Pearl IRB Board

Gretchen E. Parker PhD, RAC, CIP | Co-Chair

Dr. Parker serves as a co-chair board member of Pearl IRB and provides regulatory and clinical research support services for Pearl Pathways’ clients. More about Dr. Parker.

Jason Henderson, DO, JD | Co-Chair

Dr. Henderson serves as a co-chair board member of Pearl IRB. As a member of Pearl IRB, Dr.
Henderson assumes responsibilities for approving, monitoring, and reviewing medical and
behavioral research involving humans. More about Dr. Henderson.

Ariane Stallard, M.S.

Ariane Stallard serves as a nonscientific board member for Pearl IRB and has over 20 years of diverse business experience. Her expertise in communications and training enable her to her make important contributions and enrich IRB insight. Ariane’s work experience includes such organizations as Macy’s and Flagstar Bank. She currently works with companies and employees to increase performance and profitability as an Account Executive at Ivy Tech Community College. Ariane is also highly involved in the Indianapolis community as a volunteer at J.R.’s Food Pantry and Girls Inc., teaching and motivating youth to have strength, confidence, and the courage to make positive changes in their lives. Ariane earned her undergraduate degree in Business Management from Indiana University, and a Masters of Science in Management with a concentration in Strategic Planning from Indiana Wesleyan.

Roberta J. Smithey

Roberta Smithey serves as a key board member with over 30 years experience in clinical research and product development. Roberta’s extensive sponsor experience ranges from large multinationals to start ups, which allows her to bring a strong sponsorship perspective to the board. Roberta has been the Director of Regulatory Affairs at a startup biotech where she was responsible for all aspects related to Regulatory global operations and submissions. She has 25 years experience related to the planning, implementation, and process of completing global regulatory submissions. She provides expertise on CTD and eCTD formats, risk management, and post submission activities. She has been directly involved in most major submissions made by Eli Lilly and Company during her tenure there. As a member of the original Lilly regulatory component, Roberta established the first centralized submission team. Her expertise in clinical trials also spans protocol development, CRF design, data capture and edits, as well as authoring integrated documents and labels for submissions. Roberta is a graduate of the University of Indianapolis.

Todd G. Vare, JD

Todd Vare is a trial and appellate lawyer with a national litigation practice focused on intellectual property and business disputes involving patents, trademarks, copyrights, trade secrets, IP and technology licensing, software development, data protection and privacy matters.

IP Litigation Experience

Mr. Vare’s patent litigation experience includes a wide variety of technologies, including Internet-based systems and processes, online retail systems, telecommunications, integrated circuits, software, cellular antenna systems, pharmaceuticals, medical devices, herbicides and pesticides, dielectric fluids, and mechanical devices. Mr. Vare has led teams in jury trials and argued numerous Markman and summary judgment hearings. Mr. Vare also has litigated business disputes involving trademarks, copyrights, and trade secrets. He has been listed since 2012 in the Best Lawyers in America for Intellectual Property Litigation and Patent Litigation. In 2017, Mr. Vare was recognized as a “Lawyer of the Year” by The Best Lawyers in America for his work in Patent Litigation. and is consistently recognized as an Indiana Super Lawyer in Intellectual Property.

Read more: http://www.btlaw.com/todd-g-vare/

Patti Hunker, MS, ATC, CCRC

Patti Hunker serves as a Clinical Research Advisor for Pearl Pathways. She has over 10 years of clinical research experience in both biologic and device trials. Previously, she was the Director of Research and Education at the Methodist Sports Medicine Research and Education Foundation. Hunker has extensive expertise in the orthopedic industry and has practiced as an athletic trainer. She is also adept at medical writing, protocol development, GCP quality systems, and negotiating contracts and budgets for industry sponsored studies. Hunker also served on an academic IRB Board for five years.

As a Clinical Research Advisor for Pearl Pathways, Hunker provides both clinical research associate and clinical research coordinator services for clients, builds GCP compliant quality management systems, executes internal and vendor audits, offers medical writing services, and supports remediation assistance for clients. She also assists with administration of Pearl IRB and serves on the IRB Board as a scientific member and primary reviewer.

Hunker received her Masters of Science Degree, Athletic Training from Indiana University. She has co-authored several journal articles, has received a patent for an orthopedic shoulder brace and has a certificate in medical writing and editing from the American Medical Writers Association (AMWA). Patti is an active certified member of the Association for Clinical Research Professionals (ACRP) and a member of the National Athletic Trainers Association (NATA).

Mary Anne Gfell, MBA, CCRP

Mary Anne Gfell serves as a Regulatory Compliance Advisor for Pearl Pathways. She has over 15 years of managing pharmaceutical and medical device product development, non-clinical and clinical research, and leading teams. She is a certified and experienced project manager having led complex multidisciplinary programs both in her work at Covance and Indiana University.

Previously, she was a Global Project Manager for Covance, a multi-national CRO where she managed central laboratory services global trials. She led a cross functional team and managed complex global trials requiring her to integrate multiple stakeholder’s goals, complex regulatory requirements, and aggressive deadlines. She is adept at regulatory requirements, clinical trials, medical and technical writing, creation and oversight of GXP quality systems, and project management for outsourced services for pharmaceutical companies.

Gfell received her Masters of Business Administration and Bachelors of Science from Indiana University. Gfell holds her project management certification and is an active certified member of the Society of Clinical Research Associates.

Adjunct Board Members

We staff our adjunct board to ensure we always have a quorum and the breadth of therapeutic or scientific knowledge required for your study.

Advisors

While our advisors do not vote, they do attend meetings and consult with our board to provide their knowledge and specific areas of expertise on an as needed bases.

Contact us for more details about our staff.

IRB Roster

Do you need a copy of the Pearl IRB Board Roster? Request the roster online or call us at 317.899.9341, extension 103.

The office is open during normal business hours of 8am to 5pm EST except the following holidays:

  • New Year’s Day
  • Memorial Day
  • July 4th
  • Labor Day
  • Thanksgiving
  • The day after Thanksgiving
  • December 23rd
  • December 26th
  • January 2nd