JAnuAry/FebruAry 2014
`VOL. 9, NO. 1
`
`COMPANY
`COMPANY
`PROFILES
`PROFILES
`Copay programs’
`Copay programs’
`increased value
`increased value
`to manufacturers
`to manufacturers
`
`HDMA looks at
`HDMA looks at
`‘buy and bill’
`‘buy and bill’
`
`The roll of labels
`The roll of labels
`in patient safety
`in patient safety
`
`PERMIT 268
`PONTIAC, IL
`PAID
`US POSTAGE
`PRSRT STD
`
`Peyton Howell, Senior Vice President,
`Peyton Howell, Senior Vice President,
`AmerisourceBergen; President, Global
`AmerisourceBergen; President, Global
`Sourcing and Manufacturer RelationsSourcing and Manufacturer Relations
`
`
`Page 1 of 32
`
`ACRUX DDS PTY LTD. et al.
`
`EXHIBIT 1626(a)
`
`IPR Petition for
`
`U.S. Patent No. 7,214,506
`
`

`

`JAnuAry/FebruAry 2014
`VOL. 9, NO. 1
`
`COMPANY
`COMPANY
`PROFILES
`PROFILES
`Copay programs’
`Copay programs’
`increased value
`increased value
`to manufacturers
`to manufacturers
`
`HDMA looks at
`HDMA looks at
`‘buy and bill’
`‘buy and bill’
`
`The roll of labels
`The roll of labels
`in patient safety
`in patient safety
`
`PERMIT 268
`PONTIAC, IL
`PAID
`US POSTAGE
`PRSRT STD
`
`Peyton Howell, Senior Vice President,
`Peyton Howell, Senior Vice President,
`AmerisourceBergen; President, Global
`AmerisourceBergen; President, Global
`Sourcing and Manufacturer RelationsSourcing and Manufacturer Relations
`
`
`Page 1 of 32
`
`

`

`
`
`HOW LOGISTICS FINDS HIDDEN
`
`VALUE IN YOUR SUPPLY CHAIN.
`
`Knowing where to look is vital. Looking across your supply chain reinforces how enormously complex it can be to
`
`manage for greater agility, find efficiencies and identify cost savings. When you collaborate with UPS, you can tap
`
`into our expertise in healthcare logistics and utilize tools that can help better position your company for success.
`
`ENGINEERED SUCCESS
`
`network of healthcare distribution facilities. Coupled with our
`
`The health of your supply chain has never been more important
`
`flexible transportation network, UPS can help identify cost savings
`
`or strategic. The ability to quickly respond to market demands,
`
`throughout your supply chain.
`
`target growth markets and ensure reliable supply is essential
`
`for success. UPS can help you rethink and redesign your supply
`
`chain to take advantage of new opportunities, investigate new
`
`channels and improve outcomes.
`
`FINDING EFFICIENCIES
`
`LESS LOSS
`
`Your products are developed for specific outcomes.
`
`If there'sa
`
`compromise in quality, everyone loses. The patients health suffers,
`
`your spoilage rates go up and your reputation can be tarnished.
`
`At UPS, our experts work with you to understand your products
`
`Turning supply chain inefficiencies into opportunities takes
`
`and offer a range of safeguard options to help shipments arrive
`
`collaboration and innovation. You can reduce waste by using
`
`only the space you need when you leverage UPS’s global
`
`UPS has the expertise and experience to find hidden value in your supply chain.
`See how we did it for EndoChoice at ups.com/endochoice.
`
`in optimal condition, reducing product
`
`loss and improving your bottom line.
`
`Page 2 of 32
`
`

`

`Brand Marketing & Communications
`
`Copay programs’ increased value to manu-
`facturers is matched by rising criticism
`Despite proven medical value, coupon and copay offset programs continue
`to draw fire from insurers; meanwhile, will the programs extend to ACA in-
`sureds?
`by Suzanne Shelley, Contributing editor
`
`Coupon or copay-offset provisions
`are aimed at the “out of pocket”
`(OOP) expenses of commercially
`insured or cash-paying patients. When
`such a discount program is used, the
`drugmaker pays the differential between
`what the patient’s insurance plan will
`pay for that drug, and the wholesale
`price plus dispensing fee paid back to the
`pharmacy. The goal is to ensure that the
`patient’s final OOP cost is capped by the
`dollar figure offered by the coupon or
`copay-offset program. “When a patient
`can use a coupon or copay-offset card
`to pay a lower rate than a top-tier copay,
`they are much more apt to fill that
`prescription,” says Devin Paullin, EVP
`at Physicians Interactive (Marlborough,
`MA).
`Coupons and copay-offset programs
`are currently available for nearly 400 branded products, with the majority being for chronic conditions for which
`drug treatment could be expected for several months or more and can easily cost hundreds if not thousands of
`dollars per month.
`In one study of more than 10 million prescriptions for over 5 million patients, researchers found that when
`patients had copays of $50, their prescriptions were three times more likely to be abandoned at the pharmacy
`than when there were no OOP costs, and over twice as likely to abandon the prescription when they had a copay
`of $25. [1]
`Today, a confluence of factors is driving the deployment of copay-offset programs. One big driver that has
`made many medications less affordable for financially strapped patients is tier creep—“whereby Tier 2 drugs no
`longer carry a $25 copay, but a copay closer to $35–$75—resulting in lower medication adherence,” says Chris
`Dowd, SVP for PSKW (Bedminster, NJ).
`Copays and the copay differential between tiers continue to grow. In 2012, copays for retail pharmacy generic
`and traditional brand prescriptions grew between 10% and 13% while specialty copays grew by 26% (from $84
`to $106 average for a 30-day supply), in an effort to keep pace with the rapidly increasing cost of specialty drugs,
`according to the Pharmacy Benefit Management Institute (PBMI; Plano, TX).
`Tighter economic conditions and competitive pressures from other in-class products are also driving
`demand: Manufacturers are realizing that “remaining competitive in their respective markets if other products
`in the class already offer copay programs is an important factor,” notes Tracy Foster, president of Lash Group, an
`AmerisourceBergen Consulting Services company (Charlotte, NC).
`Pharma marketers have a variety of resources for managing copay-offset programs. Dedicated vendors include
`PSKW, Physicians Interactive, Opus Health (a unit of Cegedim, Bedminster, NJ), Trialcard (Cary, NC), Lash
`Group (Charlotte, NC, a unit of AmerisourceBergen Consulting Services), Triplefin (Scottsdale, AZ; now a
`unit of H.D. Smith Medical Solutions), McKesson Patient Relationship Solutions (Scottsdale, AZ), Medimedia
`Health (Yardley, PA) and QPharma (Morristown, NJ). Various copay-assistance programs are available from
`the many operators of patient assistance programs (Pharmaceutical Commerce, March/April, p. 1); and vendors
`of consumer-oriented, retail patient services such as Catalina Health (now a unit of Adheris) and Inmar, Inc.
`(Winston-Salem, NC).
`
`Formulary fight
`Where the insurance industry cries foul is with the longstanding argument that the very existence of these copay
`programs undermines the formulary-tier-designation efforts that are so strenuously negotiated with drugmakers.
`This has the potential to undermine the insurer’s bottom line in two ways: (1) By allowing physicians to prescribe
`outside the tiered formulary system, thus forcing insurers to reimburse for more costly branded drugs when
`cheaper, on-tier drugs (both branded and generic) are available, and (2) by denying insurers rebates (contracted
`with drugmakers as part of the tier-designation negotiations) that might have been available had an on-tier therapy
`continued on page 16
`
`Legal & Regulatory
`Finding the value in outsourced con-
`tract administration
`The growing complexity of managed-markets
`contract support makes outsourcing a near-neces-
`sity for Small Pharma, and a better option for big
`Pharma
`by John Still, PharmaMetrics Inc.
`
`The breadth and depth of prescription, transaction, reimbursement
`and channel data has never been as accessible as it is today. Big Pharma
`companies have invested tens of millions of dollars or more in contract
`administrative software, along with related implementation costs, to
`manage and process payer agreements and minimize the potential risk
`linked to governmental legislation. In many cases, components of the
`investment may be justified by the returns obtained in better contract
`compliance with payers and government entities; a faster and more accurate
`view of marketplace activity. Access to third party data sets including claims
`and formulary information have become a core requirement to determine
`an enhanced level of contract compliance.
`Yet the question should be asked: Is the expense and complexity of
`administrative systems to achieve these results worth the cost? Can contract
`administration be performed more economically and more efficiently? Our
`answer is that yes, for some organizations, the advantages of outsourcing
`these tasks are a better choice. For many small to medium sized pharma
`organizations, it is a cost-effective, strategic alternative that should be
`considered.
`
`Optimizing managed markets contracting
`Up until the early 2000s, the more common managed care contracts
`were fairly straightforward; often a fixed “base discount/admin fee” and
`various types of incentive based terms often linked to market share or
`volume movements. Today, managed markets agreements entail more
`complex interplay between pharmacy benefit managers (PBMs), insurance
`companies as well as group purchasing organizations (GPOs) for the
`continued on page 20
`
`Supply Chain/Logistics
`Air carriers double down on winning
`business from life sciences
`rising production and trade, along with tightening
`regulations, make life sciences an attractive target
`for air cargo and logistics services
`by nicholas basta
`
`At the start of the new year, the air cargo companies and logistics
`providers are done with their holiday rush shipping, and can now look
`at non-seasonal trends in logistics. And one of the themes that resonates
`throughout the business—especially for global transport—is the rise of
`healthcare products as a category of business development. Air cargo
`has been the traditional way to ship time- and temperature-sensitive
`pharmaceuticals, especially finished products; and in a past era, when
`delivery costs could easily be eaten, was the preferred mode of shipping.
`Today, air cargo is under stress from rationalization in shipping practices
`(such as employing second-day air rather than express delivery, provided
`that the packaging ensures temperature maintenance throughout), and
`from an intensified effort by ocean carriers to pull more cargo from air
`lanes with dedicated healthcare-products services.
`Seabury Group, a global air cargo consultancy (New York) presented
`data from its Global Trade Database at a meeting of the Cool Chain Assn.
`continued on page 18
`
`January | February 2014 Visit our website at www.PharmaceuticalCommerce.com 3
`
`Page 3 of 32
`
`

`

`Dispense
`as Written
`
`DQSA: a bargain for the life sciences industry
`The Drug Quality and Security Act will change industry for the better
`
`A favorite movie of mine from the 1970s, The Candidate, shows a US senatorial candidate, played by Robert Redford, thrashing through all the
`behind-the-scenes mechanics of what was then a fairly modern version of campaign politicking. At the end, having unexpectedly won, Redford
`looks at his campaign manager blankly and asks, “What do we do now?”
`
`That feeling is certainly the case with what dominated healthcare news in the latter half of 2013—the Affordable Care Act—with the
`unfortunate realization that the “What do we do now?” question never got properly addressed after the law passed in 2010. But a similar feeling
`can be had with another healthcare-related piece of legislation: the Drug Quality and Security Act (DQSA), signed into law in November (p. 9).
`
`If nothing else, DQSA can now be the shorthand for what has been called, over a decade of law-making, “pharma track-and-trace,”
`“serialization,” “e-pedigree” and “anti-counterfeiting.” In reality, what got the bill passed, finally, was the more recent urgency around
`compounding pharmacies and the need to provide FDA with better tools to manage a process that is half-pharmacy, and half-manufacturing. In
`the Senate, existing legislation on drug serialization and tracking got bolted together with new legislation on the compounding pharmacies, and
`together the momentum was enough to get the bill to President Obama’s desk. (Business Week recently noted that there were 684 healthcare bills
`introduced in 2013; DQSA was one of six that passed.)
`
`Going forward, the compounding-pharmacy part of DQSA will rapidly become a specialized area of FDA oversight, affecting a relatively small
`number of high-volume companies (most brick-and-mortar neighborhood pharmacies will continue the practice, more or less unchanged). But
`the serialization and tracking part will affect every manufacturer, every wholesaler and distributor, and even participants new to FDA oversight,
`such as 3PL (third-party logistics) firms that handle healthcare products.
`
`PriceWaterhouseCoopers, in its Top Health Industry Issues for 2014 report (see p. 7), estimates that DQSA will cost manufacturers $10–$50
`million each. Multiply that by, say, the 50 manufacturers that have substantial packaging operations of multiple products, and you get a figure
`of $500 million to $2.5 billion. I will freely admit that it’s easy for me to recommend spending someone else’s money, but: $2.5 billion represents
`less than 1% of one year’s sales in the US for the industry. Moreover, the spending needn’t happen all in one year (and in fact has already been
`occurring at most of the larger branded and generic manufacturers).
`
`So, the “why” part of “what do we do now?” question is fairly easy to answer: for that investment, the industry is going to get tighter control
`of drug distribution, lower returns, better security and—the biggest ROI of all—a better view of marketplace activity, which will provide multiple
`paybacks through understanding marketplace trends.
`
`The “how” part of “what do we do now?” is still being worked out, but the industry now has a reasonable timetable to produce data, coordinate
`activity with trading partners, and analyze results. We’ll be covering this evolution in every forthcoming issue of Pharmaceutical Commerce, and
`the prospects for getting the industry to a better place are truly exciting.
`
`COrreCTIOn
`Following the publication of the November/December 2013 issue, World Courier went on the record to say that their position described in the article “Clinical Trials from a logistics perspective”
`(page 30) was inaccurately stated. The company’s position is that it maintains a position of neutrality in regard to relationships between study sponsors, CMOs and CROs, and strives to provide
`the best value proposition to all involved parties in executing a trial logistics plan. Also, for the record, Mr. Cook’s last name is misspelled, for which Pharmaceutical Commerce apologizes.
`
`Required reading from Pharmaceutical Commerce
`Value Chain eNewsletter – published twice monthly • Cold Chain eNewsletter – published monthly
`The latest biopharma commercial operations and cold chain management news.
`Free SubSCrIPTIOnS
`
`Visit our new website...
`www.PharmaceuticalCommerce.com
`
`4 Visit our website at www.PharmaceuticalCommerce.com January | February 2014
`
`Page 4 of 32
`
`

`

`~CAPDM
`
`Sunday, March 9-Wednesday, March 12, 2014
`JW Marriott Desert Springs, Palm Desert, California
`
`Why attend this year's event?
`We have two compelling reasons!
`
`To Participate in Affordable, Quality Education
`
`Offering four insightful general session presentations and nearly 30 concurrent
`business, policy and technology sessions, this is the one event you cannot miss in
`2014. Breakout topics include:
`
`• DEA-related updates and trends, including perspectives on controlled
`substances abuse prevention and diversion, suspicious order monitoring
`programs and inspections;
`
`• Regulatory implementation of the Drug Quality and Security Act,
`highlighting timelines and the anticipated process; and perspectives on how
`trading partners are extracting business value from product serialization;
`
`• The latest legislative proposals affecting the healthcare supply chain in
`statehouses across the country;
`
`• Reimbursement update on CMS anticipated AMP final rule and the
`3408 Drug Pricing Program;
`
`• Steps and strategies for managing product recalls and withdrawals;
`
`• An update on healthcare supply chain facts, figures and trends;
`
`• And much more.
`
`To Explore Cutting-Edge Supply Chain
`Technologies and Solutions
`
`Technology and service providers at the 2014 Technology Expo will
`showcase products and services on track with the latest trends in the
`healthcare supply chain. For potential attendees, this means
`you will have access to the most current solutions.
`
`!--------•• Register today at
`
`www. HealthcareDistribution.org/ dmc.asp.
`
`Page 5 of 32
`
`

`

`Table of Contents
`
`4
`
` editorial
`
`DQSA: a bargain for the life sciences industry
`The Drug Quality and Security Act will change industry for
`the better
`
`7
`
` Op-ed
`
`Top health industry issues for life sciences in 2014
`PwC’s annual forecast of the year’s most important
`healthcare trends
`
`networking for life science logistics
`The Health & Personal Care Logistics Conference brings
`industry leaders together
`
`8
`
` Top news
`
`Contract administration software market heats up with new
`offerings
`Both Revitas and Model N bring out enhanced script-
`validation modules to ensure rebate accuracy
`
`16
`
`
`
` brand Marketing & Communications
`
`Promotional experimentation and consumer outreach will
`be available via the Truvio network
`New service launched by WEGO Health offers rapid feedback
`from key opinion influencers in consumer healthcare
`
`Copay programs’ increased value to manufacturers is
`matched by rising criticism
`Despite proven medical value, coupon and copay offset
`programs continue to draw fire from insurers; meanwhile, will
`the programs extend to ACA insureds?
`
`Cardinal Health repeats as no. 1 organization in Gartner
`healthcare supply chain rankings
`
`Annual Cegedim survey finds emphasis on changing
`commercial models
`Multichannel marketing is high in attention, but low on
`execution; Docnet will be a new social media platform
`
`Drug Quality and Security Act becomes law
`Long-awaited track-and-trace law ushers in a new era of
`pharmaceutical supply-chain monitoring; compounding
`pharmacies get a new structure also
`
`Walgreens combines operations with CareMetx to address
`specialty-patient hub services
`Walgreens’ Pharma Dynamics subsidiary will be merged into
`CareMetx
`
`18
`
`
`
` Supply Chain/Logistics
`
`Air carriers double down on winning business from life
`sciences
`Rising production and trade, along with tightening
`regulations, make life sciences an attractive target for air
`cargo and logistics services
`
`20
`
` Legal & regulatory
`
`Finding the value in outsourced contract administration
`The growing complexity of managed-markets contract
`support makes outsourcing a near-necessity for Small
`Pharma, and a better option for Big Pharma
`
`21
`
` Information Technology
`
`Full-line distributor sales topped $300 billion in 2012,
`representing 91% of pharma sales
`HDMA’s 2013–14 Factbook updates member financial,
`operational performance
`
`ValueCentric updates its flagship IT service, ValueTrak, with
`advanced data-visualization capabilities
`Finance, marketing and other nontraditional users find value
`in the company’s sales and inventory data
`
`Cold Chain Technologies upgrades materials, insulation for
`temperature-controlled packaging
`New KoolTemp GTS parcels have higher performance and
`lower cost and weight
`
`Cloud computing and big Data will dominate IT healthcare
`trends in 2014
`Liaison Healthcare Informatics predicts trends for healthcare
`and life sciences
`
`Industry group rx-360 lays plans for expanding activities
`in China
`An inaugural planning meeting was held in November;
`meanwhile China cracks down on online sales
`
`Consulting firm puts compliance front and center for
`clinical-stage drug developers
`New “emergent biopharma” service combines compliance
`with pricing, market access
`
`QPharma offers QLaunch advisory service
`
`12
`
` business/Finance
`
`A conversation with Peyton Howell, Amerisourcebergen
`
`HDMA looks closely at ‘buy and bill’ in specialty pharma
`distribution
`Will ‘white bagging’ and specialty-pharmacy business
`practices change distribution dynamics?
`
`22
`
` Manufacturing & Packaging
`
`The role of labels in patient safety
`Advanced label technologies serve functions far beyond
`product identification
`
`PCI breaks ground on new clinical storage and distribution
`facility
`Contract packager addresses growing clinical-products
`business
`
`reminder packaging is a “consistently effective
`medication-adherence intervention strategy,” says Decision
`resources
`Analysts find that better adherence can be a competitive
`advantage in new-product introductions
`
`educating patients on self-administered drug injections
`The trend toward self-administered drugs creates a pressing
`need for better patient-education resources
`
`IMS Institute projects global pharma market of $1.17–1.20
`trillion in 2017
`Growth includes 1–4% CAGR in US, 0–3% in Europe and
`14–17% in China. US specialties have a twist
`
`26
`
` Company Profiles Section
`
`2014 Pharmaceutical Commerce Category Leaders
`
`31
`
`
`
` Meetings and editorial Index
`
`6 Visit our website at www.PharmaceuticalCommerce.com January | February 2014
`
`VOL. 9, NO. 1
`
`Founder and editor in Chief
`Nicholas Basta, 718 282 6112
`nbasta@pharmaceuticalcommerce.com
`
`Contributing editors
`Lena Anthony, F.J. Quinn,
`Bob Sperber, Suzanne Shelley, Peggy Wright
`
`editorial board
`Jeffrey Berkowitz, Walgreens
`Richard Carlson, Blue Fin Group
`Liz Coyle, IMS Health
`Adam Fein, Pembroke Consulting
`Rich Minoff, 1 Global Partners
`Mark Seitz, Eli Lilly & Co.
`Robert Zachow, Bracco Diagnostics
`
`Advertising Sales
`Senior Vice President and Publisher
`Clifford P. Tallman, Jr., 203 831 0771
`ctallman@pharmaceuticalcommerce.com
`new england
`Vince Cavaseno, 617 232 2000
`vcavaseno@pharmaceuticalcommerce.com
`Jody Estabrook, 774 283 4528
`jestabrook@pharmaceuticalcommerce.com
`Midwest
`David Gerchen, 314 878 3939
`dgerchen@pharmacueticalcommerce.com
`Southeast
`Cathy Williams, 843 410 2739, ext. 101
`cwilliams@pharmaceuticalcommerce.com
`West
`Richard Ayer, 949 366 9089
`rayer@pharmaceuticalcommerce.com
`
`Advertising and editorial Production
`Advertising: Heidi Nelson, 203 852 6570, ext. 228
`hnelson@pharmaceuticalcommerce.com
`Editorial Layout: Media Ventures, Inc.
`www.mediaventuresinc.com
`
`Circulation and Administration
`Senior Vice President and General Manager
`David Soskin, 203 831 0711
`dsoskin@pharmaceuticalcommerce.com
`
`reprints, research and Custom Publishing
`David Soskin, 203 831 0711
`dsoskin@pharmaceuticalcommerce.com
`
`Circulation Subscription Changes
`Jennifer Lee
`jennifer.lee@emscirc.com
`
`Healthcare Commerce Media Corporation
`Pharmaceutical Commerce is published by
`Healthcare Commerce Media Corp.
`85 Westminster Rd., Brooklyn, NY 11218.
`
`editorial/Advertising Queries:
`718 282 6112, or
`info@pharmaceuticalcommerce.com
`
`Copyright 2014. All rights reserved. Printed in the United States of
`America. Send all subscription inquiries or requests to Subscriptions,
`Pharmaceutical Commerce, 151 Fairchild Avenue, Plainview, NY
`11808-1709, Tel: 800 437 7456. Fax: 516 908 3802
`
`The management and editors of Pharmaceutical Commerce
`make every effort to publish accurate information.
`However, neither the management, editorial board, editors or
` reporters can be held liable for erroneous information.
`Opinions of Pharmaceutical Commerce columnists are
`their own, and do not necessarily represent those of
`employees or other contributors to Pharmaceutical Commerce.
`
`www.PharmaceuticalCommerce.com
`
`Page 6 of 32
`
`

`

`Op-Ed
`
`Top health industry issues for life sciences in 2014
`PwC’s annual forecast of the year’s most important healthcare trends
`by Michael Swanick, PwC
`
`each fall, PwC’s Health Research
`Institute (HRI) polls 1,000 consumers
`and interviews industry experts to
`identify the top health industry issues
`for the coming year. The scope of the
`survey ranges across the entire healthcare
`landscape, from manufacturers to
`providers to insurers and retailers. We’ve
`identified 10 key drivers of the overall landscape, many of
`which focus on how consumers engage with the health system.
`Four of the 10 findings that we believe will directly impact
`pharma, biotech and device manufacturers (in no particular
`order) are:
`
`• Corporate venture capital is picking up the slack as
`traditional venture funding slows for pharmaceutical
`start-ups
`• Drugmakers must rethink their clinical trial research
`methods, embracing alternative approaches
`• New regulation aims to eliminate counterfeit medications
`in the drug supply chain
`• Social, mobile, analytics, and cloud technologies are
`driving new health industry business models.
`
`Venture capital
`As traditional venture firms pull away from funding life
`sciences start-ups, corporate capital will pick up the slack
`in 2014. Corporations are launching venture arms; they are
`involved in a growing share of healthcare deals. In recent years,
`corporate venture firms bet almost one in three dollars on life
`sciences’ newcomers, investing more money in biotechnology
`than any other sector except software.
`Start-ups should consider seeking corporate partners,
`which often offer longer investment horizons, industry
`connections, managerial expertise, skill navigating regulatory
`and reimbursement minefields, and marketing prowess. For
`smooth marriages, start-ups should consider how involved
`the new partners will be and how involved they want them to
`
`be.
`
`Corporations should nourish healthcare product pipelines
`with corporate venture arms, which also will expose them to
`fresh ideas and talent. Through partnerships with traditional
`venture firms, corporations broaden their reach into start-up
`communities.
`
`Clinical trials
`It’s hard to argue with 50 years of scientific achievements.
`The randomized, double-blinded, placebo-controlled clinical
`trial has had a remarkable run as a cornerstone of therapeutic
`and diagnostic development. In 2014, as the industry comes
`under increasing pressure to replenish its product pipeline
`faster and with fewer dollars, drugmakers must rethink their
`research methods. Alternative approaches that use consumer-
`generated data, adaptive design, and remote sensing
`technology will become more common.
`In the year ahead, research insights drawn from consumer-
`generated data will play a bigger role in clinical trials. As
`new trial methods take shape, companies will increasingly
`need personnel who can design studies that evolve over time,
`incorporate new data, coordinate remote studies, and model
`outcomes. Nearly 70% of consumers surveyed by HRI agree
`that biomedical research is an important economic growth
`engine, but they are unsure of their role. Trial sponsors must
`make trial participation less taxing, more transparent, and
`convey better information about trial options, results, and
`how patients can participate.
`
`Drug supply chain
`The Drug Quality and Security Act, which passed Congress
`with bipartisan and widespread industry support, will be
`phased in over 10 years, culminating in an inter-operable,
`unit-level drug tracing system for the entire country. PwC
`estimates that the program will cost drugmakers $10 million
`to $50 million per manufacturer, depending on the size of
`the company and the complexity of its supply chain. Global
`firms will incur additional costs to comply with upcoming
`
`networking for life science logistics
`The Health & Personal Care Logistics Conference brings industry leaders together
`next Conference April 1–3, 2014 “emerging Trends in Managing Global Supply Chain Integrity”
`by Charles bennett, Pfizer
`
`Since 1922, a group now known as
`the Health & Personal Care Logistics
`Conference, Inc., has been gathering
`semiannually to learn from each other,
`and from experts in their respective fields,
`in our area of business about maintaining
`safe and cost-effective supply chain
`practices supporting the distribution
`of life sciences and health care products nationally and
`globally. I have personally been an attendee since 1974—
`a long time ago!—and I can attest to the value I obtained
`from participating, both early in my career and at our last
`educational conference in October.
`
`More than anything else, I would stress that the
`HPCLC conference is uniquely focused on our industry
`and the members are only from the life sciences (pharma,
`biotech and medical devices) and personal care (OTC, health
`& beauty) companies. We have a valued relationship with
`
`vendor sponsors, and the main goal is to create an educational
`forum for industry members to gather, learn and share
`information. HPCLC is run as a nonprofit with reasonable
`membership and conference fees, and the group’s activities are
`focused on issues that are important to us professionally.
`
`Supply chain practices generally, and logistics
`specifically, have become a more central part of business
`management at multinational pharma companies. In my
`company, a supply chain leader sits at an executive council,
`and we are not unique in this regard. However even the
`smaller life sciences companies, with a few products, have
`significant supply chain issues to deal with and can benefit
`from attending our conferences and becoming an active
`member. Non-member companies are also welcome and
`often attend our conferences.
`
`The program for our upcoming meeting, to be held
`in Philadelphia April 1–3, will center around the theme of
`“Emerging Trends in Supply Chain Integrity.” The range of
`
`international standards.
`To meet upcoming regulations, manufacturers should
`work closely with distributors and develop an open dialogue
`with regulators to guide and monitor changing requirements.
`This will be particularly important during the first year of the
`federal law’s implementation.
`Serialization and track and trace regulations in the
`pharmaceutical industry continue to be a global regulatory
`issue with local implications. Pharmaceutical companies will
`need a global, holistic strategy that they can also implement
`locally.
`Pharmaceutical and biotech manufacturers should
`consider establishing executive-led governance structures
`focused on supply chain security and regulatory compliance.
`They should convene strong program management teams
`that will head up the initiative and engage key leaders across
`the organization to maintain a global focus on evolving
`regulations.
`
`Mobile health
`While the health industry has dabbled in social, mobile,
`analytics, and cloud technologies during the past few years,
`many organizations have failed to connect them to the major
`information systems they use to run their businesses—
`electronic health records (EHRs), research and development
`systems, and member and sales management systems used by
`insurers and retail pharmacies.
`Drug and device companies should enhance their
`understanding of what drives consumer behavior and
`satisfaction as consumers become more brand-aware through
`their interaction with smartphone apps and social media sites.
`
`AbOuT THe AuTHOr
`Michael Swanick is the global leader of PwC’s
`pharmaceuticals and life sciences practice, part of PwC’s
`Health Industries Group, a leading advisor to public and private
`organizations across the entire health industries landscape.
`This group also includes PwC’s Health Research Institute, which
`provides new intelligence, perspectives, and analysis on trends
`affecting health-related industries. The comments above are
`excerpted from PwC’s Health Research Institute’s Top Health
`Industry Issues for 2014 report, available at www.pwc.com/us/
`tophealthissues.
`
`topics being addressed in the sessions will focus on “Creating
`Value and Integrity through SC Visibility,” “Serialization,
`Globalization, and other Trends,” and “Supply Chain Risks
`and Security Management.” Other sessions are being organized
`around “Challenges and Trends Managing Temperature
`Sensitive Products” and “Trends in Supply Chain Security
`Management.” And, as we do at every conference, we will have
`a presentation from our legal counsel, who keeps us informed
`of key logistics and transportation issues in Washington and
`abroad. Finally, we will conclude the conference with a session
`facilitated by our Service Provider Council. This Council is
`run by service providers that attend HPCLC, and provides key
`continued on page 30
`
`AbOuT THe AuTHOr
`Charles Bennett is director, global specialty & cold
`chain logistics at Pfizer, Inc., responsible for developing,
`implementing, and standardizing the proces