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Meet the Scientific and Regulatory Experts

The knowledge and resources gained from our expertise will add value to your research investments

Cardinal Health Specialty Solutions is comprised of more than 150 scientific and regulatory consulting experts, averaging 15 years of industry and FDA experience and training. Our team is proficient in all areas of drug development and provides strategic pharmaceutical development services to help companies obtain global product approval and maintain filings throughout the entire product lifecycle. We’ve had successful interactions with global regulatory agencies and have worked with every review division of the FDA. Visit the profiles below to get to know some of our experts!

Biographies

Stephen Amato

Stephen Amato, PhD, MBA, RAC, is Managing Director, East Coast Operations, for the Regulatory Sciences group of Cardinal Health Specialty Solutions.

Diane Beatty

Diane Beatty, PhD, specializes in regulatory affairs and is an industry expert on orphan drugs and the FDA expedited programs.

Gina Burgess

Gina Burgess specializes in authoring clinical and regulatory documents used for in clinical trials and regulatory applications.

Kimberly Frieze

Kimberly Frieze has more than 23 years of experience in the pharmaceutical industry, focusing in clinical research and medical writing.

Chris Kavlick

Chris Kavlick has more than 22 years of experience with general drug development and business development management.

Boyd Lund

Boyd Lund provides regulatory consulting services for CMC pharmaceutical product development and performs global compliance audits.

Beth Minter

Beth Minter has more than 28 years of experience in the pharmaceutical industry, specializing in CMC product development.

Lavonne Patton

Lavonne Patton has more than 29 years of experience in the pharmaceutical industry and specializes in nonclinical drug development.

Todd Phillips

Todd Phillips, PharmD, RAC, has extensive experience preparing New Drug Application submissions and participating in FDA meetings.

Gina Ross

Gina Ross has extensive experience with regulatory submission operations and electronic Common Technical Document (eCTD) format.

Wayne Vallee

Wayne Vallee, RPh, MBA, RAC, has more than 32 years of experience in pharmaceutical formulation development and regulatory affairs.

Holly Winchell

Holly Winchell has 20 years of experience in the pharmaceutical industry focusing on animal health product development.

Rick Angelo

Richard Angelo, PhD, helps companies ensure compliance with FDA regulations, specializing in Good Clinical Practices.

Christine Bentley

Christine Bentley has more than 27 years of experience developing regulatory strategies and providing CMC consulting expertise.

Brian Cudney

Brian Cudney specializes in developing global regulatory strategies, compliance, technical writing and formulation development.

Laurie Henricks

Laurie Henricks has extensive experience with the compilation and publishing of pre- and post-approval regulatory submissions.

Bill Kelce

William Kelce, MS, PhD, leads nonclinical development programs from discovery to approval and authors regulatory applications.

Stan McDermott

Stan McDermott, PharmD, MS, RPh, specializes in clinical development planning and clinical trial design and management.

Greg Onyszchuk

Greg Onyszchuk has more than 30 years of technology and life sciences experience, specializing in New Drug Application submissions.

Jignesh Patel

Jignesh M Patel, PhD, has extensive experience in the pharmaceutical industry, specializing in pharmacokinetics, clinical pharmacology and regulatory strategy.

Tom Rosanske

Thomas Rosanske, PhD, has more than 35 years of experience in the pharmaceutical industry, specializing in CMC product development.

Kathy Scott

Kathy Scott has been in the drug development industry for 28 years with roles in clinical trial management and clinical operations.

Debra Webster

Debra Webster, PhD, has more than 25 years of scientific and regulatory consulting expertise gained from industry and FDA training.