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Pharma Bio World
INTERVIEWS 08
“We have a competitive edge based on the diversity we present in our portfolio” - Rahul Dev, Vice President India, Datwyler Sealing Solutions
FEATURES 16
Ecosystem of Biosimilars in India & Across the World - Debayan Ghosh
22
08
The Internet of Things (IOT) and Pharma - Navin Parti
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Techno-Healthcare: Impact of Technology on Healthcare industry - Dr Dharminder Nagar
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Performance of Aluminium Based Packaging Materials Related to the Structure
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Next Issue Focus: Biosimilars/Biopharmaceuticals
6 January 2018
Pharma Bio World
interview
Rahul Dev
“We have a competitive edge based on the diversity we present in our portfolio�
8 ď‚ƒ January 2018
Datwyler Sealing Solutions has been providing state-of-the-art solutions for pharma packaging and recently made news on expansion of the Pune facility, which is one of the key steps for Datwyler in strengthening and growing business activities in India. Rahul Dev, Vice President India, Datwyler Sealing Solutions in an interview with Mahesh Kallayil discusses more on this.
Going by the presence of Datwyler in the global markets, how has the company performed so far? How is the company positioned in the Indian and global pharma market?
I n t h e P u n e f a c t o r y, D a t w y l e r m a n u f a c t u r e s components in the field of container closures, eg.
Datwyler has performed very well globally in the last years. In the first half of 2017, business grew by 3.9 per cent, adjusted for currency and acquisition by 2.2 per cent. Particularly the Sealing Solutions division performed very well and is one of the growth drivers for the company.
In 2017, close to four billion components were manufactured in India.
In India, Datwyler is positioned as major player in the health care industry supplying the ten most important pharma companies with its products.
The Indian Pharma Packaging Industry is
for (glass) vials, syringes and pre-filled syringes, and components for diagnostic devices.
What is the standing of Indian Pharma Packaging Industry in international market?
gaining importance in the international market. Currently, the Indian market is quite focused Pharma Bio World
interview on generic medication, but also has the highest number of FDA approved products worldwide. This development towards more high-end products also means investments in Research & Development which will push the Indian market even further. As a global player in pharmaceutical packaging, what developments would you like to see Indian pharmaceutical market? We are happy to see a more R&D focused approach in the Indian pharmaceutical market and are sure that companies can only profit from this development. More high-end manufacturing methods like cleanroom manufacturing is something we as Datwyler actively push with our factory extension which will incorporate our highest manufacturing standard First Line for production in cleanroom environments. What are the emerging trends in packaging technologies? The emerging trends that are relevant to us are certainly the continued rise in biologics and biosimilars, which require specialized packaging. This is particularly important when it comes to coatings as a source of extractables and leachables such as silicon oils, which can potentially contaminate the medication and endanger patient safety. Requests for coated products such as cartridge components or pen packaging are rising. High value products will be an essential driving factor for growth. Specialization is certainly important, so that medication can be packaged according to the specific needs of the pharmaceutical product and the customer alike. In this fiercely competitive market, it seems that you have a competitive edge over others. How do you perceive it? 10 ď‚ƒ January 2018
We d o t h i n k t h a t , a s a c o m p a n y, w e have a competitive edge based on the diversity we present in our portfolio. We are always looking at the next step we need to take to strengthen and expand our position as one of the major players in the global market. As a globally acting company in the pharma industry, we need to anticipate any upcoming future trend. There are several developments at the moment which we consider to be important and interdependent trends in the pharma market. The future of injectables and the provided possibilities for administration, for example. Closely connected are also the developments in the sector of self-administration and what the field of digital health can contribute to the issue. These kinds of new health care solutions are a main focus in our research and development efforts. We see partnerships as the way forward and a competitive edge, which is why we established partnerships with the Interuniversity Microelectronics Center (IMEC) Institute in Belgium and the Holst Center in the Netherlands to do research in the wearables sector. Kindly brief us about Datwyler’s GMP principles in production and control of pharma packaging materials within organization. The production standard First Line is dedicated to guaranteeing the highest levels of quality and safety for pharmaceutical rubber components. The First Line production operates in a fully integrated good manufacturing practice (GMP) environment using innovative automated processes and conforming to the highest industry standards. Each zone has been meticulously designed and constructed to prevent bio-contamination and is equipped with material airlocks. State-of-the-art pass-through washing equipment has its automatic loading side in one zone and its automatic unloading side in a zone of
even higher cleanliness. The process flow, gowning protocols, personnel and material flow, and state-of-the-art automation all result in the lowest endotoxin, bioburden, particulate, and defect levels available in the industry. The new clean room also incorporates the latest generation of camera inspection techniques. The entire facility incorporates rational and lean production flows in accordance with the Six Sigma methodology. The First Line manufacturing concept exceeds the most stringent quality standards of regulatory authorities and is certified to ISO 15378. It is designed to operate under a zero-defect philosophy. Datwyler recently completed expansion of its facility in Pune. Could you please tell more on this? How is it going to meet the requirements of India’s domestic pharmaceutical packaging market? The expansion of the Pune facility is one of the key steps for Datwyler in strengthening and growing business activities in India. The facility will manufacture according to the First Line standard (please see question 10 for details). Therefore, it will provide state-of-the-art components and packaging solutions which will cater to customers who are looking to manufacture advanced and high-end pharmaceutical products. With the facility and its First Line aligned expansion, we will not only be able to better cater to customers and companies with operations in the region, but can also concentrate more on our Indian customers, who make up a quite substantial market share for us. The same applies to our facilities in Europe and the United States which are either already manufacturing according to the First Line Standard or will open later this year (2018). Pharma Bio World
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interview quality of life is improving. Quite frankly, we are looking at a fast-growing market with lots of opportunities.
such as the construction of a local school a n d e ff o r t s i n t e r m s o f w a t e r q u a l i t y and resources.
Due to its healthy growth development What are company’s future plans? and high potential for new business, we believe that the Indian pharma market The most important development will w i l l p l a y a n i m p o r t a n t p a r t i n f u t u r e certainly be the expansion of our Pune g l o b a l h e a l t h c a r e . O n e o f t h e m o s t facility and the start of production to important factors is the Indian population, full capacity. This will also have positive which is growing at an estimated 5-7 effects on our employee structure: while per cent per year. The living standard we are currently employing more than i s c o n t i n u o u s l y i m p r o v i n g , a n d s o i s 400 people, we should be closing on 500 ADVERTISE TO EXPAND the health care sector. We see bigger employees by the end of 2018. your reach through efforts by the government to match this development with investments in It is important to us that we staff the majority health care. As a result, health care of all positions with local and regional services and medication are much better workforce. We also place high value on accessible for the population and the social and environmental engagements,
Datwyler is a growth-oriented company. In the last couple of years, we have been investing very heavily for two reasons. The first reason is to be globally present in different geographical regions, which enables us to supply regional and global market players. The second reason is to further strengthen our customers’ confidence in the high quality of our products.
How do you see Indian pharma packaging sector vis-à-vis the “Vision 2020”?
Presently, we are investing in India and have strong confidence in this market and its opportunities.
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Pharma Bio World
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Ecosystem of Biosimilars in India & Across the World This article seeks to explain what it takes to establish a thriving biosimilar market terms of accessibility, competition, regulatory strategy, and other facets.
U
S FDA defines biosimilars as “Biosimilar is a biological product that is highly similar to a USlicensed reference biological product not withstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product�. Over the past few decades, the biosimilar industry has played a significant role in the field of healthcare around the globe. Biosimilars, is the emerging market in India and is considered the future. The Indian biosimilar market has developed rapidly over the last 10 years. Indian Biosimilar Ecosystem is still in rudimentary stage in terms of accessibility, regulatory strategy, and other facets. Till recent times, most of the Indian drug makers have been small molecule generic manufacturers. However, in the wake of the new potential of Biosimilars in the region, this trend gradually seems to be changing. There are multiple generic companies that have stepped into the biosimilar space, however very few have been able to create a scale and a roadmap for significant market share in this rapidly growing field. There is also indication that large amounts of capital is lined up behind biosimilar drug development, targeting the massive opportunity coming up in the path of biosimilars with the expirations of multiple blockbuster Biologics Patents. Its sales are expected to grow much faster compared to conventional chemical drugs, in years to come.
Debayan Ghosh Founder & President Epygen Biotech Pvt. Ltd. 16 ď‚ƒ January 2018
Unlike traditional small molecule drugs, biologic drugs are much harder to replicate and have allowed originators to maintain market dominance even after their patents
have begun to expire. However, generic drug manufacturers are keen to invest in the biosimilar area, eyeing long term revenue opportunities. The ecosystem of the biosimilars seems to be taking shape in India, however it will take some time to assume maturity. A paradign shift in required in the mindset of the Biotech/Pharma companies as well as the drug distribution and access system to match up with the rapidly evolving field of Biosimilars. As we know that biosimilars are far more complicated than the average competing medicine as they are produced using living cells and have a few caveats, unlike generics which are chemical-based drugs like antibiotics that can be interchangeable with branded versions. Biosimilar products are approved by FDA on the basis of being highly similar to an already approved biological reference product, unlike a generic drug. The original innovator drug itself is highly complicated being in most cases expressed by a recombinant organism, which has undergone genetic manipulation. To add to the misery, most of these protein drugs are subject to molecular modification or proteomic steps including an array of critical purification procedure and handling. It takes much more time, energy, and money to get a biosimilar approved, compared to a generic medicine. For example, where a generic chemical drug has to pass through a few head to head comparisons to be registered as authentic, a recombinant biotech biosimilar drug passes through an battery of around 50 characterization tests followed by some phases of Clinical trials, including 100s of patients. To develop a biosimilar, it could take anywhere from 5 to 10 years and can costs 100s of million dollars. In comparison, a generic drug takes at the most about two years and costs one tenth of the price compared to a biosimilar drug. Pharma Bio World
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While the current global biosimilar market is only to the tune of 2.5 billion dollars, by 2020, it is predicted to jump up 50 billion dollar market across the world and by 2030 it is estimated to go up to around 250 billion dollars. Though Europe had opened its door to biosimilars several years back, allowing upto 40% penetration to its sizeable Biologics market, USA has only opened its flood gates to the biosimilars two years back. Despite, its last entry, the country that will largely contribute to this number will be U.S.A., Europe and Japan would contribute proportionately for another 25% of the huge number and the countries that will closely follow will be Korea, India, Russia, China, and Turkey. USA is the largest market of biologics globally, estimated currently around 42%, and will remain to be the largest contributor for biosimilars in few years 18 ď‚ƒ January 2018
time, resulting upto 20 to 30 percent of the global revenue generated. As far as India is concerned, one needs to understand the critical barriers to the biosimilars for this country. The number one barrier is Technology Barrier. Biosimilars will have to be produced using recombinant organisms using state of the art technology and highest level of care needs to be taken in terms of protein purification and characterization. The process being extremely sensitive to potential contamination, more often thats not over expression of the protein and purification and down streak processing efficiency will be the key parapets to cross this most critical barrier. The second important aspect is the regulatory barrier. Biosimilar guidelines in
India were laid down in 2012 and further amended in August 2016. The regulatory bodies made responsible for approval of ‘similar biologics’ in India were Department of Biotechnology (DBT), Review Committee on Genetic Manipulation (RCGM), and the Central Drugs Standard Control Organization (CDSCO). India has approved more than 70 biosimilars till now with a robust pre-clinical and clinical data requirement to establish similarity with the reference drug. To further strengthen regulatory framework, post marketing phase IV studies were introduced, which includes a pre-defined single arm study of more than 200 evaluable patients and compared to historical data of the reference product. The study has been advised to be completed within two years of the marketing permission/manufacturing license unless otherwise justified. This matches with the highest requirement Pharma Bio World
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standards of proof of Biosimilarity worldwide and further prepares Indian companies to be able to face international regularity needs. The third important barrier to the Biosimilars in India is its affordability and market access feature. Affordability of biosimilars will be the most important factor for growth in India and other ROW markets. However price erosion in these markets is not expected to be greater than that of Europe. To use as a reference, examples from Europe will continue to set price erosion patterns across global markets. There is no doubt that the Indian market for biosimilars is getting competitive and busy and will continue to be so. While the number of Indian companies to make it to the developed markets could only be few, the Indian market itself will continue to see multiple players including several international companies marketing products in India through collaborations and further contributing the emerging Eco-system for biologics in the country. Considering the current scenario in India, the Ecosystem for Biosimilars development and manufacturing seems to be quite polarized in the south, namely Bangalore and Hyderabad. Setting examples, these cities are at the forefront and doing a great job of utilizing the facilities provided to them by the Government. However, Maharashtra is also trying to get into the league and establish a well structured eco-system for biosimilars, to once again play a key role in catapulting the countries’ economy to the next level. There is a tremendous need of biosimilars in countries like India because of its financial advantage over innovator drugs for critical ailments like oncology and immune disorders. The plan to launch cheaper biosimilar drugs is in congruence with the government’s affordable healthcare policy and makes India’s biotech industry globally competitive. 20 January 2018
Serving twin purposes of providing affordable drugs to critical patients and making Indian biotech industry globally competitive, the department of biotechnology has led the opportunity for the existing biotech companies and the new-comers to progress in this sector. The factors and driving points that are applied& carried out in India can be applied in other nations in the region as well. The biologics in the developed countries are very expensive, with annual treatment costs reaching up to $100,000 per patient for rehematoid artheritis. This is practically impossible for the patient population in developing countries to afford such costs, and thereby creates an opportunity to harness the local industry and operating environment to develop biosimilars. There seems to be a great potential for biosimilar products in the emerging markets as they allow for early entry and launch, with more affordable pricing, greater access to patients and the medical community. Markets like Russia, Turkey, South Korea, and Argentina have sustained strong biosimilar sales for many years. Nations such as Vietnam and Taiwan are also moving in the same direction. Citing examples of regional co-operation, India and Malaysia are forging an alliance for biosimilars, both in the government and the private sector. Steering through the teething issues, R&D expenditure for biosimilar development in India increased substantially to $ 1.4 Bn during the year ended March, 2015, a 28.8% increase from $ 1 Bn in the previous year. [Source: OPPI November 2015-Assocham]. This increased R&D expenditure is results from the engagement of life science companies from large biopharma, major generic companies, young biotech JV ventures and start-ups developing skills for biosimilars manufacturing. It is reported that there are more than 10 companies in India, genuinely developing biosimilars for
the highest selling monoclonal antibodies of the world. Even globally, the technology development landscape for biosimilars reflects deeper engagement. The current vibrant landscape includes companies across the spectrum of large, mid-sized and smaller ventures. With several active global programs on biosimilar opportunities, there is a good possibility today to partner for technology access. While technology still remains key to competitive biosimilar business, its threat as a barrier is diminishing given the expanded global partnership possibilities. In the coming years, it is very critical that the biosimilar aspirants in India streamline their regulatory compliance with new stipulations while not only producing and processing of molecules, but also in generating clinical trial data. This will open the gates to a larger global biosimilar market, potentially changing the game for the Indian biosimilar developers. Biosimilar drugs will definitely reshape the global pharmaceutical market as they grab market share in the years to come. The speed with which this happens will depend only on how the biosimilar manufacturers choose to use their capital to position themselves in the global market, keeping their focus squarely on affordability without compromising quality.
Contact:ashwini.equationsmedia@gmail.com Pharma Bio World
The Internet of Things (IOT) and Pharma Journey of drug and medical equipment starts from its manufacturing to its consumption by the patients and hospitals. Use of IOT in pharmaceutical industry is not only limited to collection of data using fitness wearables, but the sensors are also being used in drug manufacturing plants to monitor the different parameters like temperature and humidity, required to meet the regulatory compliance for drug manufacturing. Sensors are being used in the manufacturing plants to monitor the performance of machineries and predict any failures. Sensors are also going to play a vital role in Logistics and supply chain of these drugs where these sensors can be used to monitor the movement of the drugs from manufacturing units to their desired destinations.
G
artner, Inc. forecasts that 8.4 billion connected things will be in use worldwide in 2017, up 31 percent from 2016, and will reach 20.4 billion by 2020. The total spending on endpoints and services will reach almost USD 2 trillion in 2017. With growing footprints of digital transformation across different industries and verticals, digitalization is not only limited to becoming paperless, but it has moved a step ahead, where data from different sources are helping organizations in their growth. Q3 feels this is where IOT is going to be one of the key contributors. In fact, McKinsey estimates the potential economic impact of IOT applications to exceed USD 11.1 trillion per annum by 2025. As we all know, Internet of Things or IOT is about building a network of physical objects. The world has moved from a network of interconnected computers to a network of interconnected everything. Increased usage of linked devices, faster cloud adoption, growth of high-speed networking systems have motivated every industry to embrace IOT solutions to augment their infrastructure. Wi-Fi, Bluetooth, NFC, RFID, and QR codes are the widely used technologies to enable IOT ecosystems. With IOT, intelligently linked devices embedded with sensors are able to communicate and exchange data. Any device fitted with sensors and actuators gains the ability to produce, transmit and process data. The data generated is not being used to its full potential and serves around 2 per cent of what it is capable of. Right now, the focus of using IOT is mainly on
Navin Parti Vice President Q3 Technologies 22 ď‚ƒ January 2018
abnormality detection, control mechanisms or for instructional purposes. IOT data for optimization and predictive analysis is yet to be fully exploited and tapped. IOT in Pharma The journey of drug and medical equipment starts from manufacturing to its consumption by the patients and hospitals. IOT in pharma Industry can be used in the following stages of a drug/equipment lifecycle: Manufacturing - Drug manufacturing and production units are using IOT to automate their maintenance processes. Sensors attached to their production units regularly send data against different parameters to assess the performance of machineries and predict any possible failures. Similarly, various assets and raw materials required in these industries are being monitored through sensors which will send notifications before any actual shortage of raw material happens. Industrial Internet of Things (IIOT) could add USD 14.2 trillion to the global economy by 2030. Moreover, investment in IIOT is expected to exceed USD 60 trillion in the next 15 years. Drug Compliance / Quality Control Several predefined parameters needs to be monitored while manufacturing any drug. These predefined parameters if violated can lead to disqualification of the whole batch of drug leading to a production loss. Sensors can be used to monitor such parameters in real time during manufacturing and raising proper alarms if any of such parameter is expected to go beyond the set values.
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Supply chain/Logistics - Drugs and Medical equipment once manufactured, need proper storage and transportation in a controlled environment. IOT sensors can be used to monitor such controlled environment so that one can track the drugs while in transit.
this data to draw meaningful insights etc. The ability of IOT systems to function effectively in an organization requires interoperability between these systems. This interoperability is required for 40-60 percent of the implementation.
Implementing IOT
Conclusion
The implementation of an IOT ecosystem in an organization requires a change in the business model. Technical as well as governance obstacles need to be overcome for an organization to set up an effective, value driven IOT ecosystem. Creative business models equip organizations to position their products as services. Small business cases that churn out a quick ROI while addressing minor pain points with IOT devices and networks can be a good start.
The real value-add of IOT depends on the data that these devices generate. Industries can improve operations and plan future roadmaps by analyzing this data. The success of any IOT project primarily depends on the predictive/prescriptive analytics done using the data generated. Data generated from IOT devices, when used for optimization and predictive analysis, creates maximum value for both the stakeholders and consumers of the organization. Use of IOT in pharmaceutical industry is not only limited to collection of data using fitness wearables, but sensors are also being used in drug manufacturing
Implementing IOT is not just about installing sensors, it involves lot of other activities like receiving data from sensors, processing 24 ď‚ƒ January 2018
plants to monitor the different parameters like temperature and humidity, required to meet the regulatory compliance for drug manufacturing. Sensors are being used in the manufacturing plants to monitor the performance of machineries and predict any failures. Sensors are also going to play a vital role in Logistics and supply chain of these drugs where these sensors can be used to monitor the movement of the drugs from manufacturing units to their desired destinations. We believe that implementing IOT would test conventional business models and would generate maximum worth through interoperability, optimization and analytics.
Contact: garima.channelpr@gmail.com Pharma Bio World
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Building Supply Chain Competencies for Indian Pharma Logistics Supply chain and logistic are critical and essential enabler for the pharmaceutical industry to deliver the right product, in the right quality, and at the right time to the end consumer. In the complex Indian environment, there arise many challenges that place a hurdle in our effort for smooth process. This article tries to identify those constrains and challenges and also include what are the developments that need to fall in place to meet requirements.
T
he biopharma market is in the early stages of its next transformation. Thus, unless supply chain logistics keeps pace with these transformations, the end solution for which we are all putting in our best efforts will remain a distant dream for all of us. Clinical pipelines are being filled with increasingly intricate targets and medicines, including next generation cell and gene therapies, an emerging field known as regenerative medicine. This is the next generation advancement towards which globally, the pharma labs are destined to move to.
is pegged at $30 billion, with the country accounting for the highest number of FDA approvals after the USA. Companies have embarked on a growth trajectory, aspiring to become a hub for low cost manufacturing and R & D, and yet they are also facing a unique set of local and global challenges that are creating significant pressure to tighten the end to end supply chain operations. This is the key in pharma logistics. Unless Supply Chain operations get revamped with additions of technology, skilled man power and strategic thinking, we will not be able to move forward.
With growth rates far outpacing other areas within the pharmaceutical industry, it is anticipated that the regenerative medicines market size will reach USD 49.41 billion by 2021, a CAGR of 23.7 per cent.
Companies are looking at the next phase of growth, but there is significant gap between the strategic vision and operational reality. Quality issues and price pressures have spiralled across the value chain , triggered by more regulatory scrutiny . Infrastructure although better than in the past , is still a serious concern. Key challenges that Indian organization face is that the business differentiator is shifting from being reverse engineering experts to having improved operational performance parameters such as service levels and cost to deliver.
Without question, advanced cellular therapies require comprehensive, welldesigned and enhanced cold chain management solutions based on all elements of packaging, data collection and analysis, as well as supply chain logistics expertise to ensure effective patient treatments with the highest quality products. Where the industry is headed for storage requirements for these therapy medicines? Unless, the required temperature controlled storages are ready with most modern technology to keep monitoring the cold effects, we will not be able to realize the final results. Companies in this space have been racing to adapt and develop new standards, best practices and technology innovations. Indian Scenario V Raju Vice President – Contract Logistics - Chemical, Pharma & Food Sector Avvashya CCI Logistics 26 January 2018
As a global pharma player, India is going through an interesting phase in the pharma world. Currently, the Indian pharma market
Growth for India’s pharma industry hinges on:
• hsica capacit an aiit to pan usinss oums an fac op rationa chans. • ncras in manufacturin capacit • pansion of co chain an paca in capaiitis • umntin pop an orania tion capacit ith onus on uait sis an trainin • rocss capaiitis • aor instmnts that ar n to op n ru formuations • mpro utomation an tchnoo transfr • roth support throuh supp chain maturit an uait assuranc Pharma Bio World
The above mentioned concerns have been triggered by varying degrees of infrastructural development in developing markets of Asia along with rapid growth rates and non-harmonized regulations. Along with infrastructure issues, the handling of pharma cargo through transshipment ports and transshipment points is also an issue in our country, where inadequate training or care on the part of site staff can lead to supply chain logistics problems. Lack of IT sophistication in the domestic logistics sector, whose efficacies have been marred by the limited use of RFID sensors and technological tools, has made it difficult for manufacturers to execute basic tasks like tracking cargoes. There is a dire need for high technology enabled and process managed cargo storage and handling facilities to operate efficiently in India, which calls for high level 28 ď‚ƒ January 2018
of investments. India is well established and recognized for its intellectual talent and as a low cost sourcing location. However, it needs to be backed by an increasing trend in world class storage and handling infrastructure for its imports and exports. A long-term investment strategy is needed for augmenting the country’s warehousing, ground handling, storage, and IT infrastructure and transportation capabilities. Today, the need of the hour is good standard warehouses with high sense of technology and efficient processes being implemented at the ground level to instill the confidence in importers and exporters of pharma products. Good storage practices and good manufacturing practices go hand in hand and it is the duty of manufacturers and service providers to ensure their smooth
provision. . There is a need to expedite the building of temperature controlled warehouses at key locations to increase the lifespan of pharma products and maintain their quality standards, failing which the products may get damaged and finally become redundant. Creating a resource pool of quality control experts having advanced technology knowledge and updated with the subject expertise is imperative to rooting out contamination of pharma goods at the inception stage from storage locations. Quality checks and notes on every shipment or consignment leaving or moving into the warehouses have to be maintained. Proper record keeping along with routine audit checks on the storage, handling practices need to be implemented at ground levels. Manufacturers have to be extremely careful while selecting supply chain logistics providers to ensure that Pharma Bio World
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A well designed supply chain with robust planning cycles that take care of various lead times in the end to end supply chain can help achieve speed to market as well as an agile supply chain. Logistics competencies of pharma products in developed countries are far evolved as compared to the Indian market, but the emerging growth opportunities in the sector will drive us towards achieving international standards.
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Temperature controlled warehouses need to have data loggers and regular monitoring procedures that shall ensure that required temperatures are provided. In addition trained professional staff wearing the required protective clothing is required to ensure quality work is done at all times. Such good storage and handling practices ensure in preservation of the products and stabilizes prices by managing their shelf life and regulating the supplies.
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White Paper
Performance of Aluminium Based Packaging Materials Related to the Structure
Dr. E. Pasbrig GM Development and Technology ACG Pharmapack
C
old form laminate in India normally has aluminium thickness of 50 µm. Internationally, 45 µm is used
for packaging of standard products. If a higher dent resistant of cavity is needed, the thickness of aluminium will be 60 µm. Difference of 5 µm in thickness does not provide a better dent resistant, as shown in next table.
Aluminium thickness (µm)
45
50
1 reel (20 kg) in m2
84.4
79.8
Running meter (width 200 mm) 422
399
2 blister/cycle
844
798
2 lac blister (1320 sqm) (kg) 313
331
Saving (kg)
18
CFF
Stifness (Nmm)
25-45-60
1.13
25-50-60
1.14
40 cycle/min, blister 120 x 55 mm
25-60-60
2.12
Possible savings over a year, depending how many shifts per day are done, are in the range of ` 22 to 89 Lakh.
oPA-Al-PVC Formability of the laminate with 50 µm aluminium is not increased compared to the standard laminate with 45 µm Al. Use of laminate with 60 mm aluminium provides a slightly better formability and more consistent forming results related to pinholes (higher cost). Reduction of aluminium thickness by 5 µm for a cold form blister with dimension of 120 x 55 mm results in 18 kg material saving for packing 2 Lakh of blister. 32 January 2018
Approximately Saving (INR) 6311
kg
INR (Lakh)
1 shift/day
6552
22.3
2 shifts/day
13104
44.6
4 shifts/day
26208
89.2
The example is showing, that CFF with 50 µm does not have an advantage in performance, needed higher amount of material by area and more frequent changes of reels during production.
Lid Foil, Aluminium Thickness 25 µm and 20 µm Similar result we get for the change of 25 µm to 20 µm aluminium thickness for lid foil. Beside the USA market, all other countries use a thickness of 20 µm, and Japan uses even 3 µm less. For aluminium foil p r o d u c e d in Europe, the max imum a mo u n t o f pinholes per m 2 with 0 .5 , r e s p e c tiv e 0.4 for 25 µ m a re s imila r a n d d o n o t influenc e the barrier pr o p e r tie s o f th e s ealed blis ter. Savings of material for the lid foil, as mentioned in the following table, are up to 21.8 per cent. Al
HSL Lacquer wgt.
Yield
Saving 21.80%
54.0
7
1
62.0
16.1
67.5
7
1
75.5
13.2
For a production of blister (60 x 95 mm; 4 blister/cycle; 40 cycle/min; weight of reel = 14 kg) switching from 25 to 20 µm, produces 7040 blisters more, with 20 µm foil. In addition, time until reel needs to be changed is increased by 44 min. Pharma Bio World
White Paper
Figure 1: Performance of Aluminium Based Packaging Materials Related to the Structure erence between the 20 and 25 µm foil used for converting.
Cycle per reel (14 kg) Thickness (µm)
20
25
14 kg = m2
225.8
185.4
Cycle/14 kg
9956
8176
Running time per reel Thickness (µm)
20
25
Production time (min)
249
205
Difference (min)
44
Related to seal strength, heat resistance, abrasion of printing ink, there is no di Pharma Bio World
Burst pressure is increasing with the thickness of the foil. With this push through, force is increasing too. It is di cult to push a hart gelatine capsule through 25 µm foil without denting/ pressing the capsule. Reduction of Packaging Material Strip Pack – CFF – Tropical Blister Moisture sensitive products packed in strip pack are as well protected as in CFF. If sealing layer of CFF has to be identical as
strip pack, LDPE or HDPE can be used. As sealing layer of lid foil an extrusion coating of LDPE on 20 µm aluminium is used. Comparison of strip pack and CFF highlights the main points as; • more packaging material has to be used. • product is in direct contact with sealing roller (hard gelatine capsule can stick on PE) and temperature sensitive products cannot be packed. Calculations to compare size of pack have shown, that with usage of CFF, 30% to 70% reduction is possible, depending on product geometry. If tropical blister is used, January 2018 33
White Paper further saving is possible. Reduction in size is not identical with saving of cost. But if all points are taken, every example shows savings; • production time and output • lower weight • smaller folding carton • more blister in shipper • lower cost for logistics These calculations come into play if a customer expresses an interest to switch from strip pack to CFF or tropical blister. Lid PE Sealing layer of lid foil (push through) for sealing to CFF with polyethylene (LDPE, HDPE, CFF with desiccant) is produced by extrusion coating. To get su cient adhesion to the aluminium surface a primer (lacquer) is
used between aluminium and PE. Because of this sealing, the layer related to lid foil is double in thickness compared with lacquer of 7 g/m2 where double amount of humidity and oxygen is migrating through it into the cavity. We were able to develop a push through foil with a lacquer in sealing to polyethylene with 5 or 7 g/m2, depending on customer requests. Not only is the cost less, but more importantly, the cross migration is reduced by 50 per cent. This lid foil is on the market already and replacing the material with extruded LDPE. Summary • Use of CFF with aluminium of 50 µm compared with 45 µm does not have any advantage related to performance; costis higher related to area.
• Switching of lid foil with 25 µm aluminium to 20 µm provides an advantage related to cost and change time of a reel. • Change from strip pack to CFF can reduce pack size by 30 – 70 per cent. • Lid foil for sealing to polyethylene with a lacquer can replace the currently used lid foil with LDPE extrusion coating. It provides cost advantage and better barrier related to cross di usion of a CFF blister. • If barrier layer of thermo form films are on inner side barrier properties after forming is increased by 11 – 15 per cent. • ACG Pharmapack is offering a unique service to the pharmaceutical industry related to thermo forming, cold forming and sealing.
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34 January 2018
Pharma Bio World
Techno-Healthcare: Impact of Technology on Healthcare Industry From improved operational efficiency to standards in patient care, the healthcare transformation has enhanced the entire experience for both patients and medical professionals. This article discusses the healthcare industry trends and innovations that are revolutionising the field.
I
n today’s world, technology plays a crucial role in the functioning of every industry and has made our lives totally different than before. Out of all the industries, technology plays one of the most dynamic roles in healthcare industry. The advent of techno-healthcare, promises to improve and save countless lives all around the world. Techno-healthcare is a broad field where innovation plays a crucial role in sustaining health. Areas like biotechnology, pharmaceuticals and information technology along with the development of medical devices and equipment have made significant contributions to the healthcare industry. From development of adhesive bandages and ankle braces to complex more innovations like MRI machines, robotic prosthetic limbs and artificial organs, technology has made a remarkable impact on healthcare. Doctors are able to carry out better diagnosis, surgical procedures, and improved patient care due to technology. The change is palpable with the way doctors and patients interact with each other nowadays. Doctors are increasingly adopting technology like using notepads to take down and save patients’ history. Mobility
Dr Dharminder Nagar Managing Director Paras Healthcare Pharma Bio World
With doctors and hospitals incorporating technology in their systems, more and more fuctions are carried out effortlessly and efficiently. Physicians have been given the gift of mobility. Doctors now have access to all kind of information required, be it drug information, research or studies, patient history or records and much more, within mere seconds. With the ability to effortlessly carry mobile devices around throughout the day, information is never too far from them. Devices that aid
in identifying potential health threats and examining digital information like x-rays machines and CT scan machines also contribute to the benefits that information technology brings to healthcare. Analytics Predictive algorithms hold immense potential in solving some of the acute problems faced by the healthcare system and delivery in India. With this technological development, doctors are able to diagnose their patients more precisely. Analytics are being applied in other countries for diagnosis and the same technology can be adopted in India. This helps the doctors in discovery of a new source of data which helps them draw the complete picture about the diseases of the patients. This also makes possible the complete analysis of a medical problem like diabetes or any other problem and then find a revolutionary solution. Digital The push towards digitization augers well for the healthcare industry. Digitization is helping in conversion of patient records from paper driven to electronic storage systems. This is resulting in more efficient delivery of healthcare to the patients as their medical history and even treatment is no longer tied to one location and can be sent for reference and cross checking to any part of the world in no time. With Aadhar number linkage of the health records of the patients, there will be further simplification of the process of getting OPD appointments in hospitals. Patients need not stand in long queues and just need to mention their Aadhar numbers and forego the process of registration at hospital counters. January 2018 ď‚„ 35
Patient Care Another key area that has benefited from techno-healthcare is patient care. The use of information technology has made patient care much more reliable at hospitals. Nurses and doctors working at the frontline now regularly use hand-held computers to record important real-time patient data and then share it instantly within their updated medical history. It is an excellent contribution of technology to health care industry. Being able to store lab results and other crucial patient data at one centralized area has altered the level of care and efficiency a patient can expect to receive when they enter the hospital. Medical Research An improved level of efficacy in data collection means that an immense pool of patient history and case studies is now available to scientists online, who can easily study extensive patient case studies and make medical breakthroughs
at a faster rate. Scientists and physicians are persistently conducting research and finding new procedures to prevent, diagnose and cure diseases in a more efficient way and develop new drugs and medicines that can reduce the symptoms or treat ailments in a quicker way. Vaccines Through the use of technology in medical research, scientists have also been able to study and examine diseases on a cellular level and produce vaccines against them. These antibodies against life-threatening diseases like malaria, polio, MMR, etc, prevent the onset of diseases and save millions of lives all around the planet. In fact, according to World Health Organization estimates, vaccines save about 3 million lives each year and prevent million others from contracting deadly viruses and diseases. Advancements in technology have rendered an extraordinary impact on the
healthcare industry and dealing with medical problems has never been easier. Physicians are able to better diagnose and treat their patients, ever since the beginning of the professional practice of medicine. Scientists and researchers are able to formulate better medicines and vaccines, thanks to the resources made available by technology. Countless lives have been saved and the overall quality of life continues to improve over time owing to the growing scale and size of technohealthcare industry.
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Biopharmaceuticals are produced inside bacterial, fungal, plant, animal or human cells. This makes the manufacturing process very special and different from traditional (chemical) pharmaceuticals. Nevertheless, just like these traditional medicines, biopharmaceuticals are protected by patents that prohibit copying. Once the patent period has expired (after 20 years), companies can put their own versions on the market, the so-called biosimilars. A biosimilar is a medicine that is modelled on the original biopharmaceutical (the biological reference product); however, it is not identical to it. In the February issue of Pharma Bio World, themed on Biosimilars/Biopharmaceuticals will cover articles, case studies and guest columns which could focus on broad areas of biopharmaceuticals and biosimilars. To ensure Pharma Bio World continues to meet your needs, we would appreciate your feedback. Please feel free to write to us at mahesh_kallayil@jasubhai.com if you think we can serve you better.
36 January 2018
Pharma Bio World
Market Research
3QFY18 Results Preview
Pharma Bio World
Revenues (Rs bn)
370.0
%YoY Growth - RHS 15.0
360.0 350.0
10.0
340.0
5.0
330.0
-
320.0
-5.0
310.0
-10.0
2Q 18
4Q 17
2Q 17
300.0
Overall EBITDA Margin To Improve Sequentially EBITDA (Rs bn)
100.0
Margin (%) - RHS 30.0
80.0
25.0
60.0
20.0
40.0
15.0
20.0
10.0
3QFY18E
2QFY18
1QFY18
4QFY17
3QFY17
5.0 2QFY17
-
1QFY17
Differentiated/diversified business models to prosper: We believe that pharma companies having differentiated business models like CRAMs (DIVI and DCAL) or highly diversified business mixes (GRAN, JUBILANT and STR) are likely to report good numbers in 3QFY18E due to the absence of the current
Expect ~3% YoY Rev Decline For Our Coverage Universe
4Q 16
Laggards: Companies like SUNP, DRRD, LPC, GNP and ALPM, while having strong domestic presences will struggle to show growth in 3QFY18E due to the absence of significant launches in the US market. Current regulatory issues for SUNP (Halol WL), LPC (Goa and Indore WL), DRRD (Duvvada WL) and GNP (Baddi 483s) have stifled launches in the US market in the recent past and we expect this to reflect in the current quarter’s US numbers. LPC and GNP will also suffer from high bases in3QFY17 where there were significant sales of limited competition products.
pressures of being a front-end player in Top picks: CDH, LPC, ALKEM, DISH the US market. We expect (1) tailwinds in and GRAN PHARMACEUTICALS : 3QFY18E RESULTS PREVIEW JUBILANT’s chemicals business, (2) scale up in Australia plus a couple of significant launches in the US for STR, (3) impact of core capacity expansion for GRAN and (4) a full commercial quarter for Niraparib for DCAL to drive strong performances for these companies.
4QFY16
P
ost the bumper domestic sector numbers in 2QFY18 which provided a temporary boost to the pharma pack, we believe that 3QFY18E is likely to be more of a mixed bag. Companies with limited competition launches in the US such as CDH, CIPLA, ARBP and STR are likely to report strong numbers in 3QFY18E. Domestic focused companies like ALKEM and TRP are likely to benefit to some extent from the low base of 3QFY17 which was impacted by demonetisation and the trailing effects of channel re-stocking. However, sequential growth looks difficult. Overall, we see 1.4% YoY growth for our coverage universe and the EBITDA margin to remain steady sequentially at 21.9% in 3QFY18E.
-
January 2018 37
2
Market Research COMPANY
3QFY18E OUTLOOK
WHAT’S LIKELY
KEY MONITORABLES
AVG
• The top-line is likely to decline ~11% YoY, owing to the high base (gGleevec) and increasing pressure on Taro’s business. The launch of • FY19E generic launch guidance gCoreg CR (first generic) will mitigate some of the decline. • Updates on Halol facility re• EBITDA margin to continue to show some sequential improvement on the inspection back of QoQ growth in the US business and resulting operating leverage. • Specialty pipeline progress • We upgrade our earnings multiple from 18x to 20x and maintain NEUTRAL rating with a TP of Rs 560
VERY GOOD
• With the launches of gRenvela and gPulmicort Respules, Cipla is likely to post strong numbers in 3QFY18E. Favorable base in the domestic market • Commentary on launch of further will also provide a boost. Foresee ~10% top-line growth YoY. limited competition opportunities • EBITDA margin will expand to ~21% (up ~250bps YoY) owing to the in the US launch of the limited competition products in the US.
VERY GOOD
• After a strong 2QFY18, 2HFY18 is expected to be along the same lines. Continued sales of gLialda under exclusivity and sales from gTamiflu • Guidance on other significant (suspension and capsules) will provide a strong thrust to CDH’s numbers. approvals such as gToprol XL, Foresee ~27% growth YoY. transdermals and topicals • EBITDA margin too will be strong at ~24.5%, up ~700bps YoY
BAD
• On a high base, Lupin will likely post ~13% decline on the top-line in • Progress of remediation at Indore 3QFY18E. A slight sequential decline is also expected (~1%) as the and Goa and expected resolution business normalizes. We expect Lupin to struggle to show growth in the timeline near-term post the warning letter for two plants, which would cause a • Visibility on significant product slowdown in launch momentum in the US. launches in the US market in • EBITDA margin will be ~22%, flat QoQ. A significant YoY decline will 2HFY18 be seen, owing to the sales of gGlumetza and gFortamet with limited • Commentary on erosion in competition in 3QFY17 gGlumetza and gFortamet
Dr Reddy’s Labs AVG
• We expect ~4% top-line decline in 3QFY18E as the business normalizes post 2QFY18 bumper domestic sales. Continued erosion in DRRD’s key • Update on regulatory matters (Duuvada, Srikakulam) products will weigh on the US numbers. The launch of gRenvela during • Base business erosion. the quarter will provide some relief. • EBITDA margin is likely to be ~20.3% for the quarter, down ~270bps YoY • Details of gCopaxone CRL. as base business erosion continues.
Sun Pharma
Cipla
Cadila Healthcare
Lupin
Aurobindo Pharma
Divi’s Labs
Alkem Labs
38 January 2018
GOOD
• gRenvela launch in the US will lead to ~9% YoY top-line growth in 3QFY18E. However competition has entered swiftly and hence a slight • Guidance on complex product decline is likely QoQ (~4%). approvals in FY19 • While the EBITDA margin will continue to be strong at ~24.5%, there will • Base business growth in the US likely be a sequential decline (~100bps). market • Post the recent correction in the stock price, we upgrade our rating to BUY • Capex and debt reduction plan with a TP of Rs 830 (16x Dec-19E).
AVG
• Recovery in the business post the • With the import alert being lifted in Nov-17 and 2H traditionally stronger for lifting of the import alert DIVI, we foresee ~13% growth on the top-line QoQ and a pick-up in margins • Pending Unit 1 inspection to ~34%, up ~290bps sequentially. • Commentary on capacity • Comparisons on YoY basis would not be appropriate due to the regulatory expansion disruptions to the business in FY18
GOOD
• With close to 70% revenues from the domestic market, ALKEM will likely have the strongest benefit of the demonetisation base. Expect the US business will remain more or less flat and foresee • ~15% overall top-line growth in 3QFY18E. • Commentary on US business • EBITDA margin to post ~50bps expansion YoY at 18.5%. ramp-up from 2HFY18 • We upgrade our earnings multiple from 22x to 25x and maintain • BUY rating with a revised TP of Rs 2,560.
Pharma Bio World
Market Research COMPANY
Divi’s Labs
Alkem Labs
Torrent Pharma
Glenmark
Jubilant Life Sciences
3QFY18E OUTLOOK
WHAT’S LIKELY
KEY MONITORABLES
AVG
• With the import alert being lifted in Nov-17 and 2H traditionally stronger for • Recovery in the business post the DIVI, we foresee ~13% growth on the top-line QoQ and a pick-up in margins lifting of the import alert to ~34%, up ~290bps sequentially. • Pending Unit 1 inspection • Comparisons on YoY basis would not be appropriate due to the regulatory • Commentary on capacity expansion disruptions to the business in FY18
GOOD
• With close to 70% revenues from the domestic market, ALKEM will likely have the strongest benefit of the demonetisation base. Expect the US business will remain more or less flat and foresee ~15% overall top-line growth in 3QFY18E. • Commentary on US business • EBITDA margin to post ~50bps expansion YoY at 18.5%. ramp-up from 2HFY18 • We upgrade our earnings multiple from 22x to 25x and maintain BUY rating with a revised TP of Rs 2,560.
AVG
• Integration of Unichem’s India brands (from mid Dec-17) will provide an optical boost top-line growth for TRP. However, in the absence of any significant • Pick-up in filings for the US launches in the US market we foresee only ~7% growth YoY. market • Expect EBITDA margin to be at ~21% (down 90bps YoY, 200bps QoQ) in • Timeline for launches of in3QFY18E as the business mix normalizes (heavy domestic contribution in hand products in the US market 2QFY18).
AVG
• Progress on debt reduction • With the base of gZetia launch under 180-days exclusivity in • Baddi 483 implications and 3QFY17, GNP is likely to post a ~13% YoY top-line decline in resolution timeline 3QFY18E. A ~3% sequential decline is also likely with the domestic • Guidance on pick-up in US business normalizing. launches • EBITDA margin is likely to contract ~1000bps YoY, but improve • Progress of novel pipeline products and any out-licensing ~200bps sequentially (high one-time employee costs in 2QFY18). arrangements
GOOD
• Integration of Triad and continued traction in the specialty chemicals • Progress in radio pharma business, especially Ruby-Fill business should see the top-line grow ~36% YoY. • Pricing tailwinds in the specialty chemicals business and operating • Debt reduction and update on JPL listing in Singapore leverage from CRAMs will boost the EBITDA margin. However, the Triad acquisition is margin dilutive, leading to an optical decline of • Long-term outlook on specialty ~245bps YoY to ~20%. chemicals business
Alembic Pharma AVG
• Low base effect in the domestic market is likely to be offset by continued pressure in the US business. Foresee ~2% top-line • Guidance on growth revival in growth overall. • EBITDA margin to remain flat YoY but decline sequentially due the US business normalization of the business mix (heavy domestic contribution in 2QFY18).
Strides Shasun
• Launches of gLovaza and potassium citrate in the US market and • Progress in the Australia business continued ramp-up in Australia should translate to top-line growth and launch guidance of ~6% YoY. • Visibility on further niche product filings / launches in the US • After a subdued 1HFY18 performance, we expect the EBITDA marginto come in at ~17%, a sequential pick-up of ~380bps
GOOD
Dishman Carbogen Amcis GOOD
Granules India
Pharma Bio World
AVG
• Foresee ~26% top-line growth YoY, led by a full quarter of niraparib • Guidance/visibility on further commercial supplies. commercial launches • Operating leverage to drive EBITDA margin higher to ~29% (up • Recovery in the Vitamin D ~290bps YoY). business • Update on ANDA filings • Revenue to grow at ~12% YoY, with the business expected to expand • Management commentary on quickly in 2HFY18, boosted by core capacity expansion. launch of the US formulations • EBITDA margin to be ~18%, down ~320bps YoY. A lower gross business and potential visibility on margin will be the chief cause of the margin contraction during the approvals, upcoming TADs etc quarter.
January 2018 39
PHARMACEUTICALS : 3QFY18E RESULTS PREVIEW
Market Research Financial Summary NET SALES (Rs bn) 3Q QoQ YoY FY18E (%) (%) 70.2 5.6 (11.3)
Company Sun Pharma
EBITDA (Rs bn) 3Q QoQ YoY FY18E (%) (%) 15.6 13.3 (36.5)
EBITDA Margin (%) APAT (Rs bn) Adj. EPS (Rs/sh) 3Q QoQ 3Q QoQ YoY 3Q 2Q 3Q YoY (bps) FY18E (bps) FY18E (%) (%) FY18E FY18 FY17 22.2 151 (880) 9.7 6.3 (34.1) 4.0 3.8 6.1
Cipla
40.0
(1.9)
9.8
8.5
5.2
24.8
21.1
142
254
4.8
14.5
29.0
6.0
5.3
4.7
Cadila Healthcare
29.3
(9.4)
26.8
7.2
(16.0)
78.1
24.6
(193)
708
4.8
(4.9)
47.8
4.7
4.9
3.2
Lupin
39.1
(1.1)
(12.8)
8.5
(0.2)
(30.0)
21.8
19
(534)
4.8
6.4
(23.5)
10.7
10.1
14.0
Dr. Reddy's Labs
35.8
0.8
(3.5)
7.3
9.4
(14.9)
20.3
159
(270)
3.2
11.8
(32.3)
19.2
17.2
28.3
Aurobindo Pharma
42.0
(4.4)
8.7
10.3
(8.1)
14.7
24.5
(99)
129
6.6
(15.9)
16.3
11.3
13.3
9.9
Divi's Labs
10.1
13.0
3.0
3.4
23.4
(10.2)
34.0
286
(499)
2.6
32.1
(3.2)
9.8
7.4
10.1
Alkem Labs
17.0
(8.9)
14.7
3.1
(31.7)
17.3
18.5
(619)
41
2.5
(30.0)
6.8
20.8
29.8
19.5
Torrent Pharma
15.5
8.4
7.3
3.3
(1.1)
2.9
21.0
(203)
(90)
2.0
0.3
(10.7)
12.1
12.1
13.5
Glenmark Pharma
21.5
(3.4)
(12.8)
3.9
8.9
(44.2)
18.0
202
(1,014)
1.9
(7.4)
(60.3)
9.8
7.4
10.1
Jubilant Life Sciences
19.8
20.8
36.0
4.0
31.5
21.3
20.3
166
(245)
1.8
38.4
45.2
11.1
8.2
7.9
7.9
(0.3)
2.1
1.5
(18.5)
0.4
18.5
(416)
(33)
0.9
(26.6)
3.1
4.7
6.4
4.6
10.0
(0.1)
6.6
1.7
28.9
(15.3)
17.0
382
(439)
1.0
357.6
(63.4)
11.0
2.4
29.9
4.6
2.8
26.0
1.3
0.5
39.7
29.3
(65)
4.0
2.6
12.0
0.7
(5.8)
(5.1)
18.0
(159)
(323)
0.4
(8.2)
(5.2)
1.5
1.8
1.5
366.7
0.4
1.4
80.2
1.3
(10.9)
21.9
19.5
(302.0)
47.5
1.6
(15.0)
Reco
TP
FY18E
FY19E
FY20E
Alembic Pharma Strides Shasun Dishman Carbogen Granules India Aggregate
Source: Company, HDFC secHDFC Inst Research Source: Company, sec Inst Research Peer Valuation
PHARMACEUTICALS PREVIEW 288 0.6 21.3 : 3QFY18E 103.0 RESULTS 3.6 3.0 1.8
Company
Mcap CMP (Rs bn) (Rs/sh)
EPS (Rs/sh)
P/E (x)
RoE (%)
FY17
FY18E
FY19E
FY20E
FY17
FY18E
FY19E
FY20E
FY17
1,415
588
NEU
560
26.0
14.6
20.8
27.9
22.5
40.0
28.2
21.0
17.9
9.4
12.4
14.9
Cipla
492
612
NEU
665
12.5
21.2
27.6
35.2
49.6
29.2
22.5
17.6
8.4
12.8
14.7
16.3
Cadila Healthcare
456
445
BUY
555
14.5
11.5
19.1
25.8
30.5
38.6
23.2
17.2
23.5
15.5
21.8
24.3
Lupin
418
929
BUY
1,215
56.9
36.4
46.2
65.6
16.3
25.5
20.0
14.1
20.9
11.7
13.5
16.9
Dr Reddy's Labs
412
2,425
NEU
2,400
72.7
71.0
117.5
161.2
33.3
34.1
20.6
15.0
9.5
9.2
14.0
16.9
Aurobindo Pharma
395
675
BUY
830
39.3
37.7
46.7
53.7
17.1
17.8
14.4
12.5
27.6
21.3
21.5
20.3
Divis Labs
292
1,102
NEU
1,130
39.9
35.9
46.5
53.1
27.0
30.1
23.2
20.3
22.0
16.8
19.4
19.8
Alkem Labs
273
2,283
BUY
2,560
74.6
65.9
87.6
107.4
31.1
35.3
26.5
21.6
21.9
16.5
19.1
20.1
Torrent Pharma
234
1,382
BUY
1,590
51.2
46.2
57.7
77.1
27.3
30.3
24.2
18.1
22.1
17.5
19.7
22.4
Glenmark Pharma
177
627
BUY
1,000
29.6
22.3
38.7
50.9
20.9
27.6
16.0
12.1
18.1
11.8
17.3
19.2
Jubilant Life Sciences
129
809
BUY
865
37.0
42.1
56.5
71.3
21.0
18.4
13.7
10.9
18.0
17.9
20.2
21.2
Alembic Pharma
106
563
NEU
590
21.4
21.3
24.7
31.1
26.8
27.0
23.2
18.5
23.0
19.5
19.5
20.9
Strides Shasun
74
827
BUY
1,270
34.0
31.3
51.6
67.5
24.2
26.3
16.0
12.2
13.1
10.6
16.1
18.4
Dishman Carbogen
53
329
BUY
430
9.0
11.8
16.7
22.9
37.4
28.6
20.2
14.7
3.0
3.9
5.3
6.9
Granules India
37
147
BUY
180
7.5
6.9
9.0
12.2
18.7
20.4
15.6
11.5
21.0
15.5
16.0
19.1
Sun Pharma
7
Source: Company, sec Inst Research Source: Company, HDFC secHDFC Inst Research
Amey Chalke Siddhant Mansukhani HDFC securities
Institutional Equities Unit No. 1602, 16th Floor, Tower A, Peninsula Business Park Se napati Bapat Marg. lower Pare I., Mumbai- 400 013 Board:+91-22-6171 7330 www.hdfcse c.com 8
40 January 2018
Pharma Bio World
marketing initiative
Change of Managing Director at B&R India B&R India appoints Mr Jhankar Dutta as the Managing Director, with effect from January 1, 2018.
Mr Jhankar will be supported by Mr. PV Sivaram who assumes the role of NonExecutive Chairman for B&R India.
Mr Jhankar Dutta brings extensive experience of 16 years in industrial automation
especially
in
machine
and factory automation in different Industry verticals. Jhankar began his B&R career in International Sales at Austria. Subsequently he was heading one of the major offices of B&R India in Jhankar Dutta
preparation for his new role.
For details contact: B&R Industrial Automation Pvt. Ltd. 8, Tara Heights, Mumbai-Pune Road, Wakdewadi, Pune 411 003, India T +91 20 414 78 - 999 F +91 20 414 78 - 998 office.in@br-automation.com
ADVERTISE TO EXPAND
your reach through
INSIGHT INTO THE PHARMACEUTICAL AND BIOTECH INDUSTRIES
For Details Contact
Jasubhai Media Pvt. Ltd.
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
Pharma Bio World
January 2018 ď‚„ 41
marketing initiative
Creating Value for Pharmaceutical Industry through Better Customer Service in the Logistics Sector
C
ustomer is King is an age old mantra which talks about the importance of customers in any business. Approaching ways to manage a company’s reaction with customers is where Customer Service comes into play. This leads to increasing revenues and profitability by coordinating, consolidating and integrating all points of contact that the enterprises have with their customers, which is what in effect integrates sales, marketing and service . A wholistic Customer Service Program helps achieve better query resolutions, problem analysis, handling guarantees, complaints, claims, replacements and so on. The program targets at creating long term and sustainable relationships with the customers. Implementation of these processes enables companies to increase share of business with existing customers and increase in customer satisfaction. The Indian pharmaceutical industry is one of the fastest growing sectors of Indian economy and to stay ahead in the game, it must implement customer centric strategies as a way to drive growth. The challenge we face is that the medicines we take logistically are not stored and transported the way they ought to be. Pharmaceutical companies face issues related to choosing and working with the right logistics partners and designing the right system of transportation.
In such a scenario, it is vital to have a reliable logistic partner to help in timely distribution of pharma products, serving consistently at all transaction levels to tackle the ever changing business environment. For example Gati’s Customer Service team integrates information and gets closure to customer. One of the many ways are that it offers online tracking facilities and automatic e-mail & sms updates. One can watch the progress of your cargo from its origin to its destination at the click of a mouse and can also get instant status through e-track. Apart from this, customers can dial the company’s call center number and track their shipments. A login ID & password is provided to customers which enable them to access complete records of their transactions like POD’s, Invoice details, Payment details, Consignment status etc. With e-POD, customers can view the scanned image of the Proof of Delivery. Gati’s Cutting Edge Technology keeps customers informed on inventory and delivery status and these hi-tech IT systems ensure seamless integration, full transparency and control in the supply chain. The below features remain critical in getting the best performance to the customers. • Managing Regional-Central distribution Hubs / Customized warehousing • Managing inbound & outbound Logistics • Managing Pharmaceutical stock & sample distribution
• Reverse logistics ( Drug recalls /Goods Returns /Expired drugs) • Distribution of bulk and high value/life saving drugs. • Initiate Bar coding to prevent Spurious drugs entry • MIS / WMS customized reports • Cold chain distribution • Distribution of Medical / Surgical equipments • Critical Time bound Shipment through Air Many pharmaceutical products are also temperature sensitive and need to have end to end cold supply chain with temperature control in the correct range at the factory gates, loading area, vehicle, unloading area and storage. Such integrated supply chain takes much time to build in house and is very expensive to manage and utilize to the fullest. End to end integrated cold chain suppliers like Gati Kausar through state of the art reefer trucks and warehouses and real time temperature control and isolated pharma zones help overcome the logisitics challenges in the cold chain industry in India. A hub and spoke distribution network like Gati Kausar’s is needed to expand one’s reach to tier II and tier III cities. Better demand planning and forecasting is possible when one has a full view and control over the entire supply chain and consumption points. Overall logistics industry has evolved in the past decade and it is instrumental to pharmaceutical sector’s business penetration and expansion and an integrated cold chain further adds to the comlex situtation. Customer Service coupled with value added services mentioned above help manage the complexity of daily operations with ease and help the business grow further. Author Details
Mandar Babre Chief Business Development Officer, Gati (For more information, please visit the website www.gati.com or write to businessenquiry@gati.com) 42 January 2018
Pharma Bio World
press release MedGenome Receives Accreditation from CAP MedGenome, India’s market leader in genetic diagnostics announced today that its NGS (Next Generation Sequencing) technology based clinical laboratory in Bangalore has been awarded accreditation from the College of American Pathologists (CAP) based on the results of an on-site inspection. The CAP Laboratory Accreditation Program is a globally recognized program and is the only one of its kind that utilizes teams of practicing laboratory professionals as inspectors and is designed to go well beyond regulatory compliance. During the accreditation process, inspectors do a detailed check of the laboratory’s records and quality control procedures. They also assess the laboratory’s staff competency/qualifications, equipment, facilities, safety program, and overall management to ensure it meets CAP’s broad and stringent quality criteria. This accreditation is awarded to facilities meeting the highest standards of excellence in clinical laboratory practices. With this accreditation, MedGenome’s India laboratory joins the ranks of the most elite laboratories in the world. With this accreditation, MedGenome is the only Indian laboratory to be CAP accredited for Whole genome/exome sequencing, PGS/PGD, CfDNA (Cell free DNA) testing for liquid biopsy and NIPT (Non-invasive prenatal screening test) and also the high resolution HLA typing.
DocExa by GlobalSpace Technologies Launched at DigiPharmaX Awards 2017 GlobalSpace Technologies launched DocExa, “an exclusive digital platform developed using AI technology to help Doctors efficiently manage their patients & other engagements”, during DigiPharmaX (Digital Pharma Excellence) Awards 2017 at Mumbai. DocExa leverages artificial intelligence, cloud & mobility technology to empower Doctor, Patients & Pharma companies for meaningful & transparent engagement. DocExa helps create a transparent engagement between the Doctor and Pharmaceutical communities, while adhering to the Government regulations and guidelines like UCPMP. Additionally, doctors can file ADR through DocExa which provides real-time access of adverse drug reactions reports to Pharmaceutical companies and helps them to improve the quality of drugs. Doctors can also avail medico-legal consulting from a team of trusted, verified and reputed Legal Advisors, with the help of just a click or a tap. Today 60% of India’s population lies in tier two or three states. With greater penetration of mobility and growing number of internet users in rural India, pharmaceutical companies will be able to expand their reach to connect with increasing number of doctors through the DocExa platform. Leveraging technology, Doctors based in rural areas will be able to stay updated with Pharma Bio World
the latest medical advancements and drug brands in the market, creating a win-win for the entire industry. Speaking on the launch, Mr. Krishna Singh, Founder, Chairman & Managing Director, GlobalSpace Technologies said, “DocExa is the industry’s first AI driven Doctor-Pharmaceutical-Patient Connect Platform. In India, still the Doctor- Patient ratio is abysmally low at 1:1700. In its evolved form Docexa can enable Doctors to carry out differential diagnostics & help more number of patients, efficiently.
Purushottam Agrawal, Founder Ajanta Pharma Ltd Receives Lifetime Achievement Award Purushottam Agrawal, Chairman – Gencrest & Founder – Ajanta Pharma Ltd receives Jeevan Gaurav Navratna Sammaan by Maharashtra Rajya Agrawal Sammelan for his unparalleled achievements in the field of business as well as philanthropy. A visionary businessman and compassionate human being, he embodies all that is best in the entrepreneurial spirit of the famed Marwari community that has been the backbone of the saga of India’s commerce, industry and philanthropy. Coming from a very humble background in a small remote village in the state of Maharashtra, his entrepreneurial journey started with a borrowed capital of Rs. 10,000 in 1973. His efforts turned a small repacking unit in a garage in Aurangabad into a pharmaceutical empire. Ajanta Pharma operates in 45 countries, which includes US, Europe, Asia and most of the least developed countries in African continent. The company, today, has a market capitalization of over Rs 13,000 Cr and employee strength of around 8,000 across the globe. His astute business acumen has resulted in introducing several revolutionary 1st to the market products in India.
Dr. Reddy’s Launches Melphalan Hydrochloride for Injection in US Market Dr. Reddy’s Laboratories Ltd has launched Melphalan Hydrochloride for Injection, a therapeutic equivalent generic version of Alkeran (melphalan hydrochloride) for Injection in the United States market approved by the US Food and Drug Administration (USFDA). The Alkeran brand and generic had US sales of approximately USD 107 million MAT for the most recent twelve months ending in October 2017 according to IMS Health. Dr. Reddy’s Melphalan Hydrochloride for Injection is available in a carton containing one single-dose clear glass vial of freeze-dried melphalan hydrochloride equivalent to 50 mg melphalan and one 10 mL clear glass vial of sterile diluent. January 2018 43
press release Clinigen Extends Deal with Eisai to Supply Medicines to Africa Clinigen Group plc the global pharmaceutical and services company, has extended its exclusive agreement with Eisai Europe Ltd to obtain the marketing authorisation and subsequently launch Halaven (eribulin), Fycompa (perampanel) and Lenvima (lenvatinib) into 10 African countries. The new agreement follows the successful launch of Halaven and Fycompa in South Africa in February and July 2017 respectively. All three medicines will be submitted for registration in Namibia, Botswana, Zimbabwe, Zambia, Ghana, Nigeria, Kenya, Uganda and Tanzania, subject to local regulatory approval. Eribulin is currently licensed in South Africa only for the treatment of women with locally advanced or metastatic breast cancer who have received at least two chemotherapeutic regimens for their disease. These would usually include an anthracycline and taxane, unless not suitable. In 2012, breast cancer was the leading cancer among the female population in the majority of countries in Africa and is responsible for one in four diagnosed cancers and one in five cancer deaths in women worldwide. Perampanel is currently licensed in South Africa only for the adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older. Across Africa, the prevalence of epilepsy varies between 2.2 to 58 cases per 1000 people, with an average prevalence of 15.8 per 1000. The World Health Organisation estimates that in Africa, epilepsy directly affects 10 million people. Lenvatinib is not currently registered in any of the 10 countries. In Europe, lenvatinib is licensed for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated thyroid carcinoma (DTC), refractory to radioactive iodine. DTC is the most common form of thyroid cancer. Overall annual incidence globally is about 1/10,000, and the incidence appears to be increasing.
IIL Launches India’s 1st Intranasal Vaccine for Parvo Virus in Dogs Indian Immunologicals Limited (IIL) launches India’s first “nasal vaccine against dreaded Parvo virus” for Dogs- Branded as MEGAVAC-P NASAL the vaccine will protect pups as young as 4-6 weeks old. MEGAVAC-P NASAL is an intranasal vaccine containing live attenuated canine Parvovirus grown in cell culture. Hitherto only an injectable vaccine was available for vaccination against Parvo virus. Canine parvovirus (CPV) infection in dogs has been associated with outbreaks of acute gastroenteritis characterized by bloody diarrhea, vomiting, depression, leukopenia, pyrexia, dehydration, with very high mortality rate. Puppies below 6 months of age are severely affected and adult dogs having inadequate immunity suffer from the disease. Interference of maternal antibodies, long survival rate of the virus in the environment, high infectious /contagious nature of the virus and susceptibility of the pups and weak animals are the factors that propagate 44 January 2018
the disease. Contaminated surroundings especially in kennels make it a difficult disease to control. Mortality rates are very high in affected dogs. Effective immunization is essential for the protection of the individual pet and the decrease of virus population. Live attenuated vaccines are currently used worldwide affording prolonged immunity that would confer protection against disease. When MEGAVAC-P NASAL gets absorbed in the mucosal membrane in the nose it generates a mucosal immune response against the Canine Parvo Virus. Some of the important advantages are that Vaccine is administered at the source of natural infection (nasal cavity), provides fast immune response leading to superior protection against diseasecausing pathogens, safe, long-lasting and broad protection, less likely to cause allergic reactions and higher safety. It is extremely convenient to use the intra nasal vaccine than the injectable vaccine.
Hilleman Laboratories Partners with Innovative Future Vaccine Manufacturing Hub Hilleman Laboratories, an equal joint-venture partnership between MSD and Wellcome Trust, is honored to be one of the key partners of the new Future Vaccine Manufacturing Hub led by Imperial College London. The hub has been established to increase immunisation coverage across the globe and improve the response to disease outbreaks through the rapid and cost-effective deployment of vaccines. £10 million of funding has been granted by the UK Department for Health, and will be managed by the Engineering and Physical Sciences Research Council (EPSRC). The all-new Future Vaccine Manufacturing Hub aims to address two major challenges facing creation of future vaccine manufacturing systems: How to design vaccine production systems that can produce tens of thousands of new doses within weeks of a new threat being identified; and How to improve current manufacturing processes and change the way vaccines are manufactured, stabilized and stored so that existing and new diseases can be prevented effectively, at reduced costs. The hub will collaborate with the Developing Countries Vaccine Manufacturing Network on manufacturing projects in India, Vietnam, Bangladesh, Uganda and China. Integrated approaches that will be explored by researchers at the Hub include the development of synthetic RNA vaccines which can be rapidly manufactured; the rapid production of yeast and bacterially-expressed particles that mimic components of pathogenic viruses and bacteria; and protein stabilisation to preserve vaccines at high temperatures, avoiding the need for refrigerated distribution and storage. The Hub is led by Imperial College London, and also involves the Universities of Bristol, Cambridge and Nottingham, Cranfield University, the Clinical Biotechnology Centre (CBC) as part of NHS Blood and Transplant, UK National Biologics Manufacturing Centre, CPI and National Institute for Biological Standards and Control (NIBSC). The hub will also collaborate with the Developing Countries Vaccine Manufacturing Network (DCVMN) and African Vaccine Manufacturers Initiative (AVMI) to maximise dissemination of knowledge. Pharma Bio World
Pharma News B i o c o n & M y l a n ’s B i o s i m i l a r Trastuzumab Gets ANVISA Nod Biocon and Mylan N.V have announced that its biosimilar trastuzumab has been approved by ANVISA, the Brazilian regulatory agency, through their partner Libbs Farmaceutica (Libbs), a leading Brazilian pharmaceutical company. Co-developed by Biocon and Mylan, this is the first biosimilar trastuzumab to be approved in Brazil and is indicated for the treatment of overexpressing HER2-positive metastatic breast cancer, HER2-positive early stage breast cancer and HER2-positive advanced gastric cancer. Libbs will commercialize the product in Brazil under the brand name Zedora, which will provide affordable access to a cutting-edge biologics therapy for patients in Brazil. Biocon and Mylan are responsible for the development of biosimilar trastuzumab. While currently the trastuzumab will be manufactured by Biocon and supplied to Libbs for commercialization in Brazil; over a period of time the technology will be transferred to Libbs and the public partner Butantan through a Productive Development Partnership (PDP). Libbs have already built the biotechnological site to manufacture Zedora for the Brazilian market. This is a significant approval as it sets the stage for the entry of our biosimilar trastuzumab into Brazil, which is among the top three emerging markets globally for trastuzumab. The pharmaceutical market in Brazil is predicted to grow to US$ 30 billion in 2021 from US$ 26 billion in 2016.
Takeda to Acquire TiGenix for EUR 520 Million Takeda Pharmaceutical Company Limited has announced its intention to acquire TiGenix NV, an advanced biopharmaceutical company developing novel stem cell therapies for serious medical conditions, and as a result has entered into an offer and support agreement with TiGenix which provides for a recommended potential voluntary public takeover bid for TiGenix. The Takeda agreement has the unanimous support of the TiGenix board of directors (including its CEO). The acquisition is a natural extension of an existing partnership agreement between Takeda and TiGenix, which aims to bring new treatment options to patients with gastrointestinal disorders. In July 2016, Takeda and TiGenix entered into an exclusive exUS license, development and commercialization agreement for Cx601, the leading investigational therapy in TiGenix’s pipeline. Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC) locally administered for the treatment of Pharma Bio World
complex perianal fistulas in patients with non-active/mildly active luminal Crohn’s disease, who have had an inadequate response to at least one conventional or biologic therapy. In December 2017, the CHMP of the EMA adopted a positive opinion recommending a marketing authorization for Cx601 in this indication, the first allogeneic stem cell therapy to achieve this. A decision from the EMA on the marketing authorization for Cx601 is expected in the first half of 2018.
Mallinckrodt Seeks US FDA Approval for Stannsoporfin Mallinckrodt, a leading global specialty pharmaceutical company, has successfully completed the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) to seek approval of its recently acquired developmental product stannsoporfin. If approved, the drug is expected to become the first and only pharmacologic option in the US indicated for treatment of neonates at risk for developing severe hyperbilirubinemia, or severe jaundice. “We are pleased to complete this important milestone for stannsoporfin,” said Steve Romano, M.D., chief scientific officer and executive vice president of Mallinckrodt. “This brings us one step closer to addressing an unmet need for therapies to treat thousands of infants at risk for severe jaundice, and we look forward to working closely with the FDA toward the goal of obtaining approval of stannsoporfin to treat this population.” Stannsoporfin, a heme oxygenase inhibitor, is under investigation for its potential to reduce the production of bilirubin. The safety and effectiveness of stannsoporfin have not yet been established by FDA. If approved, stannsoporfin is expected to be used for latepreterm and full-term infants at risk of developing complications associated with severe jaundice.
US FDA Approves to Market Lupin’s Generic Dovonex Scalp Solution Lupin has received final approval from the US Food and Drug Administration (FDA) to market calcipotriene topical solution, 0.005% (scalp solution), a generic version of Dovonex scalp solution, 0.005% of Leo Pharmaceutical Products Ltd. Lupin’s calcipotriene topical solution is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp. Calcipotriene topical solution had annual sales of approximately USD 5.9 million in the US. With this approval, Lupin scrip moved up by Rs. 10 to Rs. 890 in the morning session on BSE. January 2018 45
Pharma News US FDA Accepts NDA for Acacia Pharma’s Baremsis Acacia Pharma Group Ltd, a pharmaceutical company developing and commercialising hospital products for US and international markets, announces that the New Drug Application (NDA) for Baremsis (amisulpride injection, formerly APD421) for the management of post-operative nausea & vomiting (PONV), has been accepted for filing by the US Food and Drug Administration (FDA). Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of 5th October 2018 to complete its review. The NDA submission includes data from four positive phase 3 studies, including the first ever randomised, controlled trial to show successful treatment of active PONV in patients who have failed prior prophylaxis. More than 3,300 surgical patients and healthy volunteers were enrolled in the Baremsis clinical development programme. Dr Julian Gilbert, Acacia Pharma’s chief executive officer commented: “We are delighted to have achieved this major milestone for the Company. Our goal is for Baremsis to be the first drug specifically approved for the treatment of PONV in patients who have failed prophylaxis, an area of high unmet need, and to become established as the new standard of care. The broad and unique label we have targeted also includes prophylaxis of PONV, alone and in combination with other anti-emetics. We are now moving forward with our US commercialisation plans to deliver an effective management option for the millions of patients each year suffering from, or at risk of, PONV.”
This alliance marks the third innovative data partnership that Verge has struck in the last six months and its first expansion into the pharmaceutical data landscape. Since September, Verge has forged two innovative public-private partnerships across a dozen academic and national institutions, leading to the creation of one of the world’s largest collections of ALS and Parkinson’s Disease patient data. Roivant Sciences, with the investment support of SoftBank Vision Fund and Founders Fund, spun out Datavant in September 2017 as an important part of its goal to reduce the time and cost of the drug development process.
US FDA Okays Marketing of Zydus’ Clomipramine HCl Capsules Zydus Pharmaceuticals, a wholly owned subsidiary of Cadila Healthcare Limited, has received the final approval from the US FDA to market clomipramine hydrochloride capsules USP in strengths of 25 mg, 50 mg and 75 mg. The drug is used to treat obsessive compulsive disorder which is characterized by uncontrollable, reoccurring thoughts (obsessions) and behaviours (compulsions). It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. The group now has more than 180 approvals and has so far filed over 310 ANDAs since the commencement of the filing process in FY 2003-04.
US FDA Accepts GW Pharma’s NDA D a t a v a n t , Ve r g e G e n o m i c s I n k Filing for Epidiolex Strategic Drug Development Deal GW Pharmaceuticals, a biopharmaceutical company focused on Datavant, a company focused on organizing and structuring healthcare data to inform actionable insights for the design and interpretation of clinical trials, and Verge Genomics, a company using artificial intelligence to discover and develop new therapeutics, announced a strategic alliance to unlock the value of pharmaceutical datasets to accelerate drug discovery and development. Datasets with relevance to drug development are currently siloed and fragmented across pharmaceutical companies, payers, hospital systems, and many others. Datavant partners with a wide range of healthcare organizations to aggregate and integrate these datasets, with over 100 clinical datasets reflecting over 150 million unique patients integrated to date. This is complementary to Verge’s proprietary machine learning algorithms, drug discovery engine, and patient database. When combined, the collaboration aims to connect the full stack of data from early discovery to clinical development and apply machine learning to unlock dozens of breakthrough opportunities and insights for clinical trial design and interpretation. 46 January 2018
discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced that the US Food and Drug Administration (FDA) has accepted for filing with Priority Review its recently submitted New Drug Application (NDA) for Epidiolex (cannabidiol or CBD), an investigational treatment for seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome, two rare and difficult to treat conditions of childhood-onset epilepsy. The PDUFA (Prescription Drug User Fee Act) goal date for completion of the FDA review of the Epidiolex NDA is June 27, 2018. Priority Review status is designated for drugs that may offer major advances in treatment or provide a treatment where no adequate therapies exist. The granting of Priority Review for the Epidiolex NDA accelerates the timing of the FDA review of the application compared to a standard review. In its acceptance letter, the FDA has stated that it is currently planning to hold an advisory committee meeting to discuss this application. Pharma Bio World
Biotech News Sinovac Biotech Gets Positive Decision from WHO on Healive Sinovac Biotech, a leading provider of biopharmaceutical products in China, announced that it has received a positive decision from the World Health Organization (WHO) on the acceptability, in principle, of its Healive, a hepatitis A vaccine product, for purchase by United Nations (UN) agencies. The company’s Healive product was assessed according to the WHO Prequalification Procedure. Weidong Yin, chairman, president and CEO of the company, commented that “I am very pleased that Healive has passed the assessment under WHO Prequalification procedures. This is an important milestone for Sinovac which we expect will provide opportunities to supply this vaccine to respective UN agencies as well as accelerate the regulatory approval process for this vaccine in international countries outside China.” Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases.
Adverum Bio Initiates Advance Phase 1/2 Trial of ADVM-043 Adverum Biotechnologies, a clinical-stage gene therapy company targeting unmet medical needs in serious rare and ocular diseases, announced the dosing of the first patient in the ADVANCE phase 1/2 clinical trial of ADVM-043 for alpha-1 antitrypsin (A1AT) deficiency. The ADVANCE clinical trial is designed to evaluate the safety and protein expression following a single administration of ADVM-043, Adverum’s novel gene therapy candidate. “We are excited to dose the first patient in the ADVANCE trial, which is an important achievement for Adverum as we are now in the clinic developing a potential new treatment option for individuals with A1AT deficiency,” said Amber Salzman, Ph.D., president and chief executive officer of Adverum Biotechnologies. “We are working diligently to develop ADVM-043 as a single-administration gene therapy for individuals living with this disease.” “Patients with A1AT deficiency need new therapeutics to prevent the progression of this disease,” said Charlie Strange, M.D., professor of pulmonary and critical care medicine at the Medical University of South Carolina (MUSC) and principal investigator for the Alpha-1 Foundation Research Registry, the largest registry of individuals with A1AT deficiency. “We are excited to be part of this phase 1/2 study evaluating ADVM-043, a gene therapy approach that has demonstrated promising potential in preclinical studies.” The ADVANCE phase 1/2 clinical trial is a multi-center, open-label, dose-escalation study of ADVM-043 in patients with A1AT deficiency. The study will include up to 20 patients across up to four dosing cohorts of up to 5 patients each. The first cohort will receive an intravenous (IV) low dose of ADVM-043 of 8E13 total vg (equivalent to approximately Pharma Bio World
1E12 vg/kg based on an 80-kg patient). The next two cohorts will receive an intermediate IV dose or high IV dose, with the fourth cohort potentially evaluating intrapleural (IP) delivery of ADVM-043.
Odonate Begins Phase 3 Study of Tesetaxel Odonate Therapeutics, a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, has initiated CONTESSA, a multinational, multicenter, randomized, phase 3 study of tesetaxel in patients with locally advanced or metastatic breast cancer (MBC). Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Currently available taxanes must be delivered intravenously, typically at an infusion center. Tesetaxel has several potential therapeutic advantages over currently available taxanes, including oral administration with a low pill burden and a patient-friendly dosing regimen and a formulation that does not contain solubilizing agents that are known to cause hypersensitivity (allergic) reactions. More than 500 patients have been treated with tesetaxel across 22 clinical studies. In patients with MBC, tesetaxel was shown to have robust single-agent antitumour activity in two, multicenter, phase 2 studies.
NeuClone Discloses Details of Denosumab’ Biosimilar Candidate Australian biopharmaceutical company NeuClone Pty Ltd has disclosed the fifth biosimilar candidate being developed in its pipeline of monoclonal antibody (mAb) products. The product is a biosimilar candidate for denosumab (branded as Prolia and XGEVA) currently in preclinical development. NeuClone has been developing the denosumab biosimilar in parallel with several other biosimilar candidates and has partnered with Serum Institute of India for the low-cost manufacture of ten biosimilars including denosumab. As part of this collaboration, NeuClone is responsible for preclinical development and biosimilar product characterisation, whilst Serum Institute of India is responsible for process development and supply of commercial and clinical product. The announcement of the Prolia/XGEVA biosimilar follows on from the four previously disclosed biosimilars being developed that reference Herceptin (trastuzumab), Stelara (ustekinumab), Humira (adalimumab) and Synagis (palivizumab). Denosumab is an IgG2 fully human mAb that is a RANK ligand (RANKL) inhibitor. Prolia/XGEVA was developed by Amgen and first approved in the United States in 2010. Prolia and XGEVA are approved for various indications including the treatment of osteoporosis, treatmentinduced bone loss, metastases to bone, giant cell tumour of bone and hypercalcemia of malignancy. January 2018 47
Material Characterisation Tools Archimedes is a new, highly innovative instrument which uses the technique of resonant mass measurement to detect and accurately count particles in the size range 50 nm - 6 um, and reliably measure their buoyant mass, dry mass and size. It is particularly useful for the characterisation of protein aggregates in formulation or buffer. Archimedes is also able to distinguish between proteinaceous material and contaminants such as silicone oil by means of comparing their relative resonant frequencies and buoyant masses. For more information, please contact: AIMIL Ltd Naimex House A-8 Mohan Co-op Indl Estate Mathura Road, New Delhi 110 044 Tel: 011-30810200, Fax: 91-011-26950011 E-mail: info@aimil.com
Linear Liquid Filling Machine The Nihira NP-LLF Series of machine is for filling of all type of liquid foods and pharma/chemical liquids. The machine is suitable for filling of glass/PET/PP bottles and jars used in packaging of foods and also variety of container used in cosmetics filling. It features easy and fast changeover for different size of bottles; no bottle no filling safety device; volumetric filling by piston pump driven by pneumatic or servo motor; etc. In servo driven filling, volume can be adjusted with touch screen. Machine is constructed in SS-304. For more information, please contact:
Nihira Food Engg LLP Plot No: 185, Sector No: 07, PCNTDA Bhosari, Pune Maharashtra 411 026 Tel: 020-66350099 E-mail: santosh@nihira.in / santoshkarale@yahoo.com
High Shear Mixer Granulator The high shear mixer and granulator RMG are multi-purpose process equally suitable for high speed dispersion of dry powder, aqueous or solvent granulations and effervescent production and melt pelletization. It is available in 2 to 1,200 litre working capacity. High shear mixing and granulation in single bowl with short batch time, problem free cleaning and residue free discharge. Unique design with four arm mixing impeller with chopper blade to cut lumps and makes granules. Optional features includes VFD for mixing and granulating, inline milling, bowl jacket for heat and cool, vacuumize process, binder spray system, explosion-proof motor and PLC controls.
For more information, please contact:
Prism Pharma Machinery Plot No: 37/13, Phase IV, GIDC Vatva, Ahmedabad Gujarat 382 445 Tel: 079-290952-4 Fax: 91-079-25841623 E-mail: mkt@prismpharmamachinery.com / sales@prismpharmamachinery.com
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Extruder-Spheroniser The extruder spheroniser is a self-contained compact system for the special purpose of making pellets with GMP compliance. System is specially used for making dense pallets for controlled release solid dosage of oral form with minimum expicients. Extruder is the necessary first step for spheronisation. Extruder is often used to eliminate dust in formulation even when spheronization is not the final objective. The raw material to be extruded is introduced axially from the feed hopper into screw housing where it is exposed to rotating screw which conveys the material towards rotor. Rotor forces the material to pass through the mesh with the effect of scraping impact resulting in formation of cylindrical extrudes. The size of the extruder screen operature will dictate the size of the spheroids. The extrudes are dropped axially from the feed hopper into the spheroniser on the rotating checker plate to get sized; further exposure to the checker plate results in conversion of the extrudes into the shape of spheres, ie, pellets. The groove pattern used for the checkered plate is cross-hatched square pattern, which forms a grid of truncated pyramids on the processing surface.
For more information, please contact:
Sunsai Pharma Equipment 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
Multi-column Distillation Plant Distillation is the primary process used for the production of USP water for injection for pharma applications. Komal’s multi-column distillation plants are designed to produce pyrogen/endotoxin-free water conforming to IP/BP/EP/USP Standard. As the name suggests, MCDP consists of individual pressure vessels (single column) assembled in series.These individual columns are designed, constructed and tested as per the American Society of Mechanical Engineers (ASME, Section VIII, Div 1 – Unfired Pressure Vessels) since they operate at pressures as high as 6 to 10 bar. Plants are available from 50 to 10,000 litres/hr. Komals WFI combo design optimises the control panel by combining the panel for WFI generation and distribution system. For more information, please contact: Komal Industries 108 Creative Indl Centre 12 N M Joshi Marg, Lower Parel (E) Mumbai 400 011 Tel: 022-23091174, 23091090 Fax: 91-022-23062711 E-mail: sales@komalwater.com
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Particle Shape and Chemical Imaging Image analysis is a technology which is particularly suited to analysing particle size and particle shape as it generates data by capturing direct images of each particle. This provides users with the ultimate sensitivity and resolution as subtle differences in particle size and particle shape can be accurately characterised. Chemical identification of these particles is possible using Raman microscopy. For more information, please contact: AIMIL Ltd Naimex House A-8 Mohan Co-op Indl Estate Mathura Road, New Delhi 110 044 Tel: 011-30810200, Fax: 91-011-26950011 E-mail: info@aimil.com
Mini Pleat HEPA Filters For clean r o o m technology with advance features, DYNA X line mini pleat filters have an energy cost saving, characteristics. Dyna Filters’ minipleat filters have much airflow with less pressure drop. The filter media used is of high quality glass fibre paper with various dust extraction or penetration efficiencies. Due to its structure and composition the media is temperature and moisture resistant. It finds application in laminar flow for clean benches and other clean room equipment, clean room applications, pharma and chemical research laboratories, nuclear industry, food processing industry and microbiology. For more information, please contact: Dyna Filters Pvt Ltd Plot No: 14 & 15 Ramtekdi Indl Estate Hadapsar, Pune, Maharashtra 411 028 Tel: 020-66067500 Fax: 91-020-26877955 E-mail: dynafilt@vsnl.com
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Speed Mixing & Granulator SM unit among Sejong Granulation Line is speed mixing which is mixing and crushing many kinds of powder. It is also available to apply automatic or manual nozzle and spray system for binder as the option while mixing in order to make wet granulation. Another option is double jacket type vessel providing warm water inside the jacket to make best condition of mixing the powder by maintaining certain temperature. For more information, please contact: Allpharma Technologies Pvt Ltd A-404 Rajeshri Accord Teli Galli Cross Lane Andheri (E) Mumbai 400 069 E-mail: ravi.sharma@allpharma.in
Silicone Inflatable Seals and Gaskets Imaseal is made from advanced grade silicone rubber conforms to FDA 21 CFR 177.2600 for food grade criteria suitable for various sealing applications. These inflatable seals start inflation range from 5 to 20 mm when 2-4 kg/cm2 pressure is applied after installation in door.Imaseal is certified by Food Grade Certificate (conforms to FDA 21 CFR), Laboratory Test Report, TSE/BSE Free Certificate and Phthalate Free Certificate. Imaseal is used in fluid bed dryers/processors/coaters, autoclaves, sterilizers, isolators, glove box, furnaces, rapid mixer granulators, nuclear door seals, robotics and fluid sealing, airlock door seals, powder and bulk solid handling machineries, electronic/wafer semiconductor processing, etc 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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Deep Freezer Door Designed specifically to provide a perfect solution where temperature control is critical and safety concerns are at a premium. The high operating speed combined with an excellent seal optimises the internal traffic flow and provides energy saving. Internal heating system provided within the guide prevents ice formation even during intensive cooling. It is suitable for both positive and negative temperture, operating temperature range +5 to -35oC. It has special double curtain construction with insulation, heavy duty motors 400 V three-phase, opening speed up to 2.5 m/s with inverter system. Size is up to 4,500 x 5,000 mm (W x H).
For more information, please contact: Gandhi Automation Pvt Ltd Chawda Commercial Centre Link Road, Malad (W), Mumbai 400 064 Tel: 022-66720200, 66720300 Fax: 91-022-66720201 E-mail: sales@geapl.co.in
Auto Coating VANTIX C Series is designed with the most effective air supply and exhaust structure to maximise drying efficiency while its patent-earned spray gun auto-sliding is designed to enable easy nozzle replacement and cleaning. All coating systems are fitted to various GMP Standards in different countries. Their simple and stylish external design further satisfies customer’s taste. Lab auto coating system is able to replace coating pan depending on different amount of coated tablets. The coating pan of simple structure is designed to facilitate easy and fast replacement without extra device. While the exterior of the machine is fashioned in SS in accordance with GMP regulations, the front-middle part is made up of polished SS to give it a simple and elegant design. As all operation panels are located on the front area of the machine, it offers enhanced convenience for users to easily and promptly monitor and control the machine. Also, windows on the left and right sides allow users to check coating pan operation without opening the door. The entire bed part of the coating pan is perforated and the baffle is attached to the hopper part. It is easy to mount and dismount as it is a bolt type. Furthermore, it is designed in a way in which tablets will not stick to other parts as drug contacting parts such as coating pan and baffle are made up of SS-316L and mirror-polished. Also mirror polished are the air supply and ventilation ducts. It is classified by coating pan quantities and easy to replace with its sanitary clamping method. Newly developed HMI system based on Windows system is designed to allow users to use and operate it without any difficulty. Also, it acquired a 21CFR Part 11 approval for the US FDA with PLC or HMI programming to allow various functions such as storing and bringing in coating data and printing them. It is also compatible with other devices. The biggest advantage of Sejong Pharmatech’s HMI system is that it can easily transmit data to SCADA system.
For more information, please contact: Allpharma Technologies Pvt Ltd A-404 Rajeshri Accord Teli Galli Cross Lane Andheri (E), Mumbai 400 069 E-mail: ravi.sharma@allpharma.in
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Pure Steam Generator
Explosion-proof Vacuum Cleaner
Komal’s pure steam generator is a packaged skid-mounted unit incorporating all necessary controls and functions to produce pure steam as per latest IP/ BP/USP Standards. Plants are available from 50 to 2,000 kg/ hr.These generators are basically used for sterilisation of vessels, sterilisation of distribution systems, autoclave, reactors and also humidification of sterile area. For more information, please contact: Komal Industries 108 Creative Indl Centre 12 N M Joshi Marg, Lower Parel (E) Mumbai 400 011 Tel: 022-23091174, 23091090’ Fax: 91-022-23062711 E-mail: sales@komalwater.com
It is a wet and dry vacuum cleaner for hazardous areas and can be used for cleaning as well as material recovery. It is available in SS version. It is available in ATEX 21 and 22 versions and consists of HEPA and ULFA filter. It is useful in cleaning of production areas, stores in bulk drug, active intermediates, etc. For more information, please contact:
Ultramax Hydrojet Pvt Ltd AC-31/4A, 6th Main Road SIDCO Indl Estate, Thirumudivakkam Chennai 600 044 Telefax: 91-044-42852262, 42852264 E-mail: marketing@hydrojet.co.in
Magnetic Agitators The big advantage of ZETA magnetic agitator is the complete separation of the interior of the tank from the outside. In contrast to conventional agitator, there is no shaft penetrating the tank and therefore no mechanical seal. This eliminates the risks of leaks and microbial contamination and the need for special maintenance that are associated with conventional agitators. ZETA Biopharma offers magnetic agitators with special emphasis on optimising their cleanability, which is essential for sterile processes. Independent tests, eg, EHEDG confirm that these agitators can be qualified for such applications. ZETA Biopharma offer various types of bottom mounted and top mounted magnetic agitators. Bottom mounted magnetic agitators are state of the art for low viscosity liquids in pharma and bio technology production. The compact design, low maintenance and high reliability guarantee trouble-free production. As well as ZETA Biopharma standard range of agitators, also make customized versions to order. Features including the dimensions of the impeller, rotational speed or the type of impeller can be modified to perform customer specific mixing tasks. With monitoring of the liquid level and rotational speed, and using a type-approved motor, the agitators can be used for vessels in ATEX Zones 0 or 1 according to the directive 2014/34/EU. For more information, please contact: ZETA Biopharma Zetaplatz 1, 8501 Lieboch/Graz Austria Tel: + 43 3136 90 100 E-mail: info@zeta.com
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Change Parts Cleaning System
Ribbon Mixer Blender
The washing system meets high level cleaning requirement of pharma industry. Low volume of cleaning fluid with high pressure ensures effective washing. Smooth finish inside wash chamber to avoid contamination. Different chamber size can be made to match customer requirement. Specific product wash rack can be made on request. It finds application in machine change parts and runners; glass bottles, containers and trays; filling machine parts and filling line components; compressed tools, valves and feeding hoppers; hoses, tubes and fittings. It is useful in cleaning of production areas, stores in bulk drug, active intermediates, etc.
For more information, please contact:
Ultramax Hydrojet Pvt Ltd AC-31/4A, 6th Main Road, SIDCO Indl Estate Thirumudivakkam, Chennai 600 044 Telefax: 91-044-42852262, 42852264 E-mail: marketing@hydrojet.co.in
The ribbon mixer blender is used for uniformly dry and wet mixing and blending application in the foods, chemicals, pharma, cosmetics, confectionary, detergents and pesticides industries. It is available in 10 to 20,000 litre working capacity. U Shape container shape with ribbon blade stirrer gives sufficient axial movement to materials to mixes. Inner and outer ribbon blade is with double or triple action blending. It is suitable for mixing of ingredients and coating with spray system. Optional features include VFD, binder spray system, FLP and PLC controls.
For more information, please contact:
Prism Pharma Machinery Plot No: 37/13, Phase IV, GIDC, Vatva, Ahmedabad, Gujarat 382 445 Tel: 079-290952-4, Fax: 91-079-25841623 E-mail: mkt@prismpharmamachinery.com sales@prismpharmamachinery.com
DM Plants Hydropure DM plants are used in combination with UV and UF for generation of high purity water for pharma, biotechnology, semi-conductor, and food and beverage industries. The typical pre-treatment is filtration, and DM plant consists of a two bed system followed by a CATPOL or MB polisher. The plants are built using FRP housing and UPVC valves and piping system. The DM plants are designed for achieving highest treated water quality with lowest consumption of chemicals for regeneration. The DM plant based systems are custom-built for any capacity and come with option of fully automatic or manual plant operation. Resins for this are carefully selected to meet the application requirements. The post DM UF system are built using hollow fine fibre membrane of less than 10 KD MWCO for microbial and TOC rejection to achieve the treated water quality complying USFDA, MHRA, WHO, EU and other international pharmacopias and standards. The UF system is hot water sanitisable up to 85oC. For more information, please contact: Hydropure Systems Pvt Ltd 412 Diamond Estate, Off WE Highway Dahisar (E), Mumbai 400 068 Tel: 022-28978725, 28979097 E-mail: info@hydropure.in
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Automatic Twelve Station Laminated Tube Filling and Sealing Machine The machine is sturdy, compact and easy to operate. It consists of a rotating disc with interchangeable tube holding sockets of different tube sizes. Features auto loading along with orientation of the loaded tubes; filling with auto sensing mode only when tube is present; hot air sealing of the tubes by very efficient heating system. The sealing is done along with the batch coding arrangement with interchanging types as required. Auto cutting helps provide tube a sharp edge finish along with auto ejection. Capacity single head 30-40 tubes per minute, double head 60-70 tubes per minute. Machine complies to GMP Model.
For more information, please contact:
Pharma Chem Machineries 311/2484 Motilal Nagar No: 2 M G Road, Goregaon (W), Mumbai 400 090 Telefax: 91-022-28735321 E-mail: pharmach@gmail.com / pharmachem79@gmail.com
Fully Automatic High Speed Triple Head Container Filling Machine Automatic high speed triple head/ four/six container filling machine for filling paste, ointment, etc, and also other kind of semi-liquid in plastic or glass bottles. It features fully automatic except turntable feeding. All parts are easy cleaning and sterilise. Easy to operate and maintain. Filling range 5 to 150 gm in syringe / 5 to 150 gm in container.
For more information, please contact:
Pharma Chem Machineries 311/2484 Motilal Nagar No: 2 M G Road, Goregaon (W), Mumbai 400 090 Telefax: 91-022-28735321 E-mail: pharmach@gmail.com / pharmachem79@gmail.com
Rapid Mixer Granulator The RMG is a rapid mixer and granulator with specially designed Z Type impeller and high shear chopper blades for efficient dry mixing and wet granulation in an enclosed bowl with GMP compliance. The ingredients are charged into the bowl. Initially the ingredients are dry mixed by rotating the impeller blade, after dry mixing binder solution is added into the bowl. The flat bottom and truncated conical top of bowl with rotating Z Type impeller blade creates spiral flow pattern of material for uniform mixing. The strategically mounted high shear chopper blade performs the de-lumping and enhances the binder distribution within the product. The uniform and homogeneous wet granules are discharged from pneumatically operated side discharge valve.
For more information, please contact:
Sunsai Pharma Equipment 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@rediffmial.com / sunsaipharma@gmail.com
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events diary Date: 15 th - 17 th February, 2018 Venue: Bangalore International Exhibition Centre, Bengaluru India Pharma 2018 is a major event to increase overall growth of Pharma sector including exports and focus on increase of Domestic production in the sector by Government of India & FICCI, with the active participation from all Stakeholders. this event provides a platform to global investment community to connect with stakeholders in Pharma sector in India, Central and State Governments, leading business leaders and top executives from the industry, academics and experts from the world. India Pharma 2018 covers the whole process of Pharmaceutical Manufacturing, from various kind of manufacturing/processing machineries to Lab Equipment, Analytical Instruments, APIs and other total solutions. Ravi Verma Assistant Director Ph: +91 9873522631 Email: ravi.verma@ficci.com
Date : 17 th February 2018 Venue: The Oberoi Dubai, The Oberoi Centre, Al A'amal Street, Dubai International Conference on Drug Discovery & Development (ICDDD-18) is a globally recognized, highly appreciated platform globally with the richness of abundance. To be held on 17 th February, 2018 at Dubai, this event is sure to repeat its history again. Encapsulating with it the different domains of people, researchers, thought leaders, speakers and unique visitors, International Conference on Drug Discovery & Development (ICDDD-18) brings out the best of the best to the world.
56 January 2018
Date: 26 th – 27 th February 2018 Venue: London, UK Following the tradition of successful Congresses held in several European countries, Dubai, Spain, Italy, India, South Africa and USA, the Organizing Committee of ConferenceSeries Ltd is pleased to invite all the participants across the globe to attend the 12 th world Congress on Pharmaceutical Sciences and Innovations in Pharma Industry. The conference is a specially organized two day event which will provide a multi-channel communication platform that brings together both “producers” and “consumers” of pharma world of generic sector. It includes prompt keynote presentations, Oral talks, Poster presentations and Exhibitions. It is a perfect platform for researchers, scientists and, delegates to share experience, foster collaborations across industry and academia, and evaluate emerging technologies across the globe. Ph: 7025085200 Email: pharmaindustry@pharmaceuticalconferences.org
Date: 19th – 21st March 2018 Venue: Berlin, Germany After a successful conference of Pharmaceutica 2017, ConferenceSeries Ltd is currently bringing forth “16 th International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems” (Pharmaceutica 2018) at Berlin, Germany. This event covers various aspects of Pre-Formulation & Formulation Aspects, Pharmacokinetics and Pharmacodynamics in Drugs, Drug Targeting and Design, Routes of Drug Delivery, Nanoparticulate Drug Delivery Systems, Nanotechnology in Drug Delivery, Pharmaceutical Nanotechnology, Smart Drug Delivery Systems, Biomaterials in Drug Delivery, Vaccine Drug Delivery Systems, Medical Devices for Drug Delivery, Peptides and Protein Drug Delivery, Global Drug Delivery Policy, Entrepreneurs Investment Meet. Dileep G Ph: +44 8000148923 Email : pharmaceutica@pharmaceuticalconferences.org
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bookshelf Quality by Design for Biopharmaceuticals: Principles and Case Studies (Hardcover) Authors: Anurag S. Rathore, Rohin Mhatre (Editors) Price: USD 107.74 No of Pages: 328 Pages Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.
Antiepileptic Drug Discovery: Novel Approaches (Hardcover) Authors: Alan Talevi, Luisa Rocha (Editors) Price: USD 99.51 No of Pages: 386 Pages This thorough volume delves into antiepileptic drug discovery with a comprehensive collection of innovative approaches for the development of antiepileptic therapies, focusing on novel molecular targets for antiepileptic drugs, computer-aided approaches for the identification of new drug candidates, and therapeutic strategies to overcome refractory epilepsy. The last section illustrates the potential benefits that network pharmacology and rational drug repurposing could bring to the antiepileptic drug discovery community. Written for the Methods in Pharmacology and Toxicology series, chapters include the kind of detailed description and implementation advice to ensure results in the laboratory. Authoritative and practical, Antiepileptic Drug Discovery: Novel Approaches aims to provide medicinal chemists, pharmacologists, and other researchers with the tools need to further explore the study of pharmacoresistant epilepsy and the discovery of new antiepileptic drugs.
Outsourcing of R&D in the Pharmaceutical Industry: From Conceptualization to Implementation of the Strategic Sourcing Process (Hardcover) Author: Bianca Piachaud Price: USD 35.10 No of pages: 192 pages This book examines the strategic aspects of outsourcing in relation to the firm. It provides a holistic view of the outsourcing process, starting with conceptualisation, through to implementation and management of the process. Although the book is based on a case study of the pharmaceutical industry, the general principles derived from the Strategic Sourcing Model are generic in nature and the model can be applied to instances of outsourcing in other industries. Pharma Bio World
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