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Remote synchronous online weekly Zoom lessons

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Translational Research Fundamentals (CLRE-236)

Learn and discuss the various topics that encompass translational science

Learn about the application of translational science principles and tools to the discovery/design and development of biomedical products. Encompassing everything from drugs and cell & gene therapy to medical technology, including diagnostics, devices, wearables, and digital health. 

Each topic taught by a different expert faculty from the biomedical industry!

Lesson Topics:

  • Overview of Translational Medicine & Biomarkers 
  • Omics Tools
  • Functional Omics Analysis / Presicion Medicine 
  • Translational Imaging
  • Diagnostics
  • Drug Discovery
  • Non-Clinical Development
  • Clinical Development
  • Cell & Gene Therapy
  • Medical Technology

Applied Translational Research (CLRE-238)

The complete arch from ideation of a new biomedical product to marketing authorization for the diagnosis or treatment of patients.

The course is taught through taking as an example a family of drugs used to treat one the most prevalent chronic diseases today, the course will illustrate the critical analysis of all the steps necessary to progress a new idea into clinical development and to the market. Through carefully designed home assignments the students will learn the fundamentals of now to analyze the relevant literature and publicly available data. The students will also have opportunities to discuss with the faculty their real-life experience in the pharmaceutical industry.

Using drugs as the archetypal biomedical product you will learn how to perform critical analysis of the following tasks:

  • Evaluate the science behind the new concept and potential for translatability to humans
  • Determine which additional fundamental research may be needed
  • Assess whether real-world conditions are favorable for going into proof of concept in patients
  • Assess the regulatory environment
  • Determine what are the Investigational New Drug (IND)- enabling pre-clinical activities
  • Determine clinical development activities needed to reach proof of concept in patients (the true translational step)
  • Determine clinical development activities needed to obtain drug approval for desired indication(s)
  • Assess market penetration and pricing
  • Assess post-marketing activities
  • Assess life cycle management and competition

Applied Translational Research II (CLRE-239)

Now it's your turn to show what you have learned so far

This course applies the translational scientific knowledge acquired in previous courses to create a comprehensive plan to develop a new biomedical product.

Students are divided into cross-functional teams and assigned a drug class and indication to develop, focusing on a different translational science concept each week. Each team is guided/mentored by a pharmaceutical industry veteran.

Scenarios where this is fundamental:

  • New academic discovery – should it be carried into translational activities?
  • New mechanism of action, pathway, molecular target, cell type, drug, metabolite, protein, etc.
  • Perform a proof-of-concept trial in patients with a "prototype" biomedical product in an academic environment. Publish and let the biomedical industry discover/design a bona fide biomedical product.
  • Start up a pharmaceutical, biotechnology, or medical technology company based on a new academic discovery
  • Promote a new project at a pharmaceutical, biotechnology, or medical technology company
  • Perform a due diligence exercise at a pharmaceutical, biotechnology, or medical technology company for in-licensing a biomedical product
  • As background while involved in any role in biomedical product discovery/design & development in a pharmaceutical, biotechnology, or medical technology company
  • As background while involved in clinical development in academia/research institutions
  • As background for independent professional occupation
  • Intellectual property lawyer, venture capital evaluator, patent agent, physician, pharmacist, therapist, medical writer, etc.

Translational Regenerative Medicine (CLRE-237)

This course is focused on the practical application of the principles of translating stem-cell-based therapies that focuses on the discovery, non-clinical development and Phase 1 clinical trials required to translate these interventions from the bench to the bedside. This course will highlight the unique aspects of stem-cell- based therapy discovery and development compared to drug discovery and development. Lectures given by a multidisciplinary team of academic subject matter experts will teach concepts that are linked to application of translational science principles to the discovery and development stem-cell-based therapeutics.

Learning Objectives
By the end of this course, the student should be able to:

  • Understand the bench to bedside concept
  • Understand the process of development of new stem-cell- based therapies
  • Understand the preclinical work needed to support first-in-human studies
  • Understand the discovery process in cell and gene therapy.
  • Describe the processes to deliver first-in-humans studies.
  • Understand basics for phase 1 first-in-human studies
  • Understand the regulatory landscape for cell and gene therapy.
  • Design a target product profile (TPP) for a cell or gene therapy product
  • Understand the human subject ethical issues

Capstone Project: Certificate Project (CLRE-40004)

The Capstone project is the certificate program's crowning achievement. Through this activity, students, working in teams or individually, apply their learnings gained from prior courses and their own experience as professionals. The project focuses on addressing the needs that actual life science companies or academic groups have in the translational science and/or business areas. Such efforts could include new asset due diligence assessment, positioning research, indication selection investigation, Investigational New Drug (IND) application development, Investigator’s Brochure (IB) creation, and research protocol writing. At the end of the project, the students present the final deliverable to course faculty and the client company management or academic group leadership for evaluation. This last stage successfully closes the certificate and, most importantly, aids the student's career development with valuable skills and experience.