Master's Degree in Drug Development & Product Management

Curriculum

The master’s degree in Drug Development & Product Management focuses on building the managerial, regulatory, and pharmacoeconomic skills and insight to equip graduates to effectively lead the complex facets of the drug development process from discovery-to-patient.

Program Format

The master’s degree in Drug Development & Product Management consists of 72 quarter units of study over six quarters. It is a two year program which provides 36 units of general courses and 24 units of professional specialization courses.  In the final quarter of study, students participate in 12 units of on-site practice internship work with an industry sponsor.

Students enter the program fall quarter (September).

Students attend class fall, winter, and spring quarters. During the second year of study there is a Comprehensive Exam between winter and spring quarter.

Scheduling of Classes:
  • Classes will be held Tuesdays/Wednesdays/Thursdays between 4:00pm – 8:00pm
    (Schedule Subject to Change)
The portfolio of course offerings includes:

Program Course Offering Overview (PDF)

Course Descriptions

Fall Quarter

Opportunities in Pharma, Biotech and Managed Care - 1 units - DDPM - 200

This course is taken fall quarter of the first year.

Biotech, Pharmaceutical and Managed Care companies are facing complex issues that are increasingly challenging and constantly evolving. Healthcare reform, changes in technology, government policy, and consumer expectations are revolutionizing relationships among key stakeholders, thus impacting operations in a multitude of ways.  One of the most crucial questions facing companies is identifying talented people with leadership skills needed to navigate this complex and changing landscape.

The objectives of this course are to
i.              Provide an overview of the range of post MS career opportunities, and
ii.            Introduce critical skill sets that are essential for success within this industry

Students will learn and hear from industry executives about the wide range of career opportunities that exists from clinical trials to managed markets.  In addition, the course will introduce skill sets that will form a foundation for students to apply and hone throughout the two-year curriculum.


Pharmacotherapy and Diseases - 3 units - DDPM - 201

This course is taken fall quarter during the first year.

This course is designed to provide students an introduction and survey of pharmacological concepts, constructs and essential considerations necessary through the multiplicity of stages in new drug design, development, testing and therapeutic trials and testing.  The course presents a core body of knowledge in pharmacology and toxicology to students with varying academic backgrounds of didactic and/or experiential learning and experiences. Such a body of knowledge should enable future managers to better guide their efforts in drug discovery and clinical testing. This course will seek to “segment” the issues and challenges in new drug design based on known pharmacological and pharmaco-therapeutic principles and knowledge.

Specific topics in the course include:

  • Origin, history and basic principles of pharmacology, pharmacokinetics and toxicology.
  • Cardiovascular and cardiac pathophysiology.
  • Pulmonary and immunology.
  • Cancer and growth dysfunctions.
  • Behavioral and sensory disorders.

Pharmaceutics for Small Molecules and Macromolecules - 4 units - DDPM - 202

This course is taken fall quarter of the first year.

The course has the following key objectives to:

  1. Examine the systemic bioavailability of drugs following various routes of administration and the bioequivalence of drug products.
  2. Delineate the physiologic processes determining the rate and extent of drug absorption.
  3. Summarize the physicochemical properties of a drug and the formulation factors influencing the rate and extent of drug absorption.
  4. Present the pharmacokinetic principles used to summarize and predict the time course of drug in the body.
  5. Understand the process used by companies to take a newly identified drug candidate to a commercial product pre-formulation, excipients, manufacturing, and packaging.
  6. Be able to evaluate and select an appropriate dosage form, including:
    1. understanding the chemical, physical chemical and physiologic,
    2. barriers that must be considered in the design of the dosage form,
    3. understanding the processes used to manufacture the dosage forms,
    4. being aware of the critical factors associated with the integrity of dosage forms.
  7. Become familiar with devices and formulations being used to effectively administer drugs.

Descriptive elements of the course are outlined below:

  • Introduction to topic (vocabulary and definitions) and team projects
  • Regulatory agencies/considerations/global
  • The Drug (API overview) – Small molecule and biologics
  • Excipient functionalities
  • Preformulation studies
  • Site of administration to systemic circulation
  • Oral absorption: anatomic and physiologic considerations
  • Capsules, tablets, manufacturing (including laboratory)
  • Systemic exposure and assessment of drug absorption
  • IV/invasive delivery
  • Sterility considerations
  • Extravascular administration
  • Repeated dosing/accumulation
  • Novel delivery formulations and systems (SR, ER, )
  • Issues and regulatory perspectives in BA and BE
  • Pharmaceutic considerations for generics/Biosimilars
  • Stability
  • SISPQ
  • Dissolution (as related to bioequivalence)

Pre-Clinical and Clinical Regulatory Submissions & Strategy - 4 units - DDPM - 203

This course is taken fall quarter of the first year.

This course provides an overview of the common regulatory filings during pre-clinical and clinical development, including Investigational New Drug Applications and New Drug Applications.  Using a case study format, the student will gain an understanding of the regulations governing pharmaceutical and biologic products in the United States and globally. The process of writing multidisciplinary reports and submissions to regulatory agencies is reviewed.  Generic drug regulation is also being explored.

The course objectives are:

  • Describe the timeline of regulatory submissions to move drug products and biologics toward approval.
  • Examine key elements for successful regulatory filings, including INDs, BLAs, NDAs, sDNAs.
  • Understand the role of project managers and other regulatory professionals in the drug development process.
  • Conduct case studies to illustrate the potential pitfalls in interacting with regulatory agencies in the United States and abroad.
  • Understand harmonization of the drug development process from a global perspective.

Challenges & Needs in Therapeutic Areas in Drug Development - 4 units - DDPM - 205

This course is taken fall quarter of the second year.

This course will evaluate drugs that are currently in clinical development and examine the possible impact on unmet medical need compared to drugs currently approved. The course will analyze the shortcoming of the drug discovery and development approach using different models such as reversing the experimental pipeline by starting in humans for target identification and validation, then moving to animal models for target engagement, which could improve the drug development process. Many UCSD Health Sciences Faculty have both research and clinical understanding of diseases in the lab and in the clinic and will participate in teaching this course exposing students to many leading-edge research and development projects conducted to improve disease treatments and patient outcomes.

The course will concentrate on key disease areas of interest to the pharmaceutical and biotech industry such as oncology, cardiovascular diseases, metabolic disorder, immunology, central nervous system diseases and infectious diseases.


Foundations of Project Management - 4 units - DDPM - 207

This course is taken fall quarter during the second year.

Using multiple case studies and real-world examples, this course describes the complexity of today’s project management in a global drug development effort.  We discuss how the underlying risk markets are very challenging to manage drug development and how project management can help mitigate risk. We then define project success and how different types of projects may emphasize different dimensions of success. A phased approach to projects is introduced for structure and consistency. Discussions cover Project Planning and Scheduling Essentials: Critical Path and Schedule Risk Management.  The course then closes with an in-depth coverage of project execution issues, including managing teams, meetings, and the psycho-social issues of project management.

Key objectives of the course include:

  • Communicate the key role of project management in the drug development success.
  • Describe how project portfolio management guides the drug development effort to make it more efficient and effective.
  • Learn the central project management concepts of critical path and critical chain planning and scheduling as well as detailed methods/tools that help implement these concepts.

Managed Markets – Post Marketing Drug Utilization Management - 4 units - DDPM - 211

This course is taken fall quarter of the second year.

This course provides an overview of U.S. Managed care system and will teach how to navigate the system to successfully launch new drugs in a managed care environment


Winter Quarter

Clinical Trial Development from Phase 0 to Phase 3 Studies - 4 units - DDPM - 204

This course is taken winter quarter of the first year.

At the completion of this course the students will be able to have a better understanding of early stage clinical drug development.  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. It also includes legal and ethical regulations that apply to drug development.

The course objectives will be to:

  • Provide 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.
  • Identify outcomes and/or endpoints differences between a Phase 0 Phase 1 vs. drug-drug interaction vs. bioequivalence trial.
  • Incorporate study design methods for consideration in the design of clinical protocols to access safety, tolerability, and efficacy in multiple therapeutic areas.
  • Understand the challenges and bias related to the conduct of clinical research and/or clinical trials.
  • Develop clinical plan from POC trials Phase 2 to pivotal trial Phase 3.

Health Outcomes Evidence - 4 units - DDPM - 213

This course is taken winter quarter of the first year.

This course examines the breadth of data and study types that build evidence of a product’s value from potential estimates during the early development stages through to post marketing actual value realized over time in various populations.

The course objectives are to:

  • Review common sources of health outcomes evidence including clinical, economic and humanistic outcomes.
  • Examine the application, strengths and weaknesses of value evidence data from Phase 2, 3 and 4 clinical trials.
  • Describe common analysis techniques and strategies for assessing product value using pharmacy and medical claims utilization data.
  • Describe modeling methodologies, including regression, decision analytic, and Markov techniques, commonly used to examine product value post marketing.
  • Discuss appropriateness, limitations and strategic utilization of different types of data and analyses across the drug development and management continuum.

Analysis of Industry Needs in Drug Development & Product Management - 4 units - DDPM - 212

This course is taken winter quarter of the first year.

This course prepares students to identify, obtain, and succeed at a practice-based internship.  Accepting a collection of individual and group assignments to research corporations and public agencies in drug development and product management field.


Patent Strategy, Freedom to Operate & Corporate Law - 4 units - DDPM - 206

This course is taken winter quarter of the second year.

The Patent Strategy & Freedom to Operate course explains how to maximize Pharmaceutical Patent Life Cycles in the pharma and biotech industry. Unprecedented patent losses starting in 2016 on small molecule pharmaceutical products having values more than $100 billion annually will occur in the next few years.

This course will:

  • Provide fundamental concepts in patent law as they relate to pharmaceuticals.
  • Explain patent terminology to enable better understanding of patent law concepts presented in the course.
  • Inform and analyze on patent life cycle management for both small and now large molecule pharmaceutical products.
  • Cover both US PTO and European Patent office.
  • Describes the major components of a patent document and how the invention is incorporated into the patent application.
  • Explain how pharma and biotech are using IP assists to increase value and monetize their IP portfolio, compared to the software industry for example.
  • Provides a historical perspective, along with provisions for generic companies to challenge patents covering brand name drugs; Including topics such as patent validity and infringement.
  • Cover and discuss how Pharma R&D vertical fragmentation creates transformational IP paradigm for the companies. If not managed properly, this can increase risks to the company and, as an industry trend, can lead to destabilization over the longer term. Potential IP increased risk caused by allocation of control and inherent conflicts of interest in licensing arrangements, patent invalidation, cost of assets caused by dramatic increase in number and intensity of licensees.
  • Analyze recent critical cases affecting patent life cycle planning using case study.
  • Assess the impact of PTO procedures under the AIA on Hatch-Waxman strategies relative to Patent Life Cycle Management.
  • Explain how Biosimilars development and approval will influence pharmaceutical patent life cycle and portfolio strategies in view of the further implementation of Biologics Price Competition and Innovation Act of 2009(BPCIA) and the inevitability of the patent cliff.
  • Present and discuss key pharmaceutical cases decided by the Supreme Court that could have a major effect on drug development.
  • Understand the impact of negotiations from the Trans-Pacific Partnership and Trans-Atlantic Trade & Investment Partnership and impact on patent laws on pharmaceutical products.

Pharmaceutical Business Development, Managing R & D Innovation & Entrepreneurship - 4 units - DDPM - 214

This course is taken winter quarter of the second year.

This course has three key objectives: (1) learning the entire process and language of deal making within the pharmaceutical and biotech industries, from search and evaluation to closing the deal, (2) acquiring principles of negotiation strategy, valuation and how to best manage the contract phase and how to avoid the financial and legal pitfalls that can break a deal, and (3) understanding effective alliance management and the importance for a successful relationship between partners.

Descriptive elements of the course include:

  • Learn the language, the concepts and tools from an executive’s point of view including search selection criteria.
  • Understand the processes for in-Licensing vs. out-Licensing.
  • Profiling product opportunities that will the most suitable depending on each company’s profile.
  • Quantify and differentiate BD opportunities and gain insight using benchmarking and SWOT analysis Strength weakness opportunity and threat.
  • Develop analytical and personal skills necessary to become a successful BD executive.
  • Learn valuation; risk and return analysis and the difficulties in forecasting.
  • Pricing and reimbursement in valuing BD transactions.
  • Analyze and understand different deal structures: joint ventures, licensing, M&A..
  • Discussion and analysis of successful and failed deals.
  • Learn what makes up a good “Term Sheet” and how to assess those from other parties.
  • Effective negotiation planning: key success factors in the process including dos & don’ts during negotiation meetings.
  • The final contract: what it should include to avoid problems and address dispute resolution.
  • The deal is closed now each company needs to manage the relationship. Students will learn alliance management.

Learning outcomes: completion of this course will equip students with a strong understanding of the business development process, skills in valuation, deal structuring, due diligence, negotiation and contracts. Students will receive hands-on, advanced training from business development professionals and legal advisers using real world case studies. In addition, students will be split into teams to conduct a mock negotiation over rights for pre-clinical, clinical stage compounds.

Teaching Methods: team work and discussion based case-study examples including a real-world focus to help apply learning and build practical skills.


Comprehensive Analysis of Key Principles in Drug Development & Product Mgmt - 4 units - DDPM - 215

This course is taken winter quarter of the second year.

This course assists students in obtaining an integrated and comprehensive view of all the key principles presented in the program, so they can articulate issues and practices in a professional manner, and continue to develop new knowledge in the field after they complete the program. The course is presented prior to the comprehensive exam for the degree.  In the course, students work individually and in groups to review and present key elements of previous courses, while also identifying new concepts that arise from integration of key principles across subjects.


Spring Quarter

Biologics and Biosimilars Drug Development - 4 units - DDPM - 210

This course is taken spring quarter during the first year. 

The Biologics and Biosimilars course has three key objectives: (1) explain how biologics are developed and commercialized as therapeutics, (2) explore how the process differs from the traditional pharmaceutical approach for small molecules, and (3) outline the challenges and opportunities for producing more affordable generic equivalents, also known as biosimilars.

A description of course content is summarized below:

  • Define basic concepts of recombinant DNA technology and terminology.
  • Describe key phases of biologics research and development, from target identification through the end of clinical testing and regulatory approval.
  • Compare and contrast the biologics process with that for small molecule pharmaceuticals.
  • Explain the scientific and regulatory challenges that have limited the development and approval of follow-on equivalents of biologics, or biosimilars.
  • Review recent advances in analytical and regulatory sciences that facilitate the development of biosimilars.
  • Highlight regulatory pathways available for biosimilars approval in the US, Europe, and other key geographic regions.
  • Outline opportunities and areas of uncertainty for the development and commercialization of biosimilars.
  • Explore how biosimilars development and approval will influence pharmaceutical patent life cycle and portfolio strategies.

Marketing Strategy, Product Management, and Life Cycle Product Management - 4 units - DDPM - 208

This course is taken spring quarter during the first year.

The course has four key objectives: (1) Explain key components of global drug marketing strategy in a highly regulated environment; (2) Explore portfolio strategy as it relate to drug product management; (3) Describe and explain LCSP process including what happens once the patent on a drug goes generic and what are the strategies to protect the brand; and (4) Provide students with multiple case study describing the complexity of today brand management on a global basis, and how pharmaceutical drugs are commercialized in today’s environment.

Course content:

  • Define and cover the Four P’s of drug marketing; Place, Product, Price, Promotion.
  • Define the Four C’s explaining the complexity of marketing today.
  • Analysis and understand of market research principles and factors influencing marketing strategy.
  • Discuss and analyze pharmaceutical marketing strategy tools.
  • Maximizing tactical plan including utilization of Social Media.
  • Increasing impact through effective segmentation & targeting.
  • Building competitive advantage through creative product positioning, to ensure successful product launch.
  • Role and application of branding.
  • Building an effective and engaging marketing plan & promotional mix.
  • Discuss and analyze what constitute a highly-differentiated drug product profile.
  • Review principles and process of launching a brand successfully, including key stages of launch planning and priorities for each stage.
  • Explain and discuss the role of the launch Team Leader, consider leadership skills and qualities for working with and leading cross-functional launch team.
  • Define importance of customer, market understanding and segmentation on how to optimize customer focus and successful launch.
  • Learn about measuring marketing effectiveness.
  • Discuss and analyze purpose of portfolio management.

Principles of Cost Effective Analysis in Drug Development and Markets - 4 units - DDPM - 209

This course is taken spring quarter of the first year.

This course provides an overview and understanding of the types of analyses that contribute to developing a body of cost effectiveness evidence demonstrating product value.  The student will advance from basic understanding of analysis types, to ability to critically analyze the strengths and weaknesses or published pharmacoeconomic evidence, on to conducting their own pharmacoeconomic analysis.

The course objectives are:

  • Illustrate basic types of analyses that contribute to a body of pharmacoeconomic evidence, including clinical, economic and humanistic data.
  • Examine the requirements for cost effectiveness evidence to support reimbursement decisions by payers across major global markets.
  • Understand the role of pharmacoeconomic analyses throughout the drug development and marketing process.
  • Critically evaluate the common types of cost effectiveness studies presented in the medical literature to determine quality and relevance to decision-making needs.
  • Conduct a cost effectiveness analysis using cost data from public sources and effectiveness data from the published literature.

Practice-Based Internship in Industry, FDA, CDS Managed Care - 12 units - DDPM - 216

This course is taken spring quarter of the second year. Various (student advisors.)

This course consists of a full-time, three month supervised internship with a suitable company or public organization.  The faculty will assist/guide students in getting an Internship, but it is up to the student to take the initiative to obtain the internship. Students apply the knowledge they have obtained in the program to assist their internship host in managing drug development projects and/or constructing and implementing product management strategies.  The internship includes frequent research and analytical assignments.  Students meet weekly with their academic advisor, and their practice supervisor to review progress on assignments, challenges and questions, and overall performance.

Students learn and share their findings regarding current industry challenges and concerns, workforce dynamics, and specific business opportunities.

Key objectives of the course include:

  • Identifying suitable organizations and positions for practice-based internships.
  • Learning and practicing skills to define and secure a productive internship experience.
  • Identifying current scientific and business challenges facing the industry as they relate to development, and management of drug products.
  • Identifying current practice in the industry regarding talent acquisition and retention, workforce development, distribution of professional responsibilities, organization structure, and salary structure.
  • Identifying current promising areas of drug development, as well as current opportunities and threats about the expansion of approved drugs.
  • Sharing information and generalizing findings to understand the current scope of industry business practice.

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