Courses

PMTO 200 Precision Medicine Overview for Cancer Screening (1 Unit)

Instructor: Samir Gupta, M.D., Professor, UC San Diego School of Medicine

Course Description & Learning Objectives:

Recent discoveries in “omics” promise a new era of personalized cancer screening utilizing biomarkers, such as from blood and stool, and other technologies, such as whole-body imaging. However, translating promising discoveries into validated strategies, and strategies that increase key patient outcomes such as reduced cancer incidence and mortality requires a careful, structured approach. This course will provide an overview in key concepts required to understand the growing need for novel cancer screening tests, established and emerging approaches to cancer screening, principles of cancer screening, and steps required to establish the clinical test characteristics of novel tests, as well as the clinical effectiveness of novel test-based strategies for screening. Learning will be through a series of lectures and directed readings, as well as interactive journal clubs and case-based discussions. The course will provide interactions with faculty from the UC San Diego MCC and the UC San Diego SOM, as well as industry representatives invested in the goal of achieving high quality, precision cancer screening. 

Learning Outcomes & Skills Acquired from the Course:

• Understand the epidemiology of cancer, including disparities in incidence and cancer screening participation
• Understand the public health and clinical principles of cancer screening tests and cancer screening strategies
• Gain an awareness of novel strategies for cancer screening utilizing genomics, proteomics, radiomics, and other “omics” strategies
• Understand the best practices for developing and validating a novel cancer screening test
• Understand study designs required for establishing the clinical and public health effectiveness of a screening strategy
• Gain an overview of the processes required to gain FDA approval, and Medicare support for a novel cancer screening test

PMTO 201 Applied Precision Medicine: Impacting Patients, Families, and Populations (1 Unit)

Instructor: Lisa Madlensky, Ph.D., CGC Professor of Medicine, UC San Diego Moores Cancer Center

Course Description & Learning Objectives:

This course will focus on how precision medicine is impactful beyond direct medical care, with an emphasis on inherited disease predisposition and germline genetic testing. Using case studies, learners will follow the process of informed consent, germline testing, disclosing results, and sharing genetic information with family members. Learners will also look at the testing and results disclosure process for several ongoing large studies that are providing germline information to individuals in the general population. It is critical for learners to have exposure to the “real-world” impact that precision medicine (derived from germline genetic testing) has on individuals and families beyond the development and administration of precision therapies. Heritable disease risk impacts family dynamics, self-identity, and can cause a wide range of emotions from empowerment to distress. As data are beginning to emerge from germline testing studies in large populations, the course will also investigate the real-world evidence of benefits and harms that are observed.

A variety of resources will be used for this course, including:

• Case studies of individuals and families going through the genetic testing process
• Detailed review of informed consent documents for germline testing
• Mock genetic counseling sessions
• Content from support, education, and advocacy organizations that focus on hereditary diseases
• Published behavioral and psycho-social outcomes from ongoing population-based studies of germline genetic testing at scale
• Where possible, materials from other courses in the program will be utilized to create continuity (example—using a molecular profiling report from course 202 that has an incidental germline finding as a starting point for results disclosure)

Learning Outcomes & Skills Acquired from the Course:

By the end of this course, learners will be able to:

• Summarize the unique elements of informed consent for germline testing
• Describe the core elements of the genetic counseling process (pre-testing and post-results)
• Identify pros and cons of various mechanisms for notifying family members of germline findings
• Compare existing study workflows for providing germline genetic test results at scale
• Appreciate the psycho-social issues and themes that arise in the germline genetic testing process

PMTO 202 - Biological Basis of Precision Medicine in Cancer (3 units)

Instructors: Dwayne Stupack, PhD, Professor, Ob/Gyn & Reproductive Sciences, UC San Diego;
Shweta Joshi, PhD, Assistant Professor, Pediatrics, Moores Cancer Center, UC San Diego

Course Description & Learning Objectives: 

An overview of the hallmark biological changes found in tumor cells, the signaling networks that modulate them and an overview of their genetic and epigenetic underpinnings. After completion of this course, students will understand the molecular interactions that provide cancer with its unique characteristics.

Learning Outcomes & Skills Acquired from the Course:

By the end of this course, learners will be able to:

• Recognize immune populations within the tumor microenvironment.
• Critically evaluate new literature
• Access and use online resources
• Understand and assimilate genomic and transcriptomic data.
• Link nucleotide data to biological outcomes.
• Understand major changes in cancer cells that alter their biological properties.
• Understand how different mutations can promote tumorigenesis.
• Be familiar with major pathways mediating disease.
• Understand how molecular pathways create networks.
• Identify molecular similarities between disparate tumor types.
• Evaluate tumors for key drivers of malignancy.
• Understand key concepts and complications of immunotherapy.
• Appreciate the complexity of tumor ecology.

PMTO  203 Companion Diagnostics in Oncology Drug Development: Regulatory Implications and FDA Approval (1 Unit)

Instructor: Ramez N. Eskander, M.D. Professor, UC San Diego SOM & Moores Cancer Center

Course Description & Learning Objectives:

In solid tumor oncology, companion diagnostics (CDxs) are playing an increasingly important role in identifying treatments by enriching for patients who are likely to benefit from a novel drug. The United Stated (US) Food and Drug Administration (FDA) is currently placing a larger emphasis on CDxs development in an effort to ensure safe and effective use of therapeutic products. In 1998, Trastuzumab was the first drug to ever obtain US FDA approval together with a CDx assay examining HER2 expression. Using real world examples (i.e. development of Mirvetuximab Soravtansive and its CDx Folate Receptor alpha expression (FOLR1)) this course will demonstrate the importance of thoughtful clinical trial design and CDx development from the perspective of a clinical trialist. The course will additionally highlight areas of vulnerability during CDx development that can ultimately affect drug approval and access. 

Our understanding of cancer biology has resulted in a dramatic shift in oncology drug development. In an era of “precision oncology” it is critically important to understand how to both design and interpret clinical trials that are focused on enriching patient response. This course is timely and relevant as it will explain CDx development in oncology and regulatory implications with practical clinical examples.

Learning Outcomes & Skills Acquired from the Course:

By the end of this course, learners will be able to:

• Clearly define what a CDx is in oncology drug development.
• Be able to design a clinical trial incorporating a CDx.
• Explain to both colleagues and patients what a CDx “means” in cancer care.
• Discuss limitations to CDx development in oncology
• Understand the definition of a CDx from a regulatory perspective
• Define the differences between US FDA and European Medicine Agency (EMA) approach to CDx development
• Incorporate US FDA guidance documents in drug development and clinical trial design (what is a high risk, class III device?)
• Understand regulatory implications of developing a CDx. Does the CDx have to be approved for the drug to be approved?
• Pragmatic approach to clinical trial design, with predictive biomarker assays to enrich the clinical population with responders
• Understand prospective-retrospective study design for CDx development with clinical examples
• Describe how do CDxs fit into accelerated approval drug development programs

PMTO 204 Analytical Approaches to Precision Cancer Medicine: Data, Models, Systems, and Paradigms (3 Units)

Instructors: Pablo Tamayo, PhD, Professor, UCSD Genomics and Precision Medicine Division, Department of Medicine, Moores Cancer Center and Center for Novel Therapeutics;

William Kim (external advisor), Assistant Professor, Yale School of Medicine.

Course Description & Learning Objectives:
The overarching goal of this course is to provide a conceptual framework and an overview of analytic approaches relevant to precision cancer medicine models, systems, and paradigms. The course will introduce diverse types of relevant data including clinical, genetic, genomic, cellular, and immune profiles that can be used to analyze and characterize cancer samples. It will also provide an overview of various statistical or computational models based on observable or measurable biological indicators, e.g. molecular omics or biomarkers, that are useful to guide therapeutic decisions in cancer treatment. The students will learn about existing, as well as newly emerging systems and paradigms that provide the foundations for current applications and future advances in precision cancer medicine. The course will combine lectures on the relevant background knowledge with hands-on analysis experience through computer exercises, group activities, and homework assignments. Besides the core lectures, there will be invited presentations by precision medicine practitioners at UCSD and other universities to highlight their approaches, philosophy, and experiences. This course aims to be technical and detailed but accessible to a broad audience of students, postdocs, biomedical investigators, clinicians, organization leaders, and principal investigators.

Learning Outcomes & Skills Acquired from the Course:

• The students will learn a unifying information-based analytic framework based on quantifying evidence for predicting outcomes and treatment responses, and specific techniques to evaluate existing approaches and understand emerging paradigms.
• Understand relevant data: clinical, genetic, genomic, cellular, and immune features and the most important resources containing large cohorts of cancer genomics data, tumor profiles, etc.
• Understand models and analytical frameworks: statistical methods, bioinformatics, and computational biology/machine learning techniques relevant to cancer precision medicine.
• Understand the different types of biological and clinical responses, surrogates, and clinical phenotypes relevant to cancer precision medicine.
• Understand the different systems and paradigms for precision medicine in cancer including traditional approaches and emerging, e.g. machine learning and AI-based.
• Become acquainted with the data analysis challenges and barriers to developing and deploying a cancer precision medicine system.

PMTO 205 - Precision Cancer Imaging & Artificial Intelligence Applications (1 Unit)

Instructor: Haydee Ojeda-Fournier, MD, Professor and Division Chief, Department of Radiology, Division of Breast Imaging, UC San Diego Health.

Additional faculty: Sherief H. Gamie, MD, PhD, Division Chief & Medical Director of Nuclear Medicine & PET/CT, Professor of Clinical Radiology;

Rebecca Rakow-Penner, MD, PhD, Assistant Professor Breast and Body Imaging; Tara Retson, MD, PhD, Instructor Breast Imaging
 
Course Description & Learning Objectives:

This course provides a comprehensive exploration of imaging techniques in the context of precision medicine for oncology and infectious diseases. From the fundamentals of various imaging modalities to cutting-edge advancements, the learners will gain a deep understanding of the role of imaging in clinical practice, research, and the development of personalized treatment strategies. The course also examines the application of Artificial Intelligence (AI) development and applications to clinical trials. There will be a focus on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI) and advanced DWI techniques with examples of translational innovations such as Restriction Spectrum Imaging (RSI) for Breast, Ovarian, and Prostate cancer imaging developed at UC San Diego Health. Finally, molecular imaging and applications in clinical trials and research will be covered. Real-world examples, such as the ISPY clinical trial, will be used to illustrate the use of imaging biomarkers in precision medicine. 

This course stands out by bridging the gap between imaging techniques and their application in precision medicine. The focus on AI in clinical trials and the in-depth exploration of advanced imaging methods, such as DWI, RSI, and molecular imaging, sets this course apart from traditional imaging courses. Introduction to the theoretical, technical, and analytical methods for precision cancer diagnosis and for identifying individualized treatments using real-world examples.

Learning Outcomes & Skills Acquired from the Course:

By the end of this course, learners will be able to:

• Develop a strong foundation in the fundamentals of various imaging modalities and understand the principles and applications of X-ray, Ultrasound (US), Magnetic Resonance Imaging (MRI), and Nuclear Medicine Imaging in the context of precision medicine.
• Understand the fundamentals of molecular imaging and its applications in drug development, target identification, and therapy monitoring.
• Become familiar with the principles of MRI and advanced diffusion-weighted imaging techniques for assessing tissue microstructure and cellular properties.
• Acquire the knowledge and skills to identify and utilize imaging biomarkers for precision medicine applications.
• Recognize the importance of imaging biomarkers in patient stratification, disease monitoring, and therapy response assessment. Analyze the ISPY clinical trial as a case study.
• Explore the role of Artificial Intelligence in clinical trials, including image analysis, data integration, and decision support.
• Additionally, students will gain expertise in the application of AI in clinical trials and advanced imaging techniques like DWI and molecular imaging.

PMTO 206 Precision Cancer Diagnosis and Individualized Treatments (2 Units)

Instructor: Lukas Chavez, PhD Associate Professor, SBP Medical Discovery Institute

Course Description & Learning Objectives:

This course is an introduction to the theoretical, technical, and analytical methods for precision cancer diagnosis and for identifying individualized treatments.The course will provide participants with a critical understanding of the methods available for analyzing tumor biopsies to enable precision cancer diagnosis and individualized treatments. Methods include genomic, epigenomic, and transcriptomic characterization of tumors, bioinformatic and statistical analysis of the collected data, AI image analysis of tumor histology slides and MRI scans, and high-throughput cancer drug sensitivity testing. Using real-world examples, it will be demonstrated how the results of these multimodal analyses are used by a molecular tumor board consisting of physicians, pathologists, biologists, and bioinformaticians to identify individualized treatments. Learning objectives include:

• Sequencing methods available for identifying DNA mutations, structural variants, and fusion genes in tumor biopsies.
• Diagnostic yield and limitations of clinical tumor and germline DNA sequencing.
  DNA methylation array technologies and machine learning methods for the molecular classification of tumors based on epigenetic fingerprints.
• Bioinformatics methods, computational tools and statistical analysis of the different -omics data types.
• Digital histopathology and AI methods for predicting cancer biomarkers from histological tumor images.
• High-throughput drug screening in patient-derived tumor cells to determine individualized drug sensitivity.
• Objectives and workflow of a molecular tumor board.
• Critical parameters for precision medicine therapeutics in oncology, such as cost, technical and time constraints, and regulatory conditions including data de-identification and CLIA certification

Learning Outcomes & Skills Acquired from the Course:

Upon completion of the course, students will be able to:

• Critically evaluate a report of DNA mutations and the suggested treatment options.
• Understand strengths and limitations of the different -omics assays and how they relate to each other.
• Identify and explain analysis methods and results of bioinformatics tools for processing the different-omics data types.
• Tumor type classification using DNA methylation array data and interpretation of confidence scores.
• Work with CLIA certified high-throughput drug screening facilities to determine drug sensitivity of patient tumor material.
• Coordinate a molecular tumor board that meets critical parameters for precision medicine therapeutics in oncology.

PMTO 207 - Genomics: Human Somatic and Hereditary Alterations and Cancer (3 units)

Instructors: Shumei Kato, M.D., Medical Oncologist, Associate Clinical Professor of Medicine, UC San Diego Moores Cancer Center;

Sandip P Patel, M.D., Professor, Medical Oncology, UC San Diego Leader, Experimental Therapeutics/ Co-Leader, Solid Tumor Therapeutics, Deputy Director, Sanford Stem Cell Clinical Center, Medical Director, Clinical Research Informatics

Course Description & Learning Objectives:

Along with rapid technological advancement, interrogating genomic alterations among individual cancer patients, such as with next-generation genomic sequencing, is now routinely done. As a result, many actionable molecular targets for cancer treatment emerged that potentially predict the response to both targeted and immunotherapies. Certain germline alterations that are associated with hereditary cancer predisposition syndromes are also rapidly recognized as an important factor for treatment selection.The course will also discuss the conundrum of genomic driver in benign conditions. Upon completion of this course, students will have a better understanding of cancer genomics and its actionability for matching patients with targeted therapy and immunotherapy. 

Learning Outcomes & Skills Acquired from the Course:

After completion of this course, students will acquire the skills to be able to understand:

• The cancer associated genomic alteration in general, as well as how to translate the information for targeted anti-cancer therapy approaches.
• Somatic Alterations in cancer
• Specific somatic mutations that are important for cancer care Oncogenic drivers and benign conditions.
• Hereditary Cancer Predisposition Syndromes
• Linking genomics and immune system biology

PMTO 208 Immunotherapy, Impact of Precision Medicine (Omics and Immunotherapy) on Diagnosis and Treatment (3 Units)

Instructor: Scott M. Lippman, M.D., Distinguished Professor of Medicine, FAS, Adjunct professor at the MD Anderson Cancer Center;

Ezra Cohen, M.D., Chief Medical Officer at Tempus Labs, Inc.

Course Description & Learning Objectives:

Precision oncology aims to optimally select treatment for each patient by first identifying and, subsequently, targeting molecular defects in the patient’s tumor, best matching patients for a given therapy. A greater understanding of the human genome, transcriptome, and proteome coupled with advanced next-generation sequencing, liquid biopsy and AI technology have led to an unprecedented era of personalized therapy. Currently, all approaches for detecting clinically actionable genomic targets in the clinic rely on molecular profiling, creating clinical workflow and precision medicine bottlenecks. The severity and magnitude of this problem clinically was highlighted in a recent high-profile report (Schilsky. NEJM. December 2022), revealing that only ~3% of patients in the US are actually receiving FDA-approved companion diagnostics and precision therapy, leading to suboptimal, ineffective, or inappropriate treatment, disproportionately impacting underserved, resource-constrained clinical settings. This course will cover basic tumor biology, developing personalized therapies, use of predictive biomarkers, limitations, challenges and mechanisms and manifestations of targeted and immune therapy. The former is increasingly complex and challenging given treatment recommendations of treating all patients while only a very low rate of durable clinical benefit and extreme costs, making the importance of immune-checkpoint resistance biomarkers to identify and treat likely responders based on pre-treatment genomic biomarkers. This course will address all of the above aspects and issues of precision medicine development, implementation and uptake in the US and globally and provides an understanding of the clinical application of novel immunotherapy in oncology.

Learning Outcomes & Skills Acquired from the Course:

Upon the completion of this course, students will be able to:

• Have a better understanding of the impact, limitations, and new approaches to enhance precision therapy in oncology and non-oncology settings in standard therapy and clinical trials.
• Learn the process of individualized genome- and immune-directed therapy and biomarker development through specific examples and case studies to better understand the issues facing and challenges surrounding personalized therapy of cancer and other major human diseases, notably infectious diseases.
• Acquire the understanding of genomic testing, targeted therapy and how a specific immune response is generated and the parameters employed in developing personalized immunotherapies as well as predictive biomarkers for current immune drugs.
• Understand the requirements, both scientific and regulatory, to develop precision therapy, including a cellular therapy or vaccine for cancer.
• Develop an understanding of the biology of human immunity and cancer as it applies to developing precision approaches to targeted treatment
• Review recent innovations in immunotherapy in the fields of cell therapy and personalized vaccines
• Review targeted and/or immunotherapy drugs currently in practice or under clinical development, e.g. checkpoint inhibitors, with a focus on mechanisms of sensitivity, resistance, and predictive biomarkers.
• Understand immune responses and immune-related toxicity

PMTO 209 Regulatory and Ethical Framework for Clinical Trials (2 Units)

Instructor: Anthony Magit, M.D., M.P.H., Clinical Professor of Surgery, UC San Diego

Course Description & Learning Objectives:

This course will provide an overview of human subject research with an emphasis on FDA regulations for clinical research and expanded access programs. Lectures and course activities will provide the necessary skills for submitting studies to the IRB and managing ancillary institutional reviews (e.g., Conflict of interest, Radiation Safety, Biohazard Committee). Specific topics will include the application of ethical principles to ensure recruitment strategies and subject accrual address racial, social, economic, and geographic diversity.

Learning Outcomes & Skills Acquired from the Course:

At the conclusion of this course, students will be able to:

• Prepare and submit a protocol for IRB committee review.
• Apply FDA regulations relevant to clinical trials and individual patient care.
• Distinguish between clinical care and research activities in a clinical trial.
• Incorporate study elements to support an inclusive and diverse subject population.
• Recognize and discuss the political and ethical aspects of medical innovation and “first in human” therapies.
• Create consent documents that are subject appropriate.

PMTO 210 - Cell and Gene Therapy (4 units)

Instructors: Alysson R. Muotri, Ph.D. Professor, Dept. of Pediatrics & Cellular Molecular Medicine, UC San Diego School of Medicine | Rady Children’s Hospital, Sanford Consortium;

Dan S. Kaufman, MD, PhD, Professor, Dept. of Medicine, Division of Regenerative Medicine, Director of Cell Therapy program, UC San Diego School of Medicine.

Course Description & Learning Objectives:

Cell and gene therapies are versatile medical approaches that are becoming increasingly popular. CAR-T cells, AAV viral delivery, ASOs, and CRISPR genome editing enzymes are examples of recent advances that are now part of the clinical vocabulary. However, the rapid development of this field and the complexity of these technologies make it difficult to evaluate when the treatments could be beneficial or to decide what patients would qualify. The course is designed to prepare the students with current knowledge of the diverse cell and gene therapy approaches available for precision medicine. Students will be exposed to several situations where cells and gene therapies could (or could not) be used for medical practices, how these protocols evolved over time, the use of different preclinical model systems,and what is the expectation of this technology in the near and long-term future. Finally, students will also learn how to find reliable resources and educational materials and to critically evaluate these treatments around the world.

The focus is on the scientific rationale for the use of diverse cell and gene therapies in precision medicine. We will go beyond the hype and focus on cutting-edge applications while providing the students with examples of useful and failed pre-clinical and clinical trials.

Learning Outcomes & Skills Acquired from the Course:

• Students in this course will learn the most current cell and gene therapies for forward looking clinicians who can bring novel ideas into the clinic.
• Students will become facilitators and industry leaders on these emerging technologies to advise on clinical trials, make decisions to enter into this space and become future scientists to join cutting-edge research labs.

PMTO 211 Precision Medicine to Prevent and Treat Infectious Diseases in Hospitalized and/or Immunocompromised Patients (3 Units)

Instructor: Victor Nizet, M.D., Distinguished Professor & Vice Course Faculty for Basic Research, Department of Pediatrics; Distinguished Professor, UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences; Chief, Division of Host-Microbe Systems & Therapeutics; Faculty Lead, Collaborative to Halt Antibiotic-Resistant Microbes (CHARM)

Course Description & Learning Objectives:

This course will take a translational science based approach to educate current and future health care professionals and researchers on the needs and opportunities for personalized medicine in the treatment and prevention of infectious diseases in hospitalized and immunocompromised patients. This course will give an in-depth review of existing clinical infectious diseases problems and contemporary therapeutic and diagnostic approaches, and their limitations within the hospitalized and immunocompromised patient populations. Cutting-edge translational research moving the management of infectious diseases into the realm of precision medicine will be showcased. This course will move beyond traditional antibiotic therapies, extensively covering science-based alternatives, and proposing paradigm shifts in how we think about restoring the health of patients suffering infectious diseases. Highlighted will be the expanding global health crisis of antibiotic resistance, current and future pandemic threats, leveraging emerging technologies and big data science, and next-generation modalities such as bacteriophage therapeutics and nanomedicines.

Our course will focus on the science underpinnings and clinical feasibility of next-generation treatments that go beyond and complement our current antibiotic arsenal. UC San Diego faculty will showcase the cutting-edge therapies and antibiotic resistance solutions currently happening in leading academic medical centers worldwide to move infectious disease treatment into the realm of precision medicine, reinforcing key points with their own research knowledge and discoveries.

The objectives of this course are to:

• Understand the unique susceptibility of oncology patients and the challenge to prevent and treat their infections.
• Understand the need for precision therapeutics for infectious disease in immunocompromised patients.
• Understand the scope and effectiveness in contemporary clinical infectious disease therapeutics, as well as their key limitations.
• Consideration of the innovative scientific solutions poised to bring personalized medicine into infectious disease therapeutics.
• Discuss the potential of personalized medicine approaches to optimize patient outcomes in infectious diseases and reduce future antibiotic resistance.

Learning Outcomes & Skills Acquired from the Course:

Students in this program will gain foundational skill sets that allow them to apply their learning to careers in the broadest infectious disease context, including clinical, technological, research, and educational settings. Student groups will apply knowledge gained through lectures and discussions in practical exercises to apply the concepts of personalized medicine toward novel approaches for infectious disease therapeutics or diagnostics.

PMTO 212 Clinical Trial Drug Development in Oncology (3 Units)

Instructors: Joseph Ma, PharmD Professor, Clinical Pharmacy, SSPPS, UC San Diego; Andrew Chang, PharmD, Ph.D. Lumanity Executive Consultant, Medical Affairs Consulting;

Kenneth A. Kern, M.D., Executive Medical Director; Early Development Head, and Global Clinical Lead, Division of Early Oncology Drug Development and Clinical Research, Pfizer Inc.

Course Description & Learning Objectives: 

Clinical trials of experimental therapeutics are a significant element of drug development. Current regulatory authorities require the initiation and completion of clinical trials to evaluate safety, tolerability, and efficacy. Each subtype of a clinical trial has a specific objective and/or endpoint. Precision medicine has the ability to impact traditional clinical trial design. This course will focus on the impact of precision medicine primarily on oncology and contrast with non oncologic clinical trials study design that is required and/or needed for regulatory approval for investigational agents.

This course provides an understanding of all the stages of drug development clinical trials such as:

• Phase 0, Phase 1, drug-drug interaction, drug-food interaction, and bioequivalence trials. Genomically driven trial design and classic clinical trial design: Phase II, III and IV studies
• Immunotherapy trial design
• Precision prevention/interception

Learning Outcomes & Skills Acquired from the Course: 

Upon completion of this course, students will have a better understanding of precision medicine impact on oncology and non oncology clinical trials. Students will learn the process of drug development through specific examples of case studies to better understand the issues facing the challenges of delivering a new drug on the market. 

Students will learn how to:

• Identify outcomes and/or endpoints differences between oncology and non-oncology clinical trial types.
• Incorporate precision medicine impact on study design methods for consideration in the design of clinical protocols to assess safety, tolerability, and efficacy in multiple therapeutic areas. 
• Understand the challenges and bias related to the conduct of clinical research and/or clinical trials in the era.

PMTO 213 Clinical Pharmacology and Regulatory Sciences in Precision Medicine (2 Units)

Instructor: Jeremiah Momper, PharmD, PhD, Professor, Skaggs School of Pharmacy and Pharmaceutical Sciences, UC San Diego

Course Description & Learning Objectives:

This course will provide a comprehensive overview of current regulatory filings during pre-clinical and clinical development, including Investigational New Drug Applications and New Drug Applications as related to precision medicine in oncology. Unique challenges in developing unique therapeutic treatments, such as CART-cell therapies, therapeutic vaccines, gene therapy and immunotherapy will also be covered. In addition, pharmacogenomic data in drug development and enrichment strategies for clinical oncology trials will be covered.

Students will:

• Examine the role of pharmacogenomics in precision medicine including variability in drug disposition and response
• Describe regional differences between the EMA and FDA
• Explain the role of companion diagnostics in precision medicine
• Understand enrichment strategies in clinical trials
• Discuss regulatory aspects of clinical trials in the drug development landscape

Learning Outcomes & Skills Acquired from the Course:

Upon the completion of this course students will have a thorough understanding of the regulatory requirements for drug development in oncology, as well as novel tools, standards, and approaches to assess the safety and performance of precision cancer therapeutics.

PMTO 214 Drug Commercialization in the Era of Precision Medicine Therapeutics (2 Units)

Instructor: Williams Ettouati, PharmD, Executive Advisor, Graduate Programs, Office of the Vice Chancellor of Health Sciences, UC San Diego, Health Sciences Associate Clinical Professor, N.S.

Course Description & Learning Objectives:

This course will provide a comprehensive overview of pharmaceutical marketing strategies and specific trends in commercializing precision medicine therapeutics. The course will cover marketing mix considerations; strategies for gathering customer insights through market research; how marketing has evolved from a linear system to an interconnected system; interaction and considerations for marketing with other internal departments or external agencies.

This course will provide students with key knowledge to understand the unique challenges comparing traditional marketing strategies “one size fits all” with drug products tailored to an individual’s genetic and proteomic such as precision medicine therapeutics. A flip classroom structure will use case studies throughout to emphasize learning points, foster active learning, in class discussions and give students the opportunity to apply the skills they will be learning throughout the course. In addition, students will work in teams to apply knowledge gained through lectures, homework, and discussions and develop a marketing plan on a drug selected by the instructor.

Students in this course will:

• Assess what pharmaceutical marketing means in today’s environment.
• Understand the complexity of marketing precision medicine therapeutics to health care professionals.
• Examine requirements for increasing market utilization of precision medicine therapeutics and diagnostics by payers across major global markets.
• Students will create a marketing plan applying all the skills they learned throughout the course to illustrate a firm understanding of market strategy, brand planning, market research principles, segmentation, product differentiation and evaluation of marketing effectiveness.

Learning Outcomes & Skills Acquired from the Course:

Upon the completion of this course students will be able to have a better understanding of the commercialization peculiarities of marketing a new drug in the field of precision medicine, addressing patients, HealthCare professionals and payers.

Students will understand:

• What is involved with the marketing of precision medicine therapeutics in the US and Europe
• The role of strategic marketing in a product’s life cycle success
• Markets, segmentation, targeting and product positioning product
• How to define sustainable competitive advantages.
• Brand positioning and how to engage the audience through branding..
• Gain market access and demonstrate the value of the product.
• Drug product pricing, forecasting, and reimbursement.

PMTO 299 - Capstone Project (2 Units)

Instructor: Raphael E. Cuomo, Ph.D., M.P.H., Associate Professor, UC San Diego School of Medicine, Associate Member, Moores Cancer Center, Member, Altman Clinical and Translational Research Institute

Course Description & Learning Objectives:

The capstone course PMTO 299 serves as the culmination of the MAS program in Precision Medicine Therapeutics in Oncology, offering students a unique opportunity to apply and integrate the knowledge and skills they have acquired throughout the program's courses. Students will focus on a real-world problem or clinical scenario in the field of oncology therapeutics, demonstrating an understanding of the practical applications of precision medicine and its potential impacts on patient care.

Unlike a traditional thesis, this capstone project emphasizes practical experience and direct applications, allowing students to tackle real-world challenges in precision medicine therapeutics in oncology. Students will work under the guidance of a faculty mentor, beginning their projects seven months prior to enrolling in the capstone course, ensuring thorough preparation and project development.

Learning Outcomes & Skills Acquired from the Course:

• Critical Analysis and Problem-Solving: Ability to critically analyze, evaluate, and solve real-world problems or clinical scenarios in the field of oncology therapeutics.
• Integration and Application of Knowledge: Ability to synthesize and apply knowledge and skills from various courses within the program to a practical context.
• Project Management and Organization: Skills in planning, managing, and executing a comprehensive project from concept to completion, demonstrating self-direction, organization, and time management.
• Research and Information Literacy: Capability to review, interpret, and integrate scientific literature, both from academic and industry sources, into the capstone project.
• Communication Skills: Proficiency in clearly and effectively communicating complex scientific concepts, both in written and oral forms.
• Ethical Awareness: Understanding of the ethical, legal, and social implications related to the application of precision medicine in oncology.
• Collaboration and Mentorship: Experience working with a faculty mentor and understanding how to leverage expertise and guidance to enhance project outcomes.
• Practical Understanding of Precision Medicine: Gain an in-depth understanding of the real-world applications, challenges, and implications of precision medicine in oncology.