Translational Research Fundamentals (CLRE-236): Régent Laporte, DVM, MSc, PhD & Kanthi A. Kollengode, MD, MAS

Translational Research in Medicine is a discipline within the Biomedical and Public Health Research areas that “translates” Basic Science findings into medical applications (e.g., diagnostics, drugs, cell and gene therapies, medical devices, procedures, policies, education)—it is moving Science from bench to bedside and back! This course is focused on the practical application of the principles of Translational Research in Medicine in your own field of expertise and has for ultimate goal to equip you with tools that will allow you to practice Translational Research in your own clinical research.

Topic Learning Objectives Faculty

​Introduction & Definitions

The Changing Role of Big Pharma

  • ​Define Translational Medicine, explain why it is needed, what are its main remits, what is its current challenge, and what is the NIH Roadmap
  • Describe how Translational Medicine is changing Big Pharma Drug Discovery & Development 
​Régent Laporte
Biomarkers
  • Define biomarkers and describe their impact and remits in drug development
  • Describe how biomarkers could be used for decision making in drug development
  • Describe how biomarkers could be developed
  • Describe the predictivity classification of biomarkers and scores
  • Describe the use and value of biomarkers for health authorities and consortia
  • Describe the principles and types of tissue biobanks and the current challenges that they are facing
  • Describe the main biomarker localization technologies and immunoassays and their values for molecular medicine
Kanthi A. Kollengode
 
Intellectual Property & Innovation
  • Define what is intellectual property (IP) in Translational Science
Michael K. Dunn
The OMICs
  • Define the “Omics” and their roles in Translational Medicine
Timothy R. Geiger
Translational Imaging
  • List the main translational imaging modalities and describe how they can be used in drug discovery and development
Patrick McConville

Diagnostics
  • Define a diagnostic test
  • Evaluate when it is appropriate to use a diagnostic test
  • Learn the main quantitative aspects of a diagnostic test
  • Describe the paradigm shift that led to the discovery and development of companion diagnostics and list 3 merits and demerits of the same with examples
  • What are complementary diagnostics and how do they differ from companion diagnostics
  • Describe 3 key elements that distinguish point-of-care testing from centralized laboratory testing and list 3 limitations of the same

Roberta V. Alexander

&

Kanthi A. Kollengode

Pharmacogenomics- Driven Treatment
  • Explain the role of Translational Pharmacogenetics in driving clinical decision making related to drug therapies
Grace M. Kuo
Drug Discovery
  • Understand the place, role and purpose of drug discovery (i.e., Research) within pharmaceutical R&D 
  • Integrate the business and economic considerations impacting drug discovery programs
  • Recognize and appreciate the diversity of therapeutic modalities and their respective strengths and limitations
  • Map the drug discovery processes, from conception to execution
Pierre J.-M. Rivière
 Non-Clinical Development
  • Describe what is regulatory safety and
    toxicology assessment in drug development
Marina S. Nelson
Clinical Development
  • Describe the methodological principles of Phase I clinical trials
  • Define what are Phase 0 clinical trials (a.k.a. exploratory clinical trials/studies) and how they can be used in drug development
  • Describe what is adaptive trial design
  • Describe what are basket or umbrella trial designs
  • Describe how regulatory and exploratory clinical trials could be combined and accelerate the generation of a clinical proof of concept.
Mark S. Hixon
Translational Stem Cell Research
  • Explain the challenges associated with Translational Stem Cell Research
  • Explain how Stem-Cell-Derived Therapies Discovery & Development differs from Drug Discovery & Development
  • List the Stem-Cell-Derived Therapies and illustrate their applications
Catriona Jamieson

Course Schedule Summer 2018

Course Syllabus Summer 2018

Course Director:

Régent Laporte, DVM, MSc, PhD
Principal Consultant, Laporte & Associates LLC
Senior Director, Translational Pharmacology, Peptide Logic, LLC
Research Fellow, Bio Nova Institute





Assistant Course Director :

Kanthi Athreya Kollengode, MD, MAS
Clinical Scientist, Celgene Corporation
Assistant Research Fellow, Bio Nova Institute


Course Assistant (Teaching Assistant):

Oluwakemi Okwuegbuna, MD, FMCPath, MSc, MAS
Post-Doctoral Fellow, Div. of Neurology, Dept. of Medicine, UCSD
Hematopathologist Consultant, BTG, LLC


Teaching Faculty:

Roberta V. Alexander, PharmD, PhD
Director of Clinical Research & Medical Affairs
Exagen Diagnostics



Michael K. Dunn, PhD, MBA

Senior Director, Scientific Information & Intelligence
Ferring Pharmaceuticals


Timothy R. Geiger, PhD

Field Applications Manager, North America West
ProteinSimple


Mark S. Hixon, PhD,

Principal, Mark S. Hixon Consulting LLC

Catriona Jamieson, MD, PhD
Professor of Medicine, Division of Hematology-Oncology
Chief, Division of Regenerative Medicine
Deputy Director, Sanford Stem Cell Clinical Center
Co-Leader, Hematologic Malignancies
Program Director, Stem Cell Research Program, Moores Cancer Center
University of California, San Diego

Grace M. Kuo, PharmD, MPH, PhD, FCCP
Professor of Clinical Pharmacy
Associate Dean for Strategic Planning and Program Development
Skaggs School of Pharmacy and Pharmaceutical Sciences
Adjunct Professor of Family and Preventive Medicine
Director of SDPharmNet™ & PharmGenEd™
University of California, San Diego


Patrick
McConville, PhD
Vice-President, Non-Clinical Research Services, inviCRO, LLC
Adjunct Professor, Department of Radiology, School of Medicine
University of California, San Diego


Marina S. Nelson, PhD

Drug Development Leader, Early Phase Development Solutions
Covance Laboratories


Pierre J.-M. Rivière, PhD

CEO, Peptide Logic, LLC
Research Fellow, Bio Nova Institute