A Logistics Partner with Local Knowledge and Strong Infrastructure for Clinical Trial Distrubution is Essential for Success

If handled badly clinical trial distribution in Latin America can be very frustrating. Delays occur at each step, setting back trials and ultimately launch dates. Being able to move a package from A to B is just one component of successful, delay-free logistics. An integrated approach, combining transport capabilities with customs know-how, regulatory experience and cold-chain expertise is the best strategy.

Awareness of these issues has lagged behind clinical trial growth. From 2007 to 2011 the number of new clinical trials in Brazil increased almost 100%, according to data from ClinicalTrials.gov, and a similar boom in interest in logistics is now needed. Until this happens sponsors and CROs will fail to realize the vast potential of clinical trials in Latin America.

The most frustrating thing for clinical trial managers is having no idea how to overcome delays. This is often the case when shipments are seized at borders as a result of complex and diverse regulatory mandates. The three biggest markets, Mexico, Brazil, and Argentina, have unique regulatory challenges and without local knowledge delays are inevitable.

Working with integrators that offer little support increases the likelihood of delays. Clinical trial managers are left knowing their package is at the airport but without a clue how to get it released. This uncertainty is compounded when the experimental drug is temperature sensitive. Each hour a package sits at customs is an hour of potential loss of drug efficacy and potential loss for patients who could be benefiting from the experimental medicine.

Once a package has cleared border control, the problems continue. Mexico and Brazil are vast countries with limited transport links to second and third-tier cities. Relatively few flights link these cities to the big commercial hubs, and of these only a fraction will transport biologics.

Consequently ground transportation is the primary way to ship to second and third-tier cities, which are underserved by the big couriers but increasingly important clinical trial locations. Less than half of the 395 recruiting trials in Mexico listed on ClinicalTrials.gov include a site in Mexico City. The situation in Brazil is similar. Reaching second cities overland means travelling long distances, creating challenges for temperature-sensitive drugs.

The potential for delays is high. While it is impossible to predict some delays, contingency plans and an understanding of the region will minimize the impact. It is through preparation and local knowledge that Marken was able to continue working in Chile when all other couriers stopped after the 2010 earthquake. Marken sent vehicles through the mountains linking Santiago to Mendoza, 105 miles as the crow flies, to make sure a shipment arrived on time.

In Latin America reaching a city is only half the challenge. Strikes, traffic, and poor understanding of the cold-chain are problems. A logistics partner must know the city. Marken has 26 vehicles in Buenos Aires alone. Through micromanagement, local knowledge, and strong infrastructure delays can be prevented. Without these capabilities, shipping from one part of São Paulo to another can be almost as challenging as transport across Brazil.

Alejandro Mancenido, Branch Manager, Argentina

Alejandro joined Marken in 2003 to develop the Latin America network. He has more than 17 years experience in logistics working in different companies in Argentina, Uruguay, Brazil and USA .He has a bachelor degree in IT systems at the UTN in Buenos Aires.

Record Snow, Road & Airport Closures Can’t Stop Marken from Delivering

When you are faced with a life threatening disease, you will do anything for an effective treatment to save your life, or at least extend your life. Sometimes those treatments are not yet approved by the FDA. The FDA has a compassionate use designation to help patients in that position. The American cancer society explains compassionate use as “the treatment of a seriously ill patient using a new, unapproved drug when no other treatments are available.” (1)

The last thing these scared and sick patients need is adverse weather conditions like heavy snow, thick fog or torrential rains to block their access to these treatments. Yet these severe weather conditions do affect the drug distribution networks and jeopardize the health of patients who rely on them. In the winter of 2010, Marken had shipments of compassionate use medications that HAD to arrive in Germany and Sweden, during the blizzard of 2010. Let me set the scene for you…

Scotland, Blizzard Conditions., December 6, 2010

This was the coldest and snowiest winter conditions in Central and Eastern Scotland, in the last 40 years. Accidents and stranded vehicles made the M8 motorway impassable; the gridlock forced many on the road to spend the night in their car. For the first time in history, the Forth Road Bridge that connects Edinburgh and the Lothians to Fife was closed, as were the Edinburgh and Glasgow airports. How were we going to deliver the life saving treatments? We had the answer.

“We knew we had to find a solution, as the medicines were for compassionate use, so we had to think outside the box and I knew a family member whose 4-wheel-drive Land Rover could get through the snow and make the collection possible.” Said Heather Blagg, Customer Services Manager, Marken Edinburgh

We picked up the medications, waited for snowploughs to remove snow and police to remove stranded vehicles blocking the road and drove through the night to London Heathrow Airport. The packages made it just in time for the first morning flights to Leipzig and Linkoping and the patients waiting on the medications got the call, we had their medicine!

We are very proud that in the face of unprecedented winter blizzard conditions, Marken utilized our 25 years of experience in global supply chain management services to ensure timely delivery of compassionate use medicines to patients in Germany and Sweden.

Our extensive network of offices, the size of its transportation fleet and its unwavering commitment to customer service, our operations staff, namely Heather Blagg, used their creativity and the patients lives were not in jeopardy.  Marken’s successful management of the crisis underscores the vital importance of contingency planning and highlights our ability to quickly come up with an alternate supply chain solution to meet customer’s expectations.

 Don Riach, Director, Cold Chain Solutions, Marken

Don Riach has extensive freight forwarding, import, export, clinical trial distribution, cold chain and courier experience having previously worked for Scottish Express Intl, Syntex Research, Roche and Quintiles. Don holds an IATA FIATA Diploma with distinction, Institute of Export and Dangerous Goods by Air qualifications and graduated from Napier University Edinburgh gaining a BA with Distinction in Business Studies in 2005. Don joined Marken from Quintiles in 2000 and is currently the Director of Cold Chain Solutions based in Edinburgh.

(1) American Cancer Society June 29, 2011 Compassionate Use http://www.cancer.org/Treatment/TreatmentsandSideEffects/ClinicalTrials/compassionate-drug-use

Marken is here to help streamline your business in Latin America

Marken understands the critical nature of maintaining continuity and assuring quality through clinical trials. We support over 1200 investigator sites in Latin America and over 6000 globally. We are the leading premium courier in Latin America with a network of pharmaceutical service depots and branch offices in Latin America specifically designed to support inbound, outbound and local services in the region. Our Latin America operations offers competitive pricing, a flexible network with late call and pick up times, and 99,8% on time delivery of biological samples back to any US facility.

We are here to help streamline your business in the region and keep you up to date on all regulatory changes, including this latest industry alert for Argentina:

Please be advised that the government of Argentina has imposed a new Customs Fee on shipments originating in, destined to or transiting through Argentina that began on Feb. 1st. A fee of $25.00 USD will be assessed to each responsible party (Carrier & Importer/Shipper) for each manifest transmitted to Argentina Customs. These charges result in a total cost of $50.00 USD per manifest declared. Please  Click here for more detailed import information.

Interested in our Latin American Depots?  Here is a sneak peak at our Mexico and Argentina depot shipping times.

Ernest Batista, Regional Manager, Latin America, MARKEN

Ernest Batista, Regional Manager of the Latin America market, brings over twenty-five years of logistical experience specializing in regional regulatory and customs management.  Having worked closely with the TSA, Department of Homeland Security and customs offices of every country within Latin America, Ernest can ensure the appropriate regulatory measures are made in advance to ensure delivery is made on time and within specifications.

While overseeing the day-to-day operations of the Miami office, Ernest and his team have developed an in-depth knowledge of the intricacies of serving the clinical trial needs of his clients throughout Latin America. Not only does he have the regulatory know how, but also his years of experience in working in the Latin American region have given him an unmatched expertise in dealing with the most effective distribution networks across the region

A CEO Blog Series Changing the Way We Look at Life Sciences Logistics

Part one of  Marken CEO Wes Wheeler’s ten part blog series about the changing face of Life Science Logistics in today’s fast-paced pharmaceutical industry.

The increasing complexity of supply chain logistics due to the growing number of biologically derived drugs is impacting the cost of logistics. Some recent estimates predict that the cost of cold chain logistics will rise by 12-15% each year.  Adding to this complexity, the FDA is increasing the requirements for handling these important new medicines.

Marken is already well positioned to support these new expanded requirements.  We have finished conducting extensive market research to be sure that our services are well aligned with our customer’s needs. We are delighted to share the results that will clearly demonstrate Marken’s perceived leadership in the life sciences supply chain services market. We are in this position because we take great pride in our high level of hands-on, reliable and personal touch which has, in turn, built strong relationships, trust, and a reputation for quality service.  We have a 99.8% on-time performance record and a 99.9% client retention history.

We also heard from our clients something interesting about their supplier base.  All of them want fewer providers.  Most sponsor companies already have ‘preferred providers’ in place, but many admit that they still have too many vendors and manage too many hand-offs.  They seem willing to convert their ‘preferred providers’ to more strategic relationships and in turn benefit from further savings with fewer interfaces.  Interestingly, such ‘strategic relationships’ are more likely to develop when a supplier can provide their clients with a full service, anywhere in the world.  Marken can deliver virtually anywhere in the world from its base of 24 locations.  And we will add and move our footprint as the market changes.

I will be ‘blogging’ on these and other topics in the coming weeks. In these postings I will explore areas of future industry needs, metrics for success, new technologies and services as well as new regulatory trends affecting the supply chain in emerging markets.

For drug companies looking to optimize supply chain logistics, Marken makes it happen. We’re more than just a premium courier service…we’re your global life science supply chain specialists and partner.  Our supply chain experts work hard to increase efficiency, lower costs, and ensure the success of your trials. In fact, we guarantee reduced costs on equal volumes. Customers who partner with us on 3-5 year agreements should see real savings immediately.

Marken’s experience and expertise in supply chain logistics can support every aspect of your clinical trial, leaving you more time to focus on what you do best.

Wesley Wheeler
Chief Executive Officer, Marken

Wesley Wheeler is the Chief Executive force for the company’s strategic vision to realize our potential as the leading supply chain services provider for the life science industry.

Mr. Wheeler has worked in the pharmaceutical industry for over twenty years, and has held senior executive positions in four companies over the last fifteen. By helping develop a strategic vision and then using his leadership skills to implement strategies that achieve that vision, he has been instrumental in the success of these companies.

During Mr. Wheeler’s thirty-year career, he has been involved in virtually every key functional area, including manufacturing, marketing, logistics, R&D, and engineering. This breadth of experience has given him the unique ability to identify the unmet needs of customers, and then develop business plans that address those needs. By being directly involved with companies that span the globe, and living overseas himself, Wheeler has gained a unique perspective in managing businesses that cross many borders and cultures.

Mr. Wheeler holds a Bachelor of Science degree in Mechanical Engineering from Worcester Polytechnic Institute and a Master of Business Administration, with an emphasis in Finance.

• Argentina Federal Tax Authorities (AFIP) – Early Import Declaration System: AFIP’s General Resolution 3252 requires that all importers file a declaration providing the tax authorities with certain information related to all importations. AFIP estimates that the average time to process and declaration will be from 3 to 10 days. Note that this additional process will affect the total transit time of importations since a declaration needs to be accepted and approved before an import can arrive into the country. For more information please review this link

The declarations are submitted by a customs broker on behalf of an Importer. We are in negotiations with our contracted customs brokers in Argentina to determine a cost for the process these declarations will require. We hope to have a final determination on the related costs shortly.

• ANMAT (MOH) Fee: The Ministry of Health in Argentina has increased the fee associated with the import declarations (15 point form) required for each importation. The fee has increased from $100.00 to $250.00 USD. As of now this increase is only applicable to import declarations.
• Customs Manifest Fee: The government of Argentina has imposed a new Customs Fee on shipments originating in, destined to or transiting through Argentina that began on Feb. 1st. A fee of $25.00 USD will be assessed to each responsible party (Carrier & Importer/Shipper) for each manifest transmitted to Argentina Customs. These charges result in a total cost of $50.00 USD per manifest declared that will be assessed to Marken.

In summary the regulations and new processes described above will result in a significant financial impact for the transactions involving Argentina. Marken is working with all the agencies involved as well as our local contractors and suppliers to minimize this impact as much as possible for our clients. We will maintain all interested parties advised of our progress and any new developments that should arise.

 Should you require any specific or additional details concerning these matters, please contact your local Marken representative or Customs Service department in US: +800 Marken1   www.marken.com

Marken will be at the  IQPCs Cold Chain and Temp Management Conference Feb. 27-March 1 in Toronto

Let us help you get a 20% discount to attend! Use Code “Marken”

Don’t miss Dan Bell’s session on Maintaining Product Integrity through the Supply Chain at 9:45 am on March 1st. Dan will discuss:

• • Temperature controlled Supply Chain and distribution methodologies
• • Regulatory documentation strategies for global programs
• • Examples of common regulatory pitfalls and solutions to avoid them

Also, meet Paddy Hanlon to chat about our exciting new announcements:

Dan and Paddy led a webinar on Temperature Controlled Supply Chain planning for BRIC Countries and Africa Listen here

About the  IQPCs Cold Chain and Temp Management Conference

The Only Event for Canadian Cold Chain & Temperature Controlled Life Sciences
Temperature control and sensitive handling are fundamental requirements of most life sciences products today. The 10th annual February 2012 event will address how Canadian and International quality distribution professionals are implementing new data monitoring processes, passive technology and supply chain integrity plans, including:

Domestic Canadian Distribution

• • Re-qualification of pack-outs and trailers for Canadian distribution
• • Assessing 2-8C and Ambient transport solutions for Pan-Province distribution
• • Shipping to northern Canada in the winter, extreme cold shipping solutions
• • Auditing distribution sites and partners for robust processes and 0069 compliance

International Distribution & Import

• • European regulatory temp distribution and GDP guidelines
• • Customs and border issues for road and air freight US ≤≥ Canada
• • Shipping temperature sensitive clinical supplies to international and new markets

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London, January 31, 2012. Marken announced today the introduction of ‘CORTEC’, an internal corporate function led by industry experts to support the development of industry best practices, packaging technology and innovation. The vision for CORTEC is to ensure Marken remains at the forefront of cold chain packaging, new temperature monitoring technologies and regulatory changes.

Marken’s new CORTEC Group is a play on “Core Technical” but is an acronym for Cold chain, Operational assurance, Regulatory, Technical Excellence and Compliance. The team is headed by Robert Tungatt, Vice President CORTEC. Mr Tungatt is also Marken’s representative for the Cool Chain Association and is a current member of the IATA Time & Temperature Task Force. In addition to a number of industry qualifications, Robert is a trained ISO9001 auditor and a member of the European Compliance Academy.

“The dynamic changes in the regulatory environment and the rapid introduction of new technologies have the need for supply chain expertise in selecting the right solutions to support their supply chains.” Marken CEO, Wes Wheeler commented in his internal announcement. “The CORTEC team will work alongside our strong Quality and operational teams to develop, integrate and deploy state-of-the-art solutions while maintaining the high level of assurance that Marken clients have grown to expect.”

Marken’s new CORTEC team, together with the recently announced Marken SoloTM clinical distribution management application and the new version of Marken MaestroTM, their supply chain management application, establishes Marken as the clear choice for innovative global clinical supply chain solutions. Visit www.marken.com for more information on Marken’s innovation in supply chain management for the life science industry.

About Marken
Marken is the leading global clinical supply chain service provider dedicated to the pharmaceutical and life sciences industries, supporting over 6,000 investigator sites in more than 100 countries. With decades of experience in the logistics, transport and distribution of temperature sensitive life saving pharmaceuticals, clinical trial supplies and specimen collection; Marken integrates Depot and Logistics services into solutions that extend the reach of clinical trials to even the most remote treatment naïve geographies. Our team members and network of facilities bridge the distance between patients and the essential resources of life science companies.

CONTACT: Elan Josielewski, info@marken.com, +1-347-855-3526, www.marken.com

Click Here To Download This Press Release

I relate it to hiring a tax consultant. Yes, you can go through the forms and fill them out and file them, but you don’t. You hire a tax consultant who has the experience and understands the tax codes to afford you a larger tax return and ensure compliance. Instead, you hire them for experience, just as you would hire a premium supply chain provider.

When I have a new API, my thoughts go beyond how to move the API. To me, the bigger picture is what’s important. We need to analyze the documentation to understand what we’re moving and to see if it is categorized correctly as the stakes are getting higher. In 2009, U.S. imports of APIs and other pharmaceutical products totaled over $85 billion. Using lower cost suppliers in emerging markets has been the industry standard for sourcing APIs, yet tariffs of up to 6.5% ad valorem can be imposed on items not considered to be for pharmaceutical use.

A list of HTS codes for APIs has been created as part of a tariff-elimination agreement between the US and 33 other countries. This list of roughly 10,000 products can be imported without duties being levied; however, in some cases these products can be imported at a lower rate or duty free if they meet the criteria for the “K” special-rate-of-duty code. Provision K status is granted if the party importing the bulk API can show FDA that it qualifies for the designation.

Some of you from large companies have the luxury of brokers within your company to provide the importation experience you need. Medium- and small-sized pharma don’t have that expertise in-house, and need a resource for that knowledge.

As we see a rise in biologics and expenses mount, this 6.5% has an immense impact on your bottom line. This analysis is a gratis part of our premium logistics service, as our experience tells us to look deeper for cost savings for you.

Want more information? Check out my White Paper:
Securing Provision K Status For A Client’s API Helps To Expedite Shipping And Reduce U.S. Importation Costs

ABOUT DAN BELL
Director of Commercial Operations / Director Regulatory Compliance

Dan Bell, Director of Commercial Operation, has led Marken’s operations on the West Coast of the United States since he joined the company in 2003. He is a licensed US Customs Broker and a Certified Customs Specialist with more than ten years of combined education and practical experience in global life science supply chain solutions, with a focus on trade compliance aspects. His clients include pharmaceutical and medical device companies, Clinical Research Organizations, Central Labs, and Contract Manufacturing Organizations.

London, Jan 13th, 2012 – Marken is pleased to announce that Dr. Andrea Zobel has joined Marken in the new role of Senior Director, CTD Operations.  In this capacity she will assume responsibility for all activities within the growing network of Marken operated Clinical Trial Depots once they are completed and qualified for use and will also manage the relationship with Marken’s affiliate depot network.

Dr. Zobel is a biochemist by training and spent her early career in drug development as a scientist in various academic institutes and then in Preclinical Development in the biopharmaceutical industry.  She has a deep knowledge of managing strategic partnerships within the pharmaceutical industry, specialist knowledge in managing clinical trials logistics worldwide but particularly within Europe and a passion for professional Project Management.

“We are excited to welcome Andrea to our team, her expertise and knowledge of the industry further strengthens the market leadership of Marken’s Clinical Trial Distribution service line.”  Marken CEO, Wes Wheeler commented, “Our continued enhancement of our purpose build Pharmaceutical Service Depot network establishes Marken as the clear choice for innovative global clinical supply chain solutions.”

As the premium provider of life science logistics solutions, Marken reinforces its commitment to the Clinical Trial Distribution (CTD) business by accelerating the creation of its global network of Clinical Trial Depots.  The company plans to significantly expand its current owned and operated network of depots in 2012 and is supported by an extensive network of specialist third party depot service providers.

Dr. Zobel will be based in the new Marken Berlin office which is scheduled to begin operations in the first quarter of 2012.

Click here to download this press release.

LONDON, December 22, 2011 – Marken announced today that Steve Roese is named Vice President of Marken’s Global Quality Assurance organization, which will support Marken’s continued investment in their expanding network of pharmaceutical service depots around the world. Marken is now accelerating construction of several new depot facilities in Europe, Asia and the US, which will supplement existing locations in Singapore, Mexico and Argentina.

Steve Roese comes to Marken with more than 30 years experience in quality operations at Wyeth Pharmaceuticals (now Pfizer) which included global operations in the consumer health and nutritional products divisions. He has extensive experience in both clinical and commercial manufacturing, packaging and distribution and has routinely interacted with the world’s most important regulatory agencies. Prior to Wyeth, Mr. Roese worked with Perrier / Nestle, Abbott Laboratories and General Foods in various quality and operations roles.

“We are excited to welcome Steve to the company,” commented Wes Wheeler, CEO of Marken. “Given our emphasis on clinical storage and distribution of drug products, Steve’s responsibilities will be a critically important priority for us. Quality has been, and will remain, a key part of our strategy in the future, and Steve’s experience in the pharma industry will enable us to take quality to a whole new level.”

About Marken
Marken is the leading global clinical supply chain service provider dedicated to the pharmaceutical and life sciences industries, supporting over 6,000 investigator sites in more than 100 countries. With decades of experience in the logistics, transport and distribution of temperature sensitive life saving pharmaceuticals, clinical trial supplies and specimen collection; Marken integrates Depot and Logistics services into solutions that extend the reach of clinical trials to even the most remote treatment naive geographies. Our team members and network of facilities bridge the distance between patients and the essential resources of life science companies.

CONTACT: Elan Josielewski, info@marken.com, +1-347-855-3526

Click here to download this press release.