Clinical Development Strategies: Beyond Clinical Trials

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14 weeks
Online and Live Virtual

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Harness Today's Clinical Development Challenges for Tomorrow's Breakthroughs

Disruptive changes in the pharmaceutical industry landscape are opening up new approaches to optimize clinical trial strategy. This includes patient-centric study design and digital technologies to enhance clinical research, trial efficiency and revenue generation. Opportunity also exists for data science to revolutionize drug development and clinical trials, with insights from real-world data informing trial strategies, protocol design and exclusion criteria; however, rapid innovation has increased the complexity of trials and costly delays are common, placing unsustainable pressure on trial sites. Clinical development leaders must understand how technological advances like artificial intelligence can improve drug development, while finding solutions to diversity and equity in trials.

The 14-week Clinical Development Strategies: Beyond Clinical Trials program from Harvard Medical School Executive Education will equip you to address these challenges and unlock increased value in clinical development projects. Using the latest digital tools, frameworks and case studies taught by Harvard Medical School faculty and leading practitioners, you will learn to improve clinical trial design and performance as well as think beyond trial outcomes to facilitate the success of products throughout their development lifecycles.

You will also explore AI's impact on clinical workflows and health care transformation. This includes examining its strategic implications and addressing AI adoption considerations, including feasibility, integration challenges and stakeholder engagement, considering both short-and long-term organizational needs.

80%

of clinical trials fail to meet the initial patient enrollment target and timeline, resulting in up to US$8 million per day in lost revenue for drug developing companies.

Source: National Library of Medicine

56%

of clinical trial sites say trials are more complex now than three years ago.

Source: Bain & Company

Key Takeaways

  • Identify key drivers of change in the life sciences industry
  • Explain how traditional clinical trials practices are evolving to address the demands of the life sciences industry
  • Understand how digital solutions and real-world evidence can add value across the clinical development life cycle
  • Leverage the strategies and emerging technologies needed to accelerate results when leading clinical development projects
  • Apply frameworks and innovative approaches to guide key decision making during clinical research

Who Is This Program For?

The Clinical Development Strategies: Beyond Clinical Trials program is designed for:

  • Leaders of clinical trials looking to stay informed about and embrace industry changes to drive tangible value for clinical development organizations
  • Experienced technical professionals in clinical trial functions seeking to broaden their understanding of the clinical development process and pharmaceutical industry trends to grow in their careers

Why Harvard Medical School

Harvard Medical School Executive Education provides emerging and established companies with the knowledge they need to address the industry's toughest business challenges. Our extensive portfolio of learning solutions helps teams achieve their potential by advancing their knowledge and capabilities in areas ranging from medical science and emerging diseases to employee health and wellness. A comprehensive ecosystem of online, in-person and hybrid solutions support learners at all levels—from new hires to CEOs and their leadership teams.

Learning Experience

Icon of Comprehensive Curriculum

Comprehensive Curriculum

Benefit from a powerful curriculum that combines evidence-based frameworks with an application-based approach

Icon of Self-Paced Learning

Self-Paced Learning

Learn at your own pace with a weekly commitment of three to five hours

Icon of Expert Faculty

Expert Faculty

Glean insights from leading subject matter experts with deep life sciences industry experience and expertise in Gen AI, data, patient centricity, trials design, and other significant domains

Icon of Live Sessions

Live Sessions

Live sessions with faculty and weekly office hours conducted by program leaders

Icon of Capstone Project

Capstone Project

Work on a capstone project with a series of reflective exercises combining theory with leadership realities in the life sciences industry to address your organization's challenges for immediate impact at work

Icon of Case Studies

Case Studies

Access case studies and industry examples from the pharmaceutical and biotechnology sectors

Icon of Frameworks and Tools

Frameworks and Tools

Apply useful frameworks and innovative approaches to incorporate digital tools and guide key decision-making in clinical trial functions

Icon of Hands-On Learning

Hands-On Learning

Work on Leadership Lens activities across modules, with general feedback provided by the grading team and periodic knowledge checks and self-study activities

Curriculum

    Learn to identify recent global changes in therapeutic modalities, the rare diseases landscape and patient advocacy roles that capture value in approved therapies within the life sciences industry.

    Analyze the life sciences industry's external landscape and big tech's influence on consumer health care expectations as well as the opportunities and risks in digital medicine.

    Assess opportunities and risks in digital medicine, recognize the scope of success for therapeutic modalities and the role of access and equity, and strategize for equitable access in clinical trials designs.

    Trace the origins of patient centricity, distinguish between reactive and proactive patient involvement and articulate how patient input informs decisions throughout the development life cycle.

    Understand the evolving landscape of clinical trials, identify knowledge dissemination among role groups in the trials life cycle and leverage clinical design to optimize development timelines and recruitment.

    Explore opportunities for integrating digital technologies in clinical trial functions, outline the process of developing these technologies, identify their revenue potential and leverage your digital technology knowledge as a leader to make strategic decisions for your organization.

    Explore how to best leverage digital technologies in clinical development and throughout the value chain.

    Examine the application of real-world data in the pharmaceutical life cycle, summarize regulatory guidance, explore advanced real-world evidence analysis methods and assess the deployment of a real-world evidence strategy.

    Explore fundamental concepts and AI approaches across the pharmaceutical life cycle.

    Explore emerging concepts surrounding the value that novel therapies can offer to patients, caregivers and society with a focus on evidence and insights before and after market launch.

    Explore key concepts of the product development framework, beginning with patient needs and working backward, to facilitate decision making on topics such as team structure, resources and clinical trial operations.

    Between Clinical Development, Medical Affairs Explore key concepts of the product and Commercial.

    Understand how clinical development, medical affairs and commercial functions can work together to address the challenges of regulatory approvals and timeliness.

    Understand key concepts that enhance your leadership effectiveness and management skills within your organizational context.

    Conclude your learning experience with a capstone project that provides insightful reflections on preceding modules.


*Note - Modules are subject to change

Capstone Project

The capstone project is an integral part of your learning journey, a series of reflective exercises across three critical stages of the program. It is designed to strategically consolidate and deepen your leadership skills within the context of clinical development and practice. Each checkpoint will address key aspects of leadership in clinical development, from personal mindset to skill advancement and strategic application, to foster a deeper understanding of how effective leadership can influence and drive success in clinical research and development.

This comprehensive component combines theory with the practical realities of leadership in life sciences, addressing your organization's challenges.

Program Faculty

Profile picture of the Associate Dean for Executive Education, Harvard Medical School  - STANLEY SHAW

Stanley Shaw, MD, PhD

Associate Dean for Executive Education, Harvard Medical School

Dr. Stanley Shaw designs and directs a growing portfolio of programs for companies and executive leaders from diverse sectors of health care. He is a practicing cardiologist at the Brigham and Women’s Hospital and the chief scientific officer for One Brave Idea (at Brigham and Women’s Hospital), an initiative funded by the American Heart Association, Verily, AstraZeneca and Quest to understand and treat the earliest changes in coronary heart disease. His research seeks to understand how digital health, bioinformatics, the gut microbiome and patient-reported data can be leveraged to better assess health and disease. Previously, he co-founded the Center for Assessment Technology and Continuous Health (CATCH) at Massachusetts General Hospital, and his team led the development of one of the first ResearchKit iPhone apps in partnership with Apple.

Guest Faculty

Profile picture of Founder & CEO,The Kith Collective - Kimberly Mcleary

Kimberly McCleary

Founder & CEO,The Kith Collective

Profile picture of Harvard Instructor; Founder, The MYLO Center - Margaret Andrews

Margaret Andrews

Instructor, Harvard University; Managing Director, The MYLO Center

Profile picture of Assistant Professor of Epidemiology, Harvard Medical School - Andrew Beam

Andrew Beam, PhD

Assistant Professor of Epidemiology, Harvard Medical School

Profile picture of Neurologist, Pain Physician, Chief Medical Officer, Click Therapeutics - Shaheen Lakhan

Shaheen Lakhan, MD, PhD, FAAN

Neurologist, Pain Physician, Chief Medical Officer, Click Therapeutics

Profile picture of SVP, AlixPartners - Robert Chamberlain

Robert Chamberlain, PhD

SVP, AlixPartners

Profile picture of Fellow, The Aspen Institute - Shamiram Feinglass

Shamiram Feinglass, MD, MPH

Fellow, The Aspen Institute

Profile picture of Chief Product and Solutions Officer, TriNetX; Senior Advisor, The Carlyle Group; Teaching Associate, Harvard Medical School -  Arnaub Chatterjee

Arnaub Chatterjee, MHA, MPA

Chief Product and Solutions Officer, TriNetX; Senior Advisor, The Carlyle Group; Teaching Associate, Harvard Medical School

Profile picture of Director, Center for Thoracic Cancers Program; Massachusetts General Hospital; Associate Professor of Medicine, Harvard Medical School - Justin Gainor

Justin Gainor, MD

Director, Center for Thoracic Cancers Program; Massachusetts General Hospital; Associate Professor of Medicine, Harvard Medical School

Profile picture of Joseph P. Newhouse Professor of Health Care Policy, Department of Health Care Policy, Harvard Medical School; Professor of Medicine and Associate Physician in the Department of Medicine, Massachusetts General Hospital; Host of Freakonomics, MD podcast - Anupam Jena

Anupam Jena, MD, PhD

Joseph P. Newhouse Professor of Health Care Policy, Department of Health Care Policy, Harvard Medical School; Professor of Medicine and Associate Physician in the Department of Medicine, Massachusetts General Hospital; Host of Freakonomics, MD podcast

Paul Eisenberg, MD, MPH

Venture Partner at Apple Tree Partners

Certificate

Certificate

Upon completion of this program, you will receive a digital certificate from Harvard Medical School Executive Education.

FAQs

  • How do I know if this program is right for me?

    After reviewing the information on the program landing page, we recommend you submit the short form above to gain access to the program brochure, which includes more in-depth information. If you still have questions on whether this program is a good fit for you, please email learner.success@emeritus.org, and a dedicated program advisor will follow up with you very shortly.


    Are there any prerequisites for this program?

    Some programs do have prerequisites, particularly the more technical ones. This information will be noted on the program landing page, as well as in the program brochure. If you are uncertain about program prerequisites and your capabilities, please email us at the ID mentioned above.


    Note that, unless otherwise stated on the program web page, all programs are taught in English and proficiency in English is required.


    What is the typical class profile?

    More than 50% of our participants are from outside the United States. Class profiles vary from one cohort to the next, but, generally, our online certificates draw a highly diverse audience in terms of professional experience, industry, and geography—leading to a very rich peer learning and networking experience.


    What other dates will this program be offered in the future?

    Check back to this program web page or email us to inquire if future program dates or the timeline for future offerings have been confirmed yet.

  • How much time is required each week?

    Each program includes an estimated learner effort per week. This is referenced at the top of the program landing page under the Duration section, as well as in the program brochure, which you can obtain by submitting the short form at the top of this web page.


    How will my time be spent?

    We have designed this program to fit into your current working life as efficiently as possible. Time will be spent among a variety of activities including:



    • Engaging with recorded video lectures from faculty
    • Attending webinars and office hours, as per the specific program schedule
    • Reading or engaging with examples of core topics
    • Completing knowledge checks/quizzes and required activities
    • Engaging in moderated discussion groups with your peers
    • Completing your final project, if required

    The program is designed to be highly interactive while also allowing time for self-reflection and to demonstrate an understanding of the core topics through various active learning exercises. Please email us if you need further clarification on program activities.


    What is it like to learn online with the learning collaborator, Emeritus?

    More than 300,000 learners across 200 countries have chosen to advance their skills with Emeritus and its educational learning partners. In fact, 90% of the respondents of a recent survey across all our programs said that their learning outcomes were met or exceeded.

    All the contents of the program would be made available to students at the commencement of the program. However, to ensure the program delivers the desired learning outcomes the students may appoint Emeritus to manage the delivery of the program in a cohort-based manner the cost of which is already included in the overall program fee of the course.

    A dedicated program support team is available 24/5 (Monday to Friday) to answer questions about the learning platform, technical issues, or anything else that may affect your learning experience.


    How do I interact with other program participants?

    Peer learning adds substantially to the overall learning experience and is an important part of the program. You can connect and communicate with other participants through our learning platform.

  • What are the requirements to earn the certificate?

    Each program includes an estimated learner effort per week, so you can gauge what will be required before you enroll. This is referenced at the top of the program landing page under the Duration section, as well as in the program brochure, which you can obtain by submitting the short form at the top of this web page. All programs are designed to fit into your working life.

    This program is scored as a pass or no-pass; participants must complete the required activities to pass and obtain the certificate of completion. Some programs include a final project submission or other assignments to obtain passing status. This information will be noted in the program brochure. Please email us if you need further clarification on any specific program requirements.


    What type of certificate will I receive?

    Upon successful completion of the program, you will receive a smart digital certificate. The smart digital certificate can be shared with friends, family, schools, or potential employers. You can use it on your cover letter, resume, and/or display it on your LinkedIn profile.
    The digital certificate will be sent approximately two weeks after the program, once grading is complete.


    Can I get the hard copy of the certificate?

    No, only verified digital certificates will be issued upon successful completion. This allows you to share your credentials on social platforms such as LinkedIn, Facebook, and Twitter.


    Do I receive alumni status after completing this program?

    No, there is no alumni status granted for this program. In some cases, there are credits that count toward a higher level of certification. This information will be clearly noted in the program brochure.


    How long will I have access to the learning materials?

    You will have access to the online learning platform and all the videos and program materials for 12 months following the program start date. Access to the learning platform is restricted to registered participants per the terms of agreement.

  • What equipment or technical requirements are there for this program?

    Participants will need the latest version of their preferred browser to access the learning platform. In addition, Microsoft Office and a PDF viewer are required to access documents, spreadsheets, presentations, PDF files, and transcripts.


    Do I need to be online to access the program content?

    Yes, the learning platform is accessed via the internet, and video content is not available for download. However, you can download files of video transcripts, assignment templates, readings, etc. For maximum flexibility, you can access program content from a desktop, laptop, tablet, or mobile device.

    Video lectures must be streamed via the internet, and any livestream webinars and office hours will require an internet connection. However, these sessions are always recorded, so you may view them later.

  • Can I still register if the registration deadline has passed?

    Yes, you can register up until seven days past the published start date of the program without missing any of the core program material or learnings.


    What is the program fee, and what forms of payment do you accept?

    The program fee is noted at the top of this program web page and usually referenced in the program brochure as well.

    • Flexible payment options are available (see details below as well as at the top of this program web page next to FEE).
    • Tuition assistance is available for participants who qualify. Please email learner.success@emeritus.org.

    What if I don’t have a credit card? Is there another method of payment accepted?

    Yes, you can do the bank remittance in the program currency via wire transfer or debit card. Please contact your program advisor, or email us for details.


    I was not able to use the discount code provided. Can you help?

    Yes! Please email us with the details of the program you are interested in, and we will assist you.


    How can I obtain an invoice for payment?

    Please email us your invoicing requirements and the specific program you’re interested in enrolling in.


    Is there an option to make flexible payments for this program?

    Yes, the flexible payment option allows a participant to pay the program fee in installments. This option is made available on the payment page and should be selected before submitting the payment.


    How can I obtain a W9 form?

    Please connect with us via email for assistance.


    Who will be collecting the payment for the program?

    Emeritus collects all program payments, provides learner enrollment and program support, and manages learning platform services.


    Are there any restrictions on the types of funding that can be used to pay for the program?

    Program fees for Emeritus programs with Harvard Medical School may not be paid for with (a) funds from the GI Bill, the Post-9/11 Educational Assistance Act of 2008, or similar types of military education funding benefits or (b) Title IV financial aid funds.

  • What is the program refund and deferral policy?

    For the program refund and deferral policy, please click the link here


Didn't find what you were looking for? Write to us at learner.success@emeritus.org or Schedule a call with one of our Program Advisors or call us at +1 315 284 5718 (US) / +44 204 538 5575(UK) / +65 3138 4864 (SG)

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