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FEATURES
08
08.
Need for Integrated and Cloud Based Data Management Solutions in Clinical Research -Amit Chopra, Managing Director and VPGM India and Middle EastThermo Fisher Scientific
15.
Phygital: Future of Pharmaceutical Industry -Dr. Sandeep Narula, Professor at School of Pharmaceutical Management IIHMR University, Jaipur
18.
Maximizing the Efficiency of Clinical Trial Supply Chain -Sujay Salvi, Head, Clinical Trial Supplies Management, SIRO Clinpharm, & Partha Chatterjee, Head - Clinical Research SIRO Clinpharm
21.
Good Clinical Practices -Ketan Zota, Chairman, Zota Healthcare
23.
Helping Patients Stay on their Medication Regimen with Integrated Drug Delivery Systems -Graham Reynolds, Vice President and General Manager, Global Biologics, West Pharmaceutical Services, Inc.
26.
Ensuring Effective Safety & Risk Management for Biosimilars -Suhasini Sharma, Director, Medical Affairs, Sciformix Corporation MARKET RESEARCH
15
29.
Innovation in Indian Pharma – Empowering Stronger Global Presence but Fraught with Challenges for Serving Indian Market -Pushpa Vijayraghavan, Director, Sathguru Management Consultants DOCTOR’S PERSPECTIVE
31.
The Effectiveness of a Dendritic Cell Therapy: Who can Benefit from Treatment with Dendritic Cells? -Dr Hari Goyal, Senior Oncologist, Artemis Hospital Gurgaon
33.
Molecular Epidemiology and Transmission Dynamics of Drug-Resistant Tuberculosis in High Burden Countries -Dr Zarir Udwadia, Consultant Chest Physician, P D Hinduja Hospital & MRC & Dr Camilla Rodrigues, Consultant Microbiology & Chairperson Infection Control Committee P D Hinduja Hospital & MRC
21
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Need for Integrated and Cloud Based Data Management Solutions in Clinical Research Clinical research, trial management, and implementation can be costly, complex and timeintensive. Traditionally, clinical trials data and documentation have been kept as paper records, which compromises security and is inefficient. Digitizing clinical processes mitigates these issues. This article examines potential of cloud based data management for streamlining clinical development processes, accelerating timelines, and cutting information technology (IT) costs.
There has always been a need for lab information management software (LIMS) in clinical labs, and, until recently, it was common for many different types of software systems to be purchased separately and then customized for the lab’s needs. This commonly involved lab IT involvement or, in many cases, skilled scientists managing software implementation and customization. Key among the needs of these labs was not only data management within the lab, but also sharing that data with colleagues and other collaborators across diverse industry environments so that findings could lead to other discoveries across multiple related disciplines. In labs where this was a common practice, this often led to conflicts in priorities, as scientists could not focus on doing research but instead were forced to manage lab infrastructure issues and complex software integration problems that required large amounts of data crucial to drawing conclusion from their research. It has become imperative for clinical labs to efficiently manage huge amount of data generated by using new technology platforms that offer accurate and reliable lab data management system and allow that allow seamless integration with instrumentation. With advancements in technology such as sequencing, microarray and qPCR, sample throughput has increased in these labs. Likewise, the drive towards precision
Amit Chopra Managing Director and VPGM India and Middle East Thermo Fisher Scientific 8 ◄ April 2018
medicine has accelerated the demand for these technologies. This, combined with CLIA/CAP requirements for clinical labs, has driven processes away from paperbased methods towards LIMS, which securely captures, stores and archives sample data as well as any permissions or training records related to the expertise of the staff executing specific test protocols. Along with the need to automate more of the lab to manage the increase in throughput, a LIMS becomes a critical tool enabling scientists to focus more time on science and less time entering data or collating results. Increased Demand for Clinical Testing Drives Need for Integrated and CloudBased Data Management Solutions With an increased focus on precision medicine, targeted next-generation sequencing is empowering laboratories of all sizes to confidently pioneer breakthroughs in cancer research. At the core of these breakthroughs are assays and panels designed to achieve highly sensitive results from minimal sample input, and this can help deliver information that may lead to the next companion diagnostic test or therapy in the future. In addition to the regulatory requirements related to accuracy and reliability of test results (such as CLIA/CAP) as well as patient privacy concerns regulated by HIPPA and FDA guidance (FDA 21CFR part 11), clinical labs are tasked with increasingly time and patient sensitive test regimes and require not only highly
“With an increased focus on precision medicine, targeted nextgeneration sequencing is empowering laboratories of all sizes to confidently pioneer breakthroughs in cancer research. At the core of these breakthroughs” Pharma Bio World
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“For researchers in clinical labs, Core LIMS software gives companies a strategic advantage by enabling them to efficiently collect and analyze data. The Core LIMS software runs” specialized and accurate instrumentation, but also systems that deliver rapid analysis and results. With the advent of cloud computing, newer informatics solution models have emerged. With the cloud model, clinical labs are able to purchase informatics solutions that can scale up and down depending on their business needs, rather than committing valuable capital resources to an on premise installed LIMS solution, which will also require a commitment to service and support contracts. This cloud-based model frees the labs from investing heavily in IT (and the personnel required to support this IT-based environment) and allows labs to focus more on the clinical science. The Unique Data Management Requirements for Clinical Labs Companies today offer various services models such as Platform-as-a-service (PaaS), Software-as-a-service (SaaS) and infrastructure-as-a-service (IaaS). Each of these models addresses different requirements. With any of these options, the clinical lab can benefit from a data management solution that has no infrastructure footprint. With this type of cloud-based solution in place, clinical labs are better able to focus on their core activities, where clinical workflows can be rapidly mapped, instrument interfaces are instantly made available from a library and lab resources are utilized more productively. Companies offering clinical data management solutions in the cloud provide the option to choose the best practices in the industry, in standard offerings, allowing users to more easily meet the global standards. 10 ◄ April 2018
Of the three popular services, PaaS can be more easily adopted in the clinical lab domain since the clinical workflow is typically an ensemble of multiple workflows. Each workflow requirement could be met by a specific app, and, in turn, these apps could be seamlessly integrated to build a holistic solution. For example, accessioning the samples could be one distinct workflow, while sample registration and testing could be another workflow. Instrument interface to auto analyzers, NGS, RT PCR etc. require different techniques for data acquisition and processing, which represents yet another distinct workflow requirement, while validation and audit management is another configuration-based workflow. All of these or a selected group of them could be integrated at specific touch points to offer a clinical workflow solution defined by each clinical lab as it suits their unique business requirements. Thermo Fisher Scientific delivers on cloud-based informatics for clinical labs: Thermo Fisher’s™ Platform for Science is a flexible, extensible, cloud-based platform that helps labs easily collect, store, access, share, and use their scientific data. It is a validated cloud environment, ensuring users that their operations and data integrity requirements are meeting GCP and other quality and regulatory requirements. The Platform for Science clinical solution has apps that map the entire clinical operation from study creation and management to generation of study reports. Depending on the lab’s requirement, public (shared) cloud, enterprise (private) cloud or other validated cloud platforms are available from Thermo Fisher Platform for Science.
Thermo Fisher’s Platform for Science Software helps scientists perform the most simple or complex tasks, from tracking sample inventory to automating data collection for high-throughput screening and physicochemical profiling, all while collaborating real-time from any device. Platform for Science users can create an integrated environment by configuring applications to meet their unique requirements. In a research environment, flexibility in configuring applications to meet continuously changing workflow needs is as important as meeting the increasing demand for more collaboration. Thermo Fisher’s Core LIMS software enables scientific data collection as well as the sharing, analyzing and archiving of the data. The Core LIMS software can automate workflows and manage samples and data. Pre-built workflows can be quickly configured to meet the exact specifications of your lab. The information in the LIMS can be easily reported on, shared, analyzed and audited. For researchers in clinical labs, Core LIMS software gives companies a strategic advantage by enabling them to efficiently collect and analyze data. The Core LIMS software runs on the Platform for Science and integrates seamlessly with instruments and software from an organization’s preferred vendors while sharing information with other products on the platform. This includes the electronic lab notebook (ELN), scientific data management system (SDMS) and Core Connect, a suite of software integration services designed to make data in the Platform for Science available to be analyzed, used, and shared. The Core LIMS software increases the efficiency of scientific processes by enabling users to manage data in a secure, 100 percent web- and cloud-based environment.
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Phygital: Future of Pharmaceutical Industry Technology adoption has spun the way healthcare and pharma industries are operating these days. This article explains how going Phygital - a marketing term that describes blending digital experiences with physical ones – will help to bridge the gap between technological possibility and real-world application in pharmaceutical industry.
Dr. Sandeep Narula Professor at School of Pharmaceutical Management IIHMR University, Jaipur Pharma Bio World
Phygital (Physical +Digital) is the latest buzzword, which probably is going to hang around for a good amount of time. Phygital is marketing term that describes the amalgamation of digital experiences with physical ones. What is Digital? Digital, as we all know is an electronic technology which generates stores or processes data in positive (i.e. 1) and non-positive states (i.e. 0). The data is transmitted/stored either though analog signals (which has continuous frequency waves) or through Digital (i.e. in discrete form, either 0 or 1). So, the digital technology is transfer of this data from one machine to another, and this data is transferred by breaking this message (it can be any form of communication) into binary code, 0 or 1. So, it means, in digital technology, first this data is stored in Binary form in one machine (remember it is stored as bits, and a string bits is called byte) and then it is transferred to other machine where again it is read/ downloaded by other machine in the form of Binary (i.e. 0 and 1) and that too with a much faster speed. Hence, because, of this ease of transmission and faster speed, storage of data (i.e. upload and download) has become very easy and simply easy. It is this attribute, which has made business world crazy and has given a revolutionary changes in the business process esp. at the operations levels, forcing the organizations to change their business models and empowering the consumer, not only to demand specific but giving opportunity to the business organizations too serve more. As Chris Anderson (Future Laboratory) combines Physical and Digital world to form a new experience which is full of “Immediacy, Immersion and Interaction”. In business parlance, people use Digital (or Digital Technology) as an acronym for S.M.A.C.T (Social Media, Mobile, Analytics, Cloud computing, Internet of Things)
S.M.A.C.T: Social Media: Every month passing by, social media is soaring new heights and hence forcing marketing professionals to design new strategies in the new interconnected social networking world. The following stats, given by statista.com in Jan.2018, hopefully will motivate further the business professionals to think about new innovating ways of building networking, brand equity and prospecting in this new phygital world: Social Media Active users (in millions) Facebook
2167
Youtube
1500
1300
Facebook messenger
1300
980
800
Tumblr
794
330
Skype
300
260
Reditt
250
Pintrest
200
Mobile Technology: As per Hootsuite report, with total 8.05 bn mobile connections, and with total 4.92 bn mobile users worldwide certainly unleashes huge untapped potential to business organization forcing them April 2018 ► 15
declare their business strategy as “mobile first� strategy and compelling them to think new ways to get connected with the customers with latest mobile apps and mobile technology with mobile-friendly promotion of products and services. Analytics: Recent proliferation of data on social media platforms and eagerness of people to leave their digital prints is simply enticing the business organization to discover new techniques to study consumer behavior, usage patterns and market trends and then offering customized solutions. Advanced and real time analytics, Artificial intelligence, Machine learning, Neural networks are competent enough to derive and offer right product to right customer at right place and at right time. Cloud platforms: To be digitally progressive in the current business scenario, organization have to invest in cloud platforms as without
16 â—„ April 2018
cloud computing digital transformation will be incomplete. As per recent Dell report, companies that invest in cloud computing, big data, and mobility, have 53% faster revenue growth than competitors. Business organizations can have the advantages of cost-saving, security, flexibility, mobility, insights, Increased collaboration, quality control, disaster recovery, loss prevention with cloud computing. Internet of Things (IoT): Connectivity with daily working devices is certainly now a routine for the society. With increased usage of sensors and smart devices, connectivity is going to touch its new height in coming times. Manufacturing operations, smart building, smart cities, connected cars, smart lighting are some of the most common areas where IoT is in full swing. Apple, Google, IBM, Intel, Microsoft, Blackberry, Gartner, SAP is some of leading companies in IoT business, with Intel and Microsoft leading the race.
Pharmaceutical companies need to fully leverage the existing potential of SMACT elements, by combining the digital elements with traditional physical channels and making them Phygital. The Phygital World: Since majority of the business organizations are using SMACT, but when it comes to Pharmaceutical industry, the picture is dismal and far from satisfactory, as per YellowElephant report, only 6%7% of the pharmaceutical companies are using Digital Mediums for their product promotion. As compared to Banking and Insurance sector, where they are claiming of Omnichannel customer experience, for Pharmaceutical Industry this appears to a distant reality. In context to the pharmaceutical product, the companies can start from Stage 1 and eventually they can scale up to Stage 5, as shown below: The Omnichannel experiences with the customer gives the business organizations a
Pharma Bio World
Make your Business Digital - by Changing your themes of Technology, Management and Organization Change Pillar
Impact on Business
TECHNOLOGY Cloud computing platform
Ease of delivery of business of business application ONLINE with the help of large and flexible number of computers
Big Data
Various Social Media platforms are huge sources of Big data which organizations can use (Data Management tools required to Capture, Store and Analyze)
Mobile digital platforms
Current generation of PCs are becoming obsolete; Computing Machines now need to be supportive and collaborative to work in tandem with thousands of Apps and Platforms for Consumer and Corporate computing
MANAGEMENT Collaborative Managerial Staff
Online and Social networking collaboration to support blogs, project management, online meetings, personal profiles, social bookmarks, and online communities
BIApps(Business Intelligence apps)
Requirements of powerful Data Analytics and interactive dashboards (to track real time performance for immediate decision making)
Virtual Meetings
Video/Web conferencing, teleconferencing for collaborative and instant decision making
ORGANIZATIONS Social Media Tools – are now rich sources of BRAND STRENGTHS and BRAND ASSOCIATIONS and hence Social Business
BRAND EQUITY ( Facebook, Twitter, Linkedin, Goggle, Youtube, Blogs, Wikis etc. deepens the interactions with employees, customers and all relevant stakeholders)
Telework (may replace physical work!)
Smartphones, wireless laptops, Tablets are making possible for GenY to work away from traditional office.
Co-creation (in context to Business value)
“Experiential Solutions” replacing traditional products/services. Supply Chain and product Development teams to work more closely with customer interactions for developing new products/services.
great amount of leverage to interact with the customer and to improve the understanding and relationships with the customer, hence which can lead to loyalty and ease of implementation of CRM strategies and the CRM tools obviously gives us the platform to use Sales and Marketing Automation tools which helps in sending customized SMS, emails or even personalized messages too. Among this probably, the best tool which comes to my mind is Beacon (in fact Beacon is small Blue tooth radio transmitter), so far in my knowledge at least in the pharmaceutical sector, this tool has not been explored, where as in retail business, this is nowadays used aggressively. In Pharmaceuticals, the companies can use it ESP. In CMEs, Drug Promotion conferences, API gatherings or any other promotion platforms which the companies can explore, esp. in case of geolocation services (again a blend of Pharma Bio World
Phygital) it utility becomes significant. The same can be used in a wearable device (IoT, again Phygital) by a patient (in OPD or IPD) can offer a great help in patient navigation/hospital services. It also offers great advantage in data transmission too. Digital Transformation-Need of the hour Pharmaceutical companies should think to transform their business in a holistic manner; it is not an individual responsibility, but it’s a collective responsibility. Like in past for a CEO, knowledge of finance was extremely important to run the business, similarly in the current business situation, it is imperative for the business leader to have a sound and comprehensive knowledge of digital technology, as from now onwards every processes, every product, every services, which are going to be delivered will be using digital technology. Since it is very difficult to chart
out the specificities of digital transformation in this article, but one thing is sure, the process need to be initiated by revamping the existing Management Information System. In my opinion the following in terrelated themes, as shown in the table above, needs to be revamped/ upgraded in order to make the organization digitally transformed: The story of Phygital world and Digital Transformation is not to end here. Pharmaceutical companies must need to address the need of the hour diligently and must take long strides in achieving the Digital transformation activities. In my opinion this is the best, sound and safe strategy. The five elements, SMACT is simply setting the pace towards the Phygital world.
April 2018 ► 17
Maximizing the Efficiency of Clinical Trial Supply Chain Clinical trials are an essential part of the product development process for both pharmaceutical and biotech companies and if run efficiently can provide the company with a competitive advantage. This article discusses various key factors pertaining to an efficient and effective clinical trial supply management.
F
or a new drug to reach the market it has to undergo a robust clinical trial process which requires considerable amount of investment and can continue in excess of 10 years. The process involves global multicenter trials and recruiting a large number of patients to achieve the trial objectives eg, safety and efficacy. Different types of clinical trial supplies, from investigational products to ancillary supplies are required to conduct clinical trials. The clinical trial supply chain is an integral part of any clinical trial; it constitutes packaging, labeling, storage, distribution to patients located in different geographic locations, and accountability and destruction of clinical trial supplies.
The primary goal of clinical trial supply process is to deliver
18 ◄ April 2018
investigational products eg Oncology products are very expensive and available in limited quantity, hence any wastage could affect the fate of the clinical trial.
• • Each kit used at the investigational site is accounted for down to the unit level eg tablet, capsule and it needs to be returned to the sponsor for destruction.
• • The trial data is submitted to the regulatory
• • The compliance level of the investigational
Randomization Envelopes
Head - Clinical Research SIRO Clinpharm
• • Some
•• Investigational Product & Comparators,
•• Equipment & Lab Kits, CRFs, Blinding /
Partha Chatterjee
manufactured and packaged depending on the trial design so they are not available off-the-shelf.
authorities for registration hence clinical trial supply chain is prone to regulatory audits and inspections.
•• Clinical Trial Non Drug Supplies:
Head - Clinical Trial Supplies Management, SIRO Clinpharm
• • Investigational Products are exclusively
Below are the examples of Clinical Trial Supplies: •• Clinical Trial Drug Supplies: Background / Rescue Medication
Sujay Salvi
by the patient, while all the extra supplies are accounted for and destroyed.
product during the trial has a direct corelation with the final outcome of the trial. If it is not as per the desired level, the entire trial data would be of no use. Hence, one needs to have built-in quality checks in a study design and monitor closely so that the final outcome is achieved.
The RIGHT SUPPLIES at the RIGHT TIME to the RIGHT INVESTIGATIONAL SITE for the RIGHT PATIENT
Therefore, it is imperative to optimize the clinical trial supply chain process with respect to time, quality, safety & integrity, and at the same time, bring in cost efficiencies.
Although the basic principles of logistics apply to Clinical trial supply chain, it is different from Pharmaceutical commercial supply chain due to the following aspects:
In order to maximize the efficiency of clinical trial supply chain, it's important to know the various challenges associated with the process and the approaches/ techniques to address them.
•• Investigational Products are still under
Geography - Multicenter/ Multinational Trials
testing hence many aspects of the investigational product are still under 'investigation' or in other words the product needs to be administered to a selective group of patients who has consented for the clinical trial. It is, therefore, extremely critical to have a controlled use of such products right from the lab where it is being produced, till the time it is consumed
One of the biggest challenges is the geographical location of the source and sites. With the rapid growth in the number and spread of clinical trials, there are many multinational & multi-center trials, where multiple countries across the globe and various hospitals in Pharma Bio World
Clinical Trial Supply Chain
Site 1 Receipt
Manufacturer
Sponsor’s Warehouse
Dispatch
Vendor’s Warehouse
Dispensing Site 2
Drugs
Unused
Returned
Drugs
Subject
Site 3
Accountability
Destruction
Monitor/ CRA
those countries are involved. The clinical trial supplies need to be delivered at these sites from the source eg, central depot. This could result in longer transit time, for example the central depot could be in USA and the sites in South East Asia.
chances of improper handling of supplies at the custom warehouse which could ultimately compromise the cold chain and affect the quality of the product. There is also a risk of shipments being misplaced resulting in product wastage.
In most of the countries, the drugs cannot be shipped to sites unless necessary approvals from Regulatory and Ethics committee are in place. Hence the clinical trial supplies cannot be sent in advance.
Product wastage can also be caused due to inaccurate forecasting, eg supplying excess investigational product to sites with low or no recruitment, or supplying products with short expiry date. Such incidences will have an adverse impact on the outcome of the clinical trial.
Global Regulatory Requirements Regulatory requirements could differ from one country another and inadequate knowledge about it could lead to delays in customs clearance. In many countries, import license is required to import drugs and the invoice should match the import license. The labels on investigational product kits should be as per country regulatory requirements which could be country specific. For example, expiry date on the kits is not mandatory in USA but it is mandatory in India. These situations could result in longer transit time. In case of delays in clearance, there are Pharma Bio World
Poor subject compliance can occur if the investigational product is not available as the subject will not be able to adhere to the protocol specified time regime. This will adversely affect the company's reputation as it is the social and ethical obligation of the sponsor to make the investigational product available to the patients at all times during the trial period; this is also a GCP requirement. Substandard products resulting from improper handling may jeopardize the clinical trial outcome and there could be chances of data being rejected by the regulatory
authorities. Such issues will also delay the completion of the clinical trial and, in the worst case scenario, could lead to cancellation of the trial all together. The sponsor ultimately could incur heavy losses because of all these issues.
Based on years of industry experience, here's a checklist which could help in developing the right clinical trial supply chain strategy. Use of a service provider (local depot) The sponsor can appoint local depots in the countries which are participating in the clinical trial. As Clinical Trial Supplies Management is a niche area, many sponsors prefer to outsource it to the experienced partners rather than managing it by themselves. These depots are GxP compliant and provide end-to-end service from receipt till destruction of the investigational product. These depots can be audited and approved by the sponsor's Quality Assurance department. This partnership has many advantages, shorter transit time to sites being the most important advantage. The local depot can receive the drugs from the central April 2018 â–ş 19
depot after DCGI approval is received for the trial & import license is in place. Once the ethics committee approval is in place, the local depot can distribute the supplies to various sites. Shorter transit time also ensures lower courier costs. The drugs can be shipped by the central depot /sponsor to the local depot as a bulk supply instead of supplying in bits and pieces, thus there will be fewer shipments imported for a trial resulting in less frequent customs clearance. Appointing a local depot will give an added advantage of excellent awareness of local regulatory requirements. The supplies will be always available at the depot and can be dispatched to sites on a short notice. The local depot can provide dedicated resources/ project team handling a particular client ensuring a customer-focused approach and prompt action. Many clinical trials like Oncology trials require comparators, background or rescue medication. Local depot can also provide support in sourcing the comparators from the local market; this can ease the burden on the sponsor as the sponsor won't have to make arrangements for procuring it centrally and then distributing across the globe. Local sourcing will save time and ensure availability of supplies. By delegating this responsibility to the service provider, the sponsor can increase focus on the investigational product.
Selection of the right courier partner A courier agency with the right experience and expertise is essential for the Clinical Trial Supply Chain to succeed. Sponsor can directly or through the depot partner appoint a courier agency which is focused on the life sciences and has a proven track record in cold chain management. This will ensure ontime and safe delivery of supplies without any transit issues, eg, excursions, off-loading. Such issues may result in product wastage and add to the overall cost as the product 20 â—„ April 2018
will have to be resupplied to the sites. The courier agency can be audited by Sponsor/ Depot partner. The courier agency should have processes in place for conditioning / preconditioning of gel packs, preparation of insulated shippers. They should always use validated shippers and calibrated dataloggers for the shipments. The courier agency should track the shipment till delivery and provide the POD and data logger readings to the sponsor/ depot partner upon delivery. They should ensure that the supplies are delivered to the right person. In case of any issue, the courier agency must proactively and promptly inform the client. Technology and Innovation Technology and innovation play an important role in the optimization of clinical trial supply chain. Multilingual labels or booklet labels are used for multinational clinical trials. Their main advantage is the flexibility of drug supplies. The supplies can be used in more than one country or redistributed between countries. This minimizes the drug wastage and reduces the overall medication cost. This hugely helps in trials where drugs are in short supply or expensive, e.g. Oncology trials. Booklet labels also complement the use of IXRS technology and pooled supplies.
In a multicentre, randomized, blinded trial number of shipments containing investigational products were sent to the sites. After using these drugs on patients at the sites, these supplies were returned to the depot on an ongoing basis by the sites. The study had a long duration of about three years. After the recruitment target and all the patient visits were over the sponsor asked the depot to provide the drug reconciliation records. As the depot had not done the reconciliation of investigational product at the time of receipt of the returned supplies they faced lot of issues in the accountability. The depot staff spent no. of days in conducting the drug accountability and found that the documentation received from sites was not adequate, mismatch between the quantities mentioned on the returned documents and the physical returned stock received at the depot. Even after spending considerable time in this activity all the kits dispatched to the sites could not be accounted for and finally sponsor had to report them as missing with a great risk of potential audit and inspection finding. This situation could have been easily avoided if the drug accountability was done on a real time basis and all the discrepancies were promptly reported and resolved. Conclusion:
Case Study
The number of global multi-center clinical trials is increasing by day. Trial design and dosage regimes are becoming complex, and so are the challenges in clinical trial supply chain. The clinical trial supply chain has evolved over the past few years. The testing phase is over; sponsors nowadays are actively looking to reduce the cost of clinical trial supply chain without compromising the quality and integrity of the trials. The sponsors can achieve this by collaborating with the service providers who are experts in their domain and can provide a customized solution to their clinical trial supply chain requirements.
Here's a case study to help demonstrate the how a sponsor can save much of their precious time and co-ordination exercise with an experienced clinical trial supplies vendor.
Contact: ruchi.sanganeria@siroclinpharm.com
IXRS (IWR /IVR) - Interactive Web / Voice Response System is used for forecasting, randomization, drug distribution, Inventory Management etc. This system also tracks the expiry date. As this system is linked to randomization, the drug orders are generated as per the patient recruitment and visit schedule. This minimizes product wastage and ensures the availability of supplies at sites. It also underlines the importance of using a local depot in order to manage the JIT (Just in time) delivery to the site.
Pharma Bio World
Good Clinical Practices
C
linical practices are regulated by Good Clinical Practice (GCP), which is an internationally acknowledged document which regulates certain requirements of the members like investigators, sponsors, monitors and IRBs, responsible for the conduct of clinical trials. GCPs incorporate aspects such as designing, archiving and reporting clinical trials that are concerned with humans as subjects. The aim of GCP is to make sure that the studies are authenticated scientifically and that the clinical properties of the investigational outcome are appropriately filed. There are certain organizations which have to abide by the standards of GCP and they are pharmaceutical companies, clinical laboratories, charities, universities, NH hospitals, GP practices and contract research organizations. Acquiescence with GCP pledges in providing an assurance, publically, of the protection and consistence of the trail subjects� well-being, safety and rights. The standards are achieved through quality assurance and inspections. The guidelines for good clinical practices which will be discussed further have been provided by International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH).
Chairman ota Healthcare Pharma Bio World
The conduction of clinical trials has to be in link with the ethical principles that are originated in the Declaration of Helsinki which are also congruous with GCP and the pertinent regulatory wants. Before initiating a trial, foreseeable risks and troubles should be measured against the probable advantage for the individual trial
subject and society. Only after anticipating the benefits which will justify the risks, a clinical trial should be initiated and carried forward. The concerns of science and society are less significant than the well-being, rights and safety of the trial subjects. The clinical and nonclinical information on an investigational product which is available has to be satisfactory to support the proposed clinical trial. Clinical trials have to be scientifically appropriate and the protocol in which it is described should be clear and detailed. Only a qualified physician or a qualified dentist possesses the right to take medical decisions and only he/ she can govern the medical care of the subjects. A good clinical practice involves the participation of only those individuals who are educated, trained and experienced to perform his respective tasks. The consent which is given freely by the subjects should be acquired before their participation in any clinical trial. An accurate report, analysis and affirmation are possible only if the information of the clinical trials are handled, recorded and stored in an appropriate manner. The privacy and confidentiality rules by applicable regulatory requirements should be respected in terms of maintaining confidentiality of the identity of the subjects. The Good anufacturing Practice (GP) is the only body responsible for manufacturing, handling and storing the investigational products. The products have to be used in accordance with the protocol. The implementation of the system complying procedures is necessary to assure the quality of the trial's each aspect. A clinical trial should be performed in accordance with the protocol that has received, in prior, the opinion from April 2018 ► 21
clinical pharmacologists and physicians to be done at every level of the clinical trial process. The financial aspects of the clinical trial have to be timely documented in an agreement between the investigator and the sponsor. Noncompliance by any member of the clinical trial should be dealt promptly and compliance should be secured by the sponsor.
independent ethics committee (IEC) or institutional review board (IRB). The qualifications of the investigator have to be taken into account through his curriculum vitae or any other documents as demanded by IEC/IRB. The IEC/IRB should conduct reviews on each ongoing trial either at intervals or per year. The investigator is restricted to participate in any deliberations of the IEC/IRB; he is just allowed to provide some amount of information in the context of trial. The IEC/IRB should provide a written approval for the admission of a subject to a trial. A Clinical trial is considered complete and safe when each step is well analysed and performed. The risks involved should be equally justified. The products involved should also be investigated properly in accordance with the protocol in order to ensure the positive outcome of the trial. When an investigator is put into picture, it is necessary that the investigator is educated, trained and experienced for conducting the clinical trial properly. He has to comply with Good Clinical Practice. In order to conduct the trial safely and properly, the investigator needs to have 22 â—„ April 2018
adequate facilities and qualified staff. The responsibility of all trial-related medical decisions falls on the qualified physician who acts as an investigator of the trials. Though the subject is not liable to give any reason for withdrawing from a trial, an investigator has to make an effort to know the reasons, while respecting the subject's rights. It is the investigator's responsibility to have all the required documents to be supplied to the subjects before the clinical trial. Neither the investigator nor the trial staffs possesses any rights to influence the subjects to participate in the trial. The language containing the information about the trial should be non-technical and understandable by the subjects. If the trial is suspended or prematurely terminated for any reason, the trial subject has to be promptly informed by the investigator. If a sponsor makes any agreement with either the investigator or any other parties in involvement with the clinical trial, it has to be formulated in a written document as part of the protocol. The trial related medical questions has to be answered by a qualified medical personnel appointed by the sponsor. The sponsor has to ensure the proper utilization of the individuals like
In terms of multicenter clinical trials, the communication between the investigators is required. A trial design should include the description of the design of the trial and a schematic diagram of its procedures and stages. The criteria for the termination of the trial should also be stated. The Investigator's Brochure is a compilation of the clinical as well the nonclinical data on the investigational products that are in relevance with the study of the products on human subjects. It is necessary to have in hand, the summary of each completed trial. Essential Documents are significant because they regulate the evaluation of a clinical trial and also determine the quality of the produced data. These documents are developed before, during and after the clinical conduct of the trial. At the beginning of the trial, it is necessary to establish trial master files. Only after the monitor has reviewed all the documents, will the trial will be closed. Lastly, all the documents have to be available for audit and inspection.
Contact: infoariapr@gmail.com Pharma Bio World
Helping Patients Stay on their Medication Regimen with Integrated Drug Delivery Systems e increase in selfadministered drugs is part of an even larger sift towards a more patient centric approac to te production of integrated delivery systems ecause of tis renewed focus on te patient drug delivery system manufacturers are continually reevaluating te processes by wic tey improve eisting systems and ow tey develop new ones s a result delivery system manufacturers ave become an invaluable partner to parmaceutical companies
raham enods Vice President and eneral anager, lobal iologics, West Pharmaceutical Services, Inc. Pharma Bio World
A
round the world, patients with chronic diseases are seeking new freedom from frequent doctor's office visits by self-administering their critical medications at home. et with these new home-based administration plans, it can sometimes be more difficult to comply with a prescribed treatment regimen than when injectable medicines are administered by a nurse or physician. Drug delivery systems can help make self-administration a less painful, more streamlined and simplified process and help patients realize the freedom they desire. For most patients, an easy-touse, integrated drug containment and delivery system can be key to enabling the consistent routines that bring about compliance with care plans. When delivery systems are intuitive and efficient, they stand a better chance of encouraging compliance with their treatment protocol because the impact on daily routines lessens. Conversely, drug delivery systems deemed inconvenient, intimidating or complicated can negatively affect a patient's emotional attitude and motivation to sustain adherent behavior. And in many cases, looks count, too: discreetness of the drug delivery system can be very important to patients. ew integrated delivery systems can enable use without calling undue attention to the administration process, creating distractions to others or feelings of stigmatization. Such a shift from a product-centric focus to a patient-centric focus can help manufacturers design a product that encourages compliant behavior.
tting patients first in drg containment sstem design o matter what type of delivery system is selected for a particular injectable drug product, there are several elements that must be carefully considered when designing a drug delivery system. The primary goal of any drug delivery system is to ensure that a patient safely receives a proper dose of a prescribed medication. In years past, if a delivery system failed or was used incorrectly, patient error was most often the culprit. While providing detailed instructions is important for any pharmaceutical manufacturer, failure to follow directions should be minimized by providing proper training to the patient or caregivers. ow, the industry is rethinking that stance, and the priority is engineering usability into the drug delivery system to help patients achieve better outcomes. In order to design a drug delivery system that meets the needs of both the drug and the patient, the pharmaceutical manufacturer and its packaging and delivery system partner must consider the interface between the drug, container, delivery system and patient. nderstanding patients informs saiit Effective drug therapy requires more than simply having an effective molecule. ather, it is the combination of a safe drug within a suitable container and/or delivery system, as well as an understanding of patient needs as it relates to administration. Drug manufacturers should take into account four main facets of integrated drug April 2018 ► 23
ensure that the stress placed on the glass does not cause breakage or that the force in the auto-injector is enough to overcome variability in dimensions, functional performance and siliconization effectiveness to ensure complete dosing. Patient Interaction - Perhaps the most essential consideration is how the patient will use the drug delivery system. Even the most innovative drug can only provide the appropriate therapeutic benefit if it can be delivered effectively and the patient adheres to the necessary treatment regimen.
Figure 1: Electronic wearable injector designed to easily integrate into a patient's lifestyle
delivery that, when planned early in the development process with a packaging and delivery system partner, can lead to better outcomes: Primary Container Format - The selection of a drug's primary container is an important consideration for drug efficacy and stability. Vials may be necessary for initial use, but a syringe or cartridge system may provide a desirable solution for the patient when the system reaches the market. Custom systems may also help to differentiate the product, and should be considered early in the development process. Drug/Container Compatibility - Hand-inhand with the type of primary container is making sure the container material can be safely and effectively paired with the drug product. Is the elastomeric material compatible with the drug? What are the levels of extractables and leachables? Will a barrier film or coating be required for the elastomer? Choosing the proper drug container material can help prevent chemical incompatibility issues that could impact a drug's purity, stability or efficacy. While glass is suitable for many 24 â—„ April 2018
pharmaceutical products, high pH drugs or otherwise sensitive drug products may require vials or syringes made from alternative materials such as cyclic olefin polymers. The filling, handling and secondary assembly processes must also be considered as an integral part of providing the overall delivery system. Container/Delivery System Interface Once the primary container system has been selected, efforts must be made to ensure that it works with the delivery system. Dimensional tolerances and functionality should be tested to ensure proper activation and gliding forces. If the interface between the primary container and the delivery system is not effectively understood, the performance of the combined system may suffer. For example, when considering the use of a glass prefillable syringe in an auto-injector, manufacturers must
Simply designing a drug delivery system that patients/users "can" use, is no longer sufficient. Delivery systems should be designed for affinity, and encourage patients to "want" to use them. Even then, effective training, onboarding, and ongoing adherence are critical to ensuring effective outcomes. Forward-thinking partners make the difference for patients West's SmartDose platform is a singleuse, electronic wearable injector that was designed to easily integrate into a patient's lifestyle. The discreet, wearable technology adheres to a patient's body, usually on the abdomen, and is designed to minimize discomfort. The SmartDose platform currently incorporates a polymer-based drug container (made from Daikyo Crystal Zenith cyclic olefin polymer) with a drug delivery system that can be pre-programmed to deliver high volumes of sensitive drug products, making it easier for patients to self-
"When delivery systems are intuitive and efficient, they stand a better chance of encouraging compliance with their treatment protocol because the impact on daily routines lessens." Pharma Bio World
comply with their prescribed treatment regimen. Connected health innovations like this help to boost motivation by incorporating game-like technology that enables short-term rewards for patients, by tying rewards and education to the drug administration process. A drug can only truly have the desired patient benefit if it is taken as prescribed, delivered effectively and maintains performance over time. Together, drug delivery system and drug manufacturers can work seamlessly as partners to provide innovative solutions that help mitigate risk, improve patient outcomes, and enhance value through unique integrated delivery combinations.
Figure 2:Electronic wearable injector
administer medication outside of the clinical setting. West is currently collaborating with HealthPrize Technologies, LLC-a
leader in digital solutions for patient engagement and medication adherenceto enable connectivity between a variety of injection systems and their adherence programs, to help motivate patients to
Contact : renisa.dsouza@mslgroup.com
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April 2018 â–ş 25
Ensuring Effective Safety & Risk Management for Biosimilars The use of biopharmaceuticals has significantly increased in recent decades. Biosimilars are new biopharmaceuticals that are similar but not identical to the innovator product. Characteristics of biopharmaceuticals are closely related to the manufacturing process, which implies that the products cannot be exactly duplicated. Minuscule differences in the products structure and manufacturing process can result in different clinical outcome. This raises concerns over the safety, efficacy and even pharmacovigilance of biosimilars. This article will focus on pharmacovigilance and risk management for biosimilars, the issues and challenges faced in monitoring their safety and possible solutions.
B
iologics have made great contributions to the treatment of many diseases including cancers, and are expected to provide significant therapeutic benefits to many patients. However, due to their unique source material and complex manufacturing processes, biologics are very expensive, making them unavailable to a large number of patients. Moreover, many biologics are still under patent - contributing to their high price. This scenario is soon to change. It is estimated that around two dozen biological products with global sales of more than USD 67 billion will go out of patent by 2020. 1
End of patent exclusivity and advances in biotechnology facilitating their manufacture have opened up huge opportunities for follow-on biosimilars. IMS Health forecasts that the global biologics market will reach USD 250 billion by 2020, and biosimilars and non-original biologics will represent 4-10 per cent of that market. 2 The price of a biosimilar is on an average between 10 and 35 per cent lower than the respective reference product. 3 Therefore, growth in biosimilars will drive down healthcare costs and generate significant savings for healthcare systems. Biosimilars, unlike generic chemical drugs, are similar but not exactly identical to the reference products, and this poses multiple challenges in their development, safety monitoring and regulatory approval process. Challenges and Solutions in Safety Monitoring and Risk Management for Biosimilars
Suhasini Sharma Director, Medical Affairs Sciformix Corporation 26 â—„ April 2018
Pharmacovigilance: Post-approval pharmacovigilance is of vital importance for a biosimilar as fewer patients are exposed to it during development, since the number/ size of studies required for approval of a
biosimilar is much smaller compared to that for the innovator. Furthermore, because biologics are complex proteins which may stay longer in the body safety concerns may only become apparent outside of the timeframe of controlled clinical trials. 4 Since a biosimilar drug is not a replica of the reference innovator product, the efficacy and safety data generated for the latter cannot be directly and completely transferred to the biosimilar. Hence, compared to a chemical generic there is a bigger need for strict post-marketing product vigilance for a biosimilar in order to correlate its safety profile with that of the reference product, and to detect additional safety issues. Accurate Product Identification: Despite the fact that a biosimilar and the reference drug can show similar efficacy, the biosimilar can exhibit a different safety profile in terms of nature, seriousness or incidence of adverse reactions. Therefore, when an adverse event (AE) is reported in relation to the use of a biosimilar product, there is a need to clearly identify the product associated with the AE. Product naming therefore becomes an important issue for biologics/biosimilars. While the EU follows the International Non-proprietary Names (INN), the US Food and Drug Administration (FDA) is still in the process of developing its policy on biosimilar naming. 5 Possible regulatory solutions to aid product identification currently being deliberated include assigning distinct proprietary names to biosimilar products from different manufacturers, adding manufacturing company's name and specific codes to the product labels, and making biological products non-substitutable or noninterchangeable at the dispensing level. On the part of PV teams, collecting detailed and accurate information on the product Pharma Bio World
involved (including the correct brand name, manufacturer's name and even the batch number) when an AE is received is of paramount importance. Adverse Events Immunogenicity:
Related
to
A n i m p o r t a n t s a f e t y c o n c e r n re l a t i n g to biosimilars is their potential for immunogenicity. Biologics are complex proteins and have the capacity to trigger an immune response that may be humoral or cellular, and could become apparent in a variety of ways such as anaphylaxis, hypersensitivity and infusion reactions, cross-reactivity to endogenous proteins, altered pharmacokinetics of the molecule, or loss or lack of clinical efficacy. 6 In the case of biosimilars, the nature and severity of immunogenicity reactions could vary from those seen with the reference innovator product. An additional hurdle in establishing immunogenicity of a biologic product could be the variable and often long "at-risk window." Biologics may persist in the body over a long time, resulting in a long, variable period between the intake and appearance of the reaction, making causality assessment difficult. Full characterisation of immunogenicity profile of a biosimilar may not be established at the time of approval. Hence, long term studies as well as continued postmarketing surveillance become crucial for risk management. Information on the Label: Labelling is critical to the safe and effective use of a medicinal product. When an adverse reaction to the drug is encountered, information in the label is used to decide whether a specific adverse event/safety issue is already identified as a risk or could be a new, potential safety issue. The general principle of labelling for biosimilars, based on the 2012 EMA Pharma Bio World
guideline, is that the label for a biosimilar medicine has to be consistent with that of the reference medicinal product for the common information applicable to the biosimilar product. 7 However, the unique nature of a biosimilar requires a labelling approach that combines information on both the reference product and the specific biosimilar product, linking each piece of information to the source product. Moreover, there must be "adequate mechanisms" to differentiate between adverse events associated with the biosimilar product and referenced product, including the ability to identify adverse events that have not been previously associated with the reference product. Risk Management Plan (RMP): Data from pre-authorisation clinical studies are not enough to identify all potential differences between the biosimilar and its reference product. Therefore, clinical safety of similar biological medicinal products must be monitored closely on an ongoing basis during the post-approval phase, including continued risk-benefit assessment. EMA requires that the biosimilar applicant must submit a risk management plan (EU-RMP) and pharmacovigilance programme with its application. The information must include a description of the potential safety issues associated with the similar biological medicinal product that may be as a result of differences in the manufacturing process from the reference biologic. Thus, the safety specifications in in the RMP of a biosimilar would include both identified and potential risks of the reference product, as well as risks identified from studies on the specific biosimilar product, making the safety profile as complete as possible. Requirement for Post-Approval Studies: Both EU and the US guidelines require extensive analytical studies to show comparability of the biosimilar to the reference innovator product. Clinical comparability is established by a stepwise procedure with Phamacokinetics (PK)
and pharmacodynamics (PD) studies followed by clinical efficacy and safety trials. PD parameters are selected on the basis of their relevance to demonstrate therapeutic efficacy of the product. If there are several potential indications, the most sensitive disease model to detect differences is chosen in a homogeneous patient population. 8 It is recommended to evaluate safety data within the scope of combined safety and efficacy trials, hence, the size of the safety population evaluated maybe small. Consequently, there is need for additional post-approval studies to establish efficacy in indications not studied during the approval process and long-term safety studies to establish immunogenic potential and other safety issues which may be different from the reference product. Cohort Event Monitoring: While spontaneous safety reporting is a passive way to gather safety data, it is limited by under-reporting and inadequate details. Patient/disease registries are a tool for active safety surveillance and are extremely useful for detecting safety issues early in post-marketing user population. New adverse events including rare events or latent onset events can be detected sooner than through spontaneous reporting system and better qualification of known AEs can be done in the cohort being followed. Summary End of patent exclusivity and advances in biotechnology have unleashed opportunities for follow-on biosimilars to enter the market and serve the needs of patients globally in a cost-effective manner. However, pharmacovigilance (PV) and risk management for biosimilars presents a number of challenges. Routine PV processes may need to be adapted to address these issues and some possible measures include: maintaining a repository of information on biological products available, developing special scripts that would allow for the collection April 2018 â–ş 27
of detailed information on the product associated with the AE, careful medical evaluation of all suspected immunogenicity reports, understanding of "at risk window", implementing frequent aggregate review of safety data and comparison with the safety profile of the reference product, designing an RMP with additional measures to detect/evaluate yet unknown safety issues, setting-up special product/patient registries for cohort event monitoring, conducting adequately powered post-approval efficacy and safety studies in all indications and target populations and having a product label with efficacy and safety information related to both the reference product and biosimilar identified by source. A number of biosimilars have been available in Europe for more than a decade now and despite rigorous safety monitoring and tracking, no significant safety issues have been identified with these products. This provides a measure of assurance that safety
and risk management for biosimilars can be effectively managed by carefully and diligently following regulatory guidelines and good pharmacovigilance practices. References . B nline, billion worth of biosimilar patents expiring before , enerics and Biosimilars nitiative aB, nternet httpwww. gabionline.netlayoutsetprintcontent viewfull, ccessed May M ealth hite aper, Biosimilars and onriginal Biologics . oan ovira, aime spn, eticia arca and ntonio lry de abry, . The impact of biosimilars entry in the market, MT. . This ieen, abine MM traus, . harmacovigilance of Biosimilars challenges and possible solutions, enerics Biosimilars nitiative ourna, olume , ssue , .
. mily lexander, The biosimilar name debate whats at stake for public health, enerics and Biosimilars nitiative ournal aB ournal. . .uub chellekens, Biosimilar therapeuticswhat do we need to consider Clinical idney ournal, olume , ssue suppl , p. ii. . e a n M i l m o , . a b e l i n g o f Biosimilars, Bioharm nternational, olume , ssue . raft uidance, . cientific Considerations in emonstrating Biosimilarity to a eference roduct Contact: sghscottpr.com
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Arial NarrowExcipients are crucial to drug delivery within the body. Generally, an excipient has no medicinal properties. Its standard purpose is to streamline the manufacture of the drug product and ultimately facilitate physiological absorption of the drug. Excipients might aid in lubricity, flowability, disintegration, taste and may confer some form of antimicrobial function. In the April issue of Pharma Bio World, themed on Excipients will cover articles, case studies and guest columns which could focus on broad areas of the issue theme.
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28 ◄ April 2018
Pharma Bio World
Market Research
Innovation in Indian Pharma – Empowering Stronger Global Presence but Fraught with Challenges for Serving Indian Market
I
ndia enoys a dominant position in global generics, has the largest number of FA approved labs outside the and accounts for around 30 per cent of generics market (by volume). However, more recently, several new entrants (including companies from outh orea, MENA and China) are seeking to establish their presence in global generics. This intensifying competition combined with significant pricing pressure means that it is no more business as usual.
buse deterrent opioids Indian companies have strategically responded by developing greater strengths in complex generics. These include complex inectable formulations (liposomal, microsphere based depot formulations et al), inhalation drugs (PIs and MIs), topical products and transdermals. Case in point includes un Pharmas ipodox, a pegylated liposomal doxorubicin formulation (generic of anssens oxil) where un Pharm could commence selling the drug in 2012 prior to patent expiry in due to a drug shortage and continues to the only generic on the market even after the oxil patent has expired. iding the b wave and building front-end presence - the specialt pharma strateg
ushpa iaraghavan irector athguru Management Consultants Pharma Bio World
specialty pharma product portfolios and front end presence in the form of a salesforce in . Again, innovation adoption is a key driver for success and Indian companies are actively riding the wave of 505(b)(2) products. Notable innovation adoption examples include dermatology products developed by Promius Pharma (r eddyss subsidiary), upins pediatric products such as Alinia and ocoid lotion and ymista, a respiratory combination product out licensed by Cipla to Meda A.
Indian pharma companies are also taking initial steps to breakout of the backstage in the pharma market. Most leading companies have started nurturing specialty pharma presence in strategically identified therapeutic areas such as oncology, ophthalmology, dermatology, CN, pediatrics, dermatology and respiratory. This entails innovation adoption for building
As a relatively recent interest, Indian pharma companies have also been active seekers of innovation platforms for abuse deterrent opioids, an opportunity triggered by the FAs March 2016 draft guidance. With their pulse on the markets, interest in innovation adoption is palpable. In this area of innovation adoption, ydus Cadila recently announced an acquisition of based entynl Therapeutics for 171million. ctive technolog seekers strengthening the arsenal
-
The Indian pharma industry seeks to secure its compeitive advantage and move up the value chain with the pursuit of innovation led complex generics and specialty pharma opportunities. Innovating adoption is now recognied as a priority. There is great willingness to explore multiple models for technology access including in-house development, in-licensing as well as acquisition of products, technologies and technical capabilities. We notice equal momentum across these access possibilities. April 2018 ► 29
Market Research The slower adoption landscape in manufacturing innovation
The big question ahead - incentivizing innovation in domestic markets
While there is high level of momentum
While applauding the quest for innovation and higher value addition in global markets, I cannot conclude without drawing attention to the most concerning factor - a gloomier landscape for Indian market. While there has been a very active innovation adoption landscape in formulation pipelines for regulated markets, we need to note that close to 85 per cent of API used for the domestic market is imported. In FY16, India imported about ` 13,000 crore of API from China of the total API imports of ` 21,000 crore. Even at the formulation end, there has been
in innovation adoption for formulations and innovative products, there has been a relatively slower momentum in
manufacturing
is
significant
innovations
innovation.
scope
for
to
enhancing
There
embrace process
efficiency, green manufacturing and most
importantly,
improved
quality
control in manufacturing. IoT adoption and greater innovation adoption in manufacturing
quality
control
will
be critical to maintain the success accomplished by the industry so far.
very limited focus on innovation for the Indian markets. With price control threat looming large on companies, reward for innovation is often found lacking and there is apprehension to invest. While we cheer for our pharma industry rising to the next level of global presence, it is pertinent we engage in a multi-stakeholder discussion to address economic barriers for India focused innovation and prime the market to reward it.
Without this, the goals set
out in the National Heath Policy 2017 (approved by the Parliament in March 2017) could remain an aspiration. Contact: pushpa@sathguru.com
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Each monthly edition of PBW covers a separate area of pharma and biotech industry and includes articles from a range of peers, consultants and commentators, interview with industry experts, Market research analyzing industry trends, News Features, News Updates, Product Trends, Events Diary and Bookshelf. Target readers for PBW are Drug manufacturers, Intermediates, Pharma machinery/equipment manufacturers and suppliers, Pharma packaging firms, Research institutes, Academic institutes, Biotechnology firms, Consultants and Government bodies. You are most welcome to share editorial content with us such as technical articles, case studies and product write-ups. The length of the article should not exceed 1500 words with maximum three illustrations, images, graphs, charts etc. All the images should be high-resolution (300 DPI) and attached separately in JPEG or JPG format. Have a look at our editorial calendar on our website www.pharmabioworld.com. To know more about Chemtech Foundation, Jasubhai Media and other publications and events, please visit our website – www.chemtechonline.com
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30 ◄ April 2018
Pharma Bio World
Doctor’s Perspective
The Effectiveness of a Dendritic Cell Therapy: Who can Benefit from Treatment with Dendritic Cells? Cancer develops when any given cell in the body escapes the strict control of growth, size and mobility, begins to multiply uncontrolled and produces offspring that can invade surrounding tissues. This invasion stage may be followed by the formation of metastases when the malignant cells spread through the lymphatic system and the blood stream. About one hundred different types of cancer are known in humans, and all are different from one another regarding, for instance, the average age at which they appear, the growth rate and the tendency to metastasize. Besides, today many factors are known that play a role in the development of cancer, and many more factors are at least suspected of contributing to the emergence of cancer. Therefore, it is rather questionable whether a single main cause for the development of cancer will ever be identified, although there may certainly exist general mechanisms leading up to this disease. Every organism consists of a harmonic structure of cells, each of which has a specific function at a specific location. Dr Hari Goyal Senior Oncologist Artemis Hospital Gurgaon Pharma Bio World
U
ntil now, the effectiveness of a treatment with dendritic cells could be proven in the case of skin, kidney, and breast, pancreatic and prostate cancer. Even patients with colon or ovarian cancer benefited from treatment with dendritic cells. For most types of cancer, however, there exist standard treatments which have been developed over decades. Therefore, we recommend making use of these treatments and supplementing them with immune therapy, since it is known that tumor cells damaged by chemotherapy or radiation are much easier to destroy with immune cells than undamaged tumor cells. Treatment with dendritic cells is also often used when conventional therapies have not been successful This was demonstrated, for example, in the case of kidney carcinoma and malignant melanoma. Vaccination with dendritic cells is most promising, however, when only small numbers of tumor cells are present. Today we know that the immune system of patients with a low tumor mass often still functions much more efficiently than that of patients with a high tumor load. Just as with chemotherapy and radiation, the earlier dendritic cell therapy is begun, the more successful it is. What is Immunotherapy? Immunotherapy is defined as the “treatment of disease by inducing, enhancing, or suppressing an immune response,” using immunomodulators, particularly cellular signaling molecules like cytokines. Some immunotherapies activate the immune system, while others suppress it, depending on the situation. In cancer immunotherapy, the aim is to build the immune system to fight tumors
and prevent metastasis, or the spread of cancer. In the 1980’s, the National Health Institute published an article detailing their combination of immune cell therapy with specific chemotherapy regimens. They stated that this combo would be the future of cancer immunotherapy. Cancer and the immune system - Can the immune system protect from cancer? The immune system is our body‘s own defense against harmful pathogens, such as bacteria, fungi and viruses, but also against cells that have degenerated and divide uncontrolled. Every day of our life, about 8 malignant cell proliferations occur in our body. Nevertheless, only 1 cancer on average develops for every 200 years of life. This demonstrates that the human immune system recognizes and destroys almost all cells that show mutations which could lead to cancer. Scientists examined this issue. They tested the function of the immune system in 3,625 healthy persons aged over 40 for a period of 11 years. Humans with a normal or even an extraordinarily good immune system had about 40% less risk to come down with cancer. A good immune system is, therefore, important to protect oneself from cancer. Yet it may happen that our immune system does not recognize these cells precisely because of their mutations. Moreover, tumors exceeding a certain size can produce messenger substances leading to a weakening of the immune system. Thus, the immune system of a majority of patients with cancerous diseases is weakened. Based on this knowledge, physicians try to strengthen the immune system of cancer patients with medications, vitamins April 2018 ► 31
Doctor’s Perspective and trace elements, but also by using complementary forms of treatment. As a result of intensive research, knowledge about the immune system, the individual factors and the cell types, that play a crucial role in the defense against pathogens or cells, has grown significantly in recent years. Today a lot more is known about the cells of the immune system than it was 10 years ago. Amongst other things, one is aware of the fact that dendritic cells occupy a very important role in this system. Dendritic cells: The therapy‘s principle • Precursor cells that have the potential of becoming dendritic cells can be isolated from the blood by a special procedure. Certain messenger substances, to which the cells are exposed in a culture dish, promote this capability. • While the precursor cells are in the maturation phase, they are capable of absorbing protein (e.g. tumor antigens out of the patient‘s plasma). • The not yet completely matured precursor cells can take up these proteins under clean laboratory conditions even outside of the body. • Once the cells have taken up the tumor antigens, they rearrange and present them on their surface. Thus, the Characteristics of these antigens can later be recognized by other immune cells. • During this process, the precursor cells mature into fully developed dendritic cells that carry the characteristics of harmful tumor cell structures related to a special marker on their surface. The immune cells can detect and Identify this marker as harmful. • When the meanwhile fully developed dendritic cells are injected subcutaneously, they travel to the lymph nodes and activate various types of killer cells (the so-called cytotoxic T-lymphocytes) that have the capability to destroy degenerated cells. 32 ◄ April 2018
• These activated killer cells “remember” the foreign structure characteristics. They enter the vascular system, Spread throughout the whole body and search for cells having exactly these characteristics in various tissues.
small syringes. The attending physician carries out the immunization with dendritic cells by injecting them subcutaneously in the groin region. Afterwards, the patient receives high dosed vitamin infusions and can then return home.
• When the killer cells encounter relevant cells during their search (in the concrete case, tumor cells), they try to destroy them and send out messenger substances that alarm other defense cells.
Treatment with dendritic cells is gentle treatment
How are dendritic cells produced? For the purpose of isolating dendritic precursor cells, 200 ml of blood is drawn from the patient, transported under stable temperature conditions and processed immediately in a clean room certified according to EU GMP directives. After centrifugation, the blood is separated into various fractions in order to separate the white blood cells from the red ones and the nonspecific defense cells, the granulocytes. The fraction containing the red blood cells and the granulocytes is discarded. The fraction with the lymphocytes contains the cells, from which dendritic cells develop. After several cleaning steps, the isolated cells are put in a nutrient solution. These cells, among them also the precursor cells of the dendritic cells, come of. The optimal maturation in the cell incubator is stimulated by a nutrient solution and specific growth factors, and even at the beginning of the maturation process antilogous tumor antigens out of the patient‘s plasma are added to the precursor cells.
In contrast to other forms of treatment, such as chemotherapy or radiation, where foreign substances or damaging radiation are used to fight the tumor, the treatment with dendritic cells uses the body‘s own immune system for fighting the cancer. Compared to other forms of treatment, side effects only occur very rarely after vaccination with dendritic cells. If they do so at all, they subside quickly and affect the patient only slightly or not at all. Therefore, no hospiral stay is required for the treatment, since it can be performed on an outpatient basis. For these reasons, the vaccination with dendritic cells can be carried out in addition to other treatments. Care should be taken, however, that the timing of the various treatments is coordinated properly. Although the number of studies on the therapeutic benefit of dendritic cells in the treatment of tumors Is growing constantly, standard treatments should under no circumstances be cast aside. These forms of treatment have largely proven their effectiveness in extensive studies and represent the basic therapy for quite a number.
The dendritic cells are grown in the incubator for 7 days and monitored microscopically. These cells, marked by a very conspicuous form, differ from other cells due to their thin, hair-like growth. Before the cells are harvested on day 7, the Specification of the surface characteristics, the quantity of cells and their vitality in the low cytometer is carried out. After that, the cells are harvested, cleaned several times and put into two Pharma Bio World
Doctor’s Perspective
Molecular Epidemiology and Transmission Dynamics of Drug-Resistant Tuberculosis in High Burden Countries During the period 1998 to 2015, the concept of a "high burden country" (HBC) became familiar and widely used in the context of TB. In this article, an array of views presented on the status of drug-resistant tuberculosis in high burden countries with the aim to highlight challenges and to provide practicable solutions and a roadmap for progress
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press release Apitope phase 1 trial to treat Graves’ disease reports positive results Apitope, a clinical stage biotech company developing potential first-in-class antigen-specific immunotherapies targeting autoimmune diseases, announced positive results from the Phase I first in man clinical trial of its product candidate, ATX-GD-59, in development for the treatment of Graves’ disease. Graves’ disease is one of the most common autoimmune diseases with approximately 10 million patients across Europe and the US and yet there have been no innovative treatments in more than 60 years. With Graves’ disease, the immune system mistakenly attacks the thyroid gland and causes it to become overactive. Symptoms can include an enlargement of the thyroid gland, swelling of the neck, localised abnormalities of skin, tremors, heat intolerance and sweating, significant weight loss, osteoporosis, atrial fibrillation and ocular changes in patients. Each year 20-30 out of every 100,000 people are newly diagnosed with Graves’ disease. The ratio of women versus men diagnosed with Graves’ disease is 6:1 and around 2 per cent of all women will develop Graves’ disease during their lifetime. The phase I clinical study met the primary endpoint to assess the safety and tolerability of ATX-GD-59 in 12 patients with Graves’ disease. The majority of the per protocol subjects were either euthyroid, the clinical objective of therapy, or close to being euthyroid by the end of treatment; the effect was maintained during the 3 months follow up off therapy. Importantly, TSHR antibody levels were also reduced with close correlations between percentage decreases in antibody and thyroid hormone levels in line with the mechanism of action. The investigational product was administered intradermally (ID) every two weeks over a period of 18 weeks in male and female patients that were not otherwise being treated with anti-thyroid therapy. Following a titration period of 25, 50, 100, 400 and 800 µg in the initial eight weeks of treatment, a dose of 800 µg was administered fortnightly for an additional 10 weeks, comparable to the regime followed in the successful ATX-MS-1467 multiple sclerosis (MS) trials.
Temasek to buy 31 million shares of Bayer Bayer announced that Temasek, an investment company headquartered in Singapore, signed an agreement to subscribe to 31 million new shares of Bayer, corresponding to around 3.6 per cent of the capital stock, for total gross proceeds of 3 billion euros. With the consent of the Supervisory Board, the Board of Management of Bayer AG resolved to execute the capital increase out of authorized capital against cash contributions and excluding the subscription rights of existing Bayer shareholders. Under the agreement, Bayer is to issue to a subsidiary of Temasek at an at-market price the new registered (no-par value) shares Pharma Bio World
with an entitlement to dividends as of January 1, 2017. On completion of the capital increase, together with its existing shareholdings in Bayer, Temasek will hold approximately 4 per cent of the issued capital stock of Bayer. The shares issued to Temasek will not be subject to any lock-up period. The proceeds from this placement will be taken into account when determining the size of the previously announced share capital increase through a rights offering with subscription rights to existing shareholders to finance the proposed acquisition of Monsanto. Bayer is a global enterprise with core competencies in the life science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. Incorporated in 1974, Temasek is an investment company headquartered in Singapore. Supported by 11 offices internationally, Temasek owns a portfolio of 275 billion Singapore dollars (184 billion euros) as of March 31, 2017, mainly in Singapore and the rest of Asia.
PRAC to review risk of dosing errors with methotrexate The Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of the risk of dosing errors with methotrexate medicines, used to treat cancers such as acute lymphoblastic leukaemia and various inflammatory conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis and psoriatic arthritis. When used for inflammatory diseases, methotrexate is taken once a week, whereas for some types of cancer, the dose is higher and the medicine is used more frequently. Mistakes have led to some patients incorrectly receiving a dose every day instead of every week, with serious consequences in some cases. The Spanish Agency for Medicines and Health ProductsExternal link icon therefore asked the PRAC to further investigate the reasons why dosing errors continue to occur in order to identify and put in place measures to prevent them. PRAC to further consider unmet medical needs for hydroxyethylstarch (HES) solutions for infusion Following the PRAC recommendation in January 2018 to suspend the marketing authorisations for HES solutions for infusion across the EU, the European Commission has requested that the committee further consider any possible unmet medical need that could result from the suspension, as well as the feasibility and likely effectiveness of additional risk minimisation measures. The PRAC is now looking at these specific aspects and will discuss its recommendation at its May meeting. The PRAC’s revised recommendation will then be sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a final position. April 2018 ► 39
press release Alcon launches new age monthly disposable contact lens Alcon, the global leader in eye care and a division of Novartis, launched their new age monthly disposable contact lens ‘Air Optix plus HydraGlyde.’ recently. ‘Air Optix plus HydraGlyde’, has a unique technology called ‘SmartShield’ that repels dust and grime and ensures clarity of vision through your long day. Alcon has combined two advanced technologies, ie, SmartShield Technology and HydraGlyde Moisture Matrix, to help provide excellent deposit protection and support long-lasting lens surface moisture. SmartShield Technology helps deliver superior resistance to lipid deposits throughout the lens, through an ultra-thin protective layer to help shield the contact lens wearer. Air Optix plus HydraGlyde contact lenses are made with a highly breathable material that allows nourishing oxygen to flow continuously through the lens, keeping the lenses with longer-lasting hydration for 16 hours for white, healthy-looking eyes. The contact lenses enable you to focus on your goals through your long day without the hiccups of itching, burning or watering in your eyes and ensure clarity of vision all month long. Now even spectacle users who have resisted contact lenses due to discomfort can try New Air Optix plus HydraGlyde contact lenses. Air Optix plus HydraGlyde are monthly disposable lenses, ideal for those with an active lifestylewhether you have a busy day at the office or play sports.
US FDA approves Roche’s cobas CT/ NG to detect Chlamydia trachomatis & Neisseria gonorrhoeae DNA Roche, a global pioneer in pharmaceuticals and diagnostics company, announced that the US Food and Drug Administration (FDA) has provided 510(k) clearance for cobas CT/NG for use on the cobas 6800/8800 Systems for the direct detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in both symptomatic and asymptomatic individuals. cobas CT/NG is the first assay available in the US for the testing of sexually transmitted infections on the cobas 6800/8800 Systems. It is cleared for use with male and female urine specimens, clinicianinstructed self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, endocervical swab specimens (all collected in cobas PCR media) and cervical specimens collected in PreservCyt Solution. Other STI assays are in development and will further allow laboratories to consolidate high volume STI testing on a single platform. In addition to cobas CT/NG, cobas 6800/8800 Systems menu in the US includes viral load monitoring tests for HIV, HBV, HCV and CMV, as well as MPX, WNV, DPX and Zika for use in screening blood donations. Since its introduction in 2015, the fully automated cobas 6800/8800 Systems have offered labs the fastest time to results with the 40 ◄ April 2018
highest throughput and the longest walk-away time available among automated molecular platforms. Chlamydia trachomatis is the most common bacterial Sexually Transmitted Disease (STD), with the highest prevalence among youth. Routine screening for chlamydial infection in young women has been demonstrated to reduce infection rates and the longterm consequences of untreated disease, as well as lowering the financial burden on the healthcare system. The Centers for Disease Control and Prevention (CDC) recommends annual Chlamydia trachomatis screening for all sexually active females under 25 years old and additional testing for pregnant women and those with risk factors.1 Since 2014, the cobas 6800 and cobas 8800 Systems have established the new standard for routine molecular testing by delivering fully integrated, automated solutions that serve the areas of viral load monitoring, donor screening, sexual health and microbiology. Based on Nobel prize-winning PCR technology, the systems deliver proven performance with full automation, increased throughput, fast turnaround time and complete track connectivity, providing users with greater flexibility to consolidate their testing to a single system while increasing overall workflow efficiencies.
Novartis helps to preserve kidney function in heart failure patients with diabetes Novartis announced a new post hoc analysis of the pivotal phase III heart failure study, PARADIGM-HF, demonstrating that treatment with Entresto (sacubitril/valsartan) helped to preserve kidney function, as assessed by estimated glomerular filtration rate (eGFR), in patients with heart failure with reduced ejection fraction (HFrEF). HFrEF patients treated with Entresto had a slower rate of decline in eGFR than those treated with ACE inhibitor enalapril. In a sub group of patients who had both HFrEF and diabetes, the magnitude of benefit was twice as high. The findings of the analysis are published in The Lancet Diabetes & Endocrinology. Non-diabetic HFrEF patients in the PARADIGM-HF study were shown to lose kidney function twice as fast as the general population. This was further accelerated in HFrEF patients with diabetes, who experienced a decline in kidney function that was twice as fast as the non-diabetic patients. When compared with enalapril, treatment with Entresto significantly slowed this decline in all HFrEF patients (-1.3 vs -1.8 ml/min/1.73 m per year).In HFrEF patients who also had diabetes, the benefit of treatment with Entresto was doubled vs. those without diabetes (+0.6 (0.4, 0.8) vs. +0.3 (0.2, 0.5) ml/min/1.73m per year). Entresto is a twice-a-day medicine that reduces the strain on the failing heart. It does this by enhancing the protective neurohormonal systems (natriuretic peptide system) while simultaneously inhibiting the harmful effects of the overactive renin-angiotensin-aldosterone system (RAAS). Other common heart failure medicines, called angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs), only block the harmful effects of the overactive RAAS. Entresto contains the neprilysin inhibitor sacubitril and the angiotensin receptor blocker (ARB) valsartan. Pharma Bio World
press release Adocia begins phase 1 study of insulin in people with type 1 diabetes Adocia , a biopharma company, announced the initiation of a phase 1 study of BioChaperone Pramlintide Insulin (BC Pram Ins), its ready-to-use co-formulation of pramlintide and human insulin. The BioChaperone proprietary technology enables the solubilization and stabilization, in aqueous solution at neutral pH, of pramlintide, the only FDA-approved amylin analog for the treatment of diabetes, hence allowing its combination with insulin. This study aims to investigate the pharmacokinetics, pharmacodynamics, and the safety and tolerability of BC Pram Ins in people with type 1 diabetes compared to separate injections of human insulin (Humulin, Eli Lilly) and pramlintide (Symlin, AstraZeneca), and also to an injection of insulin lispro (Humalog, Eli Lilly). In people without diabetes insulin and amylin are co-secreted by pancreatic beta cells and act in synergy to control blood glucose. While insulin controls glucose disposal, amylin modulates glucose appearance in the blood by suppressing liver glycogenolysis through glucagon inhibition and by controlling gastric emptying and decreases food intake by inducing a feeling of satiety. As diabetes progresses, neither insulin nor amylin are eventually secreted. While life-saving for people with type 1 diabetes and ultimately required for people with type 2 diabetes, insulin therapy alone is often not sufficient to achieve optimal prandial control, possibly because amylin is also needed. Many people using insulin therapy exhibit profound glycemic variability, especially after a meal, and they frequently fail to reach their treatment goals. Pramlintide (Symlin, AstraZeneca), a short-acting amylin analog, is the only molecule in this class approved by FDA for the treatment of diabetes. Pramlintide is approved in the USA for both type 1 and type 2 diabetes as an adjunct therapy to insulin treatment. The Phase 3 trials leading to pramlintide approval showed that, when added to an existing insulin regimen, pramlintide strongly improves post-prandial glucose control by flattening postprandial glucose excursions. After 6 months of use, pramlintide as an adjunct to insulin therapy, resulted in improved HbA1c, reduced prandial insulin consumption and induced weight loss compared to the use of insulin alone in both people with type 1 and with type 2 diabetes. Like amylin, pramlintide delays the timing and reduces the amount of postprandial blood glucose. Some studies suggest that, because of the resulting delay in glucose appearance, human insulin’s slow action profile makes it the most suited agent to combine with pramlintide in order to enable an optimal reduction of postprandial glucose excursion. However, as intensified insulin therapy requires multiple daily injections and frequent glucose monitoring, the addition of three injections of pramlintide a day has proved a challenge to patient adherence, compliance and persistency. Indeed, to achieve optimal long-term effects, new treatment options in diabetes Pharma Bio World
should not only demonstrate superior efficacy, but also avoid increasing the everyday burden of disease management, while remaining affordable. This should be achieved with this novel combination product, BioChaperone Pramlintide Insulin. Adocia is a clinical-stage biotechnology company that specializes in the development of innovative formulations of already-approved therapeutic proteins and peptides.
Glenmark initiates phase 2b trial to treat atopic dermatitis Glenmark Pharmaceuticals, a global pharmaceutical company, announced the initiation of a phase 2b clinical trial of GBR 830, a novel, investigational treatment for moderate-to-severe atopic dermatitis. The trial’s primary endpoint will assess the efficacy of GBR 830, compared to placebo. Secondary and exploratory trial endpoints include additional measures of efficacy, safety and pharmacodynamics. Trial enrollment is expected to begin in June 2018. The phase 2b, double-blind, placebo-controlled multicenter trial will randomize approximately 392 patients across four dosing arms of GBR 830 and placebo. The trial’s primary endpoint will assess the effectiveness of GBR 830, compared to placebo, on reducing the severity of atopic dermatitis as measured by Investigator’s Global Assessment (IGA). Secondary efficacy measures include patients with a greater than 75 per cent improvement in disease severity, as measured by the Eczema Area and Severity Index (EASI), along with other measures including disease activity using validated assessment tools such as EASI response, and Scoring Atopic Dermatitis (SCORAD). The trial will also assess safety, and biomarkers relevant to the disease and unique mechanism of GBR 830. In addition to moderate-to-severe atopic dermatitis, Glenmark is evaluating the potential for conducting studies with GBR 830 for the treatment of other inflammatory autoimmune conditions where dysregulation of OX40 overexpression is implicated in disease activity. Preparations for a clinical trial assessing GBR 830 for the treatment of systemic lupus erythematosus (SLE) are currently underway. GBR 830 is designed to inhibit OX40, a costimulatory immune checkpoint receptor expressed on activated T cells and memory T cells. Costimulatory signals are essential for T cell activity, and binding between OX40 and OX40L is a biomarker for the severity of autoimmune diseases. The activation of this pathway leads to conversion of activated T cells into memory T cells, which promotes inflammation. In addition, regulatory T cells also contribute to inflammation, and OX40 signalling by these cells downregulates immune suppressing functions. It is believed that GBR 830 inhibits the dual activities of OX40 and OX40L binding in both activated T cells and regulatory T cells, thus potentially reducing inflammation associated with symptoms of atopic dermatitis. April 2018 ► 41
marketing initiative
Abb to Invest €100 Million in Global Innovation and Training Campus ABB makes largest organic investment in industrial automation at home of B&R in Austria
One year after announcing its acquisition of B&R (Bernecker + Rainer IndustrieElektronik GmbH), ABB is to invest €100 million in Austria to build a state-of-the-art innovation and training campus at the home of B&R in Eggelsberg, Upper Austria. It is the largest organic investment in industrial automation in ABB’s more than 130year history and lays the foundation for around 1,000 new high-tech jobs in Austria.
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he new innovation and training campus will develop technologies for the factory of the future, based on ABB Ability TM, in which production will be undertaken autonomously by smart and cloudconnected machines and robots. With this investment, ABB is delivering on its Next Level strategy, which defines innova-tion as a key driver of profitable growth. The company invests $1.4 billion in R&D annually, and has a team of around 30,000 R&D and application engineers. B&R has more than 1,000 employees working in R&D and application development.
With the new campus, the world’s second-largest provider of industrial automation solutions will further ex-pand its leadership position in machine and factory automation. The development of disruptive technologies will enable ABB to better serve the highly attractive
$20-billion machine and factory automation market segment. ABB acquired B&R, then the largest independent provider of product- and software-based open-architecture solutions for machine and factory automation worldwide, in July 2017. Today,
The new research and development campus will cover 35,000 m² and be home to a significant number of state-ofthe-art facilities. Alongside ultra-modern R&D laboratories, which will develop and test new automa-tion technologies, from industrial control systems up to machine learning and artificial intelligence, there will be an Automation Academy to train and educate customers, partners and employees in these technologies. The ground-breaking ceremony is planned for this summer, and the new campus is expected to be up and running in the course of 2020. Once complete, the Eggelsberg site will be one of ABB’s largest research and development centers. 42 ◄ April 2018
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marketing initiative B&R is integrated into ABB’s Industrial Automation division as its global Machine & Factory Automation business unit. With the combined portfolios, ABB is today the only industrial automation provider offering customers the entire spectrum of technology and software solutions around measurement, control, actuation, robotics, electrification and digitalization. “B&R has had an excellent start within ABB and has exceeded our expectations. We are well on track to achieve our goal of revenues of more than $1 billion soon,” said ABB CEO Ulrich Spiesshofer, at a press conference in Linz with the Austrian Chancellor, Sebastian Kurz. “With our €100 million investment, we are strengthening this dynamic and the pillars of this success story: innovation and people. In addition to the new research and development capacity, our
investment will expand B&R’s Automation Academy, offering customers, partners and employees globally unique education and training programs.”
strengthening our good relationships with Universities, universities of Applied Sciences and Higher Technical Education Institutes is part of our innovation and research strategy. This way we can further accelerate our speed of growth and innovation as well as extend our technology leadership,” said Hans Wimmer, Managing Director of B&R.
“With this clear commitment to the Eggelsberg location, ABB has established itself as the market leader in automation in Austria,” said Chancellor Sebastian Kurz. “True to its word, the company is now making an investment that is “This is a great day for B&R,” said Josef of tremendous importance to Austria Rainer, Co-founder of Bernecker & Rainer as a business location of international Industrie-Elektronik GmbH. “The smooth standing. This is the starting signal for a integration shows that the company Erwin location offensive in the key segment of Bernecker and I founded 39 years ago is digital industry. It is an important impulse in excellent hands. I am delighted that for the creation of highly qualified new ABB continues to write and accelerate jobs and the positioning of Austria as a our success story with this historic investment.” high-tech location.” This will also be beneficial for the country`s educational landscape “Further
About B&R B&R is an innovative automation company with headquarters in Austria and offices all around the world. On July 6, 2017, B&R became a business unit of the ABB Group. As a global leader in industrial automation, B&R combines state-of-the-art technology with advanced engineering to provide customers in virtually every industry with complete solutions for machine and factory automation, motion control, HMI and integrated safety technology. With Industrial IoT communication standards like OPC UA, POWERLINK and openSAFETY as well as the powerful Automation Studio software development environment, B&R is constantly redefining the future of automation engineering. The innovative spirit that keeps B&R at the forefront of industrial automation is driven by a commitment to simplifying processes and exceeding customer expectations. For details contact: B&R Industrial Automation B&R Strasse 1 5142 Eggelsberg Austria Tel: +43 7748 6586-0 Email: press@br-automation.com
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marketing initiative
Secure and Seamless Communication with POWERLINK & OPC UA OPC Foundation publishes OPC UA specification for POWERLINK
An OPC UA companion specification is now available for POWERLINK according to a joint announcement by the OPC Foundation and the Ethernet POWERLINK Standardization Group (EPSG). The companion specification describes how payload data is exchanged between POWERLINK and any OPC UA platform. The result is integrated communication from the sensor to the cloud – without any interfaces whatsoever. A joint working group between the OPC “As technologies, OPC UA and POWERLINK A single network Foundation and the EPSG had been complement each other perfectly,” emphasized Thomas Burke, President of “This specification allows OPC UA and working on the specification since 2016. the OPC Foundation, in his announcement. POWERLINK to fuse into a single network,” The document can be downloaded from “POWERLINK is among the leading real-time added Stefan Schönegger, managing the OPC Foundation website: https:// bus systems used in plants and machinery. director of the EPSG. “We’re then able to opcfoundation.org/markets-collaboration/ Together with OPC UA, POWERLINK networks join devices from different manufacturers e t h e r n e t - p o w e r l i n k - s t a n d a r d i z a t i o n can now communicate seamlessly and securely and across different levels of the automation group-epsg/ with the IT environment and into the cloud.” pyramid into a single, cohesive system.” About the EPSG The Ethernet POWERLINK Standardization Group (EPSG) is an independent organization founded in 2003 by leading companies from the fields of motion control and automation technology. Its aims are the standardization and further development of the POWERLINK protocol first introduced by B&R in 2001. This high-performance real-time communication system is an advanced protocol based on the IEEE 802.3 Ethernet standard designed to ensure real-time data transfer in the microsecond range. The EPSG cooperates with leading standardization organizations such as CAN in Automation (CiA), the OPC Foundation and the IEC.
For details contact : Ethernet POWERLINK Standardization Group (EPSG)
Thomas J. Burke (left), president of the OPC Foundation, and Stefan Schönegger, managing director of the EPSG, announced their collaboration on the now-published companion specification in 2015. 44 ◄ April 2018
POWERLINK OFFICE Bonsaiweg 6, 15370 Fredersdorf Germany Tel.: +49 . 33439 . 539 270 Fax: +49 . 33439 . 539 272 Email: info@ethernet-POWERLINK.org Pharma Bio World
marketing initiative
Real-Time Communication in the Industrial IoT State-of-the-art communication architectures with OPC UA TSN
At this year’s Hannover Messe (Hall 9, Booth D33), the Ethernet POWERLINK Standardization Group (EPSG) will demonstrate how interface-free communication can provide seamless connectivity from the sensor layer to the ERP layer and into the cloud. The foundation has already been laid with the companion specification for OPC UA and POWERLINK
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he EPSG will also be showing how the open and standardized protocols POWERLINK, openSAFETY and OPC UA TSN come together to create open architectures for real-time communication in the Industrial IoT. The TSN Ethernet extension makes OPC UA deterministic. In combination with the openSAFETY protocol, it now meets all the requirements for safe line automation at the factory level. OPC UA provides semantic descriptions of information models and security mechanisms that facilitate the convergence of IT and OT.
About the EPSG The Ethernet POWERLINK Standardization Group (EPSG) is an independent organization founded in 2003 by leading companies from the fields of motion control and automation technology. Its aims are the standardization and further development of the POWERLINK protocol first introduced by B&R in 2001. This high-performance real-time communication system is an advanced protocol based on the IEEE 802.3 Ethernet standard designed to ensure real-time data transfer in the microsecond
range. The EPSG cooperates with leading standardization organizations such as CAN in Automation (CiA), the OPC Foundation and the IEC.
For details contact : Ethernet POWERLINK Standardization Group (EPSG)
POWERLINK OFFICE Bonsaiweg 6, 15370 Fredersdorf Germany Tel.: +49 . 33439 . 539 270 Fax: +49 . 33439 . 539 272 Email: info@ethernet-POWERLINK.org
At Hannover Messe, the EPSG will show how POWERLINK and openSAFETY combine with OPC UA TSN to create open architectures for real-time Industrial IoT communication. Pharma Bio World
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marketing initiative
Manage Hardware Configurations with Ease New software component simplifies management of machine variants
Modular applications can now be implemented even more easily. B&R’s new software component, mapp IO, makes it possible to add I/O modules at any time. This can happen before a machine is delivered or even at runtime, thereby greatly simplifying the task of managing variants of machinery and equipment.
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ith mapp IO, I/O configurations can be generated directly from an ERP or order management system. No engineering tools are required, even if third-party drives or modules are added. Additional variants and options are configured directly on the machine using mapp IO and then programmed using mapp CodeBox. With mapp CodeBox, you can program options in ladder logic without affecting the machine’s primary application. The machine can be commissioned without having to modify the original machine software.
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With the new software component mapp IO, B&R’s entire hardware portfolio can be added to machinery and equipment at runtime. About B&R B&R is an innovative automation company with headquarters in Austria and offices all around the world. On July 6, 2017, B&R became a business unit of the ABB Group. As a global leader in industrial automation, B&R combines state-of-the-art technology with advanced engineering to provide customers in virtually every industry with complete solutions for machine and factory automation, motion control, HMI
and integrated safety technology. With Industrial IoT communication standards like OPC UA, POWERLINK and openSAFETY as well as the powerful Automation Studio software development environment, B&R is constantly redefining the future of automation engineering. The innovative spirit that keeps B&R at the forefront of industri-al automation is driven by a commitment to simplifying processes and exceeding customer expectations. For details contact : B&R Industrial Automation
B&R Strasse 1, 5142 Eggelsberg, Austriat Tel: +43 7748 6586-0 Email: press@br-automation.com
Pharma Bio World
marketing initiative
Ultimate Corrosion Resistance: A4 Stainless Steel
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hen it comes to corrosion resistance, stainless steel is the first choice. This is why Elesa+Ganter has for many years offered standard parts in A2 grade and most recently also in the even more resistant A4 stainless steel grade.
Food Sector, Pharmaceutical and Medical Sector, Shipbuilding and Offshore Constructions are The Beneficiaries. Enhanced corrosion resistance has become an ever more important requirement in many different industries – with stainless steel gaining in importance because the material not only safeguards hygiene standards, but also ensures a long service life, low or no maintenance and therefore makes for safe investments. The Elesa+Ganter range of products has always featured many standard elements made of non-rusting steel. But stainless steel is not necessary the same as stainless steel: today‘s material compendiums list around 120 grades with different alloy proportions. While Elesa+Ganter has so far focused on the use of A2 grade, one of the market leaders in standard parts now
Standard parts in A4 stainless steel offers selected products in the even more corrosion-resistant A4 variant specially intended for use in chloride-rich environment, for instance within reach of the sea. These include the matt shot-blasted handwheels GN 227.4, DIN 39 ball grips, drop-forged DIN 580 eyebolts and eye nuts DIN 582. The hinges GN 237, GN
128.2 and GN 129.2 are now available in A4 stainless steel, and so are cabinet “U” handles (GN 425), star knobs (GN 5334.4), threestar handles (GN 5345.4), and one and twoarmed clamp nuts (GN 99.6 and GN 99.8) as well as slotted and split set collars (GN 706.2 and GN 707.2). It is mainly the chrome, nickel and molybdenum constituents which lend the A4 austenite steel its high resistance against chloride and acids. All this makes Elesa-Ganter‘s A4 standard parts the ideal choice not only for use in shipbuilding or in the offshore industry, but also for the food sector, for pharmaceutical and medical applications or for swimming pool construction with its chlorinated water or water rich in minerals. A wide field, in other words. One reason why Elesa+Ganter will gradually enlarge and expand its offer of standard parts in A4 stainless steel. For details contact : Elesa and Ganter India Pvt. Ltd.
Product family stainless steel Pharma Bio World
A-54, Sector-83 Noida-201305 (U.P.) INDIA Tel: +91-120-4726666 Fax: +91-120-4726600 Email: info@elesaganter-india.com April 2018 ► 47
Trace Hydrocarbon Analyser Incorporation of the latest advances in gas sensing technology and signal processing methodology, the new SERVOPRO NanoChrome revolutionises ultratrace purity measurements for the semiconductor industry. The new PED sensor technology enables sub-ppb measurement of H 2, CH 4, CO, CO 2 and NMHC; no consumables or fuel gas required; and enables unique total servomex solution for UHP gas analysis. For more information, please contact: Spectris Technologies Pvt Ltd Plot No: A-168 MIDC Thane-Belapur Road Khairane Navi Mumbai 400 710 Tel: 022-39342700 E-mail: MEI_Sales@servomex.com
Safe Area Oxygen Monitor Safe area monitor utilises advanced non-depleting paramagnetic technology to accurately monitor O 2 levels without sensor deterioration that affects outmoded electrochemical sensors used in competitor detectors. Features latest Hummingbird Paracube sensor never needs replacing; independent auto calibration of all measurements with up to 8 isolated analogue outputs and up to 12 relays with follow or freeze option; and alarm, fault and calibration history logs. For more information, please contact: Spectris Technologies Pvt Ltd Plot No: A-168 MIDC Thane-Belapur Road Khairane Navi Mumbai 400 710 Tel: 022-39342700 E-mail: MEI_Sales@servomex.com
Tablet Coater Tablet coater is available in standard cGMP and customised 12”, 18”, 24”, 30”, 36”, 48”, 60” and 72 inch Models with SS-304/316/316L contact parts; and efficient aqueous organic solvent-based film coating as well as sugar coating of tablets, pallets, granules and seeds. Automated process technique for coating as coating fluids are sprayed/dosed on the product by means of a state-of-the-art spray gun. Features complete automatic modern PLC control system; outlet exhaust blower with wet scrubber for treatment of exhaust air for pollution-free; double scan inside SS-304 and outside powder-coated inlet AHU (air handler unit) with pre-filter, final filter, HEPA filter and heat exchanger; peristaltic pumps with variable drive so as to give control dosage of the spray guns; solution holding tank with pneumatic stirrer for thorough mixing of solvent; and CIP system for washing. For more information, please contact: IPEC Engg Pvt Ltd Plot No: 5175, GIDC Ankleshwar Gujarat 393 002 Tel: 02646-221175 Telefax: 91-02646-225175 E-mail: md@ipecengg.com marketing@ipecengg.com
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Turntable
Fluid Bed Dryers Pharma Chem Machineries offers turntable used for transferring the bottles to filling station or conveyor system for automatization of automatic line.
For more information, please contact:
Pharma Chem Machineries 311/2484, Motilal Nagar No: 2 M G Road, Goregaon (W), Mumbai 400 090 Telefax: 022-28735321 E-mail: pharmach@gmail.com / pharmach79@gmail.com
The system is based on air suspension technology with cGMP compliance. The SFBD is used for drying of powders and granules by fluidising them in the expansion chambers with filtered and heated air. R&D Models include Mini FBD (500 g), 1 kg and 5 kgs; and Production Models include 10, 30, 60, 120, 260 and 500 kg sizes. For more information, please contact: Sunsai Pharma Equipments Pvt Ltd Plot No: 1, Survey No: 77 Nr Laxmi Indl Estate, Sativali Road Vasai (E), Thane, Maharashtra 401 208 Tel: 0250-3200130 E-mail: sunsai.pharma@rediffmail.com / sunsaipharma@gmail.com
Case Packer Packing sensitive liquid food pouches is particularly challenging. Meypack is the specialist for individual end-packaging solutions and with the VP600 case packer it meets the current demands of the market. In a fully automatic process, the machine packs formats ranging in dimension from 70 x 50 x 80 mm up to 200 x 150 x 200 mm (W x L x H). A very small number of finely tuned format parts enable fast and reproducible format changeovers that can be carried out without any tools. A high degree of accessibility is made possible by the use of low-maintenance linear bearings and guiding elements as well as self-cleaning vacuum valves. The product infeed of the VP 600 is carried out via a paddle chain with interchangeable belts that have product-specific pockets and paddles and are able to stack and erect products. With a fast changeover function, the belts can be exchanged immediately and then automatically adjusted for tension and positioning. The blank magazines, which can be adjusted in height, are easily loaded and can be equipped with saw-tooth belts for the tray transport. This prevents the creation of too much pressure at the blank pickup. The interchangeable format-dependent safety guards, also equipped with quick-change elements, provide additional magazine protection in addition to the certified SICK sensors (Safeguard Detectors). Meypack will also be completing a model of the VP 600 Series to efficiently pack miniature bottles (glass and PET) as well as small cans and jars. A future variation of the model with a larger machine footprint will process wrap-around cases, shoulder trays and trays with external lids. For more information, please contact: Meypack Verpackungssystemtechnik GmbH Industriestr. 3 48301 Nottuln, Germany Tel: +49 2509 94240, Fax: +49 2509 948240 E-mail : julia.pauls@meypack.de
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De-dusting Tunnel/Booth
High-speed Doors
The de-dusting tunnel/booth system is used to remove the loose particles/ dust present on the receiving materials, which will be brought into the warehousing area before they are transferred into the quarantine area. Vehicle arrives and docks at receiving bay. An operator starts the de-dusting chamber’s blowers first and then conveyor by pushing the buttons on the pushbutton station. Loose material (one at a time) is manually loaded on to the conveyor. The material passes through the de-dusting chamber and on the exit side. These are again manually retrieved from the conveyor for further movements.
For more information, please contact: Viswakarma Engg Jagat Khana, PO Manhali Tehsil: Nalagarh, Dist: Solan Himachal Pradesh 174 101 Tel: 01795-265318 Fax: 91-01795-265319 E-mail: vishwakarma.hp@gmail.com
Ion Trap Mass Spectrometer The cost-effective Thermo Scientific LCQ fleet ion trap mass spectrometer delivers rich information for routine analysis of complex samples while providing excellent fullscan sensitivity, ruggedness and reliability.
For more information, please contact:
Thermo Fisher Scientific India Pvt Ltd 102, 104 Delphi, C-Wing Hiranandani Business Park Powai, Mumbai 400 076 Tel: 022-67429494 Fax: 91-022-67429495 E-mail: sagar.chavan@Thermofisher.com
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Prime conveyor specially developed to work in combination with the conveyor system for continuous operation in galvanised steel on standard, aluminium or stainless steel structure which integrates traction unit and rapid wirings. It has flexible curtain in selfextinguishing material complete with anodised aluminium extrusions for holding the interchangeable sections. Modular sections permit easy replacement in case of accidental damage. It has heavy duty motor consisting of 400V, 3-phase, opening speed up to 2.0 m/s with inverter system, advance control device, with option of integration with PLC system They are available in sizes up to 4,000 x 4,000 mm (W x H).
For more information, please contact: Gandhi Automations Pvt Ltd Chawda Comml Centre Link Road, Malad (W) Mumbai 400 064 Tel: 022-66720200, 66720300 Fax: 91-022-66720201 E-mail: sales@geapl.co.in
Automatic Air Jet Cleaning Machine Pharma Chem Machineries offers automatic air jet cleaning machine suitable for cleaning bottles and containers to be filled and this machine does not require water consumption because the container is exposed to pressurised air jet followed by vacuum suction to clean the inner surface. For more information, please contact: Pharma Chem Machineries 311/2484, Motilal Nagar No: 2 M G Road, Goregaon (W) Mumbai 400 090 Telefax: 022-28735321 E-mail: pharmach@gmail.com pharmach79@gmail.com
Pharma Bio World
Sterility Test Pump
Fluid Bed Dryer The fluid bed drying involves fast drying, cooling and agglomeration of particulate wet materials. It is ideal for heat sensitive and non-heat sensitive products. Available Models from 2 to 1,200 litre working capacity. Batch type drying of bed of solid particles are fluidized by passing a stream of clean and hot air upward in closed chamber. Single piece construction with integrated retarding expansion chamber-cum-filter bag housing, builtin explosion vents and isolation valve protect equipment.Optional features include double scan inlet air AHU, HEPA filtration, steam, gas or electric heating, solid flow detection, silencer, scrubber, PLC controls and explosion-proof, etc.
For more information, please contact: Prism Pharma Machinery Plot No: 3713, Phase IV, GIDC, Vatva Ahmedabad, Gujarat 382 445 Tel: 079-29095204 Fax: 91-079-25841623 E-mail: mkt@prismpharmamachinery.com
Closed-loop sterility testing is one of the most critical tests in microbiology. Shreedhar Instruments offers solution for Closed Sterility Test System with one of the best technical solution. Wherein HTY sterility test pump is a matching device used together with Steritailin Sterility Test Kits or any other make canister. Under the positive pressure by peristaltic pump the sample is transferred into the filtration units, then filtered and incubated with culture media to examine if there are any germs. For more information, please contact: Shreedhar Instruments 16 Shreeji Krupa Society, Opp: MGVCL Circle Office Next to GMERS Medical College Gotri Road, Vadodara, Gujarat 390 023 E-mail: sales@shreedhargroup.com
Liquid Manufacturing Plant The liquid manufacturing plants are ideal tools for the pharma industry for the production of oral and suspension liquid. It is specially designed to take care of two critical factors which directly affect the quality of liquids. It has minimum manual handling of liquid. Available in standard cGMP and customised models with SS-304/316/316L contact parts. It is designed exclusively to be used by operator and one helper. All vessels are suitable for internal pressure of 1.5 kg/cm 2 and hence can be sterilised. All pipes, pipe fittings and valves are of seamless quality, internally electro-polished with tri-clover ended points. All material transfers are done by vacuum or by transfer pumps. The entire plant can be operated by centralised operating panel capacity ranging from 50 to 10,000 litres. For more information, please contact:
IPEC Engg Pvt Ltd Plot No: 5175, GIDC Ankleshwar Gujarat 393 002 Tel: 02646-221175 Telefax: 91-02646-225175 E-mail: md@ipecengg.com / marketing@ipecengg.com
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Liquid Particle Counter Model APSS2000 is an automated parenteral sampling system - a precise sample volume within 0.1 ml is achieved with the syringe sampler, producing repeatable results. SamplersSight complies with FDA21CFR-11. This system reduces operator error and ensures process accuracy with recipes for repeat sample processing to USP, EP or JP Standards. Automated particle counter calibration wizard is for full calibration or routine verification. Alarm level for pass/fail criteria ensures quality control. Sizing capability is from 1.5 to 125 micrometers. For more information, please contact: Aimil Ltd Naimex House A-8 Mohan Co-operative Indl Estate Mathura Road, New Delhi 110 044 Tel: 011-30810200 Fax: 91-011-26950011 E-mail: info@aimil.com
Liquid Filling Machine Pharma Chem Machineries offers liquid filling machine. This machine is clean, sturdy, elegant and easy to operate which is suitable for filling oral liquids, oils, chemicals, pesticides, etc. Features output from 1,200 up to 3,600 bottles per hour depending on fill capacity; easy to operate, user-friendly; filling range from 1 to 1,000 ml; designed as per cGMP standard. The machine is attached with ROPP capping machine, bottle inspection machine or labelling machine. For more information, please contact:
Pharma Chem Machineries 311/2484, Motilal Nagar No: 2 M G Road, Goregaon (W), Mumbai 400 090 Telefax: 022-28735321 E-mail: pharmach@gmail.com / pharmach79@gmail.com
Continuous Mixer The single shaft continuous paddle mixer blender is designed for uniformly wet and dry mixing and blending technology provides the ideal environment for effectively optimum mixing a wide distribution of particle size and bulk densities without segregation of powder, granules, short fibered, moist solids and liquids together with pasty substances up to and including highly viscous mass in the chemical, herbal, cosmetic, food, pesticides, detergents and plastics industries. The mixer produces high quality intermediate and end product with homogeneity. Available models from 2 to 12 tonne per hour working capacity. Specially designed paddles have special mixing effect with axial and fluidization movements of materials to homogeneous mixing independent of large range of particle size, shape or density. Minimum heat generated and high particles movement. Fast, even liquid and ingredients addition and coating with spray system. Optional features include VFD, liquid spray system, FLP and PLC controls. For more information, please contact:
Prism Pharma Machinery Plot No: 3713, Phase IV, GIDC, Vatva Ahmedabad, Gujarat 382 445 Tel: 079-29095204 Fax: 91-079-25841623 E-mail: mkt@prismpharmamachinery.com / sales@prismpharmamachinery.com
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Liquistation and Liquiport for Safe Sampling The stationary and portable samplers enable the automatic extraction, distribution and preservation of liquid samples. Regardless of whether they are used in wastewater treatment for the monitoring of water bodies or in drinking water, the sampling process complies with all international legislation. Failsafe temperature monitoring prevents corruption of the sample. Open communication standards make for easier integration into your process. One standardised menu for all devices be it in the sampler or in the Liquiline field device, prevents you from making operating errors. Thanks to modular hardware and flexible software, one can adapt the sample to all applications and sampling conditions with just a few hand movements. Simulataneous sampling and measurement of different parameters used for modern environmental monitoring. For more information, please contact: Endress+Hauser (India) Pvt Ltd 7B, Godrej One, 7th Floor Pirojshanagar, Vikhroli (E) Mumbai 400 079 Tel: 022-30236100 Fax: 91-022-30236219 E-mail: info@in.endress.com
Monitoring Solutions for Utilities LumaSense Technologies, Inc offers solutions for utilities. Industry professionals can get a first-hand look at sensors that connect to software platforms to gather, visualize, and analyze data to monitor and extend the life of their assets. LumaSense’s portfolio features a wide range of technologies suited for Transmission and Distribution (T&D) applications, including fiber optics, pyrometers, gas sensors and thermal imaging systems. For continuous, online monitoring of dissolved gases found in insulating oil of transformers and load tap changers, LumaSense suggests the SmartDGA system. This solution is cost-effective and based on proven, non-dispersive infrared (NDIR) technology to use industry standards to detect changes in gas rates, ratios and values. Implement automated, remote monitoring of substation assets using thermal imaging with the ThermalSpection 724 (TS724DV) system. Designed specifically for substations, this solution allows utilities to identify thermal abnormalities within electrical substations using high resolution cameras.LumaSense is the leader in Fiber Optic Technology, offering LumaSMART for transformer winding hot spot monitoring. This Fluropotic sensing system is the most advanced and reliable real-time monitoring solution available. For Sulphur Hexafloride (SF 6) leak detection, the Innova 3731 provides highly reliable, high sensitivity SF 6 area monitoring. This solution is based on highly accurate and repeatable Photoacoustic Spectroscopy (PAS) technology for an unmatched combination of performance and convenience. For more information, please contact:
LumaSense Inc LorenzstraĂ&#x;e 29 76135 Karlsruhe, Germany Tel: +49 (69) 97373198, +49 (0) 721 98 77 93 17 Fax: +49 (69) 97373167, +49 (0) 721 98 77 93 11 E-mail: s.schiepe@lumasenseinc.com
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Septa and Bottle Stopper Flexible seals for glass provides internal as well as external secure grip to avoid risk of spillage while opening or closing glass stoppered chemical containers, offers convenience of drawing or injecting small quantity of samples using syringe and needle. For stronger chemicals options of fluropolymer septa and for repeat autoclaving in sterile applications option of silicone rubber available are B14, B19, B24, B29, silicone septa for fermentators and autoclaves are available.
For more information, please contact:
Shree Gaurav Rubber Products 112-B Marudhar Indl Estate, Opp: Old Syndicate Bank Goddev Road, Bhayandar (E), Dist: Thane Maharashtra 401 105 Telefax: 91-022-28197355 E-mail: Gaurav_rubber@rediffmail.com
TSQ Quantiva Triple Quadrupole Mass Spectrometer The Thermo Scientific TSQ Quantiva Triple Quadrupole Mass Spectrometer with Active Ion Management (AIM) technology delivers unrivalled sensitivity, speed and dynamic range for scientists facing the most difficult quantitative challenges now and in the future. This extreme performance is achieved with reliability and ease of operation that help users spend more time thinking about their analysis and less time worrying about instrument setup and operation.
For more information, please contact: Thermo Fisher Scientific India Pvt Ltd 102, 104, Delphi ‘C’ Wing Hiranandani Business Park Powai, Mumbai 400 076 Tel: 022-67429494 Fax: 91-022-67429495 E-mail: sagar.chavan@thermofisher.com
Liquiline System Guarantees High Precision Measurement Analysers do not need to be complicated. Here again, plug and play with Memosens Technology and the user-friendly Liquiline operating concept make for easier commissioning and operation. In addition, the analysers offer advanced diagnostic options that can be availed of easily by remote access. In Sum parameters, to assess the organic load in water and wastewater, the four main parameters measured are TOC, SAC, BOD and COD. In Nutrients, modern wastewater treatment plants remove not only carbon but also nitrogen and phosphate. Online measurement of nutrient parameters plays a key role here. In metals and other waste-treatment parameters, the requirements vary between industrial sectors. However, most process water is softened and almost all manufacturing processes require corrosion-free water that does not exhibit turbidity, has no colour and does not contain iron or manganese. For more information, please contact: Endress+Hauser (India) Pvt Ltd 7B, Godrej One, 7 th Floor Pirojshanagar, Vikhroli (E) Mumbai 400 079 Tel: 022-30236100 Fax: 91-022-30236219 E-mail: info@in.endress.com
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Sunmill Dry
Liquid Particle Counter The sunmill dry is a conical screen mill. A high speed rotating impeller forces the product through the perforation of fixed cone shaped screen. The product discharged from the bottom of the mill is reduced in size. It is GMP compliance with low heat, low dust and low noise.
R&D Model includes SM-R&D; and Production Models include SM-100 and SM-300. For more information, please contact: Sunsai Pharma Equipments Pvt Ltd Plot No: 1, Survey No: 77 Nr Laxmi Indl Estate, Sativali Road Vasai (E), Thane, Maharashtra 401 208 Tel: 0250-3200130 E-mail: sunsai.pharma@rediffmail.com sunsaipharma@gmail.com
HiacRoyco the oldest most recognised and technically the best liquid particle counter in Indian and world pharma industry brings you Model 9703+. It can provide solution to all your needs of injectable and opthal samples. May your sample have viscosity, dark coloured, particle range, quick results, this LPC can do all.
high high
For more information, please contact: Shreedhar Instruments 16 Shreeji Krupa Society Opp: MGVCL Circle Office Next to GMERS Medical College Gotri Road, Vadodara Gujarat 390 023 E-mail: sales@shreedhargroup.com
Platinum-cured Silicone Hose Reinforced with Polyester Braiding and SS-316 Helical Wire Imavacfit is platinum cured silicone hose reinforced with SS-316L helical wire and polyester braiding having better flexibility with high pressure resistance. Imavacfit is having high burst pressure rating along with high vacuum resistance compared to Imavac. The product is suitable in pressurized fluid transfer application. Imavacfit conforms to US FDA 21 CFR 117.2600 Food Grade Standard, USP Class VI and ISO 10993-1. It is certified by ROHS and Animal Origin Certification (free of animal derived material), free of restricted heavy metals. It is free of Phthalate/ Bisphenol/Volatile Plasticizer. It has USFDA DMF accreditation #26201. Complete validation package available upon request. Imavacfit has high burst pressure resistance compared to Imafit and Imavac. It is designed for high vacuum rating applications. It has anti-static properties to dissipate static electrical charge makes it suitable for highly volatile flammable fluid transfer. It imparts no taste and odour. It is lot traceable. Its temperature range is -80°C to 180°C. It is available with SS-316 L TriClover end. It is sterilizable by Autoclave, Ethylene Oxide Gas and Gamma Radiation. For more information, please contact: Ami Polymer Pvt Ltd 319 Mahesh Indl Estate, Opp: Silver Park Mira-Bhayander Road, Mira Road (E) Thane, Maharashtra 401 104 Tel: 022-28555107, 28555631, 28555914 E-mail: mktg@amipolymer.com
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events diary Date: 17 th – 18 th May 2018 Venue: Shanghai, China The 2018 China International Pharma 4.0 Summit will bring together over 300 delegates from relevant governments, associations, institutions, pharmaceutical manufacturers, pharmaceutical equipment suppliers, intelligent solution providers of pharmaceutical, packaging, warehouse and logistics, among those the industry regulators, experts and opinion leaders will share the latest policies and regulations, global market trends, technical innovation in the whole chain of drug production, architecture and practice of intelligent pharmaceutical plants as well as advanced technologies such as robotics, AI, informatization, IoT, big data, cloud computing, comparing notes on the transformation and upgrading of pharmaceutical industry.
Date: 24 th – 25 th May 2018 Venue: Sheraton Grand Bangalore Hotel at Brigade Gateway, Bengaluru, India The Biomarkers India, organized by the SELECTBIO will take place from 24th May to the 25th May 2018 in Bangalore, India. The conference will cover areas like bioinformatics & big data analytics for biomarkers development, biomarker discovery & identification techniques, biomarkers in drug discovery & development and many more. Maninderjit Singh, Exhibition Manager Ph: 7696225050 Email: mjsingh@selectbio.com
Patrick Chow Ph: +86 21 6485 6566 – 614 Email: patrick.chow@borscon.com
Date: 20 th – 23 rd February 2019 Venue: Bombay Exhibition Center, Mumbai
Date: 23 rd -24th May, 2018 Venue: Montreal, Canada Biopharmaceutics 2018 is an international platform for sharing knowledge and representing work in the field of Challenges in Biopharmaceutics, Biopharmaceutical Drug Discovery & Development, Clinical Trials in Biopharmaceutics, BA/BE Studies, Biosimilars & Biologics Drugs and more under the theme “Addressing the Challenges in Biopharmaceutics and Biological products”. The conference aims at promoting interaction among the researchers, students, industrial professionals, Biologists, exhibitors, professors and pharmacists from all around the globe. It is a campaign to create awareness about the recent advancements, researches, breakthroughs, technology developed in the area of Biopharmaceutics: Research Scope and Prospects, Novel Approaches in Biopharmaceutics. Biopharmaceutics 2018 will serve as a motivation for the young scientists. We invite you to join us with your prestigious studies & together we will make this world a better place to live. Office Ph: +1-888-843-8169 Toll No: +1-800-216-6499 (USA & Canada) Email: biopharma@alliedmeetings.com biotherapeutics@alliedmeetings.com
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BioPharma World Expo 2019 will be a perfect destination for Bioprocess Solution Providers, CROs/CMOs, Clinical Trial Supply Chain Providers, Cold Chain Packaging & Cargo, Global Pharma, Regulatory Consultants, Analytical Instrument Manufacturers, Local Biotechs & Start-ups, Quality Control Consultants, Academics, and Regulators to showcase and promote their product and services as well as offer unique opportunity to meet, network and discuss current industry trends, establish business partnerships and be updated on investment opportunities in India. The concurrent conference tracks will explore areas like biosimilars and vaccines development, antibodies, orphan drugs, stem cells, innovations in biologics manufacturing and regulatory compliance; growing issues in generic drug manufacturing and more. Amrita Patkar Event Coordinator Tel: 91-22- 4037 3617 Email: amrita_patil@jasubhai.com
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bookshelf Family Based Treatment for Restrictive Eating Disorders: A Guide for Supervision and Advanced Clinical Practice Authors: Sarah Forsberg, James Lock and Daniel Le Grange Price: USD 140.00 No of pages: 194 pages (Hardcover) Family Based Treatment for Restrictive Eating Disorders unpacks some of the most common dilemmas providers face in implementation of Family Based Treatment (FBT) across the spectrum of restrictive eating disorders. Directed towards advanced clinicians and supervisors, this manual is rooted in the assumption that true fidelity requires ongoing self-reflection and an understanding of the nuances involved in translating manualized interventions into rich clinical practice. Combining the key tenets of FBT with the best practices in supervision, it provides a framework to support each phase of the treatment process. Each chapter contains a wealth of resources, including clinical vignettes, a treatment fidelity measure, and other useful tools to assist both supervisors and advanced clinicians in becoming expert FBT practitioners.
Managing Negative Emotions Without Drinking: A Workbook of Effective Strategies Authors: Paul R Stasiewicz , Clara M Bradizza and Kim S Slosman Price: USD 140.00 No of pages: 194 pages (Hardcover) Managing Negative Emotions Without Drinking is the ideal companion to Emotion Regulation Treatment of Alcohol Use Disorders. Each of the 12 individual weekly treatment sessions presents scientifically tested strategies for managing emotions without alcohol, including mindfulness practices, direct experiencing of emotion, and cognitive and behavioral skills to manage high-risk drinking situations and prevent relapse to alcohol use. The step-by-step exercises, user-friendly worksheets, and in-session and between-session skill practice help clients gain a basic understanding of the role that emotions play in harmful alcohol use and assist them in developing the skills needed to manage these emotions and cravings without alcohol.
Understanding Teen Eating Disorders: Warning Signs, Treatment Options, and Stories of Courage Authors: Cris E Haltom, Cathie Simpson and Mary Tantillo Price: USD 140.00 No of pages: 204 pages (Hardcover) Understanding Teen Eating Disorders introduces readers to common teen eating disorder scenarios, their warning signs, and treatment options. Each chapter examines a teen or tween and brings the factors, whether they be environmental, genetic, co-existing conditions, etc. that contribute to his or her eating disorder, to life, while seamlessly integrating the latest research in gene inheritance, brain chemistry, and eating disorders in accessible, reader-friendly language. Each chapter provides treatment options, including outpatient, group therapy, and in-patient programs, for both the young person and the family. Each also ends with a Q & A section that reflects the concerns a parent, loved one, or treatment professional may have. Pharma Bio World
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ad index Sr.No
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Taj Building, 3rd Floor, 210 Dr D N Road Fort, Mumbai - 400 001 Tel: 022-4037 3636, Fax: 022-4037 3635 Email: industrialmags@jasubhai.com 58 â—„ April 2018
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Stand A100, Hall 5.1 11 - 15 June 2018 Frankfurt am Main Germany.