Julian Upton

Lance Hill, CEO of insights management company Within3, talks about how the insights gathering process supports better drug discovery and more representative outcomes, and how data can democratize healthcare and mitigate DE&I in the industry.

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Insights on Insight Gathering

Jay Johnson, senior manager of Labelmaster Services for Labelmaster, is a long-time expert in packaging and logistics solutions for the chemical and biotech industries, with a focus on dangerous goods (DG) and hazardous materials. He has been an active participant and major resource in the development and implementation of international dangerous goods regulations and is an active member of the Council on Safe Transportation of Hazardous Articles (COSTHA) and the Dangerous Goods Trainers Association (DGTA).

 to share his thoughts about recent disruptions and advances in the area of cold chain, and to emphasize that companies need to choose packaging and distribution systems that really fit a checklist of their needs.

: With the pandemic and other crises, what key changes have you seen affecting cold chain in the last couple of years?

 As the global pandemic has exposed logistical problems for lithium batteries and temperature recorders, people are going back to something of an “old school” approach. There had been this desire to have devices that could do everything—track shipments from space, for example—but they take a lot of power to run. And it is annoying to try and figure out whether such devices activate while they’re in the air, which the airlines certainly don’t like from a security standpoint. So, I’ve seen people going back to things like mechanical temperature recorders and chemical monitors, which only tell you when something’s gone out of range. These are inexpensive devices, particularly for last mile, and so are appealing to companies that have been scaling back from a cost standpoint.

Another change is that companies aren’t filling warehouses with Styrofoam coolers anymore. Instead, there are all sorts of things happening with insta-boxes, pop-up liners, fabric bags, cool liners, and products that have reflective metal or recycled material. We’re getting very creative with the new packaging that’s available. Now, we can ask, is all of it good? No. Does all of it work for everything? Hell, no. Companies must map out what they’re doing and select the packaging system that 1), fits their needs; 2), fits their time period; and 3), fits their price point. Now, Styrofoam panels were inexpensive, but it was difficult to sustain the right temperature because of gaps in the panels. And you’ve also got countries that don’t want Styrofoam, as they’re not able to recycle it. But if your system is built so that you can get your molded coolers back, you can run these coolers 10, 20 times. As long as you set up parameters to make sure that they’re not contaminated and you can easily replace the outer box if it gets damaged, the cooler itself could go on not indefinitely, but certainly for a long time, which means major savings.

People always want the less expensive option. They want something that takes up less space and they want something that will work for the duration and at the price point for what they’re doing. But companies should really look at what they’re trying to accomplish. What temperature range do they actually need? Is it 2–8℃? Or could they really go for 0–8℃, which is much easier to maintain? Do they really need seven-day monitoring? Or would they know by the third day if something is wrong and move on? These kinds of questions help them to pick a better price point for what they’re trying to do.

In terms of DG in the cold chain, what else has changed over the last two years?

I think that the way information is being communicated is different. There are still lots of conferences, but there’s not going to be as many as before because people have figured out a way to get their information from other sources. You’ve got people turning more than ever to pay services and websites and trade magazines because they couldn’t get together and hash it out at a conference during the pandemic. And people realized that the world didn’t come to an end when they didn’t go to conferences.

From my standpoint as a trainer and educator in the field of dangerous goods, we used to feel that if you didn’t do a DG class live then you weren’t getting trained. Now, people feel very different about that. But it took a pandemic to open that Pandora’s box. There were countries in Europe, Switzerland for example, that previously didn’t allow online training. They have had to make adjustments. Now I’m getting requests globally for training where they don’t expect me to fly over there; they want me to teach the class virtually and answer questions live. That’s a big difference.

Are you seeing changes in the way life sciences companies are approaching cold chain challenges?

People are asking more questions and pharma companies are getting more pushback from different regions internationally regarding packaging. One region might not want a particular item and so the pharma company has to figure out what alternatives they can use to get them even close to the temperature range they were getting at the price point they had previously. I’m getting a question like, “As opposed to Styrofoam or urethane foam, if I used an open-cell polyethylene foam, or even air bubbles or bubble bags, what kind of temperature can I maintain?” I usually try to push back and tell them really need a thermal lab to make sense of that; you can’t just take a chance on bubble wrap.

Pharmaceutical companies are held to a higher standard; it’s about more than just fines and penalties for regulatory noncompliance. If a company starts to cut corners in storage and shipping, people are going to say, “Are they also cutting corners to make the drug that I’m taking? Are they cutting corners to make the device that I’m using to keep me alive?" A pharma company could be setting itself up for a PR nightmare that it really doesn’t need to have, because complying with regulations is going to be significantly cheaper than the PR ramifications of not doing that.

What balance are you seeing in terms of active and passive temperature control?

I’m seeing more active systems, and I think there’s a lot of opportunity there. Couriers can build refrigeration or heating into certain sections of the vehicle that is shipping the goods. I know they’re stiving to make customers feel more comfortable that refrigeration is maintained throughout the entirety of a shipment, without the use of additional insulation or passive materials. If an item is only being shipped from A to B and the courier can guarantee the temperature range without the need for cold chain packaging, then it might be worth companies paying more to ship it that way because they will save on the packaging.This technology is really moving forward because courier operators like UPS and FedEx want to keep all the stuff within their systems. By having active temperature control, whether it’s elevated or refrigerated, couriers can make the customers more dependent on them for a particular route, so I think we will see more investment in this active technology.

Articles

A conversation with dangerous goods expert Jay Johnson

‘Old School,’ New Technology

This month at the European Society for Medical Oncology (ESMO) Congress in Paris (September 9–13, 2022), AstraZeneca (AZ) presented new data supporting its ambition “to redefine cancer care.” A total of 15 approved and potential new medicines from AZ were featured across more than 75 abstracts in 13 tumour types, including results underscoring the efficacy and safety of Imfinzi, Tagrisso, and Lynparza across multiple cancers with high unmet need and data reinforcing Enhertu’s transformative potential in HER2-targetable cancers.

 sat down with with Greg Rossi, AZ’s senior vice president of oncology, Europe and Canada, to talk about these results, AZ’s other oncology activities, and his vision for the future of cancer treatment.

Pharma Commerce: What key changes have you seen over the course of your career in oncology, and particularly during your last 11 years at AZ?

 There have been huge advances. When I started 25 years ago, we were talking about how much chemotherapy could we deliver in what we called dose-dense chemotherapy, and how could we support those patients that we knew were going to receive toxicities. Now, we talk about really exquisite chemistry, really exquisite protein engineering, have a deep understanding of biology in terms of biomarkers, and are much more precise in thinking about patient selection. That’s manifested in things like immuno-oncology therapies, where we talk about harnessing the immune system to interact with tumors, or, for example, the antibody drug conjugates (ADCs) such as Enhertu that we have in our pipeline, which I think will be transformative medicines. These represent really intricate engineering work in terms of taking a cell surface protein and basically linking an antibody to it and looking at how you deliver chemotherapy at a dose that is unparalleled into the precise tumor cell. How do you make sure that everything dissociates in the right place at the right time, so that you’re killing the cancer cell but sparing the healthy tissue? A hundred years ago this was the stuff of Paul Ehrlich’s magic bullet, but now it’s a reality. I think it is the biggest transformation we’ve seen, and it’s not stopping there. Where will we go now with this technology we have at our fingertips?

Among these innovations, what have you been proudest to be associated with at AZ?

For me, LYNPARZA has been interwoven in my last 10 years, as it has with many people at AstraZeneca. First, the impact it’s having on patients—whether in ovarian cancer, prostate cancer, pancreatic cancer, or breast cancer—is transformational. And this is complex biology; we were pioneering the science here. We were trying to understand which patients would respond best, how to best use the drug, at what dose, and what schedule. There are two studies in ovarian cancer, the SOLO1 study and the PAOLA-1 study, for which we just presented results at ESMO. The five-year follow-up of the PAOLA-1 Phase III trial showed that LYNPARZA plus bevacizumab meaningfully extended survival with 65.5% of homologous recombination deficiency (HRD)-positive patients surviving 5 years versus 48.4% treated with bevacizumab and placebo, doubling the rates of what you would’ve seen historically. The SOLO-1 Phase III trial demonstrated 67% of advanced ovarian cancer patients with BRCA mutations treated with Lynparza were alive at seven years vs. 47% on placebo. Ten or 15 years ago, that figure of 67% would have been more like 25%. So, that has been a very proud part of the last 10 years for me. And it shows that pioneering in a space is tough—it takes dedication, resilience, and a bit of humility. But when you succeed, you can really have an impact.

How has COVID-19 impacted AZ’s activities in the oncology space?

COVID has clearly had a very significant and negative impact on cancer patients on a number of levels. Firstly, there are the referral rates. I read a report recently saying that up to a million cancer patients went undiagnosed through the pandemic, with 10 million screening appointments missed. We know that diagnosing early is really important if we want to have the opportunity to cure patients. The impact of the pandemic is that more people will be diagnosed at a later stage and their outcomes will be poorer. But I’m proud of AstraZeneca, not just for its work on the COVID vaccine side, but for the effort and energy that the organization put into its oncology efforts during the pandemic. We worked with patient groups and the healthcare system to make sure this issue of timely referral was not forgotten. We supported campaigns in many markets to put the message out there. And we provided support for patients so they could be treated at home, with tools to help review symptoms and toxicities, for example. A lot of these ideas and practices have applications beyond the pandemic; some of the things we were able to do we’re going to apply more broadly going forward.


What kind of innovations are you advancing to help alleviate the health system burden?

First and foremost, AstraZeneca is focused on delivering really high impact medicines in oncology. We’ve delivered seven over the past few years; we hope to double that over the next few years. We have been very faithful to that concept of “the right patient at the right time with the right medicine.” This involves using biomarkers; making sure that health systems understand the potential value of diagnostic technologies and adopt these biomarkers; and making sure that patients are getting the most precise diagnosis that helps match their right treatment. We have positioned, as a central pillar of our oncology strategy, the concept of moving early, because that’s where we think the cure is most appropriate. That requires us to partner with a number of folks within the oncology ecosystem, not just health systems but also technology partners.

One company we’re working with, Grail, for example, has a multi-cancer detection test called the Galleri test that is very interesting and aligns very closely with our principles of being able to diagnose cancer early. And we’re continuing to innovate in diagnostics and medicines in the lung cancer space. There are lots of patients who are not diagnosed early enough with lung cancer. But they might come into the health system for a chest X-ray or something else. We actually saw this during COVID. People were coming in for chest X-rays and the new technologies were picking up potential cancer signals from those images. So, we are working with a couple of companies to take these radiographic images and scan them using AI technologies to identify the 1% of people with what we call incidental pulmonary nodules (IPNs), which could become cancerous, and then triage them into an early referral process. This is where new technology is really starting to make a difference.

We hear about patient-centricity a lot. What have you actually seen in your career in terms of the involvement patients in oncology?

Many companies talk about patient centricity and with very good intentions, but at AstraZeneca it’s a core theme in how we think about the way we develop and commercialize our medicines. But I think it is always worth questioning how we are implementing our plans, strategies, and engagement to validate that patient-centric approach. Actually, I would say there has been an increase in the way we’ve been thinking about that over the last few years. First, we now have a patient partnership program that is a part of how we design our trials. Patients and patient groups can basically come and talk to us about the impact of certain studies from the patient perspective. That’s been very influential. We are also working very closely with patient groups around the support, education, and awareness that they need to manage their disease, and also in terms of policy initiatives. In Europe we are involved with the European Union’s Beating Cancer Plan; that is now expanding to national cancer plans. Having a common purpose with patients, identifying patients appropriately, and promoting early diagnosis is an essential part of our work.

As I mentioned, our COVID learnings showed us how new technologies and tools can be really valuable in the routine care of patients. And we’re thinking more about things like equity and access to clinical trials for different underserved patient groups. What is the variation in access to care across the region and what can we do around that? These are the sorts of areas that have become central to our work more recently and that we are committed to engaging in further.

Can you outline what the next few years will look like in terms of AZ’s oncology efforts?

I think we’ve had a remarkable journey over the last 10 years. Much of what we have been doing has become more visible in the last five years, but it was initiated by CEO Pascal Soriot when he joined in 2012; he really provided the impetus, the pace, and the urgency to change. I’m very excited when I look toward the next 10 years in terms of what we have in our clinical pipeline, our technologies, and the philosophical approach we are taking to partnerships. We know that not all the science is done inside the walls of AstraZeneca, so it requires broad engagement and partnership, both on the science and patient sides.

In particular, our ideas around early diagnosis, precisely identifying patients, and harnessing a range of different technologies in combination to treat them are going to be transformative. Being able to do that in a way that delivers local solutions to physicians and patients around the world is going to take us, I think, to a leadership position in oncology.

AZ’s Greg Rossi talks about the company’s oncology activities and his vision for the future of cancer treatment

AstraZeneca: Redefining Cancer Care

: What has been the main impact of the last two years on Lundbeck’s supply chain activities?

Like many others, we are seeing increasing costs and increasing lead times. There are a number of elements at play, not just the pandemic. Some of it relates to capacity issues in the industry and the increasing cost of raw materials, energy, freight, etc. But those are the main challenges we face: cost increases and longer lead times.

Among other things, the pandemic emphasized an over-reliance on raw materials and goods from India and China, for example. Was that something that affected Lundbeck seriously?

For several years, we’ve done an annual business impact analysis, where we host workshops related to supplier risk and facility risk, looking into things that might occur at our production warehouse facilities. Based on scenario planning, we focus on the main risks in terms of potential impact and we formulate and implement mitigation strategies. These could involve dual sourcing, inventory management strategies, stronger relations with key suppliers, etc. So, we had been doing that, but then COVID came along and, subsequent to that, the high inflation that we’re seeing now. All this put extra pressure on us. I’d like to say that we’re in a better position to deal with it than if we’d done nothing, but to prepare for all this disruption was extremely difficult.

Some of the scarcity, for example, we had not predicted, even when COVID broke out. One of the things that we expected was the impact on glass for vials, etc., which did occur and which we were able to mitigate with our suppliers by planning ahead. But one of the things we did not expect was the shortage of filters for production, for example, and that hit the industry widely. Suddenly, everyone was fighting to get their filters up and running. We had to look at our portfolio and quickly take action on this.

Have you been further impacted on the supply chain side by the Russia–Ukraine war?

We don’t have direct supply from Russia or Ukraine, but we do have second- and third-tier suppliers there. That’s where it gets tricky in terms of trying to get visibility and understanding the dribble-down effects of the conflict. Our first- and second-tier suppliers obviously also start to look for alternatives as soon as they are hit by difficulties, but that puts pressure on the markets in other area. Again, it can be hard to predict the fallout from all this.

Has this period been the toughest in your career?

Certainly, the industry-wide impact has been profound, and I could point to single incidents that for us as a company were extremely difficult to navigate. Everything has been hit: our fiscal supplies, our energy consumption, our ability to transport goods around, everything inbound and outbound.

We hear a lot of US-based companies talking about increasing domestic manufacturing and ushering in America-first type policies. Could you see this kind of thing happening more in Europe?

I want to say yes, but it’s a long journey. To fully internalize some of these supply chains is extremely difficult if not impossible. One element that has previously driven decision to source within Europe is regulations such as REACH, the European Union’s (EU) regulation on chemicals and their safe use. This requires companies to register any substances imported or manufactured in quantities of more than 1 metric ton per year with the European Chemicals Agency (ECHA). The existing 30,000 substances produced or imported within the EU must be registered. However, active pharmaceutical ingredients (APIs) and excipients are exempt from registration, evaluation, and authorization if they are already registered with the European Medicines Agency (EMEA) as an ingredient of a medicinal product for human or veterinary use. Lundbeck has made some progress here in terms of its excipient starting materials. Our API plants are in Europe and our suppliers are largely European based, which puts us in a good place in terms of our first-tier supplier base, however not the full supply chain.

What are your hopes and fears for the next 2–3 years in terms of managing the supply chain?

We’re going to be living with all these implications for a while. Getting costs down again is going to be a struggle for us all. And then there is the whole shift toward sustainability, which has been a consideration for some time but is definitely picking up speed now and adds to an already challenging environment. We want to balance sustainability initiatives with certainty of supply at a competitive cost, which is still very hard. Part of it will be driven by demand in society, but I’m sure we will also see further regulation, either by carrot or whip, in terms of pushing the industry toward sustainability goals.

How much is increased digitalization helping in terms of facilitating a more efficient and secure supply chain?

From a supply chain point of view, we can use digitalization to create transparency and also to analyze data and offer predictions and suggestions. There are definitely opportunities with digitalization that we can harvest. From a cost perspective, using data and advanced analytics also helps us to see what we can optimize, partly with our supplier base, but also internally. The difficult part is setting it all up. There is not a lot out there in terms of standards, so this digitalization is not something you can achieve overnight.

In this Q&A, Kristian Sibilitz, senior vice president, pharmaceutical production & supply chain at Lundbeck, outlines the impact of the last 2+ years on the Danish drugmaker’s supply chain activities

Julian Upton

Articles

Insights on Insight Gathering

‘Old School,’ New Technology

AstraZeneca: Redefining Cancer Care

Lundbeck: A Supply Chain Perspective