LT0A8330Mike Rutherford was awarded the 2014 Max Seales Yonker Member of the Year Award, which recognizes an ISPE Member who has made significant contributions to ISPE in the past year. Mike was recognized for his contributions specifically to the GAMP® community.

1What motivated you to pursue a career in the pharmaceutical industry?

 My first exposure to the industry was when I worked as a summer intern at Merck in West Point, PA.  I worked on projects in the R&D group that gave me a broad understanding of the pharmaceutical development process. I also saw how my interest in computer science could be applied to the laboratory and to this industry. The internship established my career direction in the pharmaceutical industry and resulted in my joining Eli Lilly and Company in 1988, where I have spent my entire 27-year career. Lilly’s focus on improving quality of life for patients, community service and philanthropy makes me proud to be associated with the company and this industry. We have a direct positive impact on peoples’ lives – I cannot think of any better reason to be motivated every day of your career.

2. What is your current position? Briefly describe what you do in this position.

 My current position at Lilly is Consultant – Laboratory and Quality Systems, Medicines Development Unit (MDU) – Business Systems Support. The MDU –Business Systems Support organization provides leadership and systems expertise to support key initiatives that maintain or enhance our Regulatory, Safety, Clinical and Product Research and Development (PR&D) operational needs. My primary focus is computer system support, including computer lifecycle management of laboratory systems, within the clinical and PR&D areas, as well as the ADME/ Tox/ PK-PD areas. I also support our Protect  Program focused on the security of our corporate Intellectual Property.

3. Describe your Volunteer experience with ISPE.

I have been an ISPE Volunteer for over 13 years primarily focused on GAMP ®. I held leadership roles in the GAMP ® Americas CoP Steering Committee for the past seven years and currently serve as Chair. I am also a member of the GAMP® Global Council and will take over as the Global Chair at this year’s Annual Meeting. This is quite an honor considering the individuals who have held this position like David Selby, Guy Wingate, and Randy Perez — many of whom have gone on to serve as prominent leaders within ISPE. I have also sponsored a number of Special Interest Groups within GAMP® and supported the publication of several GAMP® Good Practice Guides. I have been a speaker and session leader at numerous ISPE and GAMP® Conferences and currently serve as the Information Systems Track Leader for the 2015 Annual Meeting. I would say I am a very active ISPE Volunteer, which has been extremely rewarding and has allowed me to impact our industry in many ways.

4. How did you first become involved in ISPE?

I first got involved in ISPE and GAMP® in 2002 when I was asked to participate at a GAMP® Forum in San Francisco.  I presented in a round table discussion on recent FDA regulatory inspections focused on computer system validation and infrastructure qualification. Through that conference and some other factors, I became involved in the GAMP® Americas CoP and have become an increasingly active Volunteer in ISPE.

5. What is your favorite part of Volunteering with ISPE?

First is the relationships and contacts I have made as a result of volunteering in ISPE. Through ISPE and GAMP, I have the ability to interact with amazing industry experts and opinion leaders, many of whom I now consider colleagues and friends. My second favorite part is the impact ISPE has on our industry.  It is truly beneficial to work with colleagues and regulators across our industry to define best practices that align with regulatory expectations. This is not possible as individual companies, but only through an international society like ISPE.

 6. What do you like to do for fun? What are your hobbies?

I have several hobbies and fun activities I enjoy. I like to play golf, although I would still put myself into the “hacker” category. I also enjoy woodworking and have a lot of really neat “toys” to play with in my shop. And in my remaining spare time, which is not much, I enjoy fly fishing – although I am still very much a novice. It is one of my most relaxing hobbies and I hope to have more time to for it in retirement.

Do you know someone who deserves recognition for their dedication? Now is your chance to nominate them for one of this year’s ISPE International Honor Awards.  Awardees will be recognized at the Membership and Awards Breakfast on Tuesday 10 November in Philadelphia, PA, USA during ISPE’s Annual Meeting. Please submit your nominations by completing this simple form and submitting it to no later than 7 August 2015.