dhl the pulse – fall 2012€¦ · regulatory and trade comp liance ... tion services, clinical...

Customer FeedbaCk | p. 5

INsIGHts From our 2012 CoNFereNCe & WorksHops more

NetWork | p. 22

respoNdING to rare dIsease treatmeNts more

NetWork | p. 19

dHL’s NeW mumbaI dIstrIbutIoN CeNter more

dHL Life sciences & Healthcare

tHe puLseFaLL Issue 2012

page 1 | 25

Editorial 3

NEws Indian government opens ports 24/7 4 LSHC trends based on conference exit survey 5

From thE rEgioNs Rome & Milan Pharma Forums 7 China customer event 9EyeforPharma and Canifarma events 11

NEw solutioNs & sErvicEsMedical Express global footprint extension 13Product recall 15DHL: Pharma Select 18

NEtworkLSH distribution center, Mumbai 19Hungary MUWH capability 21DHL facility targets rare diseases 22

iNvitatioN Save the date for next year’s conference 24

coNtENts

22

19 08statE-oF-thE-art liFE sciENcEs Facility iN mumbai thE italiaN pharma markEt

NEw kittiNg aNd rEwork sErvicEs Facility iN thE NEthErlaNds

impriNtPublished by Deutsche Post AG charles-de-gaulle-straße 20 53113 bonn

Represented by: angelos p. orfanos, president life sciences & healthcare customer solutions & innovation dhl

silje skogstad, svp global media relations

Editorial Contact: [email protected]

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page 2 | 25DHL | THe PuLse | FaLL 2012

Throughout 2012, the Life Sciences & Healthcare (LSH) industry has continued to offer both tantalizing opportunities and complex challenges. As we face 2013, that picture remains unchanged — but so does DHL’s commitment to respond to our customers’ quality needs. That’s why we have been investing in sector-specific processes, sector-specific people and good distribution practice(GDP)-compliant and good manufacturing practice(GMP)-compliant infrastructure.

INFrastruCture INvestmeNt

In 2012, we continued to improve and expand our global life science footprint with a vast range of logistics development and innovation. DHL is currently developing five warehouses in India to support the growth of the Life Sciences & Health-care sector (one of these has already opened in Chennai). In June we launched a 58,000 square meter facility in Mumbai; plus, we have invested in our domestic express network in In-dia to equip it with temperature-controlled express capability.

Also in 2012, we opened two new Life Science Competency Centers in Miami and Atlanta to add to our 28-strong competen-cy center network; while our European Hub now benefits from an end of runway Integrated Solutions Center at Leipzig Airport.

Other key developments include the opening of a new warehouse in Hungary to support our Eastern European development. We’ve also been investing in temperature-controlled air freighters from Paris to Cincinnati and mapping our Leipzig to US flights and our India to Europe flights.

reGuLatory aNd trade CompLIaNCe

Looking ahead, the challenges the LSH sector faces are con-siderable. Emerging markets are soaring and will continue to do so in 2013. At DHL, our response will be to increase our

dear Customers aNd readers

footprint and capabilities in those areas to allow our custom-ers speed to market.

Country to country regulatory and trade compliance for the transportation and storage of medicines will become strict-er in 2013 and further increase pressure on the industry. Our customers, therefore, will continue to demand a high quality regulatory responsive service. Apart from our state-of-the-art facilities which offer protective, standardized environments, we are investing in specialist people — such as pharmacists — who have knowledge and experience in the Life Sciences sector that is second-to-none. We are also creating global customs platforms that centralize visibility of the customs brokerage process; and we look forward to DHL Global Forwarding launching our Thermonet solution in early 2013 — a new ad-dition to our temperature management services.

GLobaL CoNFereNCes aNd WorksHop eveNt

The need for collaboration with our customers will become more acute in 2013. As companies in the industry become leaner, they will be looking for new ways to re-engineer their supply chains in terms of cost-efficiencies and/or meeting regulatory need. That’s exciting because it takes us into new conversations about their future requirements and future demand. Out of those new conversations come exciting new ideas and new solutions.

That’s why, since 2001, DHL has hosted an annual Global Conferences and Workshop event, offering customers the chance to talk to us about the challenges they face and the solutions they need. In 2012, our Global Conferences and Workshop event was held in Berlin and was an enormous success. Attending were approximately 200 customers from 48 different countries, 35 supplier partners and a representa-tion of DHL Life Science executives, all drilling into the key issues and trends we will be facing together in the coming years. I would therefore like to take this opportunity to invite you to join us for our 2013 Global Conferences and Workshop in Miami, 11–12 June — so make sure to save the date!

I hope you enjoy this Fall issue of The Pulse, which looks back at the Berlin event and outlines our recent investment, in-novation and solutions activity. And, as 2012 comes to an end, I and the rest of DHL Life Sciences & Healthcare team look forward to working with you in 2013!

Sincerely, Angelos P. Orfanos President Life Sciences & Healthcare Customer Solutions & InnovationDHL

angelos p. orfanos

president

Life sciences & Healthcare

Customer solutions & Innovation

dHL


INdIaN GoverNmeNt FaCILItates rouNd-tHe-CLoCk Customs operatIoNsIn august, the Indian government announced that it would be making 24×7 customs operations available at identified sea ports and airports.

one of the major constraints for international trade in India has been the non-availability of customs clearance

and other facilities at the country’s airports and seaports round-the-clock, seven days a week.

This means that import and export cargo, delivered at a time when clearance facilities are unavailable, have to wait until clearance facilities are open to move on to their destination. At airports and ports — which normally operate round the clock — cargo piles up awaiting clearances.

In order to remove this bottleneck, the Government of India has announced that, from August, customs clearances will be available at identified sea ports and airports around the clock in order to facilitate trade services.

The four airports where this 24×7 service is available are Delhi, Bangalore, Chennai, and Mumbai; and the four ports where this service is available are Chennai, Kolkata, Kandla and JNPT, Mumbai.

operatIoN beGINs oN a pILot basIs

The 24×7 operations will begin on a pilot basis with customs operations along with all other complementary services. Along with customs clearances, other government agencies such as the concerned port/airport authority, drug controller, FSSAI (Food Safety and Standards Authority of India), quar-antine — and private players such as custodians, CHAs (Cus-toms House Agents), banks, transporters — are also working 24×7 to synchronize with the extended work hours. This would be initially for four months after which efforts would be made to expand similar operations at other locations.

“This customs clearance facility is allowed for specified types of cargo (import and export) and at specified customs ports/airports to begin with,” says Amit Dawar, Director — Customs & Integrated Logistics, DHL Global Forwarding. “Eligible customers can now ask for such facilitation with a right. This obviously brings about faster turn-around of cargo. DHL welcomes this move as it will enable us to provide enhanced services to our customers. Closer coordination between all stakeholders will yield greater benefits to a larger number of importers and exporters.”

restrICted to a seCtIoN oF tHe trade

For imports, 24×7 operations cover the category “No Assess-ment No Examination”. This accounts for 70% of imports. For exports, the 24×7 facility could be extended to those exports not claiming benefits.

“Since this service is currently restricted to a section of the trade, its impact has been limited,” says Amit Dawar. “Closer alignment amongst the various stakeholders — i.e. carriers, custodians, customs brokers, freight forwarders, transporters, etc — will result in improved facilitation. Customs depart-ments at various stations are themselves following divergent practices and, as of now, we have received a limited response from our customers for this service.”

India’s Department of Revenue will assess the 24/7 cus-toms operation pilot and propose expansion of coverage if it is required.

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DHL’s 12tH Life sciences & HeaLtHcare conference anD WorksHops DHL’s 12th annual customer event for the Life sciences and Healthcare (LsH) sector pinpointed current and future industry trends and demonstrated how DHL is listening and responding to customer needs.

DHL’s 12th annual cross-BU customer event for the Life Sciences and Healthcare (LSH) sector was held in Berlin on 12-14 June. Approximately 200 customers from 48 different countries attended, with experts from the pharmaceutical and medical device industries, healthcare and hospital distribu-tion services, clinical supply chain and regulatory affairs, plus executives from across DHL’s life sciences team.

Forty workshop sessions were held over three days on 20 dif-ferent topics, offering attendees the opportunity to network

with expert colleagues, focus on the most current topics af-fecting their business, and to help DHL define its way forward and develop the services that its customers need.

Interactive sessions included managing global cold chain networks, supply chain outsourcing; order to cash and direct to pharmacy distribution, end of runway solutions, clinical trials logistics, and the challenges of recent regulatory devel-opments. At these sessions, customers were able to voice their concerns, share their needs and hear innovative ideas.

DiVerse representation

Information booths were set up for DPDHL divisions such as DHL Express, DHL Global Forwarding, DHL Freight, DHL Supply Chain, DHL Global Mail and DHL Sameday. Exhibi-tion booths for 15 leading suppliers of cold chain packaging and data logging were also set up to further reach out and disseminate sector knowledge to customers.

Plus, before the conference started, customers were offered a unique opportunity to visit DHL’s European Express Air Hub in Leipzig to see how multiple flights are handled and the process for rapid sorting of shipments.

“As ever, we had a very successful and productive conference,” says Angelos Orfanos, President, Life Sciences & Healthcare, Customer Solutions & Innovation. “It’s extremely useful to convene with a diverse representation of customers and ex-perts from across the industry in order to spend time drilling into the key issues and challenges we’re facing together. It’s essential to understand the different trends shaping the sector now — and identify the trends of the future.”

conference finDinGs

Trends and findings from the conference, outlined from customer and supplier partner conversations, included the importance of continuing and widening the focus on temper-ature compliance, and understanding the impact of new GDP guidelines on temperature-controlled products.

roger crook, ceo DHL Global forwarding, freight

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Customers highlighted that direct-to-market strategies have been growing in importance, especially in new and emerging markets. They also stressed the significance of the challenge to reduce costs across the value chain and capture sustainable efficiency gains.

Also emphasized was the continued growth in outsourcing services (such as multi-user warehousing), the importance of understanding how infrastructure can be moved from fixed to variable cost while increasing efficiency and quality, and the continued value of DHL developing LSH specific solu-tions (e.g. DHL Product Recall Solution and DHL Medical Express).

Future treNds

Attendees looked toward the future, too, and highlighted mega trends with logistics implications as key challenges in the months and years ahead — such as ever-increasing regulation, personalized medicine (targeted directly to smaller populations) and home care solutions for chronic patients.

The growing complexity of global supply chains, the pat-ent cliff, the rise of generics and OTC medicines, slow or no growth in health systems in developed economies and the growing importance of emerging markets were all earmarked as key trends to watch in the future.

Customer Needs

“As a service provider, we came away from the conference with a good understanding of our customer needs and what we need to do to support them,” says Angelos Orfanos. “And our customers learned what solutions we have introduced since our last conference and what we plan to work on going forward.”

DHL investments include the introduction in 2013 of Ther-monet and Temperature Controlled Freighters, new additions to DGF’s temperature management services, solutions such as DHL Medical Express, an LS-graded courier, and LS-graded infrastructure such as the new ‘end of runway’ warehouse at Leipzig Airport, the Life Science Competence Center network and new LSH warehouses, most recently in Hungary and Mumbai.

DHL’s 13th Life Sciences & Healthcare Conference and Work-

shops will take place on June 11 & 12, 2013, Miami USA

tHe reCeNt 12tH dHL LIFe sCIeNCes & HeaLtHCare

CoNFereNCe aNd WorksHops highlighted the many concerns facing Life Sciences and Healthcare teams, in-dustry leaders and suppliers in today’s challenging supply chain space. Key observations voiced by customers in a post-event survey included:

• Cost efficiency continues to remain the most important issue

• Gaining in significance was temperature control / cold chain networks – moving to second from fourth position last year in terms of importance

• Regulation/compliance is the third most important issue for customers

• The DHL-organized workshop sessions brought together expert speakers from different sectors within the industry to discuss and share best practices to meet these concerns and challenges

For more INFormatIoN oN HoW dHL CaN HeLp deLIver LoGIs-

tICaL soLutIoNs IN tHe LIFe sCIeNCes & HeaLtHCare seCtor,

pLease CoNtaCt your Customer maNaGer represeNtatIve.

ken allen, Ceo dHL express


ocean transportation, special equipment, customs. These were the keywords for the 2012 edition of DHL Global

Forwarding Italy Pharma Forum, which gathered delegates in Rome and Milan from many of the leading Italian pharma-ceutical companies, eager to talk about their issues and pain points — and to hear about solutions.

In Italy, 65% of Life Sciences and Healthcare companies are located in Lombardia and Lazio. “That’s why we decided, for the first time, to hold not one but two Forums, in Milan and Rome,” explains Bruno Bergonti, Business Development Manager, DHL Global Forwarding. “We wanted to give our customers the chance to join us easily and with the highest comfort.” And the customers answered our call and made our forums a success, with over 40 companies attending.

temperature-CoNtroLLed sea traNsportatIoN

The focus of this year’s conference was on sea transporta-tion for temperature-controlled goods with a very technical approach. Representatives of two carriers — MSC and Hapag Lloyd — and their handling agent explained to customers the main features of a reefer container and how the cooling system works. “We also brought a 40’ reefer container to our Milan and Rome Competence Centers,” continues Bruno, “be-

sea CHaNGe For tHIrd ItaLIaN pHarma Forum on april 19 and may 11, 2012, dHL Global Forwarding Italy hosted the third pharma Forum in rome and milan. this was a platform to discuss with customers the challenges, opportunities and innovations in the Life sciences and Healthcare sector.

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participants of the pharma Forum in milan

cause we wanted to give our customers the possibility to see and touch the equipment we use to ship their precious goods.”The visit to our state-of-the-art Life Sciences and Health-care Competence Centers in Rome and Milan was a very important moment for the Forum delegates. Attendees had the opportunity to enter the temperature-controlled rooms, examine the monitoring system and the security appliances, analyze the standard procedure and touch the new generation airfreight container RAPe2 by Envirotainer®.

Customs soLutIoNs & vaLue added servICes

During the Forum, Ferruccio Giuliani, Customs Procedure Manager, gave an overview of our customs solutions and value-added services, such as the availability of bonded ware-houses and VAT warehousing service, to facilitate the storage of goods before customs duties and VAT are paid. Many questions and comments came from the audience, such as the possibility to expand the LCL import service from India to Italy and to make it available also for export from Italy.

“We are very proud to say that both events have been suc-cessful,” says Bruno. “Life Sciences and Healthcare is a very technical sector, and for our customers it is very important to understand that we speak the same language they do and that we are ready to listen to their suggestions and needs. That’s why we are already working on the next Pharma Forum!”

aN overvIeW:

tHe pHarmaCeutICaL market IN ItaLy aNd

dHL GLobaL ForWardING CapabILItIes

Up to 10 years ago, Italy was the leading producer of API (Active Pharmaceuticals Ingredients). But even now, with India and China leading the way in the API market, Ital-ian pharmaceutical companies sell around 60% of their production abroad. Looking at the entire industry, export remains a key activity: between 2000 and 2010, 85% of the growth of the Italian production was driven by export and in 2011 the export of pharmaceutical products grew by 19% over the previous year.

LIFe sCIeNCes aNd HeaLtHCare is also a key sector for DHL Global Forwarding Italy: in 2011, the sector-dedicated staff shipped 1,500 Envirotainer® or Unicooler® containers, moved 1,300 ocean reefer containers and managed over 13,000 air freight export shipments. Every day, a team of 27 dedicated and well trained people takes care of pharmaceutical goods and ensure they are man-aged in the most professional, risk-free and effective way.

dHL GLobaL ForWardING Italy’s huge investments in this sector have led to the realization of two Life Sciences and Healthcare Competence Centers in Milan and Rome as well as a dedicated GDP warehouse in Verona.

top: dHL Competence Center in milan

bottom: New generation airfreight container envirotainer®

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dHL Hosts ‘evoLvING LIFe sCIeNCes’ LoGIstICs eveNt IN CHINa a dHL customer interactive event took place in shanghai in september to address the issues the LsH industry is facing in China and drive the future development of new solutions and strategies.

the Life Sciences and Healthcare industry in the emerg-ing market of China is facing a transformation in sup-

ply chain, creating demand for solutions with reach across sub sectors, products and geographical regions within the country. To address this, a regular one-day DHL Life Sci-ences & Healthcare customer interactive event took place in Shanghai in September.

Called Evolving Life Sciences Logistics in China, the event provided a forum for sharing learning experiences, best practice and collaborative dialogue between industry lead-ers and DHL’s dedicated Life Sciences and Healthcare sector teams.

It was also a chance to explore industry trends and cover the latest innovations in logistics products and services with an array of leading keynote speakers from the pharmaceutical industry and DHL, plus customer presentations and work-shops.

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LoCaL voICes

“Evolving Life Sciences Logistics in China was about listening to local voices and, in so doing, getting closer to the market,” says Sue Arden, VP Life Sciences & Healthcare, Customer Solutions & Innovation Asia Pacific.

“We really need to understand the idiosyncrasies of this complex market and by opening up a dialogue and exploring the issues facing customers — such as the fragmented market and the challenges facing manufacturers who want to get their products out to the second and third tier cities. How can we at DHL help them reach some of these more remote areas?”

The event’s workshops, says Sue, addressed some of the most talked about problems. “We looked at some of the solutions that are successful in other markets and explored the possibil-ity of leveraging from that knowledge to support the market in China,” says Sue. “The conference invites MNCs and local Chinese manufacturers to gain a clear understanding of what suits the Chinese local market.”

Workshops included ‘Managing Complex Temperature Chal-lenges Throughout the Logistics Chain’, ‘Hospital Logistics – Future Trends and Opportunities’, ‘Managing the Medical Device Supply Chain in China’ (including bonded and non-bonded strategies), and ‘International Logistics and Regula-tory Changes – Impact for Emerging Markets’.

INdustry Issues

The event was very well-received by delegates who welcomed the chance to share their experiences and talk about industry issues. Key trends validated included regulation and infra-structure challenges and increasing price pressures.

The new serialization, SFDA (Shanghai Food & Drug Ad-ministration) regulatory change mandated for 2014, 1D bar coding which necessitates an additional label, was also a hot topic. “This will add further costs to the supply chain as the manufacturers endeavour to find a solution for this new re-quirement and potentially slow down supply,” says Sue.

“The implications are potentially enormous for manufacturers — so we at DHL wanted to understand the impact of this new development and ask how we could help.”


tHe maIN eveNts: dHL at CaNIFarma aNd eyeForpHarma 2012 dHL supply Chain sponsored two of this year’s biggest life sciences events — the eyefor-pharma Congress in miami and the Canifarma conference in mexico.

Two of the most relevant life sciences events focusing on Latin America took place this summer — and DHL sponsored both of them: Canifarma (in Mexico) and Eyeforpharma (in Miami). The objective in both cases was to engage with — and better understand the needs of — pharmaceutical manufactur-ers and medical device companies.

DHL has solid capabilities in the region’s key markets, notably Brazil and Mexico, with a total of more than 20 Life Sciences focused sites. In addition, DHL offers a regional hub solution in Panama to store goods ‘near to target market’ and benefit from inventory consolidation across several countries.

At both events, stimulating industry discussions and work-shops highlighted the importance of customer relationships and direct-to-market solutions.

maJor preseNCe at CaNIFarma

Canifarma — the Mexican Chamber of Pharmaceutical Com-panies Annual Conference — was held in Mérida, Yucatan, Mexico, June 13-16, with 230 delegates from government, regulatory authorities, manufacturers and pharmaceutical suppliers participating.

DHL Supply Chain had a major presence at the event, includ-ing a booth where new and established customers had oppor-tunities to discuss logistics opportunities in Mexico. DHL also leveraged the global sponsorships of Manchester United and Formula 1 Racing to offer raffle prizes.

Buses sponsored by DHL Supply Chain provided complimen-tary transportation for customers’ spouses as well as transpor-tation for 180 delegates to a luncheon at La Hacienda Temon-zon. Bus passengers watched a welcome video that featured


solutions and capabilities developed during DHL’s 16 years in the industry in Mexico.

NeW INdustry treNds aNd Latam markets

Later in June (28 -29), DHL was a major sponsor of the mar-keting and sales excellence Eyeforpharma Congress, held in Miami, Florida. The event played host to 180 delegates from domestic and international manufacturers who participated in conferences and workshops mainly focused on new trends in the Latin American market.

Again, DHL Supply Chain had a central presence with a booth at the event entrance and hosted a dinner at the Epic Hotel for more than 20 customer executives.

Eyeforpharma attendees participated in ongoing discus-sions around regaining channel control, best ways to leverage direct-to-market to increase product availability, recovering supply chain margins, reducing unmanaged cross-border trade flows, and improving sales force effectiveness.

Angelos Orfanos, DHL’s President of Life Sciences and Healthcare, also presented a workshop called “Servicing Multiple Supply Chains: A key to success for customers.” As a follow-up to the session, DHL will also be presenting at ANEVIFAC, a Mexico-based pharmaceutical industry association.

dHL presence at eyeforpharma

dHL raffle took place during customer dinner / eyeforpharma Congress

dHL at Canifarma Conference 2012

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dHL Medical Express — the unique logistics solution spe-cifically tailored for the life sciences industry — is expand-

ing its global footprint.

DHL Medical Express is now available in 70 countries glob-ally. Leveraging the global DHL Express network, it provides express transport services for time-sensitive pharmaceuticals, medical devices and human specimens.

Next to a variety of standard specifications, such as priority handling and inhouse customs clearance, DHL Medical Ex-press offers a certified temperature packaging range ensuring ambient, chilled or frozen product temperature throughout the journey. Dry ice supply and replenishment capabilities are available in most countries of service.

Plus, customer needs are handled in an integrated manner by experienced staff who are dedicated full-time to the transpor-tation of investigational new drugs (INDs).

DHL Medical Express simplifies the complexity for labo-ratories of running a clinical trial. Because it is a modular solution, DHL Medical Express can easily be tailored to meet

dHL medICaL express exteNds GLobaL FootprINt Customer feedback around dHL’s medical express solution has been excellent — and, as a result, its global footprint is being extended.

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a customer’s individual needs; and it’s also a sustainable solu-tion that maintains compliance with local life science regula-tions, customs legislation and environmental guidelines. Plus it offers handling priority — from pick-up to delivery — and full global visibility and traceability with 24-hour customer service support.

DELIVERING WITH THE EARLIEST POSSIBLE SERVICE

“DHL Medical Express focuses on small to medium-sized par-cels and delivers shipments with the earliest possible service,” says Marco Hogenboom, DHL Express Head of Industry Life Science and Healthcare. “It’s been specifically designed to deal with the requirements of clinical trials and customers who supply medical devices and has been very well-received. Feed-back has been excellent. Customers have been telling us that this is exactly the kind of solution they need.” DHL Medical Express is already available widely across Europe and is also available on demand in countries in the Middle East, Africa and Asia-Pacific. Roll-out to the US is being completed.

In real terms, extending the global footprint of DHL Medi-cal Express means intensively training operational teams and couriers. “It’s important that life science and medical products are dealt with by experts who completely understand the nature of the package being handled,” says Marco. “For example, some shipments require active monitoring — otherwise, if the prod-ucts are not kept within the correct temperature range, they could fail; or samples might not be usable for research purpos-es. It’s vital that these materials arrive on time and in order.”

THERMO-CONTROLLED PACKAGING INNOVATION

Because packaging requirements vary from product to prod-uct and country to country, DHL Medical Express has framed the most frequently used packaging into one easy solution: a global Thermo-Controlled Packaging (TCP) range of 12 dif-ferent certified box types for ambient, chilled and frozen ship-ping. The range is currently being rolled out on a global basis, and is already available in Europe. Many DHL customers are now using the TCP range to standardize packaging dimen-sions, weight and cost.

“I see our DHL Medical Express solution being leveraged by customers with high service need at a more cost-effective price point,” says Marco, “particularly with regards to medical devices and clinical trials and supplies; but also for specialized pharma, such as drugs that need to be shipped under a con-trolled environment. I see a big growth in the life sciences sec-tor, and this is where DHL Medical Express will come into its own. It’s a very efficient, controlled and affordable solution.”

CONTACT OuR ExPERT:

[email protected]

DHL’s SMARTSENSOR technologyVaccine scanning in a DHL Supply Chain warehouse Drugs labelling at a DHL Supply Chain warehouse

| 25DHL | THe PuLse | FaLL 2012

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produCt reCaLL: pLaNNING For tHe uNexpeCted recalling a product is a major undertaking — but doing it quickly, sensitively and in accordance with each country’s statutory regulatory protocols is absolutely vital. that’s why dHL supply Chain has created dHL recall solution, a scalable, end-to-end recall and fulfilment solution.

according to the US Food and Drugs Administration (FDA), the average number of medical device recalls

per year has quadrupled over the last decade. Enforce-ment in this area is a top priority of the regulatory bodies around the world. Major manufacturers see their annual results impacted by recalls, and insurers typically refuse to cover the risk of recalls for medical devices manufacturers.

Despite the efforts of the increased regulations, over-sight and communications methods in most product recalls only successfully recover a fraction of the affected products. Most recall activities need to be executed in a short time frame and need to comply with the strict requirements of regulatory bodies such as the FDA. This means recalling and scrapping ALL affected devices, reimbursing customers for the value of the recalled device, and assisting in finding a replacement for the end-user.


seamLess Customer experIeNCe

The core challenge, then, is to devise a sophisticated, three-stage response across multiple countries, within short time period, over millions of end-users requiring product regis-trations, validations and receipt of repaired or replacement products. This is exactly what DHL Supply Chain has done, building on its pioneering insight into this vital part of the logistics operation to develop DHL Recall Solution. This is a scalable, end-to-end recall and fulfilment solution managing local, regional, global, multi-lingual recall scenarios.

Recalling a product is a major undertaking. Although the risk of end-user injury could be very small, a potential safety risk will see the manufacturer eager to act without delay. Recalls require a seamless customer experience. Logistics planning must coordinate networks of local depots, creating efficient hubs to administer and process returns.

The process must also be handled sensitively: parties and part-ners must act with discretion. Statutory regulatory protocols for handling end-user product recalls vary from country to country, and each jurisdiction has its own end-user protec-tion codes regarding safety awareness notification, customer treatment and product replacement. End-user notification timescales, for instance, range from 14 to 20 days. Despite the complexity, the expectation for initiation and completion of an entire recall cycle is limited to only a few months.

tHree steps For suCCessFuL reCaLL

In creating DHL Recall Solution for customers, DHL Supply Chain recognized that, firstly, end-users, hospitals and clinics needed a way to pack and return their product, with mini-mum inconvenience. Secondly, returns had to be gathered and shipped to an agent for inspection, repair or replacement.

Thirdly, replacement units had to be returned to end-users within a defined lead-time.

With DHL Recall Solution, key data collection is done during the Request Phase to map all logistic processes and design the most optimal operational model. Once the solution design is ready, the Setup phase will ensure all the components are integrated and ready for the execution.

Within a few weeks of the request, the DHL team can present the project and is ready to execute the end-to-end solution orchestrated by the unique DHL Recall Management System (RMS), the flexible and fully integrated DHL IT Solution sup-porting recall projects that connects product registration, E2E order management, monitoring, performance and exception management as well as “state-of-the-art” reporting.

The new DHL Recall Solution is enhanced with several important features. The global network of DHL offers an immediate activation capability and an advanced IT system now handles the customer registration. The system engine can manage any logistics partner, so clients have the choice of us-ing their own agents in addition to DHL resources. Call center services, can be integrated into the process if required.

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Customer CHaLLeNGe

• Urgent safety recall• End users, hospitals, clinics and pharmacies local —

global• Complex logistics: network infrastructure plus multiple

language communications

dHL reCaLL soLutIoN

• Customized end-user registration web portal • Product return/drop-off, inspection/replacement and

return • Product repair and return • Integration of packaging, replacement product ware-

house, repair vendor, scrap and recycle vendors • Dashboards and reports • Individual end-user monitoring webpage and e-mail

communication

Customer beNeFIts

• Brand protection, restoring trust• Manageability, visibility and control• Global reach, ability to execute• Agility and flexibility• Regulatory compliance

Customer beNeFIts

Despite very tight timescales, DHL Supply Chain is able to develop and implement a global solution spanning active recall management across multiple countries. On average, customers only have to wait 12 working days for a repaired or a replacement product – a key factor in protecting the manufacturer’s brand reputation. The recall is executed fast, professionally and in consideration of the customer’s specific supply chain model.

DHL’s IT infrastructure provides open information flows to the customer at any point in the recall process which provides full visibility and control. Plus DHL’s extensive transportation network and flexible pool of key service providers can provide the required global reach.

“Building on our learning, DHL Supply Chain’s innovative new Recall Solution now offers customers fast, scalable response with customized control,” says Stefan Buschak, Director Global Service Logistics DHL Supply Chain. “Schemes can be developed and activated within 24-48 hours of customer brief. Pre-integration of DHL worldwide logistics resources ensures recall solutions are configured quickly, customized and deployed to create dense service network coverage across multiple territories.

“Our ability to augment or replace a customer’s own repair vendors with DHL’s own service partners provides ultimate flexibility and scalability.”

CoNtaCt our experts:

[email protected]

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dHL GLobaL maIL deLIvers For maIL-order pHarmaCIes oN prICe, speed aNd reLIabILIty

DHL’s Pharma Select product is a popular solution specifi-cally designed to meet the needs of mail-order pharmacies, offering “a courier level of customer service, support and performance management.”

DHL has been serving mail-order pharmacies for many years; but in the USA — after identifying the specific needs of this valued section of its customer base — DHL Global Mail launched a specialized solution called Pharma Select.

Designed specifically to meet the business requirements of mail-order pharmacies, Pharma Select is a comprehensive do-mestic direct-to-patient service offering reliable, fast delivery — between two to five days from pick-up — for high-value shipments. What’s more, it features enhanced customer ser-vices and reduced postage costs. Since its launch, it has been a popular innovation for mail-order pharmacies, delivering an average of five million packages a month on their behalf.

speCIaLIZed reQuIremeNts

“Mail-order pharmacies have a number of specialized requirements,” explains Bill Sweeney, Director Life Sciences & Healthcare, Pharma Select. “For instance, customers look for enhanced security at facilities where packages are being processed, and they also want to know where their packages are at any given time. This is important because the majority of the products we carry are pharmaceuticals — and primarily maintenance medications.”

DHL Global Mail has a Workshare Partnership with the US Postal Service where Pharma Select parcels are brought as

close as possible to their destination by Global Mail before they are transferred to local postal authorities for final deliv-ery. While this partnership reduces postage cost significantly for the shipper, the additional services provided by Pharma Select such as proactive performance management, on demand reporting and enhanced tracking abilities increase the savings and offer the best possible return for their postage spend.

Pharma Select customers gain access to an unsurpassed level of help and transparency with Global Mail’s industry-leading Customer Web Portal. This enables companies to not only track their shipments with tremendous visibility, but also set up email notifications for patients and create internal reports

to manage information. Additionally, Global Mail offers re-ship management assistance and monthly dashboard perfor-mance overviews.

best vaLue For moNey

A team focused on the pharmaceutical industry is also on hand to help ensure optimum service quality by analyzing delivery performance on a network-wide and customer-by-customer basis.

“The main benefit our mail-order pharmacies say they enjoy with Pharma Select is the focus on protecting the patient delivery experience,” says Bill Sweeney, “while also providing a cost benefit to the pharmacy.

“Our customers also enjoy the high level of service they receive. Even though their package is being delivered through the regular mail service, pharmacies can contact us to receive support on its performance. Plus, through access to our Web Portal they have a transparent view to every aspect of their business relationship with us, from Performance Summaries and Detailed Reporting to Invoicing and Tracking.

“What we offer these customers through the Pharma Select service is a courier level of customer service, support and performance management — with added cost advantages.”

For more INFormatIoN oN pHarma seLeCt aNd otHer

dHL GLobaL maIL servICes, vIsIt

www.dhlglobalmail.com (USA) or www.dhl.com/mail©

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MUMbaI

state-oF-tHe-art dIstrIbutIoN CeNter opeNs IN mumbaI to serve the rapidly growing life sciences and health-care market in India, dHL has opened a state-of-the-art distribution facility in mumbai, offering a complete portfolio of innovative services to LsH customers.

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emerging markets are forecasted to contribute approxi-mately 75 percent of global pharmaceutical sales growth

by 2015. India is one such market and a major growth engine. Indeed, according to IMS Research, India’s rank as a pharma-ceutical market is expected to increase from 12th to 8th place between 2010 and 2015. The market’s share of US pharmaceu-tical spend is also expected to grow from 4% to 8% over the same period.

This, then, is one of the most important emerging Life Sci-ences and Healthcare markets in the world. That’s why, in June, to serve the enormous and growing demand from LSH customers, DHL launched a new Supply Chain Life Sciences & Healthcare distribution center in Mumbai.

meetING INCreasING LoGIstICs Needs

The state-of-the-art life sciences facility in Mumbai is located within a newly constructed 56,000 square meter multi-client distribution center and will cater to the requirements of India’s rapidly growing Life Sciences industry and to other sector requirements as well.

“The new platform in Mumbai will enable us to provide a world class service to our customers, enabling them to expand their businesses,” says Vikas Anand, Chief Operating Officer, DHL Supply Chain India. “Life Sciences & Healthcare is a key industry for DHL Supply Chain in India. By setting up this world class infrastructure we continue to meet the industry’s increasing logistics and warehousing needs. We have the capa-bilities to distribute to wholesalers, pharmacists and hospitals from our new center in Mumbai based on customer demands.”

portFoLIo oF servICes

The new center offers a complete portfolio of innovative services to manufacturers of pharmaceutical products, with facilities ranging from order management to warehousing and distribution, plus very specific solutions such as postpone-ment services, clinical trials logistics and order-to-cash. The Multi-Client Site (MCS) also uses green technology such as LED lighting and wind-assisted ventilation.

DHL now has more than 150 life sciences and healthcare facil-ities worldwide, including 28 competence centers, 22 clinical trial depots, four regional hubs (Turkey, Dubai, Singapore, Panama) and five European road cross-docks. In India, DHL is now constructing MCS facilities in Gurgaon, and Bangalore

and planning sites in Chennai and Ahmedabad. Other sites in Delhi, Kolkata and central India are also being reviewed.

“DHL is strongly committed to investing in markets of grow-ing importance,” says Angelos Orfanos, President and Global Head of Life Sciences & Healthcare, DHL Customer Solutions & Innovation. “Looking to 2015 and beyond, India, China and other emerging markets are expected to be the key drivers of growth in the pharmaceutical and medical device sectors. With this warehouse, we take another step in pursuing DHL’s global industry sector strategy by opening our new platform and deliver exactly the specialized services that our clients are asking for.”

New life sciences facility in mumbai


since then, the Budapest Pharma Platform has been ready-ing itself for its first two customers. Respectively, these are

one of the biggest global generic and specialty pharmaceuti-cals companies, headquartered in the USA, and a biopharma-ceutical company specialized in the development, production and distribution of plasma-derived products.

Over the last six months, customer implementations have been conducted at the Budapest facility in preparation for the customers’ arrival. Work has included facility upgrades and customization of processes for both customers’ special storage areas and goods handling requirements.

muLtI-Customer WareHouse

For example, for one of the customers, a cold room has been built for their finished products, plus a sampling room where sampling of bulk products can be carried out. A new Plasma Operation Center, where blood plasma can be stored and manipulated, has also been created. This area has four different temperature zones, including an office area with a laboratory.

In collaboration with the second customer, the Budapest Pharma Platform has developed a specific 12M service includ-ing warehousing and sampling of the customer’s bulks, primary and secondary packaging materials and transportation to their manufacturing plant.

At 34,000 square meters overall, the Budapest Pharma Platform is a multi-customer warehouse than can accommodate 60,000 pallets. It offers storage zones for ambient (15°C to 25°C) and chilled (2°C to 8°C) goods, along with a 2,400 square meter Good Manufacturing Practice (GMP) area with a capacity for storing 4,000 pallets.

budapest pHarma pLatForm to reCeIve FIrst Customers earlier this year, dHL’s budapest pharma platform — operated by dHL supply Chain Hungary — came on stream to boost dHL’s ability to respond to the needs of the Life sciences and Healthcare industry in eastern europe.

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a recent study published by Thomson Reuters claims that rare diseases can generate as much revenue for their

manufacturers over the lifetime of their treatment as those used for much more common health conditions. The study also notes that the rare disease market was worth just over $50 billion globally at the end of 2011, with a compound an-nual growth rate between 2001 and 2010 of almost 26%.

Rare disease is defined differently around the globe. In the US, a disease is rare if it affects fewer than 200,000 people, which means that around 30 million Americans are afflicted with rare diseases. In Europe, the definition is slightly broader. A disease is considered as rare when it affects no more than 5 in 10,000 people in the EU — equivalent to around 250,000 people or fewer for each disease.

tHe speCIaLIst Needs oF rare dIseases

Whatever the definition, many new treatments for rare oncol-ogy and metabolic diseases are now coming to market, and in many cases these treatments are extremely expensive. Rare diseases are an area in which big pharma wants to have a pres-ence and these companies know that expertise in this area is different from the ‘mass market’ pharma business.

respoNdING to tHe uNIQue Needs oF rare dIseases dHL supply Chain’s packaging and kitting services facility at its regional distribution Center (rdC) in Nijmegen, the Netherlands, targets rare diseases.


beNeFIts oF a CeNtraLIZed soLutIoN

The DHL facility receives from the pharma manufacturer the relevant components and naked vials within a segregated, secured and dedicated area. Manufacturing of final presenta-tions include label printing, batch-number assignment, carton printing, leaflet printing and physical packing for market spe-cific products. QP release and storage is followed by regional (cross-border) distribution (managed by DHL Supply Chain) to pharmacies and hospitals across Europe.

The benefits of DHL’s centralized RDC solution for the rare diseases manufacturer are clear: reduced investment in fin-ished goods stock, in particular in difficult to predict market-specific inventory levels, short lead-time / response time to market specific requests (usually within a two day turnaround period) and having one contract partner for both GMP certi-fied warehousing and distribution.

INFormatIoN

For more information contact: arjen Hellinga, business

development manager, dHL supply Chain, Netherlands

Email: [email protected]

The specialist needs of rare diseases naturally extend into the logistics arena. Very high value, temperature-controlled (mainly chilled) product, with patients geographically dispersed and relatively few in number, and with individual market demand often difficult to predict, requires a logistics partner capable of offering a very flexible, fast-reacting solu-tion, which both reduces inventory levels and controls costs.

DHL provides a GMP environment for packaging and kit-ting services at its Regional Distribution Center (RDC) in Nijmegen, the Netherlands, and has recently strengthened its assembly and postponement capabilities. It provides an end-to-end service comprising warehousing and regional (EMEA) cold chain distribution, production from naked vials to final product, secondary packaging activities, and final packing. Each element of the process meets different, country specific legal and compliance requirements before finished products are shipped across the region.

the facility provides an end-to-end service of warehousing and regional

cold chain distribution, production from naked vials to final product,

secondary packaging activities, and final packing.


save tHe date the 13th dHL Life sciences & Healthcare Conference and Workshops: June 11 & 12, 2013, miami, usa.

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the Life Sciences and Healthcare sector continues to face a complex environment of tightening regulations, increasing

cost pressures and evolving business needs, such as access to emerging markets.

In order to help address these and other challenges and shape industry direction, DHL is delighted to announce its 13th Global Conference and Workshops event for 2013 — this time taking place in Miami.

This annual event is a successful, dynamic and productive forum for logistics professionals, including those from phar-maceutical and medical devices manufacturers, distributors and clinical trial/research organizations. Delegates meet to highlight and discuss the issues and trends affecting life sci-ences and healthcare today — and those the sector is likely to face in the year ahead.

tHe CoNFereNCe aNd WorksHops eveNt Is tHe IdeaL

opportuNIty to eNGaGe aNd exCHaNGe

• Listen to top-level industry speakers sharing best practice• Learn from recent experience in the industry in workshops

and presentations• Exchange ideas and opportunities with other participants• Learn about recent trends and shape future logistics

solutions• Network with your peers and suppliers

Attendees can also choose from 40 workshop sessions explor-ing the most current topics affecting their businesses, hear inspiring guest speakers from around the industry, and meet with leading suppliers involved with some of the most innova-tive and advanced solutions in our sector.

Information booths from vendors of active and passive ther-mal packaging solutions for freight and express, suppliers of

WorksHops WILL INCLude:

• Cold chain/temperature management• Global market access• Cost management via shared infrastructure• Cost management via road / ocean freight / mode mix• Using control towers/ LLPs to outsource more of your

logistics and improve operational efficiencies• Managing distribution• Clinical trial logistics and express transport solutions

temperature sensors and loggers — as well as DHL Express, DHL Global Forwarding, DHL Freight, DHL Supply Chain and DHL Global Mail — will allow for direct discussion. As ever, the Conference and Workshops underpins our ongoing commitment to listen to our customers — and then develop innovative and tailored supply chain solutions based on their specific requirements.

A formal invitation will be released in January 2013, describ-ing the agenda and offering a registration site. Do come and join us at this unmissable industry event, help us understand your current and future needs — and hear about our recent investment and solutions activity in this most vital of sectors.angelos orfanos, president Life sciences & Healthcare Customer solutions & Innovation dHL, addresses a previous conference

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dhl the pulse – fall 2012€¦ · regulatory and trade comp liance ... tion services, clinical...

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