INNOVATION


How would you define the stages and categories of innovation in clinical trial supply? I consider clinical trial supply no different from any other area of innovation. It begins with an idea and a scouting process, either inside our company or outside with potential partners, a proof-of-concept step and then scale-up and eventual introduction to the real world.


What are the keys to success in clinical supply innovation? Innovation in clinical supply must start with the patient in mind. You need to appreciate a patient’s journey with his or her disease to then assess how your product can create value – from a treatment perspective and an overall clinical trial site experience.


Can you give a high-level overview of the types of innovation in end-to-end clinical supply chain?


The trend in digitalisation is key in this space to reduce the distance between companies, investigators and patients and investigators. In addition, digitalisation can potentially increase the speed in delivering new therapies to the market. At Janssen, we have developed an innovative solution for “just-in-time” labelling, which is a great example of digitalisation.


Which distribution models do you think are revolutionising trial supply operations, for instance the direct-to-patient (DtP) model? Certainly the trend in moving from hospital care to home care of patients with many diseases goes along with a more strategic adoption of the direct-to-patient distribution model in industry.


How has the COVID-19 pandemic affected your innovation strategy? The pandemic has accelerated ideation that takes place in the initial stage that, historically, has been tough to make happen in a short time frame, given the regulatory requirements in which we operate. During the pandemic, we learned new ways of partnering between the public and private sectors, which enabled innovative approaches to be introduced at a much faster rate. This is possible by maintaining high standards of transparency, clear communication, and, fundamentally, great respect for the role of industry to invest and look for innovation,


78 | Clinical Trial Supply Handbook


and for institutions to evaluate and assess critical value for patients. During these unprecedented times, we learned we can successfully disrupt and change how we do business as long as we keep the patient at the centre of all we do.


What are the benefits of automated packaging and labelling in operations? Clearly, automated operations provide an advantage from an efficiency and cost perspective. The big differentiator is the level of reliability and quality that can be brought forward in the always changing environment in which we operate in clinical supply.


How do you measure quality and compliance in your innovation?


It is really about the ability to provide a superior experience to patients working within our regulated protocols and controls. Making sure we can immediately feed back to our colleagues any type of comment, or suggestion for improvement, is fundamental to strengthening the quality of our process development work and bringing products to market with a “right first time” quality and compliance capability.


Can you outline how your just-in-time model has affected your waste levels in clinical trial? The flexibility of our just-in-time model enables us to leverage products and batches at API and drug product level across multiple studies and protocols that in the past had to be reserved specifically for single trials or even arms of a trial. Now the waste level of our inventory at the end of studies has gone below 20%, which is a great industry benchmark.


How can we ensure the proper control reconciliation of batches with e-label? We need to make sure the systems that oversee the process are GXP [good practice guidelines and regulations] compliant with proper validation and design verification in place. The future trend towards more personalised medicine will require personalised labelling, and innovation will need to support this transformation. In other sectors, it was impossible to think that someday groceries would be delivered at our door by a drone. The same will happen in the future for pharma, and innovation can enable a robust and compliant process even in the most challenging areas.


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80  |  Page 81  |  Page 82  |  Page 83  |  Page 84  |  Page 85  |  Page 86  |  Page 87  |  Page 88  |  Page 89  |  Page 90  |  Page 91  |  Page 92