May 31-June 2, 2022


Tuesday, 31 May
17:00 CT
Registration Desk Opens

18:00—19:30 CT
Join us on the third floor at the Hilton for our Welcome Reception for networking, cocktails and hors d'oeuvres.

Wednesday, 1 June
8:00—9:00 CT

9:00—9:45 CT
Opening Keynote: Times are Changing & So Should We
Join the opening keynote for a new Veeva Product Announcement and to hear Ravyn Miller discuss the changing world we live in and why change is necessary, challenging, and exciting.
Ravyn Miller
Vice President, DS Portfolio Strategy and Business Development

10:00—10:45 CT
Illumina will share how creating a clinical center of excellence has improved global collaboration resulting in faster and higher quality study data delivery and speed to market.
Matthew Purner
Sr. Director, Regulatory & Clinical Affairs
Illumina, Inc.
Kellie Hazell
Sr Manager, Clinical Affairs
As medtech evolves, there are various trends across regulatory affairs helping to shape the future. Learn about the top trends and hear about Alcon's regulatory transformation, best practices, and lessons learned.
Lori Holder
Senior Director, Regulatory Operations
MDIC's Case for Quality Collaborative Community is a public/private partnership among the FDA, healthcare providers and the medical device industry. Its Leadership Engagement initiative has identified several key factors contributing to compliance, performance and quality outcomes, including the use of metrics and benchmarking to help MedTech organizations enhance visibility, foster data-driven decisions, make process improvements, and maximize patient safety & product efficacy. Please join Pat Shafer, Managing Director of FTI Consulting, to hear the genesis of this initiative, the challenges that the industry faces, and what good looks like.
Patterson Shafer
Managing Director
FTI Consulting
Hear perspectives from Roche Diagnostics on the evolving role of medtech marketing and how an effective digital asset management strategy and modernized processes are critical to support the industry change.
Ayaz Malik
Group Marketing Manager
Roche Diagnostics Corp.

10:45—11:15 CT
Networking break with peers.

11:15—12:00 CT
Learn how Lucid Diagnostics, a small medtech, is leveraging technology across clinical to speed study build, ease execution, and scale for the future.
Christine Miller
Manager of Clinical Data Management
PAVmed Inc.
USDM shares insight into the growing UDI landscape, and the similarities and differences of various UDI regulations; as well as discuss EUDAMED an other emerging regulations challenging Medtech.
Jay Crowley
VP, Medical Device Solutions and Services
USDM Life Sciences
Hear industry experts on current market insights and dynamics in Supplier Quality Management, where they discuss the current state of the union, their challenges, future outlook, as well as how technology can play an important role in overcoming those challenges, maximizing efficiency, and elevating the discipline to the next level.
Scott Nilsen
Sr. Manager – Supplier Quality Systems
Boston Scientific
James Markfort
IT Manager, Corporate Quality & Regulatory Systems
Boston Scientific
EUMDR has increased the focus on claims across medtech. Hear how BD is applying systems thinking overhaul global claims management tools and processes to support change management efforts.
Montoya Love
Assoc. Director, Regulatory Operations & Systems

12:00—13:00 CT
Second floor

13:00—13:45 CT
Insights on the future of digital health from the patient, provider and manufacturer perspective with data from a recent MDIC survey. Hear perspectives from Exact Sciences, Veeva, and patient, Heidi Douhse, on engaging patients, how to leverage patient data, and transforming to propel digital health forward.
Alexandra Massoud
VP, Clinical Affairs
Exact Sciences
Heidi Dohse
President & Founder
Tour de Heart
EU MDR and IVD regulations have created operational challenges for medtech including portfolio rationalization and significant change assessments. Join for insights from Cook Research on their approach to address these new regulations to remain competitive and compliant.
Ann Zarubaiko Sturgill
Regulatory Operations, Global Director
Cook Medical
Panel discussion on industry trends in the field of postmarket surveillance, how technology is evolving to better support the process, and best practices for success that everyone should consider.
Janna Parks
Sr. Director, Customer Quality & Compliance
Rajesh Misra
Speed is critical for commercial content success. Industry leaders will bring marketing, medical and regulatory perspective to the advertising promotional review process.
Jim Wilson
Sr. Director, Digital Marketing Transformation and Customer Communications
Cardiovascular Systems, Inc.
Kathryn Nichol
VP Clinical and Medical Affairs
Larry Litle
Sr. Director Global Regulatory Affairs
Baxter Healthcare

14:00—15:00 CT
See the new features across Vault Clinical Operations, including eTMF, CTMS, and Payments, and how to leverage these capabilities to improve clinical operations and trial performance.
Product Roadmap: Vault RIM
Product Roadmap: Vault Quality
Join this session to hear about a new product, available later this year, Vault CRM for MedTech.

15:00—15:30 CT
Connect Break

15:30—16:15 CT
Join this panel session for perspectives from Terumo, Abiomed, and ConvaTec on enterprise-wide implementation and adoption of digital solutions across clinical operations.
Jason Parsell
Sr. Manager, Clinical Data Management
Casey Mnich
Manager, Clinical Systems
Anne Swearingen
Adjunct Professor and Independent Consultant
St. Cloud State University
Exchange thoughts, approaches, and experiences on the regulatory challenges of new regulations and portfolio rationalization.
Interactive discussion on risk management as part of quality management and the impact of the proposed changes to QSR, including how to rethink processes.
This two-part session will highlight the Vault PromoMats product roadmap, including modular content; followed by an interactive discussion on the connections with CRM and PromoMats to drive commercial excellence.
Discussion with Veeva Business Consulting leaders to understand how to plan for an manage organization change.

17:30—18:30 CT
Join us for networking, cocktails, and hors d'oeuvres on the third floor at the Hilton.

18:45—23:00 CT
Join us immediately following the networking reception for more networking, food, and fun at the Punch Bowl Social. Transportation will be provided from the Hilton to the Punch Bowl beginning at 6:45pm departing every 15 minutes. Return transportation will run from 8:30 pm until 10:45 pm.

Thursday, 2 June
8:00—9:00 CT

9:00—9:45 CT
See the new features across Vault Clinical Data (EDC), and how to leverage new capabilities to speed study build and optimize clinical data management.
A panel session on changing regulations (QMSR, MDR, IVDR) and the increasing need for sustainable digital quality transformation. We will hear from Cardinal Health and PwC on challenges, considerations, and success practices in transforming quality by leveraging digital technologies in a time of changing regulatory landscape.
Steve C de Baca
Chief Patient Safety and Quality Officer
Kareem Elwakil
Hear perspectives from regulatory affairs and IT leaders at Exact Sciences, Baxter, and Cook on moving to a global, digital RIM approach including process and system updates. Best practices for building the business case for RIM, ensuring adoption, and metrics to enhance regulatory operations.
Ram Iyer
Senior Director, Global Regulatory Science - MedSurg
Cook Medical
Jaya Vaishnav
IT Project Manager
Exact Sciences
Kelly Barbeau
Regulatory Affairs Manager
Exact Sciences
Hear about Exact Sciences' growth journey from the commercial leadership perspective, including vision, strategies, and lessons learned across their organizational change.
Chris Larsen
Director, Commercial Services
Exact Sciences

10:00—10:45 CT
Best practices and lessons learned from Edwards' TMF evolution across divisions, countries, and business practices including working in a new climate during and coming out of the pandemic.
Brenda deJesus
Director, Clinical Systems Operations
Edwards Lifesciences
Global adoption of software as a medical device brings additional regulatory requirements and cybersecurity concerns. Join this session for best practices on incorporating a cybersecurity framework into your total product lifecycle.
Brian Edwards
Principal Specialist - Digital Health / Cybersecurity
Boston Scientific
Seth Carmody
VP, Regulatory Strategy
A modern, enterprise-ready learning management system (LMS) is a foundational element in any digital quality transformation. Please join Nicole Donovan of Tolmar, Inc. and Kent Malmros of Veeva Systems to hear how an LMS can help streamline business processes and increase training effectiveness when it's unified and connected with Quality; the resulting efficiency gains will enable organizations to focus on what truly matters - improving processes, people, products, and patient outcomes. We will hear Tolmar's journey on what drove the modernization efforts, the success practices utilized before, during, and after the implementation, their lessons learned, and the value delivered via this transformation.
Nicole Donovan
Director, Organizational Development
Tolmar Inc.
BD, Exact Sciences, and Roche Diagnostics share their experience and best practices for driving commercial content management excellence in this panel discussion.
Montoya Love
Assoc. Director, Regulatory Operations & Systems
Ayaz Malik
Group Marketing Manager
Roche Diagnostics Corp.
Chris Larsen
Director, Commercial Services
Exact Sciences

10:45—11:15 CT
Connect Break/Refreshments

11:15—12:00 CT
Closing Keynote: Preparing for Digital Transformation
We'll wrap up Summit with a panel discussion from both the business and IT perspectives of digital transformation, including thinking about change and the disruption of moving to a digital approach.
Carissa Rollins
Chief Information Officer

12:00—13:00 CT
Lunch and Networking