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Opportunities: Advancing the Pharmaceutical Industry
Through Mobile Technologies
An ArcStream Solutions White Paper
This paper briefly explores why mobile solutions are
sweeping the pharmaceutical industry. It gives a high-level overview of
some exciting mobile opportunities, and invites you to consider how you
might leverage these and similar opportunities in your own organization
today.
The pharmaceutical and biotech industries are enjoying a time of
tremendous opportunity. Phenomenal strides have been made in producing
more effective drugs and treatments to improve the quality and length of
human life. An aging population and growing demand for life-enhancing
drugs promise an even healthier future.
Technology is responsible for where pharmaceutical and biotech
companies are today, and offers even greater opportunities going forward.
Already a vital enabler of research, technology is also essential to other
functions from clinical trials to commercialization. New technologies,
especially mobile solutions, that streamline these processes, speed
time-to-market and empower sales forces, are rapidly being deployed.
Mobile technologies offer perhaps the greatest benefits, as they are
uniquely suited to the types of distributed work involved in research,
clinical trials, physician detailing, patient monitoring and even internal
business operations.
Balancing these tremendous opportunities are challenges. No doubt,
pharmaceutical companies have their work cut out for them. But help, in
the form of powerful mobile applications, is on the way.
- On the marketing front, competition has become more aggressive, with
pharmaceutical companies spending $15 billion in 2000 to market
products.1 Capturing and protecting market share is
essential to recoup rising R&D costs, yet windows of exclusivity
are shrinking, and gaining mind share is an uphill battle as hordes of
competitors vie for the limited attention of physicians and other
influencers.
How can mobile technologies help sales and marketing efforts?
Mobile solutions such as e-detailing provide welcome tools to reach
information-saturated constituents. Sales representatives equipped
with complete marketing information on handheld devices are increasing
the effectiveness of detail visits. Pharmaceutical companies are able
to contact physicians directly by sending information to their
wireless devices.
- On the financial front, Wall Street is demanding ever-higher returns
and full pipelines of promising drugs. Consequently, pharmaceutical
companies are in a dollar-intensive race to discover more blockbuster
drugs and bring them to market even faster. In 2000 alone,
pharmaceutical companies spent $54 billion on research,2
with some directing 20% of revenues to the effort.3 Drug
development costs have soared to an average of $900 million per new
drug,4 and development times, from synthesis to approval,
are at an all-time high of 15 years.4
How can mobile technologies help the development process?
Pharmaceutical companies are turning to mobile applications to make
the R&D process more efficient and cost-effective, and speed drugs
to market. In the research phase, mobile applications are hastening
data collection and integration, providing a faster path to trials. In
the clinical phase, mobile applications are enabling more timely
collection and analysis of data, reducing protocol violations and
assisting investigators in administering trials.
- On the regulatory front, pharmaceutical companies must cope with
growing scrutiny from government bodies and a complex regulatory
regime, while simultaneously running a profitable business. Despite
recently enacted regulations, such as 21 CFR Part 11, blessing
electronic data capture, compliance remains burdensome. Evolving
guidelines for record keeping, patient confidentiality and laboratory
operations demand painstaking attention to detail. The consequences of
unintentional non-compliance are delays, which translate into lost
opportunities.
How can mobile technologies help with compliance? Judicious
use of mobile applications in the development process can dramatically
improve compliance levels. Researchers, physicians and other personnel
can access guidelines, protocols, training materials and forms from
handheld devices, helping them avoid violations and observe full
compliance.
Fortunately, the climate couldn't be better to move ahead on mobile
initiatives. Powerful yet inexpensive hardware, sophisticated software,
robust infrastructures and tighter security are enabling pharmaceutical
companies to apply mobile technologies in innovative ways. In fact, mobile
applications are permeating the larger healthcare industry. E-prescription
applications allow physicians to transmit prescriptions electronically to
pharmacies and review related drug information. E-laboratory applications
let doctors order clinical tests and view results. E-practice applications
allow medical professionals to capture charges, submit claims, and review
formularies. E-diaries allow clinical trial patients to record and
transmit study information remotely.
A World of Opportunities
When it comes to mobile applications, the opportunities are endless.
E-prescriptions, e-practice and e-diaries are but a few examples. Let's
take a look at some of the other opportunities that you should consider.
Opportunity One: Drug Discovery
From initial synthesis to the submission of new drug applications (NDAs),
pharmaceutical companies conduct significant amounts of expensive research
to win approval for new drugs. Mobile applications promise to streamline
R&D processes, reduce reliance on paperwork, improve the accuracy of
data, and save time and costs. The result is a faster path to NDA
submission and clinical trials. Here are some ways that mobile solutions
are enabling R&D processes.
|
Issues |
Mobile Improvements |
Business Benefits |
|
Research laboratories and facilities are geographically
distributed, making data collection and integration burdensome |
Mobile applications allow independent researchers and facilities
to communicate, and enable synching and transmission of data to a
central repository in a timely manner |
Reduced reliance on paperwork and manual data entry
Increased efficiency
Lower operating costs
Less opportunity for human error, inaccuracy, missing data |
|
Voluminous data resides in conflicting formats -- researchers'
handwritten notes and outputs from laboratory instruments -- and
must be integrated and put into electronic format, often manually |
Mobile devices such as IBM's TransNote ThinkPad laptop allow
researchers to record and submit notes in a common, electronic
format, enabling automatic and quick integration |
Timely and automatic data collection
Earlier availability of data
Faster path to NDA submission and clinical trials |
|
The integrity and security of physical environments must be
ensured |
Using chips, locator devices and wireless networks, laboratories
can track and monitor sensitive equipment and assets |
Avoid compromised data, breaches in research environment
Increase reliability of data
Avoid costly re-works and delays |
|
Mobile laboratory "assets" -- equipment, animals,
chemicals, etc. -- require tracking and monitoring |
Mobile applications can monitor laboratory assets, and also
assist in tracking and finding assets that are moved among physical
locations |
Locate assets
Protect investments
Reduce theft, loss and damage
Comply with regulations |
Opportunity Two: Drug Development
The most time-consuming stage of bringing a new drug to market is the
development phase (clinical trials in phases I through IV). Two factors
make clinical trials particularly amenable to mobile solutions. First, a
clinical trial is inherently distributed, involving multiple sites and
players that are on the move. Second, trial investigators must perform a
variety of administrative tasks, all in strict compliance with protocol
and guidelines that aren't always easily accessible. Mobile technologies
can improve the development process by enabling communication, and more
timely information sharing among parties; by increasing the
effectiveness of trial site administration; by aiding cost control
efforts; and by accelerating time to market. Here are some ways that
mobile solutions are enabling the drug development process.
|
Issues |
Mobile Improvements |
Business Benefits |
|
Mobility of parties makes it difficult to communicate, share
current information in a timely manner, collect data and schedule
meetings and training |
Mobile applications allow parties to communicate at will, synch
and transmit data and documentation (CRFs, drug logs, etc.), share
notes and calendars, and schedule appointments |
Improved communications
Earlier and more timely sharing of information
More effective trial site administration, accounting, site
closure and audits
Better cost control |
|
Trial monitors and investigators must understand and observe a
plethora of strict rules for trial management and compliance with
regulations |
Mobile applications can provide monitors and investigators with
to-do lists and other guides to trial rules and management, and
automate the production of audit trails through data and time
stamping to comply with regulations |
Better trial management
Improved compliance
Better cost control |
|
Investigators must perform a variety of tracking tasks and fill
out paperwork for patient screening and enrollment, drug usage,
budgets, supplies, CRFs, adverse events, biological samples, etc. |
Mobile applications can assist investigators in performing all
tracking tasks by creating forms for patient screening and
enrollment, drug regimens and ordering supplies, etc.; and by
printing labels and handling information for biological samples |
Fewer exclusions and invalidations
Fewer protocol violations
Increased compliance
Better cost control |
|
Timely collection, analysis and validation of patient clinical
data is difficult due to unautomated data capture methods. Accuracy
and reliability of data is suspect, inconsistencies are prevalent,
and data collection and transmission occurs irregularly |
Mobile applications prompt patients to record required clinical
data and information in prescribed, common, electronic formats.
Enables quick, timely and easy transmission of data to central
repository for analysis, reaction and trial adjustment. Fulfills
regulatory compliance. |
More efficient data collection
Improved data accuracy and quality
Accelerated time to market |
|
Essential to train investigators in conducting and administering
trials, completing CRFs, and avoiding protocol violations, but
scheduling time is difficult, and lengthy documents preclude easy
reading, retention and reference |
Store a variety of trial documents (protocols and potential
violations, clinical practice tutorials, rules for sample handling,
inclusion/exclusion criteria, annotated CRF templates) on
investigators' mobile devices for easy reference |
Better trial management
More accurate administrative records
Improved regulatory compliance
Fewer protocol violations
Better cost control
Quicker report generation
Accelerated time to market |
Opportunity Three: Commercialization
In the highly competitive pharmaceutical industry, capturing and
protecting market share is a costly necessity. Complicating this task is
the complexity of the information that must be conveyed, and the variety
of constituents (consumers, physicians, insurers, pharmacies, etc.) that
must be reached. With major markets saturated with sales
representatives, the number of effective detail visits is dropping
dramatically.5
Mobile technologies, specifically electronic detailing, are allowing
pharmaceutical companies to develop more cost-effective marketing and
communication channels. They enable rich information sharing with
customers and prospects; make detail visits more effective; limit the
need for follow-on visits; and reduce administrative overhead. Mobile
applications are enabling commercialization efforts in these ways:
|
Issues |
Mobile Improvements |
Business Benefits |
|
Major markets saturated with sales reps; physicians overloaded
with information; duration of effective details shrinking |
Use mobile applications to perform e-detailing. Reach physicians
through emails, online advertisements and other electronic
information sent directly to handheld devices |
Ability to share rich information
Greater number of effective details
More cost-effective details
Gain greater mind share and market share
Reach physicians in remote areas |
|
Ability to convey complex, accurate and complete drug information
in short windows of time |
Arm sales reps with mobile devices containing complete,
up-to-date marketing information; synch information on periodic
basis |
Ability to convey rich information
More productive detail visits
Limit need for follow-on detail visits |
|
Promote and leverage adoption of handheld devices in physician
community |
Sponsor (to some extent) the supply of mobile applications and
devices to physicians in exchange for increased access, content
posting, etc. |
Develop more cost-effective marketing and communication channels |
|
Completing administrative tasks in a timely manner from the field |
Outfit sales reps with mobile applications to perform
administrative chores such as expense reporting, drug sample logs,
etc. |
Reduce administrative overhead
Better cost control |
Opportunity Four: Patient Compliance and Utilization
Getting patients to take the medications prescribed by their
physicians, at the proper dosage and for the specified period of time,
is a tough challenge for doctors, insurers and pharmaceutical companies.
From a health perspective, patients compromise their treatment when they
fail to follow their drug regimens. From a financial perspective,
pharmaceutical companies are losing revenues in situations where they
have already won the sale. Mobile applications that can help boost
compliance levels and increase utilization are advantageous for all
parties. Moreover, wireless devices provide a cost-effective way to
monitor and communicate with patients, particularly in remote areas.
|
Issues |
Mobile Improvements |
Business Benefits |
|
Drug and treatment effectiveness are compromised when patients
fail to comply with drug regimens |
Physician mobile applications can track and show prescription
histories, including whether a patient filled a new prescription
and/or obtained a refill on time. |
Raise compliance rates
Increase drug utilization
Promote drug effectiveness
Maximize revenues |
|
Revenues fail to reach anticipated levels when patients
under-utilize prescribed drugs |
Mobile applications like those cited above, plus other
innovations -- smart chips embedded in prescription containers;
email alerts for drug expirations, renewals; wireless messages
prompting patients to take drugs |
Raise compliance rates
Increase drug utilization
Promote drug effectiveness
Maximize revenues |
Opportunity Five: Internal Operations
Just like companies in other industries, pharmaceutical and biotech
companies can benefit by applying mobile applications to a variety of
internal functions, and using them to complement existing intranets,
executive dashboards, email systems and other employee-facing
applications. Examples include mobile applications that can facilitate:
- Scheduling and dispatching maintenance crews within facilities
- Short message transmission for quick communication
- Retrieval of company-specific information such as telephone
directories, benefits policies, etc.
- Expediting approvals, authorizations, and other notifications tied
to the purchasing function
- Asset tracking in warehouses, distribution centers, shipping, etc.
Why Start Now?
Why start investigating mobile applications now? For three good
reasons: healthcare professionals everywhere, and your competitors, are
turning to them; the regulatory environment is accommodating them; and
technology is enabling them.
Your Constituents and Your Competitors
From e-prescription, e-laboratory, e-practice and e-diary
applications, mobile solutions are becoming the norm. Even
physicians-to-be are graduating from medical school more technically
savvy and wireless addicted than their predecessors. Just consider
Harvard Medical School (HMS). To enhance student learning and improve
access to information, HMS developed a mobile solution, the MyCourses
™ Mobile Platform, which provides the faculty with more accurate data
for monitoring and evaluating students' progress throughout their
medical school program, and gives students access to course calendars,
class notes and syllabi. New physicians, like these HMS graduates, will
have no aversion to using mobile applications, and will likely demand
them as part of their jobs.
Not only are physicians jumping on the mobile bandwagon, pharmacies,
insurers and even your competitors are taking the plunge too.
SmithKlineBeecham was an early sponsor of electronic patient diaries.
Eli Lilly is experimenting with the use of handheld devices by
physicians. Johnson & Johnson is partnering with private handheld
companies. Aventis launched a web site accessible by WAP (wireless
application protocol) devices. Pfizer, IBM and Microsoft are starting a
company to market wireless software and services for physicians
including e-practice and e-prescription applications. Tufts Health Plan
in Massachusetts is outfitting its physicians with handheld devices and
e-prescription applications.
The Regulatory Environment
Operating within a highly regulated industry, pharmaceutical
companies are rightfully cautious when it comes to pushing the envelope
with new technologies. When it comes to mobile applications, however,
they need no longer be timid. The Federal Drug Administration (FDA) has
effectively blessed electronic data capture (EDC) with the promulgation
of 21 CFR Part 11. These regulations give the pharmaceutical and biotech
industries the guidance to move forward with new technologies and to
embrace electronic forms of data capture, signatures, auditing and
archival. Imminent Guidance for Industry documents on these regulations
is intended to give the industry even more comfort, and allow widespread
adoption of various forms of EDC.
Enabling Technologies
Enabling technologies for wireless and mobile solutions have hit
prime time. What's more, they are safe and reliable, and capable of
supporting the unique regulatory needs of the pharmaceutical industry.
Just as mainframe and server-based applications can be designed to fully
support compliance, so too can mobile applications. Mobile applications
have the ability to reproduce consistent results on demand, can generate
time stamps and other audit trails, and are amenable to current
validation and archival methods.
Security is better than ever. A variety of techniques, from
encryption to firewalls to virtual private networks, make it virtually
impossible to compromise mobile solutions. These same security
measures are being used to great success right now by the financial
services industry, an industry with heightened security and
confidentiality requirements similar to the pharmaceutical industry.
Wireless infrastructures are more robust. National carriers and
regional operators have now created an extensive wired and wireless
network, providing virtually nationwide coverage. Evolving wireless
capabilities and broadband services promise ever more powerful mobile
applications.
Technology platforms are stable, reliable and affordable. Increased
standardization makes it cost-effective to develop and deploy mobile
applications, and aids adoption rates among the extended community of
healthcare professionals from physicians to patients to insurers.
Wireless devices are becoming more ubiquitous, powerful and
affordable than ever. From Palm devices to Pocket PCs, there are many
options to satisfy the unique requirements of researchers, sales
representatives, physicians and patients.
In Conclusion
Mobile solutions are fast becoming mainstream throughout the
healthcare industry. From medical students to physicians and
pharmacists, mobile solutions are appearing everywhere. This acceptance
is hardly surprising given the overwhelming opportunities to gain
breakthrough improvements from mobile applications. For pharmaceutical
companies, mobile applications can increase the effectiveness of detail
visits, improve the efficiency of the R&D process, speed clinical
trials and streamline internal operations. Whether you need to increase
your market share, shorten your discovery and development cycles, speed
time to market for new drugs, or outflank your competitors, a mobile
solution can help you achieve your goals. The time is ideal to consider
how you can exploit mobile technologies to maximize your competitive
advantage. Why not start an evaluation today?
Footnotes:
- Estimate from "The Cure is in Hand," WR Hambrecht+Co,
October 2000.
- Parexel Sourcebook, 2000.
- "The Pharma Apps Prescription," Forrester Research,
February 2001.
- Tufts Center for the Study of Drug Development and Boston Consulting
Group.
- "The Cure is in Hand," WR Hambrecht+Co, October 2000.
Copyright 2001 ArcStream Solutions. All rights reserved.
For more information on ArcStream
Solutions, visit www.arcstreamsolutions.com.
To download a pdf version of this white paper, visit
www.arcstreamsolutions.com/resources/whitepapers.asp
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