About

A history of medicinal substances and dangerous drugs in wider context, with a focus on gender, race, class, business, and other analytical categories. “Medicines” and “drugs” change over time — and concepts of risk, danger, legality, and even scientific evidence are elastic. Histories of laws, regulations, and key historical actors, as well as specific drug biographies, will be provided.

Primary Domain: History and Humanities
Secondary Domains: Clinical Application, Drug Development

LEARNING OUTCOMES:
1. Outline the key theoretical issues in history of medicine and drugs.
2. Explain the relationship, including explanatory models of change, between specific medicines and drugs and society.
3. Assess critically the historiographies of the history of medicine.
4. Evaluate the reputations of specific medicines, medicinal substances and drugs.
5. Communicate effectively conclusions regarding the history of medicines and drugs
6. Apply historical understandings to contemporary issues regarding drug regulation and political conflicts.

Discusses federal statutes and regulations related to drug manufacturing, drug distribution, and drug use, with an emphasis on drug scheduling and controlled substances. Describes the governmental framework within which pharmaceutical development is regulated and practiced. Covers statues and regulations protecting human subjects’ privacy and autonomy in research.

Primary Domain: Program Management
Secondary Domains: Drug Development, Clinical Application

LEARNING OUTCOMES:
1. Identify and describe the major federal statutes and regulations affecting use of controlled substances
2. Identify potential legal problems in use and handling of controlled substances before they may occur
3. Apply knowledge of the statutes/regulations to various research setting
4. Locate and identify reputable sources of legal information

Discusses the biological and pharmacological basis of dependence of substances of abuse. Teaches the skills required for best practices in prescribing agents of abuse. Drugs of abuse covered include opioids use for acute and chronic pain, in addition to other abused substances such as cannabinoids, psychedelics, amphetamines and related agents. Students will learn appropriate methods of therapeutic tapering and treatment of withdrawal, as well as the treatment of known and unknown agent overdose. Teaches skills in interpreting and responding to findings of urine drug tests and the prescription drug monitoring database.

Primary Domain: Clinical Application
Secondary Domain: History and Humanities

LEARNING OUTCOMES:
1. Demonstrate knowledge about the neuro-and psycho-pharmacology of substance dependence
2. Define and distinguish between substance use, misuse, abuse and dependence
3. Explain the public health implications of substance misuse
4. Identify optimal treatment of patients with chronic, malignant pain, including management, alternative opioid-sparing approaches, and how to address opioid use disorders
5. Interpret urine drug tests and the Prescription Drug Monitoring Program, and create patient treatment plans based upon these findings
6. Understand pharmacology, appropriate use and misuse of CNS stimulants and CNS depressants
7. Identify the symptoms of toxicity from overdoses of abused drugs
8. Manage patients admitted with toxicity from overdoses of abused drugs
9. Anticipate the agents of misuse in specific populations as athletes and students

Overview of the science behind therapeutic use of psychedelic drugs such as psilocybin and LSD; basic medicinal chemistry of the tryptamine and phenethylamine psychedelics, as well as the neurochemistry and neuropharmacology of their action. Fundamentals of drug development and FDA approval process; Standards of screening and guiding individuals before and during a therapeutic psychedelic session contrasted with the recreational use of these drugs; Appraisal of current clinical research including an objective analysis of risk/benefit for indications such as depression and addiction. History of traditional, ceremonial use of psychedelics, as well as the relationship between recreational use and attempts to regulate and restrict their use. Role of psychedelics in indigenous cultures, impacts of psychedelic tourism and wild-crafting of plants and animals on indigenous peoples. Contrasts in psychedelic treatments to other therapeutic interventions such as mindfulness and meditation.

Primary Domain: Clinical Application
Secondary Domains: History and Humanities, Drug Development

LEARNING OUTCOMES
1. Describe the roles of psychedelic compounds in the traditional rituals of indigenous peoples, and the impact of psychedelic tourism upon these native societies and their environment.
2. Describe the history and rationale for the regulation and prohibition of these compounds in the past century.
3. Describe the similarities between efforts to decriminalize cannabis and psychedelics, including pros and cons for each position.
4. Describe the path by which psychedelic drugs may be proposed to the FDA for approval drugs, and rescheduled by the DEA.
5. Identify the basic chemical structures of the most common psychedelic tryptamines and phenethylamines, and their usual pharmacologic targets in the brain.
6. Describe and critique examples of the research literature on the human use of psilocybin and LSD for the treatment of diseases such as depression and substance abuse disorders, including proposed metrics of effect.
7. Describe the usual screening, preparation, and care of a subject receiving psilocybin, and the expected skills, training, and role of the attending clinicians.
8. Describe the relationship of psychedelic treatment to other methods of care such as meditation, mindfulness, and cognitive behavioral therapy.

Provides an overview of the history, botany, and legal policies of cannabis and examines cannabinoid pharmacology and the most common therapeutic applications. Assessment of cannabinoid therapy with an emphasis on evaluating the risks and benefits of cannabinoid therapy for these conditions, product and dose regimen selection, monitoring and titration.

Primary Domain: Clinical Application
Secondary Domain: Drug Development, History and Humanities

LEARNING OUTCOMES:

1. Describe the role of the endocannabinoid system in human disease.
2. Identify appropriate cannabinoid use in various disease states.
3. Describe the mechanism of action of THC and CBD on several body systems and disease states.
4. Explain the pharmacology of THC and CBD.
5. Describe common / serious drug interactions and adverse effects of cannabis therapies and methods for preventing or minimizing their occurrence.
6. Analyze and present primary and lay literature regarding cannabinoid therapy.

This two-course series provides a foundational understanding of how chemical features can influence the biological activity of a molecule on molecular targets within the central nervous system (CNS), how alteration of signaling through these targets occurs and leads to physiologically relevant changes, and how major classes of pharmaceuticals acting on the central nervous system are applied in healthcare settings to improve patient outcomes. Integration between concepts arising at the chemical, molecular, cellular, systems, organism, and societal levels will be explored.

Primary Domain: Drug Development
Secondary Domains: Clinical Application

LEARNING OUTCOMES:
1. Identify CNS active drug classes and origins of psychoactive drugs, based in part on structural aspects of the molecule
2. List physicochemical properties of drugs that influence their ability to access the CNS
3. Recall anatomical structures and molecular machinery that influences drug access to and efflux from the CNS
4. Describe the major neurotransmitters of the central nervous system, including their physiological role, distribution, synthesis, storage, and release
5. Recall the principal mechanisms by which receptors affect cellular signaling in the CNS
6. Compare and contrast the actions of psychoactive pharmaceuticals on different signaling systems within the CNS
7. Recognize the psychiatric conditions and target symptoms of these conditions that are commonly treated with psychoactive pharmaceuticals
8. Explain how the use of psychoactive pharmaceuticals fits in with other non-pharmacologic approaches to clinical care for psychiatric conditions
9. Describe common / serious adverse effects of psychoactive pharmaceuticals and methods for preventing or minimizing their occurrence
10. Match psychoactive pharmaceutical agents to the psychiatric conditions they are commonly used to treat

Familiarizes graduate students with basic ethical issues associated with biomedical science research, taught via a case study approach. Content structured to meet NIH and NSF requirements for Responsible Conduct of Research (RCR) training.

Primary Domain: Program Management
Secondary Domains: Clinical Application, History and Humanities

LEARNING OUTCOMES:
Evaluate ethical issues and the responsible conduct of biomedical clinical and translational research spanning the following topic areas:
1. Research misconduct and policies for handling misconduct
2. Ethical consideration for human subjects and role of institutional review boards
3. Ethical consideration for live vertebrate animal subjects in research
4. Mentor/trainee responsibilities and relationships
5. Data acquisition and laboratory tools
6. Data management, sharing and ownership
7. Conflict of interest (personal, professional, and financial)
8. Responsible authorship, peer review, and publication
9. Intellectual property
10. Collaborative research

Overview of the drug development process from target identification, development, preclinical studies, clinical trials to post approval monitoring. Small and Large molecules (biologics) will be covered along with a basic coverage of regulatory authorities. Brief history of drug development as well as case studies that offer insights into the development and approval process. Comprehensive overview of the process of drug development, some of the decision-making logic, the vocabulary, and the ability to communicate within the industry.

Primary Domain: Drug Development
Secondary Domain: Program Management

LEARNING OUTCOMES:
1.Describe the overall steps involved from product discovery to final market approval and the ultimate goals and deliverables during each of these steps.
2.Explain the role of and deliverables expected from the various scientific disciplines involved in the drug development process
3. Describe the processes and requirements for making and characterization drug substance and drug product
4. Understand key differences in the drug substance and drug product development process and characterization for small molecules versus biotherapeutics.
5. Know the different stages of clinical development and what activities take place during the different phases.
6. Recognize and describe important clinical considerations when developing a clinical trial plan, clinical pharmacology plan and biomarker and companion diagnostics plan.
7. Describe and appreciate the type of information that goes into an FDA IND and NDA or BLA submission and how this is represented in the drug label.
8. Apply the above learnings to 1) predict the next steps in a molecules life cycle, 2) troubleshoot common issues that arise during development, 3) consider ways to innovate processes and 4) assemble sections of a mock IND or NDA/BLA.

Identifies and examines the key regulatory agencies and practices that govern the highly regulated and diverse biotechnology industry, both domestically and internationally. Highlights current and emerging FDA and ICH regulations and guidance documents to successfully navigate meeting with the agencies and to submit required documentation for successful product development.

Primary Domain: Drug Development
Secondary Domain: Program Management

LEARNING OUTCOMES:

1. Identify which specific regulatory pathways apply to different aspects of drug approval in the US.
2. Associate these regulations with actions to be taken in the different phases of drug development and post approval commitments.
3. Apply this knowledge to address various regulatory challenges and obstacles that occur during the long process and with the varying phases of drug development.

Provides an introduction to key terminology and lays a foundation of the critical body of knowledge project team members must master in a contemporary drug development enterprise. The latest project management theory is integrated with practical techniques and tools so that course participants learn to properly manage and schedule quality, budget, and progress objectives. Provides an overview of the economic structures, management and policy issues that drive and challenge the pharmaceutical and biotechnology industries.

Primary Domain: Program Management
Secondary Domain: Drug Development

LEARNING OUTCOMES:
1. Explain core concepts and definitions of project management
2. List the nine knowledge areas defined by the Project Management Institute
3. List the five process groups defined by the Project Management Institute
4. Explain project planning and execution
5. Describe project risk management
6. Compare and contrast the cost structure of these dominant market players with a focus on the management and economics of the powerful R&D process and its relationship to an ever-changing technological environment and innovation dominance
7. Explain the role of government regulation on these industries, as well as the ethical issues and challenges these industries face.

Provides the experience and skill to find, read and critically analyze scientific and regulatory literature in the field of drug discovery and development.

Primary Domain: Drug Development
Secondary Domains: Clinical Application, History and Humanities

LEARNING OUTCOMES:
1. Know where to search for appropriate primary literature and guidance documents associated with drug discovery and development.
2. Critically analyze primary research literature, guidance documents and investigative journalism in the field of drug discovery and development.
3. Succinctly and accurately communicate the merits and limitations of primary drug discovery and development research publications, guidance documents and investigative journalism.
4. Become comfortable and confident communicating in a team setting and online environment.

Study of the interactions between human cultures and plants. Topics include: traditional resource management and agriculture; crop domestication, evolution, and conservation; archaeobotany; indigenous knowledge; folk taxonomy; plants in symbolism and religion; dietary patterns; phytochemistry; global movement of plants and peoples.

Primary Domain: History and Humanities

Course designed for the biomedical researcher. Topics include: descriptive statistics, hypothesis testing, estimation, confidence intervals, t-tests, chi-squared tests, analysis of variance, linear regression, correlation, nonparametric tests, survival analysis and odds ratio. Biomedical applications used for each topic.

Primary Domain: Program Management

A history of psychedelics in the U.S. and more globally. Read texts that were formative in the development of the history of psychopharmacology, pharmaceuticals, and the “war on drugs.” Examine readings that represent different themes, subfields, or areas of research interest within the history of psychedelics (medicine & science). Beyond biomedicine, types of analysis include: consumerism, class, ethnicity, gender, and military history. Histories of laws, regulations, and key historical actors, as well as specific drug biographies, will be provided.

Primary Domain: History and Humanities

Explore the mechanisms of action of classical psychedelics in the brain, including their effects on the neural basis of perception, cognition, and consciousness, and how these actions underlie their success as pharmacological adjuncts for treating psychiatric disorders such as depression, anxiety, and substance use disorder.

Primary Domain: Drug Development

Directed study projects as arranged with a faculty member.

Primary Domains: Clinical Application / Program Management

Quantitative aspects of drug absorption, distribution, metabolism, and excretion. Philosophy and applications of pharmacokinetic modeling and its use in clinical practice.

Primary Domain: Clinical Application

Summation of core coursework to a real-world project and/or internship experience. Synthesis of knowledge, skills and abilities to demonstrate aptitude for careers in respective industries.

Primary Domain: Drug Development