Technology Transfer, Business, and Industry

Developing effective leadership capabilities is critical to the success of individuals at all levels of an organization. This course is designed to grow students’ understanding and knowledge of their own leadership skills and potential. Students will learn about the traits, qualities, and styles of effective leaders. They will evaluate and define their own leadership and gain insights on effective communication as leaders. The course also provides students with experiential learning on how personal leadership development influences their capacity to (1) lead and work in teams, (2) drive change in organizations, and (3) embody leadership as a way of being in the world.

According to the latest edition of A Guide to the Project Management Body of Knowledge, project management is the application of knowledge, skills, tools, and techniques to a broad range of activities in order to meet the requirements of the particular project. These results are defined in terms of four factors: cost; schedule; performance; and scope. Cost is the budget allocated to the project; schedule is the timeline for the project’s deliverables; scope is the magnitude of the job and, performance captures how well the team members do their work. This workshop provides a comprehensive introduction to the essential aspects of project management for scientists. The workshop will draw on relevant case studies, and prepare participants to apply learning gained from the workshop in their organizations.

In the knowledge economy, we create value using projects and project teams. Advanced Project Management Fundamentals is the second in the series of workshops developed for the Foundation for Advanced Education in the Sciences (FAES). This class builds on the foundational knowledge from the Project Management Essentials workshop. In Essentials, students learn how to plan and execute a project. In this workshop, they discover how to structure and organize the project for success. Best practices for managing programs and portfolios and advanced Agile are also part of the curriculum.

This course focuses on the responsibilities of the federal agency throughout the drug development process and understanding the processes and regulations surrounding drug and biologic approvals that guide how regulatory decisions are made. Course content will include lectures, weekly readings (including journal publications, articles, and regulatory documents). Assignments will include weekly discussion posts, midterm paper, final presentation, and final case study.

Specific topics covered will include: Animal Studies, In Vitro Studies, Good Laboratory Practice (GLP), Good Clinical practice (GCP), current Good Manufacturing Practices (cGMP), Chemistry, Manufacturing and Controls (CMC), Pharmacology/Toxicology, Clinical Trials, Statistics, Ethics, Inspections, and Labeling.

Note: This course is NOT meant to cover anything outside of the scope of what the FDA Regulates. This course is focused on drug and biologic regulation, not device regulation.

This course introduces the relevant skills needed for effective oral and written scientific communication in the diverse settings encountered within biomedical vocations. Students will interpret and critically review scientific information, practice oral presentations for defined audiences, and construct effective arguments to inform and/or influence listeners. 

Students will have an opportunity to leverage communication models and learning theories within their practice in order to strengthen their speech and authorship qualities. In this course, special emphasis is placed on field-specific activities performed by biomedical professionals, such as communicating with the public or scientifically untrained audiences and ensuring understanding.

The course provides an introduction to the financial and business aspects of valuation in biomedical sciences. We use practical presentations and case study methods to give students hands-on valuation experience. Assigning a value to an innovative technology or a valuation to a technology company in biomedical sciences can be seen as challenging, given their novelty. This course helps students identify the assumptions and factors required to establish value.  We then develop a framework to help prioritize which factors affect that value the most.  Students will learn how to assign current and future worth to a technology, a product, or a company, based on the market potential, market need, and competition.  Students will work on projects involving evaluation of a therapeutic, a diagnostic, and/or a life sciences tool/instrument.  This course provides the framework for making judgments and valuations, including: Market analysis and market research processes to form assumptions and define elements that contribute to a technology's or a company's value; Market sizing techniques; How to assess a biotech company for financing rounds and M&A; How to consider future value of a product when assessing the value of the intellectual property today; Net present value models in Excel; Assigning value to a management team's expertise and track record; Types of risks (discounting); Excel models for defining market sizes and valuation (NPV). This class is interactive, and students work in groups to allow interactive learning.
 

The FDA is a science-based regulatory agency whose mission is to protect and promote the public health. It exists at the interface of science, law, and policy—and some would say, increasingly, politics. This course explores the complex scientific and policy issues the FDA must address in regulatory decisions that affect all Americans and cover products that account for approximately one-fifth of the American economy. It reviews some of the major forces that have shaped the FDA, surveys the broad range of FDA’s regulatory mandate, explores the FDA’s role as gatekeeper for emerging medical technologies, and examines the current state of the agency in a rapidly changing environment.

This course focuses on learning to manage and lead people who report to you, across team, and your supervisor. You will learn through scenarios, case studies, and experiential learning, how what you say and do directly impacts outcomes. The roles of managers and leaders in biomedical science companies undergo constant change. This course includes in-depth discussions of leadership skills, communication, conflict resolution, and goal integration. You will have the opportunity to manage and lead your own team to a desired outcome, analyze what works and does not work within the management systems, and suggest alternatives.
 

Developing effective leadership capabilities is critical to the success of individuals at all levels of an organization. This course is designed to grow students’ understanding and knowledge of their own leadership skills and potential. Students will learn about the traits, qualities, and styles of effective leaders. They will evaluate and define their own leadership and gain insights on effective communication as leaders. The course also provides students with experiential learning on how personal leadership development influences their capacity to (1) lead and work in teams, (2) drive change in organizations, and (3) embody leadership as a way of being in the world.

The FDA regulates, to differing extents, drugs, biologics, medical devices, foods, cosmetics, and tobacco. The Federal Food, Drug & Cosmetic Act (FD&C Act) gives FDA authority to regulate these products. Students will gain familiarity with FDA’s regulatory authority under the FD&C Act. The course will begin with an overview of the United States Government and Administrative Law. Then, it will provide an overview of drug, biologic, and medical device approval processes. It will also cover how FDA regulates food, dietary supplements, cosmetics, and tobacco. Students will learn how FDA enforces its regulations. Individual and/or group projects may be assigned.

This introductory survey course is designed for both scientists as well as new or future technology transfer professionals. This course will be a hands-on experience and employ a “workshop” approach for internalizing the concepts presented. Specific topics will include: the history, legislation, and public policy that drive federal technology transfer (i.e., life before and after codification of the Bayh-Dole Act); the role of Technology Transfer Offices both in the Federal Government and in Universities; the major types of intellectual property; patents and patentability; the patent application process (i.e., reading patents and drafting claims); freedom to operate; patent litigation; infringement and invalidity; licensing of inventions; collaborative research; and, transactional agreements. Special emphasis will be placed on understanding and drafting the foundational documents of technology transfer. These documents include Non-Disclosure Agreements (“NDAs”); Material Transfer Agreements (“MTAs”); Data Transfer Agreements (“DUAs”); Licensing Agreements; and Collaborative Research and Development Agreements (“CRADAs”).

Course Description: This course targets scientists and others interested in learning how research discoveries are brought to market and transformed into commercial products and the issues encountered along the pathway of moving from invention to innovation. Students will gain insight from professionals in a variety of institutions with substantial experience and expertise in the field. This course provides a unique opportunity for students to comprehend the processes and issues in technology transactions and to prepare for careers in technology transfer.

Designed for technology transfer specialists new to the field or scientists and other individuals wanting to learn the nuts and bolts of technology transfer activities, this course will delve into the day-to-day tools utilized by professionals in the field. The course will begin with setting the context with an introduction to intellectual property law and, then, will turn to a focused review of the various types of agreements relating to collaborations, exchanges of materials, license agreements, and clinical trials, along with the potential issues or problems they are designed to address. Finally, the field of technology transfer will be put into a broader context, with a look at its relationship to contracts, grants, and other forms of government/non-government interactions, in addition to customer-service techniques and negotiation tactics.

This course offers an overview of legal issues affecting biotechnology and other science-based industries and frames basic philosophical and ethical considerations regarding genetic data and manipulation. The course includes a discussion of intellectual property issue.

This course will discuss in detail various aspects of nonclinical evaluation of novel drugs. Students will gain an understanding of animal studies submitted to support the safety of clinical studies and marketing application. Specific nonclinical study design, interpretation, and risk assessment for general toxicity, genotoxicity, reproductive toxicity, immunotoxicity, local toxicity, and carcinogenicity will be discussed in detail. Nonclinical studies that address alternate routes of administration, such as inhalation or intravaginal application, will be explored. Further, students will explore how the pharmaceutical industry uses nonclinical studies to prioritize and make business decisions, including in-licensing, academic/professional partnering, and entering the international market. Students will also investigate how nonclinical studies can be used to address the new paradigm of pharmacy compounding and after-market safety evaluations. By the end of the class, students will have the opportunity to discuss case studies, analyze nonclinical studies of various drugs, and make decisions based on the interpretation of these studies.

Licensing life science products has become a critical avenue for many established life science companies to fill their pipeline needs for new products. This course is designed to provide functional knowledge of the elements, tools and processes of licensing deals for a variety of life science products. Students will gain an understanding of the” buy” and “sell” side of licensing deals from non-confidential disclosure meetings through financial term sheet considerations. We will also examine the various types of licenses such as business to business, academic to business, as well as the variations of licensing constructs which are most common and “in vogue”. Finally, students will share in analysis of case studies throughout the course and a team project (buy and sell side) as a final project. All designed to enhance students career skills in licensing with immediate applicability. This course is designed for Life Sciences professionals in Tech Transfer, entry level licensing professionals, scientists and professionals engaging in Business Development/Licensing activities.

This course will take a practical, hands-on approach to business plan development, venture capital, and technology transactions. Using current examples from the active technology portfolio of the NIH Office of Technology Transfer or an example of their own choosing, students will learn and participate in reviewing a scientific innovation and determining whether the discovery makes a realistic business proposal. The course will look at the history of venture-capital and its relation to science and technology. The course will emphasize technology-transfer issues (particularly from the NIH standpoint) related to real-world technology partnerships and venture capital investments. Issues related to legal considerations, including due diligence and licensing issues, will be also highlighted.

This course will take a practical, hands-on approach to studying the strategy and dynamics necessary for the growth of a biotechnology company from a basic research effort located in a research institution to a fully financed, stand-alone business operation prepared to place finished products in the life science marketplace and to generate a financial return for investors. Through a different panel of expert speakers each week—with specific experience in the week’s topic—the discussion will build on the previous weeks’ topics to arrive at a finished construct of a fully operational biotechnology company. There will be an emphasis on interactive discussions between class members and panelists. Panel members will offer first-hand observations, insights, and personal anecdotes concerning their experiences in building different aspects of a life-science company. Discussions will include critical-thinking and management decisions during times of technology challenge, financial adversity, and growth.

This course will assess the growing global marketplace for innovative biomedical products and research, particularly in developing countries, with a focus on business plans, market development, venture capital, technology transactions, and relevant international partnerships. Using current examples from the technology portfolio of NIH and other organizations, students will review scientific innovations and determine whether a particular discovery constitutes a realistic business proposal from an international perspective.

This course explores the role of marketing in science-based organizations that seek to reach their goals in technology development, product development, public health impact, or other societal needs. The course will start with a clarification of what constitutes marketing by providing the students with the basic concepts, terminology, and practices of marketing.Next, the course will focus on the role of marketing in a research or scientific organization and the specific issues related to marketing technologies. Using a case-study approach, students will be provided with examples of conducting market analyses in the biomedical area. Students will use real-world examples of technologies to create an effective marketing strategy, with details of administering specific marketing programs. Additional topics will include startup marketing, socially responsible marketing, and marketing technologies in international markets, specifically in developing countries.

Finance and accounting are the language of business, yet this language is not well understood by people in non-profit or scientific research institutions who work with for-profit companies. This course will give an overview of how companies keep score, and how outsiders can understand the financial health of internal activities. The course will make extensive use of financial statements (Annual and Quarterly Reports) from well-known companies and use these reports to introduce principles of financial accounting. These principles will be tied to an understanding of: (1) how an individual can assess the financial stability and capabilities of a partner; (2) how financial issues can impact potential collaborations and deals with companies; (3) how financial issues directly impact agreements in which students may participate. The class will also look at the operation of financial markets, and how the reported financial issues of a company interact with the broader financial markets. Students will make extensive use of publicly available financial information that may be found online. The class will have periodic assignments that will provide an opportunity for students to present their analyses in class.

This course will provide a general review of the intellectual property (IP) ecosystem and a comprehensive analysis of the patenting process from a business perspective. IP is a currency that connects the global community, and this course explores how patents and other intellectual property spur innovation, new product development, and business growth. The course will also explore how one values and uses a protected technology, covering issues such as the place of technology in the research and development pipeline, and the effects of regulatory compliance. Using an historical approach to account for social, economic, and technological changes, students will gain greater knowledge of the history of the patent system, the evolution of U.S. patent law, the process of obtaining, defending, and attacking patents

A significant amount of scientific information is available in a patent that is not available in any other publication. Therefore, in every stage of research, knowledge of patent data is essential to developing a clear understanding of the state-of-the-art. Designed for scientists, engineers, and researchers, this course teaches students where to find patent data, how they are organized, and what strategies are required to conduct high-quality patent research. An overview of leading patent databases is provided, while students will also receive training and free access to a number of top-tier subscription-based databases for the semester. Databases required for biology and chemistry research are also covered. Students will be exposed to the basic legal framework underlying patent research required at key points of the innovation lifecycle along with strategies for developing state-of-the-art reviews, patentability and invalidity assessments, freedom to operate analysis, and competitive intelligence through patent analytics.

To be competitive in industry, scientists must understand the intricate process of translating basic research into innovative, market-driven products. Further, these scientists must be able to navigate the complex pathways of intellectual property management and regulatory affairs of agencies such as the FDA. This course will provide life-sciences students with the skills to integrate industry-relevant training and experience with basic science education. This course will explore the licensing, marketing, and regulatory processes through which a bioscience product is developed and brought to commercialization.

This course provides a comprehensive overview of policy and programmatic issues related to the support of research & development (R&D) and innovation internationally. It addresses U.S. domestic as well as international issues and is concerned with governmental and non-governmental policies related to scientific innovation and making medicines, devices, and other technologies affordable and accessible to Low- and Middle-Income countries in a sustainable way. The course also includes discussion of how R&D-based innovation is now seen as crucial to advancing public health and economic growth and development as well as societal well-being. This course will examine public policy and programs and the role of the U.S. Government, national governments abroad, foundations, universities, industries and international organizations in the R&D health-innovation policy system. Additionally, this course will prepare students who are either currently in the field of or are planning careers in global health, international R&D, and scientific innovation to get involved in policymaking and/or national and international program management.

This course offers an overview of the historical development of food and drug laws and regulations as they apply to drugs, biologics, and medical devices, including radiological products, with an introduction to marketing clearance and approval processes, regulations covering import, export, current good manufacturing practices, labeling, reclassification, establishment registration, and medical device listing.

Students will utilize the information and experience gained in the other technology transfer courses, along with scientific training, to complete a project of their design and choice at the NIH or in their regional community. This course is customarily taken after a student has completed at least six previous courses in technology transfer and has accumulated a strong academic record. As part of the course, students will be identifying a research topic and a mentor who is familiar with their prospective inquiry and who is willing to provide guidance and oversee the project. Assistance is available to students in selecting a topic and locating a mentor. The research project must be independent of current work-related responsibilities, as determined by the project mentor. The mentor may be from the NIH, the local business community, a supervisor from the student’s place of work, or any expert with appropriate credentials. Students are required to submit a formal proposal for review and approval by the course instructors. Student projects can include internships, but such are not specifically required. Students must meet with the course instructors periodically to discuss the project’s progress. A written document, poster presentation, or similar outcome, must be completed and approved by the course instructors and project mentor in order for the student to receive credit.