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. Explain the biological and pharmacological basis of substance dependence and the mechanisms of commonly abused drugs, including opioids, cannabinoids, psychedelics, amphetamines, and related agents
2. Differentiate between substance use, misuse, abuse, and dependence, and analyze their public health implications
3. Apply best practices for prescribing opioids for acute and chronic pain, including initiation, titration, tapering, and opioid-sparing strategies
4. Develop evidence-based treatment strategies for opioid use disorder and withdrawal management
5. Interpret urine drug tests and Prescription Drug Monitoring Program data to inform clinical decision-making
6. Identify and manage toxicity and overdose from known and unknown substances of abuse
7. Evaluate patterns of misuse in specific populations (e.g., athletes, students) and apply preventive strategies

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.

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. Describe the laws and regulations associated with drugs, biologics, and medical devices in the United States
2. Justify the importance of regulatory affairs in Life Sciences
3. Develop a meeting and communication strategy for interacting with the FDA and submitting appropriate documentation
4. Analyze the regulations that impact drug and biologics development, dietary supplements, medical devices, and diagnostics
5. Analyze and compare nonclinical and clinical product development

Scientific process of drug development from discovery through clinical trials. Brief history of drug development, along with an overview of drug discovery, preclinical, and clinical activities that take place during development. Application to real-world drug development scenarios and challenges, especially as they apply to development of drugs to treat neurological diseases.

Primary Domain: Drug Development
Secondary Domain: Program Management

LEARNING OUTCOMES:

1. Provide historical context for the modern drug discovery and development process.
2. Describe the high-level goals and activities that take place during discovery, preclinical development, and clinical development and the different functional areas that perform this work.
3. Apply the knowledge learned throughout the course to address specific drug development scenarios.
4. Propose novel strategies to address current drug development challenges.
5. Evaluate scientific literature and regulatory documents to find important information about specific drugs.

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.

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). The first course explores how chemical properties influence molecular targets in the central nervous system (CNS), how altered signaling drives physiological changes, and how cholinergic and glutamatergic pharmaceuticals improve patient outcomes. This course also develops skills in primary literature analysis to enable conceptual integration of information across chemical, molecular, cellular, systems, and societal levels. The second course applies knowledge regarding the molecular and anatomical factors that influence the actions of central nervous system active drugs to understand the medical applications of drugs acting on the GABAergic, adrenergic, dopaminergic, serotonergic, and opioid systems. Additionally, the second course develops written communication skills regarding the integration of chemical, molecular, cellular, and systems information to explain the discovery, development, and applications of these compounds.

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. Describe the major neurotransmitters of the central nervous system, including their physiological role, distribution, synthesis, storage, and release
4. Recall the principal mechanisms by which receptors affect cellular signaling in the CNS
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
11. Assess challenges to development and use of psychoactive pharmaceuticals that are either shared across major neurotransmitter systems or unique to specific classes of drugs

Explores basic ethical issues associated with biomedical science research and application, particularly as pertains to the development and marketing of drugs and emergent pharmaceutical therapies, such as psychoactive-assisted therapies in the context of regulatory, safety, and legal concerns.

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. Apply Deontological and/or Utilitarian arguments to examine personal moral values and use personal experiences to evaluate positive and negative features of current Psychedelic research, access, and use
2. Explain how socially responsible scientific practices can be used in scientific and medical research, scientific communication, and intellectual property, and whether these practices address societal goals beyond advancing scientific knowledge
3. Describe elements of proper scientific conduct, the institutional oversight that regulates scientific conduct, and whether these elements are grounded in optimizing research outcomes or following Bioethics Principles
4. Identify best practices for clinical research by evaluating the costs and benefits of actions necessary to ensure patient safety, reliable data, and public benefit
5. Explain the elements of misconduct in scientific literature and publishing. Give examples of how this misconduct causes harm to both scientific reputations and public health

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 neural mechanisms of the therapeutic effects of serotonergic psychedelics, focusing on how the actions of these drugs at specific serotonin receptor subtypes might couple to cellular, network, and behavioral effects, and how these mechanisms intersect with current models of the neural basis of perception, cognition, and consciousness.

Primary Domain: Drug Development

Directed study projects as arranged with a faculty member.

Primary Domains: Clinical Application / Program Management

Key concepts and body of knowledge of Project Management (PM) applied to the specifics of the drug development process. PM theory and language. The life cycle of a project: Initiating, Planning, Executing, Monitoring and Control, and Closing. Predictive, adaptive and hybrid PM frameworks and tools. Project Charter, statement-of-work, scope of work, work-breakdown structure, project network and timelines. Critical path method and earned value analysis to adjust schedules, allocate resources, and implement corrective actions. Risk management in pharmaceutical projects. An overview of documents management and decision-making strategies.

Primary Domain: Program Management
Secondary Domain: Drug Development

LEARNING OUTCOMES:

1. Explain the concepts, principles and language of PM and its impact and role in the drug development process
2. Describe the functions of a Project Manager in general and within the drug development process (pre-clinical and clinical phases).
3. Compare and contrast different frameworks and tools of PM to make informed decisions on tailoring the PM approach to suit the project needs.
4. Develop a project charter, statement-of-work, scope of work, work-breakdown structure, a resource-loaded timeline, and a project plan.
5. Apply the critical path method and earned-value analysis to track progress and forecast outcomes against a project’s plan baseline.
6. Weight proper corrective measures according to earned-value analysis forecast methods, to ensure a project’s outcomes and deliverables.
7. Implement risk identification, mitigation and management strategies during project planning (pre-mortem), life cycle, and project closeout (post-mortem).
8. Consolidate the PM concepts and principles studied during the course by developing a Project Plan as Final Project.

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

Explores business aspects of pharmaceutical product development and post-approval product maturation. Covers startup financing, risk management, intellectual property considerations, supply chain management, and strategic decision-making, as applied to both large and small pharmaceutical companies.

Primary Domain: Program Management

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