Pharmaceutical Commerce - September/October 2017 - 34

Op-Ed

Change is a constant for sales incentive planning
continued from page 6

companies can anticipate outcomes. Then
by building flexibility into their plans and
into their culture, they will have an easier
time implementing changes as markets and
company strategies evolve.
Success = sales compensation change
aligned with business goals
The hundreds of sales forces we work
with every year, along with our surveys
of sales and compensation professionals,

suggest that more than 75% of companies
will make changes to their sales
compensation plans in any given year.
These ongoing plan changes help to keep
sales compensation aligned with a changing
business environment. Some plan changes
are brought about by external market forces,
such as changing customer needs or new
competition. Other changes are designed to
exploit new opportunities for the company,
such as a product launch or entry into a new

market. Still, other changes are designed
to give the sales force a motivational lift
or to deliver better on the wide-ranging
expectations of sales and marketing leaders.
Whatever the reason for changing your sales
compensation plan, finding the right plan
design and implementing it effectively in
today's complex world is no easy task.
ABOUT THE AUTHORS
Andris Zoltners and Prabhakant Sinha are

the founders of ZS Associates, Inc., now a
global consulting firm on sales and marketing
practices across many industries. Chad
Albrecht and Steve Marley are principals at the
firm, and Sally Lorimer, a business writer, is a
former ZS principal.
Sales Compensation Solutions, from
which this article is excerpted, is available
for purchase at www.amazon.com/SalesCompensation-Solutions-Andris-Zoltners/
dp/0998934704/.

Clinical Operations

The power of strategic data standardization
continued from page 28

biomarker. [8] The drug was approved
for "microsatellite instability-high" or
"mismatch repair-deficient" solid tumors,
based on a study involving just 149 patients.
Ninety had colorectal cancer, while the
remaining 59 had one of 14 other tumor
types. This is the first time a cancer
treatment not linked to a tumor's original
location in a particular tissue type has been
approved.
Keytruda's approval, in connection with
the drug's mode of action (influencing the

immune system), rather than a specific
tumor type, is a prime example of the
power of strategic data standardization.
The drug's developer was able to find
individuals across a host of cohorts with
a specific molecular identifier who would
respond to this compound.
Gathering and organizing data for
submission to FDA or other regulators
is often considered a daunting task.
Companies can, however, simplify the
process by defining the data needed for

submission during trial design. With this,
protocol would automatically drive the
database setup. Findings would be collected
and analyzed in consistent ways and results
would flow more smoothly into the clinical
study report.
The tremendous heterogeneity of
healthcare information systems remains
a key difficulty. It's a challenge with deep
roots that pre-date the digital era: as just
one example, there may be as many as 50
descriptions for myocardial infarction. Yet

recent years have also seen genuine progress
towards data standardization.
Companies should consider leveraging
an outsourced partner early on to assist
with gathering, storing and analyzing data.
Many vital decisions made at the onset of
trial design determine how each successive
step of the development journey proceeds.
Getting it right from the start can help
organizations save time, mitigate risk and
improve the overall clinical development
process.

References
1. Biotechnology Industry Organization study, February 2011
2. www.transceleratebiopharmainc.com/common-protocol-template-now-available/
3. Marks, P. (2017). FDA and NIH Release Final Template for Clinical Trial Protocols. FDA Voice, May 2, 2017. (https://blogs.fda.gov/fdavoice/index.php/2017/05/fda-and-nih-release-final-template-for-clinical-trial-protocols/)
4. 114th Congress, Public Law 255, Act: To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes. US Government Publishing Office. December 13, 2016. http://legislink.org/us/pl-114-255
5. Patient-Centered Outcomes Research Institute (www.pcori.org)
6. Use of Electronic Health Record Data in Clinical Investigations: Guidance for Industry, Draft Guidance. U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and
Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), May 2016. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/
UCM501068.pdf
7. European Medicines Agency, News and press releases (2017). Use of big data to improve human and animal health: Task force to establish roadmap and recommendations for use of big data in assessment of medicines. March 23, 2017.
www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/03/news_detail_002718.jsp&mid=WC0b01ac058004d5c1
8. Martins, I. (2017). FDA Approves Merck's Keytruda for Colorectal, Other Solid Cancers with Specific Genetic Feature. Colon Cancer News Today. May 25, 2017. https://coloncancernewstoday.com/2017/05/25/colorectal-cancer-patientsspecific-genetic-features-win-fda-approval-keytruda-access/

Legal & Regulatory

Clearing the path by understanding the obstacles:
The 2017 Sharing Conference
continued from page 33

Attendees value the chance to discuss any
and all compliance-related subjects with
conference colleagues in this interactive
open forum setting.
Speed learning sessions
Our conference agenda also includes
eight "Speed Sessions" designed to provide
attendees with a 15-minute introduction
to important, emerging issues. Scheduled
topics include:

* Serialization update/DSCSA/
FDA/DQSA
* 340B Audits
* The opioid crisis
* UDI-medical device security, tracking
and protection
* Drug stewardship a nd Ta ke Back
overview
* You asked, the Alliance got you answers
* L i fe A f ter a C or p or ate I nte g r it y
Agreement (CIA)
* Rep-facilitated meeting requirements

34 Visit our website at www.PharmaceuticalCommerce.com September | October 2017

Special Guest Speaker
As this article went to press, the Alliance
was finalizing plans to add an exciting
Special Guest Speaker to our agenda.
This guest is likely to keep attendees on
the edge of their seats with a story that
is exciting, engaging and motivating. His
headline-making experiences are sure to
be a can't-miss hour. Make sure you visit
sharingalliance.org regularly for this
important announcement.
As you can see, 2017 is an eventful

year for both the Sharing Alliance and the
Sharing Conference, which means it's also
an eventful year for our Alliance members.
We've expanded our content. We've
sharpened our focus. We've rebranded to
better identify what we offer. And we've
gathered an impressive collection of
speakers and presenters to deliver some
very important information. If you haven't
already registered to attend the conference
and become an Alliance member there's still
time. See you in October!


http://www.amazon.com/Sales-Compensation-Solutions-Andris-Zoltners/dp/0998934704/ http://www.amazon.com/Sales-Compensation-Solutions-Andris-Zoltners/dp/0998934704/ http://www.amazon.com/Sales-Compensation-Solutions-Andris-Zoltners/dp/0998934704/ http://www.transceleratebiopharmainc.com/common-protocol-template-now-available/ https://blogs.fda.gov/fdavoice/index.php/2017/05/fda-and-nih-release-final-template-for-clinical-trial-protocols/ http://www.legislink.org/us/pl-114-255 http://www.pcori.org http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM501068.pdf http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM501068.pdf http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/03/news_detail_002718.jsp&mid=WC0b01ac058004d5c1 https://www.coloncancernewstoday.com/2017/05/25/colorectal-cancer-patients-specific-genetic-features-win-fda-approval-keytruda-access/ https://www.coloncancernewstoday.com/2017/05/25/colorectal-cancer-patients-specific-genetic-features-win-fda-approval-keytruda-access/ http://www.sharingalliance.org http://www.PharmaceuticalCommerce.com

Table of Contents for the Digital Edition of Pharmaceutical Commerce - September/October 2017

Table of Contents
Pharmaceutical Commerce - September/October 2017 - Cover1
Pharmaceutical Commerce - September/October 2017 - Cover2
Pharmaceutical Commerce - September/October 2017 - Table of Contents
Pharmaceutical Commerce - September/October 2017 - 4
Pharmaceutical Commerce - September/October 2017 - 5
Pharmaceutical Commerce - September/October 2017 - 6
Pharmaceutical Commerce - September/October 2017 - 7
Pharmaceutical Commerce - September/October 2017 - 8
Pharmaceutical Commerce - September/October 2017 - 9
Pharmaceutical Commerce - September/October 2017 - 10
Pharmaceutical Commerce - September/October 2017 - 11
Pharmaceutical Commerce - September/October 2017 - 12
Pharmaceutical Commerce - September/October 2017 - 13
Pharmaceutical Commerce - September/October 2017 - 14
Pharmaceutical Commerce - September/October 2017 - 15
Pharmaceutical Commerce - September/October 2017 - 16
Pharmaceutical Commerce - September/October 2017 - 17
Pharmaceutical Commerce - September/October 2017 - 18
Pharmaceutical Commerce - September/October 2017 - 19
Pharmaceutical Commerce - September/October 2017 - 20
Pharmaceutical Commerce - September/October 2017 - 21
Pharmaceutical Commerce - September/October 2017 - 22
Pharmaceutical Commerce - September/October 2017 - 23
Pharmaceutical Commerce - September/October 2017 - 24
Pharmaceutical Commerce - September/October 2017 - 25
Pharmaceutical Commerce - September/October 2017 - 26
Pharmaceutical Commerce - September/October 2017 - 27
Pharmaceutical Commerce - September/October 2017 - 28
Pharmaceutical Commerce - September/October 2017 - 29
Pharmaceutical Commerce - September/October 2017 - 30
Pharmaceutical Commerce - September/October 2017 - 31
Pharmaceutical Commerce - September/October 2017 - 32
Pharmaceutical Commerce - September/October 2017 - 33
Pharmaceutical Commerce - September/October 2017 - 34
Pharmaceutical Commerce - September/October 2017 - Cover3
Pharmaceutical Commerce - September/October 2017 - Cover4
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