History of GCSG

A few years after she began her career, Jeri Weigand of 3M realized that she needed to find a way to broaden her knowledge base and also realized that there just weren’t any classes or training for people in the CTM (Clinical Trial Materials) area.

In the Spring of 1986 Jeri began looking for a forum that could address issues relating to clinical supply preparation. At that point, coursework and workshops on these topics were minimal to non-existent. She believed that as Maister stated in the book, Credibility by Kouzes and Posner, “Left untended, knowledge and skill, like all assets, depreciate in value-surprisingly quickly”.

She had tried, unsuccessfully, to get herself invited to a luncheon group of Clinical Trial Material (CTM) professionals that met on the East Coast where they discussed CTM issues (this latter became the Investigational Materials Discussion Group – IMDG). Jeri had been told that she could attend but kept getting put off. (She later reasoned that this was an “elite group” of representatives from the major Pharma companies, were Pharmacists by trade, and this was why she was never allowed to attend.) So, after three years of frustration at not being allowed to attend one East Coast meeting, Jeri decided to take things into her own hands and create her own group. She created an organization that would provide training and development for people in the Clinical Trials area. This organization became the Global Clinical Supply Group (GCSG, formerly Midwest Clinical Supplies Group MCSG).

To start, she took out the PDR and got the names and addresses of all of the pharmaceutical companies that looked like they might make products requiring clinical studies, and that were listed as operating anywhere except on the East and West coasts, (figuring it would be too far for those two areas to travel). She then sent a letter and questionnaire to those companies asking for interest in participating in a meeting regarding CTM topics and asked for volunteers to lead a discussion group. As Jeri recalls, letters were sent to approximately 60 companies.

The first letter about the GCSG meeting went out on March 1, 1988. The information stated that a meeting was planned as an informal gathering where people involved in clinical trial preparations could openly discuss state-of-the-art procedures for clinical supply preparation and documentation. Interested participants were asked to bring samples of packaged clinical supplies, showing types of containers, labeling, etc., for a display of samples from companies.

Workshops were planned on the following topics: Formulation of Clinical Supplies, GMP training, Controls & Documentation of Packaging Operations & Supplies; Packaging & Labeling Systems, and The Packaging Process/coordination of Clinical Supplies. The event also included a tour of Riker Laboratories. In the letter, Jeri asked for volunteers to assist her with facilitation of workshops and she ended up with assistance from Bob Shaffer at G.D. Searle, Myron Slotsky from Marion Laboratories, and Doris Balgoyen/Diane Hansen/Michele Ryan from Upjohn. They decided that a two day meeting would be the best venue. That first year, the GCSG meeting had 20 attendees representing 10 companies.

From there, Jeri asked for volunteers to serve on a steering committee and on October 10, 1988, Upjohn hosted the first steering committee meeting where they reviewed evaluations from the May meeting, discussed the roles of the steering committee, a name for the group, future plans such as how often to meet, the location, membership, format, topics, cost, etc. The first set of Bylaws was written, dated 10/10/1988, and the name of the group, objectives of the group, membership, meetings, steering committee size, terms and functional operations were established.

The group objectives at that time were:

1. To provide a forum for the open exchange of ideas and information (non-confidential) related to clinical supply preparation and packaging;
2. To promote closer professional relationships among personnel in the Global region engaged in clinical supply preparation and packaging;
3. To promote closer relationships between the clinical supply group and other segments of the Pharmaceutical industry.

Today GCSG is a very successful venture, currently in its 26th year, with over 55 companies and 150+ participants represented yearly. In the past 25 years, many CTM personnel have shared and been educated on the current issues in the CTM business and we believe the industry is a better place because of it.

GCSG Founding Member

Jeri Weigand

GCSG Steering Committee Charter Members, 1988-1992

• Doris Balgoyen – Upjohn
• Dorothy Dolfini – Marion Laboratories (later joined McNeil Consumer Products)
• Garnell Rogers – Reid-Rowell
• Bill Mercer – Merrill Dow – Cincinnati
• Jeri Weigand – 3M Pharmaceuticals

The GCSG membership began in 1988 with 20 attendees representing 10 companies attending the May 9-10th lst meeting.

In 1997 at the 10th anniversary meeting, there were 70 attendees representing 21 companies.

In 2009, more than 160 people representing 55 companies were in attendance.

GCSG Top Meeting Topics 1988-1991

Bar CodingContract Manufacturing of Clinical Supplies Streamlining Procedures Controls of Computer Generated Labels Shipping of Supplies Stability Guidelines Electronic Systems Returned Goods

Comparative Products/BlindingFormulation of Clinical Supplies GMP Training Controls & Documentation of Packaging Operations & Supplies Packaging & Labeling Systems Coordination of Clinical Supplies

The GCSG meeting has turned out to be one of the best forums to share, exchange and learn new information about clinical supplies, while benchmarking how the rest of the industry is doing with their clinical supply chain challenges.

Each year the reviews from meeting attendees are glowing and the membership and attendance continues to grow.

What is most fascinating is that even though the clinical supplies industry continues to evolve the topics are amazingly similar to the ones discussed during the very first meeting, in a group that Jeri Weigand pioneered more than 25 years ago.

Jeri Weigand
First GCSG Steering Committee Member

Steve Jacobs
GCSG Steering Committee Member