Life Science Future – MedTech Speakers

Supply Chain Globalization or Localization in a Post-Pandemic Era? | 10:15 am – 10:45 Friday, July 17

Mr. Albert DeRitis is an Assistant Clinical Professor at Drexel LeBow College of Business. He brings over thirty-five years of unique & diversified experience in accounting, finance, and supply chain in the healthcare industry. He has an in-depth understanding of domestic and international marketplace dynamics across Supply Chain, Commercial Sales & Marketing, and R&D organizations.

Most recently, he served as Worldwide Supply Chain Product Management Director for Johnson & Johnson, where he was responsible for all aspects of Life Cycle Management and End-to-End (E2E) supply chain for J&J’s top selling pharmaceutical product across 111 markets, impacting 2.7 million patients worldwide.

Mr. DeRitis previously served as Worldwide Financial Controller for a French Pharmaceutical company. He possesses knowledge in both Chemical (small molecule) and Biologic (large molecule) API business models, and has manufacturing plant experience in both environments.

• Executive Faculty Member for LeBow College of Business
• MBA from St. Joseph’s University Haub School of Management
• Certified Public Accountant (CPA), Certified Supply Chain Professional (CSCP), and Chartered Global Management Accountant (CGMA).
• Courses include: Essentials of Financial Reporting for MBA/EMBA, Operations & Supply Chain Management, Cost Accounting, Advanced Cost Accounting, Strategic Cost Management, Integrating Supply Chain with Financial Management, and Strategy & the Master Budgeting Process

Managing Clinical Trials for Start-Up Companies: Making the Most of What You Have | 12:00 pm – 12:30 pm Wednesday, July 15

With more than 15 years of experience managing all phases of clinical research for medical devices, Mr. Marc Penna started with Intact Vascular in 2015 and Vesper Medical in 2016 and is responsible for creating short-and long-term clinical strategies with a focus on enhancing trial enrollment. He has held both executive and clinical data/clinical trial program management roles within the cardiovascular, endovascular and oncology therapeutic areas.

Previously, he served as the Senior Director of Clinical and Medical Affairs at AngioDynamics, where he was responsible for all global clinical activity. Earlier in his career, Mr. Penna worked on the transcatheter aortic valve replacement (TAVR) pivotal trials at Edwards Life Sciences as well as on the drug eluting stent program at Boston Scientific.

Mr. Penna holds a B.S. in Management Information Systems from Central Connecticut State University.

Supply Chain Innovation: 3D Printing | 12:45 pm – 1:15 pm Thursday, July 16

David Dalessandro is a new product development leader who developed and commercialized over 20 medical devices in the cardiovascular, surgical, orthopedic, diagnostics and consumer markets. He was a pioneering member of the Johnson & Johnson startup venture that developed the first cardiovascular stent changing the standard of care in cardiac revascularization and becoming the fastest medical device to achieve $1B in sales.

During his 30+ year career with J&J David held several leadership positions in R&D, Project Management and Supply Chain across the medical device, pharmaceutical and consumer sectors of J&J. He is currently the Technology Transfer Director with J&J Supply Chain Strategy Innovation & Deployment, responsible for the application of 3D printing technologies.

David holds a BS in Mechanical Engineering and an MS in Engineering Management, both from New Jersey Institute of Technology. He is a Certified Project Management Professional (PMP) and holds a Certification in Innovation and Entrepreneurship from Stanford University.

COVID-19: Testing, Testing, Testing | 11:00 am – 11:30 am Thursday, July 16

Susan Van Meter is executive director of AdvaMedDx. AdvaMedDx represents manufacturers of in vitro diagnostic (IVD) tests and technologies. AdvaMedDx member company innovations allow early detection of disease, facilitate evidence-based medicine, improve patient health and health care, and enable personalized medicine, while often lowering overall health care costs. AdvaMedDx is the only advocacy organization exclusively addressing policy issues facing diagnostics manufacturers in the U.S. and around the world. 

AdvaMedDx operates as a division of AdvaMed, the Advanced Medical Technology Association. AdvaMed is the world’s largest medical technology association, with over 400 member companies that develop medical devices, diagnostic tools, and health information systems. 

Prior to joining AdvaMedDx in 2018, Ms. Van Meter served as senior vice president at the Healthcare Association of New York State (HANYS), focused on hospital and health system policy, payment, quality and health information technology priorities. Ms. Van Meter has an undergraduate degree in Political Science and French from Villanova University and a MA in Political Science from Boston University. 

COVID-19 Impacts on Supply Chain | 10:15 am – 10:45 am Wednesday, July 15

Marla founded Xavier Health in 2008 at Xavier University, where she advances the industry with FDA officials and Pharmaceutical and Medical Device professionals. Marla began working in the pharmaceutical industry for Merck in 1996 where she took on roles of increasing responsibility, culminating in the position of Head of Quality Operations at the Merck North Carolina facility. Additionally, Marla is the Founder, CEO and President of Pathway for Patient Health, leading the implementation of a Quality Science Education program that is free for undergraduate and graduate students around the world, and is working with Chief Quality and Operations Officers to Mobilize Enterprise-wide Effectiveness. Marla holds a B.S. in Chemistry from Xavier University, and a Ph.D. in Organic Chemistry from the University of North Carolina – Chapel Hill.

Supply Chain Virtual Audits: Temporary Change or Permanent Impact? | 11:25 am – 11:55 am Wednesday, July 15

Jim Fries is a success based executive with over 25 years of experience building medical device and diagnostic companies. He became CEO of Rx-360 in February of 2018. Jim’s dedication to healthcare supply chain security and patient safety has always been his personal mission. In 2020 Rx-360 also founded the Rx-360 Education and Research Foundation (501c3) that is dedicated to bringing awareness of patient safety to everyone worldwide through educational programs and research. His personal vision coupled with the Rx-360 mission brings a wealth of awareness and success to all Rx-360 members and the industry as a whole.

The Impact and Implications of 1 Year Delay in EU MDR Date of Application | 10:50 am – 11:20 am Wednesday, July 15

Gert is an expert in European regulations based on 18 years hands-on working in the field, as auditor, product reviewer, regulatory specialist, Head of notified body and strategic consultant. He has been leading the Notified Bodies in Brussels for many years, and has strongly supported the regulatory debate with the EU Commission, EU Parliament and the EU Council of Ministers. He combines strong experience in quality, compliance and regulations with a pragmatic, result driven approach at both operational and strategic level. From his PhD in Biomaterial Sciences, and PostDocs in controlled release of drugs
and gene therapy, he has dealt as technical reviewer and consultantwith a large range of devices mostly in the non-active device area. For his contributions to the regulatory profession he has been awarded as Fellow of RAPS. Gert is president-elect of RAPS, and serves as board member of RAPS Europe.

BARDA and Medical Devices: How We Approach Platform Development | 12:10 pm – 12:40 pm Thursday, July 16

Ms. Bonnie is a Project Officer from Biomedical Advanced Research and Development Authority (BARDA) a component of the Office of the Assistant Secretary for Preparedness and Response in HHS. BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. Ms. Shen joined BARDA in November 2010 focusing on product development specifically for Medical Devices and Diagnostics.  Since joining BARDA, Ms. Shen has successfully lead multiple products from early stage development through FDA clearance/authorization, and eventual acquisition into the Strategic National Stockpile, including an all hazard ventilator for pandemic use, a ZIKA blood screening diagnostic, and a COVID-19 point of care diagnostic.  Ms. Shen’s current portfolio includes respiratory masks and devices, point of care influenza, COVID 19 diagnostics, and  biothreat diagnostics.  Prior to joining BARDA, Ms. Shen focused on product development for global health in Africa and Asia. Ms. Shen has a  Bachelor of Arts in Economics from University of Michigan and  Masters of International Health from Brandeis University.