HDMA Track and Trace Technology Seminar - A Snapshot

I recently attended the HDMA Trace and Trace Technology seminar in MD. It was my first HDMA seminar, and even though attendance was down from previous years, it was a great opportunity to catch up with many existing TraceLink customers.



The focus of the seminar was on serialization and EPCIS much more than ePedigree. The general feeling seems to be that if an organization can tackle the serialization/EPCIS challenges that lay ahead, then pedigrees should follow on relatively easily. To an extent, I can see this point as many of the underlying technologies and some of the processes are shared between the domains. Yet, based on the work that we did back at SupplyScape on the harmonization of serialization/EPCIS/ePedigree, much depends on the definition of 'pedigree' and the specific use cases that you want to support in business operations. If serialization and EPCIS efforts push towards "point in time authentication" rather than end-to-end chain of custody, there will still be much work to do to incorporate the pedigree model.

Here are my takeaways from the sessions and coffee break discussions:

Pedigree Regulations
Not much has changed regarding pedigree regulations. There have been a few changes to some of the state regulations (e.g. CO delayed to 2017), but for the most part, it is status quo. In discussions, most people seem to think that the FDA will eventually develop nationwide regulations that are relatively close to the CA regulations. Unfortunately, the representative from the FDA did not seem ready to discuss the issue in any great detail at the event and did not offer any particularly new insights. I suspect there might have been a desire to keep a low profile given the policy tug of war going on in Washington. However, he did use the term “centralized database” at one point when speaking about technologies, which became a talking point in a few follow-on discussions that I participated in.

CA Compliance Readiness
While in the past, much of the serialization discussion in the U.S. centered on California, today, the majority of the serialization efforts among manufacturers are occurring in Europe, not in the U.S. As a result, U.S. based serialization vendors are shifting personnel to Europe or partnering with local companies to meet demand.

In an interesting case of financial tug-of-war, supply chain operational departments seem to be struggling to get budget for serialization pilots in 2010 when the CA regulations are still 5-6 years away even though they expect it to take multiple years to achieve full CA compliant serialization in production. A familiar refrain from those who have limited pilots in place to those who don’t is: “better get started soon or you won’t make it”.

This leaves open the question of tying the two threads together. Work is going on in Europe and resources are being shifted there yet initiatives in the U.S. are being starved. One would like to say that the European projects are a good testing ground for the requirements of CA and perhaps Federal initiatives. Yet, knowing the unique technical and process challenges in Europe, my take is: Don’t bet on it!

Interoperability Challenges
The industry as a whole continues to struggle with the interoperability of the various available technologies. The roundtable discussion regarding serial number aggregation, inference and data management drew large groups who engaged in some vibrant debates.

Heather Zenk from AmerisourceBergen, who is a licensed pharmacist, brought the plight of the pharmacist to the forefront. With so many technologies being discussed, tested and piloted, organizations need to make sure that they do not forget the pharmacist at the end of the line who may not necessarily be technically savvy and who cannot be expected to support a different technology from each vendor. These questions arise at every step in the supply chain, although in my experience the pharmacy has to deal with the added complexity of supporting the “pharmacist bench” along with the normal receiving and internal distribution processes.

The industry, regulatory bodies and standards orgs clearly have their work cut out to define acceptable approaches to provide full end-to-end product traceability.

GS1 2015 Readiness Program
One item that I heard a fair number of people discussing is the GS1 2015 Readiness Program that Bob Celeste announced. GS1 plans to simulate serialized products moving through the supply chain to help organizations gain valuable experience without having to spin up full trading partner pilots. Follow this link for more information.

All in all, it was a good event although you could feel the reticence of the audience in truly committing towards any one initiative. Perhaps understandable after the past few years of "hurry up and wait". The unfortunate thing is that this cycle will probably continue until more clarity is provided on many fronts.

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AMR Healthcare Exchange an Evergreen Opportunity for Value

 I recently attended the AMR Healthcare Exchange and I walked away with a feeling of Déjà vu. First of all, Hussain Mooraj and the AMR team do a great job of stimulating ideas and connections for joint value creation at all ends and aspects of the supply chain, including pharmaceutical, life sciences and health care participants. As always there was a clear sense of urgency and a feeling of lost time and missed opportunities. This was accentuated by the closing remarks by Johnson and Johnson (J&J) President of Supply Chain and Business Processes, Tom Sullivan. Tom outlined the major value opportunities attained by CPG that remain distant goals for the Healthcare industry. His challenge to the industry was to do for life saving drugs and devices what we do for Coke cans.

This year’s conference provided case studies of value attainment by connecting providers into a Demand-Driven Supply Network (DDSN) of Pharmaceutical and BioTech companies. Roddy Martin made the case for Patient Outcomes as the Moment of Truth for the Healthcare value chain. From the presentations it was clear that significant value attainment was possible when companies collaborated to identify and understand each others business issues and in turn develop mutual trust to enhance integrated cross-company business processes for shared and measurable value.

The frustration and excitement for all of us is the sheer volume of opportunity and the feeling that four years ago we were discussing the same opportunities. Because other industries dominate the annual Top 25 Supply Chain list, Healthcare needs its own special list of Healthcare Top 25 to identify the leaders in this lagging industry. However, our industry has complexity and dynamics that require greater care and hence can support change in very measured steps. These steps need more investment and oversight in our industry.

As an entrepreneur by nature and profession, I am an optimist! In my first job in the summer 1981, between high school and college, I worked for an entrepreneur who was starting a company to provide Local Area Networking (LAN) gear. In doing research for him I was so excited by the fact that he was entering a market at a time when market data identified the 1980’s as the Network Decade. As years and decades past, I was told that every year was the breakthrough year and every decade was the Network Decade. Now it is clear that networking is an endless source of value which grows exponentially as it matures.

DDSN is the same class of evergreen opportunity and the Healthcare industry is transforming to leverage the value from integrating processes, people and information. The strategic imperatives in all parts of the value chain require greater network integration for the next level of financial performance. We work across the value chain and it is obvious to us that business plans more so than regulatory force will drive the adoption of supply network solutions.

Please share with me your perspective. Are you as optimistic as I am and what parts of the supply chain do you see collaborating more effectively?

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Cancer Care Centers seek ePedigree counterfeiting protection

Interesting little article popped up today by San Antonio TV station KENS 5 that discussed how the Cancer Care Centers of South Texas are using E-Pedigree for drug counterfeiting protection. CCS uses an ePedigree-based online tracking system to help caregivers validate the authenticity of pharmaceuticals prior to their delivery or dispensation to patients. The ePedigree system helps create a secure chain of custody as a drug moves along the supply chain while providing a quick snapshot of this chain of custody at any time via a browser-based portal available at point of dispensation. For cancer drugs, providing traceability through this kind of anti-counterfeit barrier has been particularly important to establish as the high value and demand of these pharmaceuticals make them noted targets for counterfeiters.

Unlike many stories of these types, it was the human element of this story that caught my eye. Often, the human side of the equation gets lost when talking about anti-counterfeiting technologies and supply chain traceability initiatives. The bits, bytes, system integration and other business issues typically come to the foreground instead. Perhaps this is understandable given everyone has a business to run and drug track and trace systems can be likened to an insurance policy against counterfeiting, diversion, theft, etc. Thus, a poignant comment made by an oncologist in the story tended to stand out to me: “It’s very important for patients to feel that where they are getting treated, they’re actually getting what’s prescribed for them because it’s a matter of life and death,” explained oncologist Dr. Anu Dham. “It’s cancer treatment.”

I also have more than a casual interest in a story like this as CCS is affiliated with US Oncology, a leading cancer treatment and research network. US Oncology has been a long standing customer of TraceLink / SupplyScape and we have worked closely with USO to assist them in building out their portal-based online drug tracking system. I haven't had the opportunity to visit one of USO's clinics in the past like several of my colleagues here have. So, little stories like these are particularly nice when they give you a little snapshot of those fighting the good fight "from the field".

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Technorati Claim Code Setup Pardon Our Dust

The team here at TraceLink continues to build away and that definitely includes the marketing side of the house. As part of that, we are working with a number of various directories and services such as Technorati to get the word out. Those who have played w/ Technorati know that it requires a post containing the claim token below to finalize a listing on there.

A quick apology to our readers and subscribers for the interruption.

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I mulled over a variety of schemes to "hide" the code from our dear human readers but then thought "let's just tell it like it is". Definitely an interesting spin on the question of knowing that you are the "owner" of the blog.

I now return you to your regularly scheduled program...already in progress.

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PDMA drug pedigree reemerges...or does it?

I was thinking about PDMA this week. What PDMA you ask? I am referring to the Prescription Drug Marketing Act of 1987 (enacted by Congress in 1988) that contained several clauses intended help protect American consumers and the overall drug supply from the risk of counterfeit, diverted or adulterated pharmaceuticals. To this end, PDMA established that a “pedigree” or chain of custody of the drug would be created that provided legitimate participants in the drug distribution system with a history of a drug's source.



Why was I thinking about PDMA? Because in a little noticed action back in September, the Federal District Court in Eastern New York threw out a suit (RxUSA Wholesale Inc. v. Alcon Laboratories Inc. et al.) which had the effect of creating an injunction against the FDA from implementing the law. [Kudos to Pharmaceutical Commerce for its coverage of this event.] Thus ends another saga in the somewhat tumultuous history of the PDMA and its supporting rules.

For those that weren’t keeping score, here are the highlights. After enactment, the PDMA was modified by the Prescription Drug Amendments Act of 1992. The PDMA required the FDA to promulgate implementing regulations with respect to the pedigree provisions. As a result, the agency issued a proposed rule in 1994 and published a set of final regulations to the Federal Register (64 FR 67720) in 1999. Due to a variety of concerns raised at the time, the FDA delayed the effective date of two sections of the law. In 2006, the FDA finally announced that it would no longer delay the effective date and everything looked set for December 1, 2006. Until…that is…a complaint was filed in federal district court by a set of wholesale distributors which sought judgment against 21 CFR 203.50 for a variety of reasons including potentially anti-competitive behavior. The complaint was quickly followed up with a movement for preliminary injunction seeking to stay the effective date once again until there was a final resolution of the case. The FDA appealed in the spring of 2007, the injunction stopping enforcement against non-Authorized Distributors of Record was upheld in July 2007 and the issue bounced around in the courts for the next two years. With this September 2009 ruling in New York, that time seems to have come.

What I am curious about is what next shoe will drop. The regulatory environment is very different now in 2009 than it was back in 2006. Back then, Florida had just implemented a pretty stringent set of pedigree regulations that had caused an initial upsurge in industry adoption of pedigreed drug products. California was coming right on the heels of Florida in 2007 and numerous other states were either enacting or discussing pedigree regulations. So, even though PDMA had its own unique set of data and process rules, it was just one more requirement to put into the hopper while companies were very active with projects in this area.

Today, life is different. The state environment is much less active, particularly given the California delay to 2015+. Many companies have already implemented their systems and processes to handle current business and operational requirements in this area. Much of the current work going on focuses on drug serialization, secure distribution and overall pharmaceutical traceability pilots. Instead, all eyes are turned towards the federal government but for very different reasons than PDMA. The FDA’s Amendments Act of 2007 (FDAAA) kicked off a set of initiatives and FDA guidance, one facet of which relates to the development of standardized numerical identifiers (SNIs) for prescription drug packages. As originally stated, by March 2010, the FDA shall develop a standard identifier and by October 2012 all manufacturers and repackagers of pharmaceutical drugs in the US have to have applied package level SNI’s to their product lines. In addition, bills such as Buyer-Matheson and others continue to get introduced in Congress which have varying levels of pedigree, pharmaceutical traceability, drug serialization and other track and trace requirements. And yes…there is something about heath care reform I seem to remember hearing something about.

While there are a myriad of details related to the FDAAA, SNIs and the general concept of a serialized “federal pedigree” which are beyond the scope of this particular post, it does throw into question the current role of the PDMA pedigree and the FDA’s support of it. Now that the road is clear, will the FDA push forward with more vigorous enforcement beyond than which was laid out in the Compliance Policy Guide back in 2006? Will the FDA keep its powder dry given the onset of new regulations stemming from FDAAA and other federal initiatives? Will the ongoing health care reform debate and its implications for FDA policy keep this issue generally on the back burner for now? Finally, does the concept of “pedigree” as defined in PDMA even make sense in this environment? With all the ongoing analysis, debate and technology work occurring in serialization technology, EPCIS systems and other track and trace approaches, is the best approach to just start fresh with pharmaceutical traceability?

My view is that it might be hard for the FDA to justify any aggressive enforcement of PDMA at this point given the potential for new pharmaceutical traceability requirements next year and the uncertain implications for the industry given health care reform.

I see that at the upcoming HDMA Track and Trace Technology event starting on Nov. 30th, David Dorsey, Deputy Commissioner for Policy, Planning and Budget for the FDA will be speaking. Mr. Dorsey’s presentation will cover broad ground including the aforementioned FDAAA regulations and the SNI initiative. It will be interesting to see if Mr. Dorsey will also provide a glimpse in to the current thinking on PDMA. Our own Peter Monahan will be providing a detailed readout of the entire HDMA event. So, check back to see if PDMA has emerged from the shadows and what other hot button issues have bubbled up!

Comments

Anonymous commented on 24-Jan-2010 06:15 PM

If I am not mistaken, the September ruling on the RxUSA suit is a separate case from the RxUSA, et. al., vs. FDA pedigree lawsuit. The suit that was ruled on in Sept. was RxUSA's suit against various distributors and manufacturers for alleged restraint of trade violations -- i.e., not the suit challenging FDA's interpretation of the PDMA. The FDA pedigree case has yet to be heard and therefore could not have received a ruling -- the proposed pedigree rule is still very much enjoined. The plaintiffs and the FDA, in anticipation of the passage of the Buyer-Matheson pedigree bill being passed this year, agreed last year to approach the federal court hearing the case and request an postponement of the proceedings. Since both parties were in support of the Buyer-Matheson pedigree language, both thought it would be unnecessary to litigate an issue that would ultimately be rendered irrelevant by the legislation's enactment. Since, like everything else on Cap. Hill, pedigree has taken a back seat to health care reform efforts, it is anticipated that proceedings may be postponed in to 2010 to allow Congress an opportunity to move a pedigree bill.

Brian Daleiden commented on 24-Jan-2010 06:17 PM

You are indeed correct on the separation of the cases. Thank you for pointing that out. I should have been a bit clearer in my commentary on the court proceedings. The case against the plaintiffs mentioned (RxUSA v. Alcon et al) was ruled upon in Sept. This is indeed separate from the RxUSA v. HHS case directly affecting the FDA which is still in litigation. My read of RxUSA v. HHS was that the FDA was partially, but not completely, enjoined from implementing the pedigree provisions of PDMA given RxUSA v. HHS. The original preliminary injunction stopped the FDA from implementing two specific elements of the PDMA under 203.50(a): • Requiring that a pedigree identify each prior sale, purchase, or trade of a drug back to the drug’s original manufacturer. • Requiring that a broad set of information be encoded on a pedigree, including lot numbers and container sizes. Given that, the FDA put out a compliance policy guide clarifying some issues and stating that they (the FDA) decided to exercise enforcement discretion rather than potentially create confusion and enforce partial provisions of the PDMA. Thus, the FDA did not intend to initiate any enforcement actions against wholesalers solely for failure to either include extended data (lot numbers, dosage, etc.) or to provide a pedigree that goes back to the manufacturer as long as the pedigree otherwise identifies the last Authorized Distributor of Record that handed the pharmaceuticals. So, this is why I mentioned that in my view the ball is in the FDA’s court. My belief is that they could decide to change their view of enforcement discretion as stated in the policy guide on the issue. I will check on this opinion. But, I don’t see why they would given the other activities going on. I wholeheartedly agree with your closing thoughts. I believe the FDA would prefer a clear signal from Congress on a national "pedigree", however that is interpreted in the end.

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Peeking behind the Cloud by CNN

We at TraceLink have been taking a hard look at Cloud computing for a while now and it isn't a huge surprise. The solutions we built at SupplyScape shifted from on-premise software with perpetual licenses to SaaS-based software with term licenses back in 2005. There was admittedly a lot of wailing and knashing of teeth as we tried to determine the appetite in the pharmaceutical supply chain for hosted software running critical operations. To the surprise of a few of us, adoption actually occurred pretty quickly as performance and security questions were quickly put to rest. As a result, our SaaS infrastructure continues to bubble along nicely running our Nexus, E-Pedigree and RxAuthentication solutions.

Thus, my antenna was up as I came across this article (and video) by CNN today. Fun stuff! The synopsis is that the author (John Sutter) basically woke up one day and became intrigued at where does all of his data go when he uses Flickr, Google, YouTube, Twitter, Facebook, etc. The hunt is on as the John starts down the path of trying to put his arms around the Cloud. (Spoiler Alert) What John finds is that the Cloud is far from soft and fuzzy...rather it is made up of a huge infrastructure of data centers, servers and all of the other accouterments of a typical IT shop. Now, that isn't exactly a surprise to us here but his exploration is a fun ride. Especially as he tries to get the people in charge of these systems to talk about them.



One question in particular that Mr. Sutter raises relates to service levels and trust in an infrastructure that you have a hard time touching. As he puts it: "I thought about what I want in a cloud service. I want my data to be available all the time. And I don't want there to be any chance the company could lose it, a tricky request since the hardware that stores our data is designed to fail from time to time." This is a common question that we have worked with customers on over the years and our own John Kordash will be diving deeply into the Cloud in all its glory over the next few months. Until then...don't let the Cloud rain on your parade!

Comments

Nate Brown commented on 24-Jan-2010 06:22 PM

Great article! With the Google model becoming more and more prevalent (they are gaining a lot of traction with their corporate Gmail and office productivity products) as well as advances in mobile technologies (4g networks, huge bandwidth), I have a feeling many more companies will jump in once they see how they can defray IT costs and decentralize their data, but still maintain security as high or higher than if it was behind their own firewall. Great stuff all, I miss working with you! ~Nate

Russell: Bioreactor Sampling commented on 24-Jan-2010 06:24 PM

Thanks for the link to the article; I really enjoyed it. Unfortunately, some of the people that I work with are a bit more methodical in their consideration of the use of the cloud to store our data. Frankly, I can understand their hesitation but I would think that its benefits would far outweigh the drawbacks.

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Pharma and Twitter - Patients and Providers but what about Operations?

I have been keeping an eye on Twitter for a while now. Not that I paint myself as an expert by any stretch of the imagination and Tweeting is still more of an activity that I consciously force myself to think about rather than feeling it is part of my DNA. A little different than, say, our own Peter Spellman here who I swear needs a third hand just to keep up with all the ideas that he would like to convey. Can you say drinking from the fire hose??

Much of the buzz about Tweeting usually centers on its usage for personal interests. A 24x7 channel for thoughts and ideas that you want to share. What has been on my mind lately, though, has been the business communications side of the issue. In that light, any new bi-directional channel that enables me to listen to what others have to say and improves my ability to communicate back to them is great.

A recent post by ePharmaRx got me thinking more about how this channel is used and viewed by the Pharmaceutical industry. As ePharmaRx comments, many pharmaceutical companies have just started to "officially" Tweet in the past year. This is somewhat understandable given the concerns noted in several places over the liability issues involved, particularly in the patient care arena. Certainly, these official channels are somewhat separated from the individual discussions that pharma employees have already opened via Twitter.

So what about the operational groups and Twitter? How do the people leading the charge in manufacturing, supply chain, contract outsourcing and other functions view and use it? Based on my conversations with people in these areas, the responses are all over the map. Some are starting to find it a valuable new channel for "pushed" information from companies and individuals which they can take note of if interested or ignore if not. Others are keeping Twitter solely in the personal realm, for now.

This is an issue that we here at TraceLink are looking at closely. Today there are such a variety of ways for us to share information about what we are doing, listen to what others are doing and gain quick, pointed feedback on key issues. What exactly is the right role in B2B for the 140 character soundbite?

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Pharmaceutical Supply Network Challenges Continue According to IMS Health Forecast

Based on the recently released IMS Health industry forecast, it looks like the macroeconomic trends driving increased complexity in pharmaceutical manufacturing (both organic and contract manufacturing), supply chain operations and sourcing will continue to grow. The question facing the planning and operations leaders in these areas is how to get ahead of this curve.

According to the new report, the seven "Pharmerging" markets comprised of China, Brazil, India, South Korea, Mexico, Turkey and Russia will contribute more than half of the expected global market growth in 2009. While this share in 2009 is higher than the recent historical average, these seven markets will be the source of more than 40 percent of total global growth through 2013. This trend isn't surprising as these countries are still climbing up the curve of broad access to primary care, particularly in rural areas. Improved health insurance access is stimulating improved health care regimens while the traditional focus on acute care and infectious disease treatment is giving way to a new focus on longer-term care of chronic illnesses such as cardiovascular diseases and diabetes.

As this trend shows no signs of abating anytime soon, the question that has been facing many of our customers is: Do we make tactical adjustments in our manufacturing and supply chain plans or is now the time to look at a strategic change in the way we do business? Markets are becoming increasingly global yet at the same time the specific desires of each country and region are becoming more local. In parallel, the growing emphasis on operational improvement stimulates a desire for global sourcing and global access to contract manufacturing, packaging and distribution partners. This push into a more virtual environment is straining traditional management processes and technologies to the limit.

Is now the time to completely reexamine the foundation that all this operates on?

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Contract Pharma 2009 - The Pharma Outsourcing Event Recap

The TraceLink team just returned from this year's Contract Pharma conference and we all agree that it was a stellar event. Interesting and diverse sessions on a range of issues from globalization, pharmaceutical outsourcing and clinical manufacturing were combined with an enthusiastic audience and smooth logistics. This was the second time we have attended and in my opinion, the bang-up job that Gil Roth's Contract Pharma team continues to do is one reason for the great crowd this year.

While I really cannot do the speakers justice in representing their sessions, a few comments did jump out at me:

• Mac Lynch (VP, Contract Manufacturing, Pfizer Global Manufacturing) highlighted several expected benefits of outsourcing that revolved around the general theme of agility in the face of uncertainty. This has been a recurring theme in many of our customer discussions. Namely, as therapies get more targeted and markets get more diversified, it becomes even more imperative to create network flexibility, manage demand volatility and address new product uncertainty in a capital-efficient manner.
• Rachael Zuckerman (Research Analyst, Tufts Center for the Study of Drug Development) talked about the explosion of contract clinical services. The number of companies actively managing clinical projects more than doubled in recent years to over 2,300 in 2008 according to Rachael's research. Combined with the growing globalization of clinical trials (32% of all CTs in 2007), this has been putting pressure on sponsors to find ways to effectively manage these far-flung operations. Rachael's research also highlighted how a focus on accountability can improve the contracting process. Driving visibility into operations and creating insight through knowledge management promotes the ability to optimize new contracts and reduce the number of contract changes.
• Deirdre Ogorzalek (Celgene Corp.) discussed how important it is to understand the team culture and process working style of your contract partner. While the going-in position of a sponsor may be to outline a specific working model for its partner, the reality is that the day-to-day working style and communication methods will greatly impact how a project is ultimately executed. So, creating bi-directionally open communications between the project teams on both sides is crucial in delivering a project that meet outlined KPIs and SLA metrics.

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