The FAES Academic Programs at NIH offers a unique Advanced Studies in Technology Transfer to persons with a Bachelor’s degree in science or engineering or a related field. Courses are offered in the evenings, making it convenient for working professionals and postgraduate Fellows to gain expertise and experience in patenting, licensing, collaborative agreements, and other fundamental intellectual property transactions. The technology transfer profession field employs more than 10,000 professionals in the U.S., with many practicing their trade in the greater Washington, D.C. metro area.The course instructors are leading practitioners in the field, so students can simultaneously gain the necessary knowledge and build professional networks.
Open to persons with a Bachelor's degree or higher in a STEM field. The program comprises a self-paced 15-credit curriculum of required and elective courses that can be completed in approximately two years. The program culminates in an independent Capstone Project through which students will be required to demonstrate their knowledge of the theory and practice of technology transfer by completing a project of their design and choice at the NIH or in their regional community.
CHEM 327 | The Art of Drug Design and Discovery
PHAR 328 | FDA Perspective on Drug Development
TECH 490 | Communication in Biomedical Sciences
TECH 491 | Market Assessment for Innovative Technologies in Biomedical Sciences
TECH495 | The FDA: Science, Health Policy, and Regulation in an Uncertain Environment
TECH 498 | Leadership Strategies in Biomedical Sciences I
TECH 508 | Regulatory Affairs and FDA Regulation
TECH 521 | Tools for Technology Transfer Managers - Handling Intellectual Property, Collaborations, and Agreements
TECH 525 | Legal and Ethical Issues in Public Health and Biomedical Sciences
TECH 528 | Preclinical Evaluation of Novel Drugs and Beyond
TECH 566 | Building a Biotechnology Company: Leadership and Management Strategies
TECH 567 | International Strategic Partnering and Business Development
TECH 572 | Marketing Strategies for Scientific Organizations
TECH 575 | Accounting and IP Valuation for Non-Accountants
TECH 582 | Intellectual Property and Patent Prosecution for Scientists
TECH 583 | Patent Research for Scientists and Engineers
TECH 584 | Translational Medical Product Development
TECH 586 | International Health Science, Technology, and Innovation
TECH 588 | FDA Regulatory Strategy in Medical Product Development
TECH 607 | Capstone Course in Technology Transfer (second time would count as an elective)
Upon completion, students will be able to:
- Understand fundamental technology-transfer processes for transferring scientific findings from one organization to another for the purpose of further development and commercialization
- Explain and describe the role that intellectual property will play in the transition from a manufacturing-based economy to a knowledge-based economy as part of industrial and societal development
- Describe and explain specific technology transfer processes involved with: (1) identifying new technologies; (2) protecting technologies through patents and other forms of intellectual property; and, (3) forming development and commercialization strategies, such as marketing and licensing to existing private sector companies, or creating new startup companies based on the technology
- Learn to apply technology-transfer processes to ensure that new discoveries have the opportunity to reach the stream of commerce and that investments in intellectual property are returned to the public through products that benefit the public and increase employment as well as state and federal taxes
- Understand how commercialization of scientific innovations can be pursued without disrupting the core research institution values of publication and sharing of information, research results, materials, and know-how
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 course provides a comprehensive introduction to the essential aspects of project management for scientists. The course will draw on relevant case studies, and prepare participants to apply learning gained from the course in their organizations.
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.
After successful completion of this course, students:
- Will understand the elements that are important for communicating effectively to mixed audiences in written and oral formats;
- Will have developed relevant knowledge regarding communication studies theoretical underpinnings pertinent to scientific communication; and
- Will be able to write persuasive, engaging, and effective scientific information.
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.
Students will learn:
- The basic factors involved in assessing a technology, market or company
- Which concepts, tools and techniques are useful for assessing a market and valuation
- How to assess a company prior to the valuation
- How to value an idea, platform, technology, or company
- How to calculate value of a technology students may currently be working on
- Understanding the key components of a therapeutic product valuation, and which are the key value drivers
- Understanding investors' objectives in considering a biomedical company/product
Sample syllabus is subject to change.
- Understand the FDA’s mission, how that mission has evolved, and how science informs the FDA’s policy and pro-duct decisions
- Explore potential career paths at the FDA and in industries that produce FDA-regulated products
- Appreciate the importance of effectively communicating FDA’s decisions on a multitude of complex scientific, medical, and public health matters
- Identify the various forces and interests that confront the FDA, and evaluate their potential impact on the agency in an uncertain and evolving political 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.
Sample syllabus is subject to change.
- Become familiar with the U.S. legal system and FDA’s administrative regulatory authority
- Learn about FDA’s regulatory oversight over drugs, biologics, medical devices, foods, cosmetics, and tobacco
- Gain an understanding of current FDA news
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”).
Technology Transfer Society/Washington, D.C. Chapter This course is an elective for Advanced Studies in Technology Transfer.
This is the first part of a two-part course. Registration is required separately for each part of the course.
- Develop a basic understanding of technology transfer and its role in the biological sciences
- Comprehend the basis and subsequent interaction of technology transfer in the overall developmental process of moving new discoveries to the marketplace
- Gain a greater appreciation of career options in technology transfer
Develop a basic understanding of technology transfer with a bias towards technology transfer in the biological sciences. Comprehend the basis and subsequent interaction of technology transfer in the overall developmental process of moving new discoveries to the marketplace. Understand the fundamental documents used in the technology transfer process.
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.
When you successfully complete the Learning Activities, you will be able to:
- Explain TT and its role in transitioning technology towards commercialization.
- Analyze the basic steps and interactions for moving technology into the marketplace.
- Summarize and compare the motivations of the different stakeholders involved in technology transfer.
- Evaluate and assess potential career opportunities in technology transfer.
Tools For Technology Transfer Managers — Handling Intellectual Property, Collaborations, and Agreementss
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 is an elective for Advanced Studies in Technology Transfer.
The above course(s) or permission from the instructor.
- Develop a working understanding of basic intellectual property law
- Comprehend the broad regulatory and business framework for technology transfer
- Assess the different tools available for transferring technology, with a focus on federal labs
- Discuss ethical issues, the basis and influence of moral theories on resolving bioethical issues
- Survey the legal, medical, and scientific aspects of current bioethical issues
- Learn about the U.S. patent process and the interdependency of marketplace and laws which regulate it
- Explain how the principles of property and ownership relating to intellectual property and biological materials impact the development of new therapies and diagnostics
- Understand the impact of biotechnology on healthcare and the medical community
- Review the history and fundamentals of pharmacology/toxicology and challenges faced by these disciplines in the drug-approval process
- Discuss how non-clinical study results are interpreted, and how the pharmacology/toxicology discipline assesses hazard identification that affects advice provided regarding safety and efficacy in human clinical trials and for drug approval
- Explain the nonclinical study requirements and types of data reviewed by the pharmacology/toxicology Center for Drug Evaluation and Research (CDER) reviewer discipline
- Discuss how the pharmaceutical industry uses nonclinical studies to make business decisions, including partnering with academic and contract-research organizations, in-licensing, and moving to international markets
- Explore post-marketing safety of drugs via epidemiology, and how nonclinical studies can be used to address after-market safety concerns as well as pharmacy compounding
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.
- Develop a working knowledge of the elements, tools and processes of life science licensing deals
- Analyze existing life-science licenses to understand current standards & benchmarks
- Perform term sheet design for a license of a “real-world” life science product
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 is required for Advanced Studies in Technology Transfer.
This is a 14-week course.
Basic or advanced knowledge of science; no business credits required.
- Develop an appreciation of the role of venture capital and other investors in the development of new biomedical technologies
- Understand and be able to complete the essential elements of a business plan
- Communicate effectively, orally and in writing, to potential investors the commercial advantages of a new technology
Sample syllabus is subject to change.
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 is an elective for Advanced Studies in Technology Transfer.
basic or advanced knowledge of science; TECH 565 is helpful, but not required.
- Develop a working understanding of the structure and management of biomedical business firms
- Comprehend the critical thinking needed for management decisions during times of financial hardship and growth
- Be able to effectively interact with biotech stakeholders to discuss issues relating to finance, R&D, marketing, manufacturing, and human resources
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 is an elective for Advanced Studies in Technology Transfer.
Basic or advanced knowledge of science; no business credits required.
- Understand the growing marketplace for innovative biomedical products and research, particularly as they relate to developing countries
- Examine approaches taken by different institutions, including the NIH, and new institutional frameworks such as PDPs
- Assess sources of funding in relation to innovation and the development of biomedical products
- Develop expertise in branding products and companies
- Use market research tools to develop strategies for real technologies
- Interact with guest lecturers to learn how people get to be marketers
- Understand the basics of marketing: Product, Price, Promotion, and Place
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.
Experience with or interest in collaborations or agreements with for-profit organizations. This course is an elective for Advanced Studies in Technology Transfer.
- Develop basic understanding of accounting principles and financial statements as they apply to biotech and other life-science companies
- Utilize transactions as the basis for building balance sheets, income statement, and other financial statements
- Analyze the performance of public biotech and life science companies using standard financial tools
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
- Distinguish between patents, trademarks and service marks, copyrights, and trade secrets.
- Compare four primary types of Intellectual Property in supporting business development.
- Draft the essential parts of a basic patent application based upon the application of core principles of U.S. patent law and practice.
- Compare U.S. and international patenting processes in the context of movement toward global harmonization.
- Identify common career positions in the intellectual property field.
- Apply technical/legal terms in intellectual property related written and oral communications.
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. This course is an elective for Advanced Studies in Technology Transfer.
- Gain the know-how to develop the search strategy required to make informed research decisions and the ability to select the best resources to conduct patent research in diverse technology areas
- Understand what information is found in patents, and how patent research is leveraged to inform research-related decisions throughout the innovation lifecycle
- Develop an understanding of the basic strategies and legal requirements for common patent research goals required in research
- Acquire knowledge and tools of different aspects of medical product development
- Understand strategic considerations of medical product development
- Discuss the importance of R&D and its impact on science, technology, and health systems internationally
- Understand the NIH model for enhancing public health, R&D, and technology transfer process
- Discuss case studies related to public health and technology transfer applicable to different countries
- Share global health R&D activities and programs at NIH, other U.S. government agencies, international organizations, and institutions in different countries
- Gain an understanding of the history and development of food and drug laws and regulations as applied to drugs, biologics, and medical devices
- Get introduced to processes, regulations, manufacturing practices, reporting, listing, inspection involved in medical device and product development
This course is designed as a final course of the FAES Advanced Studies in Technology Transfer. 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.
Permission of the instructor. This course is required for Advanced Studies in Technology Transfer. This course may be taken two times.
- Identify an area related to technology transfer or technology development that is of strong interest to the student and merits further exploration and independent study
- Complete the project for a client or mentor that will focus on a practical experience outcome
- Utilize the project and practical experience obtained as part of a career-development or transition strategy for future employment