The Catalyze Seminar Series presents a monthly program of seminars, lectures, and workshops about early-stage product development oriented towards academic innovators. The seminars are open to all faculty, staff, and students interested in early-stage product development.
Title:How to Source, Vet, and Oversee Medical Product Development Contractors to Ensure Efficient, Timely, and High-quality Studies and Data for Regulatory SubmissionsPresenters:Dr. Greg Gatto and Dr. Willie SalminenDuration:1 hour
This Webinar will be presented by Greg Gatto and Willie Salminen who have extensive experience sourcing and vetting medical product development contractors. The seminar will provide practical advice for outsourcing medical product development studies at 3rd party laboratories (e.g., Contract Research Organizations [CROs]) and manufacturers (e.g., Contract Development and Manufacturing Organizations [CDMOs]). This will include highlighting the importance of vetting and selecting CROs and CDMOs, oversight of the work, and final reporting and wrapping-up projects. As a case example, the Webinar will focus on designing, contracting, monitoring, and reporting Investigational New Drug Application (IND)-enabling Good Laboratory Practice (GLP) nonclinical studies, which encompasses pivotal toxicology studies to support first-in-human clinical trials. However, the general concepts are applicable to all work that is outsourced to 3rd parties such as Clinical Studies and Chemistry, Manufacturing, and Controls (CMC) work and some examples of these activities will also be covered.
June 16th, 2022 12:00pm - 1:00pm EasternTitle:Applying to the Catalyze Program: Tips from the director and programmatic offerings that set us apartPresenters:Dr. Mike Pieck, Emily Vernon, MMB, and Brailey Faris, MSDuration:1 hour
The Catalyze Program is a translational science program that offers a unique set of resources to support you along your innovation journey in moving your projects into practical application. Accepted investigators not only receive clinical, manufacturing, and regulatory expertise from the Catalyze team, but have access to broader resources at RTI International, including market and value proposition assessments from the RTI Innovation Advisors. Interested in learning more?
Join Dr. Mike Pieck (the Catalyze Scientific Director) and members of RTI Innovation Advisors team ahead of the next application receipt deadline (due: July 21st, 2022) to:
- learn what types of resources you have access to as a member of the Catalyze Program
- receive guidance for developing a competitive Catalyze application
May 18th, 2022 12:00pm - 1:00pm EasternTitle:Preparing, Initiating, and Approaching the Pre-IND MeetingPresenter:Dr. Carmella MoodyDuration:1 hour
What is a pre-IND? Why have a pre-IND? What goes into preparing for a pre-IND? And, what documents are required? All of these questions and more will be answered in this webinar presented by Dr. Carmella Moody, a regulatory affairs specialist at RTI International. Dr. Carmella Moody brings her expertise in regulatory affairs and the development of small molecules to the Catalyze program, where she serves as a technical project lead. In this 1-hour webinar, Dr. Moody will explain the process of preparing and approaching an effective pre-IND meeting, but also what to expect from FDA feedback and how to incorporate it into your project to ultimately save time and money.
April 25th, 2022 12:00pm - 1:00pm EasternTitle:Beyond the Science: Entrepreneurial Support and Commercialization Resources Available through OTACPresenters:Dr. Kathleen Rousche and Dr. Stephanie DavisDuration:1 hour
In our webinar series, you have already heard from many team members of NHLBI's Office of Translational Alliances and Coordination (OTAC), including Dr. Steve Flaim and Dr. Renée Arnold. In April's webinar, OTAC's Director, Dr. Kathleen Rousche, will be joined by NHLBI's Small Business Program Coordinator, Dr. Stephanie Davis, to connect the information you have learned about in previous seminars to the resources and services available to MedTech innovators through OTAC. The presenters will cover in detail who makes up OTAC and what they aim to do, the professional advisory services OTAC offers, tailored support available to small businesses, additional funding opportunities, and networking capabilities.
March 11, 2022 12:00pm - 1:00pm EasternTitle:Demystifying the Process of Approaching the FDA as a MedTech InnovatorPresenter:Kwame UlmerDuration:1 hour
After 12 years working for the FDA and personally evaluating over 1,000 medical technologies, Mr. Kwame Ulmer is ideally positioned to share insights on the process of approaching the FDA as a MedTech innovator. In this educational webinar, Kwame will provide an introduction to the FDA and regulatory issues, tailored to innovators that have not reached the FDA previously. He will also provide practical tips for digesting, distilling, and understanding guidance documents for engaging the FDA as a MedTech innovator.
Presenter Kwame Ulmer brings nearly twenty years of experience evaluating medical technologies in the government and serving in senior operating roles at medical device companies. He is currently an Entrepreneur-in-Residence at NHLBI and an active MedTech executive, lecturer, and researcher.
February 18, 2022 12:00pm - 1:00pm EasternTitle:Understanding Key Payers within the US Healthcare System: Fundamentals of Reimbursement & Health Economics and Outcomes ResearchPresenter:Dr. Renée ArnoldDuration:1 hour
Join presenter Dr. Renée Arnold as she walks through Reimbursement and Health Economics and Outcomes Research as evidence development. This webinar aims to provide a basic understanding of the structure of the US Healthcare System and components of reimbursement and to convey how evidence development support reimbursement. Attendees will gain a deeper understanding of why and how reimbursement guides product development and ultimately which products eventually reach market.
Dr. Renée JG Arnold is currently the President & CEO of Arnold Consultancy & Technology, LLC, where she develops and oversees outcomes research and affiliated software for pharmaceutical companies and the federal government. She is also an Entrepreneur-in-Residence in the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health. Her special interest in evidence-based health derives from her research that deals with the use of technology to collect and/or model real-world data for use in rational healthcare decision-making by healthcare practitioners and policymakers.
January 21, 2022 12:00pm - 1:00pm EasternTitle:Creating your Roadmap - The Importance of Developing Effective Milestones and Project ManagementPresenter:Erin McKenna, MBADuration:1 hour
Writing focused, effective, and realistic milestones is a critical component of product development and a key element of funding applications. Milestones provide key indicators at defined points during product development to guide the project and its management. In this webinar, you will learn the differences between specific aims and milestones, how to create well-designed and thoughtful milestones, and how appropriate project management keeps your product on schedule saving time and money.
Presenter Erin McKenna is the Deputy Director and Senior Project Manager in the Boston Biomedical Innovation Center (B-BIC), a life science accelerator program. She has extensive expertise in medical device product development and commercialization, from Research and Development to company-wide process improvement.
November 12, 2021 12:00pm - 1:00pm EasternTitle:How To Successfully Engage Private Capital InvestorsPresenter:Steve Flaim, Ph.D., F.A.C.C., F.A.H.A.Duration:1 hour
This presentation will provide an overview of the different types of investors interested in early-stage companies, their preferred investment strategies, and what they are looking for in an investment deal. We will also discuss some of the key features of a successful investor pitch, what to include and what to avoid. Finally, we'll discuss the typical process that the entrepreneur needs to understand to navigate their way through to a successful early-stage investment round.
Presenter Dr. Flaim holds a doctorate in Human Physiology and Pharmacology from the University of California at Davis. He is a Technology and Business advisor to the Institute for the Global Entrepreneur at the University of California, San Diego, Senior Special Advisor & Investor-in-Residence with the Innovation Office of the Division of Extramural Research Activities at the National Heart, Lung, and Blood Institute of the National Institutes of Health and an Entrepreneur-in-Residence with the Small Business Education and Entrepreneurial Development (SEED) Office in the Office of the Director at the NIH.
September 8, 2021 4:00pm - 5:00pm EasternTitle:Make it Matter - Preparing and Delivering Effective PitchesPresenter:Steve Flaim, Ph.D., F.A.C.C., F.A.H.A.Duration:1 hour
Delivering a successful pitch for your project can often depend on a practiced approach. It's strongly encouraged that you join Steve Flaim as he breakdowns real-life pitches and outlines what changes a pitch from good to great! The seminar "Make it Matter - Preparing and Delivering Effective Pitches" is specifically designed for Catalyze Investigators to prepare for a pitch contest, an exciting module in the upcoming Catalyze Annual Meeting.
August 24, 2021 12:00pm - 1:00pm EasternTitle:Beyond Technical Milestones - Incorporating Desirability Into Your InnovationPresenter:Moline PandiyanDuration:1 hour
Presenter Moline Pandiyan is an RTI Innovation Advisor with more than 12 years of experience guiding, supporting, and empowering innovators along their innovation journeys, enabling them to bring their research, inventions, and capabilities into practice.
This presentation will emphasize the importance of desirability in a successful innovation, highlight techniques to engage the market and incorporate critical stakeholder insights early, and introduce a framework tool — ICANVAS for Medical Applications — that can help guide your innovation journey from concept to impact.
July 21, 2021 4:00pm - 5:00pm EasternTitle:Get There Faster - Therapeutics Development to CMC IND SubmissionPresenter:Carmella S. Moody, Ph.D.Duration:1 hour
Presenter Carmella S. Moody, Ph.D. is a Regulatory Program Director at RTI; she has more than 33 years of experience developing small molecules, large molecules (biologic), and combination products with emphasis in product development and regulatory affairs.
This presentation will focus on developing therapeutics from a Chemistry, Manufacturing, and Controls (CMC) perspective. Information will be provided regarding important considerations to keep in mind during development and an overview of data included in the CMC section (Quality Section) for early phase IND submissions.
June 22, 2021 12:00pm - 1:00pm EasternTitle:Gaining the Edge – Medical Device Products Development to RegulatoryPresenter:Diane Earp, BSMT, SBB(ASCP)Duration:1 hour
Presenter Diane Earp has 25 years of experience working in regulatory affairs and quality assurance with expertise in the U.S. and international regulatory requirements applicable to biologics and medical devices development, testing/validation, manufacturing, and distribution.
This presentation will provide a general overview of the medical device landscape for a sound regulatory plan/strategy and explain how it can provide a competitive edge for product development. Additionally, the speaker will provide a list of reference material and briefly discuss the evolving framework for new devices and combination product clearance/approval by the US FDA.