Curriculum

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

1.       Provide an overview of the range of post MS career opportunities, and
2.       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 program.

This course provides students an introduction to pharmacotherapy concepts and essential considerations in new drug design, drug development, and clinical trials, enabling future managers to guide efforts in drug discovery. An emphasis will be placed on discussing therapeutic challenges encountered by healthcare providers and patients in the real-world setting. The goal of this course is to provide students with a body of knowledge that enables them to consider real-world therapeutic challenges when participating in the drug discovery process.

The course objectives will be to:

1. Describe the pathophysiology of select human diseases (e.g. neurologic, cardiovascular, cancer, pulmonary, endocrine, infectious diseases, and autoimmune disorders).
2. Understand how pharmacologic therapy is used to achieve the desired therapeutic goals and health outcomes for common conditions.
3. Describe the current treatment gaps and barriers to achieving optimal health outcomes for select human diseases.
4. Identify common therapeutic challenges encountered when treating human disease (e.g. side effects of drugs, impact of pharmacogenetics on response to drugs, non-adherence to drug therapy).
5. Apply knowledge of pathophysiology and pharmacotherapy to the drug discovery process (e.g. drug development, clinical trial design, post-marketing surveillance, and product management).

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 drugs 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)

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.  Students 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 covered.

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, DNAs.
• Understand the role of project managers and other regulatory professionals in the drug development process.
• Describe interactions with regulatory agencies during drug development in the United States and abroad
• Understand rules and regulations pertaining to advertising and promotion
• Understand harmonization of the drug development process from a global perspective.

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.

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.

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.
• Analyze and understand 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 constitutes 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 teams.
• 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 the purpose of portfolio management.

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.

The first half of this course evaluates the complexity of project management in global drug development efforts. We discuss how underlying risks makes it 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. This course also provides an overview of Drug Utilization Management structures and techniques in both U.S. Public and Private Sectors. Practices in Formulary Management, Contracting for Product Placement, Pricing Strategies, Positioning to Gain Market Share and the Impact of Public Policy on Product Utilization are to be covered.

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 be 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.