I interviewed Hedley Rees who discussed Patient-Centric Approaches to Pharma Supply Chains.

 

 

 

 

 

 

It’s nice to speak with you today, Hedley, and today we’re going to talk about patient-centric approaches to pharma supply chains. Can you start by providing a brief background of yourself?

 

Sure, thanks, Dustin. Well, I’m a qualified production engineer of 30 years now. I work in the pharmaceutical industry both in permanent positions and as a consultant, basically working at building and managing outsourced supply chains across the whole end-to-end pharma industry, starting with raw materials, intermediates, active ingredients, and then products to market.

 

My passion, if you like, is considering the supply chain from very early stages of development rather than leaving the aspects until much later in the development process. That’s what I have most of my clients with. I’m currently working on a project that’s funded by U.K. government on patient-centric supply chains, and hopefully I can help you understand a bit more about what I mean by that as we go through the interview.

 

What is a patient-centric approach to pharma supply chains?

 

Well, it’s the complete opposite of the current approach that’s being taken by the industry. Typically, the industry will identify a compound through molecular modeling and all sorts of different methods to identify a product with potential. But rather than starting with a patient’s need, the actual environment in which the product is going to be administered, the need for companion diagnostics, et cetera, et cetera, the whole development process passes through both preclinical and clinical development. It’s only in the later stages the pharma companies tend to take an interest in the supply chain, and by then, of course, as we know, 80 to 90 percent of cost and performance is normally built into the design-development stage, so by then it’s all but too late to really make an impact on quality, cost, and lead time in the supply chain.

 

My experience as a consultant teaches me that that continually happens, and the industry is finding it very difficult to develop products. Like the rest of the world, if you like, other sectors do, which is to start, basically, at the point of the end user, identify their value proposition, and then develop products that are aligned with that value proposition and deliver that value physically into customers’ hands. What my approach is is to organize so that the health care practitioner and the patient are very much part of the initial scoping for a new product, a new drug; they understand the epidemiology for the drug, they understand the indication, they understand the patient issues. And then a supply chain is built as simply and effectively, with minimum handovers so that that product be physically delivered to the patient.

 

As I say, this is not an approach that the industry is familiar with or even comfortable with. Albeit it is taking very much about becoming more patient-centric, the practicalities of it are immense given that over 40 years, the industry’s become very much outsourced; the whole of the distribution approach is outsourced, a large portion of the manufacturing approach is outsourced, and the industry has very little influence on actually determining what the patient gets. I hope that gives you flavor of what I’m talking about here, Dustin.

 

Can you go into a little bit more detail about why take a patient-centric approach?

 

Well, fundamentally, the whole industry is suffering from what we call a painted cliff and numbers of other issues linked to the fact that many of the drugs—in fact, most of the drugs that go through development, 249 of the 250 actually fail to get to market, and that’s a horrific attrition rate. The reasons are many; some of them are down to supply chains that eventually fail and create toxic substances on scale which were not toxic at normal scales. Also, there’s a lot of activity going on in the later stages but not in the early stages, where things could actually be influenced. If we look at further impact other than attrition, we also see that there are many me-too drugs getting to market.

 

By the time they get through the development stage, they’re basically no better than drugs that are already on the market, so we’re seeing regulators and health economics elements of government actually rejecting drugs because they didn’t meet the sort of original criteria that they were supposed to meet. My argument is: These days predictive technologies exist to be able to identify drugs which are manufacturable; to identify drugs which don’t have potential toxicity issues, safety issues; and to identify drugs that have a certain level of efficacy.

 

Over the past 40 years, there’ve been huge advances in in silico methods, which is computer modeling and prediction of drug performance, and also ex vivo methods, whereby rather than testing in patients, drugs can be tested in tissue and other means outside of the human body to really screen out the drugs that were never going to make it because, eventually, they would not be able to build a supply chain through to market. I don’t know if that makes sense to you, Dustin.

 

What about the how? Can you go into a little bit about how this is done?

 

Yes, I’m working with a company at the moment. As I say, it’s U.K.-funded and it’s a consortium of the National Health Service. We have one of the largest tracks in the U.K. engaged, so we have a leading specialist in the particular indication actually explaining how the procedures are carried out so that the manufacturer gets a very clear idea of how the product’s used, the critical success factors, the quality aspects, and you get a much better understanding of if their product actually has the potential in the market and also what characteristics they would have to have to deliver the value that the surgeon and  their practitioner is looking for, which ultimately benefits the patient.

 

That provides both to the customer and the manufacturer and we’re all familiar with—well, many of us are familiar with the voice of the customer and the importance of doing that before policy is deployed into manufacturing or organization. But along with that, we have, Cranford University are providing the innovation, the access to the theory of practice of innovation and the fact that invention is very much different to innovation, and innovation is really all about making commercial advantage of ideas and inventions. And then we have the manufacturer themselves, who really can learn from the voice of the testament and have built an integrated supply chain that constantly refers back to: Is this delivering value for our end user?

 

In the development process early stage, it’s about involving patients, health care practitioners, surgeons, physicians, marketing, procurement, supply chain. All those people who are going to be involved in the process of bringing drugs to market need to be involved at that early stage. The organization impacted that quite significantly because the whole industry has been organized basically on an R and D model, where R and D discover and develop the product and commercial then eventually get it handed over somewhere further down the line. That model has to be turned on its head before we can really see effective supply chains in pharmaceuticals biotech and life sciences.

 

Thanks, Hedley, for sharing your views on patient-centric approaches to pharma supply chains.

 

You’re very welcome, Dustin. Thank you very much for asking for my views.

 

 

 

About Hedley Rees


Below are some links to my book and some articles/podcasts all covering the patient-centric topic from various angles:

 

Book

- http://eu.wiley.com/WileyCDA/WileyTitle/productCd-0470555173.html

Articles

- http://www.pharmaphorum.com/articles/patient-centric-pharma-brave-new-world-or-same-old-empty-promises-part-three

- http://www.pharmaphorum.com/articles/the-supply-chain-patient-is-sick-is-there-a-cure-for-the-pharma-supply-chain-part-2

- http://www.pharmaqbd.com/rees_aiming_for_roots/

Podcasts

- http://www.in-pharmatechnologist.com/Regulatory-Safety/Two-stage-development-model-needed-to-cut-attrition-rates-says-expert

- http://www.in-pharmatechnologist.com/Processing/Pharma-needs-to-rethink-supply-chains-in-an-era-of-patent-expiry-and-global-outsourcing

 


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Hedley Rees

 

Managing Consultant at PharmaFlow

 

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