Innovating the Biologics Supply Chain: New QuickFire Challenge Looks to Spark Ideas from Pharma and Beyond

The pharmaceutical supply chain is a complex yet well-orchestrated system responsible for bringing medicines from manufacturing all the way to patients. Yet with the rise of biologic therapies—which are much more difficult to store, transport and administer than traditional small-molecule pharmaceuticals—many new challenges have emerged, adding to the cost and complexities of the process.

With the goal of identifying solutions that can help bring drugs to patients faster and more affordably than today, Janssen Supply Chain has kicked off a Next-Gen Supply Chain QuickFire Challenge , to an person or a team who can solve one of several key problems:

· Eliminate cold-chain requirements: Stabilize protein formulations in liquid stage without refrigeration.

· Increase concentration of protein-based drugs: Optimize process environment methodologies to significantly increase cell production titer in the range of 50 to 100 percent improvement from common monoclonal antibody baselines.

· Enable oral absorption: If biologic drugs could be taken orally instead of as an injection or transfusion, the supply chain would be drastically simplified—as would administration to patients.

We spoke with William Randolph, Ph.D., vice president of technical services for Janssen Supply Chain, to learn more about what inspired the latest challenge and what he hopes the contest will accomplish.

First, can you tell me a bit more about the goals of this challenge? How did your team develop these three focus areas for innovation?

As you probably know, —a lot of exciting innovation is happening in the large-molecule space right now. However, there are many limitations to bringing biologic agents to patients, particularly in remote, underserved locations. In designing this challenge, we asked ourselves: what are the biggest things that would help us do a better job of bringing transformational products to patients every day? The answers came quickly. Cold chain, titer and oral absorption.

A solution in any one of these three areas would revolutionize the way that we deliver products to patients. For example, if you can master the oral absorption issue, you wouldn’t have to put the drug into a syringe or make it sterile. If you could double titer – in other words, pack higher numbers of cells into the formulations - it would dramatically shrink the size of the supply chain by allowing for larger production in current facilities. If we could enhance or replace cold-chain storage and distribution, we could simplify the supply chain and do a better job of bringing drugs to patients in remote areas.

What are the advantages of using a QuickFire Challenge to develop these innovative solutions?

We’ve always tried to bring more scientific rigor to the manufacturing space and the supply chain space, and that’s what we’re doing here. These are our biggest challenges and we’re looking to cast a really wide net to challenge and inspire more diverse thinking–this provides a big opportunity to get a different set of eyes looking at problems we’ve looked at for years. We realize there may be people who have great ideas but might not be in the pharmaceutical space—they might be working in parallel industries—and we want to catch their attention. Take, for example, 3D printing. It started as a technology for making parts for cars, and now we’re making parts for people. This is a technology that has crossed over into other industries, and that’s along the lines of what we’re looking for. We are looking for the different vantage point to jumpstart ideas.

How will the ideas be vetted?

We will have a number of reviewers from different parts of our organization - including supply chain and R&D.; We will assess based on the highest probability of reaching the challenge’s goals, considering feasibility, cost and the manufacturing environment, among other factors.

At the end of the day, how will patients ultimately benefit from this effort?

We are all about making breakthrough, affordable medicines available at any place, any time. That’s what we’re trying to do with supply chain. We want medicines that are easy to administer, can be cost-effectively distributed, and are safe and easy to maintain in their location. That’s how patients will benefit.

Is supply chain innovation getting enough attention industrywide?

If you ask me, I don’t think so. Most people who work in the pharmaceutical space are looking for answers to disease states that are underserved or not served at all. The supply chain is a critical piece of that equation, yet it probably doesn’t get as much press or research attention. This QuickFire challenge is an opportunity to advance innovation in supply chain technologies and improve our ability to get critical medicines to patients around the world. That’s why we are so excited about it.

What is the due date for entries?

The due date is Nov. 2, 2016. Innovators can apply by registering at our event application site, . Winners will be announced by the end of the year. Good luck and thank you in advance for your submissions!