We Are Your Solution
OUR LEADERSHIP & MANAGEMENT TEAM
Matt Stroschein is a recognized leader in the pharmaceutical services industry with over 20 years of regulatory and clinical operations experience. He has held a number of executive-level positions within both sponsor and service organizations. Before founding WAYS, Matt was the Vice President, Development Operations for Bridge Medicines where he managed the development plans of early stage programs through the IND process.
Previously, Matt served as the Executive Vice President, Project Management at Aclaris Therapeutics and Executive Vice President, Global Operations at Octagon Research Solutions, Inc. During his tenure at Octagon Research Solutions, Inc., and through its acquisition by Accenture Life Sciences, he managed the regulatory and clinical operations teams. Matt received his Bachelor of Science in Management Science and Information Systems from Penn State University.
Chief Executive Officer
Head of Operations
2020 PharmaVOICE 100
Vanessa Phillips has worked in Regulatory Operations for the past 18 years and is a respected subject matter expert in global regulatory submissions. Throughout her career, she has utilized advanced skills, optimized processes, enabling technology and evolving standards to comply with global regulatory submission requirements; she has used these skills to effectively lead a team of 20 individuals to deliver high quality submissions. Leveraging this experience, she has led and participated in the evaluation and implementation of industry standard technologies for her own team’s use and on behalf of clients.
Vanessa has maintained her knowledge of evolving health authority requirements and industry best practices and is committed to combining operational and regulatory expertise to deliver value for her clients. Her specialties include global submission management and electronic publishing. She has also developed, designed and delivered customized training on eCTD submissions.
Vanessa holds a Bachelor’s degree in Biological Sciences from the University of Delaware.
Shannon Heacock
Head of Regulatory Submissions
2021 Pharmavoice 100
Shannon Heacock has 15 years of experience in regulatory operations and specializes in eCTD. Her expertise is focused on global submission management, eCTD technical requirements and data standards requirements. Throughout her career she has led teams responsible for compiling, managing and submitting thousands of investigational and marketing application submissions to the FDA, Health Canada and European health authorities in support of Centralised, Decentralised and National procedure submissions.
Shannon continues to refine her knowledge through practical experience, utilizing both her operational and regulatory expertise.
She consistently monitors emerging regulatory trends and participates in pilot programs and other industry initiatives to develop and document best practices and standards. Shannon frequently conducts high impact, multi-disciplinary training programs for her clients to help their cross-functional teams understand the requirements, nuances and challenges of eCTD regulatory submissions.
Shannon holds a Bachelor’s degree in History and Psychology from Cabrini College.
Allison Steffen has over 9 years of Regulatory Operations and leadership experience. She is well versed in the compilation and submission of eCTD applications. She has personally led over fifty Initial Applications, as well as hundreds of lifecycle sequences across multiple Global Health Authorities.
Prior to joining WAYS, Allison established a strong background in client service and account management. She became a proven leader in the Regulatory Operations department at Octagon Research Solutions/Accenture, and later served as Manager of the Regulatory Operations department at MMS Holdings.
Allison earned her Bachelor’s Degree in Biological Sciences from the University of Delaware, and completed a Dual Certificate in Medical Devices/Pharmaceuticals from the Regulatory Affairs Professionals Society (RAPS).
Allison Steffen
Submissions Lead