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Prescription Drug Regulation, Cost, and Access: Current Controversies in Context

Understand how the FDA regulates pharmaceuticals and explore debates on prescription drug costs, marketing, and testing.

Immuno-oncology

See how the immune system is being used to improve cancer treatment..

Cancer Genomics and Precision Oncology

Learn how cancer treatment is evolving due to advances in genetics..

Gene Therapy

Explore recent advances in gene therapy and learn about the implications for patient care..

Clinical Drug Development

Learning about the process of clinical drug development has important implications for anyone working in health care and related sectors.

Foundations of Clinical Research

This Harvard Medical School six-month, application-based certificate program provides the essential skill sets and fundamental knowledge required to begin or expand your clinical research career.

Global Clinical Scholars Research Training

This Harvard Medical School one-year, application-based certificate program provides advanced training in health care research and methods.

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The Next Wave of Meditation Research and Training

We believe that scientific research has only scratched the surface in exploring the potential of meditation. Most initial studies focused on using mindfulness for stress reduction and various clinical applications. The Meditation Research Program, led by Dr. Matthew D. Sacchet at Massachusetts General Hospital (Mass General) and Harvard Medical School, aims further the field by pioneering new research and training on advanced meditation .

Join us on this transformative journey into the evolving science and practice of advanced meditation.

Advanced Meditation: What Is It and Why It Matters

Advanced meditation is deeper engagement with meditative practices that with time and mastery, produce refined states of mind and awareness. These include bliss states, insights into the mind, altruistic/compassionate mindsets and ultimately, enduring transformation. Such transformation may result in profoundly altering one’s relations to psychological suffering, desire and motivations and sense of self.

Advanced meditation enables fundamental potential for human flourishing . It promises to contribute to innovation and impact in many fields and domains including mental health, personal thriving and life meaning, wisdom development and consciousness exploration. Advanced meditation also impacts research in relation to psychedelics and more generally, altered states, artificial intelligence, sustained excellence and peak performance, among others.

The Opportunity and Our Solution

We currently have a nascent understanding of advanced meditation, with current meditation research focused on clinical applications of mindfulness. There has been limited scientific research on advanced meditation, it is still in the early stages of introduction to modern culture and life.

The Meditation Research Program’s vision is to lead with the best research and education on advanced meditation. This goal is achieved through our comprehensive multidisciplinary advanced meditation research and our development and implementation of advanced meditation training programs and resources.

Multidisciplinary Advanced Meditation Research Driving Innovation from Theory to Practice

The Development and Implementation of Advanced Meditation Education and Training

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“ Advanced meditation holds significant and untapped opportunities to diminish suffering and help people flourish. […] Our work in the new wave of advanced meditation research is not just about coping with the stress of modern living. It could improve our understanding of and approach to the mind, mental health and well-being, allowing each of us to lead a more fulfilled, compassionate and ‘enlightened’ life .”

Matthew D. Sacchet, Ph.D. in Scientific American, June 2024

Our Team, Mass General, and Harvard

Our team is comprised of individuals at different career stages from undergraduates to senior professors. We are supported by a pantheon of visionaries and leaders at Harvard Medical School, Mass General and beyond that are committed to our Program’s impact and success.

Mass General is the largest hospital-based research program in the world and the oldest and largest affiliate of Harvard Medical School.

Countless medical and first-time scientific breakthroughs have been realized here including the invention of functional magnetic resonance imaging (fMRI) and magnetoencephalography (MEG), both technologies that are core tools in our neuroscience research.

“The Meditation Research Program at MGH is a visionary organization that has the potential of becoming the premier research and education center in the world for the study of advanced meditation practice.”

Richard J. Davidson, Ph.D. World renowned leader in meditation research and education Director of the Center for Healthy Minds, William James Professor, University of Wisconsin Madison

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Juliette Cubanski

Dissertation Title:  "Three Studies on Policies to Reduce Medicare Drug Spending"

This thesis consists of three related studies on policies to reduce prescription drug spending by Medicare beneficiaries. The policy context is the Medicare Prescription...

Julie Donohue

Dissertation Title:  "Pharmaceutical Promotion in an Age of Consumerism"

This thesis examines the effects of direct-to-consumer advertising (DTCA) and traces the evolution of pharmaceutical promotion and its regulation by the Food and Drug Administration...

Elena Elkin

Dissertation Title:  "Decision Analysis in the Evaluation of Breast Cancer Treatment"

Advances in breast cancer treatment have improved the prognosis of many women with this disease. Whether a patient faces a diagnosis of early-stage breast cancer or...

Laura Eselius

Dissertation Title:  "Assessing the Quality of Behavioral Health Care and Health Plans Using Consumer Reports and Ratings"

Interest in comparing consumer assessments of quality across health plans has grown. The Experience of Care and Health Outcomes...

Carrie Farmer

Dissertation Title:  "Chronic Illness, Depression, and the Patient-Provider Relationship: Toward a Model of Biopsychosocial Care"

Chronic medical conditions are the leading cause of disability in the United States, account for 70 percent of all deaths...

Jill Morris Ferdinands

Dissertation Title:  "Methods for Modeling and Valuing Life Expectancy Gains"

Over the past decade, there has been increasing concern over the inability of society to afford the growing number of health-related interventions. Decision-makers have turned...

Matthew Frank

Dissertation Title:  "Promoting Value Through Health Insurance Design: Empirical and Normative Assessments"

Chapter 1. The Effect of a Large Regional Health Plan’s Value-Based Insurance Design Program on Statin Use.

My first chapter examines a value...

Abigail Friedman

Dissertation Title:  "Essays in Health Economics: Understanding Risky Health Behaviors"

This dissertation presents three papers applying health economics to the study of risky behaviors. The first uses data from the 1979 National Longitudinal Survey of...

Ashley-Kay Fryer Basile

Dissertation Title:  "Improving Health Care Delivery: Patient Care Integration and Manager Commitment"

This dissertation investigates how patient-perceived integrated care and manager commitment influence the improvement and integration of health care...

Emmanuela Gakidou

Dissertation Title:  "Health Inequality: Definition, Measurement and Determinants"

Health inequality is defined as differences in health status across individuals in a population. I present a conceptual framework for the measurement of health inequality...

Timothy Layton

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Undergraduate Program

The Bachelor of Liberal Arts degree is designed for industry professionals with years of work experience who wish to complete their degrees part time, both on campus and online, without disruption to their employment. Our typical student is over 30, has previously completed one or two years of college, and works full time.

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• The A.R.T. Institute at Harvard University
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The A.R.T. Institute for Advanced Theater Training at Harvard University was established in 1987 as a training ground for professional theater. A two-year, graduate-level program, the Institute was created with an understanding that students can best prepare for a life in the performing arts by immersing themselves in the work of a professional theater, and by studying with faculty who are practicing theater artists.

Over the past three decades, graduates of the Institute have become leaders in the arts. Graduates of the acting program have performed on Broadway, Off-Broadway, and at theaters around the country, while also appearing in feature films and as series regulars on numerous television shows. Graduates of the dramaturgy program serve as dramaturgs, literary managers, theater critics, and artistic directors in this country and abroad. Graduates of the voice pedagogy program teach at top American universities.

In 1998, the Institute formed a historic partnership with the Moscow Art Theater School. The birthplace of the Stanislavsky System and the artistic home of the playwright Anton Chekhov, the Moscow Art Theater (MXAT) is one of Europe’s leading companies. The partnership with MXAT has given Institute students the opportunity to train with leading Russian actors, directors, choreographers, historians, and critics, and to be immersed in one of Europe’s most vibrant theater capitals.

At this time, the Institute is on hiatus in order to explore new models of training and is currently not accepting students.

Transcript Request/ Employment Verification

Please contact us at [email protected] with your full name and year of graduation to request Institute transcripts, arrange for employment verification, or for more information. You will receive a response and further instructions in a timely manner.

A.R.T. Institute Alumni

Graduates of the A.R.T. Institute have entered their respective industries with a far-reaching intellectual curiosity, a diligent sense of professionalism, and an extensive set of practical skills. Having garnered experience from their training abroad, their coursework stateside, and their collaboration alongside industry professionals, students have left the Institute prepared for the wide variety of work in today’s American and international theater.

ARPA-H funding boosts Wyss Institute's RNA therapeutic project

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With the award for up to $27 million from the Advanced Research Projects Agency for Health (ARPA-H), a collaborative research project at the Wyss Institute for Biologically Inspired Engineering at Harvard University will advance a disease-agnostic novel RNA therapeutic with the potential to treat diverse diseases, and to be effectively and rapidly deployable. By safely and naturally stimulating the "innate immune" system -; the body's first line of defense against disease-causing tumor cells and pathogens -; this approach has the potential to stimulate the immune system as a whole, including its more cancer cell and pathogen-specific "adaptive immune" responses. Its therapeutic effects in the body can significantly outlast the presence of the RNA drug itself, and potently synergize with other immunotherapies in patients suffering from various types of cancer and infectious diseases. 

"We are excited by the opportunity afforded by the ARPA-H award to develop new RNA-based therapeutics, advanced delivery vehicles, and manufacturing capabilities to provide patients with cancer and infectious diseases with new treatment opportunities. We have assembled an exceptional team that is eager to realize the potential of our proposed program," said Wyss Core Faculty member Natalie Artzi, Ph.D., who is the lead-investigator on the project with co-principal investigator and Wyss founding director, Don Ingber, M.D., Ph.D. Artzi also is Associate Professor of Medicine at Harvard Medical School (HMS) and Brigham and Women's Hospital and a Principal Research Scientist at MIT. 

ARPA-H is a federal funding agency established by the Biden Administration, which funds transformative biomedical and health research breakthroughs, rapidly translating research from the lab to applications in the marketplace. The ARPA-H award will allow the Wyss team to significantly accelerate and expand their efforts in order to advance the therapy towards an Investigational New Drug (IND) submission to the Federal Food and Drug Administration (FDA).

With its first focus on cancer as a disease target, the multidisciplinary Wyss team combines critical and highly complementary expertise in the areas of drug discovery, advanced  in vitro  and  in vivo  models for preclinical drug testing, innovative drug delivery, RNA nanotechnology, and next-generation RNA synthesis and manufacturing. After having significantly de-risked their disease-agnostic immunotherapeutic RNA therapy as a cancer treatment, the team will also validate its use for difficult-to-treat infectious diseases.

The ARPA-H project builds on a Duplex RNA technology pioneered by Ingber's team and leverages innovative drug delivery approaches that Artzi's group developed with a particular focus on programming the immune system, as well as an expansive array of human "Organ Chip" tissue culture systems advanced by Ingber's group that enable preclinical human drug testing. Artzi and Ingber are joined on the project by additional key investigators, including Wyss Director of Translational R&D Kenneth Carlson, Ph.D., a drug discovery and development specialist with extensive industry experience, who drove the development of the Duplex RNA, and Wyss Core Faculty member William Shih, Ph.D., who has developed DoriVac, a DNA origami platform that allows the precise and highly effective presentation of RNA drugs, cancer and pathogen-derived antigens , and immune activating adjuvants to the immune system. Shih and his team will provide their DNA nanotechnology approach as an additional drug delivery component to the project. Finally, the researchers will collaborate with Wyss start-up EnPlusOne Biosciences to harness the RNA solution company's novel enzymatic RNA synthesis and manufacturing capabilities that overcome key limitations of commonly used chemical RNA synthesis methods. 

"The Wyss Institute's ambition and ability to take on extraordinarily difficult challenges, and to mature promising early research discoveries all the way to real-world solutions that are prime for clinical stages, resonates well with ARPA-H's mission. We are excited and confident that our accomplished, highly multidisciplinary team will have a significant impact on future immune therapies and patients' lives with ARPA-H's tremendous support," said Ingber, who is also the  Judah Folkman Professor of Vascular Biology  at Harvard Medical School and Boston Children's Hospital, and the  Hansjörg Wyss Professor of Biologically Inspired Engineering  at the Harvard John A. Paulson School of Engineering and Applied Sciences.

Origins and validation

The project began in the middle of the COVID-19 pandemic, when Ingber's group identified a novel, structurally distinct double stranded RNA molecule (Duplex RNA) that they showed prevents the replication of various potential pandemic respiratory viruses, including SARS-CoV-2 in an animal model as well as MERS-CoV, and various influenza viruses in human lung tissues engineered in Organ Chips. It did so by stimulating an innate immune response involving a family of protective cytokines known as interferons (IFNs) without triggering potentially dangerous inflammation that occurs when the innate immune system is overactivated. As the molecular target for the Duplex RNA, the researchers identified the RIG-I protein, which normally responds to viral RNA molecules by inducing tissue-protective immune responses through the balanced activation of several gene-activating IFN pathways. 

IFN protein therapeutics have made their way into the clinic for the treatment of infectious diseases as well as certain cancers, and they also have been used to sensitize cancer cells to other forms of therapy, including chemo- and radiation therapy, as well as newer immunotherapies. However, "past therapeutic approaches, which administered a single concentrated dose of an individual manufactured IFN protein  via  injection, have often been unbalanced, as they strongly and selectively activate only one of many downstream pathways, and they had highly variable effects across patients and cancer types," said Carlson. "Our Duplex RNA approach induces the body's own innate immune response, resulting in a more balanced, highly beneficial activation of multiple types of protective IFNs with a significantly larger therapeutic window that we aim to broadly harness in this project."

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The Duplex RNA project was named a Wyss Validation Project in 2022, during which time the Wyss team further de-risked their novel approach as an infectious disease therapeutic by showing potent efficacy in a mouse model of COVID-19. Then, in a second Wyss Validation Project awarded in 2023 and coordinated by Ingber and Carlson, which also includes Artzi and Shih as investigators, they successfully pursued it as a potential cancer therapeutic. In the new ARPA-H project, they will leverage the powerful RNA delivery capabilities of Artzi's and Shih's groups along with the groundbreaking enzymatic RNA synthesis capabilities of EnPlusOne to optimize the Duplex RNA's stability and efficacy. They also will utilize human Organ Chip culture technology and preclinical animal models as highly relevant test beds. Importantly, findings obtained in human Organ Chip models, according of the 2022 FDA Modernization Act, can now be included in an IND submission to the FDA.

Delivery is key

Key for the project's success will be the team's ability to deliver an optimized Duplex RNA to the body's tumor-bearing or infected tissues. Artzi has pioneered multiple drug delivery systems that can be used to target therapies to specific sites and cells in the body, or effectively distribute them broadly. For example, her group's polymeric nanoparticles can increase the stability and loading of drugs, as well as drug uptake by cells, when compared to other delivery methods, and release their cargo in response to specific cellular cues. This enabled her team to create an immunotherapy that accumulates in immune and cancer cells, with the latter functioning as a depot – releasing the nanoparticles to innate immune cells in their vicinity, and activating them to generate a long-lasting anti-tumor immune response. 

While these nanoparticles are administered intravenously, another material-based delivery strategy developed in Artzi's group consists of polymeric microneedles that, applied as a patch, can be used to deliver drugs into subcutaneous layers of the skin. The team used these microneedle patches to administer a melanoma therapy in a mouse model, and to monitor local immune responses based on skin biomarkers collected by the patch. The utility of microneedles, including their safe and painless administration, also makes them an important future avenue to treat many more patients in clinically underdeveloped settings, allowing them to benefit from otherwise inaccessible therapies. 

We will pursue both delivery routes for the disease-agnostic Duplex RNA therapy and, together with William Shih's group, also explore their integration with DNA origami technology, which can function as a precision instrument to fine-tune and enhance the presentation of the Duplex RNA to RIG-I sensor proteins within cells. Our ultimate goal is a disease-agnostic innate immune therapeutic platform that effectively synergizes with other immunotherapies, enabling a much larger proportion of patients to be treated with them across a much larger range of cancer and infectious diseases." Natalie Artzi, Ph.D., lead-investigator on the project 

Wyss Institute for Biologically Inspired Engineering at Harvard

Posted in: Drug Discovery & Pharmaceuticals | Medical Science News | Medical Research News

Tags: Animal Model , Antigen , Cancer , Cancer Treatment , Cell , Children , CHIP , covid-19 , Cytokines , Diagnostics , DNA , Drug Delivery , Drug Discovery , Drugs , Efficacy , Food , Gene , Healthcare , Heart , Hospital , Immune Response , Immune System , Immunotherapy , in vitro , in vivo , Infectious Diseases , Inflammation , Influenza , Interferons , Manufacturing , Medical School , Medicine , Melanoma , MERS-CoV , Molecule , Mouse Model , Nanoparticles , Nanotechnology , Nucleotides , Oligonucleotide , Pandemic , Pathogen , pH , Preclinical , Protein , Radiation Therapy , Research , Research Project , Respiratory , RNA , SARS , SARS-CoV-2 , Skin , Technology , Therapeutics , Tissue Culture , Translation , Tumor , Vascular

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OCRECO Home > Clinical Research Education > Introduction to the Principles and Practice of Clinical Research (IPPCR)

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Introduction to the Principles and Practice of Clinical Research (IPPCR)

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Description Important Dates General Information Course Objectives Individual (Non-Registered) Lecture Option Texbook Contact --> Welcome

The Introduction to the Principles and Practice of Clinical Research (IPPCR) course trains registrants on how to effectively and safely conduct clinical research. The course focuses on the spectrum of clinical research and the research process by highlighting biostatistical and epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, ethical and legal issues, and much more.

Course Objectives

Provide an overview of basic biostatistical and epidemiologic methods involved in conducting clinical research.

Describe the principles involved in the ethical, legal, and regulatory issues in clinical human subjects research, including the role of Institutional Review Boards (IRBs).

Describe principles and issues involved in monitoring patient-oriented research.

Describe the infrastructure required in performing clinical research and the steps involved in developing and funding research studies.

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This course will be of interest to physicians, scientists, medical and dental students, nurses, public health professionals, and others conducting or planning a career in clinical research.

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Global Clinical Scholars Research Training

Blog April 2, 2024

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Clinical researchers today need strong grant-writing skills to get their high-impact research projects approved and funded. Yet effective writing techniques typically aren’t taught in medical school, leaving many researchers struggling to create opportunities to further their work. That’s why the Harvard Medical School Postgraduate Medical Education’s Global Clinical Scholars Research Training program fills in the gaps to strengthen participants’ skills in this area and equip them with a valuable competitive edge to move the field forward.  

Preparing Clinical Researchers for Success 

Global Clinical Scholars Research Training is a year-long certificate program designed for clinicians and clinician-scientists to provide them with advanced research training to accelerate their careers in exciting directions and prepare them to lead teams across a range of healthcare settings. This includes a strong focus on grant-writing skills, since this is such a critical part of a clinical researcher’s success, according to Djøra Soeteman, PhD, MA, a research scientist affiliated with the Center for Health Decision Science, Harvard T.H. Chan School of Public Health, who serves as co-director of the program.

The Capstone Project: Practicing Effective Grant Proposals  

Scholars enrolled in the program complete a mentored capstone project that consists of writing a grant proposal for research funding, which provides them with a real-world opportunity to put their learnings into action. As part of the capstone, each scholar submits a brief pitch of their idea, as well as a plan on how they will achieve it. These pieces are used to build the proposal itself. Harvard faculty members work with students to help them hone the writing and framing of their ideas to make them most likely to be effective, Soeteman says.  

She adds that some Global Clinical Scholars Research Training scholars have been able to get their capstone grant proposals approved and funded, which has been exciting to watch.

Gaining Other Essential Skills

In addition to sharpening their grant-writing abilities, scholars strengthen essential research skills and knowledge in several areas, including leadership, advanced statistical tools, and research ethics. This deep dive into these areas prepares participants to develop and manage their research plans when they graduate from the program.  

Some of the key takeaways for participants include: 

A deeper understanding of statistical analyses : Scholars are introduced to statistical software and computing methods to empower them to analyze their own data and put it into the right context. This advanced familiarity allows researchers to work closely with statisticians to guide the process and to ultimately be able to produce manuscript-quality figures and graphs to support their work. “Ideally, you want to do those statistical analyses yourself—or at least know what kind of options exist—so you can explain exactly what you want. This advanced knowledge gives students the confidence to do their own research, to write papers, to present at conferences, and to hold leadership positions in clinical research,” Soeteman stresses.

Recognizing the hallmarks of high-quality research : Scholars will get an in-depth look at the elements of high-quality research and will learn to critically assess research findings they are reading or reviewing to see how they measure up to the expected standards. Such insights can help scholars better interpret clinical findings while also taking a more critical view of their own work.

The value of building and leveraging important connections : One of the struggles researchers often face is forming important connections in order to build a team to support their efforts. “Scholars often want to conduct research at their institute or at their hospital, but it’s difficult to set up a research study like a clinical trial or an observational study in your own center if you’re the only one working on it,” Soeteman explains. Global Clinical Scholars Research Training provides a valuable forum through which participants can meet other, like-minded professionals and form relationships that they can build on to move their efforts forward.

Mastering Time Management

While some clinical researchers who want to boost their research and grant proposal writing skills may be worried about juggling the demands of the program with their family and work commitments, Soeteman points out that, although this may be a challenge, the concern is usually unfounded. In fact, she says that all the scholars somehow find a way to manage their responsibilities and school quite successfully. She credits this to the tremendous motivation most participants demonstrate, coupled with the commitment from the faculty and staff to support each person’s journey. A strong camaraderie among students also helps everyone stick together and support one other throughout the year. In addition, upon completion of the program, graduates often stay in touch with their classmates and other experts they met through the program and share advice, support, and networking. This can even lead to new opportunities to work together on high-impact research studies and other projects that are advancing our understanding of healthcare.

Driving Innovation in Clinical Research

“Scholars are often motivated to start doing research—or to keep going on existing efforts—because they get inspired through the program,” Soeteman says. She adds that by combining the knowledge they gain in the Global Clinical Scholars Research Training program over the course of the year with their newfound effective grant-writing abilities, scholars are well positioned to develop their careers as clinical researchers and as leaders, helping them to ultimately drive innovation and achieve better outcomes.

The next Global Clinical Scholars Research Training program begins this October and the application deadline is September 11, 2024.

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