Edward J. Johnson is an attorney in private practice advising life sciences companies on regulatory compliance matters. He has served as outside counsel for pharmaceutical and medical device companies and in-house regulatory counsel for Stelex, Inc., a GE Healthcare Company.  He has also served in regulatory affairs and strategy roles with Thomson Reuters and Siemens Healthcare.  Prior to becoming an attorney, he began his professional career as a research chemist with Bristol-Myers Squibb.  Ed received his BS in chemistry from the University of Georgia, his MS in chemistry from Emory University, and his JD from The George Washington University.

Wireko Manu-Tawiah, Ph.D.
Principal Consultant and Owner
WMT Pharmaceutical Consulting Services
WMT Pharmaceutical Consulting Services provides microbiology and quality consulting services for pharmaceutical and biotechnology companies with proven ability for managing QC/QA programs in support of development, manufacturing, and testing of sterile and nonsterile drug products, biologics, and APIs; expertise in aseptic processing, contamination control, environmental monitoring, process simulation (media fills) studies, cleaning validation, sanitization and disinfection programs, and sterilization processes. The company has experience in quality and compliance auditing and is familiar with FDA, EMEA, ISO, ICH and other regulations, guidelines and industry practices.


Dan Matlis
President
Axendia
Daniel R. Matlis is the Founder and President of Axendia--a trusted advisor to Life-Science executives on business, technology, and regulatory issues. Dan’s career in Life Sciences spans nearly 20 years and has included projects in research & development, manufacturing, regulatory compliance, business development and information technology. Prior to founding Axendia, Dan was Vice President and General Manager at Stelex (now a GE Healthcare company)--a leading consultancy to life-science companies.  He started his professional career at Ethicon, Inc., a Johnson & Johnson Company.


Suzanne Polewaski-Berg
Director of Marketing
The Center for Professional Advancement
The Center for Professional Advancement is a widely recognized accredited technical training organization in the world, offering a comprehensive curriculum of over 350 public, client-site and online courses in 18 industries including: Pharmaceutical, discovery through production; Chemical; Food and Medical Devices.


Steven G Richter, Ph.D.
President & CEO
Microtest Laboratories
Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. The company’s expertise and processes enhance product safety and security, speed time to market, and minimize supply chain disruption.


Mark Schwab
Director of Method Development and Validation Chemistry
Pace Analytical Life Sciences
Mark Schwab has been with Pace Analytical for over 13 years and brings extensive experience in developing and validating analytical methods used to characterize materials used in the medical device and pharmaceutical industries. He is responsible for overseeing the activities associated with the development and validation of analytical technologies that comply with ICH and FDA regulated guidelines. He and his staff have developed testing services that meet the requirements of ISO 10993. He is an active member of the Association for the Advancement of Medical Instrumentation (AAMI) and is a voting member in AAMI/BE/WG 14 Material Characterization and AAMI/BE/WG 63 Sterilization Residuals Working Groups.


Steve Trinter
Director of Marketing & International Sales
Donatelle
Donatelle is  a developer and manufacturer of medical devices and a full service supplier of molded and assembled products for shipment worldwide. Its team of experts provides a complete, single source manufacturing package that encompasses: Cutting-edge technical innovation; ISO 9001:2000 and 13485:2003 certified systems; FDA-compliant engineering support and design services; In-house tool design, fabrication and maintenance; Proactive, flexible, and customized service; Contract manufacturing; On-time deliveries; and Lowest total cost solutions.


Sandy Weinberg, MD
Professor of Health Care Management
Clayton State University, Atlanta
Dr. Sandy Weinberg caps a 30 year career as a regulatory consultant, trainer, and advisory to regulatory agencies. He served as Vice President for Regulatory Affairs and Quality Assurance for Tivah Therapuetics; as Senior Director for Global Biodefense at GE Healthcare; and as Director of Bio-medical Entrepreneurship at Muhlenberg College. He now serves as a Professor of Health Care Management at Clayton State University, Atlanta, and is a recognized international expert on biodefense policy and vaccine development. Sandy is a member of the NIH Advisory Committee on Biodefense, an advisor to the Georgia State Defense Force on biodefense, and a consultant to the US Department of Defense and the US Department of Homeland Security.  He has authored 15 books and more than 100 articles.


Pascal Yvon
President
BioSciences Expansion, LLC
Pascal Yvon holds a Doctorate in Pharmacy from Paris University and an MBA from Rutgers University, and has over 20 years of experience working with international diagnostics, pharmaceutical, biotechnology, and cosmetics companies. An expert in implementation of new technologies, he speaks about microbiology at international conferences, has authored magazine articles and book chapters in industry reference publications, such as “The Encyclopedia of Rapid Microbiological Methods”. Pascal is a member of the Biotechnology Council of NJ (BioNJ), and is the founder and president of BioSciences Expansion, which specializes in working with small- to mid-sized companies in the life sciences industry, in sectors such as industrial and clinical lab diagnostics, medical devices, scientific instruments, lab equipment, and biotech and pharmaceuticals.


Rick Biros
President
Innovative Publishing Company, LLC
Rick Biros has over 25 years of B2B publishing experience.  He was the founder and a principal in Carpe Diem Communications, where he developed and launched three B2B publications, a conference and trade show. In 2007, John Wiley & Sons, Inc. acquired Carpe Diem and continues to publish PFQ, Food Quality and Contamination Control. Rick continues his entrepreneurial interests with the formation of Innovative Publishing Co. and the launch of MedicalDeviceSummit.com, which publishes news, technology, trends, regulations, and opinions, apart from offering educational, career advancement and networking opportunities to the global medical device and diagnostics industry, facilitated through ePublishing, digital and live events.


Sangita Viswanathan
Editor-in-Chief
MedicalDeviceSummit
Sangita has over a decade’s experience working in publishing and PR. She holds a Bachelors degree in Life Sciences, a Masters degree in Journalism, and an MBA. Starting her career at a business publication in India, she rose from the ranks of a business correspondent to a vice president. She later worked with Carpe Diem Communications in the U.S., where she was the Editor-in-Chief for Pharmaceutical Formulation & Quality. She subsequently moved to global public relations firm Burson-Marsteller in New York, where she advised healthcare clients; followed by a brief stint the Clinton Foundation as a program manager. Sangita presently creates and manages content for MedicalDeviceSummit.com.