for including in silico modeling & simulation as an integral part of the product development plan.
Nach Davé, RPh, MS, Vice President, Development Strategy, Premier Consulting
Nach Davé provides strategic and commercial input for Premier Research’s business activities. He brings more than 20 years of pharmaceutical and contract research industry experience to the position. He previously served as the Vice President of Regulatory at Premier and has been in leadership positions at both contract research organizations (CROs) and sponsor companies.
In his current role, Mr. Davé brings innovative solutions and grows Premier’s footprint in the areas of medical device development, real-world evidence and government relations. He is keen to explore how innovative technology like artificial intelligence (AI), machine learning (ML) and other developments can best support the growth of Premier’s business.
Mr. Davé holds a master’s degree in drug regulatory affairs from Long Island University and a bachelor’s degree in pharmacy from the University of Sciences, Philadelphia. He is a registered Pharmacist.
Abie Ekangaki, PhD, Vice President, Statistical Consulting, Premier Consulting
Abie Ekangaki brings expertise in biostatistics to shape clinical trial design strategies and methodologies for regulatory submissions and otherwise and provides broad biostatistical consulting for both internal and external clients. He advises on efficient trial designs for clinical trial programs and applies his statistical expertise, drug development and operational experience across different therapeutic areas.
With more than 25 years of experience as a biostatistician, Dr. Ekangaki has worked as a Research Scientist with the World Health Organization in Switzerland, as a Statistics Lecturer at Macquarie University in Australia and has over 19 years of experience in the pharmaceutical industry — both large pharma and CROs — where he has held several lead technical and senior leadership positions.
Roberta Bursi, PhD, PMP, Co-Founder and Executive Vice President of Research and Development, InSilicoTrials Technologies
Dr. Bursi is a global healthcare professional specialized in computational modeling and simulation (CM&S), artificial intelligence (AI) methods and informatics solutions, and their applications in the pharma and medical devices industry. She obtained her master’s degree in chemistry Cum Laude at Modena University, Italy, and her PhD in computational chemistry at the University of Southern California, Los Angeles, US. After a postdoc at Twente University, The Netherlands, she joined large multinational pharma industries like NV Organon, Schering-Plough, Merck and Co. and Grünenthal where over a period of more than 20 years, she has built a powerhouse of experience in different project and line management roles across all stages of drug research and development, registration and lifecycle management.
Dr. Bursi has authored over 30 scientific papers in major journals, has delivered over 50 lectures nationally and internationally and is the inventor of six patents.
Dr. Bursi is the Co-Founder and Executive Vice President Research & Development at InSilicoTrials Technologies. InSilicoTrials Technologies has developed a web-based, cloud-based platform, a game-changing solution that enables companies to leverage cutting-edge in silico methods at low costs without specific computational expertise, IT infrastructure and solves investment requirements for the research & development of medical products and for the point-of-care.
Who Should Attend?
Senior professionals from Pharma, Biotech and Medtech companies involved in:
- Clinical Trials
- Clinical Operations
- Drug Development
- Preclinical Trials
- Project Management
- Regulatory Affairs
What You Will Learn
- Understanding the value of in silico modeling and simulation in product development
- US Food and Drug Administration (FDA)’s position on in silico methods for evaluating drugs and devices
- A practical example of utilizing in silico data as a synthetic control arm in clinical trials
- When is the right time to utilize in silico modeling for products
Premier Consulting is a strategic product development and global regulatory consulting company dedicated to helping biotech innovators transform their life-changing ideas and breakthrough science into new medical treatments. Our end-to-end solutions in strategy, regulatory, nonclinical, CMC, quality, and commercial help sponsors build and execute development plans that meet regulatory requirements and deliver results for sponsors and the patients they serve.
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