EXECUTIVE EDUCATION

Drug and Medical Device Development: A Strategic Approach - Online Program

Frontload your knowledge to achieve commercial success

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Course Dates

STARTS ON

September 2, 2021

Course Duration

DURATION

8 weeks, online
5-6 hours per week

Course Duration

What does it take to bring a new medical device or pharmaceutical to life?

Digital disruption in healthcare has opened the market for new products that are data-driven and patient-centered. But bringing a medical device or drug to market is very different from building other kinds of products. Added layers of regulation make it a highly complex process.

Who Should Attend?

The MIT xPRO Drug and Medical Device Development: A Strategic Approach program is designed for individuals and companies that operate in the health product industry as well as those looking to enter this fast-growing industry. Having a background in health sciences is helpful, but not required. The program is ideal for:

  • Engineers involved in the development of new medical device products or pharmaceuticals
  • Executives in the drug and medical device development/product management field
  • Scientists and those who lead teams of scientists in R&D
  • Quality assurance and regulatory affairs professionals
  • Professionals making a horizontal transition into the healthcare industry
  • Entrepreneurs seeking to launch a product in the U.S. healthcare market
  • Companies in need of training employees and new hires on the entire process of developing medical devices and pharmaceuticals

Participants include representatives from companies like:

  • Hoffmann-La Roche
  • BioMarin Pharmaceutical Inc.
  • Cardinal Health
  • Nanoshift LLC
  • Scimitar Inc.
  • BlueAllele
  • Genentech
  • Foundation Patents
  • Innovate Biopharmaceuticals
  • Morgans Financial
  • Proctor & Gamble
  • IQVIA

Participants hold job functions and titles such as:

  • Owner, Director, CEO, President
  • VP, Scientific Affairs and Technical Services
  • Global Chief Clinical Officer
  • Regulatory Manager
  • Sr. Product Manager
  • Sr. Quality Systems Specialist
  • Management Consultant
  • Postdoctoral Researcher
  • Physician
  • Pharmacist

What Are The Opportunities?

Image showcasing how global med-tech industry is worth $430 Bn with 5% growth expected annually

$430 Bn Industry
Global med-tech industry is $430 Bn with 5% growth expected annually.

Source: Statista
Image showcasing how jobs related to medical product development grew by 73% in the last year

73% Job Growth
Jobs related to medical product development grew by 73% in the last year.

Source: Emsi data

Impact

  • Gain a “big picture” perspective of the entire drug and medical device development process, from day one strategic planning through product commercialization
  • Understand the critical interplay between strategy and development—and how they affect each other
  • Learn frameworks for assessing both the benefits and the risks associated with developing a new product in the healthcare market
  • Gain clarity around the regulatory requirements in the U.S. market and the process for achieving approval
  • Develop professional networks for career development, industry partnerships or strategic alliances



“This program explodes the notion that there is ‘research’ followed by ‘development’. These forces are intertwined until you launch it.”
- Professor Michael Cima, Program Director and MIT Associate Dean of Innovation

Program Modules

Over the course of seven modules, you will learn how to anticipate and address the complexities involved with developing medical products. Designed to provide a big picture view of initiating a medical drug or product development, this program the whole process one concept at a time.

Week 1:

Strategy, Reimbursement, and Proof of Concept

Recognize and minimize risks. Examine the strategic role of reimbursement. Explore how having a “Proof of Concept” test is vital to development.

Week 2:

Intellectual Property, Outcome Measures, Trials and Indications

Determine the best time to seek IP protection for ideas. Learn the key sections of a patent and outcome measures of products. Discover the intended uses of medical products and how those are tested in clinical trials.

Week 3:

Quality and Medical Devices

Design a quality study. Apply quality systems to clinical trials. Discover important regulatory pathways.

Week 4:

Diagnostics, Biomarkers, and Wearable Devices

Evaluate diagnostics through sensitivity and specificity testing. Discover biomarkers, the molecular or physical indicators of disease. Understand what counts as wearable devices, How they are are used, and what is needed to bring them to market.

Week 5:

Software, Target Selection and Drug Discovery, and Absorption, Distribution and Metabolism

Review of software and hardware regulations including the FDA's General Principles of Software Validation. Identify key elements of drug discovery. Recognize the target validation process for drug development. Understand the essential processes of absorption, metabolism, transportation, and development in drug development and delivery.

Week 6:

Toxicity, Formulation, and Stability

Validate the therapeutic index of drugs. Understand formulations and how they ensure successful drug delivery. Learn about drug stability: how drugs physically and chemically break down.

Week 7:

Parenteral Products and Biologics

Examine parenteral products - drugs injected directly into the body. Explore biologics - drugs produced from living organisms.

Week 1:

Strategy, Reimbursement, and Proof of Concept

Recognize and minimize risks. Examine the strategic role of reimbursement. Explore how having a “Proof of Concept” test is vital to development.

Week 5:

Software, Target Selection and Drug Discovery, and Absorption, Distribution and Metabolism

Review of software and hardware regulations including the FDA's General Principles of Software Validation. Identify key elements of drug discovery. Recognize the target validation process for drug development. Understand the essential processes of absorption, metabolism, transportation, and development in drug development and delivery.

Week 2:

Intellectual Property, Outcome Measures, Trials and Indications

Determine the best time to seek IP protection for ideas. Learn the key sections of a patent and outcome measures of products. Discover the intended uses of medical products and how those are tested in clinical trials.

Week 6:

Toxicity, Formulation, and Stability

Validate the therapeutic index of drugs. Understand formulations and how they ensure successful drug delivery. Learn about drug stability: how drugs physically and chemically break down.

Week 3:

Quality and Medical Devices

Design a quality study. Apply quality systems to clinical trials. Discover important regulatory pathways.

Week 7:

Parenteral Products and Biologics

Examine parenteral products - drugs injected directly into the body. Explore biologics - drugs produced from living organisms.

Week 4:

Diagnostics, Biomarkers, and Wearable Devices

Evaluate diagnostics through sensitivity and specificity testing. Discover biomarkers, the molecular or physical indicators of disease. Understand what counts as wearable devices, How they are are used, and what is needed to bring them to market.

For full details on the program modules, please download the brochure.

Download Brochure

Case Studies and Assignment

Case Study: Corvia Medical Device You will play the role of a Corvia quality engineer, writing a quality systems summary for your CEO that addresses the quality elements for this market bound product

Case Study: Corvia Medical Device

You will play the role of a Corvia quality engineer, writing a quality systems summary for your CEO that addresses the quality elements for this market bound product.

Case Study: Disappearing Polymorphs You will play the role of a Lab Manager for a pharmaceutical company whose drug form, ritonavir, has inexplicably changed, impacting the drug’s efficacy and numerous patients’ lives. Your task is to provide a causal factor analysis of why this drug has changed and a recommendation to this problem

Case Study: Disappearing Polymorphs

You will play the role of a Lab Manager for a pharmaceutical company whose drug form has inexplicably changed, impacting the drug’s efficacy and numerous patients’ lives. Your task is to provide a causal factor analysis of why this drug has changed and a recommendation to this problem.

Assignment: Scoping a Proof of Concept You will play the role of a drug developer working on a new pain relief drug. Your task is to identify the surrogate endpoints and the patient population for your Proof of Concept test to ensure your drug has its desired effects

Assignment: Scoping a Proof of Concept

You will play the role of a drug developer working on a new pain relief drug. Your task is to identify the surrogate endpoints and the patient population for your Proof of Concept test to ensure your drug has its desired effects.

Case Study: Osteoporosis and the Failed Drug Trial You will play the role of a drug developer for an osteoporosis drug that has failed its clinical trial. Your task is to determine why the trial failed

Case Study: Osteoporosis and the Failed Drug Trial

You will play the role of a drug developer for an osteoporosis drug that has failed its clinical trial. Your task is to determine why the trial failed.

Industry Leaders

You will learn from industry experts from a wide variety of backgrounds, including leaders in healthcare, pharmaceuticals, venture capital, insurance, intellectual property law, and regulatory agencies. Featured experts include:
Faculty Member Noubar Afeyan

Noubar Afeyan

Senior Managing Partner, CEO, Flagship Ventures

Faculty Member Nikolai Begg

Nikolai Begg

PhD, Research Manager, Surgical Innovations at Medtronic

Cheryl Blanchard

PhD, President and Chief Executive Officer, Microchips Biotech

Faculty Member Katerine Bosley

Katerine Bosley

CEO, Editas

Faculty Member Michael Elliott

Michael Elliott

VP, Immunology Scientific Innovation at Johnson & Johnson

Faculty Member Colin Gardner

Colin Gardner

PhD, Consultant, Formerly the VP of Global Pharmacology Development, Merck

Faculty Member Todd Armstrong

Todd Armstrong

PhD, JD Partner, Clark+Elbing

Faculty Member Elain Blais

Elain Blais

Partner, Goodwin Proctor

Faculty Member Paolo Bonato

Paolo Bonato

PhD, Director of the Motion Analysis Laboratory, Spaulding Rehabilitation Hospital

Faculty Member Hongming Chen

Hongming Chen

ScD, CSO, Kala Pharmaceuticals

Faculty Member Robert Farra

Robert Farra

Executive VP & CTO, Microchips Biotech

Faculty Member Dennis Giesing

Dennis Giesing

Chief Scientific Officer, Taris Biomedical

Faculty Member Nathaniel Katz

Nathaniel Katz

CEO, Analgesic Solutions

Faculty Member Dave Mantus

Dave Mantus

PhD, Clinical and Technical Operations, Arsanis

Faculty Member Prof. Mark McClellan

Prof. Mark McClellan

PhD, MD, Duke University

Faculty Member Steven Paul

Steven Paul

MD, President and Chief Executive Officer, Voyager Therapeutics

Faculty Member Rene Russo

Rene Russo

PharmD, BCPS Chief Development Officer, Arsanis

Faculty Member David Vogel

David Vogel

President, Intertech Engineering

Faculty Member Janet Woodcock

Janet Woodcock

Director, Center for Drug Evaluation and Research, FDA

Faculty Member Mark Levin

Mark Levin

Partner, 3rd Rock Ventures

Faculty Member John Maraganore

John Maraganore

CEO, Alnylam

Faculty Member John McDonough

John McDonough

CEO, T2 Biosystem

Faculty Member Richard Pops

Richard Pops

CEO, Alkermes

Faculty Member Purnanand Sarma

Purnanand Sarma

CEO, Taris Biomedical

Faculty Member Tony Wood

Tony Wood

VP, Head of Worldwide Medicinal Chemistry Pfizer (Now SVP, Medicinal Science & Technology, GlaxoSmithKline)

Program Highlights

Decorative image relating to webinars

Webinars

Decorative image relating to over 40 interviews with industry experts

Over 40 Interviews with Industry Experts

Decorative image relating to real-world application

Real-world Application

Decorative image relating to byte-sized learning

Byte-Sized Learning

Decorative image relating to digital certificate directly from MIT xPRO

Digital Certificate Directly from MIT xPRO

Decorative image relating to peer learning & feedback

Peer Learning & Feedback

Decorative image relating to the mobile learning app

Mobile Learning App

Decorative image relating to grading & evaluation

Grading & Evaluation

MIT Faculty

Faculty Member Michael Cima

Michael Cima

David H. Koch Professor of Engineering

Michael is the David H. Koch Professor of Engineering and a Professor of Materials Science and Engineering at the Massachusetts Institute of Technology at the David H. Koch Institute for Integrative Cancer Research. He has a B.S. in chemistry and a Ph.D. in chemical engineering from the University of California at Berkeley.

He is the faculty director of the Lemelson-MIT Program, a U.S.-based program aimed at inspiring youth to be inventive. Michael is also co-director of MIT’s Innovation Initiative and the Associate Dean of Innovation for the School of Engineering. He has also started three successful pharmaceutical and three medical device companies.

Certificate

Example image of certificate that will be awarded after successful completion of this program

Certificate

Get recognized! Upon successful completion of this program, MIT xPRO grants a certificate of completion to participants. This program is graded as a pass or fail; participants must receive 80% to pass and obtain the certificate of completion.

Download Brochure

After successful completion of the program, your verified digital certificate will be emailed to you, at no additional cost, in the name you used when registering for the program. All certificate images are for illustrative purposes only and may be subject to change at the discretion of MIT.

Registration for this program is done through Emeritus. You can contact us at mit@emeritus.org
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