About Us

We are proud to have assembled a world-class team that brings more than 200 years of combined success

Regulatory Pathways Group has assembled a team of more than 30 consultants. Our consultants come from diverse backgrounds in industry, academia, medicine, and regulatory agencies.

Many of our consultants have worked together closely for years, giving Regulatory Pathways unique cohesion and synergy. As individuals, our experts offer specific and narrowly focused knowledge and functional expertise, but when combined, we bring a holistic perspective from overlapping years of practical experience and teamwork. We are passionate about our craft and we strive to generate value for our clients.
REGULATORY PATHWAYS GROUP

Executive Team

Robert_ Lee Kram MD MSE
Lee Kramm MD, MSE
Founder, President, Chief Strategist and Medical Officer
Lee Kramm is a Board-certified ophthalmologist and regulatory professional who served as a medical officer and senior reviewer…
maureen johnson executive rpgi
Maureen Johnson, RN
Founder, Senior Vice President of Consulting Resources & Program Management
Founder, Senior Vice President of Consulting Resources & Program Management Maureen Johnson is a research nurse and medical…
Kimberly Krueger
Kimberly Krueger
Vice President of Operations & Client Services
Kimberly Krueger is an attorney with a background in banking and tax law and small business operations……
REGULATORY PATHWAYS GROUP

Regulatory Strategy Team Members

Lee Kramm MD, MSE
READ MORE
Don Calogero, MSE
READ MORE
Maureen O’Connell
READ MORE
Anne Marie Ripley
READ MORE
Tonya Porter
READ MORE
Ginger Clasby, MS
READ MORE
REGULATORY PATHWAYS GROUP

Regulatory Affairs Team Members

Don Calogero, MSE
READ MORE
Maureen Johnson, RN
READ MORE
Debbie Richards
READ MORE
Greg Spooner, PhD
READ MORE
Gary Mocnik
READ MORE
Amanda Culver
READ MORE
Artemis Ailianou
READ MORE
REGULATORY PATHWAYS GROUP

Clinical Team Members

Drs. Eeke Romo, MSc
READ MORE
Lee Kramm MD, MSE
READ MORE
Don Calogero, MSE
READ MORE
Maureen Johnson, RN
READ MORE
Maureen O’Connell
READ MORE
Anne Marie Ripley
READ MORE
Tonya Porter
READ MORE
Gretchen Neumann
READ MORE
Sandhya Subramaniam, MS
READ MORE
Ginger Clasby, MS
READ MORE
Kelly Soprych
READ MORE
REGULATORY PATHWAYS GROUP

Statistics Team Members

Yi-Jing Duh
READ MORE
John Reber, PhD
READ MORE
Michael Burak
READ MORE
Jason Schroeder
READ MORE
REGULATORY PATHWAYS GROUP

Quality Team Members

Jennifer Asleson
READ MORE
Gary Mocnik
READ MORE
Rudy Zacher
READ MORE
Artemis Ailianou
READ MORE
REGULATORY PATHWAYS GROUP

Medical Writing Team Members

Drs. Eeke Romo, MSc
READ MORE
Maureen Johnson, RN
READ MORE
Laura Fletcher, PhD
READ MORE
Sandhya Subramaniam, MS
READ MORE
REGULATORY PATHWAYS GROUP

Our Subject Matter Experts Team

Maureen Johnson, RN
READ MORE
Debbie Richards
READ MORE
Jennifer Asleson
READ MORE
Greg Spooner, PhD
READ MORE
Rudy Zacher
READ MORE
Arkady Glukhovsky
READ MORE
Richard Cook
READ MORE
Brian Bone, MS
READ MORE