During this session, featured speaker Brandon Bogdalek, will interview two industry leading panelists. The panelists will discuss important factors to consider when evaluating off-the-shelf (OTS) drug delivery platforms vs. developing a novel solution. Key topics will include cost and pricing impacts, timeline to commercialization, as well as R&D, human factors and user needs considerations. Panelists will share their perspectives with respect to choosing OTS solutions or building a novel drug delivery platform.
Discover the factors to consider when evaluating off-the-shelf (OTS) vs. novel drug delivery solutions. Register now.
(Moderator) Brandon Bogdalek, Vice President, Demand Generation, Veranex
Brandon Bogdalek is Vice President of Demand Generation at Veranex, a healthcare product innovation and commercialization partner developing solutions through human-centered design and deep engineering capability. Brandon has worked with dozens of medical device, drug delivery, diagnostics, and digital health companies on outsourced innovation and commercialization projects. In his current position, he represents the product development and engineering (PDE) function from a marketing lens – helping tell stories from internal and external subject matter experts that provide value and promote new thinking. Before Veranex, Brandon helped lead business development for several companies including Worrell Design who was purchased by Veranex in 2021. He holds a bachelor’s degree in biology from the University of Minnesota and is an active participant in several life sciences communities.
Michelle Howard-Sparks, VP, Product Development, Eyepoint Pharmaceuticals
Pharmaceutical Executive with 24 years of experience in global R&D Leadership, spanning Preclinical Development through Commercial/Technical Operations under both virtual and non-virtual business models. Proven success in the development of 5 commercial products, serving on the launch team of 2 commercial products. Experience in cross functional leadership, alliance management, asset valuation, expansion of patent portfolio and CMO management. Experience in large pharma, extensive experience in pharma/biotech start ups in virtual and non-virtual environments.
Valerie Fenster, Senior Director, Packaging and Human Factors Engineering, Akero Therapeutics
Ms. Fenster, with thirty plus years’ experience as a persuasive advocate for implementing human factors engineering and human-computer interface best practices is dedicated to developing powerful and user-centered design for combination product medical devices, instructions for use, web sites, interactive voice response systems, and hand-held mobile devices for medical device and financial systems.
Ms. Fenster is currently Director, Packaging and Human Factors at Akero Therapeutics in So. San Francisco, California. Since 2022 she has been leading and developing Akero’s Human Factors Engineering (HFE) expertise to support all aspects of human factors engineering, user-centered and industrial design activities. She is responsible for planning and executing design, research and documentation activities to ensure successful global regulatory health agency submissions for combination product development programs.
Before Akero, Ms. Fenster was Director, Insights and Human Factors at Kaleidoscope Innovations, and prior to that, Senior Manager, Human Factors Engineering, Device Technologies at Amgen in Thousand Oaks, California. At St. Jude Medical’s Cardiac Rhythm Management Division, Ms. Fenster’s design and research expertise helped secure a 2009 Medical Design Excellence Award their Merlin Remote Care Patient System for patients with implantable cardiac devices.
She is an active member of the Human Factors and Ergonomics Society (HFES.org) and the Association for the Advancement of Medical Instrumentation (AAMI.org). Ms. Fenster currently holds a Masters of Science in Human-Computer Interaction from DePaul University in Chicago, Illinois, as well as a Bachelor of Arts degree in Psychology and a second Bachelor degree in Humanities.
Dustin Gaidos, Director of Product Development, Veranex
As Director of Product Development, Dustin is experienced in medical and consumer healthcare product development – from initial concept design, through testing and validation, to manufacturing.
Dustin has experience in Drug Delivery combination products, high volume disposables, complex low-volume disposables, electromechanical devices and capital equipment.
Dustin has 15 years of product development experience and is exceptionally passionate about medical product development. Spanning the last seven years, he has acted as the technical lead for several programs at Veranex. He has also managed extensive animal studies and has worked with and trained world-renowned surgeons on a breakthrough designation procedures.
Who Should Attend?
Small to midsize pharmaceutical companies that specialize in drug delivery:
- Product Development
- Combination Product Professionals
- Human Factors & Usability
What You Will Learn
- Understand important tradeoffs when considering an off-the-shelf (OTS) drug delivery platform vs. novel development
- Understand best practices for novel drug delivery design and development
- Understand important R&D considerations including timeline to commercialization, human factors, user needs and more
Veranex Product Design & Engineering
With a fully integrated concept-to-commercialization solution, Veranex’s design and engineering expertise sets us apart, providing you with visibility to development feasibility and opportunity along the way. Our expertise improves your launch readiness and expedites the development of your technology for regulatory and commercial success. We’re ISO 13485-certified and FDA-registered for medical technology product development, and with more than 30 years of experience and a global reach into emerging markets, our design and engineering specialization will make your MedTech vision a reality.