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According to our research on Global Supply chain Visibility, Control and Collaboration in Life-Sciences, 7 out of 10 industry executives are concerned about of product counterfeiting and diversion.

The Whitepaper recommended that stakeholders expand the use of existing track & trace technologies to include business intelligence and analytical tools.  DHL Same Day, the special services group within DHL Express, has taken the initiative in developing a modular device - DHL Smart Sentry, which provides both condition and location monitoring for high value shipments throughout the supply chain.

To learn more about this offering, I recently spoke with Matt Groppe, Director, Global Sales, DHL Same Day.  Matt covered how the DHL Smart Sentry program can serve the needs of the Life Science industry. According to Matt, “the unique feature of this solution for our Life Science customers is our ability to provide real time monitoring for sensitive product and specimens for both air and ground movements. ”

He continued: “Many of our customers are looking beyond traditional temperature monitoring to track humidity and how often a shipment has been opened during transit. Conditions such as pressure, humidity, shock and vibration also add new measurements to evaluate packaging options. As regulatory and governing bodies hold pharmaceutical companies to more strict policies, it has become critical for companies to seek enhanced methods of monitoring product conditions. In the current environment, you can only see shipment history and react to packaging in distress only after the fact. Now, actions can be taken to secure arrival conditions at destination.”

As part of the deployment of the Smart Sentry service, DHL Global Same Day analytics team monitors shipments’ status 24/7. Customers can track the condition of the package on demand via a secure web portal or by setting up min / max ranges for notifications only if thresholds are on the verge of being exceeded.

Since many customers have their own packaging Smart Sentry can be added to existing supply chain monitoring systems to provide continuous feedback as the product moves through the global supply chain thus identifying when product or packaging has been tampered with or diverted.

Matt provided an example of the value and the peace of mind that Smart Sentry can provide: Real-time location monitoring for air shipments are key for many laboratories as it is critical to know where their specimen is at all times. Laboratories are sometimes moving specimens that have spent considerable time in development and would cost thousands of dollars to replace.

Real-time monitoring solution such as DHL Smart Sentry can fill a void in securing the safety of global shipments and minimizing the risk for product adulteration or counterfeits entering the supply chain.

Although most life-sciences companies today are likely aware of the increasing threat of products liability lawsuits, this risk is sometimes lost on product distributors, which in actuality may be just as vulnerable as manufacturers to such claims and the financial losses they inflict.

Having underestimated their own products-liability vulnerability, distributors often find themselves hugely burdened when (1) the law imposes liability on the distributor either by virtue of its membership in the supply chain or because of its own negligence; or (2) the supplier’s policy fails to cover the distributor.

Direct Imposition of Liability on Distributors

Even when distributors are wisely using contracts with their suppliers, and even when these contracts contain the appropriate indemnifications that provide for the distributors’ defense in the event of a claim arising because of some error on the part of the manufacturer, these contracts are unlikely to assist when liability is imposed directly on the distributor.

There are many circumstances under which liability will be directly imposed, but most fall under one of two legal theories: (1) strict liability; and (2) negligence. The theory of strict liability is based on the notion that because distributors reap the benefits of participation in the supply chain, they too should bear the burden of liability when harm results from the product they distribute. Strict liability for distributors is retained by the majority of jurisdictions in this country.

The second legal theory that will likely erode any contractual protections distributors have obtained from their suppliers is negligence. Most indemnification provisions explicitly exclude indemnification for a claim or costs that are incurred by virtue of any negligence on the part of the distributor. Distributors’ negligence is most often alleged in relation to installation of the product or advice on product use. The latter is particularly fraught with regulatory and products-liability perils, including claims of off-label promotion and failure to warn.

Inadequacy of Manufacturers’ Insurance Coverage for Distributors

Beyond the direct imposition of liability, distributors still find themselves “on the hook” for products liability costs if their suppliers’ insurance coverage is insufficient to cover the often-substantial costs of a products liability claim. This occurs much more frequently than many distributors realize, and can occur for a myriad of reasons. Suppliers’ policies may have lapsed, been canceled for nonpayment, or significantly reduced, and the distributor may not be informed of any of these changes. Even if suppliers’ coverage is current and in good standing, multiple distributors may have to engage in a legal battle to eke out their fair share of the limited coverage pool, and do so at a significant legal expense.

To avoid these and other pitfalls, it is crucial for distributors to contractually require annual certificates of insurance from their suppliers, know how many other distributors their suppliers may be using, and have their own insurance policy to ensure coverage in the event manufacturers’ policies fall short or direct liability is imposed.

For the complete article, which more fully describes the circumstances under which products liability may be imposed directly on distributors, the circumstances under which distributors may find themselves without coverage or with access to only limited coverage, as well as a related risk-management checklist for distributors, click here.

In 1966 the Star Trek television series introduced us to the Medical Tricorder - a hand held device used by doctors to diagnose diseases and collect vital medical information about a patient.   Forty-five years later this object of an active imagination may in fact become reality.

The X PRIZE Foundation and Qualcomm Foundation recently announced the Qualcomm Tricorder X Prize - a $10 million global competition to develop devices that will give consumers access to their state of health by using mobile technology.  Some of the technology needed to meet this goal has already been developed.

I recently had the opportunity to chat with Rick Valencia, VP and GM of Qualcomm Life about the Tricorder X Prize, Qualcomm Life’s 2net^TM Platform and its impact on Healthcare.

“Up to 90% of health care spending today goes to managing chronic diseases,” commented Valencia.   There is a shift to a new model of health care delivery based on Accountable Care Organizations (ACOs).  The ACO mission is to keep patients healthier (and out of hospitals) through coordinated care.  Mobile communication devices play an important role in supporting this shift and making this goal more realistic.  “Hospital readmissions are a $25B problem in this country,” added Rick - enabling mobile devices to transmit medical data to health care practitioners on a periodic basis would enable early intervention.   Lower readmission costs will enable the market to support transformation to new health care models.

“Qualcomm’s 2net Platform and Hub were developed to be used in connection with wireless medical devices to support this transformation, “Rick stated.  It is important to note that both the 2net Platform and Hub are listed with the FDA as Class I Medical Device Data Systems (MDDS), which makes Qualcomm a medical device manufacturer.  The 2net Platform allows medical devices to connect via USB, Bluetooth or Wi-Fi to so that their data can be available across the continuum of care - an issue with managing chronic diseases.

“The beauty of the 2net ecosystem is that it provides medical device manufacturers with a one stop shop for wireless enablement of their devices.  It is also an open forum that encourages the creation of new healthcare apps,” noted Rick.  Using the 2net technology, data could be aggregated and analyzed for trends or anomalies.  The Platform connects patients with caregivers, family, and clinicians providing timely feedback.

Rick also pointed out that there are several benefits to device manufacturers around implementing this new technology:

• It provides a means of getting data out of devices outside of the clinical setting:
• It creates an interoperable ecosystem with medical devices, mobile medical applications and health service providers like hospitals; and
• It provides system support for tracking and tracing.

“Wireless technology is the biggest platform on earth.  We need to leverage it in health care,” declared Rick.  That is reason why the Qualcomm Foundation joined with X PRIZE to challenge the industry to develop a global customer platform.

I concur with Rick, mobile devices are the most exiting tools available today to improve health care.

By Desmond Hunt, Ph.D., Senior Scientific Liaison at USP

As the pharmaceutical industry continues to globalize, the challenges of securing complex supply chains and protecting patients from counterfeit medicines have mounted, as have the consequences of lapses in security or proper handling. In an effort to encourage comprehensive public standards across the pharmaceutical industry, the U.S. Pharmacopeial Convention (USP) is proposing a set of recommended best practices that will help ensure that medicines can be traced back to their original manufacturer, are not adulterated or counterfeited, and are transported to their intended destination with their quality intact.

Supply chain integrity involves minimizing risks that arise anywhere along the supply chain, from sourcing pharmaceutical raw materials to their manufacture and distribution. The new standard being proposed is not mandatory, and is contained in the proposed USP General Chapter <1083> Good Distribution Practices-Supply Chain Integrity. The proposal is intended to serve as a guideline document outlining the essential elements of an effective strategy. The proposed standard covers four main areas: importation, counterfeit drugs and medical devices, best practices to combat counterfeit drugs and medical devices, and diversion and theft.

The draft general chapter and comments submitted to USP will be a central topic of a Supply Chain Integrity Workshop that USP is convening May 22-23, 2012, in Rockville, Md. This will be a further opportunity to provide input, including whether additional information needs to be included in the chapter.

Some highlights of the workshop include:

• Supply Chain Members: Role, Responsibilities and Risks
• The Role of Logistic and Transportation Providers in Supply Chain Integrity
• FDA Update: Track and Trace
• Technologies: Impact and Implementation Issues for Wholesalers, Pharmacies, Pharmacists
• Regulations and Guidances Impacting the Supply Chain

More information about the workshop is available at www.usp.org/meetings-courses/workshops/supply-chain-integrity-workshop.

The expo hall stage was the setting for my interview with Daniel Matlis, the President of Axendia, an analyst and consulting firm for Life Sciences and Healthcare.  

During the interview Dan touched on:

• The hottest challenges facing healthcare providers in the current economic times, centered around asset and facilities management
• The increased pressures for managing a sophisticated mix of devices, tools & equipment, systems & technologies and all asset classes
• How there is no shortage of data within healthcare organizations, the key challenge is in the analytics to drive intelligence from that data
• The challenges of locating assets throughout healthcare facilities
• The recent series of articles published by Axendia based on conversations with industry executives on the impact of new FDA regulations on healthcare providers and
• The importance of a smarter physical infrastructure within healthcare organizations

Take a look at this insightful interview:  http://livestre.am/1k5KH

 
This interview was a nice precursor for the IBM Maximo Asset Management for Healthcare Organizations flash demo (required registration): 

We all like to think our industries present unique challenges to overcome. While that may be the case, it’s also true that in the world of high-tech manufacturing, we have far more in common than it seems. Whether you’re producing a drug, pacemaker, or an airplane, you’re probably facing many of these requirements:

• Outsourcing/offshoring significant portions of the manufacturing process to reduce cost;
• Accounting for regulatory mandates to promote security and quality standards across the supply chain;
• Obtaining visibility across a broad and deep supply chain to track and manage inventory;
• Integrating with suppliers with vastly different operating environments to enhance communication;
• Gaining overall logistics control, from in-transit visibility to load consolidation and 3PL integration, to speed deliveries;
• Conducting demand and supply planning that incorporates manufacturing floor-based pull systems to coordinate current and future needs; and
• • Dashboarding large-scale transaction volume by commodity, buyer, or other aggregation criteria to deliver the intelligence necessary for all constituencies to assess performance.

The aerospace and defense (A&D) industry is no stranger to these circumstances. In fact, firms throughout A&D are addressing them head-on, including Exostar’s founding partners: BAE Systems, Boeing, Lockheed Martin, Raytheon, and Rolls-Royce. The Life Sciences industry can benefit from the lessons we’ve learned in A&D as you look to tackle many of these same problems.

Here are my top five suggestions:

1. Don’t fight outsourcing, embrace it. Yes, there are times when you’ll want and need full control of the manufacturing process, but not always. For example, combining outsourced IT services along with mainstream manufacturing can drive down cost and increase competitiveness.
2. Look to the cloud. The scalability and flexibility of cloud-based solutions complements and accommodates dynamic outsourced demands.
3. Automate wherever possible. E-enabling the supply chain procurement lifecycle creates efficiencies and opportunities for collaboration beyond limitations of manually-intensive execution. It also promotes standardization across organizations with disparate on-premise systems and processes, while mitigating the risk of human error.
4. Expand B2B integration. Automation paves the way for integration. An “any-to-any” integration model empowers buyers and suppliers by facilitating procurement document exchanges and optimizing operating efficiencies without requiring substantial capital or workforce investment.
5. Leverage identity federation. There’s no doubt that outsourcing, the cloud, automation, and integration can be scary propositions when you’re trying to protect intellectual property and other sensitive information. Eliminate the fear factor by implementing a strong identity management solution that controls access to systems, documents, and data regardless of the number of partners in your community.

Many of the largest players in A&D have realized that the legacy approach of going it alone and relying on manual intervention and on-premise systems simply won’t work in a 21st century economy. They are reaping the benefits from making the transition to a new way of thinking. For example, one firm increased on-time delivery of goods from its suppliers by more than 10 percent, while another slashed its purchase-to-pay cycle times and freed resources to focus on its highest priority tasks.

These companies are succeeding in providing mission critical products while complying with tight regulatory environments, similar to those you experience in the Life Sciences industry. Now, it’s time for you to take a cue from A&D and get started yourselves.

By Daniel R. Matlis

Last year, I had breakfast with Dave Johnson, CEO of ConvaTec Inc. at “CEO Unplugged,” During the session; Mr. Johnson discussed the business and regulatory challenges the Medical Technology industry is facing today.  In this environment, “I sleep like a baby - I wake up every 2 hours and cry,” he said.

Over the last year, I have had the opportunity to ask Medical Device industry executives, outsourcers and regulators what keeps them up at night?

The answer boils down this: “The increasing pace of globalization and outsourcing in the Medical Device industry has created demanding challenges for brand owners, their partners, and regulators alike.”

To identify key pain-points and innovative strategies that brand owners, their partners, and regulators are undertaking to cope in this new environment, Axendia is launching a research study.

This research will evaluate the impact of globalization and outsourcing across the entire Medical Device life cycle (from R&D design, supply chain, manufacturing and distribution). The study will provide insights into how industry leaders and regulators are utilizing innovative strategies and systems to improve visibility, control, and collaboration.  It will also provide a roadmap to enable organization to mitigate risk and increase business success.

To support this project, the research team is seeking input from industry practitioners representing the broad spectrum of companies in the Medical Device sector - including organizations of all sizes and every geographic region across the broad spectrum of Medical Device products.

To provide your input for this important industry research and share your perspectives on Medical Device issues and trends, please complete the survey by clicking on this link: http://svy.mk/2012-Med-Dev-Survey

The results of this study will be published in a comprehensive research report and presented at the MedicalDeviceSummit conference scheduled for May 9th and 10th in Chicago, IL.

Industry practitioners who complete the survey will be eligible to receive a copy of the Research Report once it is completed.  Individual responses will remain confidential; responses will be aggregated to formulate the report findings.

We look forward to your contribution on this important research.  Please complete the survey by clicking on this link: http://svy.mk/2012-Med-Dev-Survey

By James McCormack PhD

On February 19, 2010, FDA published a proposed rule [75 FR 7412] that, when finalized, will have a profound effect on sponsors and the relationship between sponsors and persons they hire to plan, design, perform, review, or report biomedical research.  The proposed rule titled, “Reporting Information Regarding Falsification of Data”, will require sponsors to report to FDA, information indicating that any person has, or may have, engaged in the falsification of data in the course of performing their duties. 

Why does FDA believe this regulation is necessary?  The answer to that question can be principally found in the disqualification of a clinical investigator, Dr. Robert A. Fiddes, in June 1999 (See FDA’s Debarment Order, Clinical Investigator Disqualification List, and the Notice of Opportunity for Hearing). Among the many acts of falsification, he created false case reports for subjects that were never enrolled or did not exist, forged signatures on informed consent forms for the respective subjects, falsified records of medical procedures that were never performed, substituted test results from subjects who met the study’s inclusion criteria and improperly substituted for other subjects who did not meet the inclusion criteria, and paid Individuals, who were not study subjects, to give specimens in place of false study subjects.  Although Dr. Fiddes conducted studies for 47 sponsors affecting over 90 applications his actions were not reported to FDA.  Out of concern for the integrity of the preclearance review process and the rights and welfare of research subjects, FDA investigated why such widespread falsification could have gone unreported.  The agency determined that there was some ambiguity in the regulatory requirements regarding what information and when sponsors were to report information on possible incidences of falsification.  Therefore, the agency has proposed this rule to clarify a sponsor’s reporting requirements for studies conducted by, or on their behalf, or a study on which a sponsor relies to support a product approval.

            What research is covered by the proposed rule?  The reporting requirements will apply to information related to studies including, clinical investigations, nonclinical laboratory studies, and clinical studies in animals.

            What products are covered?  All FDA regulated products; food, drugs (human and veterinary), biologics, and medical devices.

            What do sponsors have to report?  The proposed rule does not require sponsors to make a definitive determination of falsification or establish the intent of the person who may have committed data falsification.  A sponsor is responsible for submitting information that they are aware of that a person has, or may have, falsified data.  The agency intentionally did not propose a specific threshold of information or the form, quantity, or reliability of the evidence that a person may have falsified data.  It seems apparent that the agency intends the reporting requirement to be an intelligence gathering activity that will be subject to further investigation and evaluation before serving as the basis of administrative or enforcement actions.         

When do sponsors have to report?  Under the proposed rule sponsors are required to report information they have regarding falsification, or possible falsification, to the appropriate FDA Center, no later than 45 calendar days after becoming aware of the information.

How do sponsors distinguish falsification from unintentional errors?  This is perhaps the most intriguing question raised by the proposed rule.  The agency addressed the distinction by defining “falsification” as creating, altering, recording, or omitting data in such a way that the data do not represent what actually occurred.  The proposed rule provides examples of unintentional errors, e.g., typographical errors and transposed numbers or characters, and states that such events should not be reported under the proposed rule. 

The public comment period ended in May 2010.  It is likely that the rule be finalized soon and the biomedical research environment will change accordingly.  Sponsors will need to develop robust controls to assure that possible incidences of falsification are detected, evaluated, and reported and persons performing services for sponsors should consider implementing their own controls as sponsor scrutiny will certainly increase.    

Dr. James McCormack presently serves as the Vice President of Life Sciences Compliance, at IBM.  He previously served as the Corporate Vice President of Regulatory Affairs and Compliance at Charles River Laboratories following an 18-year career in FDA as a preclearance review scientist and as FDA’s Bioresearch Monitoring Program Coordinator. 

The views expressed in this article are those of the author and do not necessarily represent those of his employer, Life-Science Panorama, its editor or Axendia, Inc.

By Mollie Shields-Uehling, President and CEO,
SAFE-BioPharma Association 

 As a global standards organization, SAFE-BioPharma has a unique perspective into developing and future IT trends in the life sciences, especially as they relate to use of our global digital identity and digital signature standard. Our staff works closely with member companies which are using the standard in a growing range of applications. We also work closely with non-member organizations to help them develop proof-of-concept studies and pilots utilizing the standard.

Based on these activities we have been able to identify three IT trends that will shape the life sciences in 2012.

1. STANDARDS-BASED INTEROPERABLE DIGITAL IDENTITIES

Industry leaders are rapidly increasing use of these unique digital identities among employees, collaborators, and clinical investigators. Issued once every three years, they take the place of multiple on line identities and can be used to control access to information and physical facilities. They also provide the ability to apply legally-binding digital signatures to electronic documents. The benefit of interoperability is that the digital identity is recognized and accepted by US government agencies, by other companies

2. CLOUD COMPUTING IN CLINICAL TRIALS

As demonstrated in a study between the National Cancer Institute and company-based cancer researchers, significant time and cost savings are realized when trial-related documents are accessed from the cloud rather than delivered by courier or mail. Interoperable digital identities (NCI researchers using government provided digital credentials; company researchers using SAFE-BioPharma digital credentials) give researchers access to the cloud-based electronic documents as well as the capability to apply legally-binding digital signatures. (Read The Paperless, Cloud-Based Clinical Trial; It’s Happening Now )

3. ELECTRONIC TRIAL MASTER FILES

Trial Master Files - the central record containing the files associated with clinical trials - are one of the last areas where clinical development records are primarily paper-based. Multiple pilot studies scheduled to start in the next few months indicate that pharmaceutical companies are preparing to make the process electronic. Companies will use SAFE-BioPharma digital identities to manage access to documents and to provide participants with the ability to apply legally-binding digital signatures.

The global SAFE-BioPharma digital identity and digital signature standard is used throughout the biopharmaceutical and healthcare communities to meet specific security and confidentiality needs. It was created with participation from the US Food and Drug Administration and the European Medicines Agency. The standard and its ongoing development is managed by SAFE-BioPharma Association, a non-profit supported by its members. For more information visit http://www.safe-biopharma.org/.

Mollie Shield-Uehling is President and CEO of SAFE-BioPharma Association. In this role she directs the business and strategic activities of SAFE-BioPharma Association. She has more than 20 years of international trade and biopharmaceutical industry experience. She is a member of the association’s Board of Directors.

Last month, I had the opportunity to chair the Global Pharma Sourcing Conference in Philadelphia. A recurring theme of the conference was the need to rigorously supervise and certify suppliers by implementing “trust, but verify” strategies. This got me thinking about the Kosher supervision and certification in the Food and Over the Counter (OTC) supply chain.

To learn more about how to keep a Kosher supply chain, I spoke with Rabbi Eliyahu Safran, Vice President - Communications and Marketing at Orthodox Union (OU) Kosher. OU is non-profit communal organization founded in 1898 and the world’s largest and most widely recognized kosher certification agency.

The Organization certifies more than 500,000 products produced in over 8,000 plants around the world. In today’s global environment, the OU certifies close to 300 facilities in China, as well as facilities in Argentina, India, Egypt and Turkey and some 80 other nations.

“Many of the brands you trust, rely on the OU for their kosher certification, including: ADM, Cargill, Coca Cola, DSM, General Mills, Hebei Welcome Pharmaceutical, H.J. Heinz, Hershey’s, Kraft/Nabisco, McCormick & Co., Nestlé, Novartis, Procter & Gamble, Pillsbury, Quest, Reynolds Aluminum, Rhodia, Unilever, and thousands more,” explained Rabbi Safran.

Contrary to popular belief, obtaining kosher certification does not involve a Rabbinical blessing over food products, or the manufacturing plants. So what is Kosher? The word kosher means proper or acceptable and it has entered the English vernacular with that meaning.

“Kosher laws have their origin in the Bible, and are detailed in the code of Jewish law. Kosher regulations are about the process, the purity and the traceability of ingredients. You may be surprised at the extent of Kosher regulations.” explained Rabbi Safran. “Kosherizing a food production or industrial facility requires a structured and meticulous process including equipment sterilization,” he added.

The OU inspects every facility where certified products are manufactured. It also requires the use of authorized ingredients from approved and qualified sources. To ensure compliance to its standards, the OU conducts unannounced, periodic inspections. “Our responsibility is making sure that things are done right. We answer to a higher authority, and are not motivated by profit,” said Rabbi Safran.

To achieve this goal, the OU employs over 600 Rabbinic Field Representatives located throughout the world - from Europe to Australia, from the China to South Africa. OU Field Representatives are proficient in modern manufacturing techniques, chemical & biological processes, as well as the intricacies of Jewish Kosher law. The agency’s New York headquarters staff consists of over 50 Rabbinic Coordinators supported by ingredients registry staff, ingredient specialists, flavor analysts and other support staff. To keep track of supply chain and product information the OU utilizes a comprehensive state-of-the-art computerized database that contains information on more than 250,000 food ingredients.

Like our industry, the OU uses a “Risk Based Approach” in its auditing process. “A facility producing a simple product, like spring water, may be inspected a couple of times a year. On the other hand, a product with a complex formula and many ingredients, or one with Red Flag Ingredients (like Glycerin) would be inspected a lot more frequently ” said Rabbi Safran. “For some high risk products, the OU has round the clock constant supervision of the facility” he added.

Partnering with the OU enables companies to leverage the organization’s vast resources. OU staff has a thorough understanding of manufacturing processes, ingredients, chemistry of additives and the procedures manufacturers employ in converting raw materials to finished products and incorporating all these resources in the kosher certification process. OU maintains a comprehensive database of approved and certified suppliers. Manufacturers rely on OU for recommendations on kosher ingredient as well new sources of raw materials and pre-certified alternate suppliers.

In recent years, over the counter Pharmaceutical and Nutritional companies have reached out to OU to obtain certification. Novartis was the first mainstream Pharmaceutical Company to achieve OU certification for its Triaminic Cough Syrup. The company has since added Maalox and Benefiber to the family of OU certified products.

Mead Johnson has OU certified many of its Enfamil, ProSobee and Poly-Vi-Sol Multivitamin products. OU also certifies products from Perrigo Holland, Maxx Performance, Robell Research, Health Management Resources and Soluble Products.

“Although we live in a society where trends come and go, as long as people need to eat, they are going to buy products that assure quality and integrity. As a result, they will look to the OU symbol as a clear indicator of both,” concluded Rabbi Safran.

So the next time you get a shipment from a supplier, maybe you should check if they keep a “Kosher” Supply Chain.