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Translational Science Certificate

Future biomedical leaders, innovators, or entrepreneurs looking to accelerate the translation of ideas into high-quality and differentiated biomedical products.​

Now Accepting Applications: Deadline December 15, 2021

  • Winter 2022 start
  • GRE/GMAT Not Required
  • Ask us about our special prices for postdoctoral scholars!

Apply Now

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    ​Learn what it takes to innovate in healthcare

    Gain a real-life, integrative, and comprehensive understanding of translational science applied 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!

    • Ideal for individuals with the motivation and potential to become leaders, innovators, or entrepreneurs:
      • Biomedical and healthcare professionals
      • Postdoctoral scholars in a scientific, engineering, or business field
    • Maximal flexibility for the working professional:
      • Classes on weekday evenings 6 to 8 pm
      • Once a week, one course per quarter
      • Four courses total, each offered twice a year
      • Flexibility to complete the certificate within 1 to 5 years • No need to commit to the whole certificate at once, only one course at a time

      Our multidisciplinary faculty team constantly co-develops and updates course content, providing expertise on emerging knowledge and practices in their respective fields, thus ensuring that the certificate program remains up to date in the rapidly evolving discipline that is translational science.

      Hands-on learning approach taught by a faculty of experienced biomedical industry leaders and academic subject matter experts.

      Multiple Areas of Interest

      • Biomarkers
      • Omics
      • Precision medicine
      • Translational imaging
      • Intellectual property
      • Biotechnology
      • Drugs
      • Cell & gene therapy
      • Diagnostics
      • Medical devices
      • Digital health

      A Stepping Stone for In Demand Entrepreneurial
      R&D Professionals

      • Senior Scientist
      • Principal Scientist
      • Clinical Scientist
      • Principal Clinical Scientist
      • Clinical Operations Specialist
      • Clinical Safety Officer
      • Associate Director, Translational Science/ Translational Medicine
      • Director, Translational Science/ Translational Medicine
      • Associate Medical Director
      • Medical Director

      Now Accepting Applications: Deadline December 15, 2021

      • Winter 2022 start
      • GRE/GMAT Not Required
      • Ask us about our special prices for post-doctoral scholars!

      Apply Now

      Visit our Certificate FAQs or contact us directly:

      Dr. M. Paz Rodriguez, Communication Director

      Scholarship opportunity aimed at passionate individuals

      • Postdoctoral scholars without a fellowship to support the certificate course fees
      • Biomedical and healthcare professionals from companies not offering educational programs

Program Flow:

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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 / Precision 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-world 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.

    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.