Archives: Speakers

Kevin Hagelin is a clinical research professional with over 15 years of progressive experience in medical device clinical trials, spanning study operations, data management and publication planning.  He currently serves as Senior Clinical Data Manager at Sonex Health, where he oversees data management functions across clinical studies for innovative medical devices. Kevin’s career includes roles at Boston Scientific, NxThera, Cardiovascular Systems, and American Medical Systems, giving him broad exposure to therapeutic areas including urology, cardiovascular disease, and musculoskeletal conditions. His expertise spans the full clinical trial lifecycle from study start-up through database lock and regulatory submission with particular depth in EDC systems, data quality strategies, and cross-functional team collaboration. Kevin holds a Bachelor of Applied Sciences in Exercise Science from the University of Minnesota-Duluth and a Clinical Research Professional Certificate.

Amanda Maltzen is a Director of Clinical Affairs with over 15 years of clinical research experience spanning both site and sponsor organizations. She holds an MBA and MPH, bringing strategic leadership to complex clinical programs. Amanda has worked across organizations of all sizes, from large corporations like Abbott and Boston Scientific to mid-size and smaller companies including St. Jude Medical and Sonex Health, giving her unique insights into how clinical operations scale and adapt across different organizational structures.

Currently at Sonex Health, Amanda manages the complete lifecycle of clinical studies for innovative medical devices. Her extensive experience includes working with research sites and staff across all experience levels from research-naïve practices to highly experienced centers while maintaining extensive rigor and compliance standards. Her dual perspective from site and sponsor roles, combined with proven expertise in regulatory affairs, team leadership, and operational excellence, makes her a compelling speaker for clinical research audiences seeking practical insights and proven strategies for achieving results in diverse clinical environments.

Rebecca Stepan is Director for Quality Systems & Compliance within Medtronic’s Cardiovascular Portfolio Business. She leads all regulatory compliance activities for the business she supports with responsibilities spanning audit, safety, compliance, and quality systems. She drives quality and regulatory compliance planning, budgeting and oversight for a global team. Rebecca has 9 years at Medtronic and over 14 years of experience in the healthcare, research, and medical technology fields. In her tenure at University of Minnesota Health, Rebecca held the roles of Director of Quality, Regulatory & Research Practice for the Solid Organ Transplant Service Line and Director of Clinical Quality of the Cardiovascular Service Line. During this time she was an Adjunct Faculty at the University of Minnesota’s School of Public Health.

Rebecca is a member of the Regulatory Affairs Professional Society (RAPS) and has her Lean Six Sigma Black Belt (LSSBB) from Villanova University. She holds certificates in Health Law, Compliance, and Privacy Law from Mitchell Hamline School of Law. She holds a Certification in Healthcare Compliance (CHC) from the Health Care Compliance Association (HCCA) and Certification as a Professional of Healthcare Quality (CPHQ) as a member of NAHQ.

Education

• Mitchell Hamline School of Law, Health Law & Compliance, Juris Doctor (JD)
• University of Minnesota, Epidemiology, Master of Public Health (MPH)
• University of St. Thomas, Biology, Bachelor of Arts (BA)

Expertise & Research Interests

• Regulatory Compliance
• Clinical Research
• Government Affairs & Reimbursement
• Ethics & Data Privacy

Pamela Wolfe, MBA, MS, CCRP, ACRP-CP, ACRP-MDP, FACRP is a versatile healthcare and clinical research professional with 25+ years of expertise.  She is currently the Vice President of Clinical and Regulatory Affairs for Agitated Solutions, a medical device start-up dedicated to the enhancement of ultrasound technologies.   Pamela was previously the Director of Clinical Affairs for Insightec focusing on MRI guided focused ultrasound.  Pamela’s responsibilities during her career have included development and hands-on management of clinical trials from concept to completion.  She collaborates to develop well designed protocols which translate into effectively run clinical studies, as well as orchestration and implementation of regulatory strategies and submissions to support pre- and post-market activities.

Pamela previously was the Principal Product Development Strategist for global medical device clinical studies for NAMSA, Director of Clinical Research and Operations at Magellan Medical Technology Consultants and Director of Clinical, Quality, Regulatory and Biomedical Engineering with Frestedt Inc. She has worked on a diverse variety of projects in a wide range of therapeutic areas with client companies around the world.  She has provided expertise in clinical investigations, regulatory support and quality systems for biotech, medical device, pharmaceutical and food products.

Pamela earned her MBA from the University of Minnesota in Strategic Management and Entrepreneurship and her Master of Science in Chemistry from Clemson University. Pamela is currently a fellow with the Association of Clinical Research Professionals (ACRP) and a past president of the Midwest chapter. Pamela has been a frequent speaker/moderator at local Minneapolis area clinical research events as well as presented at several conferences in addition contributing as a coauthor to several publications.

Christine Horton is an accomplished medical device executive with more than 30 years of commercial and strategy expertise. She is currently the president and CEO of Visura Technologies, a privately held medical device company, focused in cardiology, and dedicated to delivering state-of-the-art visualization solutions to improve the safety and success of transesophageal echocardiogram (TEE) probe intubations.

Horton previously served as the CEO of CoreSpine Technologies, a privately held spinal device company, where she successfully raised capital, formed a world-renowned medical advisory board, published data, and led the company through their FDA clearance during her tenure. Under her leadership, CoreSpine transitioned from a concept company to one that licensed its technology for use outside of spine, with a submitted patent portfolio and products cleared by the FDA. She has also launched multiple companies and products in markets such as cardiology, orthopedics, and diagnostics.

Ms. Horton’s extensive medical device experience, which started when she was a scientist, includes leading engineering, clinical, marketing, sales, and operations teams.  Deep experience and industry knowledge has made her one of the most well-rounded individuals in the industry.

Christine regularly speaks at conferences and has been the guest on several podcasts.  The companies she has led have received prestigious awards for innovation and leadership including the Minnesota Cup for CoreSpine Technologies, “Women to Watch” awarded to the top 25 women in business by Minneapolis/St. Paul Business Journal, Small Business Success Story awarded by Twin Cities Business, Tekne Award for Innovative Medical Device Development and more. Horton has also mentored, and guest lectures the next generation of medical device marketers at the U of M’s Carlson School of Management, U of MN Medical Device innovation master’s program and served as an advisor at the University of Iowa’s UI Venture program. Horton has also served on boards of directors, including SynderBio and CoreSpine Technologies, as well as numerous non-profit boards including Bolder Options and United States Tennis Association.

Serhii Zatsarynin, PhD, is the CEO and Founder of Ovulio, a women’s health startup advancing non-invasive hormone tracking through AI-powered saliva analysis. With over 15 years at Siemens Healthineers, where he led the in-vitro diagnostics business in Ukraine, Serhii brings deep expertise in diagnostics, digital health, and workflow optimization. His work focuses on simplifying complex healthcare experiences – improving accessibility, usability, and patient engagement across the care journey.

Sarah Haddad holds a PhD in molecular biology from the University of Geneva, specialised in cancer research, genetics and nutrition in diseases. She has built her career at the intersection of science, innovation and entrepreneurship, working across academia and business ventures. Her work focuses on translating life-science knowledge into improved food and nutrition products that can support better consumer health and help reduce diet-related diseases over the long term.