'Right dose differentiates poison from remedy' Dr Narendra Deshmukh, Director, INTOX, answers key queries put across by Sachin Jagdale on toxicological studies for pre-clinical safety assessment of drugs Why do we need to test safety of drugs and that too using non-human test systems, particularly animals? One should never forget the age old postulate of toxicology. This states that all substances are poisonous; there is none which is not a poison; it is the right dose which differentiates a poison from the remedy. It has also been established beyond doubts that results obtained from experiments conducted in animals, when properly qualified, provide most valuable information on the safety of a drug substance. One should know that safety of the drugs is indeed tested in human volunteers before these are given to patients. However, the first human dose to be administered to these brave healthy human volunteers has to be very carefully selected to avoid any unacceptable consequences. Hence, this is often derived from the MTD (maximum tolerated dose) obtained from animal studies. What are the steps involved in the toxicology study of any drug? The paths to be taken for safety evaluation of drugs would depend on what we already know (i.e. have reliable data) about the safety (toxicity) of that drug. If it is a new drug entity (NDE/NCE/NBE) then you need to explore toxicity to greater depths and extent. If it is a drug ‘similar’ to the one already introduced in other regulated markets of the world (generic / similar biologic) then apart from demonstrating CMC (chemistry, manufacturing controls) and biosimilarity you need to demonstrate safety in an abbreviated testing programme. For a new drug discovery programme which spans over several years, different types of toxicity studies are conducted over such period depending on the stage of
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discovery and development. Tell us about various subtypes of toxicology? The science of toxicology is very diverse and encompasses areas such as clinical toxicology (poisoning / effects of accidental or intentional exposure on humans or animals), forensic toxicology (medico-legal), environmental toxicology, mechanistic toxicology (deals with mechanism of toxicity), descriptive toxicology (concerned directly with toxicity testing) and regulatory toxicology. A regulatory toxicologist usually works in governmental regulatory agencies, and has the responsibility to decide, on the basis of data provided by descriptive and mechanistic toxicologists, whether a drug or another chemical poses a sufficiently low risk to be marketed for a stated purpose. Please know that all toxicity studies are not animal studies. Safety assessment studies also heavily draw inferences from in-vitro tests (i.e. conducted outside body), in-silico tests (using computer programmes) and the science of chemistry. However, these in-vitro systems are fairly www.expresspharmaonline.com
over-simplified simulations of the extremely complex in-vivo environments (i.e. real insidebody conditions), which at least today, are still considered indispensible. Has introduction of new molecules by pharma companies made toxicology studies more challenging? Due to advances in knowledge of complex processes in cells, tissues / organs and the body as a whole, there has been a growing insistence on molecularly targeted drugs. It is a challenge to toxicologists to select an appropriate model for conducting safety studies. The model has to be relevant and the findings of the studies require a great deal of qualification before these can be interpreted meaningfully. How are protocols and guidelines different for toxicology studies of biopharmaceuticals and allopathic medicines? Biopharmaceuticals are made of large molecules. Their absorption, distribution, metabolism and excretion occur in a different manner than that of micro-molecules, i.e. of chemical pharma.
There are issues of stability, variation in host responses, neutralisation of pharmacological activity due to antibody response, deposition of immune complexes in tissues, toxicity to immune system including exaggerated hypersensitivity reactions which can turn fatal. Biopharmaceuticals are highly specific and potent in activity and their dosing regimen and response of the body have to be monitored more closely, including effects on endocrine functions. Use of monoclonal antibodies and development of targeted delivery systems using such MABs has opened a new chapter in the science of toxicology. Due to such differences, the regulatory guidelines for safety assessment of such biotechnology derived pharma have been written separately (e.g. ICH S6). WHO has issued a separate guidance on safety assessment of vaccines. In India, the Department of Biotechnology and its RCGM with CDSCO have been very vigilant and active in issuing and updating guidance documents over past decade. The CDSCO has created an altogether separate division for biological. Toxicology study parameters/requirements/regulations may vary depending on the country where the product is to be exported. Could you provide details regarding such different regulatory requirements? Regulated markets of USCanada, Europe and Japan have laid down requirements which are also continuously reviewed and updated. Their regulatory requirements have been made available on the websites of respective authorities (US-FDA, European Medicines Agency, MHLW of Japan). Similarly, emerging markets have been specifying their requirements. Though the world pharmaceutical regulations are in continuous process of harmonisation, and the format of data submission such as the CTD are getting similar, it is important that designs of toxicity studies are Continued on Pg 107 November 16-30, 2012
Claims-based pharmaceutical R&D: Time to walk backwards As they grapple with shrinking pipelines, stricter safety requirements of the regulator, and spiralling costs to bring a product to market, pharma companies need to ensure that their products genuinely fulfill an unmet market need. In a recent whitepaper, Sanjay Parikh, Director, Indegene Lifesystems, advices that it is imperative that the R&D effort follow a ‘market to lab’ approach so as to ensure that the CDP is designed to address specific unmet market needs ver the last quarter of the 20th century, medical research made substantial advances in defining our understanding of diseases, their etiologies, and the biochemical pathways through which they were mediated. Our understanding was further augmented by human genome research. As the pathways of disease were clearly identified, pharmaceutical research largely focused on a 'lab to market' approach, which involved identifying/synthesising molecules that could mediate a disease pathway, characterising their various attributes, and then commercialising them. In several cases, new molecules had characteristics that were marginally different from others already on the market, and therefore, did not address any unmet clinical need. Commercial success was often determined by the intensity of the sales and marketing effort behind the product, which resulted in an 'arms race' (a battle for maximising share of voice by investing in larger and larger sales teams) and the emergence of 'blockbusters.' The last 10 years have seen a seismic shift in the dynamics of pharma sales and marketing. The return on investment in sales force expansion is shrinking, causing almost all major pharma companies to reduce their
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head counts. Further, it is increasingly evident that the market and regulators are interested in new therapies that address an unmet need rather than yet another prod-
uct in an existing class of molecules with little or no clinical or economic benefit. Over the last few years, most of the innovations in pharma development have been only incremental — for most indications, there are significant therapy options available and it is unlikely that a radically better 'wonder drug' will become availwww.expresspharmaonline.com
able soon. Consequently, a disproportionate amount of ongoing research and development (R&D) effort has gone into products already in the market to expand the spectrum of indications where they can be used. Figure 1 shows the number of drugs approved by the US FDA over the years. The decline in approvals is a clear indication of how difficult it will be for pharma companies to continue to show revenue growth in future. As they grapple with shrinking pipelines, stricter safety requirements of the regulator, and spiralling costs
Aligning the organisation to the goals of clinical development
to bring a product to market, pharma companies need to ensure that their products genuinely fulfill an unmet market need. Therefore, it is imperative that the R&D effort follow a 'market to lab' approach—one that reverses the conventional approach used over the last few decades.
which have become the responsibility of different functional silos in a pharma company. Consequently, clinical R&D at present involves stakeholders from the strategic, marketing, sales, medical, R&D, clinical operations, regulatory affairs, documentation, and health economics teams. Given that the collective
Clinical R&D is a complicated process involving several steps and multiple stakeholders, both internal and external, in a pharma organisation. Over the last 50 years, the journey of a product from laboratory to the market has not only become more arduous and time-consuming, but also more risky. Additionally, more and more clinical development plans (CDPs) include global, multi-centric clinical trials, their formulation and execution are broken into several sub-elements, each of
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objective of all the teams involved in the CDP is to achieve a desirable Target Product Profile (TPP) and therefore a superior product label, pharma companies must ensure that all stakeholders are aligned and share a common line of sight to the end objective. This is not always easy, but is a critical challenge that must be overcome. Failure to do so runs the risk of a CDP not being in step with current and future market needs, and oblivious to the competitive scenario in the future. The essence of 'claimsbased R&D' lies in taking a backward 'market to lab' approach so as to ensure that the CDP is designed to address specific unmet market needs. It also involves the systematic benchmarking of a product’s CDP to current and future competition while continuously evaluating scientific and market threats and opportunities. It involves the integration of multiple inputs to develop the CDP and then prospectively simulate the likely TPP of the product and a SWOT analysis vis-à-vis its inline and pipeline competitors.
The process of developing a CDP The process of claimsbased R&D is iterative since it attempts to temper the desire to develop an 'ideal' product with scientific and operational feasibility. Figure 2
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illustrates the process of claims-based R&D. With the ever-growing volume of information and data available in the secondary domain, it is now possible to pursue claims-based R&D to a far greater level of granularity than before. It also enables TPP simulation on a near real-time basis as pivotal information becomes available.
Customer insights In an earlier era of pharma development, unmet market needs were determined almost exclusively from the
rately captured so that the product(s) developed can genuinely claim to deliver a clinical and/or economic benefit. These insights are often captured through primary research and intelligence initiatives, which include engagement with physician groups, patient and caregiver groups, insurance agencies, etc. However, such initiatives can be effectively complemented by research on secondary sources of information such as online patient discussions boards and transcripts of regulatory
THE DECLINE IN APPROVALS IS A CLEAR INDICATION OF HOW DIFFICULT IT WILL BE FOR PHARMA COMPANIES TO CONTINUE TO SHOW REVENUE GROWTH IN FUTURE opinions of physicians and medical key opinion leaders (KOLs). In the modern era, however, there has been a significant shift in the level of influence exerted by different stakeholders (customers) on the patterns of pharma consumption. These stakeholders (customers) include the patient, the payor, and the regulator. While pursuing claimsbased R&D, it is critical to ensure that the insights and opinions of all the key stakeholders (customers) are accu-
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proceedings.
Scientific insights The volume of scientific research has been growing at an astounding rate. A search on www.pubmed.com (the online index of the National Library of Medicine) reveals that approximately 725,000 articles were published over the last year alone. Journal articles and congress presentations constitute a wealth of information about cuttingedge scientific developments. A thorough analysis of
such publications and academic congresses is critical at the time of developing a CDP and simulating the TPP because it serves as an advanced warning system about novel scientific developments that could threaten to make obsolete a particular product. It could reveal alternate approaches to addressing the unmet clinical need at an early stage, and therefore throw up opportunities for partnerships or ideas for development. It presents the successes and failures of competitive development programmes, thereby sparing a lot of unnecessary effort and investment. It is a good source to unveil new information about the epidemiology of a disease and therefore the size of the addressable market opportunity.
Competitor insights Ultimately, pharma R&D needs to be viewed in the context of competition because of the underlying commercial objectives associated with the process. Consequently, an understanding of the development, licensing, and marketing strategies of the competition constitutes a critical input into the development of the CDP. It is important to note that competition needs to be viewed not merely in today’s
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context, but also considering the future. Therefore, it is recommended that any CDP and its derived TPP be benchmarked to the claims and positioning strategies of competitive products already in the market as well as the likely claims and strategies of pipeline products. Fortunately, substantial amount of information about clinical trials—completed and ongoing—is available in the public domain through sources such as product labels and clinical trial registries. The main source for clinical trial information is www.clinicaltrials.gov (the official site of the US FDA), which contains several essential details about all registered clinical trials. Although the information is accessible through sources such as the ones cited above,
it is essential to note that deriving insights, simulating competitive claims, etc., is an exercise that requires substantial human expertise.
food interactions, and perhaps, even cost. In addition, the 'ideal TPP' would cover a wider patient population than all competitors.
The ideal target product profile
The real target product profile
As a first step of an iterative process to design a CDP, it is recommended to build an 'ideal TPP.' To do this, one would need to integrate the various insights and inferences described above and evolve a TPP that would address all the unmet needs of the market while also yielding superior marketing claims across all product attributes. Therefore, an 'ideal TPP' would represent best-in-class performance for efficacy, safety (ideally, would result in no adverse effects), tolerability, convenience, drug and
Much as we may aspire for an 'ideal TPP,' it is necessary to recognise that in the real world, we cannot get every product attribute we desire. Therefore, we must modify the 'ideal TPP' by prioritising the attributes and claims that the CDP must focus on and compromising on others to arrive at the 'real TPP.' This can be done by classifying the product attributes in the “ideal TPP” as either essential or desirable. The essential features of the TPP would represent a set of product attributes that represent either superiority
Ideal TPP
over competing products or, at the very least, non-inferiority to competing products. Without these features, the product would enjoy no unique selling point when launched. The desirable features of the TPP would represent additional product attributes that could enhance the product’s marketability. These additional attributes could include some side indications, tolerability improvement, application for specific sub populations, or even improved product stability. They all represent features that are not absolutely mandatory for commercial success but would certainly amplify the claim of superiority. Figure 3 illustrates at a conceptual level how an 'ideal TPP' will be modified to a 'real TPP.'
Real TPP
Parameters
“Best Case Scenario”
Parameters
“Base Case Scenario”
Indications and Usage
The drug is used in all cases of xyz indication
➤
Indications and Usage
The drug is used in xyz indication with cde criteria
Dosage and Administration
XY strength, administered irrespective of meals orally
➤
Dosage and Administration
Y strength, administered before meals orally
Dosage Forms and Strengths
Tablets
Dosage Forms and Strengths
Tablets
Contraindications
No contraindication
➤
Contraindications
Contraindicated in abc
Warnings and Precautions
No warnings
➤
Warnings and Precautions
xyz
Adverse Reactions
Minimal adverse events
➤
Adverse Reactions
Adverse events such as xyz were reported
Drug Interactions
No drug interaction
➤
Drug Interactions
Excretion increased with drug b
Use in Specific Populations
Use similar in all populations
➤
Use in Specific Populations
Caution must be used in African Americans
Drug Abuse and Dependence
Drug not prone for abuse and dependence
➤
Drug Abuse and Dependence
Has potential drug dependence
Overdosage
Has a high therapeutic window
➤
Overdosage
Overdose causes potential adverse effects
Clinical Pharmacology
Summary of the clinical pharmacology and actions of the drug in humans
Clinical Pharmacology
Summary of the clinical pharmacology and actions of the drug in humans
Nonclinical Toxicology
No long-term carcinogenic potentia
Nonclinical Toxicology
Carcinogenesis observed in rat at high doses
How Supplied/Storage and Handling
As specified in the product label
How Supplied/Storage and Handling
As specified in the product label
Patient Counseling Information
Include information for prescribers to convey to patients the use of the drug safely and effectively
Patient Counseling Information
Include information for prescribers toconvey to patients the use of the drug safely and effectively
➤
Figure 3. Modification of an ideal TPP to be more Realistic
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Clinical trial design The medical and clinical development groups must design clinical trials for the product to achieve the 'real TPP' described previously. For this, it is advisable for the clinical development group to carry out extensive and detailed clinical trial analytic on the CDs of competitive products to help derive appropriate trial parameters such as inclusion and exclusion criteria, primary and secondary endpoints, and patient populations. Such an approach helps ensure that the results obtained from the clinical trials will allow 'apples to apples' comparisons between the product and its competitors. Fortunately, these clinical trial designs are readily available in the public domain. However, substantial analytical effort is required to extract the parameters of interest, homogenise the terminology across all clinical trials, and compare one trial against another. The numbers of clinical trials that must be analysed vary depending on the therapy area and indication. However, for most large therapy areas, the numbers run into hundreds or even a few thousands of clinical trials. The analysis of such large numbers requires investment in human resources, but this investment pays for itself because of the value it adds to the process of developing the CDP. Knowledge of the distribution of endpoints, recruitment criteria, and patient populations of competitive products can help design clinical trials that enable head-to-head comparisons of the product with other products. Figure 4 shows some typical outputs from a detailed clinical trial analytic exercise on a benchmark competitor. It highlights the most frequently used trial endpoints and patient segments on which the drug is being investigated. It is also possible to analyse the results of clinical trials of competitive products wherever available. These results point to the successes and failures of similar products and CDs. At the time of developing
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the clinical trial design, it is possible that the clinical development group may identify constraints that preclude the achieving of the 'real TPP' in its entirety. In such cases, the 'real TPP' may have to be revised after arriving at a consensus among all stakeholders such as marketing, clinical development, medical affairs, and regulatory affairs teams.
Clinical operations plan While the clinical trial design is the critical determi-
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nant of whether the product will achieve its desired best in class position, the clinical operations plan focuses on the timeliness and logistics of the trial execution and therefore determines whether the product can be launched within a reasonable timehonoured that offers enough time to earn a reasonable return on the investment in R&D. In a crowded marketplace, there is tremendous competition between competitive CDs to recruit similar patients. It is well established
that speeding up the recruitment process yields a disproportionate return due to the extra duration earned between the date of launch and patent expiry. Knowledge and intelligence of investigators and global clinical trial sites in the specific therapy area of interest can contribute tremendously toward the acceleration of the patient recruitment process. Such information can be obtained through a detailed analysis of information available in the
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secondary domain, that is, through clinical trial registries and publications. However, this information ought to be refined through primary research, wherein additional data about the sites of interest such as productivity, resources, and costs are collected. The model described in this paper for developing the CDP for a product is necessarily iterative. The structure is designed to ensure that the development of the CDP incorporates all relevant information and intelligence available so that the final result stacks the odds in favour of obtaining a superior TPP to that of the competition.
Methodology of research For each of the boxes in the CDP development model in Figure 2, there are substantial volumes of information available in the public domain. However, the task of searching out the relevant information, analysing it, and deriving the necessary insight requires an approach that leveraged the power of technology along with the ability to apply the expertise of a rapidly scalable pool of
INDIA IS RAPIDLY ACQUIRING A REPUTATION OF BEING ABLE TO BUILD LARGE, COST-EFFECTIVE CENTRES OF EXCELLENCE TO DELIVER KNOWLEDGEINTENSIVE SERVICES TO THE PHARMA INDUSTRY medical and pharmacology professionals. Organisations that are moving toward claims-based R&D need to set up technology infrastructure and platforms to integrate the huge volume of information available so that multiple functions and stakeholders involved in the clinical development process can share benchmarked data, knowledge, and insights in a seamless fashion. Although technology development is often a onetime exercise, the ability to tap into a large talent pool poses a challenge in the US and the Western Europe. Not only are the resources (medical doctors, life science experts, etc.) too expensive, but they are also part of a restricted pool. These factors
together make it less attractive to develop a large-scale clinical trial analytic function in the US or the Western Europe. The challenge of accessing a scalable and cost-effective pool of human experts is increasingly being addressed through a hybrid off-shoring model of knowledge-intensive services where on-site expertise is integrated with a global delivery model. Offshore destinations such as India are rapidly acquiring a reputation of being able to build large, cost-effective centres of excellence to deliver knowledge-intensive services to the pharma industry such as medical writing and communications, medical information management, training services, health economics, and scientific com-
petitive intelligence. Some early movers in the pharma industry have already embarked on large volume offshoring of clinical trial analytics and secondary scientific research to help simulate the TPPs of competitive products, and thereby assist in the development of CDPs. Given the pressure on clinical R&D to deliver the 'best in class' or 'first in class' products, the concept of claims-based R&D will become increasingly standardised and ubiquitous. Since the benefits of claimsbased R&D are palpable, pharma companies would like to extend this methodology across all its therapy areas and pipeline products. The requirements for highly qualified experts are therefore likely to multiply in future and will be best addressed by offshore service providers in lower-cost destinations such as India. Parikh has more than 15 years of experience in the global health care industry. At Indegene, he is responsible for the company’s European business. The author can be reached at sanjay.parikh@indegene.com
'Right dose... Continued from Pg 102 made such that they would meet specifications of at least those of regulated markets. To better understand the testing needs one must know class of the drug, the intended markets and the type of application. In what way will the toxicology guidelines evolve in the coming future? Recent high-profile drug withdrawals have increased the pressure on regulators and the pharma industry to improve preclinical safety testing. Understanding mechanisms of drug toxicity is an essential step toward improving drug safety testing by providing the basis for mechanism-based risk assessments. Targets for application of new November 16-30, 2012
technologies, including in silico screening, biomarkers, surrogate assays and 'omic technologies, would gain importance. There could be more emphasis on in-vitro models and the mechanism of druginduced toxicity. Use of predictive toxicology would grow relying on structure-activity relationship (SAR) modelling to predict biological activity from chemical structure. Intox has recently expanded its facility in Pune. Kindly give some details. INTOX obtained GLP certification of its test facilities from the Governments of India and Netherlands in 2007 in toxicology, mutagenicity, clinical chemistry and environmental toxicology services. Since GLP chemistry support was vital for such www.expresspharmaonline.com
studies, INTOX strengthened its analytical chemistry capabilities in 2009 and within a year, began offering GLP certified services in the field of analytical chemistry and physical-chemical testing. INTOX’s markets have expanded to all parts of the world today and nearly 75 per cent of the revenue is generated from services offered to its overseas clients. Among the emerging markets, INTOX aggressively marketed its services in China and is known as a dependable CRO to its over 200 Chinese industrial customers. So also is INTOX’s reputation in other Asian countries, Europe and Latin American countries. To serve its European, US, and other clients in a better way, INTOX has added a dedicated SPF small animal
experimental facility and hence, offers 52 experimental animal rooms to its clients. INTOX imports high quality research animals to accommodate any specific experimental model requirements of the Sponsors. INTOX would soon be seeking AAALAC accreditation for its animal facilities. INTOX already offers a battery of mutagenicity tests but shall expand into offering validated in-vitro toxicity alternatives for some tests and product classes. In near future, INTOX would be further strengthening its chemistry services. We also plan to offer specialised packages for biopharma clients and venture into expanding our services to safety pharmacology studies. sachin.jagdale@expressindia.com EXPRESS PHARMA
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NPD: An idea whose time has come More often than not, New Product Development (NPD) projects of pharma-centric companies fail to meet their objectives not because of their uniqueness, but because of the way thay are planned and executed. Prahalad Chandrasekharan, Managing Consultant, PricewaterhouseCoopers, highlights some best practices in project management that exist in the pharma sector eing the first to file is a crucial advantage in the pharmaceutical sector and can provide much by way of financial benefits as well as exclusivity. In fact, the 180day exclusivity rider helps companies get a head-start and capture market share giving a sustainable competitive advantage. On starting a development project, one aims at getting the product to the market as soon as possible.
B
What then causes roadblocks? Is every development effort unique and can no fixed time limit be assigned? Is pharma development so highly regulated that it has to undergo multiple iterations before submission? Or is adequate management focus and attention not given at adequate intervals? Are functions like analytical development overloaded constraining capacity to execute projects on time? Or are bio-equivalence studies outsourced to an external agency so often that we cannot exert enough control over events? The list of questions can go on. It is however important to understand that more often than not projects fail to meet their objectives not because of their uniqueness, but because of the way they are planned and executed. Typically, projects have three objectives that need to be met simultaneously--time, scope and budget. Even if a single element is compromised, the development effort cannot be considered successful. For example, one may continuously refine and optimise processes to bring the most cost effective product to the market, but such efforts also require time investment which in turn might delay the project.
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What is the point then in having the most optimised cost, when we have missed the bus for filing by a year? A competitor might have filed it earlier, albeit at a slightly higher cost but gaining a headstart in market share and brand. It is therefore important to clearly define the scope, budget and time, upfront, and manage the effort within agreed frames. It is not that these three elements are independent of each other and hence a miss on one of them will adversely impact the others as well. For example, if the project is delayed (the time element) it will have an impact on profitability (the cost element).
How does one therefore ensure a successful project? A typical project has a planning phase as well as an execution phase. Planning involves agreement on scope, budget and timeline and execution involve adherence to each of these elements. Planning involves the design of various stage-gate criteria phase-wise, a decision framework for a go and no-go, the creation of a project plan and a resource plan design of measures and metrics to assess performance. Execution involves adherence to the plan through a welldefined review mechanism that works cross-functionally and helps resolve constraints, the effective execution of the various stages of a project including optimised experiments and focusing on enhanced productivity by eliminating wasteful activities. Readers might be interested to know that some of the best practices in project management exist in the pharma sector. Examples abound from MNCs to some of the well-managed Indian firms. www.expresspharmaonline.com
Some of the things that these companies do differently are as follows: ● A mechanism to launch a project only after adequate preparatory phase activities have been done ● Well-designed stage-gates and rigorous adherence to pre-defined norms for go, no-go decisions ● Knowing how to commit to a due date for the project, based on a comprehensive assessment of constraints and resource availability ● Building in the voice of end-customers in the new product development (NPD) process viz, country specific supplementary data, bio-equivalence requirements, specific validation data etc ● A project plan that takes cognisance of resource loading ● Identifying the critical path in the product development process and eliminating delays along it ● Identifying activities that can be executed in parallel at the project planning stage ● De-bottlenecking at crucial stages of chemicals and formulations R&D and the analytical method development through optimised experimentation processes ● Synchronous flow of information ● Robust review structure and adherence to review plan ● Creation of a daily management structure that ensures timely resolution of operational issues to avoid surprises at a later date ● Comprehensive measures and metrics that focus on cost and schedule performance ● Focus on efficiency and effectiveness of the lab function through the elimination of wasteful activities ● Building in manufacturability as a criteria in the development phase so that scale-up issues are avoided ● Building in minimum manufacturing and inspection cycle time as a criteria while validating batches during scale-up rather than
focusing only on the quality aspect of the project ● Cross-functionality at all levels ● Using robust experiment design to optimise on the number of experiments and the load on the analytical lab Today, companies have reduced their new product development lead times to 50 per cent of their baselines. While this may sound astounding and bring a sense of disbelief, it is true. If one looks at the entire chain of the NPD process, from selection to filing, there are several opportunities for improvement. Many of these pertain to management processes and not necessarily the technical aspects of NPD. Organisations need to approach NPD in a transformational way. It requires a mindset change and redefines the entire new product development processes. While scientists bring in the technical skills, the organisation should look at skill development and bring in project management skills to these people. Some organisations have a dedicated project management cell which tracks all projects and acts as a central coordination mechanism across all functions and all projects. Such a structure helps bring in improved coordination and synchronisation across all participating functions. NPD is a crucial lever for all organisations as they have slowly begun to understand the importance of this crossfunctional process. Organisations need to take concrete steps towards achieving NPD excellence. Pharma companies can probably take inspiration from players in innovation such as Apple, in terms of getting out new products continuously on or before time! (The author can be reached at prahalad.chandrasekharan@in.pwc.com. The views expressed by the author are his own and not that of the organisation that he represents) November 16-30, 2012
+ ‘Over the next three years, we could potentially launch five molecules’: Sameer Savkur PG 110
'Autologous Chondrocyte Implantation (ACI) has a huge potential': Satyen Sanghavi PG 111
Implementation of similar biologic guidelines in India PG 111
'We need to build a culture of drug discovery' - Dr Rama Mukherjee' PG 112
In Licensing/Out -licensing of novel technologies is the future of the pharma sector Vishal Gandhi PG 112
Over the next three years, we could potentially launch five molecules For nearly 20 years, Biogen Idec has been a leader in advancing the treatment of multiple sclerosis. In India, it is beginning to gain ground with its efforts. Sameer Savkur, Managing Director, Biogen Idec India, talks to Shalini Gupta about the company's product line and its efforts to increase awareness about the condition It has been five years since the company has set up its office in India. What goals have been realised since the operations began? Biogen Idec had for long been focussed on the US and EU markets. We realised that we needed to have a presence in emerging markets and hence set up subsidiaries in India, China and Brazil beginning 2007. From 2007 to 2009, we established our clinical operations in India and have been doing clinical trials. Our commercial operations began only in 2010 with all the functions fully operational now. We have been able to launch two products and one line extension alongwith establishing our leadership in the Multiple Sclerosis (MS) therapeutic space. Globally, Biogen Idec grew by 7 per cent overall in 2011 clocking revenues of $5 billion with 25 per cent spending on R&D. In India, we are growing at the rate of ~30 per cent currently. What are some of the products in the Indian market? Globally, the company is focussed on treatments for MS, Amylotrophic Lateral Sclerosis (ALS) also called as Lou Gehrigs disease, Alzheimers, Parkinsons, Haemophilia and autoimmune disorders (including spinal muscular dystrophy, rheumatoid arthritis and idiopathic pulmonary fibrosis). We have two drugs in the Indian market for MS: Avonex and Tysabri. Avonex (interferon beta 1a) is an injectable in a prefilled syringe indicated for relapsing, remitting form of MS called RRMS (earlier marketed by Nicholas Piramal, transferred to us in January 2010). Tysabri (Natalizumab) introduced in
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December 2010, is the second line of treatment for patients who fail on interferons. This year in March, we introduced a new device for easier administration of Avonex called the Avonex Pen. We hope that this device will help patients be more independent in administering their therapy thus improving their adherence. To encourage ease of access, the pen has been introduced at a comparable price of the pre filled syringe with a marginal premium of approximately 6 per cent. What are the challenges facing MS patients in India? Upto 75 per cent of all MS patients suffer from the relapsing, remitting form of MS called RRMS. There is currently no epidemiological data in India to support incidence of the disease. WHO estimates that between 3-5 people in 100,000 suffer from this form of MS in the Indian population. The disorder is prevalent twice as much in women as compared to men and occurs between the age of 25-40 years. It is diagnosed through an MRI of the brain and clinical assessment of the neurologist. Increase in MRI availability has led to more diagnosis, yet more awareness is required about the disease and its management. Conditions such as epilepsy, stroke and headache etc. being more prevalent, form a significant part of the practice of most neurologists in the country. The solution lies in creating awareness about the condition both amongst the clinicians and the patients and informing neurologists about the medication available in the market for treating their MS patients. We www.expresspharmaonline.com
INTERVIEW
also partner with the Multiple Sclerosis Society of India (MSSI), which has eight to nine chapters all across the country to spread awareness about MS in India. The biggest challenge in the fight against MS is the shortage of doctors, with just one neurologist per one million people. Also, since the condition is not being covered under medical insurance, patients have to incur the costs out of their pocket. Less than 5 per cent of the patients get treated by disease modifying therapies since they cannot afford treatment. What are some of the drugs the company has in the pipeline? Biogen Idec has one of the strongest pipeline of drugs for the treatment of MS, most of which help delay the relapse rate. The hunt for a cure is on, we have a drug called ANTIlingo under clinical development (Phase 1) for the same along with three other drugs in various stages of development. BG-12, an oral drug for MS, has completed phase III trials and will hopefully be launched in the US in 2013. The other two drugs include a pegylated form of Avonex interferon Beta1 and Daclizumab (a humanised monoclonal antibody). Over the next three years, we could potentially launch five molecules. We hope to be able to bring all
our pipeline products to India as well for benefiting the patients here. MNC companies in India have been in the line of fire with respect to clinical trials. What will you have to say on this? We firmly believe in the role of ethics in clinical trials. In India, we have been primarily engaged in phase II and III clinical trials. We conduct our clinical research in adherence to the (ICHGCP) international guidelines and local regulations. We invest in training the site personnel and working with global CROs to be able to ensure quality and ethics. To further ensure the patient privacy and ethics, we do regular audits on the conduct of the trials. We follow strict site selection criteria to only have the experienced and adequate centres contributing to the studies which are further strengthened by the local regulatory and ethics committee approvals. What is your view on the drug pricing policy? While we understand the need to provide affordable healthcare to the people of our country, price control is not the only way to provide access. Further, around 35 per cent of the country’s population which is below the poverty line will not be able to afford any price of medicines due to socioeconomic inequalities. Reduction in prices without simultaneous improvement in infrastructure, healthcare financing and putting in place a robust healthcare delivery process does not help improve availability of essential medicines for the rural masses. Also, for an industry that is based on innovation and is research intensive involving a lot of risk, there has to be an adequate risk-reward balance. Ultimately economy and market forces will dictate the price. Shalini g@expressindia.com November 16-30, 2012
'Autologous Chondrocyte Implantation (ACI) has a huge potential' RMS Regrow is the first and only commercial cell therapy company in India which is into Autologous Cellular Therapies. Satyen Sanghavi, Chief Scientific Officer, Regenerative Medical Services (RMS), talks about importance of this technology for cartilage regeneration, in discussion with Sachin Jagdale
INTERVIEW
What is the procedure of knee cap regeneration using Autologous Cell technology? The patella, or kneecap, is one of three bones, along with the tibia (shin bone) and femur (thigh bone), that make up the knee joint. All these bones are covered with a layer of cartilage at points. Anterior knee pain is a pain that occurs at the front and centre of the knee. It refers to many different problems, including: Chondromalacia of the patella- the softening and breakdown of the tissue (cartilage) on the underside of the kneecap (patella). Autologous Chondrocyte Implantation (ACI) is a procedure wherein a biopsy (sample) of the healthy cartilage tissue was taken from the patient's knee through an arthroscopy (keyhole surgery), which is a day care procedure. The harvested biopsy is then sent to the Stem Cell Processing Centre of RMS
–Regrow, where the Chondrocytes are isolated from the tissue, expanded and proliferated for three to four weeks. These cultured cells are implanted back into the defect site of patella or knee cap. Like nothing short of a fairytale, the patient can get back on their feet fully functional within four to six months. Which are other countries where this procedure is already in use? ACI procedure is available in the UK, Europe, the US, Netherlands, South Korea, Japan etc. What about the cost effectiveness of this treatment? Most available treatments provide temporary relief and the cost to avail regular periodic treatment can be quite unaffordable especially for the middle class which comprises a majority of the Indian popu-
lation. The treatment offered by RMS Regrow is much competitive when compared to other similar treatment like total knee replacement. We believe in long term benefits to the patients and a scenario of higher quality of life with increased productivity and efficiency in the healthcare system. Like complete knee cap generation using cell technology, is complete regeneration and transplant of knee cartilage also possible? What is RMS's success in this case? Yes, we have done complete regeneration of knee cartilage including early arthritis. Autologous Chondrocyte Implantation (ACI) has a huge potential, particularly for patients in the age group of 15-50. Cartilage cell implantation provides a new ray of hope for all such patients. In recent years, however, ACI has emerged as the oasis in the dry desert of cartilage defects and abnormalities. Known to be a two step surgical procedure, ACI has proven itself not only by the permanent repair that it provides but also because of its minimal
risk and surgical exposure. Healthy cartilage from the patient’s knee is arthroscopically harvested, cultured and then implanted into the defect site. After having seen phenomenal post-operative results in nearly 300 patients across various hospitals in India in last two years, with the help of regenerative medical services and a success rate of almost 98 per cent has been observed. Do you have any tie ups with the hospitals so that many patients would benefit with this discovery? The procedures/treatments offered by RMS Regrow are now available at all levels from corporate hospitals to day care surgical centres and private and government institutes. The company is broadening its reach to doctors through various CMEs, workshops and training programme which also trains supporting staffs. The success rates of these procedures are very high. We have done more than 350 cases of cartilage and bone implantation [Chondron and Ossron]. sachin.jagdale@expressindia.com
Implementation of similar biologic guidelines in India Rajashree Sharma, Partner, Corporate Law Group, views the guidelines as a catalyst for the current and future growth of Indian biosimilar products n June 2012, India’s Department of Biotechnology (DBT) and Central Drugs Standard Control Organisation (CDSCO) released guidelines on, Similar biologics: regulatory requirements for marketing authorisation in India describing how bio-pharmaceutical companies should address the quality aspects of similar biologic medicines and developing such products in India. It explains the requirements for the manufacture and comparability testing for biological medicines claiming to be simi-
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lar to another medicine already on the market. The guidelines have laid down the requirements regarding manufacturing processes, the comparability exercise for quality, considering the choice of reference medicinal product, analytical methods, physicochemical characterisation, biological activity, purity and quality attributes for relevant specifications of the similar biological product containing recombinant proteins and derivatives to support a marketing authorisation application.
Advantage India As these comprehensive guidelines provide a regulatory pathway to ensure that similar biologic drugs approved in www.expresspharmaonline.com
India are of good quality and demonstrably similar in efficacy, safety and immunogenicity to the reference products, Indian companies now have a good potential to become one of the key players in the development and manufacture of similar biologic drugs for the local population as well as for exports to highly regulated markets. Indian biopharma companies always wanted regulators to follow harmonised global standards in order to increase the competition for the product globally. At the same time DBT/CDSCO also wants to facilitate in creating an environment where international companies will be interested in using India as a place to manufacture biologic drugs. Therefore, an honest
effort has been made to have the guidelines in sync with international best practices and to harmonise them with international requirements for approval of similar biologics in India.
Biopharma market Biopharmaceuticals are medical drugs typically derived from living systems and produced using biotechnology. They are proteins including antibodies; nucleic acids used for therapeutic or in vivo diagnostic purposes, and are produced by means other than direct extraction from a native (non-engineered) biological source. Similar biologics are also Continued on Pg 113 EXPRESS PHARMA
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'We need to build a culture of drug discovery' Ara Healthcare, which received funding from DBT for preclinical studies on three novel molecules has made a step towards zeroing upon an anti-cancer molecule, still in the early stages of development. Dr Rama Mukherjee tells us about it and more in a chat with Shalini Gupta Tell us about the anti-cancer molecule being under development at Ara. We brought three molecules from Dabur Research Foundation(DRF) to Ara which were then modified and improved into ARA I, ARA II and ARA III. The data that we generated was interesting. ARA I which is currently in advanced preclinical stage has showed a lot of promise as a multi-functional molecule with anti-metastatic properties that could help prevent cancer spread in almost all types of cancer. It also showed chemosensitivity to most of the drugs being used against cancer. The molecule works at the level of basic signal transduction mechanism, reveal our latest findings. It also has moderate anti-cancer properties as we found with invitro studies done using nanomolar concentrations of the molecule. ARA I by itself results in 30 per cent filling of cancer cells and when used along withh Paclitaxel results in 60 to 70 per cent cytotoxicity, thereby confirming its efficacy. It could be a good value addition to existing drugs for the treatment of cancer. While taking it through preclinical development, we have found that it can be produced commercially. This is further substantiated by acute toxicity and 30 days toxicity data and also chemosensitivity of the molecule which is a good
marker. All the above facts will help us design a clinical trial better suited to the drug. How has the going been w.r.t. funding for the company? SBIRI expert committee has been supportive to us since our inception in light of a small company pursuing a few novel molecules. This has been a key encouragement for us to develop and commercialise molecules. We got an initial funding of ` 5 crore from SBIRI, out of which we utlised ` 2.5 crores and post that we have also received funding of same amount from Leapstart Trust, a VC fund. We have registered revenues of ` 4 crore last year with our molecular diagnostic arm supporting the R&D activity. Given the high costs incurred in drug development, funds are very important to sustain a start-up drug discovery firm till revenues don't start trickling in. How have the recent regulations impacted companies developing new drugs? Have they been enabling or posed newer challenges? We would like to follow regulatory guidelines, however, the procedures are expensive for small companies to invest in, thus challenging our sustenance. One has to use a common facility that is available on contract, this is not easily accessible for smaller
companies. The pilot plant facility set up by DBT for SMEs to do pre clinical and clinical is also not adequate. Western regulations are designed keeping the big pharma in mind. Instead of forcing companies to comply to norms, we need to look at technology that is usable and doable, but with too much activism on clinical trials it is difficult to do anything that leans away from global norms while not compromising on ethics. Indian pharma has for long rode the generics bandwagon. Your comments. Generic companies rule the roost in India as opposed to the West where novel drug companies are spokespersons of the industry. Once a company gets into manufacturing generics, there is a constant pressure to maintain growth at a pace that makes it difficult for a company to develop and commercialise new drugs, hence pushing any such activity down on priority. We as a country need to build a culture of drug discovery being the leading driver of the industry. Building R&D clusters, parks, incubation centres, where new companies develop and are supported could lead to an ecosystem where research and development is encouraged. How does biopharma industry rank on innovation? There are very few companies especially in the diagnostics space that are innovating, with R&D demanding long drawn out investments, sustainability is a major factor to be considered. We have no
institution for valuation of a molecule before it hits the market unlike the US. Our portfolio itself is worth ` 600 crores, but still we are facing difficulties getting funding. There has to be a greater acknowledgement of innovative products, tools and technologies alongwith creating a platform for commercialisation of them all that brings both the buyers and sellers together. An innovation culture that measures the quality and impact of innovation needs to be fostered. While Indian companies have cut down costs of anticancer drugs, MNC firms have been forced to cut down costs. Does cost control have to be at the behest of innovation? One doesn't have to be at the cost of another, we need to promote discovery and development of drugs within the country positioning it to be a leader in innovation. Science needs to contribute to the economy of the country, bringing Indian companies shoulder to shoulder with their MNC counterparts. Development of hard-core pharma science, molecular biology, instrumentation, reagents is lacking. The production of cheap generic drugs should not eclipse the innovation side which includes spending resources towards research and development of novel molecules. Policies should be structured in such a way that they look at economics instead of social point of view by empowering people to buy the drugs, instead of giving them cheaper drugs. shalini.g@expressindia.com
InLicensing/Out-licensing of novel technologies is the future of the pharma sector Vishal Gandhi, Managing Partner and CEO, BioRx Venture Advisors, shares the investment pharma sector is attracting, start ups environment and more in conversation with Shalini Gupta
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How is the PE/VC funding scenario like in pharma right now? On an average four out of 10 VC/PE deals in the past six to seven years have been in the India pharmaceutical and www.expresspharmaonline.com
healthcare sector. It is very encouraging and clearly speaks of large untapped domestic opportunity. However, there has been no upscaling of investment in the last one year due to an uncer-
tain regulatory environment which hasn't led to many product approvals. Henceforth, it is very critical to have clear regulatory pathways for new drugs/medical devices and defined timelines November 16-30, 2012
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coupled with robust capital markets in terms IPO to make this sector sustain its fund flow. Apart from PE/VC investments, Dept of Biotechnology /CSIR/DST have ramped up their investments (grants/soft loan) available to this sector to take on inherent risk in the sector to be able to support development of innovative products. From the sub sector perspective, medical devices and diagnostics are gaining further traction in terms of number of deals, from value side, pharma continues to attract larger funding. How is the M&A activity been? Is consolidation in the industry at a halt? We haven't seen any big deals in the last few months, companies are adopting a wait and watch approach in view
of the FDI policy which mandates all brownfield investments to be a screened by the Competition Commission of India(CCI). With companies who are looking at possible exits, having high value expectations, JVs are the flavour of the season, wherein both parties can share the risk and reward as compared to an outright acquisition. We have witnessed that few companies have adopted an approach of acquiring brands rather than entities as a whole, since it has a certain value in the market and hence doesn't have any market risk hence certain return to investors. How has the funding for SMEs been? Any new trends in the start-up environment? There are dozens of SMEs in Biopharma which have been able to get their round of
VC/PE funding towards developing novel products at preclinical stage. Usually we have witnessed one out of four proposals in average that have been able to secure private funding and one out of two for government grants and soft loans. New start ups are looking at developing strong platforms to expand the reach and distribution of branded generics instead of investing in core infrastructure such as plant and machinery towards manufacturing of formulations. Companies such as Eris Lifesciences and Mankind Pharma have adopted a light asset model and have been very successful in creating value for all stakeholders. I believe 'Light asset model' is the way forward. Startup Ecosystem has improved dramatically in last five to six years. As far as Biotech side of
industry is concerned, DBT has launched some innovative financing scheme to encourage product commercialisation from bench side to bed side..
In addition, post marketing surveillance and risk management plans should be in place for the approval of biosimilar products. The recent guidelines holistically have made an effort to address all these analytical factors when assessing similar biologics between a proposed similar biologic and a reference biologic for the purpose of marketing authorisation. The guidelines note that a well-defined manufacturing process and associated process controls ensure that an acceptable product is produced in accordance with good manufacturing practices (GMP). The guidelines further considered the importance of extensive analytical, physico-chemical and biological characterisation in demonstrating, elaborate functionality and immunogenicity that the proposed similar biologic is highly similar to the reference product notwithstanding minor differences in clinically inactive components.
tor known safety concerns and detect potentially unknown safety issues. The guidelines have been implemented on September 15. The defining principles which have guided India to formulate the similar biologics regulation will remain crucial to address the challenges until the first biotech product gets approved. India is an important jurisdiction due to a flourishing market for biologics and it also has a vibrant pharma industry which is leading the way in biosimilar development. India has the potential to position itself as a global leader in biotech industry and the newly created regulatory framework is harmonised with standards laid down by European Medicines Agency Evaluation of Medicines for Human Use (EMA) and World Health Organization (WHO). With these entire positive auras, Indian biosimilar products will certainly be recognised and accepted in the highly regulated western markets as the newly implemented guidelines will facilitate to comply with the stringent quality, safety and efficacy norms that are the hallmarks of internationally reputed biopharmaceutical brands.
With R&D budgets shrinking, do you see big pharma firms supporting early stage drug discovery firms along with VC firms in order to feed their pipelines? Yes, certainly, Indian CROs have adopted a risk-reward sharing model with big pharma in certain molecules during pre clinical stage. Having big pharma associated with the projects, VCs are always more comfortable in such scenario's as it increases the chance of good multiple exit to strategic player. InLicensing /Out -licensing of novel technologies is the future of the pharma sector in India. shalini g@expressindia.com
Implementation of... Continued from Pg 111 biopharma that are similar, but not identical, to an already registered reference biological product in terms of quality, safety, and efficacy. These products rely, in part, for licensing on prior information obtained from the innovator product and a demonstration of similarity based upon a detailed and comprehensive product characterisation. Unlike the more common 'small-molecule' drugs, biosimilars generally exhibit high molecular complexity, and may be quite sensitive to manufacturing process changes. The similar biologic manufacturers do not have access to the originator's molecular clone and original cell bank, nor to the exact fermentation and purification process. It is pertinent to note that the similar biologics market in India is in nascent stage; however, has considerable commercial potential. Indian similar biologic market is expected to reach around $580 million by 2012 to $1.4 billion in 2016 and about 25 Indian similar biologics have already reached the Indian markets. According to Global Biosimilars Market Analysis, the acceptability of similar biologic medicines is very high in the Indian domestic November 16-30, 2012
market and it has the potential to emerge as one of the leaders in global biologic development by the end of this decade. Furthermore, India is one of the leading contributors in the world biosimilar market and is the third-largest in the AsiaPacific region, after Australia and China.
Different criteria for biosimilars Factors that are working favourably for Indian biosimilar companies are the relative cost advantage of similar biologic product development compared to their competitors elsewhere. As similar biologics are not easily shown to be equivalent to the innovator products; therefore, there are different criteria for regulatory approval of similar biologics from traditional generics. The comparability studies are needed to generate evidence substantiating the similar nature, in terms of quality, safety and efficacy, of the biosimilar and the innovator product. Further, the reliable way of demonstrating similarity between a biosimilar and the innovator products is controlled clinical trials. As per regulatory measures non-clinical and clinical data are required to demonstrate the safety and efficacy of a similar biologic drug. www.expresspharmaonline.com
The road ahead The regulation has also taken care of extrapolation of the safety and efficacy data for a particular similar biologic product indication and a risk management plan for post market studies to moni-
The author can be contacted at rajashreesharma@clgindia.com EXPRESS PHARMA
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Abusing pain drug Opana can cause blood disorder: FDA The disorder causes clots to form in small blood vessels throughout the body, limiting or blocking blood flow to the organs RESEARCH UPDATE eople who abuse the prescription pain drug Opana ER by injecting it into their bloodstream risk developing a serious blood disorder that could result in kidney failure or death, US health regulators warned. Opana, a powerful opioid painkiller containing oxymorphone, is produced by Endo Pharmaceuticals. The blood disorder, thrombotic thrombocytopenic purpura, resulted in kidney failure requiring dialysis in some cases and at least one death, the Food and Drug Administration said. The disorder causes clots to form in small blood vessels throughout the body, limiting or blocking blood flow to the organs. Platelets, a certain type of blood cell, help the clotting process. When this disorder occurs, however, platelets clump together in the blood clots, making fewer platelets available in the blood in other parts of the
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body to help clotting there. This can lead to bleeding under the skin and purple-coloured spots called purpura, or to bleeding inside the body. Thrombotic thrombocytopenic purpura can cause death or lead to other complications with
permanent damage, including brain damage and stroke, in addition to kidney failure. The FDA said problems appear to occur with Opana ER only when it is abused and injected intravenously. Opana ER is meant to be taken orally
and should be taken only when prescribed and as directed. Prescription drug abuse leads to more deaths in the US than heroin and cocaine combined, and rural residents are nearly twice as likely to overdose on pills than people in big cities, according to the Centers for Disease Control. Law enforcement officials are alarmed by the rise of Opana abuse, which they said started after Oxycontin was changed in late 2010 to make that drug more difficult to snort or inject for a heroin-like high. Oxycontin is a brand of oxycodone. Opana abuse can be deadly because it is more potent, per milligram, than Oxycontin and users who are not familiar with how strong it is may be vulnerable to overdosing. Opana, known by such street names as 'stop signs', 'the O bomb', and 'new blues', is crushed and either snorted or injected. Crushing defeats the pill's 'extended release' design, releasing the drug all at once. Reuters
Lexicon bowel drug meets main goal of mid-stage trial The drug telotristat etiprate is being studied to treat carcinoid syndrome exicon Pharmaceuticals said its experimental bowel disorder drug met the main goal of reducing bowel movements in patients with gastrointestinal cancer in a mid-stage study. The drug telotristat etiprate is being studied to treat carcinoid syndrome, a secondary condition that develops in patients with tumours in the gastrointestinal tract. Of the 15 patients enrolled in the study, 75 per cent reported improvement
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LEXICON IS EXPECTED TO START LATE-STAGE TRIALS OF ITS DIABETES DRUG ITS MOST ADVANCED DRUG CANDIDATE IN THE FIRST HALF OF 2013 in carcinoid symptoms at week 12 of the trial. The study also met the secondary goals of reducing abdominal pain and improvwww.expresspharmaonline.com
ing stool consistency. The drug was tested on patients who were unable to tolerate somatostatin analog therapy the current treatment for
carcinoid syndrome. Telotristat etiprate is also being studied in a midstage trial to treat ulcerative colitis, a type of inflammatory bowel disease. Lexicon is expected to start late-stage trials of its diabetes drug its most advanced drug candidate in the first half of 2013. The company is also testing drugs for irritable bowel syndrome, rheumatoid arthritis and glaucoma. Reuters November 16-30, 2012
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GSK and Aeras to test TB vaccine in Africa, India Plan to launch a mid-stage phase IIb clinical study in Kenya, South Africa and India next year laxoSmithKline and the non-profit biotech group Aeras are to assess an experimental tuberculosis vaccine in 'proof of concept' tests in Africa and India, marking a step forward in the hunt for new ways to prevent the killer disease. The partners plan to launch a mid-stage phase IIb clinical study in Kenya, South Africa and India next year, following successful initial tests with the GSK product, Aeras said. TB is a growing threat around the world, especially with the emergence of strains that are resistant to multiple antibiotics. It kills
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Agenus. Adjuvants are substances that are added to vaccines to increase their effectiveness. Aeras and GSK will each provide resources to run the clinical trial in healthy adults aged between 18 and 50 years. The study is scheduled to begin in 2013, pending approvals from authorities. US-based Aeras is working on a number of other experimental TB vaccines with different partners, including one developed by scientists at the University of Oxford and another that is a collaboration with Johnson & Johnson unit Crucell. Reuters
an estimated 1.4 million people a year. The disease is spreading despite the widespread use of the currently available TB vaccine, Bacille Calmette-Guerin (BCG). BCG prevents some forms of TB but not pulmonary TB, which accounts for the majority of infections and deaths. The new GSK vaccine candidate being developed under the agreement with Aeras is designed to be used in addition to BCG. It contains GSK's proprietary antigen M72 and the adjuvant AS01E, which includes an ingredient licensed from Antigenics, a unit of
Folic acid doesn't cut risk of colon polyps: Study The study, led by Yiqing Song from Brigham and Women's Hospital in Boston followed 1,470 women with an average initial age of 62 aking extra folic acid and other B-vitamin supplements may not help protect against colon polyps, according to a US study that contradicts observational studies suggesting people who get more of the vitamins are less likely to get colon cancer. The study, led by Yiqing Song from Brigham and Women's Hospital in Boston and published in the Journal of the National Cancer Institute, followed 1,470 women with an average initial age of 62. The women were randomly assigned to take daily folic acid and vitamins B6 and B12, or a vitamin-free placebo pill, and then followed them to see who developed colon polyps. Women in the 'active' treatment group took 2.5 milligrams of folic acid, 50 mg of vitamin B6 and 1 mg of vitamin B12 each day. All participants had a colonoscopy or sigmoidoscopy to check for colon polyps, which can
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develop into cancer if not removed, sometime before mid-2007. According to their medical records, 355 had a confirmed polyp. Polyp risk was not related to treatment group, with 24.3 per cent of women taking the vitamins developing polyps compared to 24.0 per cent of those on placebo pills. The lack of benefit remained after the researchers accounted for women's weight as well as smoking, alcohol and exercise. “Where we really are is a kind of interesting impasse. The observational data continually show an inverse association between measures of folic acid, that is diet or blood level, and the risk of colorectal cancer. The clinical trial data such as we have, suggest no benefit overall,” said John Baron, an epidemiologist from the Geisel School of Medicine at Dartmouth University in Lebanon, New Hampshire,
who was not involved in the study. One hypothesis is that folic acid can help ensure DNA replicates correctly, which in theory could decrease the risk of cancer. But there's also been some concern that high doses of folic acid can feed the growth of pre-cancerous polyps in people who already have them. Baron, who wasn't involved in the study said that those worries are 'largely theoretical,' but they are a reason not to go overboard with folic acid nonetheless. He added that the combined data don't support the protective effects of B vitamins, over and above what's in a normal diet, on the colon. “Most people in the US are reasonably well nourished, and with folic acid supplementation now there's not serious concern about folate deficiency,” he said. Reuters www.expresspharmaonline.com
Pfizer says pain drug as safe as rival pills in trial The trial tested the safety of the drug, called ALO-02, when administered for up to 12 months fizer said a late-stage trial of its experimental pain drug showed that the drug's long-term safety profile was comparable to those of similar formulations. The trial tested the safety of the drug, called ALO-02, when administered for up to 12 months. The study enrolled 395 patients. About 61 per cent of them had chronic lower back pain and 18 per cent had pain from osteoarthritis. About 60 per cent of the patients discontinued from the study over the one-year period, with 19 per cent of patients reporting adverse events as the primary reason for discontinuation, Pfizer said. The pill uses a technology that discourages common methods of drug abuse associated with prescription opioid use and consists of an extended-release oxycodone pellet that surrounds a core of naltrexone a drug used to treat alcohol and opioid addiction. When used as directed,
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patients receive oxycodone in an extended release manner. But if the pills are crushed, the naltrexone is released and counteracts the effects of oxycodone. Abuse of prescription opioid painkillers is a serious concern in the US and doctors
THE PILL DISCOURAGES COMMON METHODS OF DRUG ABUSE ASSOCIATED WITH RX OPIOID USE WITH AN EXTENDEDRELEASE OXYCODONE PELLET have even urged the US health regulator to change prescription guidelines for opioids to prevent abuse. Reuters EXPRESS PHARMA
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Pharma Technology Review Colorcon Asia launches new products at CPhI India C olorcon Asia announced the expansion of its product line to include several new film coating alternatives. It has launched Opadry CA, a fully formulated osmotic coating system. This product is the first, one-step, semipermeable membrane designed to ensure consistent release from osmotic pump tablets. Use of the product reduces preparation and manufacturing time by at least two hours, with consistent coating quality. The company has also launched Opamix, a pre-formulated additive blend developed in collaboration with the BASF. The additive
THE COMPANY HAS ALSO LAUNCHED OPAMIX, A PRE-FORMULATED ADDITIVE BLEND DEVELOPED IN COLLABORATION WITH THE BASF.THE ADDITIVE IS DESIGNED FOR USE WITH KOLLICOAT SMARTSEAL 30 D. IT EFFECTIVELY MASKS UNPLEASANT TASTES is designed for use with Kollicoat Smartseal 30 D. It effectively masks unpleasant tastes and can be applied to a variety of solid forms including tablets, granules or smaller particles.
In addition, Colorcon has recently expanded the Opadry 200 product range to include formulations designed for use with actives known to interact with polyethylene glycol (PEG). The new formulas present addi-
tional colour and final product stability along with the fast coating process times and high level of moisture protection already provided with these optimised performance coatings. “Colorcon is excited to expand its scientifically validated pharmaceutical formulation coating systems and to continue our leadership role in bringing technological advancements to pharma manufacturers worldwide,” said Kamlesh Oza, General Manager, Film Coatings, Colorcon. Kollicoat and Smartseal are registered trademarks of BASF EP News Bureau
Cellectricon launches Cellaxess ACE Adherent Cell Electroporation System C ellectricon, a provider of advanced cellbased screening technologies and services to accelerate drug discovery and cell-based assay research, has launched Cellaxess ACE Adherent Cell Electroporation System which represents a revolutionary in-situ transfection of any adherent cell type. Developed to meet the growing need for in-situ transfection of hard-to-transfect adherent cell types, the platform enables transfection and delivery of non-genetic material in any adherent cell type at any developmental stage. The platform enables insitu primary and iPSCderived cell types directly in 96 - and 384-well microplates and cell culture dishes at any cellular developmental stage with excellent viability and completely retained cellular morphology. Cellaxess ACE is available as a complete system, but can also be integrated with third party pulse generators.
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“We are thrilled with the Cellaxess system. It has allowed us to routinely transfect many different types of cultured primary neurons in their adherent state, something that has not previously been possible,” said Professor Peter Baas, Department of Neurobiology and Anatomy, Drexel University, Philadelphia, US. www.expresspharmaonline.com
Applications for the Cellaxess ACE include transfection of various types of neuronal cells such as hippocampal and cortical neurons, dorsal root and superior cervical ganglia from rat, as well as mouse, and human iPSC-derived dopaminergic neurons, to mention a few. Protocols are available for a wide range
of neuronal cells as well as other adherent cell types. EP News Bureau Contact details: Cellectricon Contact: Johan Pihl, Cellaxess Product Manager Phone: +46 (0)31 760 35 00 E-mail: johan.pihl@cellectricon.com November 16-30, 2012
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Winners of first ‘Merck Millipore India Innovation Awards’ 2012 announced The awardees include scientists from governmentfunded and non-profit public research institutes erck Millipore [India], the life science division of Merck KGaA of Darmstadt, Germany announced the first set of winners of the ‘Merck Millipore India Innovation Awards’ 2012 (MMIIA). The MMIIA was set up in 2011 to recognise exemplary research undertaken by scientists from government-funded and nonprofit public research institutes in the fields of life science, i.e. green chemistry, medicinal chemistry, chemical and bio-analytics, proteomics, genomics, drug discovery and delivery, biomanufacturing, biomarkers and synthetic biology. The following three winning teams were selected from over a hundred applicants: The first prize of ` 30,00,000 was awarded to Dr Tapas Kumar Kundu, Principal Investigator from Jawaharlal Nehru Centre for Advanced Scientific Research, Bengaluru, Dr Ruthrotha Selvi Bharatha Vikru, Hari Kishore Annavarapu, Dr Mantelingu Kempegowda from Jawaharlal Nehru Centre for Advanced Scientific Research, Bengaluru. The second prize of `
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20,00,000 was awarded to Dr Dhiraj Kumar, Dr Ahmad Faisal Karim, Pallavi Chandra, Aanchal Chopra, Zaved Siddiqui, Dr Ashima Bhaskar, Dr Amit Singh from International Centre for Genetic Engineering and Biotechnology, New Delhi. The third prize of ` 10,00,000 was awarded to Dr Rita Kumar, Dr Abha Joshi, Dr Anil Kumar, Dr Tushya Kumar Saxena from Institute of Genomics and Integrative Biology, Delhi. Addressing the selection process, Dr Theodor Dingermann, Director of the Institute of Pharmaceutical Biology at the GoetheUniversity in Frankfurt and a member of MMIIA’s Scientific Advisory Board said, “India is a global leader in biotechnology, medical and health research, and R&D by the scientific community here is extremely promising. I am honoured to be a part of the MMIIA selection panel that aims to nurture the budding scientists and appreciate their significant contribution to the field of life sciences. The final selection criteria were based on the relevance of the project for the Indian society, novelty, the application, sustainability, commercial potential and impact of the project at the regional, national and global level.” Dr Claus-Dieter
Boedecker, Managing Director, Merck remarked, “The pharma market in India is growing at an accelerated pace and Indian scientists have made a significant contribution to this growth. The Merck Millipore India Innovation Awards is a biannual event with an aim to provide Indian scientists outside of the commercial research centres with appreciation and recognition. Through this award we wish to fulfil their research aspirations and provide them the necessary resources to excel. The MMIIA reflects our global vision of being a leader in pharmaceuticals, chemicals and life science.” Prantik Mukherjee, Head — Lab Solutions, Merck Millipore in India added, “The ‘Merck Millipore India Innovation Awards’ is the first-of-its-kind award conceptualised by Merck Millipore [India] in 2011. The eligibility criteria comprised of whether the research is funded by the government or non-profit institutes in India, innovations in life sciences, innovative products, technologies, processes, patents granted and papers published in 2011 and publications in highly ranked scientific journals. We are proud to honour eminent researchers in the country through this award and present a platform to fur-
ther showcase their commitment to the life sciences sector.” Besides Dr Dingermann, the Scientific Advisory Board and the jury for MMIIA comprised of the following distinguished scientists from India and Germany: Dr Dhrubajyoti Chattopadhyay, Pro-ViceChancellor (Academic), Calcutta University Director, Centre for Research in Nanoscience and Nanotechnology at Calcutta University; Dr Karl-Heinz Derwenskus, Senior Vice President, Head of Innovation Strategy, Technology Office Chemicals, Merck KgaA; Dr Yamuna Krishnan, Senior Assistant Professor, National Centre for Biological Sciences, TIFR, Bengaluru, India; Dr Ramesh Chander Kuhad, Professor at the Department of Microbiology in University of Delhi South Campus, New Delhi; Professor GD Yadav, Vice Chancellor and RT Mody Distinguished Professor of the Institute of Chemical Technology, Mumbai | JC Bose National Fellow; and Dr JS Yadav, Director Indian Institute of Chemical Technology, Hyderabad, India. EP News Bureau
Eppendorf launches 'Mobile Pipette Calibration Facility' to expectations is especially important when working to defined regimes or work protocols. Customers who intend to calibrate their pipettes can contact Eppendorf’s Chennai office to get the vehicle to their facility. The calibration will be conducted in the parking
ppendorf, a life science company that develops and sells instruments, consumables, and services for liquid, sample, and cell handling in laboratories worldwide, has launched “Mobile Pipette Calibration Facility” in Chennai. Pipette calibration is an important part of any laboratory's routine. To ensure that pipettes are always working according
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lot. The calibration certificate will also be issued instantly. Contact details: M Anthoni Jai Kumar Eppendorf India Chennai Tel: +91 44 421 11 314 Fax: +91 44 421 87 405 Email: anthoni.jk@eppendorf.co.in Website: ww.eppendorf.co.in EXPRESS PHARMA
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Thermo Fisher Scientific launches next generation high-speed centrifuge series hermo Fisher Scientific announced the new Thermo Scientific Sorvall LYNX superspeed centrifuge series, delivering productivity, safety and reliability to maximise everyday centrifuge use in shared laboratory settings. The Thermo Scientific Sorvall LYNX centrifuge features a 100,000 x g top speed performance and supports high-throughput sample processing from 50 mL conical tubes and microplates to 1 L bottles, up to a six-litre capacity, meeting the evolving needs of academic research and production facilities alike. Run set-up is easy with the intuitive touchscreen interface featuring a bright, highly visible and durable display, while on-board video tutorials and access controls, such as user login with password protection, provide advanced training and programming options. “Today’s researchers require centrifuge performance that is simplified, to accommodate the reality that labs have multiple users with
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different experience levels and a variety of processing requirements,” said Maurizio Merli, global product director, centrifugation, Thermo Fisher Scientific. “Our new
Sorvall LYNX superspeed centrifuges dramatically simplify high-speed centrifuges while increasing user safety and peace of mind. We accomplish this with breakthrough technology advancements, such as the Auto-Lock rotor exchange, Auto-ID instant rotor identification and carbon fiber rotors.” The Sorvall LYNX superspeed centrifuge series features built-in safety and rotor technology innovations
that shorten run set-up time and increase security, including: Secure, push-button Auto-Lock rotor exchange in less than three seconds, ensures that the rotor is automatically and securely locked and will not loosen during a run, enhancing user confidence. Auto-ID instant rotor identification recognises a rotor when secured in the chamber, improving safety, saving time, and protecting the integrity of your samples. Lightweight, corrosion-resistant Fiberlite carbon fiber rotors, including the new Fiberlite LEX designs, improve ergonomics and performance. Rotor lids for microbiological containment, certified by the Public Health Laboratory Service, Porton Down, UK. Latest in global safety compliance without the need to bold down the instrument to the floor, simplifying installation
and providing flexibility to relocate. Contact details: Meenal Shinde Sr Executive - MarCom Laboratory Products - India Thermo Fisher Scientific 403-404, B-Wing, Delphi, Hiranandani Business Park, Powai. Mumbai - 400 076, India. Tel: +91 22 6716 2200 Direct No: +91 22 6716 2259 Fax: +91 22 6716 2244 Toll Free No: 1800 22 8374 www.thermofisher.com or www.thermo.com
HEL conducts workshop on hydrogenation and catalytic processes 53 participants from 28 companies took part in the workshop
EL, a leading manufacturer of process development and safety systems right from small volume parallel screening, mid-volume optimisation and scale up with technology transfer by automated pilot reactor upto 50 litre, recently conducted a workshop in Mumbai. Around 53 participants from 28 companies
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took part in the workshop. Major research institutes like BARC and UICT also took part in it. A half-day presentation on 'Continuous and batch process development for hydrogenation and other catalytic processes 'was conducted by Dr Jasbir Singh, Managing Director, HEL. Dr Dhananjay Sathe, Vice
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President, Unichem Laboratories, stated that the workshop to be ' a good overview and comparison of data with regard to batch and continuous flow process' and Dr Deepak Satoskar, Head of R&D, Johnson Matthey, mentioned that it 'was a good workshop on hydrogenation and catalytic reactions'. HEL has been involved
with many customised projects with many companies such as GSK, AstraZeneca, Pfizer, Syngenta, Abott, Teva, Dishman, Watson Pharma, Dr Reddy's Labs, Cipla, HEMRL, CFEES, Defence Lab, IGCAR, UICT, US Vitamins, Sai Advantium, AptuitLaurus, Alembic, Lupin, Advinus, Shell to name a few of them, for their process developmental activities through automated reactors for different volume, process safety through Reaction Calorimetry, Adiabatic Calorimeter as hazard assessment devices, and various systems for hydrogenation, crystallisation and parallel chemistry. HEL is the supplier of more than 1,000 customised automated reactors for many applications EP News Bureau November 16-30, 2012
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EZ-fill vials and cartridges A solution for clean and sterile pharmaceutical glass containers ready to be filled he first ready-to-fill containers (syringes) were launched with success in the pharmaceutical market from the Seventies as a solution for clinical phases. During these last decades nobody thought to develop a different type of ready-to-fill container, such as vials or cartridges because nobody ever defined a standard to do it. Starting from its successful business case of the EZ-fill syringes, Nuova Ompi (main company of Stevanato Group’s glass division) developed a standard to extend the ready to be filled containers range to vials and cartridges. The EZfill vials and cartridges solution is an innovative option because it allows pharma companies various advantages: lower time to market, higher quality and safety, Total Cost of Ownership (TCO) reduction, process standardisation and filling flexibility providing a common filling platform for vials, cartridges and syringes. The manufacturing development process for new or existing drugs, especially for the emerging biotech needs or
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small batch needs such as orphan drugs, is very often in a stand-by phase or it is frequently delayed due to the limited availability of filling options and formats at existing aseptic lines. The effective availability of containers for direct filling operations could represent a consistent reduction of the time-to-market cutting cost related to the manufacturing process. Until few years ago, only syringes were available in the market in nest and tub in a steribag: a configuration that ensures a standard machinable format able to keep particle content below limits assuring sterility, thus preventing the PharmaCo from expensive treatments. The lack of different types of sterile containers does not always allow very specific production like clinical trials or orphan products
and so it implies a huge investment in capitals for washing and the sterilisation of the container itself, resulting in a consistent TCO and increased time-to-market. For this reason Stevanato Group, among the top leaders in the glass-tubing converter market, has been developing a new standardised production process to extend the existing 'ready to be filled' concept (already launched in 2007 for the syringes) to a wide range of glass containers for pharma use, including vials and cartridges: the 'EZ-fill vials and cartridges.' This kind of solution provides clean, sterile, not pyrogenic and ready to be filled glass containers for pharma use. These are different from syringes and which can be used in injection devices, simplifying and standardising the traditional production process.
In fact, with EZ-fill vials and cartridges, PharmaCo and CMO can outsource even more 'non-core' manufacturing process, thereby reducing overall costs and concentrating resources on added value 'core' activities, such as aseptic finish and filling. The development of the EZ-fill project represents a synchronised effort between the two divisions (Glass and Engineering) combining glass forming technology with engineering experience. In fact, the involvement of SPAMI (representing the Group’s Engineering Division), specialises in the design, manufacture, installation and aftersales support of high-speed precision machinery for the production and control of glass containers, as well as vision inspection systems, provided the technological support during the project. The application of SPAMI technology guarantees 100 per cent cosmetic control on vials and cartridges and no glass to glass contact. Moreover, an important point which needs to be considered is that the concept has been approved and developed with the main manufacturers of fill/finish machines and it can therefore be easily integrated into the already existing pharma manufacturing filling lines installed. Everyone of them may have format change parts already fully suitable and industrialised for the EZ-fill concept. Machine manufacturers have been involved in the development of the packaging design and concepts for proper handling and machine-ability with a wide range of fill/finish units. In addition to that, EZ fill vials and cartridges can be easily managed in clinical trials and small batch productions thanks to new machines developed by the main filling machines manufacturers, designed to be used in sterile room applications, in accordance with cGMP regulations. Changeover to different sizes can be carried out quickly, easily and without tools, by exchanging complete sets of format parts.
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tridges process can be described in the following phases (see figure): Incoming materials: Vials and cartridges are supplied to the EZ-Fill area (ISO7 and ISO5 under laminar flow); Washing: Vials and cartridges are washed into the washing machine with WFI (Water For Injection); Siliconisation: Cartridges are optionally siliconised with high performances layer distribution process; Heating: Drying and depyrogenation in an oven. The cycle is optimised in order to reduce the timing and assure an optimal drying; Packaging: The final steps place the vials and cartridges into two final packaging solutions: 1) Tray: One piece box 2) Nest&Tub: Standard nest&tub format as the PFS one Both are sealed with a Tyvek lid, packaged in steribags and case-pack allowing for sterilisation. Key attention is given to the cleanliness of the packaging components as to the production of the glass container itself. Final configuration includes packaging in pallets. Final sterilisation: Filled tubs/tray in steribags are sterilised by Ethylene Oxide (EtO). Ethylene Oxide sterilisation is mainly used to sterilise medical and pharma products that cannot support conventional high temperature steam sterilisation. This process is completed by aeration. Further developments/validation of alternative terminal sterilisation methods are ongoing, as requested from most of the top pharma companies. Capping: Cartridges can optionally (upon customers’ request) be pre-capped with selected rubber formulations. Nuova Ompi has already
launched an EZ-Fill industrial process. The second step after implementation of pilot process, and expansion of the same area. The EZ-fill process is GMP oriented, already approved by several main top pharma companies. TCO: Total Cost of Ownership for pharma companies. In a traditional manufacturing approach using a bulk vial or cartridge, there is the need to wash and depyrogenate them before the filling and closing by capping and crimping. With EZ-fill, at the pharma environment there is still the filling and closing but no more the washing and depyrogenation tunnel. A further strength is keeping compatibility with existing equipment (minimum change) and filling lines but also process simplification at pharma site and reduced costs for production equipment (washing line, depyrogenation tunnel, etc.). Other strengths are a faster validation time, a saving on production area size, a saving on qualification operations and validated state management. The result is that the EZfill approach has positive impact on the Total Cost of Ownership (TCO); Cost of Packaging: At industrial quantities, same model of syringes; Capital Investment: The concept allows a significant reduction of the capital investments because implementing the EZ-fill approach means less machines, less space, less clean rooms, less utilities, etc.; Cost of Operations (for the PharmaCo): for the same reason this concept lower the costs associated to the acquisition, validation and maintenance of traditional lines (less operators, less variable costs, less maintenance, etc.); Cost of NON Quality: considerable reduction of the breakage rate expected at
PharmaCo and prevention of recall phenomenon in the market. Another main advantage of the EZ-fill model is its flexibility: fill/finish “combo” machines able to manage vials, cartridges and syringes in a standard nest&tub format (EZ-fill platform) are already available on the market.
contracted to the other pharma primary packaging producers in order to have a unique format solution. Summarizing, the actual portfolio of EZ-fillTM Vials & Cartridges comprises the 3ml Cartridge in nest&tub format, the 2R, 4R, 6R, 8R and 10R Vials both in nest&tub and in tray configuration. More options are available upon request.
Fill finish flexibility
Conclusion
Combo machines carry out the following workflow: automatic steribag opening, surface decontamination, tyvek removal and a system to extract the glass container from the nest in order to process them in a segment transport system line in a conventional filling unit. The use of this kind of machines allows an immediate saving and an optimisation of manufacturing operations and avoids the need to use several machines for each container. Therefore, the EZ-fill approach is particularly interesting for CMO and all pharma companies that need to support customers with different containers from early steps of clinical trial up to the product launch with the big advantage to save also time. Two packaging options for an easy integration with the existing filling process: Tray or Nest and Tub The possibility to have two different formats of packaging (nest&tub and tray) is also a good advantage point: the tray sealed with Tyvek lid and protected by a steribag is the ideal solution for existing linear filling line, on the other hand, the nest placed inside a tub (sealed with Tyvek lid and protected by a steribag) is suitable for existing x-y syringe filling processes. The nest and tub format is becoming the new industry standard that could be sub-licensed or sub-
The extension of the EZfillTM range to different types of glass containers besides syringes has been permitted thanks to the strong exchange of information that Nuova Ompi had with all the leading machine manufacturers. It represents an example of direct co-development of a project by merging the skills of a manufacturer of glass containers for pharmaceutical use with the experience on aseptic filling with all the best known manufacturers of pharmaceutical equipment, in order to provide a high quality product. Thanks to all these synergies and the implementation of innovative approaches, Stevanato Group puts now on the market an extended range of clean, sterile, not pyrogenic glass containers, ready to be filled, with the following peculiarities: WFI—washed glass containers, using a validated washing and drying cycle and a set of utilities and procedures for fast switch between different types of containers and formats; Glass containers arranged in innovative nest and tub which will prevent, as for the syringes today, the glass-toglass friction, for the highest cosmetic quality of products; Packaging operations in Class ISO5/ISO7 environment; Packaging units subjected to a validated EtO sterilisation process.
Flexibility
Ion Exchange to display high purity water solutions at PMEC 2012 on Exchange (India), which pioneered water treatment in India and is today the country’s premier company in water and environment management, with a strong international presence, will display the INDION ROEDI High Purity Water Generation and Distribution System at PMEC 2012, Hall 5, Stall L42, Bombay Exhibition
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Centre, Mumbai, which will be held from November 21-23, 2012. The key features of the INDION RO-EDI are: Fully pre-validated to industry accepted standards; Packaged on single skid; Hot water sanitization; Fully functional FAT (factory acceptance test); Compliance with latest USP, Ph Eur, cGMP/cGAMP & ISPE www.expresspharmaonline.com
specifications and design standards; Fully automated with SCADA Ion Exchange has maintained a close, productive association with the pharma industry for over 48 years. Its complete, integrated, specially designed solutions include demineralised water, purified water, pyrogen-free water and water for injection that are
critical to the pharma industry's processes. Dedicated experience in total water and environment solutions, technological expertise and extensive R&D enable Ion Exchange (India) to deliver customised, specialty systems that meet stringent requirements for high purity water generation. EP News Bureau November 16-30, 2012
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CONTEC AIR FLOW PROJECTS PVT . LTD. Building No-6 , Gala No - 138, Mittal Industrial Estate, Andheri Kurla Road, Andheri East, Mumbai- 400 059. Tel - 022- 2859 8231/39 Mob - +91 9320 255 124 Fax- 022 - 2859 8229 Email : mks1_contec@yahoo.co.in. info@contecair.com. Website - www.contecair.com
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Alok Industries Limited (Alok) is the largest diversified and integrated textile manufacturer in India. Alok's state-of-the art Packaging Division, amongst the largest in the country, has purchased the licence to produce UNIPAL corrugated pallets in India under the brand name, "Alok Unipal". “Alok Unipal" is a modular system to manufacture corrugated pallets. UNIPAL currently operates in more than 10 countries across the world and is known to outperform all other corrugated pallets in the market today. An "Alok Unipal" Corrugated pallet is a patented, innovative system with flexible construction, high strength characteristics made of water resistant Kraft paper which does not require any fumigation for Export Purposes .By choosing "Alok Unipal" you will be choosing an environmentally friendly way of doing business.
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PHOTON AUTOMATIONS PVT. LTD
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■ Ahmedabad: Rajesh Bhatkal
EXPRESS PHARMA
09831182580 / 09830130965 09821313017
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November 16-30, 2012
Express Pharma Business Avenues www.airtechsys.in
An ISO 9001: 2008 Certified Company
The art of air management
the leading air management solution provider... Airtech is a customized air solutions provider. Since its inception in 1992, Airtech has cultivated an in-depth understanding and expertise of executing turnkey HVAC & Clean Room Projects. Airtech undertakes complete project management comprising of design, supply, installation & commissioning and validation of HVAC and Clean Room Systems. Airtech's Clean Room system provides an ultra-clean environment ranging from Class 100 to Class 100000 with effective control of Air flow, Pressure, temperature, Relative humidity and Filteration suitable for Clean room applications.
Modular Clean Room PUF / EPS WALL / CEILING Partitions -Thickness Range: 50-200 mm.
HVAC System
Clean Room
CLEAN ROOM EQUIPMENT AND ACCESSORIES
Reverse Laminar Air Flow (Dispensing & Sampling Booth)
Horizontal LAF Unit
Air Showers
Static Pass Box
Dynamic Pass Box
Garment Cubicle
EXPERTS IN HVAC & CLEAN ROOM SOLUTIONS Airtech offers Validation services which comply with DQ, IQ, OQ & PQ protocols conforming to following WHO cGMP US FDA UK MHRA AUS TGA International Standards ( Green Field Projects ): South Africa MCC
AIRTECH
CORPORATE OFFICE: (Mumbai) B-110, Hind Saurashtra Estate, Marol Naka, Andheri (East), Mumbai - 400 059. Tel: +91 9322218023 /+91 9324644630 /+91 9699626434 /+91 22 28592275 E-mail: sales@airtechsys.in, sunil.airtech@gmail.com • Website: www.airtechsys.in
DEALERS November 16-30, 2012
ENQUIRY www.expresspharmaonline.com
VISIT OUR STALL AT P-MEC-2012 21-23 NOV. HALL No.6 STALL No. B-64
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Express Pharma Business Avenues ONE STOP SOLUTION FOR PHARMACEUTICAL RESEARCH
Innovation is our culture…
Quality in our genes…
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BIOSIMILAR TESTING
SERVICES
ACCREDITATIONS USFDA registered cGMP control testing laboratory DSIR approved R & D Centre Drugs Controller General of India (DCGI) NABL accreditation for Chemical, Biological Medical Testing, Bioanalytical & Mechanical Recognized by Bureau of Indian Standards Drugs Control Administration (A.P) Department of Biotechnology approved Institutional Bio-Safety Committee (IBSC)
Formulation Development Microbiological Studies Biological Studies Pre Clinical Studies Analytical Research Bio-equivalence Studies Clinical Trials Dossier Preparation
4($( E(#(6","#$ .+('$%'"/ %# 1 2@; V;I1 (+" !"/%6#"! $) "#/=+" $)$(9 %#$"6+%$<7 /"'=+%$< (#! &(/$"/$ +"$+%"J(9 )& !($(W
SIPRA LABS LIMITED Industrial Estate, Sanathnagar, Hyderabad – 500 018. Tel: 040-23802000, Fax: 040-23802005 Email:sipra@sipralabs.com web: www.sipralabs.com November 16-30, 2012
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Express Pharma Business Avenues SPACEAGE
SPACEAGE
SANITARY RO SYSTEMS
Meet us at Stall No. A3-28
UF SYSTEMS
USP Purified Water Storage, Distribution & Loop Piping Turnkey solutions
CIP SYSTEMS
Over the last 10 years we have been Engineering & delivering systems for Purified Water Storage & Distribution with Loop piping. Repeat orders prove how our engineering and design benefit our clients
Ease of Validation Lower Operational costs Lower Effluents -
HEAD OFFICE: Flat No. G 1, Sri Sai Residency, Karkhana, Secunderabad – 500 0015 A.P. Tel : +91 40 32500704, +91 9848129507, 9848597481 ; MUMBAI OFF: Apollo Ind. 30-G, Gr. Flr. Apollo Ind. Estate, Opp. MIDC , Andheri –[E]
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FLC – filling and closing machine For vials and infusion bottles
Short delivery times due to
Versatile Solutions for medium
Filling Systems
output range
Depending on the product character-
The FCL is extremely flexible and
istics, five different filling systems are
reliable, meeting the highest techni-
available: rotary slide valve pumps,
cal standards with an excellent price/
a time-pressure filling system, rolling
benefit ratio. The continuous motion
diaphragm pumps, Bosch Peristaltic
machine provides a processing range
Pumps and a filling station with mass
with filling volumes of 0.5–500 ml.
flow metering. Furthermore, a
A “V-cleat” conveyor system offers
combination filling station is optional.
modular machine structure. Flexible processing, ranging from 0.5 to 500 ml. Integrated LF infeed turnable with large central opening. “V-cleat” conveyor system with automatic container size changeover (optional feature). Size components can be used for
advantages in ease of size changeover. An innovative control system
Fully automatic in-process weight
provides ease of use, high reliability
control (IPC)
Carrying container transport.
and reproducible production settings.
The IPC system (optional feature)
Gentle motion of the container
removes the containers in batches
transport through filling and
Transport system – flexibility via
from the conveyor system for tare
stoppering ensured by continuous
ease of size changeover
and gross weighing and then feeds
mode of operation.
The new linear conveyor system runs
them back into the system. If a
horizontally in continuous motion.
deviation in filling weight is detected,
(IPC) with automatic adjustment
The containers are guided by inter-
it is corrected by fully automated
of the individual filling heads
changeable size components
adjustment of the filling point.
a range of container diameters.
Fully automatic in-process control
(optional feature). Batchwise removal of containers
attached to the carrier system. Horizontal adjustment of the
FLC – the secure investment for
conveyor system allows containers
medium output range
with various diameters within a
Key features
Feed” delivery of stoppers to
specified range of sizes to be
Easily accessible, compact
minimize the risk of particle
processed without changing the size components. All sizeparts can be exchanged without tools.
structure.
for tare and gross weighing. Stoppering station with “Clean
contamination.
Outstanding price/performance ratio.
Integrated control panel (touchscreen). FLC with closed RABS execution.
Bosch Limited Packaging Technology Division NEW DELHI: Mr. Priya Ranjan Kumar Singh Mobile: +91 987 1728832; priyaranjan.kumar.singh@in.bosch.com MUMBAI: Mr. Suhas Rai Mobile: +91 982 0421660; suhas.rai@in.bosch.com FLC filling and closing machine
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Advertise in
Business Avenues Please Contact: ■ Mumbai: Rajesh Bhatkal 09821313017 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai: Vijay Kulkarni 09940047667 ■ Bangalore: Khaja Ali 09741100008 ■ Hyderabad: A K Shukla 09849297724 ■ Kolkata: Ajanta / Prasenjit Basu 09831182580 / 09830130965 ■ Ahmedabad: Rajesh Bhatkal 09821313017
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It is time to go with Genetix for Tissue Culture Labware
Technology Breathing Nature
Tel: 011-45027000
November 16-30, 2012
Fax: 011-25419631
Email: info@genetixbiotech.com
www.expresspharmaonline.com
Website: www.genetibiotech.com
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Want to know more? s for ty i act U Cont Opportun om s .c s x e e n n i Bus .in@cog les at sa
Cognex Sensors India Pvt. Ltd., Regus Level 6, Pentagon Towers P II, Magarphatta City, Hadapsar, Pune - 411 028. INDIA. Mobile: +91 98814 66003 • Tel.: +91 20 4014 7840 • email: support@cognex.in
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THE UNITED ENGINEERING COMPANY
UNITED “AFS-10” HI – SPEED AUTOMATIC AMPOULE FILLING AND SEALING MACHINE
UNITED “SAL” FULLY AUTOMATIC SELF ADHESIVE VERTICAL BOTTLE LABELING MACHINE FOR ROUND / OVAL / FLAT BOTTLE(SINGLE / BOTH SIDE LABELLING)
OUTPUT: 15000 to 18000 Ampoules/Hour RANGE : 1 ml. – 10 ml.
OUTPUT – 3000 to 12000 Bottles/Hour (Output depends on Bottle size & Label size)
Salient Features : n
n
Salient Features :
In feed of empty washed and sterilized ampoules with the help of conveyor or S.S.
n
Hopper and S.S. Tray.
n
Automatic collection of filled and sealed ampoules in erect position.
n
Vertical & Horizontal adjustment of label applicator and label position to handle
n
Both sides labelling machine is available for flat bottles. Same machine can handle round and flat bottles with minimum change parts.
n
Individual No Ampoule No Fill Arrangement.
n
S.S. 316 L syringe with rotary valve with a single volume adjuster.
Accurate Label Placement. Label dispensing with Servo Motor and Servo Drive for better accuracy. different size of bottles by means of Hand wheel.
n
A.C frequency drive & geared motor.
n
n
Fully PLC controlled with touch screen & HMI.
n
n
Machine body fabricated with Stainless Steel 304 quality.
n
Machine body is fabricated with S.S. 304 Structure & Cover.
n
Easy change over with minimum setting time for different size of ampoules.
n
Easy Change Over.
Fully PLC controlled touch screen with HMI & AC Frequency Drive.
“UNITED” PROUDLY INTRODUCES MOST COMPACT HI-SPEED ONLINE VIAL WASHING MACHINE WITH ULTRASONIC WASH AND PLC SYSTEM MODEL – “OL-VW-12”
UNITED HI-PRO “ ARBW” AUTOMATIC ROTARY BOTTLE WASHING MACHINE
CAPACITY - 5ml. to 30ml. Round Vials. OUTPUT - 10000 to 14000 Round Vials/Hour
CAPACITY - 10ml. to 1000ml. Round Bottles. OUTPUT - 4800 to 8400 Bottles /Hour.
n
Salient Features : n Most Compact Design. No Bottle No Washing. n Machine supplied with 2 pumps for two different media of water fitted with filter and s. s. housing. n Conveyor driven by separate motor with AC Frequency Drive n The washing area is covered with acrylic sheet. n All pipes connected to water are as per GMP standard. n Machine can be used for air/water cleaning or even combine cleaning. n Versatile machine used for Glass/PET/HDPE bottles of different shape and size with additional change parts. n Easy change over with variable size. n Automatic loading and unloading of bottles. n After washing the bottles are directly fed to the filling machine without any hand touch. n Machine will stop automatically in case of bottle jammed at out feed. n
Salient Features : Most Compact Design.
n
PLC with HMI and AC Frequency Drive.
n
Minimum change parts.
n
Entire machine and contact parts with water & air are made of S.S. 316.
n
Alarms for Low Pressure of Recycled Water, DM, WFI & Compressed Air.
THE UNITED ENGINEERING COMPANY 132, Damji Shamji Industrial Estate, Mahakali Caves Road, Andheri (E), Mumbai 400 093. Phone : +91-22-2687 6919 ● Fax : +91-22-2687 6676 ● E-mail : uec.mum2@mtnl.net.in Head Office : 35A, Hazra Road, Kolkata-700 029 (INDIA) ● Phone : +91-33-2475 9744. Fax : +91-33-2475 7727 ● E-mail : uec@cal2.vsnl.net.in
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Express Pharma Business Avenues THINK CLEANROOMS & HVAC for Contamination Control, sted Partner in ru T r u o Y THINK AEOLUS CLEANROOM SERVICES es! Cleanroom Servic Aeolus Led by the Founder - A subject expert with rich experience gained since three decades, along with an inspiring & dediced team. “A TRUSTED NAME IN CLEANROOM PROJECTS & SERVICES” “Having successfully founded and expanded Aeolus Technovations Pvt. Ltd. (Estd. 1995), an industry leader in the field of Cleanroom Technology, I am now proud to introduce AEOLUS Cleanroom Services, our flagship Cleanroom Services provider” - Mr. Anthony Vaz - Founder & CEO. AEOLUS Projects: I I I I I
Designing, Supply and Installation of Cleanroom & HVAC Systems Double Skin Air Handling Unit - AHU Supply & Services Laminar Flow Cleanroom Flush Doors & Windows Cleanroom Finishes (False Ceiling, Wall Partitions, Epoxy Painting & Flooring, etc.)
AEOLUS Products: I I I I I I
HEPA Filters Minipleat HEPA Filters Prefilters Horizontal / Vertical Laminar Clean Air Work Station Vertical Reverse Flow Clean Air Work Station Air Shower, Air Curtain & Other Cleanroom Accessories
Conventionl Pre-Filter
AEOLUS Services: I I I I I I
Identifying & Rectifying Troubleshooting issues - OUR FORTE! Validation of Clean rooms / LAF units. AMC (Annual Maintenance Contract) Special Maintenance Call (One time service) Supply of Cleanroom Accessories Post Project Support & Consultation
HEPA Filters
NEW
Aeolus Anemometer
"Analyzing Customer Feedbacks from different sectors & Redefining Validation Services, Aeolus now owns an Anemometer - Dwyer Make USA." - Mr. Anthony Vaz - Founder & CEO.
SELF OWNED LATEST MACHINERY
Please refer to our website or get in touch with us for more details !
AEOLUS Cleanroom Services Your Trusted Partner in Cleanroom Services!
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501, Gorai Tulsi Co-op Housing Society, Plot No.84, RSC - 48, Gorai - ll, Borivali (W), Mumbai - 400 092, Maharashtra - India Tel:0091 - 222 869 8929 / 222 868 2531 Email : info@aeoluscleanroom.com Web : www.aeoluscleanroom.com Factory (2500 Sq.ft.)-Shop No.1 Laxmi Nagar No.2, Near Laxmi Indl. Estate, Bangur Nagar, Goregaon (W), Mumbai - 400 090. Br.Office:- Vaz Villa, Plot No.4, House # 354/3, Awchit Vaddo, Near St.Anne's High School, Tivim, Bardez - Goa - 403502 - India.
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Is your company a great place to work? We spend one third of day at our workplace. While maintaining a work life balance is in our hands, companies need to be more proactive to make themselves engaging, open and happy places. Shalini Gupta finds out the attributes of a great company to work for he Pike Place fish market helped protagonist Mary Jane in the book FISH to turn around a workplace she described as a 'toxic energy dump' into an environment that was engaging, fun and happy. However, few of us might go through that kind of transformation and hence look up to our employers to give us the right kind of ecosystem that would help foster our growth both as an individual and an employee. New York-based Great Place To Work Institute has been engaged in research centered around good workplaces for 25 years now and believes that trusting the people one works for, having pride in what ones does, and enjoying the people one works with are the three tenets to a truly good company. “Our model takes the employee to be at the centre having a relationship with three chief entities in an organisation, namely, the management, their job, and the people they work with. The sum of these relationships is directly impacted by the policies in an organisation,” elaborates Yuvika Gulati, consultant with Great Place to Work Institute, India. The company annually collects data from more than
T
Yuvika Gulati, Consultant, Great Place to Work Institute, India
Divakar Kaza, President- Human Resources Development, Lupin
Prasanth Nair, Global Head, Human Resources, Cipla
2 million employees in 49 countries representing over 6,000 organisations of varying sizes, industries and structures on 62 statements reflecting various elements that constitute a great place to work for. Hiring practices for new employees rank high on the list of attributes. RPG Life Sciences for instance has a 5P model of hiring to evaluate a candidate’s reason for moving out of the company. This includes: Profits (CTC hike), Position (higher designation), Profile (better role), Place (convenient location of the workplace), and People (discomfort with the team at current workplace or eagerness to work with the team at RPG). A fitment analysis of the candidate to the job as well as to the culture pillars of the company is also conduct-
ed and post appointment of a candidate, a box of chocolates sent along with the offer letter. Dr Reddy’s Labs (DRL) conducts multi-point video conferencing of the HR with new hires from premier campuses to address their queries and concerns and set their expectations right. Lupin has introduced a standardised induction programme called ‘UDBHAV’ that is conducted at the Lupin Learning Centre, at Lonavla. Each employee up to middle management level undergoes this 12-day module from their second day of joining the organisation. Elaborates Divakar Kaza, President- Human Resources Development, Lupin, “In order to foster lateral thinking and harness the innate potential of employees, we have
the GLOW AND GROW programme that enables them to think without restrictions in areas related to work, yet unrelated to routine working. In the manufacturing facilities, each month of the year is designated a theme related to different areas of plant operations/functions, such as quality compliance, energy conservation, enhancing production etc. Employees come up with innovative ideas and solutions, thereby channelising their efforts towards achieving excellence in that particular area.” Employee engagement has also become a necessity for companies faced with a challenging global economic climate. Research by Hay Group, a global management consulting firm, shows that engaged employees lead to improved bottom line performance, reduced staff turnover and an increased customer satisfaction, all of which boost revenue growth by 2.5 times. “This figure can go upto 4.5 times when ‘barriers’ to performance are removed and employees are empowered with right mechanisms, structures, and tools that help them show initiative and take decisions,” pitches in Gaurav Lahiri, Managing Director, Hay Group India. A recent study conducted on employee engagement across 46 countries by them found that, on an average, only about 66 per cent of employees feel engaged with their jobs, including those in India. The
Best companies to work promote ... Equity: Balanced treatment for all people in the distribution of intangible and tangible rewards that includes not only financial rewards but also the 'reward' of inclusion. People look to see that they are paid fairly for the work they do, and are included as a full member in the organisation. Collaboration: Management outreach to ensure a bridge between employees and managers by genuinely seeking and responding to employees’ suggestions as well as involving them in the decisions that affect them. This not only helps build avenues through which to solicit a wealth of beneficial information but also encourages employees to feel more engaged in their work. Reliability: Management’s integrity depends on honest and reliable daily actions. Managers in great workplaces work at being consistent: whatever they say, they do; and promises are kept. Impartiality: Favouritism in hiring and promotion, and politicking in the workplace is avoided. Competence: Hire people who fit in well with the culture, to oversee employees’ work, and to clearly articulate and implement a vision for the organisation or for individual departments. Employees with faith in a competent management will be willing to trust its decisions during uncertain times. Community: When employees recognise that they are participants in a truly unique organisation, it helps foster feeling of hospitality, intimacy and a deep sense of community. It makes them confident to to develop relationships, cooperate with others, and enjoy their work thus affecting quality, productivity, profitability, and employee morale. Yuvika Gulati, Consultant, Great Place To Work Institute (India) As per ‘Best Companies to Work For – India’ study of 2012
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rest claim that their organisations has barriers that prevent them from excelling at work. Interpersonal relations seem to be game changers for employees rating workplaces as healthy. Feeling a part of a team through appreciation and acknowledgement by colleagues is important. While employees at RPG Life Sciences voluntarily donate their leaves to someone in need of time away from work on an urgent and critical basis, employees at DRL give their colleagues a URJA (U R Just Awesome) card and ribbon as a token. Absence of bias at work is another criteria with appropriate forums to resolve conflict, transparency between senior management and those at lower levels in the hierarchy, mentoring and coaching to identify top future leaders. Cipla has done away with designations, thus doing away with hierarchial structures to foster a spirit of oneness. Each person in a particular department reports to its head of business, with promotions that give added responsibilities instead of designations. Says, Prasanth Nair, Global Head, Human Resources, Cipla, “Performance development is an ongoing process at Cipla. We believe in fostering a sense of empowerment and purpose through our flat structure.” There are certain things great workplaces do better than the rest that make themstand out from peers. While each company brings a unique proposition to the table as far as giving their employees a comfortable, welcoming and open environment, perhaps what each employee would wish for can be summed up in a quote from Stephen C Lundin’s book FISH, “Imagine a place where everyone chooses to bring energy, passion, and a positive attitude every day.” Amen to that. shalini.g@expressindia.com November 16-30, 2012
P|H|A|R|M|A| L|I|F|E
JOB TRENDS Pharma sector witnesses fourth month of consecutive dip in hiring numbers October 2012 hiring is 12 per cent lower than June n October 2012, recruitment levels for the pharmaceutical sector dipped by 5 per cent when compared to last month. The matter of worry is that a dipping hiring trend has been continuously witnessed for the last four months and October hiring is 12 per cent lower than June. A year on year comparison also indicates a marginal dip in hiring levels. The key pharma hubs of the country, namely Chandigarh, Ahmedabad and Hyderabad also saw dips in their hiring levels by 9 per cent, 8 per cent and 2 per cent respectively in October when compared to the same time a month ago. Commenting on the trend Hitesh Oberoi, CEO, InfoEdge India says, â&#x20AC;&#x153;Most employers are cautiously optimistic about their hiring plans. Recruiters will continue with selective hiring for the next few months.â&#x20AC;? These index numbers are in line with predictions from pharma sector recruiters in a survey where 11 per cent of them had indicated hiring freeze. Most of the them had said that they will adopt a cautious approach and not go over board.
I
The Naukri job speak index for the pharma sector is a monthly report that indicates hiring trends across industry sectors, geographies and functional areas Methodology: The Naukri Job Speak index is on the basis of job listings added to the site every month. To calculate the index, job listings added to the site in July 2008 have been taken as 1000. The subsequent months have been indexed with data of July 2008. The monthly report shows hir-
ing trends across industry sectors, geography and functional areas. There might be high volatility for certain fringe cases like smaller cities, niche industries etc. owing to a small base, but more than 42,000 clients using Naukri.com leads to high reliability of the data.
Jobs from Naukri.com TM / ASM Company: Exp: Location: Job Id:
United Biotech 1-6 Delhi/NCR 061112001670
Medical Representative Company: Exp: Location: Job Id:
QC Microbiology Company: Exp: Location: Job Id:
Dr. Reddy's Laboratories 2-5 Hyderabad / Secunderabad 290812002219
Sr.QC Chemist Company: Exp: Location: Job Id:
Medical Officer Company: Exp: Location: Job Id:
Macleods Pharmaceuticals 1-4 Mumbai Suburbs 140812001214
Sundyota Numandis Pharmaceuticals 0-1 Panjim 061112001556
Alchem International 2-4 Faridabad 061112001377
Key Account Manager Company: Exp: Location: Job Id:
Biocon 2-5 Bengaluru/Bangalore, Chennai 061112001291
Regional Manager Assistant General Manager - Quality Control Company: Exp: Location: Job Id:
Marion Biotech 11-13 Noida 220912001474
November 16-30, 2012
Company: Exp: Location: Job Id:
www.expresspharmaonline.com
Alkem Laboratories 3-7 Bengaluru/Bangalore 061112001074
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Quintiles Technologies bags ITES award STPI, GoI and the Department of IT, BT & ST, Government of Karnataka award Quintiles for nurturing a conducive work environment for women AWARDS
n recognition of its commitment to gender diversity and women-friendly policies that have nurtured a conducive work environment for women, Quintiles Technologies India has been conferred with the Highest Percentage of Women Employer-ITES award by the Software Technology Parks of India (STPI), Government of India and the Department of IT, BT & ST, Government of Karnataka for the year 201112. The award which includes a trophy and certificate was presented to Quintiles at the STPI Karnataka IT Export
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Awards 2012 function held during Bangalore IT.biz 2012 in Bangalore recently. Hufriz Karkaria, Associate Director, HR, received the award on behalf of Quintiles. “It is indeed an honour for Quintiles to receive this recognition. The award is a tribute to the women of Quintiles India who work with passion and energy for a healthier world. Without them this award would not have been ours. I would also like to acknowledge the men of Quintiles India who are very supportive of gender equality at the workplace,”
said Anil Raghavan, Managing Director, Quintiles India. The STPI Karnataka IT Export Awards is an annual awards event organised by the STPI, Government of India and the Department of IT, Government of Karnataka to recognise top performance IT and ITES companies for
their contribution to the state of Karnataka. This is the first time that Quintiles India is receiving this award. In 200506, Quintiles was awarded the Karnataka IT Exports Award for the First Among The Fastest Growing SME Companies in Karnataka. “Receiving this award amongst all ITES companies registered in Karnataka is indicative of the womenfriendly environment we have created that makes it possible to recruit and retain so many women employees,” says Trupti Talati, Senior Director, Human Resources, Quintiles India. Close to 60 per cent of Quintiles Technologies’ employees are women. EP News Bureau
Dr Arun Bhatt awarded DIA award 2012 DIA Outstanding Service Award given in recognition for many significant contributions r Arun Bhatt, President, Clininvent Research has been honoured with the 2012 DIA Outstanding Service Award during the annual DIA conference at Hyderabad. The award is given in recognition to DIA member’s many significant contributions to medicine, regulatory science, and people throughout the world during his/her career. Bhatt has extensive experience of over three decades in the Indian pharmaceutical
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industry. He has worked as a consultant in pharma medicine and clinical pharmacology. His past positions held include CEO of CMI (India) and Medical Director of Novartis India. Bhatt has been active in industry associations and was earlier the President of Indian Society for Clinical Research (ISCR). He is joint Editor-in-Chief of Perspectives in Clinical Research – the journal of ISCR. In 2009, the Institute of
www.expresspharmaonline.com
Clinical Research UK nominated Bhatt for the Honorary Fellowship of Institute of Clinical Research. Dr Bhatt has more than 100 publications in national and international journals. He runs a regular monthly column on Good Clinical Practice – Question Answers and has published a book Clinical Trials and Good Clinical Practice in India – Your Questions Answered. EP News Bureau
November 16-30, 2012
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