Nick Basta, Editor Emeritus

At the beginning of this year, labeling giant Avery Dennison announced a competition for new technologies to enhance consumer and supply chain performance with software or product-identification technologies. Now, Varcode, a developer of digital collection, recording, tracing, and reporting solutions for supply chain compliance and monitoring, has announced that it is one of nine companies (out of over 200) to be in the first “cohort” under the AD Stretch program. (A venture firm, Highline Beta, is also sponsoring AD Stretch.) Each of the winners will partner with AD to run a pilot in the next several months to demonstrate their technology.

Dan Bogar, chief revenue officer at Varcode, says that its Smart Tag technology “sits in the middle” between low-cost chemical indicators that give a yes/no answer to temperature excursions of cold chain shipments, and higher-cost dataloggers that record time and temperature along a delivery route. The Smart Tag is a “dynamic” linear barcode label those elements record the extent and duration of a temperature excursion; the results can be read with most scanners or smartphones, and then transmitted to a cloud-based data-management system. The company currently produces 500K labels/month in Israel, and will be opening comparable capacity in the US in 2023. 

Numerous observers in cold chain monitoring, as well as those involved in the massive effort to put barcodes on each unit of sale of pharmaceuticals in the US, under the 2013 Drug Supply Chain Security Act (DSCSA), and elsewhere in the world, have noted the commonality of this track-and-trace technology with cold chain tracking. Bogar says that while Varcode’s label is not designed for DSCSA compliance, it would be a relatively straightforward process to include a 2D DSCSA barcode along with the Varcode barcode. 

Results from the Varcode AD Stretch program are expected next year.

Articles

Varcode’s variable barcode records temperature and time out-of-compliance for pharma and perishables

Varcode to Work with Avery Dennison on a Cold Chain Tracking Application 

Intent on capturing as much of the burgeoning field of healthcare shipping, including clinical trial logistics, as it can, UPS Healthcare Logistics has announced expansions of its existing Silver and Gold services, in addition to a new Platinum service. The latter capability, to become operational in the fall in the US, includes use of mesh technology (a way of creating a dedicated wireless network) to communicate temperature, location and environmental conditions of small-package deliveries in real time both within and without the UPS physical network.

UPS Healthcare Logistics announced its Premier Gold service in 2020 in the US; since then it has been expanded to Canada and Europe, and Mexico and Asia-Pacific locations are about to go live. The Silver service, based on lower-cost RFID sensors, has also expanded and will continue to be rolled out globally. Premier Gold will launch next January in India, says the company. What UPS calls “controlled product protection” includes 24/7 monitoring of shipments and the ability to intervene to recharge refrigerants, redirect shipments or otherwise recover a shipment. 

“Our involvement in Operation Warp Speed to transport Covid-19 vaccines globally served to accelerate our service enhancements,” says Wes Wheeler, president of UPS Healthcare Logistics. “As of today, we’re involved one way or another with the commercial deliveries of 5 of the approved ten cellular and genetic technologies—a field that will be transformational for biopharma.” Wheeler adds that in the next 2 to 5 years, UPS Healthcare Logistics more-then 10 million sq. ft. of global warehousing capacity will expand by another 4 million. 

Three levels of service—Silver, Gold and Platinum—are rolling out globally

UPS Healthcare Logistics Expands Premier Service, Plans New Warehousing and Delivery Capacity

As if laying the foundation blocks for the massive structure that will eventually be the interoperable, fully electronic drug-tracking system under the 2013 Drug Supply Chain Security Act (DSCSA), FDA has issued two more guidances to help pharma supply chain participants get ready for November 2023 implementation.

DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs

 is a straightforward recommendation for participants to employ the GS1 EPCIS standard for communicating product identification and transaction information. This is fairly non-controversial; the Healthcare Distribution Alliance (HDAA), the trade association of US drug wholesalers, has long promoted this standard. The GS1 organization, for its part, has written elements of the standard specifically for the needs of pharmaceutical trading partners. One nuance, though, is that HDAA and others specify version 1.2 of the standard; FDA is silent about what version to use.

Identifying Trading Partners Under the Drug Supply Chain Security Act

 is also fairly straightforward in concept, but will be more difficult to put into practice. Under DSCSA, drug transactions, up and down the supply chain, are to occur only with “authorized trading partners,” and “authorization,” in large part, means, having an appropriate license and verified identity. Under various federal and state programs, most manufacturers, wholesalers, hospitals and pharmacies have such licensure; however, FDA is still finalizing a federal system for wholesaler licensure. Additionally, a new (for FDA) category of third-party logistics providers (3PLs) will also need licensure in most cases. “Salvagers” who recover expired product, as well as reverse-logistics service providers, among others, may or may not need authorized status, depending on the nature of their service. Depending on the volume of their trading activity (as opposed to dispensing), some pharmacies might need wholesaler licensure as well.

Both guidances are subject to 60-day review and commentary, which will end on September 5.

The EPCIS communications standard is “recommended,” and trading partners are identified

FDA Issues Two Draft Guidances for DSCSA Compliance 

One of the more famous, recent crash-and-burn episodes in high technology, IBM Watson Health, is now rebranded as Merative. Francisco Partners, a private-equity company, had purchased most of the Watson Health assets in January, and is now joined with two other private-equity firms, True Wind Capital and Sixth Street, in launching the new company, based on Ann Arbor, MI.

Merative is organized into six business units: Healthcare analytics; Clinical decision support; Clinical development; Social program management; Real-world evidence; and Enterprise imaging. Global clients will exist among employers, governments, providers, health plans and life sciences companies. 

Already, the top 20 pharma companies are clients, says the firm. Specific services for life sciences include enhance clinical trial efficiency and reducing trial costs; reinforcing clinical research by providing access to over 8,500 journals and 750,000 publications; and meeting post-market requirements, by generating real-world evidence to demonstrate the clinical and commercial value of therapies, to FDA and payers.

Left mostly unsaid in all this is the “Watson” part of what had been Watson Health—IBM’s famed AI tools for natural language processing and analytics. IBM had spent billions to mate that home-grown technology with a series of acquisitions of healthcare data repositories a decade ago. Unmet expectations of a new era in healthcare data analytics led to the company abandoning its efforts late last year. 

New company targets data analytics based on a vast trove of patient health information

Merative: New Name for IBM’s Watson Health Data Resources

The multi-year movements of Clayton, Dubilier & Rice (CD&R), a major private equity firm, have reached something of a climax at the end of June, as the company announced the formation of Inizio, “a strategic partner to health and life science companies throughout the life cycle of their drug products.” Well, sort of; it doesn’t do drug development or manufacturing, but does do a lot of the communications-related consulting, advising and advertising, from its pharma clients and to patients, providers and payers. Inizio says it comprises over 10,000 employees, operating in 35 countries. An industry-related source counts 40 distinct company logos under the Inizio umbrella, all or most of which will continue to operate with those identities—good luck figuring out who will answer the phone!

CD&R started this process, arguably, with the acquisition of Huntsworth, a London-based healthcare communication company, in 2020 for about $690 million. A year later, it acquired UDG Healthcare, based in Ireland, for $3.9 billion. UDG did many pharma-related activities, but the key part brought into Inizio is Ashfield Health, another multinational communications and advisory company to pharma. Huntsworth and Ashfield, combined, represent the bulk of Inizio, but interestingly, both companies have been active acquirers of other services businesses until quite recently. 

Now, the newly formed Inizio will have five business units: 

Inizio Advisory, offering consulting including licensing, product launches, pricing and market access;

Inizio Medical, for communications, medical affairs and real-world evidence, among other services;

Inizio MarComms, for branding, media and marketing; a leading company brand here is Evoke;

Inizio Engage, for “live, hybrid, and digital channels for HCPs, payers and patients;”

Inizio Biotech, for services specific to biologics and genetic technologies development and commercialization.

This conglomerate, although seemingly unwieldy, fits a well-established pattern among agencies and communications services for life sciences—many distinct company brands brought under one corporate umbrella, with the intent that the firm can be a one-stop shop for the needs of life sciences companies. More so than some other conglomerates, Inizio will have a solid offering in commercialization services for pharma. 

Private-equity-funded conglomerate will offer life sciences commercialization services



Ashfield and Huntsworth Join Forces to Launch Inizio

It is the contention of BrightInsight, a San Jose, CA software firm, that biopharma and med-device companies seeking to develop digital health applications to wrap around their commercial products are ill-suited to the task: teams of software developers are needed to design and build the applications, including interfacing with a wide and growing variety of third-party software tools, wearable devices or monitors, all while ensuring reliable data collection and analysis, and meeting the complex strictures of (for example) FDA’s Sofware as a Medical Device (SaMD) regulations. By offering its BrightInsight Platform, a Google Cloud-based system—prebuilt with compliant reliability, privacy and interfacing capabilities, followed by easy-to-use configuration for specific medical applications—the company promises a streamlined pathway to successful digital-health resources.


Now, at this week’s international BIO meeting (San Diego, June 13-16), BrightInsight has introduced the Disease Management Solution to further tailor its platform to user needs. This solution, says Kal Patel, CEO, provides Patient App tools to communicate and engage with patients; a Healthcare Provider Interface with a clinician portal, integration with electronic health record (EHR) systems and patient-provider communication, and Analytics Dashboards to enable data scientists at biopharma and medtech companies to better understand the dynamics of drugs and devices in the real world. 

“Our clients are building regulated patient apps that support the patient care journey, including therapy administration guidance and tracking, ongoing disease monitoring, medication reminders, and communication with healthcare providers,“ he says.


Existing clients include Novo Nordisk for diabetes management, Roche for a dosing calculator for hemophila-A treatment, and CSL Behring and UCB, both for rare disease management. At Sanofi, another BrightInsight client, global leader Brad Gescheider says that “The data collected through these efforts will also help power more personalized therapies, deliver beyond-the-pill service offerings, and potentially extend the patent life of our most valuable brands.”


Patel notes that as numerous therapeutic areas become more crowded with commercialized drugs and devices, the digital health tools that the manufacturers will provide become a more crucial differentiator among those offerings. Via digital health tools, better adherence to therapy, leading to better outcomes, will result.

Configurable applications address patient and healthcare-provider interfaces, and an analytics dashboard