Summit Chairs


Kalah Auchincloss
Executive VP and Deputy General Counsel
Greenleaf Health

David Chesney
Principal and General Manager
DL Chesney Consulting LLC

Eric Henry
Sr. Quality Systems & Compliance Advisor
FDA & Life Sciences Practice, King & Spalding

Michelle Webb
Vice President, Avoca Quality Consortium
Avoca, A WCG Company

FDA Speakers


Elizabeth Miller
Asst Commissioner Medicals Products & Tobacco Ops
US FDA

Simone Pitts
FDA National Expert, Pharmaceutical
US FDA

Francisco Vicenty
Program Manager, Case for Quality
CDRH, FDA

Daniel Walter
Policy Analyst
US FDA

Speakers


Jeff Ballyns
Associate Director, Regulatory Policy, Public Affairs
Becton Dickenson

Thomas Berry
Senior Vice President, Regulatory Compliance
Greenleaf Health, Inc

Ron Branning
CEO
GXPQS LLC

Cathy Burgess
Partner
Alston & Bird

Trevor Cole
Associate Director
WCG

Bob Darius
Head of Compliance Specialty Care
Sanofi

Patrick Day
Principal Consultant
Lachman Consultants

Ted Finlan
Senior Vice President for Project Planning and Administration
Worldwide Clinical Trials

Christopher Gates
Director of Product Security
Velentium

Karen Harvey
Senior Director, Avoca Quality Consortium
Avoca, A WCG Company

Neala Lane
Associate Director, Quality Improvement Office
Indiana University

Julie Larsen
Principal & COO
BioTeknica, Inc.

Grace McNally
Senior Vice President
Greenleaf Health, Inc.

William Mestrandrea
Senior Director, Global GMP/GDP Audit
Bristol Myers Squibb

Téa Romero
Client Success Manager
Clario

Mark Schwartz
Director
Hyman Phelps

Gary Shorter
Senior Director of Emerging Technology and AI
IQVIA Tech

Kamal Sigel
Vice President, Quality
CymaBay Therapeutics. Inc

Kara Stockett Quinn
Senior Consultant
ValSource Consulting

Linda Sullivan
Senior Advisor, Metrics & Performance Management
WCG

Sarah Tanksley
President and CEO
Tanksley Consulting

John Taylor
President; Principal of Regulatory Compliance
Greenleaf Health, Inc.

Scott Thiel
Global Head of Regulatory Policy and Intelligence
Hologic

Kim Trautman
Managing Director and Vice President
MEDIcept, Inc.

Jeff Yuen
Founder, President and CEO
Jeff Yuen & Associates, Inc.