Connecting Data to the Patient: Paul McKenzie on J&J Pharma R&D's Lab-to-Patient Program

Paul McKenzie, global head of pharmaceutical development and manufacturing sciences for J&J pharmaceutical research and development, shares goals for J&J's pharmaceutical R&D, and the "Lab to Patient" program.

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To listen to a longer audio interview, click here, and for an extensive print interview, check September’s issue.

PhM: You’ve moved from a small-molecule to a biotech focus. What have been the biggest challenges involved in making that switch?

PM: In the biotech side of business, two things are increasing in diversity and complexity. One is the pipeline of products that development scientists like myself support, both in development coming out of discovery, and in manufacturing. 

You have a diversity of compounds, MABs through mimetobodies, which are modified monoclonal antibodies, through novel, now smaller molecule protein scaffolds, to stem cells. So you have that pipeline diversity, in addition to diversity of delivery method. 

In biologics, and particularly at Centocor, you move very quickly from the traditional delivery of monoclonal antibodies, in vials, which was typically lyophilized powder, to liquid in vials. But even for liquid in vials, customer expectations have increased to the point where they want the convenience of, say, an auto injector for delivery.

As we move out to more novel protein scaffolds, there may even be demand for additional drug delivery devices such as inhalers or nasal-to-brain-barrier transport systems that are needed. 

So, the amazing thing to me, on the biotech side, is the diversity of the pipeline and the diversity of the delivery methods. This creates the perfect storm in which development scientists can focus their work, to integrate those diversities within those technology areas and ensure that they’re delivering the right product with the right delivery system to the customer.

PhM: Which therapeutic areas is J&J Pharma’s R&D division focusing on now?

PM: Centocor had traditionally focused on immunology, but recently it has expanded its collaboration across J&J Pharma, which has adopted an end-to-end strategy across five main therapeutic areas. At Centocor, which was predominantly the flagship of immunology, we have found that many of the development and discovery groups can now support multiple therapeutic areasnot only immunology, which was the flagship with Remicade, but oncology, neuroscience, infectious disease and cardiovascular metabolism. So biologic targets and biologic potential products are being used across all the therapeutic areas, and that is supported by the Centocor hub. 

PhM: At BMS, you had implemented the “lab-to-plant” strategy. At Centocor, that seems to be extended with lab-to-patient. That name brings the end user of medicines to the forefront, at a time when most industry managers are focused on other key stakeholders. What was the thinking behind the whole lab-to-patient concept and what are your plans for it in the future?

PM: At Centocor, the real lab-to-patient focus was to manage pipeline diversity. Different pipelines, from MAb’s to stem cells, have different patient populations and each of those populations has different expectations for delivery technology. 

As the industry matures and we start to incorporate more advanced clinical diagnostic techniques like biomarkers, where we can start to predict how individual patient populations are responding to a potential new molecular entity, we really need to understand from the patient, back, not only the convenience factor of a device versus a liquid in vial, for instance, or a lyo in vial, but also how an individual patient responds within a given patient population. 

Centocor has looked at how it can invest, on the clinical and discovery side of the business, in understanding biomarkers. That understanding can then influence how a development group examines pipeline and delivery system diversity, as they relate to the patient.

Patients’ expectations, their knowledge of what medicines are available, and their interest in convenience of delivery have increased significantly. This is no different from what has happened in other industries. Today, for example, I have a computer on my belt, where in graduate school, the computer I used required little punch cards. As a result, my expectations of a computer are exponentially different from what they used to be. 

Today, patients want products that are best fit for their purpose. Coming along to help ensure that fit are new clinical diagnostics, diverse pipelines and delivery approaches. 

Thus, it’s critical for any pharmaceutical development group to think backwards from the patient, and how they’re going to achieve all those goals. 

PhM: Has the company changed the way it evaluates the voice of the customer, what the end user needs?

PM: We have reorganized in Johnson & Johnson (J&JPRD) to a therapeutic area, end-to-end focus. This way, therapeutic areas like oncology or immunology can really concentrate on everything from drug discovery targets on out to commercial applications under one accountability within each therapeutic area. 

One of the major things we did, which influences my group in particular, is to institutionalize a process called the Target Product Profile.  This method asks: What is the product? What does it look like, what do we want it to look like at launch, what do we want have it look like at different stages in its lifecycle?

What this approach does is to align the commercial side, sales and marketing, with development and manufacturing, creating a triangle that is aligned much earlier based on what the product is going to be about, what the clinical and lifecycle management goals are, and what commercial goals are, from a lifecycle management view.

PhM: Do you have any specific milestones in mind for the Lab-to-Patient program?

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