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2019 Cold Chain Provider Directory

Not quite a year ago, an assemblage of pharma service providers came into being as Eversana. Funded by two private equity firms with a background in healthcare—Water Street Healthcare Partners and JLL Partners, there were six acquisitions at the time: Dohmen Life Science Services (itself a prior rollup of contract logistics, rare disease patient support and specialty pharmacy), The Access Group, Alliance Life Sciences, Health Strategies Group, Triplefin, and Patient Experience Project. Shortly after, it added Seeker Health and field sales units acquired from Mission Pharmacal. Together as EVERSANA, the organization delivers a fully-integrated service ranging from clinical trial support to consulting on drug pricing, to supporting the patient journey from diagnosis to cure. It operates globally, and has over 2,000 employees.

Jim Lang was brought on as CEO of the as-yet-unnamed organization in mid-2017; former CEO of Decision Resources Group, he has a long history in healthcare consulting and leadership. Pharmaceutical Commerce sat down with Mr Lang to find out where Eversana is going; here’s what he had to say.

1. First of all, let’s talk about the unusual assemblage of companies that make up Eversana, which could be called a logistics provider, a patient-support provider or even a healthcare agency. What is Eversana trying to be?

We’re trying to be a catalyst for change to fill a gap in the life science sector. When we were forming Eversana, we recognized that both the CRO (clinical research organizations) and CMO (contract manufacturing organizations) industries were being well delivered. Yet, our end customer is in desperate need to pivot to patient-centered, value-based care. Therapies are getting far more targeted to narrower populations and we didn’t see the CMO and CRO centric players being able to make this shift quickly. And, unfortunately the commercial services sector remains highly fragmented.

Eversana offers a fully integrated commercial services platform designed to solve patient support, distribution, field force, compliance and marketing challenges in a very integrated way. We keep patients, and the value the life science industry creates for those patients, at the center of all solutions we create and execute. To build quickly, we bought only the top leaders. Our services span everything from clinical trial recruitment to long-term therapy adherence which ensures that we are patient-centered because we are with the patient every step of the way.

2. Eversana’s self-description reads that it is “the leading independent provider of global services to the life science industry.” The question is, independent of what? Another aspect of this question is what the advantages are of being owned by private equity companies, whose goal is usually to build up an asset and then sell it.

We’re independent, meaning we’re not tied to wholesalers; we’re not tied to CROs. That’s important because we believe a wholesaler is inevitably in conflict with the manufacturer. Their income depends on the spreads they take in the distribution channel. The business model inherently makes them at odds.

With the CRO industry, it’s slightly different. Both the CRO industry and our commercial services are helping the life science company be successful, but managing a clinical trial is a very different business than providing innovative patient-centered solutions. We’re independent of the biases that come from a scaled CRO model, allowing us to be much more creative in the kinds of solutions we invent.

We also gain independence by being owned by private equity players known for building market leaders. It affords us the liberty of making significant investments on behalf of our clients and their patients. We’ve probably invested more than $50 million annually in the last two years in the kind of technology transformation that’s needed for the next generation of patient-centered, value-based services. That’s really difficult to do in the public markets, but really easy to facilitate with private equity owners who share in your vision. Water Street Healthcare Partners’ business model is built on a vision for better healthcare, which is why they’ve chosen to commit 100% to that sector, and JLL Partners has about half its portfolio in healthcare. Each has proven their ability to build market leaders that continue to flourish under subsequent ownership.

3. With business units like the Patient Experience Project or Seeker Health, it’s clear that Eversana is taking to heart today’s emphasis on patient focus. Most service providers to the pharma industry make the same claim, as do many pharma companies themselves. What differentiates Eversana’s focus from all the others?

We agree—patient centricity has been a buzz word in the industry for a long time, but the reality is that the industrial complex of life sciences was really built up to serve healthcare providers and payers. Those constituents will always remain important, but our mission is to deeply understand the patient journey, especially the challenges patients are having. That’s a very complex problem when you’re looking at rare diseases and specialty products, which is the center of our focus.

Instead of allowing the businesses we’ve acquired to operate separately, we have an integrated team approach to developing solutions that are patient centric—whether it’s finding patients for clinical trials, staging them for a product launch, or creating innovative ways to avoid abandonment and keep patients on therapy. We’ve created a commercial services platform that goes the full life cycle of the product journey. That’s the same journey many patients are forced to walk alone, but Eversana is walking it with them by adding value in the pharmaceutical life cycle.

4. Several Eversana business units provide guidance on drug pricing and reimbursement policy—a topic that is being intensively argued over these days. Is there a particular 

approach Eversana takes to this topic? What should pharma companies be doing these days to anticipate value-based contracting?

While there has been the rare bad actor in the life science industry, when you look at the collective impact the industry has had on the health of humankind, it’s been massive. Diseases have been eradicated. Our quality of life has been vastly improved. Hope has been given to many who had none. It’s interesting when you consider the debate on pricing: What amounts to less than 15% of our healthcare budget has now become 100% of our attention.

As the industry develops more complex and innovative therapies, even cures for smaller populations, it needs to do a better job communicating value and impact. Some of these products save society millions of dollars a year. How do you make those arguments more consumable for both the intellectual world of regulatory and payers, as well as the common place world of newspaper headlines?

Eversana is a leader in creating value-based contracts and developing methods to measure outcomes. We’ve taken a unique approach in which we’re aligning our incentives with those same value-based contracts so that we’re a true partner with our life science partners in having their patients achieve incredible success and having a fair, value-based transaction with payers.

5. Linked to drug pricing and reimbursement is the industry practices on channel management, which Eversana controls directly through its logistics services. How does better channel management translate into better business performance by a pharma manufacturer?

When you look at the industry as a whole, manufacturers have taken a traditional approach to logistics. We have the rare privilege of stepping back and taking a broader view to see where things are headed. We can step outside that traditional box, anticipate needs, and thoughtfully invest in areas like cell and gene therapy. We’ve invested in a broad spectrum of channel services to the life science sector, helping manage costs and mitigate risk.

For example, we’ve expanded our cold chain storage and made strategic alliances in chain of custody and compliance logistics to support advancements in regenerative medicine. We’ve added the responsiveness necessary to get life-saving products into patients’ hands at a moment’s notice. In the end, it’s not just about speed, but accuracy. It’s one thing to move a common medication — it’s very different moving a life-saving biologic or transplant companion drug. We take pride in being the lowest cost on the former, and the most effective on the latter.

6. With a few of your recent announcements (e.g., the appointment of Bhaskar Sambasivan, formerly of IT services firm Cognizant), Eversana is signaling its intention to provide digital health services. What’s your vision about how this will play out in the industry, especially since Eversana has also expanded in “analog” services like field sales and clinical nurse educators?

Thank you for paying close attention to our business moves! Certainly our recent moves are key to the future DNA at Eversana. To work from your metaphor, we see healthcare as a mix of analog and digital services. Complex therapies may need to be delivered at home with a nurse, while at the same time that nurse needs to capture patient outcomes on his/her iPad to ensure we’re seeing the clinical improvement. The industry is going to be required more and more to demonstrate its value.

We are seeing a massive shift to tech-enablement both in our services and the digital therapeutics that we support with our commercial services. Many services that were done purely with people are now accomplished with tech-enabled solutions, and AI is now playing a big role and is a big investment area for us. Bhaskar looks at all processes and people solutions with that lens and will help us accelerate that shift, which was already well underway.

It’s about providing the right kind of information to all healthcare constituents quickly and accurately, whether it’s patients, payers, or healthcare providers. It’s now a two-way communication, and the more technology allows information to be shared and linked, the more powerful the solutions can become to get patients on the right therapies quickly, and keep patients on therapy to drive amazing outcomes.

7. Mr. Lang, you’ve been involved in multiple large organizations across a variety of industries. What’s the attraction of managing a firm involved in services to the pharma industry? How do you connect personally with healthcare?

I’ve been blessed to be in this industry nearly 30 years now and I’ve always found it highly interesting because of the opportunity to improve how our healthcare systems work. But my interest grew 1,000 fold starting in January of 2016. That’s when my then-14-year-old daughter developed a severe migraine. She has since been diagnosed with New Daily Persistent Headache (NDPH) which is a ravaging rare condition in which she has an almost bed-ridden level migraine 24 hours a day, 7 days a week, 365 days. It’s unrelenting and after 3.5 years dealing with it, and hundreds of treatments and tests, she remains undeterred to live as great a life as possible. I don’t believe I could have the strength.

It’s really allowed me to see the healthcare world through the lens of a patient challenged with a disease that has limited answers. I have seen firsthand how longitudinal information on a patient is not managed and kept. I’ve seen firsthand how physicians are challenged to deal with really small slices of information to make judgments about what to do, and how even as people like myself in the caregiving community become consumer centric in terms of trying to bring forward theories and ideas on what might be practical, how the industry really isn’t prepared to hear that. It’s been quite frustrating from many different dimensions.

I’m confident the life science industry will eventually find a cause and treatment for her. It has been three-and-a-half years now, but it has certainly upped my interest on behalf of the millions of patients with these rare diseases, cancers and other challenges. I view it as a moral imperative to improve this industry for people like my daughter and the many generations to come.

Building up a service offering from the research lab to the patient’s home

A conversation with Jim Lang, Eversana

 2019 Cold Chain Special Report captures two significant trends in the industry: the shift toward “cold chain as a service” by vendors of packaging and instrumentation, and the steady growth of data—its collection, distribution and analysis—as a key factor in managing shipments and meeting business objectives.

Cold chain as a service, in turn, is driven by a desire to reduce waste and increase reuse in packaging and related materials. “Before, people paid lip service to reuse as an environmental benefit,” says Kevin Lawler, VP sales for Pelican Biothermal. “Now, it’s being emphasized by the higher quality and potential cost savings that a well-run reuse program can provide.”

Conversations up and down the pharma cold chain show a diverse range of outlooks; there are still un-monitored shipments of temperature-sensitive products occurring, and there are still worrisome process upsets. Pelican Biothermal conducted a market study earlier this year among pharma supply-chain managers and logistics providers, finding that “nearly half (44.6%) of respondents report multiple temperature excursions per year, and 16% say temperature excursions are a monthly occurrence. Moreover, the reported excursions aren’t a matter of a degree or two. Two in five excursions (41%) exceed four degrees, and 21% are more than eight degrees.”

Clearly, there’s work to be done on improving the pharma cold chain for everyday commercial shipments; meanwhile, the attention being paid to the nascent field of cellular and genetic therapies (CGTs)—all out of proportion to their commercial significance today—is opening up new vistas of technologies, services and business practices.

 Fig.2. Projected sales of cold-chain pharmaceuticals will rise at 2X the rate of the industry overall.[/caption]

Vendors and service providers in the pharma cold chain can rely on a steadily growing market, both in terms of the volumes of products shipped, the destinations to which they are routed, and the regulatory scrutiny they undergo. Pharmaceutical Commerce’s annual Biopharma Cold Chain Sourcebook, published last spring, projected a 6.3% increase in the global value of shipments for 2019 over 2018 (rising to $338 billion), and a 4.7% increase in the expenditures for managing the cold chain for these products, to $15.7 billion. (This figure is highly dependent on transportation costs, whose value has moderated in recent years.) Over the long term, pharma cold chain products are forecast to grow at roughly twice the rate of the industry overall (59% over 2017-2023, vs. 33% for all products). (Fig. 2)

Within the $15.7 billion projected to be spent on pharma cold chain this year, the Sourcebook projects $11.4 billion to be spent on transportation, and $4.3 billion to be spent on packaging and instrumentation. (Fig. 3)

Those billions of dollars have justified rising investment by service providers, as well as attracting interest from private equity investors. Earlier this year, Deutsche Post DHL Group announced a $150-million investment in its North American contract logistics operations for life sciences, adding nine new warehouses, and increasing capacity from 8 million to 9 million sq. ft.

Late last year, Kuehne+Nagel acquired Quick International, an express courier company with extensive life sciences operations, for an undisclosed price (the news release noted that Quick’s net revenue was $200 million).

On the private-equity side, Cold Chain Technologies was acquired by Aurora Capital Partners (no purchase price disclosed), and AeroSafe Global garnered a $31.5-million capital injection from Peloton Equities and other investors. Both are developers of cold chain packaging.

Novo Holdings, the parent of Novo Nordisk and other life sciences companies, took a 24.9% interest in Envirotainer late last year—a case of a key customer (presumably, since many of Nordisk’s products are temperature-sensitive biologics) buying into one of its service providers.

Marken, a clinical trial logistics provider, has acquired four international firms in the past 12 months, in Japan and Eastern Europe; the company itself was acquired by UPS in 2017.

 Fig. 3. Spending for cold-chain transportation in 2019 will be $11.4 billion; spending on

packaging will be $4.3 billion, per the Cold Chain Sourcebook.[/caption]

Significant capacity expansions in temperature-controlled storage or processing were announced by PCI Pharma Services, Reed Lane, 

—all in the US; meanwhile the British government announced the enlargement of its temperature-controlled storage capacity—a preparation for possible disruptions as the October deadline for Brexit approaches.

“The cold chain was the biggest reason for our investment,” says Scott Cubbler, president of DHL Supply Chain. “The expansion will enable us to reduce transit times for temperature-sensitive products, and to get closer to the patient as direct-to-patient deliveries expand.”

Among contract manufacturing organizations, there is a scramble to acquire capacity and expertise in CGTs. Recent actions include Thermo Fisher acquiring Brammer Bio; Lonza acquiring PharmaCell, and Catalent acquiring Paragon Bioservices. Each of these acquisitions was for more than $1 billion.

Arguably, the biggest shift going on currently in the pharma cold chain is real-time monitoring and tracking of shipments. The options are bewildering, and continue to multiply: monitoring and communication devices incorporated into containers (especially true of air cargo ULDs); dataloggers and communicators that take advantage of either dedicated gateways at key transit points (airports or seaports), such as that 

, or WiFi, or satellite-based communication networks (especially for sea freight).

In the not-too-distant past, “monitoring” meant a datalogger that recorded temperature, then allowed for the trip record to be downloaded into a database. Now, adding location (tracked via GPS signals) is becoming de rigueur, with humidity, vibration and light not far behind.

SpotSee, one of the providers of both yes/no chemical indicators for simple temperature compliance, and networked communications, has recently partnered with Bosch to develop a BLE (Bluetooth Low Energy) device, which can automatically download its data via a Bluetooth connection; it also provides a cellular device, SpotBot. Angela Kerr, VP of product development, says that the data-collection protocol depends on the application: “You don’t want a complicated electronic device for shipments going directly to a patient, who may or may not have the sophistication to deal with it—that’s where a chemical indicator with a simple yes/no functionality makes sense.” The BLE device is useful in settings like hospitals or pharmacies, and the cellular connection, which in turn communicates to cloud-based network maintained by SpotSee, is for long-distance supply chains.

In the global logistics business, there are dozens of providers of networked communications, including proprietary networks offered by specific freight forwarders. Among the providers, the companies Controlant, Sendum and Overhaul Group are mentioned as ones that have targeted the life sciences industry specifically, with an emphasis on real-time reporting of temperature, location and other environmental conditions. Overhaul recently announced a partnership with CalAmp, a telematics provider. Real-time networks are also a lively area of development for blockchain developers, with the possibility that a blockchain for monitoring life-sciences cold-chain shipments can also provide compliance with the Drug Supply Chain Security Act, for tracking pharma shipment ownership across supply chains.

There is a gradual shift, which seems to be accelerating, toward providing a reusable container for case-size shipments of products. While expanded polystyrene (EPS) or polyurethane (PUR) still remains the basic insulation material for cases, higher performing insulation such as vacuum panels has been a significant competitor, offering extended range for 2-8°C shipments, and/or a better payload-to-volume ratio (because the insulation tends to be thinner). The higher performance comes at a cost, with standard-size cases priced at over $100 each, while basic EPS ones were under $50. Consignees such as clinics or hospitals have complained about the volume of EPS cases to be discarded, and efforts to route those cases to EPS recyclers have been sporadic.

Packaging manufacturers have now stepped up to provide economically viable reverse-logistics solutions, whereby the emptied case can be returned to a local depot for reconditioning, and then sent back into the supply chain. Pelican Biothermal has been on a year-long kick to site 100 such locations all over the world; Cold Chain Technologies has a partnership with a Dutch packaging provider, Topa Packaging (and the company says that expanding this capability is a key reason for agreeing to the private-equity buyout) are some of the examples of this trend.

“Reusable, packaging first became a trend in the clinical trial supply chain, where high performance was important,” says Pelican Biothermal’s Lawler. “Now, as the total cost of ownership of a reusable program becomes clearer, it’s raised interest in commercial distribution.” Pelican Biothermal’s flagship product, the Credo Cube, is now offered as a “Credo on Demand” service, and the service includes preconditioning the phase-change material (PCM) coolant of the packages, and managing the reverse logistics. In effect, Pelican Biothermal and other providers are taking as much of the responsibility for on-spec performance as the shipper is willing to give up.

“Specifying thermal packaging used to be a complex design and manufacturing process; these days, it’s become a service offering,” says Jamie Chasteen, senior product manager at Cold Chain Technologies.

“Our transformation from a product company to a leading-edge, technology-based service company has enabled us to become a partner, rather than a vendor, to our customers,” said Jay McHarg, president of AeroSafe Global, at the time of the private-equity investment.

There is another way to address the environmental consequences of thermal packaging, and a few providers are bringing it forward: the all (recyclable) paper container. At the beginning of this year, Softbox Systems, a UK-based provider with offices worldwide, introduced the Tempcell Eco package, said to be composed primarily of corrugated cardboard (some of the materials are branded as Thermaflute, and the trademark literature describes it as composed in part of cellulosic fibers from “crushed, pulverized or unraveled waste paper”). The company says that the package is 100% curbside recyclable.

Other recent efforts include (for internal use) an all-paper container from Thermo Fisher Scientific; the company is a leading provider of biomaterials for clinical research. Testing has shown that the container (see Fig. 5) performs equivalently to an EPS case, although the operating range is somewhat limited to 24-32 hours. The company says that the package is “an important step forward in our sustainability journey.”

The growth of reusable packaging raises an important question: how to determine that a package is still functionally acceptable? And, how should a package be reconditioned? A working group that started informally, but now has the imprimatur of a technical committee of the International Safe Transit Assn. (ISTA) The group published a guidance document, “Reusable Passive Thermal Packaging System: Best Practice Guideline” in the Pharmaceutical Forum publication of the US Pharmacopeia last spring.* It details agreed-on best practices by the committee participants (who are either from biopharma companies, or from a variety of packaging and container firms, including AeroSafe Global, Cold Chain Technologies, Sonoco ThermoSafe, Topa Thermal, Pelican Biothermal and va-Q-tec).

In general, the guidance recommends evaluating the useful life of the various components of a package (insulation panels, PCMs, etc.), a tracking system to monitor the usage cycles of the package and/or its components, and standard operating procedures for inspecting and reconditioning returned packages.

The USP publication was as a so-called “Stimuli” article—meant to generate industry comment, and it is not clear that USP will perform further consideration. Nor is it clear what ISTA will do with it; evaluation of the commentary on the report is ongoing.

“In general, we recondition packages based on criteria agreed to by us and a client,” notes Pelican Biothermal’s Lawler.

The usual perspective on being green is that it is more expensive, but when it comes to ocean freight, the opposite is true: Not only does ocean freight cut transportation costs by 80% or more, it is inherently greener (lower carbon footprint) than air cargo—and becoming more so.

TOTE Maritime, which operates within US territories, recently took two steps forward in this regard. It has commissioned a new freighter that runs on LNG (as opposed to the dirty bunker oil used in many freighters); it has also commissioned a fleet of reefer containers whose refrigeration is provided by carbon dioxide, rather than the fluorocarbon refrigerants commonly used (Fig. 6). (While CO2 is, of course, the primary greenhouse gas, on a per-molecule basis it is much less harmful than fluorocarbon refrigerants.)

According to numerous citations, ocean freight experiences fewer temperature excursions than air cargo, at least on an end-to-end basis. Even so, container providers such as Klinge Corp. have developed a business providing reefer containers with backup power from an integral generator set, in cases where the electrical power typically provided from the cargo ship to the container breaks down. There has been a trend toward shipping pharmaceuticals by ocean freight; AstraZeneca, for example, is said to transport 70% of its global shipments now by ocean.

Mention of such standards-setting organizations as USP and ISTA highlights the importance of agreed-on industry practices, and the one current standard that has achieved global recognition is CEIV Pharma, originated by the International Air Transport Assn. (IATA). (“CEIV” stands for Center of Excellence for Independent Validators, referring to the auditors that grant the certification.) CEIV Pharma started as something of a defensive action by air cargo interests to raise the level of transportation performance by air, and to reduce the shift to ocean freight.

“There are now 261 facilities or organizations worldwide certified to CEIV Pharma,” notes Ronald Schaefer, assistant director at IATA. “The constant addition of new participants shows us that this program really fills a need in the industry. In fact, we are already at the three-year recertification point, with the vast majority of participants from Day One still fully in the program.’’

CEIV Pharma organizations have created their own network, centered around a website, Pharma.aero; it is separate from IATA, but only CEIV Pharma-certified organizations can join.

An interesting facet of the CEIV Pharma program is that “communities”—essentially, airport hubs that organize the air cargo carriers, ground handlers and freight forwarders operating at the hub—are now able to get a collective CEIV Pharma certification. Over 20 airports, in Europe, Asia and North America (Miami, Dallas-Fort Worth and Edmonton, AB) are participating, creating so-called corridors where a shipment is going from a CEIV Pharma origin to a CEIV Pharma destination.

Kuehne+Nagel has one of the largest global networks of dedicated locations for life sciences and healthcare products available, with over 220 of them certified by an internal standard that K+N brands as PharmaChain. Many of them, in turn, are also certified by the CEIV Pharma program. “CEIV Pharma is valuable for us as an external validation of what we do for this highly specialized industry,” says Reinier Danckaarts, VP product development at K+N. “But, since we’re multimodal—air, ground and sea—we need to go beyond its requirements.” In the past year or so, the company has reorganized its offerings to make the customer’s decisionmaking almost independent of mode. “We want clients to know what they are receiving as a service irrespective of mode.”

K+N made an early and deep commitment to CEIV Pharma by having the entire KN PharmaChain (air) network certified, and Danckaarts says that it shows up occasionally in negotiations and is likely to become more frequent in time. “I would rather have industry demand this—because we want to be judged on an equivalent basis with our competitors—but often the life sciences procurement process focuses on cost to the exclusion of quality or total solution costs,” he says.

While a couple dozen firms compete for providing cases or parcels for temperature-controlled shipping, only a handful compete for the approved unit-load devices (ULDs) used by air carriers to handle pallet-sized shipments. The leader appears to remain Envirotainer, which stated publicly last year that it had nearly 6,000 of its ULDs in circulation around the world. Others include CSafe, va-Q-tec, DoKaSch Temperature Solutions, and the PharmaPort business of Sonoco ThermoSafe. These units are typically leased to pharma companies or their freight forwarders on a per-shipment basis.

Envirotainer has been busy for the past couple years expanding its network of service stations, now at 32; the company also runs a Qualified Envirotainer Program among its freight-forwarder and air carrier clients, with dozens of those companies participating. New offices recently opened include Mumbai, Shanghai and Toronto.

In a like manner, CSafe has been adding to its count of service centers and approved air carriers, opening a center in the Netherlands this year, and getting a handful of air carriers approved to deploy its RAP (multi-pallet) container.

Meanwhile, the providers of passive (non-powered) pallet-size containers have been upgrading their offerings, including the use of preformed shells (rather than a cardboard box with strapping). The active-vs-passive pallet shipping question seem to be settled, at this point, like this: active containers still represent the gold standard for product protection, but at higher operational expense. At the same time, the availability of the containers—when and where shippers need them—creates opportunities for passive pallet containers.

“A common scenario,” says Jamie Chasteen, senior product manager at Cold Chain Technologies, “is a shipper that schedules for having four active containers available at a certain location and day, but then realizes just before the shipment goes out that two more are needed.” Providers of passive pallet containers have an inventory of them ready to go and can also assemble new ones fairly quickly.

The active-vs.-passive debate is an old one, at this point; a newer debate is growing over the use of thermal blanketing, especially for controlled room-temperature (i.e., non-refrigerated) shipments. Thermal blanketing started years ago as a reflective sheet positioned around pallets while they sat on airport tarmacs, to prevent excessive heating by sunlight; they have since evolved into a variety of multilayer materials (with air-bubble layers, fiber insulation, or other combinations) that can provide extensive insulation protection. A couple years ago, Cold Chain Technologies came out with its Enshield design, which incorporated gel packs in sleeves on the blanket.

“Traditional insulating-only thermal blankets can be a good option for wide-stability room temperature products” says Chasteen, “because they can moderate some brief temperature extremes in transit” (which, of course, is what they are intended to do). “We also see a push to PCM-embedded thermal covers that can maintain strict label claim temperatures for those same products. Increasingly shippers are quantifying the costs associated with excursion investigations and looking for solutions.” While failure to maintain label claim may not result in product destruction, it does drive extensive cost and delays to market due to formal excursion investigation and product release processes.

The new PCM-embedded thermal covers are also used for refrigerated and frozen shipments. One modality that is gaining increased interest is ocean freight. Blanketing is valuable during the so called “unplug time” between the port’s reefer pad and being plugged into power on the shipping vessel (and vice versa at the destination port). Chasteen says CCT’s PCM covers can keep 2-8C product inside a reefer within range for as long as 36 hours while unplugged.

Q Products and Services, another blanketing provider, recently added gel packs to its PalletQuilt products; the system can be tailored in various configurations depending on the extent of blanket protection provided: with or without a bottom cover; with or without reflective wraps. The company’s CargoQuilt and PalletQuilt products have been used for, among other things, lining entire ocean-freight containers, or for less-than-truckload shipments that are being cross-docked (and thus exposed to heat), according to Kevin Lynch, sales director.

Other providers include Pelican Biothermal, which is a reseller of blankets from an Australian firm, Wilpak; and Softbox, which acquired a blanket provider, TP3, over a year ago.

There could be a reckoning coming soon for service providers seeking to assist biopharma companies targeting the new cellular and genetic therapies (CGTs), but at least so far, a veritable gold rush is going on, with firms ramping up their service offerings, warehousing and logistics capacity and consulting expertise. For sure, the new companies in this arena need the help; the supply chain for CGTs is highly complex, and many of the therapy developers are scientists in labs and not supply chain managers.

The fact of the matter is that there are only a handful of CGTs that have been FDA approved—and the patients receiving the therapies (often for rare diseases) number in the 100-1,000 range, and are being treated at a limited number of health centers (as opposed to picking up a drug at the local pharmacy, or getting an infusion at the local hospital).

The Assn. for Regenerative Medicine issues a regularly updated Sector Report, detailing activity in global cellular, genetic and tissue therapies. Its Q2 2019 report tallies 1,069 clinical trials, coming from 932 companies (510 in the US). That intense effort generates significant clinical trial logistics activity, and the expectation is that many of those trials will result in new commercializations—someday.

All of the well-known clinical trial logistics firms—World Courier, Marken, QuickSTAT, Biocair and many others—have been bulking up their depots, centralized tracking stations and human resources. Quick opened a 30,000-sq. ft CGT Center of Excellence in Chicago (with access to O’Hare Airport), providing both logistics management (Fig. 1) and reconditioning of refrigerated and cryogenic containers.

Contract manufacturers (CMOs) are minimally involved in CGTs currently, but that could change if the medical science shifts from using a patient’s own cells (autologous therapy) to modified cells in bulk (allogenic therapy); the latter process would enable CGTs to be manufactured in volume and to be kept in inventory and dispensed as needed. Even so, leading CMOs or 3PLs—PCI Pharma Services, Sharp, Lonza, Catalent and others. But there are wheels within wheels on this scale question. Currently, there is a scramble to build up capacity for so-called viral vectors—an intermediate product used to convey genetic material into cells. Also, Lonza, for one, is developing the Cocoon module, called “CAR-T in a box” to provide onsite manipulation of a patient’s cells.

“Five or so years ago, Big Pharma ran its commercial logistics separately from clinical trials,” notes Robert Coyle, SVP, healthcare strategy at Kuehne+Nagel (Quick’s parent). “Now the processes tend to be more integrated, and as a company we need to respond to that.”

A parallel expansion is occurring with the container and packaging providers for CGTs. CryoPort opened a global logistics center in Amsterdam at the beginning of this year, complementing another one opened in late 2018. The centers maintain the company’s cryogenic and refrigerated containers. Condition-monitoring electronics onboard the containers, combined with the CryoPortal communications network, provides data collection and tracking.

Finally, just as regulations and standards for traditional, commercial-scale cold-chain transport are continually evolving, so are the standards for the nascent CGT field. A group called the Standards Coordinating Body (SCB), an offshoot of the Assn. of Regenerative Medicine, is acting as a clearinghouse for the many standards from such organizations as ISO, USP, the International Soc. for CGT and others. A recent SCB publication lists 36 existing or evolving standards on cellular and tissue logistics and transportation alone. SCB is also actively soliciting expert input on these standards.

*The article is available, following registration at the USP site, here: 

https://online.usppf.com/usppf/document/GUID-954A72DA-5151-4E6C-A5C0-C14FD48AE815_10101_en-US

As cold-chain hardware vendors tout their new service orientation, the value of data rises

Pharma cold chain: greener and more digitized

Frequent cold chain temperature excursions afflict pharma supply chains around the world, putting patients at risk and generating intensive workflows and waste for pharma companies. The costs due to failures in temperature-controlled logistics is estimated at approximately $35 billion per year.* However, modern software infrastructure can contribute to better manage risks, reduce cost and gain control over these very specific logistics processes.

Pharma supply-chain and quality managers dream to tackle the ever-growing pain of controlling their temperature-controlled logistics processes. Looking into the future, the ideal scenario is not only to monitor the geolocation and the temperature of shipments in real time, but also the humidity level, vibrations and potential light impact on their highly sensitive products. The perfect world would offer them a personalized online monitoring tool based on Internet of Things (IoT) with accurate, tamper-proof and real-time data of their shipments. An additional dream feature is the functionality of alarming relevant stakeholders in case of imminent risk of temperature excursion to a highly sensitive payload. This way the team can proactively avoid excursions rather than coping with its consequences.

Can this dream become reality? The pharma logistics industry is working hard to meet these expectations. However, it takes time to establish the relevant IT infrastructure to make this happen and integrate it into standing pharma supply-chain processes. Large logistics companies with complex structures have to deal with semi-integrated legacy IT systems that are difficult to streamline towards optimal user friendliness and transparency. Younger, innovative and more specialized temperature-controlled container providers like SkyCell were able to build a reliable, integrated and modern IT infrastructure from scratch, which allows them to stand at the forefront of technological innovation and create a competitive advantage in this field.

Data collectors rule the world. This is what we learn from the business models of Google, Facebook and other internet giants. This is not only valid for consumer data of individuals but applies to all industries around the world as well as the pharmaceutical cold-chain logistics.

The more data is collected the more accurate predictions are. If a data base of real-life conditions is available, processes, routes and lanes of pharma cold chain logistics can be simulated with an unprecedented accuracy. This in turn helps to mitigate risks, optimize processes, reduce the expense of corrective actions, and preserve inventory by maintaining product integrity and thereby allowing immediate product releases.

The infrastructure for this kind of services is based on the IoT and is composed of the following elements:

1. Sensors. At least two independent sensors are required, integrated in different areas in each container that collect real life data during a shipment lifecycle. They have to be calibrated in a regular time span according to regulation. Modern sensors are not limited to collect data on geolocation and temperature (internal and ambient) but are also able to collect data sets around vibration, humidity and light influence.

However, only collecting data is not enough. This data needs to be accessible in real time or at least near real time to clients, despite the limitations of the airfreight standards.

2. Making data available to the client. SkyCell uses wireless technology that is approved by more than 60 airlines to communicate with gateways that have been set-up in over 100 airports and strategic locations around the world. While the sensors in each container collect data during the whole trip, the data is uploaded to the SkyCell database once the container passes one of the numerous gateways. This creates a near real-time visibility of the shipment status and condition as well as an alarm function if a shipment is at risk and needs an intervention by a relevant stakeholder.

This data is visible on the SkyCell online portal, which an Operations Team uses to monitor the shipments globally. The client can see the corresponding temperature graphs on the SkyCell extranet, accessible with the clients’ login credentials.

Once the container has arrived at its destination, SkyCell has conceived a mobile app, through which the sensors are read out via mobile phone wirelessly, speeding up the process in the service centers. Traditionally, sensor data needed to be downloaded from USB sticks with a USB port. New technologies make this cumbersome process superfluous.

3. Tamper-proof collection and storage of data. This is where new and highly innovative blockchain technology becomes relevant. Since the danger of manipulation of smart devices is mounting, SkyCell has searched for an infrastructure solution to guarantee the authenticity, integrity and confidentiality of the collected data from its containers. This is achieved by equipping each container with a smart card chip that holds its own digital identity. SkyCell chose to use banking-grade hardware security modules to generate digital identities, also called keys, for each container. It gives each container a tamper-proof identity that cannot be hacked.

All the collected data is stored in physical, georedundant datacenters based in Switzerland, which guarantees the highest level of data security and compliance.

Since SkyCell has been collecting data points in this way for years, this process has created a big data infrastructure with billions of real-life data points to simulate shipments around the world. This data collection is highly valuable to clients, because one can simulate with high accuracy if it is safer to ship a parcel, for example, in August from Basel to Shanghai through Dubai or through Frankfurt – the answer is not self-evident, as Dubai as an example is more used to deal with extreme temperatures than Frankfurt. Simulation eliminates the need for test shipments and brings speed to new product implementation.

Clients are building on this data infrastructure by introducing their desired shipping route into the “SkyCell Transport Planner” accessible with their login on the website. This allows to increase the security of shipments, consequently reducing inventory and save total costs in the supply chain to a large extent.

The SkyCell IT backbone has increased security and efficiency in the temperature-controlled logistics processes; and our data has documented an extremely low 0.1% deviation in temperature over a 12-month period. This figure has been audited by one of the Big Four audit companies. These results coupled with the possibility for insurance companies to assess risks more precisely has generated the possibility for clients to insure highly sensitive and expensive payload against the risk of loss. This additional element to mitigate financial risks is an industry novelty and only available because of the unprecedented accuracy and reliability of the described infrastructure. In essence, it provides a complete peace of mind to pharma clients on all levels.

Temperature-controlled IoT containers in combination with Big Data infrastructure will pave the way to more secure logistics processes and consequently higher levels of product integrity. Pharma supply chain managers should push the boundaries to engage service providers that deliver “risk management as a service” through real-life data, helping them analyze and better control their risk exposure rather than dealing with the consequences of temperature excursions.

Digital integration will generate more transparency in logistics processes, consequently reducing cost and increasing patient safety. Technologies such as blockchain or artificial intelligence have only started to enter this very conservative industry. Predictive analysis based on artificial intelligence will generate even more possibilities to pharma clients. It will be interesting to see how big logistics service providers will integrate such technology leaps into their existing infrastructure, while younger, more tech- and innovation- driven players seem to focus heavily on these elements to maintain their competitive advantage.

Marrie Groeneveld is the Chief Commercial Officer of SkyCell. He has a successful 30-year track record in the contract logistics and healthcare supply chain industry with some of the largest international logistics companies, such as DHL, UPS, Movianto and Expeditors, where he served in senior and executive positions.

https://www.iata.org/whatwedo/cargo/pharma/Documents/ceiv-pharma-specifications.pdf

Collecting and reporting data in near real time cuts costs and reduces risk

Big Data in pharma cold chain logistics

A still-brewing effort to provide a governance mechanism for an organization to manage industry response to the Drug Supply Chain Security Act (DSCSA) took another step forward this summer, with an 

 now being circulated to interested parties. The effort comes out of the Pharmaceutical Distribution Security Alliance (PDSA), which was formed in the early 2010s to lobby for legislative and regulatory actions in Washington when DSCSA was being written. According to a source close to the discussions, not all members of the original PDSA will be members of the new organization going forward, and conversely, non-PDSA members (especially IT vendors in this space) will want to be actively involved in the new group.

“AmerisourceBergen fully believes that some form of governance of DSCSA will be needed to make this all work,” says Matt Sample, VP manufacturer operations at the company. “At this point, the effort seems to be moving as fast as it can, with other companies actively considering the prospectus.”

 blog first broke the news in early August; his commentary on it is informative. The updated prospectus follows on the heels of a first pass, 

 and then followed by a workshop of interested participants in May. There is a tight deadline being proposed: the organization needs 25 members signed on by the end of the year (see figure).

The prospectus details a leadership structure, a tentative budget (including membership dues) and other choices to be made leading, ultimately, to a 501(c)(3) nonprofit. A 14-member board, with four members from manufacturers, four from wholesalers/3PLs, and four from dispensers, with two at-large members, is proposed. PDSA submitted a proposal for the new organization to FDA, which in turn listed it as one of the pilots it selected in a 

. According to the source, PDSA’s proposal was a “placeholder” to be taken up by the new organization, if it comes into being.

The Healthcare Distribution Alliance has been energetically moving the industry along with DSCSA compliance; here's its take on the prospectus: “The next month or so will be critical for the industry, in terms of whether the governance body has support within the industry at large, and whether FDA will be able to recognize the recommendations of such an organization. The pilot is intended to ‘set the stage,’ so to speak, and we think it is encouraging that FDA accepted this as a concept, and at least is willing to entertain the formation of a governance body and see what it can achieve in the context of a pilot." For now, HDA is onboard: 

Some of the details are yet to be determined, but HDA intends to continue to participate."

Why the delicate maneuvering? It goes, in part, to the complexity of DSCSA and its objectives, which will ultimately require coordinated actions and data-sharing among manufacturers, wholesalers and logistics providers, retail pharmacy, and health systems. Getting all these industries into the same room is the proverbial herding of cats—theoretically possible to carry out; difficult to accomplish in practice.

It is interesting, too, to contemplate the deployment of blockchain technology in this context. A surprising number of the FDA pilots—including ones from vendors and from manufacturers and pharmacies—mention blockchain, and among its advocates, one of the fundamental issues in a blockchain-based communications network is governance of the network. In sum, this could be a case where technology, policy (and maybe politics) all intersect effectively.

Updated prospectus proposes membership rules, budget and leadership

PDSA helps bring along a DSCSA governance organization

, individualized treatments like cellular and genetic therapies (CGTs) require close collaboration across healthcare: from clinics and hospitals, to pharma manufacturers and back, with logistics providers, blood centers and other participants along the way, the so-called “vein to vein” supply chain. Now, EY’s Global Health and Wellness sector (which was set up to itself cross-pollinate among healthcare and life sciences clients) is offering a data-sharing platform, branded as Pointellis, to meet these complex needs. At least initially, the focus is on oncology—which happens to be where most CGT activity is focused currently—but it’s just a matter of time before Pointellis will apply to rare diseases and other conditions that individualized therapies are suited for, according to Adlai Goldberg, EY Global Life Sciences Digital, Social and Commercial Innovation leader.

The initial press release about Pointellis emphasizes the need to maintain chain of custody as a therapy is developed for an individual patient. “Pointellis supports a supply chain as bespoke as the treatment itself, one for each and every cancer patient,” says Goldberg. “It maintains the chain of custody and identity; validating every handoff from patient through to drug manufacturer and back again, helping to enable that each patient is treated safely, securely and accurately, every time." The platform is based on Microsoft Azure, the cloud offering of that company, which has been a longstanding partner with EY. To date, three life sciences companies and several healthcare providers have been involved in the Pointellis development.

All that being said, other IT platforms, notably those of TrakCel and Vineti, offer to provide the same chain-of-custody management. But Goldberg says that he expects EY to be collaborating with, rather than competing against, those platforms. “It’s still early days, and these capabilities are evolving,” he says.

Pointellis will be a cloud-based data connector across CGT programs

Pharmaceutical Commerce - September 2019

2019 Cold Chain Provider Directory

A conversation with Jim Lang, Eversana

Pharma cold chain: greener and more digitized

Big Data in pharma cold chain logistics

PDSA helps bring along a DSCSA governance organization

EY pitches in to manage complex administration of cellular and genetic therapies