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Tuesday, December 25, 2012
Drug Development Technology
Useful Link: News, views and contacts from the global Drug Development Industry Drug Development Technology
Monday, October 22, 2012
Recap: Life Science Information Exchange Event in SW Michigan
Recap: Southwest Michigan Life Science Information Exchange 10-18-12
The first southwest Michigan Life Science Information Exchange event held in Kalamazoo at the SW Mich Innovation Center (SMIC) last week was very much like a TEDx event, or rather it was more like at TED℞ event (wonder if I can trademark that?). The audience ranged from life science manufacturing, to biotech, to pre-clinical, and on to life science business support arenas.
Ben Culp |
Everyone in attendance, including late arrivals, were provided with the opportunity to give their personal “elevator speech” so that they had a head start during the many opportunities at the event for expanding their network.
Yours truly started off the event describing the many opportunities for life science companies who want to expand their client portfolio to include the government sector. The National Institutes of Health, Department of Defense, the Office for Biological Defense, the VA, EPA, and the Navy’s Bureau of Medicine and Surgery are among just a few of the branches of government which award many millions of dollars in R&D, life science equipment, and safety evaluation studies (as well as many, many, more services). The government sector is not necessarily an easy customer when compared to a commercial client as there are many qualifications and hoops to jump through. Fortunately, the local Procurement Technical Assistance Center (PTAC) provides free training, guidance and follow-up to support the life science client. Because there are many hurdles, those life science companies who are not fully on board (lack commitment) are predictably less successful in this arena. Conversely, those companies who have developed a systematic approach to the proposal/bid process achieve more successful shots on goal. Also described was the NIH RePORTer online research tool. This government-transparency tool provides a great deal of information for researching topics, forecasting, and competitive surveillance.
Brian Knapp of MPI Research |
MPI Research Study Director Brian Knapp showcased the Quantitative Whole Body Autoradiography (QWBA) capabilities that he developed. Mr. Knapp explained that his methods resulted in the reduction in the number of animals used on study vs. n=3 for traditional tissue excision, allows for multiple data points within the same tissue or organ, and that QWBA can be run in conjunction with other ADME portions or as a standalone tissue distribution study. Brian also displayed the robust tumor mapping capabilities in their molecular imaging department.
Dr. Andrea Johanson |
Dr. Andrea Johanson from BBCetc based out of Ann Arbor, MI enlightened the entire group with the requirements and intricacies involved in securing SBIR/Small Business Technology Transfer (STTR) grants. While her presentation was an overview of the program, it was ripe with enough detail to provide a life science entity as to whether to pursue such a grant. I am certain that Dr. Johanson will be receiving several follow up phone calls.
Rounding out the speaker line up were John Underwood and Kevin Marcial from Performance Validation. Performance Validation supports companies who need to prove that their facility/equipment compliance standards are met. John explained that Kevin’s extensive experience in life science systems validation has actually expanded their company’s service offerings. Definitely value-added. I am certain that Performance Validation will get some calls as a result of their presentation.
Kevin Marcial and John Underwood |
The atmosphere at the event was comfortable for people to ask questions during the presentations and engage in a hearty dialog. Before the event, during the break, and afterwards, the room was quite animated with these professionals connecting to both new acquaintances and familiar faces.
The feedback that we received has been only positive with every respondent asking for this to be a continuing event. Once the finally tally has been made we will determine if this will be quarterly or semi-annually. As I stated in my first article regarding Life Sciences in West Michigan: It’s part of our DNA!
Sunday, September 23, 2012
West Michigan Life Science Information Exchange event
Life Science Information Exchange in West Michigan
It’s not San Diego and it’s not Boston, it’s the left half of the mitten and we have one the most broad spectrums of life sciences companies in the region. Our local skills certainly have a global reach. The range of life science companies in West Michigan is expansive:
· Drug development
· API manufacturers
· Clinical laboratories
· Pre-clinical laboratories
· Chemistry laboratories
· Biotech research
· Equipment manufacturers/suppliers
· Reagent suppliers
· Medical Device manufacturers
· Veterinary drug development
· Animal models
· Life Science consulting groups
· Life science project management
· Life Science business incubators
· Research Hospitals
· Research Universities
Life Sciences in West Michigan? It’s part of our DNA.
Event flyer: www.benculp.com/lifescience.pdf
Wednesday, September 12, 2012
The Gamification of Training Records
The Gamification of Training Records
Every day we are being “gamed” without our significant
awareness. Whether you have a competitive nature or not,
gaming elements are being used to manipulate your behavior to achieve someone
else’s goal. Gamification
is the application of gaming elements, strategies and mechanics to enhance
non-game contexts. Since you are reading
this on-line blog it is likely that you are also clued into some of the most
popular social media websites such as Facebook®, Twitter®
or LinkedIn®. It’s pretty
clear that there are games on Facebook®, but by comparison LinkedIn®
is rather dry and is “strictly business”.
So the fact that you are being gamed by it with every visit may
come as a surprise. I am certain there
are more examples, but here are three very easily identifiable ones:
1) “Your profile is 85% complete”. Much like your local United Way®
thermometer which indicates how many donations have been contributed, LinkedIn®
wants you to know just how close you are to a goal. It is our competitive nature to want to meet
the goal. And gee, I only have 15% of
the way to go. LinkedIn® will
profess what the benefits are to being 100% complete, thus drawing us into the quest to achieve their goal. We are being
gamed and for that matter, the United Way is gaming us too.
2)
“726 Connections link you to 4,569,663 professionals”. Nearly all LinkedIn® users know that the exact number of connections
isn’t public once it hits 500. That in
its self may be motivation to gain connections, despite their warning not to
connect with people you haven’t actually met, but LinkedIn® provides you with an automatic list of people that
you might want to connect with. Click on
any of them, and you have been gamed.
3) “Your
profile has been viewed 8 times in the last 3 days”. WHO viewed my profile? Thus clicking the provided link takes you to
the screen to show you who viewed your profile.
The point is to draw you to another section of LinkedIn®. Simultaneously, LinkedIn®
provides the opportunity to not only study/worry/ponder about who has been
stalking you, but to encourage you to enroll in a premium account. They have moved you along the game with your full consent. You have
been gamed.
Applying Gamification Methods to Training Records
In a GLP environment, training records
are paramount to compliance and the motivation to have complete records and at
the same time promote cross-training is a win-win situation for the
organization. Borrowing a page out of
LinkedIn®’s playbook can assist in achieving
these goals. These methods are certainly
easier to administer if the training records are in electronic format, but this
is not exclusively required.
Much like the %profile complete
described above, there is usually a defined list of procedures that the staff
must be trained in (initiated and authorized to perform). If the technician is
47% complete on their training goal, then they will strive to complete that
next 3% microgoal. It is human nature, but they have to know where they sit on
the continuum in order to make the motivation work. While there may be a financial reward (at
your institution) for completion of all of the goals, microgoals along the way
make the journey more pleasing to take.
Exactly like the number of LinkedIn® connections, the number of activities that the
staff is cross-trained in needs to also be tracked. A salesman with a higher
number of LinkedIn connections is one indicator of span of reach and similarly the
more procedures that the staff is trained in benefits the organization with
flexibility, maturity, and succession planning.
Proving the technical staff with their numerical rank on procedures
mastered, can motivate them to achieve the next milestone.
Additional reinforcement of the
microgoals may include such gamified achievements in the bronze, silver, and
gold levels. [This sort of level naming can reach
absurdities as indicated by the gamified announcements for boarding an airplane:
“Delta® now welcomes all SkyTeam® Platinum Elite
Plus members”.] Bronze level technicians
may work in a single department, silver may work in 3 departments and gold
level may work in all areas. Who wouldn’t
want to be a gold level technician?
Eventually, the technician will be financially gratified, but in the
meantime, they get a distinction that sets them apart.
Utilizing the ubiquitous Microsoft® SharePoint®
can ease the tracking of all of the aforementioned elements so that the
technician’s progress, achievements, and quests are readily available.
The gamification of your training
records can self-motivate your staff to achieve the goals of your organization.
Saturday, August 25, 2012
LEAN Six Sigma: Ready, Fire, Aim
Lean Six Sigma: Ready, Fire, Aim

That “buy-in” scenario occurs all too often and while the
answers to what a Six Sigma Green Belt is and is not are pretty quickly
answered, but the aspect of who is going to cover for the trainee when they are
out of production invariably leaves the line supervisor scratching their heads.
Clearly the target that the boss intended to hit, has turned into a miss.
What’s Wrong?
As with any new program buy-in by all levels of the company
is essential for success. For LEAN Six
Sigma (LSS), the impetus for bringing it in the house may have been one of the
following:
·
Too many errors
·
Perceived (by someone) or evident bloated
internal processes
·
Low profitability
·
Competitive advantage (or equivalence)
·
Client expectation
Is every effected stakeholder aware of the situation? If the effected individuals can recognize the need for improvement, then there is greater opportunity for buy-in. Perhaps the problem exists in an external- to-the-company situation e.g., competitive advantage. This needs to be explained in understandable terms. Example: Client A awarded the contract to Vendor B because they had a LSS program and thus had the potential for fewer errors and cost overruns.
Who’s Driving?
Who is leading the charge to make LEAN Six Sigma a resident
program?
·
Executive Management
·
Middle Management
·
Quality Assurance/Quality Control (there is a
difference)
·
CFO
Often the leaders who have been faced
with “issues” are the first to grab on to a LSS program. Executive management sees what the market is
doing, how the customers are viewing the company product/service output, and
where the company is ranked amongst the competitors by the clients. Middle management often sees first hand where
the issues are, although unable to “get a handle” on how to address them. The Quality Assurance unit had been losing
confidence with level of compliance coming out of the laboratory as too many
errors need correcting. Quality Control
has observed an increase in the number of faults/errors and re-do’s are now being
considered as part of the regular schedule.
The CFO perceives/theorizes wasted money in time and materials. All of these observations come from different
vantage points and each needs to be incorporated into the roll out program.
Who’s on Board?
Who is on board with bringing this potentially onerous program in-house to disrupt everyone’s routine? Those words
are fairly negative but if the program is rolled out in a half-hearted way that
is exactly what it will LSS become. Buy-in by ALL leaders is required otherwise
it could be a painful experience.
·
Upper Management
·
Middle Management
·
Everyone Else (unified vision)
·
No one!?
If the top of the organization is driving LSS and the front
line staff are committed to it, but the middle management is not supportive,
then the program will not succeed. Further, if the leadership is dragging (or
nagging) the staff into participation then the six sigma program is going to be
an uphill battle.
Ready, Aim, THEN Fire.
Before launching into LSS all stakeholders need to understand what the
drivers are, what is at risk if remediation (of the issue) does not occur, what
the realistic time commitments are required, and how business timelines are
going to be maintained.
At the heart of LSS is change and change is not something that comes easily
to organizations that do not recognize that there are issues. While it has nothing to do with LSS, the
movie Kinky Boots (PG-13) could well be shown to organizations that need to
change but are reluctant to do so.
Saturday, July 28, 2012
Who Moved My Silo?
Who Moved My Silo?
When high walls and self-centered actions have a place in your
organization (and when they don’t).
Just down the hall, Dr. Joe’s engineering department is just
simply not playing fair. His administrative assistant is not in the rotation
for switchboard coverage. Their expense
reports don’t have the required receipts attached to them, yet they get
paid. They infrequently show up to the
weekly staff meetings. They go around
H.R. when hiring. Dr. Joe’s casual Friday’s
are cringe-worthy. Information flows into
Engineering, but the sounds of crickets come out. How is it that this
department is not held to the same standards as everyone else? Why isn’t the VP addressing this disruptive
situation? Surely, there has been a
great deal of grumbling amongst the rest of the department heads. And now, it’s effecting turnover outside of
engineering. This silo has apparently not kept everything inside its walls.
“Silo” is a pejorative business term and no institution,
whether academic, commercial, or non-profit is immune from the silo’s
impact. Despite its relatively recent
negative connotation, the silo is not a new invention, and only gets the
moniker when others are negatively impacted.
That silo down the hall from your office, didn’t naturally occur. It was purposely established and while not
inside of it, you helped with its construction.
But maybe it’s not a mere silo.
Building
Silos
Silos are a metaphor for closed-loop internal business
communication and function. Resources
and communications are held close to the vest.
Silos might be constructed in your organization indirectly as a result
of contractual obligations. The client
has contracted for dedicated space/staff/equipment. Accounting practices may make it easier to
limit the number of hands working on a project so as to track the specific
FTE’s used on the project/product. Or specific training for the project for
very few individuals make that skill set difficult/restricted to pass on. Example:
Working with radiolabeled compounds may require hours of training by an
external source. Thus when one needs
help to get past a bottleneck, there are only a handful of people that can be
called upon to assist with the burden. Once that finite skill set is
contractually obligated to inhabit a silo, the remaining projects needing that
scarce resource will have a difficult time meeting their milestones.
The president of your organization wants to provide the new hired gun with all of the resources he
needs to get the job done. The CFO wants
that specialist to be fiscally conservative and share resources. These
are often diametrically opposed actions. One is a silo building action and
the other is a silo busting action.
There are Six
Irrefutable Laws of Silo’s
1.
A silo
will persist as long as it is profitable for the organization.
The hiring director woos a
specialist to join the company with the promise of dedicated staff, etc. The
length of the honeymoon is dependent entirely upon the profitability, bid
success, innovative output or the positive industry recognition gained by the
specialist in his silo., Performing
below promises or expectations, gets a monitored honeymoon with a shortened
silo or it may be engulfed into a different silo.
2. A silo is either a fortress or a prison.
In the obscure 1965 Movie, The War Lord, Charlton Heston’s Saxons
occupy a (silo-shaped) fortress in hostile Friesian territory. After some
questionable “public relations” decisions their castle becomes their prison as
the locals gain control of when the Saxon’s can freely leave their
quarters. Whether a silo is a fortress or a prison depends entirely on which side
of the door the key is on. Similarly, the silo in the department
down the hall may be keeping a toxic influence out or it may be keeping a contaminant contained inside. The hiring practices over in the engineering
department may not be appropriate (or legal) but at least they are isolated
away from your department. Conversely,
their perspective may be that they have discovered a fast track to expense
reimbursements and it might ruin their advantage if they let the secret out and
everyone took the shortcut. If everyone
is on your road, it’s not a shortcut for long.
3. Silos which are contractually established for
dedicated resources are impervious to process improvement programs.
It will not matter that a six
sigma program determines a new process that makes better use of labor or
equipment. If that new process involves
sharing the government-purchase electron microscope rather than have it sit
idle for 3 days/week. Then that new process will be contractually forbidden.
Similarly, if PharmaXYZ has exclusively leased 10,000 square feet of laboratory
space for their short notice development testing, they will not be a client for
long if you utilize that space for BiotechABC for 1 week a month, simply
because you did not schedule effectively.
Other organizations are limited
contractually to provide dedicated equipment, laboratory space or staff
members. These situations inherently
create silos. Government contracts will
create silos of expertise and/or equipment.
Companies which secure government contracts may purchase a specific
piece of equipment, eg. Gas chromatograph, to be used for the government
project. When that piece of equipment is
idle, it cannot be used on any commercial work, unless it was contractually stipulated
to be allowed. Thus a wall is
erected. Had the equipment been leased
on a per sample basis, then it could be used on commercial work. If the contract is based on FTE’s and the
FTE’s were to be Ph.D. level staff then the silo is erected around the Ph.D.’s and
therefore cannot be utilized to troubleshoot commercial project which may be facing a
deadline issue.
4. Incentive/Bonus programs reinforce silo
construction.
Cooperative sharing incentives for
localized leadership will expand the diameter of the silo. Incentive programs
constructed to turn lack luster groups into profitable ones, which contain no cooperation clause will
establish/reinforce “every man for himself” strategies by the incented one.
5. A
silo will be replaced by a silo with a different scope of influence.
Sometimes
called “realignment”, it may take time for the organization to recognize it
that the new organization is just a different configuration of a silo. Business Development, Marketing,
Communications and Social Media units will merge and morph into each other and
then subdivide again in varied combinations.
The break up will occur once the silo is recognized as having diminished
effectiveness. e.g. Why doesn’t Marketing talk to the Business Development
group? If we put them in the same group
they will have to work together.
6. If the CEO didn't want silos,
there wouldn't be silos.
How the entire organization is
structured will be a determinant if silos are intentional. Those enviable
start-ups are nimble because they operate in an environment where every
employee is unselfishly driving towards the same goal and they know they cannot
achieve the goal without the collaboration of the entire team. The CEO
(COO/President/General/Dean) paints the vision for the organization and
assembles the team. When the CEO has not created this environment, at the
organizational meeting it will be apparent to the most casual observer whether
a departmental update comes as news to the other departments. Retracing steps
or rehashing issues are evidence of siloed organizations.
Silos
(sometimes) Have a Place in Your Organization.
Organizations with departments with different funding
sources or with strikingly different regulatory requirements are keenly poised
to create silos. This does not have to be a negative situation if the entire
organization understands where expense and resource lines must be drawn. These are siloed organizations by design. Mergers
and acquisitions hold the greatest challenge for silo busting. Maintaining that unique identity of
the acquired group must first be determined if that is essential for continued
success of the organization. Otherwise,
let the silo busting begin!
Wednesday, July 25, 2012
Operations Management 101
Operations Management 101:
The University of Pennsylvania (Penn) has a free on-line Operations Management course: https://www.coursera.org/#course/operations

This is a 6-week course WITH homework. There are sure to be interesting discussions and if your learn nothing more than your current level of understanding you WILL expand your network!
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