The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.

Course Description:

This course discusses the FDA’s Critical Path Initiative (CPI), a national strategy developed to improve the methods used to move therapies from the laboratory to the patient in a more efficient manner. The goal is to use innovative methods to ensure that researchers developing new medical products are able to leverage the latest technology, along with existing knowledge culled from relevant clinical trials, scientific expertise, and collaborative interaction between industry, academia, regulatory agencies, and patient advocacy groups. These groups, known as C-Path Consortia, ask big-picture questions about drug development. What are the best methods for testing drug safety and efficacy in a therapeutic area? Are there any biomarkers that can be used as suitable endpoints to expedite the development process? How can we share clinical trial data without compromising patient privacy?

Course Topics:

1. Critical Path Initiative
   • Core Competencies
   • Concentration Area
   • Consort and Programs
2. Critical Questions for Trial Design
   • How many patients should be recruited to properly power the trial?
   • What should be the inclusion criteria?
   • Can the control arm be optimized?
   • What types of progression rates are expected for different subpopulations>
   • What measures of progression are most adequate, at which stages of the disease continuum?
   • How long should the trial duration be?
   • How often should I assess?
   • What is the time-varying probability of dropouts, and what are the predictors?
3. Data Science and Quantitative Medicine
   • Data Collection
   • C-Path Data Collaboration Center
   • Data Lake
4. Building Quantitative Drug Development Tools Based on Standardized Integrated Data
   • Model-Informed Drug Development approach
   • Multivariate TKV/eGFR Model
   • Joint Survival Model for ESRD
   • Polycystic Kidney Disease and Alzheimer’s Disease
5. Collaborative science transformed the landscape of drug development for:
   • Polycystic Kidney Disease
   • Alzheimer’s Disease
   • Type 1 Diabetes

Speaker:

Klaus Romero, MD, MS, FCP, is a Chief Science Officer and Executive Director of Clinical Pharmacology and Quantitative Medicine at the Critical Path Institute. Dr. Romero, a clinical pharmacologist and epidemiologist with more than 17 years of experience in academic and pharmaceutical clinical research, translational sciences, pharmacometrics, modeling and simulation and pharmacoepidemiology, has been with C-Path since December 2007 where he has helped lead clinical pharmacology, pharmacoepidemiology and modeling and simulation projects in Alzheimer’s disease, polycystic kidney disease (PKD), tuberculosis, Type 1 diabetes, Parkinson’s disease, Duchenne muscular dystrophy, kidney transplantation, Huntington’s disease, and cardiovascular drug safety. His work has helped to achieve major milestones, including the first regulatory endorsement by the U.S. Food and Drug Administration and European Medicines Agency of a clinical trial simulation tool for mild and moderate Alzheimer’s disease and the regulatory qualification of the first imaging biomarker for PKD. Dr. Romero is a fellow of the American College of Clinical Pharmacology, a founding member of the International Society of Pharmacometrics, as well as a member of the American Society for Clinical Pharmacology and Therapeutics, and the International Society for Pharmacoepidemiology. Dr. Romero is also a Research Associate Professor at the University of Arizona College of Medicine, Adjunct Professor at the College of Health Solutions at Arizona State University, Adjunct Professor at the USC School of Pharmacy and serves on the Scientific Board of Pharos Dx. Dr. Romero received his medical degree from Pontifical Xavierian University, completed his training in Clinical Pharmacology at Columbia National University and holds an MS degree in Epidemiology from the Columbia School of Medicine. kromero@c-path.org

Audience:

This symposium is designed for Clinical Research Coordinators, Project Managers, Monitors, Regulatory, Medical and Clinical Affairs Professionals or junior faculty with three or more years of experience seeking to further develop clinical research skills and principles. Clinical research professionals should have responsibilities that include clinical trial start up planning, mentoring, and complex issues involving site management, study management, and sponsor / CRO challenges.

Learner Level: Intermediate/Advanced

Learner Disclosures:

• Accreditation Status: Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s (ANCC) Commission on Accreditation.
• Financial Relationships: ENPDC has evaluated everyone who has the ability to control content of this activity (planning committee members, subject matter experts, presenters) and found that no relevant financial relationships exist.
• Awarding Contact Hours: To obtain contact hours participants must
  • Review the entire activity
  • Pass the quiz with 100% of questions answered correctly
  • Complete the evaluation at the end
  • Certificates will be distributed at the end of the evaluation.
• Enduring Materials Dates:
  • Start Date: 06/17/2022
  • Expiration Date: 06/16/2025

Need Help with Registration? Please contact us at ene@emory.edu or 404-727-9208.

Program Information: This is the first course in a five (5) course program. To complete the entire program and earn a badge CLICK HERE.