Platform Approaches to Streamline Combination Product Development

After receiving a B.S. in Chemical Engineering from Clarkson University Dr Lindsey Crawford completed a PhD from Cornell University in the school of Chemical and Biomolecular Engineering. Dr Crawford’s PhD thesis work was under Dr. David Putnam where she focused on targeted drug delivery to the blood brain barrier using P-glycoprotein as a target. She then joined the lab of Dr. Shelly Sakiyama-Elbert as a postdoctoral researcher at Washington University in St. Louis working on biomaterials for regenerative medicine prior to becoming a Senior Scientist at Pfizer. Since joining Pfizer Dr Crawford has been involved in drug product development of multiple modalities used to treat a variety of therapeutic indications. She has worked in development stages pre-clinical through commercial and now has a role where she facilitates strategic conversations between key stakeholders during the drug product development stages to ensure the best possible product is reaching our patients. Dr Crawford also has a passion for career development, and as a group leader aims to foster growth in those around her through the day to day work we do.

Dr. Monica Swinney has more than 20 years of experience in the design and development of medical devices, pharmaceuticals, and combination products. She is currently the Sr. Director of New Product Planning and Drug Delivery Innovation for Gilead Sciences. Prior to Gilead, she held both strategic and technical leadership roles with Eli Lilly, Becton Dickinson, Johnson & Johnson, and Dexcom. Dr. Swinney holds a Ph.D. in polymer science from MIT a B.S. in chemistry from the University of Massachusetts, is the recipient of many industry awards in innovation and product development, and is an inventor on over 75 patents.

Development Director at Crux with over 12 years of device development experience. Tim has worked across a wealth of medical device & combination product platforms including asthma inhalers, pre-filled syringes, pen/autoinjectors, on-body/large volume and connected devices. With a focus on evidence-led device development, he champions early-stage feasibility assessment through data-driven design and quantitative evaluation. This work includes computational simulation and modelling and early-adoption of enabling technologies. Today, Tim leads both off-the-shelf platform selection and novel device development programmes, acting as a trusted advisor and technical reviewer to support the wider Crux team.

Shirish Ingawale is a Director of Device & Combination Product Development at Takeda. With over 20 years of diverse experience in medical devices, drug delivery technologies, and combination products, Shirish is acclaimed for his strategic vision, innovative approach, and steadfast commitment to transforming patients’ lives. He blends a robust background in R&D with a strategic perspective shaped by roles in academia and leadership positions in the medical device, biotechnology, and pharmaceutical sectors. At Takeda, Shirish spearheads strategic and collaborative innovations, motivating cross-functional teams to set new industry benchmarks in device and combination product development. Before joining Takeda, Shirish spent a decade at Amgen, where he led multidisciplinary teams and managed the lifecycle of drug delivery devices and breakthrough combination products. He played a vital role in successful development and commercialization of drug delivery technologies including reconstitution kits, pre-filled syringes, autoinjectors, and on-body delivery systems along with establishing device platforms. Previously, Shirish contributed to advancement in the medical device industry and academia, with a focus on implantable devices. Shirish earned a Bachelor’s degree in Instrumentation Engineering from the University of Mumbai, India, and a Master’s and PhD in Biomedical Engineering from Wright State University, Ohio, USA.

Brad is a distinguished medical device and combination product engineer committed to translating technical innovation into meaningful clinical impact. Since 2015, he has been an integral part of AbbVie's research and development team, leading programs in delivery system platforms and combination product clinical studies. Currently, Brad plays a pivotal role in Landscape and Platform Definition, where he assesses delivery system technologies to meet pipeline needs. His educational background includes a Bachelor of Science in Mechanical Engineering from the University of Illinois at Urbana and a Master of Engineering in Bioengineering from the University of California at San Diego. Brad has over two decades of experience in med tech program leadership across startups, corporate settings, and design firms. Notably, he was the first employee hired at a startup that achieved a successful exit in under four years. His expertise spans a wide range of medical device applications, including combination products, cancer detection, cardiovascular systems, critical care, infection control, and obstetrics. Brad's dedication to advancing medical technology is reflected in his ability to guide complex projects, fostering collaborations, and driving innovations that bridge the gap between technology development and clinical application.