HDMA Track and Trace Technology Seminar - A Snapshot
Written By: Peter Monahan
Wednesday, December 16, 2009
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.
AMR Healthcare Exchange an Evergreen Opportunity for Value
Written By: Shabbir Dahod
Tuesday, December 01, 2009
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?
Peeking behind the Cloud by CNN
Written By: Brian Daleiden
Wednesday, November 04, 2009
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!
Contract Pharma 2009 - The Pharma Outsourcing Event Recap
Written By: Brian Daleiden
Saturday, October 10, 2009
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.
ContractPhama makes the presentations delivered at the event available to anybody via a simple registration process. This is a refreshing approach compared to the fees that other events will change for event proceedings. I urge anyone who wants to gain a 360-degree view of the current environment to check them out!
1
Comments
Post has no comments.