A conversation with Gary Hutchinson, Founder and President Modality Solutions and Daniel J. LittlefieldFounder and VP Engineering

As a founder and the President of Modality Solutions, Gary Hutchinson has developed logistics processes and managed supply chain professional organizations in a variety of industries.

Daniel Littlefield is a founder of Modality Solutions. He has helped establish Modality Solutions as an innovator in the cold chain logistics industry. Dan recently headed up Modality Solutions’ CDC-sponsored Ebola clinical trial operations project in Sierra Leone and NIH-sponsored clinical trial operations project in Liberia in 2015 and 2016.

  1. What do you hope attendees will gain at your event’s?

Gary: I hope attendees get a deep understanding on how to meet the changing regulatory expectations for monoclonal antibodies and most recently for the new class of immunotherapies. Expectations on drug product testing, the role of simulation and the changing requirements on the role of ASTM testing is all critical to new therapy approval.

Dan: I feel like we’ve really raised the bar on technical rationale for why and how we do simulation testing, and I’m excited to share our thoughts on how it all fits together. We want to share how our validation methodology flows logically from risk assessment through qualification results, and how the logic can be applied to the full spectrum of new treatments.

2. What discussions do you look forward to having with the attendees?

Gary: We love getting and sharing feedback received from regulators around the globe on cold chain validation strategies and expectations on execution. It’s great to see more and more harmonization on a global approach to cold chain validation focused on the patient. We are uniquely positioned to share information because of our involvement in cold chain validation for more than 75 therapies in the last 18 months, but we always love to learn about your experience, too!

Dan:  We work with a lot of very smart people in the industry who are developing new therapies, and a webinar like this helps us to broaden our knowledge base regarding the latest nuances in therapies.  Industry innovation is increasing, and we need to stay sharp about what’s out there, and what’s on the way, so we can ensure the robustness of all the work we do.

3. What do you enjoy most about your role?

Gary: Without a doubt, we love helping our clients navigate an increasing complex cold chain for the latest therapies. We enjoy being involved early in clinical trials to simulate the transport environment on early stage therapies and being part of great teams all the way through approval.

Dan:  We have a great team of engineers, and we’re always working to ensure client success.  We’re always excited when we hear of a successful submission or clinical trial, because we know we’ve done our part to make sure our clients’ patients are getting great new therapies.  Also, because I am an engineer, I personally enjoy the more technical aspects of our work.

4. How did you get into the industry?

Gary: My career in supply chain and logistics started more than 25 years ago after graduating from The Ohio State University in Columbus, Ohio with a master’s degree in business logistics and finance. I entered the life sciences industry in 2000 as part of the great medical device manufacturing team at Edwards Lifesciences.

Dan:  I’ve been an engineer for more than 30 years.  I’ve had a colorful career with a lot of great experiences.  I was fortunate to get my master’s degree in chemical engineering, which has given me more depth in my technical skills.  In addition, my 18 years with DuPont were great to broaden my skillset and address the more practical aspects of statistical and mathematical modeling, heat transfer, and thermodynamics.  As a founder of Modality Solutions, I’ve worked with almost every client, giving me a solid base in the biopharmaceutical industry.

5. Where is your favorite place in the world and why?

Gary: My favorite place in the world is blue water sailing anywhere in the world. I do not get out on the water as much before, but I take any chance I get to recharge out on the ocean.

Dan: My father and I have gone fly fishing together for more than 40 years.  The one vacation I manage to get is to travel to the Bighorn Mountains or Snowy Range in Wyoming.  Of course, I go in July and August, so there isn’t (much) snow, but the scenery is beautiful, and the fishing is pretty good too!

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