De-risking Combination Product Development involving Large Volume Subcutaneous Formulations: Key Considerations

Peter Skutnik is the Business Director responsible for the BD Medical - Pharmaceutical Systems Advanced Drug Delivery Solutions wearables portfolio and large-volume drug delivery innovation, including the BD Libertas™ Wearable Injector, BD Evolve™ On-body Injector. Mr Skutnik has dedicated his focus on this space for over seven years, and his perspective is backed by 25 years of medtech product development experience spanning from strategic innovation through market introduction in the drug delivery, diagnostics, and interventional segments.Mr Skutnik received his Bachelor of Engineering in Chemical Engineering and Master of Science in Management degrees from Stevens Institute of Technology.

Wendy D Woodley is a Staff Scientist II for the Translational and Clinical Sciences Center of Excellence at BD Technologies and Innovation (BDTI). She is a published author and inventor with 22 years of R&D and Product Development experience in the medical device industry with a focus on innovation in drug delivery devices and diagnostics. Ms Woodley has received multiple degrees (BS microbiology, BS zoology, BA English, BA history) from North Carolina State University. Her current work at BDTI focuses on drug delivery innovations with a concentration in preclinical model development, clinical testing and translation of new ideas to product development.