Track 2 Session Descriptions
NIH and its grant recipients share responsibility for compliance and oversight to ensure proper stewardship of federal funds. To fulfill this administrative partnership, NIH provides “compliance assistance” that consists of clear and easy-to-access information on federal grants, financial and management requirements for contractors, grantees and the public. Compliance assistance is crucial to the successful administration and fiscal management of grant awards and it safeguards the federal investment in America’s R&D efforts. This session will address the administrative requirements, cost principles and audit requirements applicable to SBIR/STTR grants.
The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) is tasked with regulating the manufacture, distribution and sale of medical devices in the U.S. CDRH also regulates radiation-emitting electronic products (both medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, and microwave ovens. This presentation will address basic regulatory requirements for manufacturers to legally market a medical device in the U.S. This includes a discussion of the definition of a medical device, medical device classification, premarket applications (510(k) and PMA), establishment registration and listing and post-market activities. Valuable resources to assist small manufacturers in complying with FDA’s medical device regulations will also be provided.
Inventions made under a federal research award can be a company’s most valuable asset if properly identified and managed. But while many embark upon the road to commercialization, the successful journey needs a roadmap to avoid roadblocks and potholes along the way. Effective and timely protection of intellectual property rights is of paramount importance for ensuring marketing and commercialization success. Practical information about protecting and commercializing those rights will be provided.
Part of the U.S. Food and Drug Administration, the Center for Drug Evaluation and Research regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicine. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are also considered “drugs.” This presentation will address the regulatory requirements for the approval of new drugs, generic drug approval process, overview of over-the-the counter drugs, listing and registration of product and companies with the agency and small business assistance programs and resources for information.
This is a workshop designed to teach participants how to develop basic indirect cost rates, why indirect cost rates are vital to a company’s fiscal success and fundamental auditing and accounting system issues that you need to be aware of prior to award.
So you have an idea for a potential product? Now what? It starts with feasibility planning. This session will highlight the preparation needed to put together a strong development strategy assessing market feasibility, technological feasibility, economic feasibility, and potential hurdles and means to circumvent them. Following an initial overview presented by Dr. Bough, Drs. Wermeling and McMillen will share their success stories, including hurdles and lessons gleaned, from two unique areas of expertise. Dr. Wermeling will present on his expertise surrounding pharmaceutical drug development, whereas Dr. McMillen will present on her expertise regarding web-based services and mobile applications. An interactive discussion will follow.
What are health disparities? What makes eliminating health disparities challenging? This session will showcase the ongoing search of the National Institute on Minority Health and Health Disparities (NIMHD) to identify, attract and support small business innovations designed to reduce or eliminate health disparities. The NIMHD envisions an America in which all populations will have an equal opportunity to live long, healthy and productive lives. How can your small business contribute to this vision? What populations are considered “health disparity populations”? These and many other questions will be answered during this session and examples of innovative SBIR and STTR awards supported by NIMHD will be presented.
This panel will provide information on how NIH promotes research integrity, and the policies and procedures that are in place for handling allegations of research misconduct. Special relevance and considerations for SBIR/STTR communities will be made whenever appropriate.
While NIH is the major agency providing funding for biomedical research, did you know that it also provides resources to the biomedical community that can help accelerate research? Come to this session to learn about some of the resources available including the Therapeutics for Rare and Neglected Diseases, the Bridging Interventional Development Gaps program, the Clinical and Translational Science Awards and the Human Tissues and Organs Resource for Research. Learn how small businesses have used these opportunities to help leverage their research and development programs. Note: these examples are illustrative of opportunities available at NIH. In addition, individual institutes may have other resources available. For information on these institute-specific resource opportunities for small businesses, visit the One-on-One sessions.
CDC – Small Business Innovation Research Program: Translating Innovation for Practical Solutions (Juliana Cyril)
This session will provide participants with an introduction to CDC and its global public health mission. We will describe current CDC priorities and identify areas of need where the SBIR Program can have significant impact in real world public health settings. Examples of past and current projects will be provided to demonstrate how the CDC SBIR Program has helped create practical solutions to public health problems worldwide.