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 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.
Title: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.
Title: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.
Title: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.
Title: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.