Privileged scaffolds for library design and drug discovery

This review explores the concept of using privileged scaffolds to identify biologically active compounds through building chemical libraries. We hope to accomplish three main objectives: to provide one of the most comprehensive listings of privileged scaffolds; to reveal through four selected examples the present state of the art in privileged scaffold library synthesis (in hopes of inspiring new and even more creative approaches); and also to offer some thoughts on how new privileged scaffolds might be identified and exploited.

Introduction

Small organic molecules can be powerful tools for impacting biology and medicine, functioning as both therapeutics and as probes that help to illuminate the macromolecules regulating biological processes. Yet, despite advances on many fronts, including the ability of synthetic chemists to prepare libraries containing thousands of compounds efficiently, the ability to make critical discoveries pertinent to disease remains a slow and, arguably, serendipitous one. For instance, high-throughput synthesis and screening of compound collections through phenotypic or biochemical assays often yields disappointing results in terms of a paucity of specific, useful compounds discovered, relative to the high cost in time and resources expended.

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In large part, this state of affairs reflects the fact that we simply do not understand all the factors necessary to create compound collections that have potent and specific biochemical activity. Commercial compound libraries, for example, while readily available, suffer from low hit rates; this result is in part because their members typically possess low structural diversity and poor physicochemical properties (often combined with reactive and undesirable functional groups) since they are produced with an eye towards overall quantity, rather than quality. Collections based on bioactive natural products, to some degree, overcome the issue of low hit rates since the parent structure has evolved over millennia for a specific biochemical purpose; however, these natural product collections less frequently lead to the discovery of activity distinct from the parent compound, since they are typically the product of simple analog generation by modulating functional handles, rather than rationally altered with an eye towards generating novel specificity.

Consequently, solving the challenge of creating collections of unique, highly potent bioactive small molecules, could dramatically accelerate the rate at which critical biochemical discoveries are made, and ultimately, potentially enable a number of diseases not only to be managed, but also to be eradicated. Here, we focus on one approach to this problem: creating compound collections based on ‘privileged scaffolds,’ molecular frameworks, as first coined by Evans in the late 1980s, are seemingly capable of serving as ligands for a diverse array of receptors  Though he was originally referring to the benzodiazepine nucleus, which is thought to be privileged because of its ability to structurally mimic beta peptide turns, work over the past several decades from both academic and industrial groups has revealed that there are additional such scaffolds; a major challenge is in accessing large number of a given privileged framework. In this review, we hope to accomplish  three main objectives: to provide one of the most comprehensive listings of privileged scaffolds; to reveal through four selected examples the present state of the art in privileged scaffold library synthesis (in hopes of inspiring new and even more creative approaches); and also to offer some thoughts on how new privileged scaffolds might be identified and exploited.

Download the full 15-page report 

including all graphs here: Compound Libraries. 

Privileged scaffolds
As revealed by a thorough search of the literature, the term ‘privileged scaffold’ has been used fairly liberally versus Evans’ original conception of the term, in that the ability to bind multiple targets is less thoroughly employed as a strict criterion for membership versus the notion of multiple molecules of the same scaffold having bioactivity. Such an expansion, in our opinion, is reasonable since it allows for a more thorough evaluation of the idea. We note, however, that because work with such scaffolds has derived from multiple environments and from scientists with different emphases, no exhaustive listing of privileged scaffolds has yet been assembled. Tables 1–4 attempt to provide such a listing. Their members were selected by identifying privileged scaffolds from the perspective of both molecules created de novo, which are now drugs, largely from the pharmaceutical industry, as well as compounds provided by nature in the form of natural products that either are, or have served as inspiration for, pharmaceuticals.

Critical in our evaluation of natural-product-based architectures was that they have phylogenetically diverse origins, as such ubiquity might suggest an evolutionary driving force to generate a particular arrangement of atoms. As can be discerned after study of these tables, there is a remarkable overlap between structures of both classes, as the vast majority of scaffolds have members from both groups. This outcome may not be so surprising in the sense that nature often will repeat itself once it has found a suitable solution to a particular biochemical problem, and, of course, the macromolecular structures in living systems have a high level of non-random patterning. Interestingly, there are a few examples of molecules that chemists have fashioned, but for which analogs are typically not obtained from a natural source (Table 2). Yet, as noted above, identifying privileged scaffolds is one matter; preparing collections of them is the more relevant concern that we now address.

Download the full 15-page report including all graphs here: Compound Libraries.

 

Read more on:

1. Library synthesis
2. Future perspectives: identifying new privileged scaffolds

Download the full 15-page report including all graphs here: Compound Libraries.

How can one integrate supplies into one's own company to enable successful collaboration from both sides? An exclusive interview.

Jos van den Heuvel - External Manufacturing Director at Janssen Pharmaceutica, Johnson & Johnson is answering the following questions: How can one integrate supplies into one's own company to enable successful collaboration from both sides? What are the requirements necessary for establishing a data network collaboration? What are the advantages of establishing a data network collaboration?

Listen to the interview by clicking on the media player above. Alternatively subscribe to our Podcasts at iTunes for free: http://itunes.apple.com/de/podcast/iqpc-podcasts/id438668571

The shrinking of the knowledge base – what is the impact of this on the speed and security of drug development?

an Editorial by Paul Branthwaite, TranScrip Partners LLP, United Kingdom

We have all seen the litany of redundancy as blockbusters go generic and mainstream pharma reduces its cost base and/or merges with other struggling groups to compensate and/or restructures to move into new therapeutic areas of strategic importance. Not all announcements in the last few years have been negative but overall, big pharma shrank in size and continues doing so, particularly in the Western world. Part of that is accelerating outsourcing of manufacturing activities to Asia and Eastern Europe but actual slicing into corporate size is also the case. Astra Zeneca said this year that it was cutting 15% of its 66,000-strong workforce. 

Pfizer announced that it would close its drug manufacturing plant at Sandwich in Kent, UK and the ramifications of its merger with Wyeth have yet to become wholly clear. Many companies have undertaken similar substantial reorganizations throughout 2008 and 2009. Much of that was initially aimed at sales and marketing (reflecting imminent or actual patent losses) and manufacturing plants but the move to condense  R&D groups also took hold and reports across the sector shows this is likely to accelerate. In previous decades R&D departments were protected but new realities are now reaching into all aspects of development. You can see why, when US spending on R&D alone  reached close to $63 billion in 2008, topping $1.2bn in real costs per drug licensed that year, with similar showings in Europe. As a consequence, overall, in-house R&D cost-cutting by pharma is expected to gather pace in 2010, before slackening off from 2011 onwards, although some groups continue to buck the trend and have flagged markedly increased R&D spending; Novartis and Schering-Plough to name two.

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However, many R&D cost-cutting efforts will be ultimately counter-productive if they reduce current expenditure but endanger the future drug pipeline that is the raison d’eˆtre of the company. This is the elephant in the room. Slashing R&D staff numbers will not provide sufficient savings in itself, especially if it cuts into the competencies that are critical to ensure that there will be a drug at the end of the process. In the longer term,  there must be consequences to all this cost-cutting activity and shift of emphases, particularly in loss of direct control over programmes, loss of expertise in-house to ensure reliable and positive deliverables, in the medical governance of programmes and the loss of senior mentors and role models for the next generations of drug developers.

At present, current and planned cuts in staffing may already be impacting the capabilities of major groups to process their pipelines, and will definitely do so in the future as juniors lose their mentors. Mainstream pharma ‘Old Hands’, who normally make the judgement calls, are taking advantage of generous redundancy packages, leaving behind teams of relatively junior medics and scientists to make critical operational and even strategic decisions. Furthermore, the senior staff remaining are handling ever-increasing workloads and are spread too thinly, placing the future of a vibrant pharma industry at risk. The critical question is whether the major CROs, consultants and interims realistically and effectively fill this void?

Outsourcing any knowledge-based element, large or small, on grounds of cost, without fully understanding what that actually means when you hand influence on critical issues over to an outside organization can be a risky endeavour. Drug development strategy, design and decision-making require disease area knowledge, experience, judgement and ‘feel’. When you put that in context of whole development programmes, multiplied by the number of pharma companies trying to develop their pipelines differently, and it becomes abundantly clear that the CROs on their own, as currently comprised, collectively cannot compensate for the lack of in-house knowledge in pharma; structurally they are not set up to do so, especially on the scale that might be necessary in the context of the changes taking place in big pharma. Nor are the CROs natural homes for those same ‘Old Hands’, who have no wish to be spread even more thinly, or used as business development bait whilst spending half their life in aircraft doing it. No matter how large, how experienced or how competent they are at processing and operations, CROs rarely have enough talent in their senior teams to compensate for those critical competencies that may be needed by the client.

If all of these things are true, what can be done to address the short and long-term needs; knowledge now and knowledge later? Assemblies of competencies, whether as loose alliances or tight companies are coalescing outside the regular CROs, although some larger CROs, alert to the issue, are trying to create clusters within their organizations, with variable success. Companies too are beginning to respond differently and despite the issues described, realising that outsourcing and drug development alliances will become a more dominant component of their resourcing strategy in the future, are seeking to utilise external resources to best effect while still cutting R&D costs/drug overall. 

Expertise outsourcing and partnerships will multiply, simply because the work still has to be done somewhere, not only in the traditional areas such as the use of chemists in India and China, or in the wholesale outsourcing of bits of clinical programmes to others but more importantly in the augmentation of the remaining inhouse expertise by outside competencies. Some estimates suggest a tenfold increase in this type of activity over the next five years. Accessing competencies have to balance Productivity against Efficiency and Speed against Security and Patient Safety. What tests should apply?:

• Value for money this does not necessarily imply the cheapest. Knowledge and expertise is less of a commodity than data management or clinical operations, which have tried and tested standards and measurable outcomes. As such, accessing through the same supply and tendering departments that negotiate with CROs may not work to best advantage.
• Security of the data – the data being the single most valuable element of the process chain, does your independent ‘consultant’/‘expert’ have secure IT systems? Security of access to the expertise – are there back-ups in case of accident or illness? Single experts cannot supply any of this, which is another reason driving the rise of the expert group. Single experts can also run into conflicts of interest if specialised in certain areas, where rival companies are operating. 
• Patient/volunteer safety – although the external knowledge requirement may seem to be tightly defined, without therapeutic context assessment and review by other critical eyes within the external ‘team’, mistakes can occur that endanger lives (as we have seen).
• Speed of access – although good planning can offset some issues around access to expertise, those heavy-hitters are in constant demand. The problem arises when those planning programmes do not foresee the need because of their own lack of experience. Knowing where to go has become a critical element. Much valuable time can be wasted in finding the right source. In addressing the training of the next generation of Industry physicians and scientists, assuming the trend on downsizing continues, what options are there? If we look at what big pharma used to supply in developing its in-house talent, one of the biggest positive elements in addition to formal training was working alongside exemplars of the professions. Both medics and scientists have structured access to mentors, diverse projects and functional groups that taught them much of what was required to develop drugs. These mentors are leaving, the projects are fewer and many of the tasks that functional groups did are outsourced. 

The questions are these:

• Companies – will they continue to fund the formal training of their staff? How will they diversify the experience of their staff when the silo-isation of departments is strengthening (e.g. medical affairs staffers do complain that they do little more than job-bagging)?
• Academic centres – Can they compensate for the lack of experience gained in companies? Does the Dip. Pharm. Med. and the scientific/regulatory equivalents need to be more ambitious in scope and do we need higher mandated levels of training?
• CROs – can they provide structured learning in similar vein to develop high-end expertise? Can they attract or afford to employ these people in a way that can be integrated with their financial model?
• Learned bodies – Can they do more? We sit at the start of an R&D revolution. Drug development is undergoing significant change to permanently re-shape its activities, with moves away from large budgets and research teams towards external resources. Because pricing pressures from patients, governments and insurance companies and rising cost hurdles to registering products, the drive to produce more effective, safer drugs, more cleverly and at lower development cost with less risk will continue. 

Choose your knowledge partners with care!!

 Download this article:

The shrinking of the knowledge base – what is the impact of this on the speed and security of drug development?
We have all seen the litany of redundancy as blockbusters go generic and mainstream pharma reduces its cost base and/or merges with other struggling groups to compensate and/or restructures to move into new therapeutic areas of strategic importance.

(c) Paul Branthwaite, TranScrip Partners LLP, United Kingdom

MANUFACTURING EXECUTION SYSTEMS INTEGRATED WITH ERP & SIX SIGMA FOR PROCESS IMPROVEMENTS

Name: Sumanth Pandith Surendra
Institution: Wichita State University

ABSTRACT
Majority of the today’s firms are trying to implement information integration systems with the help of Enterprise Resource Planning (ERP) planning tool for the effective execution of the plan in the shop floor. Manufacturing Execution System (MES) is one such tool used for effective execution in the shop floor. This Paper deals how MES could be used and linked to ERP & six sigma methodology in effective execution & also reducing cycle time, increasing machine productivity & process improvements.

OVERVIEW OF ERP

ERP being an effective tool in planning and its successful implementation in most of the firm’s have created a great impact in boosting productivity and improving business processes. How far the firm’s have succeeded in implementing ERP and are they successfully executing the plan done with the help of ERP? Answer for this question is no. However effective the planning tool is, the execution in the shop floor does not happen according to the plan because of the changes that occur in the demand and the planning tool will not be responsive to the changes due to which there will not be any synchronization. Hence, ERP is not a closed loop which will help for the effective execution in the shop floor. MES is emerging as an effective execution tool which could be linked to the ERP & other planning tools. 

MANUFACTURING EXECUTION SYSTEMS (MES)
MES is a tool used for executing shop floor activities effectively & efficiently as per the plan. It basically executes the production plans from the ERP in the shop floor & also helps in real time coordination of the production process. This real time coordination of the production data to the ERP helps to respond dynamically for any changes in the plan and executes the changed plan very effectively. This eliminates waste and also MES will track the production process while it is in progress and captures the data which could be converted into useful information in real time. The data here could be production report, resource capacity, labor capacity, machine capability. This real time capturing and tracking the production process and giving feedback to the production supervisors & managers for any changes that has to be done makes MES an effective tool for the execution. Overall, MES fills up the gap between the planning & the execution & forms a closed loop from planning to execution by giving feed backs back to ERP. MES mainly focuses on the real time capturing of the product process data or any shop floor data and converts the data into useful information for the production managers to take an effective decision upon the process. This also helps in preventive maintenance of the machines and also helps to improve the process capability of the production process by capturing the real time process data and improving the productivity. MES helps in incorporating changes in the plan happened due to the change in the demand forecast. ERP helps to fulfill the order requirements of the customer & MES helps in changing the production plan being responsive & flexible for changes without hampering the on going production in the shop floor, there by meeting the customer requirements and satisfaction. 

Integration of ERP & MES:ERP and MES must be integrated for the organization to perform effectively by reducing the cycle time & satisfying its customers. The critical drivers for the integration of ERP & MES are responsiveness, flexibility & productivity. Integrated supply chain will demand for an effective responsive system & ERP helps in matching customer requirements & to incorporate if there is any change in the demand, it requires a system which should be responsive & flexible for any changes. So, MES helps in being responsive & flexible for the changes. Even Productivity measurement & control has to be done in order to fulfill the demand. MES helps in tracking & monitoring the production in real time and make any changes required to meet the demand. 

Impacts after Integrating MES & ERP:
i) Cycle time reduction: cycle time after integration is reduced to 50%.
ii) Reduction in Work in Process (WIP), raw materials & finished goods inventory (FGI).
iii) Setup reduction to 30%, management time scheduling time reduced to 75%.
iv) Finally, customer satisfaction by reducing customer backlog by 90%.

Read more on:

• INTEGRATING MES WITH SIX SIGMA METHODOLOGY FOR PROCESS IMPROVEMENTS
• HOW MES FITS IN THE PLANNING/PRODCUTION CYCLE & THE INFORMATION FLOW BETWEEN THEM

Download the free 11-page Article here:  Integrated MES within the Production Industry (Integriertes MES in der Prozessindustrie).

Cold Chain Management in China

China's importance within the global pharmaceutical industry is growing. By the year 2013, China is expected to be the third largest pharmaceutical market in the world, as more and more pharma companies are attracted to a market where both clinical trials and drug development are cheaper.

This growth comes at a time when many of the top pharmaceutical products are expected to require cold chain handling. Figures from the Cold Chain Biopharma Logistics Sourcebook 2010 suggested that by the year 2014, seven of the top ten pharmaceutical products will require cold chain distribution.

The Sourcebook also predicts that regulation will increase, which could present challenges for the underdeveloped Asian cold chain market and the growing levels of cross-border transportation.


Industry growth

According to Alen Yan, general manager for World Courier, clinical trials in China can cost 30 per cent less than in the United States, and drug development can be just 10 per cent of the price it would be in the west.

"The biopharma industry in China has exploded by 20 per cent in just the past five years," he added. "But while it may be very cost effective to conduct clinical trials here, practitioners must understand the challenges of doing business in China."

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This growth requires a supporting infrastructure which allows pharmaceutical companies to transport drugs and related equipment in a safe, timely and cost-effective manner.

Particular growth in the cold chain market is expected to be seen in Asia, where the Biopharma Cold Chain Sourcebook 2010 states the market will increase, by 50 per cent on 2008 levels, by 2011. This outstrips worldwide growth of 33 per cent.

Transportation of vaccines, largely for distribution by philanthropic organisations, around the Asian continent was said to be one of the main drivers of this growth.

However, Pharmaceutical Commerce warned that the growth of the cold chain industry "will not necessarily be linear" with the number of vaccines being distributed.

"There are efforts to package vaccines more efficiently to expedite their transportation, and to develop room-temperature versions of some," it explained.

Challenges

Cold chain management in China presents its own challenges. World Courier launched operations in China in 2008, which allow for temperature-controlled transportation between more than 30 of the major Chinese cities.

Henning Voss, director for World Courier, North Asia, described the situation in China as complex, which meant, up until a couple of years ago, the needs of large pharmaceutical companies wishing to operate in China were not being adequately addressed.

"In addition, domestic transport companies do not yet fully understand the many international standards at play in handling these types of shipments," Voss said.

Logistics company DHL has been expanding its operations in China in order to help pharma operators in the country address the challenges presented by "the increasingly sophisticated needs of life science and healthcare customers in Asia Pacific."

The firm opened a 2,000 sq ft temperature-controlled warehouse at Shanghai, Pudong International airport in May 2009. The site added to the company's existing operations in China which included two 2°C  to 8°C cool rooms in DHL's Global Forwarding PVG Airport Warehouse and two more large, air-conditioned warehouses at Waigaoqiao Bonded Areaand Songjiang Jiuting Non-bonded Area.

DHL said that the opening of the warehouse reflected the continued positive growth expected in the Chinese pharmaceutical market.

Steve Huang, managing director, DHL Global Forwarding China, said: "The life science and healthcare industry in China holds its own despite the global economic crisis. We are optimistic that this sector will continue to offer promising growth."

5 Things You Should Know about Pharmaceutical Anti-Counterfeiting

Sébastien Mauel, Head of Product Security at Ares Trading SA, an affiliate of Merck Serono SA, joins Pharma IQ to discuss anti-counterfeiting.

Pharma IQ: How severe would you say the counterfeiting situation is within the pharmaceutical industry these days, and how has it changed over the past decade?

S Mauel: The pharmaceutical industry and the legitimate supply chain are highly regulated, therefore as long as you source your medicines from a reputable pharmacy, the risk of getting a counterfeit product is low. This risk becomes much higher in developing countries where the distribution system is less secure, and also when you purchase medicines from uncontrolled sources, such as certain online pharmacies, which provide no guarantee at all about the quality of the medicines they sell.

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The counterfeit problem in the pharmaceutical industry and in other industries is similar in the sense that the more you search, the more you find. It is difficult to give numbers as the situation can be very different from one country, market, or product to another. Industries and authorities are definitely devoting more efforts to this issue, and logically are detecting more cases of fraudulent activities.

Pharma IQ: What are the main threats facing the industry at the moment and what actions can industry take to protect itself?

S Mauel: Criminals have now realised that the risk-benefit ratio is clearly more favourable when dealing with fake medicines than with narcotics or any other kind of goods. The general public, on the other hand, is not yet sufficiently informed of the risk of sourcing medicine from uncontrolled sources. Consequently, it is likely that the problem of fake medicines will continue to grow, especially as long as the legislation lags behind and doesn't allow the judicial system to punish offenders much harder.

Pharmaceutical manufacturers are implementing proprietary security solutions on their products, and also working on common safety measures to secure the distribution such as those promoted by the EFPIA.

Pharma IQ: How has EFPIA serialisation impacted or changed the anti-counterfeiting landscape in pharmaceuticals?

S Mauel: The "Verification at the Point of Dispense" solution proposed by the EFPIA seems offer the highest level of security for patients while being the most cost-effective for the industry. The efficacy of such a system was demonstrated during the pilot phase and we are strongly in favour of its implementation in Europe, which will make it nearly impossible for counterfeiters to infiltrate the legitimate supply chain.

European governments should now make such a verification system mandatory in 100% of the pharmacies, which would provide a guarantee to the patients that the products they use are always genuine.

Pharma IQ: How has the culture evolved as a result of changes within the international counterfeiting landscape – and indeed, have you changed the way you tackle counterfeiters?

S Mauel: The awareness level is definitely increasing and the safety of our patients has become the key driver for product security initiatives such as not only serialisation, but also the implementation of tamper-evident sealing and authentication features on the packaging material. In all of our affiliates we have a person responsible for anti-counterfeiting who knows how to react when suspicious cases are detected and how they should be reported.

Counterfeiters are now not only prosecuted by law enforcement agencies for distributing illegal medicines, but also sued by pharmaceutical companies for intellectual property infringements.

Pharma IQ: What do you see as being the areas of highest threat, and what are likely to be the most successful preventative measures in the future?

S Mauel: In the developed countries, the lack of knowledge among the general public is still a major problem. Many are simply not aware of the existence of counterfeit medicines. Many also think of the internet as a cheaper or more convenient way to get medicines and don't realise the danger this may represent for their health. In less developed parts of the world, the way that medicines are purchased and dispensed is different and it is not likely that a secure distribution process will be put in place in the near future; in that case, a verification system using the mobile phone network could be a solution. In both developed and developing countries, well-targeted awareness campaigns are certainly a must to incite people to always source their medicines from legitimate and controlled suppliers.

Rules for Airport Cold Chain / Cold-Chain Cargo Handling

A regulation addition promotes cold-chain cargo handling.
By David Vaczek

The airline industry’s Perishable Cargo Regulations address the most difficult-to-predict segment of cold chain transport. The regulations support the pharmaceutical industry’s need for control and visibility in this supply chain area by defining the critical points where lapses most often occur in airport logistics. They also lay out best practices for meeting regulatory agency requirements for temperature-sensitive products.

Chapter 17 specifies rules for healthcare cargo, saying that shippers and carriers should work together to develop a standard operational procedure (SOP). “Pharmaceutical companies go to extraordinary lengths to protect product from environmental hazards, with very expensive packaging,” says Kevin O’Donnell, director and chief technical advisor to industry, Tegrant Corp., ThermoSafe Brands (Arlington Heights, IL). “They
overengineer packaging, because they don’t completely understand what happens after product is surrendered at the airports. 

“The airline segment has long been identified as a weak link in the chain, with significant potential for mishandling and improper storage,” O’Donnell adds. He worked with a crossindustry committee to write the regulation’s additions. “Chapter 17 updates the handling for medicinal products. The regulations describe what the airlines can begin to do to understand the drug industry’s needs for expediting freight in a safe and efficient manner.”

Airlines that commit to handling medicinal products can offer value-added services and earn higher margins for the high-value cargo. Because healthcare products account for a small fraction of airline revenues, however, observers say the established guidance will dissuade some airlines from emphasizing the segment. “There will be carriers that feel this is way too involved for them,” O’Donnell says.

Eric Raemdonck, manager, special cargo standards, International Air Transport Association (IATA; Montreal, Geneva), and secretary of IATA’s Live Animals and Perishables Board (LAPB), says that “the air transport industry has a good understanding of the needs of the healthcare industry. It will increasingly serve this market, especially now that drug manufacturing is spread across several continents.

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“Who else but the air industry can ensure rapid and efficient distribution such as in times of disease outbreaks? ” Raemdonck says. “For some airlines, [the new guidance] translates into offering customers specialized temperature management products and solutions, whereas for others the focus may be elsewhere in the cargo segment.”

Stating that drug firms and airlines share responsibility for the proper handling of packages, Chapter 17 references the World Health Organizations’ (Geneva) guide on good storage practices for drugs. The guide describes GMPs for proper personnel training, storage conditions, and labeling. Controlled conditions must be maintained in transport, with devices for monitoring temperature in transport advised. Container labeling isn’t mandatory, although the regulations note that “an industry-wide acceptance of standard labeling . . . that does not telegraph the contents of the packages would help expedite product movement [and] avoid improper storage.” It would also provide “the best, safest, and surest means of communicating the time/ temperature sensitivity of [healthcare] freight.”

“Drug companies have approached labeling by writing special instructions for handling in the airway bill,” says O’Donnell. “[But] the ground handlers on the ramp don’t see the bill of landing or read the operating procedures. A lot of ground handling is outsourced. You have people working different shifts, for different airlines, for whom English may not be their first language.”

Chapter 17 includes proposed label designs to indicate that container contents are time and temperature sensitive. At its semiannual meeting in Montreal last October, LAPB voted to consider a more definitive labeling format. Packages, for example, could be labeled with a numbering scheme, with numbers representing containers’ temperature requirements. “On this issue, no official decision has been made,” says Raemdonck. “These regulations will help the airlines understand what they are handling so they make the right decisions, such as when making a judgment call,” says Eric Isom, manager of warehouse operations, Sentry Logistic Solutions (Indianapolis). 

At the LAPB meeting, a Time and Temperature Task Force was approved to work with pharma on the regulations. “This Task Force is temporary in nature, and we encourage the healthcare industry to take advantage of this dedicated platform and delegate observers,” Raemdonck says.

Laden Sie sich diesen Artikel herunter. Cool Chain .

Source: http://www.pmpnews.com/article/new-rules-airport-cold-chain-0

A Counterfeit Era

How FDA and suppliers feel about counterfeiting issues and solutions.

By Marie Redding
Freelance Writer

Counterfeit drugs are a growing concern for pharmaceutical companies, suppliers, and consumers—and the multibillion-dollar black and gray markets show no signs of shrinking.

FDA announced it is reconstituting its internal Counterfeit Working Group, in an effort to “coordinate anticounterfeiting efforts across the agency,” stated FDA Commissioner Margaret A. Hamburg, M.D., at the Partnership for Safe Medicines Interchange last October.

The Kodak Traceless Anywhere System, a marking system capable of invisible authentication even on glass, and can withstand high temperatures during manufacturing processes.

Connie Jung, senior policy advisor for pharmacy affairs, FDA, and commander in U.S. Public Health Service, further clarified by explaining, “This will be a way for the agency to share information across its different centers, so we can coordinate and develop strategies to deal with the potential risks and vulnerabilities for all FDA-regulated products. The Counterfeit Working Group can help to make sure we’re efficiently using our resources and not duplicating our efforts.”
As FDA continues with multiple efforts for combating counterfeits, it will continue to seek input from all industry and supply-chain participants, according to Jung.

How do suppliers of anticounterfeit and authentication technologies for packaging feel about FDA’s increased involvement?

“A comment like that will certainly make the pharmaceutical market continue to address issues regarding the protection of their products, and being able to authenticate them,” says Ernie Chaplin, vice president, marketing, Keller Crescent (www.kellercrescent.com/). Ted Lithgow, chief science officer, healthcare division, MWV (www.meadwestvaco.com), emphasizes that both industry members and regulatory authorities have been working to address the global problem of counterfeiting for many years.

“As we deeply understand the seriousness of this issue, we have invested in new approaches to reducing a counterfeiter’s ability to be successful, including more secure and complex substrates. We, like many manufacturers, believe this is something to continue working closely with FDA on, to protect the integrity and fidelity of our nation’s medicines, diagnostics, and devices,” he says.

Troy Turley, market development director, Chesapeake Pharmaceutical & Healthcare Packaging (www.chesapeakecorp.com/pharma/) feels that more FDA regulation is needed to protect consumers.

“Counterfeiting is a huge problem for the pharmaceutical market. Access to prescription drugs outside of controlled pipelines is becoming a much larger issue, especially with the ability to obtain prescription drugs online. This is one area where there needs to be more focus to ensure consumer protection,” he explains.  

Tip: Global Pharma Authentication

Package Serialization
Regarding the issue of Standardized Numerical Identification (SNI) for packaging, FDA’s Guidance published in March 2010 recommends a serialized National Drug Code (sNDC) for most prescription drugs. It’s not a requirement at this time, but if a company chooses to serialize, the agency has put forth its

recommendation.

“FDA is working on developing standards for tracking and tracing of prescription drug packages to further secure the supply chain, and the SNI guidance was an initial step,” explains Jung. “You need to have some sort of unique identification of what you’re tracking, so a serialized number on a package would be an essential component,” she adds.

Adam Scheer, Advanced Optical Technologies division, JDSU (www.jdsu.com), says he agrees with the SNI Guidance. “We feel that using unique identifiers for tracking and tracing will help improve the security of the supply chain,” says Scheer.

Chaplin also agrees, and explains that some of his customers are already implementing serialized data on their labels. “It will deter counterfeiters when drug companies start serializing each and every unit they sell,” he says.

Lon Johnson, Colbert Packaging Corp. (www.colbertpkg.com/) feels that most pharmaceutical companies won’t be asking its suppliers to print serial numbers on every pharmaceutical package anytime soon. “I think there is an overreaction happening right now, which will die down,” says Johnson. “Printing every box digitally is not practical. Pharma companies won’t leave it up to printers to guarantee their track and trace security—they will handle it a different way, on their end,” he adds.

Johnson says it’s necessary to weigh the costs against the dangers, when choosing a security option. “There haven’t been any cases where a generic drug has been counterfeited,” he says.

The JDSU Phantom Authentication Label, a foil seal printed with holographic and color-changing inks.

Johnson compares serialization to the RFID issue. “Three years ago, there were a lot of people saying every package had to have two to three RFID tags, but now it’s done on every 8 or 10 packages.  People realized it wasn’t practical, economically,” he explains.

Is Consumer Involvement A Solution?
While there have been a number of high-profile incidents of product tampering and counterfeiting associated with high-value, low-volume products, many high-impact counterfeiting incidents target low-cost, high-volume branded products, according to Scheer.

“A number of counterfeiters piggyback off the branding efforts of large, multi-national brands, because it helps them market counterfeit products. In these cases, the consumer, unwittingly, as well as the branding of drugs, are drivers in the business of counterfeiting. FDA recommendations can do more to recognize the consumer’s role,” says Scheer.

Consumers are not realizing when they purchase a counterfeit drug, and need to be educated, Scheer says.
“Consumers are a part of the challenge and need to be a part of the solution. Empower them, and provide them with anti-counterfeiting tools,” he says.

Scheer feels FDA can play a role in promoting a consumer awareness program that is designed to educate the public about ways to verify that a drug is real, without having to use any tools. “Overt authentication tools can help consumers distinguish between real and fake pharmaceuticals with minimal training,” he says. “These solutions can be cost-effectively integrated into existing packaging elements.”

A number of these tools, such as color-shifting pigments, are used on U.S. currency. “The U.S. Department of Treasury has an educational program to educate consumers on how to use those tools to see if notes are genuine, and it would be useful for FDA to follow that model,” says Scheer. Turley agrees. “Human-readable security features should be on cartons, and overt security features should be considered an extension of package design,” he says.

Overt features are more about branding, and assuring the consumer the product is authentic. “It could be a holographic label that is applied to the packaging, high-end foils, color shifting inks, etc. But it has to be consistent for consumer recognition,” Turley explains.

Turley feels that covert features are necessary as well.

“Covert features are just as important for identification, tracking, and authentication, especially when the counterfeiter has taken the pains to incorporate the overt features,” he says. Johnson doesn’t see the value of overt features when the goal is providing security.

“If everyone knew exactly what to look for, someone would be able to knock it off. A covert feature is the one critical factor that will keep you a step ahead of the counterfeiters,” he says. Jung says it has to be a balance.  “If you let the public know what to look for, you’re letting the counterfeiters know as well. We have seen different anti-counterfeiting technologies used on products and packaging—some that can be seen, some cannot,” she says.

Scheer feels strongly about educating the public about overt features, however, he agrees they should be used in combination with other technologies.

“We recognize that there is no single technology that will solve the counterfeit issue alone, which is why we offer a range of solutions. But overt identification is a large part of the solution, and we’ve been consistently successful with it,” he says.

An Invisible Option
Since a counterfeiter’s goal is always to maximize their profit, technologies used on packaging that require special or expensive equipment to duplicate or detect usually won’t be their first choice of products to knock off.

“A counterfeiter will go after products that can be replicated the easiest, or they’ll move onto the next target. Kodak Traceless is not detectable by any means unless you have our proprietary equipment, which we manufacture. It’s very tough to try to duplicate what we provide on the package, because it’s invisible,” explains Steven Stein, technical account manager, Kodak.

“What cannot be seen cannot be counterfeited,” adds Keith Cutri, Director of Business Development, Kodak.

Keller Crescent has an agreement with Kodak as a preferred licensed provider of the Traceless technology. When it comes to invisible marking technologies, Chaplin says that during the last 6 months he’s seen an increase in interest in Traceless, as it pertains to track and trace.

“We currently have customers who are finding this to be an effective way of keeping their product authenticated in the market,” says Chaplin.

The Kodak Traceless products include Traceless Ultra-covert authentication system, and Traceless Anti-diversion invisible track and trace system. Proprietary markers are detectable only by handheld Kodak Traceless readers. The marks can be applied to a wide range of materials, using various printing technologies, including off set, flexo, gravure, letterpress, thermal-transfer ribbon, and continuous ink jet. “We can put Traceless on anything for pharmaceutical companies, including materials such as blisters, foils, or extruded into plastics and films,” says Cutri.

Pharmaceutical products usually contain the marks on labels, or cartons, or ampoules. “Our newest product line, Traceless Anti-diversion, deploys truly invisible serialized codes through the use of continuous ink-jet printing technology. This makes life harder for diverters, who often remove overt anti-diversion codes from packaging, in order to thwart brand protection investigators,” says Cutri. 

Besides increased security, cost reduction is a major benefit of this technology.

“A label with holographic capabilities, which have been counterfeited in the past, can be costly. We’re able to deliver this at fractions of a penny per mark,” says Stein.

Popular Security Solutions
Over the past few years, Thoro Packaging (Corona, CA) has seen an increase in customers asking for printed authentication solutions, such as reflective coatings.

“We run special coatings that have optical brighteners in them, visible under a black light. We also run some security varnishes that have a tag that can be seen through a special reader,” says Mike Jones, print manager, Thoro Packaging.

“A lot of our customers asking for special coatings are larger pharmaceutical companies,” he says. “And, they’re asking us to incorporate security into the design, and thinking about it much earlier—right from the start,” says Jones.

Many suppliers are providing different types of interactive authentication solutions.

“There is a definite push in the market for this,” says Turley. “Some companies are using QR codes, text messages, or variable data points. Consumers can verify a product through a link in an app or by sending a text message, and they receive a confirmation that the product is authentic,” he explains.

This type of security feature encourages interaction between the brand and the consumer, while also allowing companies to track who is using the product, and where.“Some brands are using this technology already, but it has not been to the extent we would expect, yet,” says Turley. “With the growth in smart phone technology, interactive features will begin to become more prominent,” he says.

Chesapeake introduced pro-tex, which offers the ability for consumers to text a variable human-readable code and receive immediate confirmation of the product’s authentication. Incorrect or multi-use codes would alert the consumer of a counterfeit, uncontrolled, or potentially harmful product.

Graphic Security Systems (Lake Worth, FL) offer different types of technology as well. “Our authentication solutions require very little training and can easily be performed using a credit-card sized optical decoding lens or a mobile smart phone,” adds Dawn Sgarlata, marketing director, Graphic Security Systems.

According to Sgarlata, authentication options that are becoming more commonly used include optical decoders (a credit card sized optical lens), digital decoders (scan decoded images to display on a screen), and iphone apps. Popular security features include embedding hidden text or images into artwork; or embedding variable hidden text or images into a patch.

When it comes to security features, however, the simplest solutions are often the most effective, even for the largest pharmaceutical companies, according to Lon.Turley agrees. “In our experience, the majority of pharmaceutical companies want to keep security features simple, and they’re mainly using covert technologies right now,” he says. 

Staying a Step Ahead
Counterfeiters have become more advanced in their abilities. Holographs, overt track and trace markings, and special inks or pigments have all been replicated in the past—even though these are expensive tools.  Combinations of security products and multilayered solutions are often used, and will offer the best protection, experts say.

“We recommend overt track-and-trace mechanisms on packaging, along with a dual invisible marking system separate from an overt label or bar code,” says Cutri.

Cutri says that a huge challenge in the industry is how far counterfeiters have come in terms of technology. “The way to address this issue is to upgrade technology within marker systems,” he says. Lithgow feels that the ability of counterfeiters often keeps pace with the development of protective technologies, underscoring the need for continued focus on new and better track and trace, and product authentication technologies.

Keeping up with advances in authentication technologies for packaging, and constantly developing new technologies, seems to be the industry’s best weapon in the fight against counterfeiting.

INTERESTED IN THIS TOPIC? 2nd congress Global Pharma Authentication 2011 Access free information, more articles and whitepapers as well as details on the Global Pharma Authentication Congress, click here:

Source: PMP News

Prof. Dr. Hans-Dieter Hermann spricht über Motivation, Erfolg und Spitzenleistung

Hans-Dieter Hermann ist seit 2004 der erste Mannschaftspsychologe der deutschen Fußball-Nationalmannschaft und ist seitdem bei allen Länderspielen, Europa- und Weltmeisterschaften mit dabei.

Neben seiner Tätigkeit als erster Mannschaftspsychologe ist Prof. Dr. Herrmann Mitinhaber eines Instituts für Sportpsychologie und Mentales Coaching. Er coacht Führungskräfte und wird von vielen Unternehmen und Institutionen im In- und Ausland zu Vorträgen eingeladen. Der „Leistungsoptimierer im Hintergrund“ ist ein brillanter Redner. Anekdotenreich, authentisch und fundiert gibt er seine Erfahrungen rund um die Themen Motivation, Erfolg und Spitzenleistung an sein Publikum weiter.

Biografie
Nach dem Psychologiestudium am Rijksuniversitair Centrum Antwerpen und der Universität Würzburg war Hans-Dieter Hermann einige Jahre wissenschaftlicher Assistent und Lehrbeauftragter am Institut für Sport und Sportwissenschaft der Universität Heidelberg. Nach zwei Jahren als Professor an der Hochschule für Gesundheit und Sport in Berlin ist er heute Professor an der Deutschen Hochschule für Prävention und Gesundheitsmanagement in Saarbrücken.


Viele Jahre lang hat Hans-Dieter Hermann deutsche und internationale Spitzenmannschaften sportpsychologisch betreut, darunter die österreichischen Ski-Nationalmannschaften, die Deutsche Hockey-Nationalmannschaft, die Deutsche Turn-Nationalmannschaft (Männer) und die Deutsche Box-Nationalmannschaft. Von 2006 bis 2010 war er Sportpsychologe der Bundesligamannschaft von 1899 Hoffenheim.

(Source: http://www.econ-referenten.de/redner/hermann-prof-dr-hans-dieter-sportpsychologe-der-deutschen-fussball-nationalmannschaft)

Prof. Dr. Hermann wird am 18. Oktober auf dem 7. Jahresforum Pharma Sales Force 2011 sprechen. Mehr Informationen finden Sie hier.

Track and Trace in der Pharmaindustrie: Der Mix machts

Bevorstehende Umsetzung globalgesetzlicher Regularien führt
zu weit reichenden Änderungen der Kennzeichnungs- und
Markierungsaufgaben von Pharmazeuten. Laut Craig Stobie,
Leiter Global Healthcare bei Domino, entscheidet nicht allein
der Einsatz des richtigen Datenträgers über Erfolg oder
Misserfolg eines Rückverfolgbarkeitssystems – ebenso wichtig
sind die nachgeordneten Schritte.

Werfen wir einen Blick in die nicht allzu entfernte Vergangenheit und erinnern uns an den gewaltigen Hype um RFID, dem vermeintlichen Königsweg bei der Erfüllung sämtlicher Rückverfolgbarkeitsanforderungen innerhalb der gesamten Lieferkette. Möglicherweise gehören Sie zu den Leuten, die sich gewundert haben,  warum sich die ganze Aufregung um diese vermeintlich revolutionäre Technologie allmählich in Luft auflöste. Die Wahrheit ist, um auf ein bekanntes Zitat zurückzugreifen, dass es sich bei den Gerüchten um das Ableben von RFID um starke Übertreibungen handelt. RFID ist vielmehr höchst lebendig und wird in der  Teileverfolgung (Asset Tracking), insbesondere bei hochwertigen Gütern, eingesetzt. 

Wahr ist auch, dass andere Kennzeichnungsstrategien, nämlich ein- und in zunehmendem Maße zweidimensionale Codes, zu festen Größen geworden sind und spezifische Vorteile als Datenträger bieten. In den Bereichen, in denen sich RFID durchsetzen konnte, wurde diese Technologie ein Motor der Veränderung. Dies betrifft insbesondere - möglicherweise aufgrund des Gebots der Einhaltung gesetzlicher Rahmenbedingungen - den pharmazeutischen Sektor, in dem die RFID-Technologie in großem Umfang erprobt wurde. Dennoch ist ihr Einsatz in diesem Bereich alles andere als universell; zum Beispiel steht ihr anerkannter Mangel an Robustheit der 100-prozentigen Prüfung auf der Ebene von Verkaufseinheiten an Verpackungsstraßen entgegen. Die im Vergleich zu konventionellen Codes niedrigeren Lesegeschwindigkeiten erhöhen die Fehlerwahrscheinlichkeit und minimieren damit die gesamte Prüfungskette. Dennoch hat sich RFID als Datenträger auf Palettenebene etabliert, da die Fehlerpotenziale durch einfaches, manuelles erneutes Einscannen im Falle eines Lesefehlers reduziert werden können. 

Grundsätzlich hat das viel gepriesene Potenzial von RFID als Datenträger sowohl Diskussionen als auch Maßnahmen bezüglich des Aufbaus einer Infrastruktur für Massenserialisierung nach sich gezogen. Während man ursprünglich davon ausging, dass RFID als Datenträger für die gesamte Lieferkette, von der Produktionslinie bis zur Apotheke eingesetzt würde, hat die Erfahrung gezeigt, dass ein Mix aus verschiedenen Technologien die praktischste Lösung darstellt. Auf dem Niveau der Verkaufseinheit besteht die Best Practice laut Handlungsempfehlungen von Regulierungsbehörden wie der FDA und industriellen Institutionen einschließlich EFPIA zur Zeit in einem Sichtlinien-Barcode, wie dem 2D-Data Matrix-Code. Im Unterschied zu früher, als RFID als die Lösung angesehen wurde, konzentriert man sich heute auf das Management der erfassten Daten, wobei der Wahl des Datenträgers weniger Bedeutung zukommt.

Auch wenn es in den kommenden vier bis fünf Jahren in einigen europäischen Märkten zur Einführung von Massenserialisierungsprogrammen kommen wird, gibt es  eine Reihe von Gründen, die für den weiteren vorherrschenden Einsatz maschinenlesbarer Codes wie 2D-Data Matrix-Codes innerhalb der pharmazeutischen Industrie sprechen. Einige Gesetzesvorschläge zielen auch auf die Umsetzung von Programmen auf Basis kodierter Vignettenlabels ab; dies würde sowohl physikalische als auch elektronische Belege für die Rückerstattung bereitstellen. Unabhängig davon, ob Codes direkt auf das Produkt oder auf Vignetten aufgebracht werden, ist es wahrscheinlich, dass der ausgewählte Datenträger ein ECC200 2D-Data Matrix- Code sein wird. 

Der ECC200 2D-Data Matrix-Code ist aufgrund seiner kleinen Größe das am weitesten verbreitete Format. Es ist ein extrem robuster Datenträger, der mit einer sehr großen Datenkapazität punktet und bei niedrigen Kontrasten in allen Richtungen gelesen werden kann. Weiterhin enthalten ECC200 2D-Data Matrix-Codes die Reed- Solomon- Fehlerkorrektur, eine erweiterte Kodierfehlerprüfungs- und Korrekturfunktion, womit
auch Barcodes mit einer Beschädigung von bis zu 60 % noch erkannt werden können. Seit 2004 gehört dieser Codetyp zur Familie der GS1-Standards (EAN/UCC), der ISO-zertifizierten Gruppe der am weitesten verbreiteten Datenstrukturen. Durch die Entwicklung von Technologien, die online 2D-Data Matrix-Codes drucken und lesen können, ist das Gesundheitswesen endlich in der Lage, einige der Ziele in Sachen Patientensicherheit zu verwirklichen, und zwar durch Authentifizierung, die Verhinderung von Erstattungsbetrug und die Bekämpfung illegalen Handels. 

Dies hat den Anstoß zu einer Reihe weiterer Gesetzesinitiativen gegeben, welche dank der großen Spannbreite von Vorteilen ein weiteres Umdenken in Richtung maschinenlesbarer Codes wie des ECC200 Data Matrix-Codes begünstigen. Wie erwähnt, erfreut sich der Bereich der Massenserialisierung eines wachsenden Interesses und zurzeit sind diverse Länder dabei, die Verpackungsanforderungen im Zuge neuer Rückverfolgbarkeitsrichtlinien zu ändern. Der neue Gesetzesrahmen soll nicht nur den Einsatz von 2D-Barcodes fördern, sondern auch zu einem erhöhten Einsatz serialisierter Nummern und visuell lesbarer Informationen führen. 

Lesen Sie mehr: so z.B. Neues vom CIP13-Code, hier geht es zum kompletten kostenlosen Artikel: Global Pharma Authentication - Track and Trace in der Pharma Industrie: Hier herunterladen.

MÖCHTEN SIE MEHR ÜBER DIESES THEMA ERFAHREN? Global Pharma Authentication / Fälschungen / Illegaler Handel Verpassen Sie nicht den 2. Kongress Global Pharma Authentication 2011 vom 04 - 06 Juli 2011 im Steigenberger Hotel, Berlin

Single Use Technologies Changing the Biomanufacturing Landscape

Contributor: Eric Langer

During the past six years, single use systems and devices have emerged as a key change agent in the biomanufacturing landscape. Acceptance in R&D and scale-up has been driven by their effectiveness in reducing risks of contamination, faster changeovers, advantages over fixed stainless steel systems in cleaning and validation, and significantly reduced time, and costs to get a new facility up and running. Now, single use products have pushed beyond an early-stage technology, and are poised to emerge into the much larger,  GMP commercial-scale operations. The emergence of single use devices onto the commercial stage is likely to  create radical changes in the biomanufacturing landscape. Key to this is first to resolve safety issues associated with leachables and extractables. Comparability with existing processes (stainless steel) will result in more rapid  adoption rates. The needs in single use technologies that will assure GMP operations—and biomanufacturers’ applications and integration of them--have driven end-users to demand vendors put R&D efforts into these devices. In fact, according to BioPlan Associates, Inc.’s 2011 8th Annual Report and Survey of  Biopharmaceutical Manufacturing Capacity and Production[1], single use devices top the list of key areas where biomanufacturers want to see product development.

Table 1: Top Areas Where Vendors & Suppliers Should Focus New Product Development Efforts (selected study results)

Source: 8th Annual Report and Survey of Biopharmaceutical Manufacturing; Preliminary data, 

pub April 2011; BioPlan Associates, Inc. http://www.bioplanassociates.com/

These responses for where new products are being demanded reflect both the growing acceptance of disposable/single-use devices, and the growing need for better systems. Nearly 39% of the industry wants vendor innovation in basic singleuse devices, suggesting significant opportunities for companies with inventive R&D initiatives and product development capabilities.

The need for more effective, standardised single use equipment is generally felt by both vendors and end-users. Improvement is most strongly called for in "extractables and leachables” which leads the list in “Reasons for Restricting Use of Single-Use Devices”, cited by 74% of 2011 respondents (up from 68% in 2010).

These data suggest an opportunity for vendors with R&D that delivers better materials. Both significant levels of innovation and incremental changes are needed to spark improvements that facilitate use of single use devices. Survey respondents indicated the following as specific areas in need of improvement:

• Simplifying change-over and cleaning operations
• Reducing overall capital investments
• Reducing risks of product cross-contamination
• Speeding up time to get facility up and running
• Improving campaign turnaround times
• Standardising devices to avoid costs of system modifications
• More ‘modular’ approaches
• Reducing space requirements
• Improving assurance of sterility
• Decreasing documentation requirements; simplify QA/QC
• Improving sterile-sampling
• Simplifying overall operations to reduce learning curve for new operators
• Improving control of bioreactors
• Reducing the need for operations staff
• Improving strength and reliability—to reduce bag breakage

Such solutions will require innovative leadership, process documentation, and training that demonstrate how devices can be effectively integrated into operations. In fact, industry experts believe process simplification will be the real driver for single use success. Single use vendors are likely to see profitable opportunities when they go beyond the current new product strategy of simply replacing stainless steel with plastics. This overall process can be summarized as strategic productionmanagement and this is a term more and more in use.

Hand-in-hand with innovation will be the need for standardisation of the currentlyproliferated, unique designs and devices. “While there is a huge amount of specific activity, we believe the future of single-use technologies will include higher levels of integrity and quality, supply chain security, faster delivery to customers and global material and specification standards for faster implementation,” says Doug Neugold, CEO, ATMI.

To get to the next level of growth and efficiency will likely require a more ‘plug-andplay’ device approach guiding product design and innovation. This kind of standardisation will also permit greater efficiency and lower costs. Thus, to get beyond the current steady rate of adoption, innovation may focus on making production easier for people with fewer skills, on a global perspective.

[1] 8th Annual Report and Survey of Biopharmaceutical Manufacturing, Preliminary Data, Publication; Date April, 2011, BioPlan Associates, Inc. www.bioplanassociates.com

Want to learn more about strategic production management in the pharmaceutical industry? Visit the Download Center for free articles, whitepapers and interviews:  

Strategisches Produktionsmanagement Pharma

An Interview with Gerd Maass, VP for R&D at Roche Pharmaceuticals: Chapter 3 - Biobanking

With a focus on biobanking Maass outlines some common difficulties in isolating biomarkers from samples that have previously been stored in a bio/tissue bank; he shares his opinions on storage techniques for samples to get the best results. He also sheds light on the state of Roche’s internal biobank, discusses the extent to which Roche sources samples externally from biobanks, and the main difficulties/challenges with this. Finally, he gives some research-side advice for new or expanding biobanks.



Missed part one? An Interview with Gerd Maass, VP for R&D at Roche Pharmaceuticals: Chapter 1 - DNA Sequencing
Missed part two? An Interview with Gerd Maass, VP for R&D at Roche Pharmaceuticals: Chapter 2 - Companion Diagnostics

 Source (c): PharmaIQ