Express Pharma December 1-15, 2013 Part II

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CLEANROOM SOLU TIONS Because, the whole is greater than the sum of its parts

E L E C T R I C AL SYSTEMS

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INS T

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EXPRESS PHARMA SILICONE TRANSPARENT TUBING F O R H I G H P U R I T Y AP P L I C AT I ONS

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1 1 1 1 1 1 1 1 1 1 1 1 1

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US FDA regulations CFR 177.2600 for contact with food USP class VI requirements European Pharmacopoeia 3.1.9 Animal derivative free Imported state of the art machine ed Highly advanced auto-curing system rtifi e C Excellent heat resistance (-50째C to 250째C) m nroo Clea Odourless Completely nontoxic Repeatedly autoclavable No leaching of particles Does not support bacteria growth Retains elasticity even after prolonged use

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We care for your family . . .

Anti-Inflammatory Enzymes Serratiopeptidase Peptizyme (enteric coated serratiopeptidase granules) Trypsin Chymotrypsin mix ( 6:1)

Probiotics Saccharomyces boulardii Lactic acid basillus sporogenous

Circulatory Health Nattokinase

Bio Catalysts Immobilized Cal B

Digestive Aids Alpha amylase / fungal diastase / fungal amylase Alpha galactosidase Bacterial alpha amylase Bromelain Hemicellulase Lactase Lipase Ox bile

Papain Pepsin Pancreatin Protease ( acid / alkali)

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Non-GMO ISO CERTIFICATION

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Products

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FDA

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big

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SPACEAGE

USP PURIFIED WATER SYSTEMS

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Pendents(Service Shafts) CIP/ SIP MODULE We also design & manufacture # IBC Washing/ Drying Modules # Containers/ Glass Ware Wash Modules # FBD Bag Washing/ Drying Modules # Cannisters Washing Modules # Drums Washing Modules 66

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SIP MODULE

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Top Tank / Reactor Sampler

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Psychotropics India Limited

Excellent Manufacturing Facilities : Tablets, Capsules, Beta Lactams, Dry Syrups, Liquid Orals, Medicated & Cosmetic Soaps, Small Volume Parentals (Both General & Cephalosporin), External Preparations, Dusting Powders & Veterinary products (Bolus Tablets, Injections, Multivitamins)

WHO GMP Compliant Plants

Corporate Office : A-32, DLF, Sector-11, City Faridabad, State Haryana-121006, India.

Contact Person : Naresh Joshi, E-mail : naresh@psychoindia.com & Director : sid@psychoindia.com Ph. : 00-91(0)-129-2282691 Fax : 00-91-(0)-129-2296764, 0129-2226635. web site : www.psychoindia.com.

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pure science – no fiction

R ap G e n i d an d t le D r y in g

Fluid Bed Dryer TG 200 ■ Strong blower allows for optimized air flow and increased drying capacity ■ Maximum drying temperature up to 150 °C ■ Digital controls for temperature, time and air flow ■ Interval mode for improved mixture of fluidized bed www.retsch.com/tg200 RETSCH INDIA PVT LTD, 1-2-45/1, 2nd Floor, Street No: 2, Kakatiya Nagar Colony, Habsiguda, 500 007 Hyderabad, India Phone: +91 40 2717 2431, Fax: +91 40 2715 4686 E-mail: info@retsch.co.in, Web: www.retsch.co.in

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TABLETS SOFTGELS HARDGELS INJECTIONS ORAL DRY POWDER SACHETS ONCOLOGY ORAL LIQUIDS NUTRACEUTICALS CREAMS/LOTIONS SOAPS VETERINARY

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Innovation is our culture…

Preclinical Toxicology Services: Single dose (Acute ) toxicity studies Repeated dose (14, 28, 90 & 180 Days) toxicity studies • Skin, Eye Irritation / corrosion • Skin Sensitization • Pharmacokinetic studies on Beagle dogs • LD50 and maximum tolerated dose • Immunotoxicity • Genotoxicity Studies • •

Test Systems: • Mouse (Balb-C, Swiss-Albino, C57, Diabetic) • Rat (Sprague Dawley, Wistar) • Rabbit (New Zealand White, Non albino) • Guinea Pig (Hartley) • Canine (Beagle Dogs)

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Facility Infrastructure: Individually Ventilated Cages Designed as per GLP/ AAALAC Independent facility for Rats, Mice Rabbits and Beagle Dogs • Ultra modern Histopathology lab • Safety alarms/call to scientists • Online Recording of Observations • • •

ACCREDITATIONS USFDA registered cGMP control testing laboratory.

DSIR approved R & D Centre.

Drugs Controller General of India (DCGI).

NABL accreditation for Chemical, Biological Medical Testing, Bioanalytical & Mechanical.

Recognized by Bureau of Indian Standards.

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NABL for ISO/IEC 17025:2005.

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BUSINESS AVENUES JAS-ANZ

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TURN TABLE

CAPPING MACHINE

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AIRJET CLEANER

UNSCRAMBLER

COTTON INSERTER

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FT4 Powder Characterisation Systems • 7 Different Tests to Characterise Powders • Flowability • Bulk Density • Shear Cell • Aeration & many more...

Freeman Technology Ltd., U.K.

Environmental Monitoring PHARMAceutical EXPO 2013 (IPC)

Particle Counting Microbial Sampling Real-Time Microbial Validation & Compliance Training & Education Service & Calibration

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PHARMA ALLY INSIGHT

Ensuring qualitywith futuristic vision technology An insight by ACG Worldwide on vision systems or inspection technology

“THE BITTERNESS of poor quality remains long after low pricing is forgotten,” said author Leon M Cautillo. What the author intends to point out is the increasing emphasis of quantity over quality. However, modern day businesses don’t want to compromise on either. Instead, they look at world-class vision technologies to ensure that products roll out at higher than ever speeds, with minimal investment, but without defects.

However, how does one understand, evaluate and choose the best available solution, ideal for their industry requirements? But before addressing this question, it is important to educate oneself with vision inspection technologies.

Camera to inspection to savings Vision systems or inspection technology, commonly known as machine vision, is the perfect blend of hardware and software. The camera forms the core of the hardware, along with lens, filters and many others. The software is usually a customisedversion of the service provider’s proprietary solution, designed specifically to meet the customer’s needs.

But what does the camera, software, lens, and other technical mumbo-jumbo mean for a businesses’ bottom-line?

Vision inspection systems ensure manufacturers continue to cost-effectively comply with evolving safety standards and ensure product quality. How? Fitted onto a manufacturer’s packaging lines, these cameras detect anomalies like broken product, defective product, empty packing, wrong product, etc.

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These cameras capture every product image that passes through the packaging line, and verify it with a reference image of the product fed into the software. Any deviations from the 'standard' would trigger an alarm for the system, and effectively, remove the faulty product.

Although machine vision solutions is utilised in almost every sector such as semiconductors, electronics, packaging, medical devices, automotive, and consumer goods, its application in the pharmaceutical industry is crucial.

mands of making a foolproof, robust, easy-to-use as well as a good-looking blister.

Cartons – Carton vision solutions inspect code and batch printing details on cartons and leaflets at the time of packing on cartoning machines.

Labels – A vision system that inspects online / offline batch codes, and code on sticker labels, leaflets and cartons.

These vision inspection systems are capable of not only preventing defects and improve quality, but also offering insights into manufacturing

turing to packaging of the drug are the solution to this problem. Not only do they serve as a protective layer of supply chain security, but also empower end-users to authenticate the genuineness at the point-of-purchase via an SMS. It also serves as an additional level of anti-counterfeiting measures that enable long-term return on investment (ROI) and track consumer insights.

The most typical trend that vision system suppliers see is for faster/smarter/smaller products every year. The suppliers

The complexity involved in design, development and deployment of vision inspection systems makes them unique instruments in a pharmaceutical production plant. Integration with the existing packaging lines - primary, secondary and tertiary - is the key to unlocking the true potential of vision inspection systems. With such advanced systems and technologies, it is ultimately a value vs. cost argument A finer look at pharmaceutical industry Today, defects such as empty pockets in blisters, broken/chipped/ different tablets or capsules, misprinted codes, mislabelling, and many others, are detected easily with vision inspection systems. Currently, vision systems are adept in tracing defects in the following kinds of pharma packaging: Blisters – Blister inspection systems are the perfect answer to the challenging de-

and R&D departments on design, quality as well as product development. And, this stands very true for the pharma industry, where the difference between good quality and average quality could endanger millions of lives and tarnish brand reputation forever.

Future trends Traceability has become paramount for pharma companies. Track and trace solutions that monitor the entire process right from manufac-

are also challenged with better-equipping inspection systems of the future not just with improved hardware, but also highly-analytical and logical-driven software. There also seems to be a demand for increased camera resolution to meet specific application requirements, as well as a broad range of cameras.

Besides these features, it is vision inspection system suppliers’ imperative to ensure ease of use. Improving on this, along with entry-level pricing,

is key to attract businesses that see inspection systems as an additional overhead cost rather than high-value return on investment vehicle.

Value vs Cost argument The complexity involved in design, development and deployment of vision inspection systems makes them unique instruments in a pharmaceutical production plant. Integration with the existing packaging lines - primary, secondary and tertiary - is the key to unlocking the true potential of vision inspection systems.

With such advanced systems and technologies, it is ultimately a value vs. cost argument. A lapse in ensuring maximum level of tracking and traceability could leave major pharmaceutical companies at the risk of huge loss to brand value, massive lawsuits & product recalls, and, most importantly, patient safety. As an example, a pharmaceutical company was saved from FDA fines, lengthy trials as well as product recall costs worth millions of dollars, thanks to vision inspection systems that detected a subtle error in data matrix patterns.

But despite these everchanging technological landscapes and decreasing human interference, one factor that significantly amplifies the effectiveness of a vision technology is a trusted and experience inspection solution provider.

ACG Inspection, a member of ACG Worldwide, is a highlytrusted service partner in hitech vision inspection systems.

(To learn more about vision inspection systems, please visit ACG Worldwide’s booth no.

H34+I34 in Hall no. V, at PMEC India 2013)

PHARMA ALLY INSIGHT

Testing strategies for generic inhaled products An introductory article on the tests applied to orally inhaled products (OIPs), focusing on generic manufacture and the demonstration of bioequivalence by Mark Copley, Sales Director, Copley Scientific

THE GENERIC sector of the pharmaceutical industry is one of India’s most successful revenue generators and is growing fast, at an annual rate of 27 per cent (compared to a global average of 10 per cent)1. Supported by domestic law that sets tight restrictions on multiple patents for a drug, the sector also benefits from significant government investment.

Current initiatives include a multi-billion dollar injection of government money to support public-private partnerships that capitalise on innovation, generous tax relief on R&D expenditure, and the introduction of 19 special economic zones to stimulate pharma sector investment. India’s generics are known for their quality and the industry not only provides inexpensive products to the fastgrowing domestic market but also substantially boosts export income. Major Indian pharma manufacturers lead the way in competing in the US generics market with an established track record of success. Indeed, of the 255 Abbreviated New Drug Application (ANDA) approvals by the US FDA from January to July 2013, 103, over 40 per cent went to Indian companies1.

With the incidence and diagnosis of chronic obstructive pulmonary disease (COPD) and asthma rising across Asia, inhaled products are an increasingly important part of the country’s generic portfolio.

However, the performance of metered dose and, in particular, dry powder inhalers (DPIs)

can be very demanding to replicate. This article provides an introduction to two of the primary techniques used to characterise orally inhaled products (OIPs): delivered dose uniformity testing and aerodynamic particle size measurement. The role of these tests in generic product development and testing is outlined by focusing on how they support the demonstration of bioequivalence. New innovations that help to secure supportive in vitro data are also highlighted.

The regulatory framework for generic OIPs Generics are prescribed interchangeably with the reference product setting a requirement for closely equivalent clinical efficacy. The regulatory framework designed to achieve this goal varies from country to country, but demonstrating bioequivalence is a unifying theme.

In Europe new regulatory guidance for inhaled generics for asthma and COPD was released in 20092. It sets out a stepwise approach to approval and indicates that bioequivalence can be demonstrated through in vitro testing alone, without any need for additional pharmacokinetic and pharmacodynamics (PK/PD) clinical studies. This approach has the potential to decrease the cost of development and reduce time to market but it requires the considered development of an appropriate in vitro testing strategy. The new EMA guidance is useful in providing quite

specific criteria to demonstrate bioequivalence and highlights the need to confirm that3: ■ the product contains the same active pharmaceutical ingredient (API), in the same solid state, as the reference product, and that any difference in crystallinity does not affect solubility ■ any qualitative or quantitative change in excipient does

not impact the performance of the product, aerosol particle behaviour, the inhalation behaviour of the patient or the safety profile of the product ■ instructions for use of the product are identical to those of the reference product and that the inhaled volume needed to deliver a sufficient dose of the API is similar in each case (within +/- 15 per cent) ■ the delivered dose of the product is the same as for the reference product (within +/15% of labelled claim) ■ the inhalation device uses the same resistance to air flow as the reference device (within +/15%) At the time of writing the FDA, in contrast, offers no directly equivalent guidance, instead appearing to prefer a ‘weight of evidence’ approach.

Currently there are three distinct pathways to regulatory approval in the US with 505 (j), a streamlined process designed specifically for abbreviated new drug applications (ANDAs), the preferred route for generics.

Demonstrating bioequivalence in an OIP

Figure 1: Image of DUSA testing apparatus set up for MDI testing

By providing specific criteria for bioequivalence, the EMA guidance supports the identification of a more widely applicable in vitro testing strategy. A primary element of testing is analysis of the constituent ingredients, to verify the chemical assay of the API and/or its morphological form.

This is an analytical requirement common to all generic

products. However, beyond that the guidance raises some explicit issues relating to OIPs. It is important to recognise that with an OIP drug delivery performance is dependent not on the formulation alone, but on interactions between the formulation and the delivery device. This is why it is essential that in vitro testing is applied to the complete inhaled product. Together formulation and device determine the amount of drug delivered and the particle size at which it enters the respiratory system; two defining characteristics for an OIP.

Delivered dose uniformity Delivered dose uniformity (DDU) testing, which measures the amount of drug delivered by each actuation of the product, is an essential testing requirement for both generic and innovator OIPs. In terms of demonstrating bioequivalence DDU testing: ■ confirms that the total dose of API delivered is comparable to the label claim of the reference product, to within the +/-15 per cent acceptable tolerance ■ helps to show that the chosen excipient results in comparable product performance ■ helps to demonstrate that the inhalation volume required to obtain the specified dose of API is the comparable for the generic and reference product A typical dose uniformity sampling apparatus (DUSA), as used for DDU testing, is shown in Figure 1. The test device is fired into the DUSA

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PHARMA ALLY which contains a filter that catches the dose as the sample is drawn through the apparatus by a vacuum pump. Recovery of the dose and the application of gravimetric and chemical analysis, (usually High Pressure Liquid Chromatography (HLPC)), enables determination of the amount of API delivered.

To make DDU testing more representative of clinical performance the test conditions applied are tailored to match the way in which the product is used and operates. The majority of metered dose inhalers (MDIs) use a propellant to drive drug delivery making delivery performance independent of the inhalation profile of the patient. For MDIs the test flow rate is therefore set at a figure of 28.3 L/min (1scfm).

This figure derives from historical calibration data for the Andersen Cascade Impactor (ACI) and has minimal clinical significance. For DPIs and nebulisers, in contrast, the efficiency of drug delivery is directly impacted by the inhalation characteristics of the patient. This is reflected in the test conditions applied.

For a DPI, the only motive energy for drug delivery comes from the patient’s inhalation manoeuvre and they are therefore considered as passive devices. As a result, the pharmacopoeias recommend that the test flow rate applied is determined for each individual product, based on an assumption that a typical patient will induce a pressure drop of 4 kPa across the device during inhalation. The internal flow resistance of the device determines the flow rate that this pressure drop induces, with lower resistance devices associated with high flows.

To prevent testing low resistance devices at excessively high flow rates, an upper flow rate limit for testing is set at 100 L/min. The duration of the test is fixed to reflect the total air volume of a single intake of breath with 4L specified by the pharmacopoeias and 2L by the FDA. Other volumes may also be used to demonstrate bioequivalence for the specific pa-

96 EXPRESS PHARMA December 1-15, 2013

tient groups to which the marketed product would be targeted. Test volumes are converted into test durations on the basis of the flow rate determined for testing (Figure 2).

With nebulisers too the amount of drug delivered is a function of the patient’s breathing profile, as well as the duration of use, as these devices are used under tidal breathing conditions (i.e. at rest). New test methods 4, 5 have been introduced relatively recently that define standardised flow conditions for delivered dose testing for nebulisers by reflecting the breathing patterns of various different types of patient. For adults the specified breathing pattern is: 500 mL tidal volume; sinusoidal waveform; 15 cycles per minute; 1-to-1 inhalation/exhalation ratio. Alternative test conditions are specified for neonate, infant and child patients, for which nebulisers are a widely used drug delivery device, as no coordination is required. Similar test conditions also exist for MDIs when used with Spacers and Valved Holding Chambers (VHC), since these add-on devices are designed to improve drug delivery performance during both coordinated and uncoordinated use.

One final point to note on DDU testing is that for multidose inhalers it is essential to verify dose uniformity across the life of the product by testing, for example, the first three, middle four and final three doses, per device tested. This too is an essential element of bioequivalence demonstration.

Aerodynamic particle size distribution (APSD) While DDU testing measures the amount of API delivered to the patient, APSD measurements are used to infer where that dose may deposit in vivo. For example, only particles less than five microns in size will tend to reach the peripheral airways of the lung.

Particles greater than five microns are prevented from reaching the lungs as they deposit in the upper respiratory tract while those that are too small, less than one micron,

150 Flow Rate (L/min)

100 50 0 0

1

2

3

4

4 l at 100L/min 4 l at 60L/min Time (seconds) Figure 2: The relationship between flow rate and test time for DPI testing

Aerosol Particles

First Stage Nozzle(s) Seal Collection Plate Second Stage Nozzle(s) Collection Plate

Intervening Stage

Last Stage Nozzle(s) Collection Plate Filter

Vacuum Figure 3: Schematic showing how a multistage cascade impactor works

risk being exhaled. In terms of bioequivalence testing APSD measurement can therefore be used to: ■ verify that the inhalation volume needed to obtain a sufficient dose is equivalent to a reference product (in combination with DDU testing) ■ thoroughly investigate the delivered particle size profile of the generic product to demonstrate the likelihood of closely similar in vivo deposition behaviour Multistage cascade impaction is the technique used for APSD measurement for all OIPs, both innovator and

generic products. The technique is valued because it comfortably spans the sub ten-micron fraction of interest and generates aerodynamic particle size data for the API alone, rather than for the whole formulation.

Multistage cascade impactors divide a dose into size fractions on the basis of particle inertia, which is a function of velocity and aerodynamic particle size (Figure 3). The resulting fractions are analysed to determine the amount of API present and produce an APSD specifically for the API. Traditionally the Andersen

Cascade Impactor (ACI) was used for this application but the Next Generation Impactor (NGI) is increasingly being chosen. This instrument was commercialised at the turn of the century and developed uniquely for pharmaceutical applications6.

As with DDU testing, the test conditions, and most specifically the air flow rate applied during APSD measurement is modified to reflect the way in which the OIP operates.

Test flow rates closely similar to those applied during DDU testing are adopted. However, cascade impactors require a constant air flow rate, making it infeasible to apply the sinusoidal breathing pattern used for nebulisers. For nebulisers testing is therefore carried out at a constant 15 L/min, a flow rate representative of the midtidal flow rate of a typical adult user.

The use of APSD measurements to demonstrate bioequivalence is especially demanding, and the EMA guidance includes some quite specific recommendations to support this exercise. It recommends the stage-by-stage comparison of data or the comparison of a minimum of four groupings justified with reference to inferred deposition site within the lung. It is vital that the distribution is compared across its entirety – 10th and 90th percentile – as well as median values, to verify bioequivalence. Furthermore, the guidance recommends testing three batches of both the reference product and the generic with maximum allowable differences calculated to support a conclusion of bioequivalence 7. Such detailed comparisons are hampered by variability in cascade impaction data which can be considerable, especially on those impactor stages containing little mass of drug. Ref 8 provides useful guidance on how to improve the accuracy of this technique.

Measuring the cold Freon effect Although delivered dose and APSD are widely recognised as critical, performance

PHARMA ALLY

Device resistance As noted in the analysis of how to set conditions for DPI measurement internal device resistance has a direct impact on DPI performance. Device resistance influences the amount of air that can be drawn through the DPI by the patient,

Figure 4: The Copley Spray Force Tester, SFT 1000, and Plume Temperature Tester, PTT 100, quantify the cold Freon effect helping to support the demonstration of bioequivalence

and therefore defines the success of drug delivery. Furthermore, DPIs with different internal resistance can feel very different to use so the issue has a direct impact on user experience. Measuring internal device resistance: ■ confirms that the inhalation device presents the same resistance to air flow as the reference device (within +/- 15 per cent) Figure 5 shows the test setup used to determine the flow rate for DDU and APSD measurements which can be easily modified to demonstrate equivalent internal resistance. The resulting test simply involves applying a known flow rate through the device and measuring the pressure drop that develops across it. Measuring across a range of flow rates ensures complete characterisation of the device, as can be seen for a range of commercially available devices in Figure 6.

Looking ahead The development of successful generic OIPs undoubtedly presents a considerable challenge. The application of all relevant in vitro test methods is therefore vital when it comes to efficiently meeting regulatory requirements for the demonstration of bioequivalence. Identifying a productive in vitro strategy, based on the techniques outlined here, can eliminate the need for additional PK/PD trials, helping to bring new generics to market quickly and cost-efficiently.

Here, the focus has been on the in vitro methods indicated

by the most recent regulatory guidance but with the evolution of inhaled product testing new techniques are becoming available to those looking to closely replicate the performance of an originator drug. For example, dissolution testing is an area of growing interest.

Currently dissolution testing is not a routine test for inhaled drugs, however, as larger molecules are delivered via the pulmonary route solubility is of increasing concern, especially given the far from optimal dissolution conditions within the lung. There are now established methods for dissolution testing for inhaled drugs and these may prove valuable in the development of certain inhaled generics.

Furthermore, advances to make in vitro testing more representative of in vivo behaviour can also be helpful as exemplified by the growing use of breathing simulators. In DPI research breathing simulators enable investigation of the impact of inhalation characteristics on the performance of the device to ensure that it operates as required for all patient groups. Such testing therefore similarly supports the efficient development of a generic to match closely tailored performance. Developments such as these indicate that going forward the inhaled product testing kit for generic manufacturers will become both more sophisticated and more efficient.

References: [1] “World’s pharma innovation base moving to India, says IBEF” Manufacturing Chemist October

Critical Flow Controller P1

Time P3

2-port/2-way solenoid valve

P2

Flow Control Valve

Figure 5: The apparatus used to determine an appropriate flow rate for DDU and APSD The relationship between pressure drop and flow rate for a range of commercially available DPIs Assi, K.H. and Chrystyn, H, et al.The device resistance of recently introduced dry-powder inhalers.Journal of Pharmacy and Pharmacology, 52 (Suppl): 58, 2000.

10 Pressure drop (cmH2O)0.5

defining characteristics of OIPs, other in vitro methods are extremely helpful when it comes to conclusively demonstrating bioequivalence. Measurement of the cold Freon effect, for example, provides evidence that: ■ any difference in excipients does not influence the inhalation behaviour of the patient The cold Freon effect is the term given to the chilling sensation felt at the back of the throat following delivery of a dose with a propellant-driven MDI. It is caused by rapid evaporation of the propellant in combination with impaction of the delivered dose and can have a pronounced impact on patient experience. A marked cold Freon effect can cause a patient to abort or unsuccessfully complete inhalation, compromising the success of delivery. The EMA guidance points specifically to the cold Freon effect highlighting it as a potential source of variability between a reference and generic drug.

The reformulation of MDIs with propellants such as HFA 134a, as a result of the banning of CFCs in the Montreal Protocol, has provided a stimulus to the development of reliable measurement methods for this phenomenon.

Alternative measurement methods remain in use but the commercialisation of dedicated instrumentation in this area is a welcome advance. One such solution is the Plume Temperature Tester Model PTT 1000 (Copley Scientific), which measures temperature as a function of distance from the mouthpiece.

Used in combination with measurements of the impaction force of the plume, it eases the analytical challenge of quantifying the cold Freon effect to demonstrate bioequivalence.

Easyhaler Twisthaler

8

Clickhaler Turbohaler

6

Accuhaler 4

Aerolizer Diskhaler

2 0

Spinhaler Rotahaler 0

20

40

60

80

100

120

Figure 6: A graph showing the relationship between pressure drop and flow rate for a range of commercially available DPI devices

2013, pg. 34 [2] European Medicines Agency “Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of asthma in children and adolescents” Issued Jan 2009 [3] C. Hippchen “Pharmacopoeial requirements for dry powder inhalation systems” Presentation delivered at 2nd open forum on pharmaceutics and biopharmaceutics.

Istanbul, Turkey, April 26/27 2012.

[4] Ph. Eur 2.9.44 [5] USP 1601 [6] M. Copley “The NGI – 10 years on…” Manufacturing Chemist March 2007 [7] A. Fuglsang “Regulatory issues and challenges relating to pulmonary products” Presentation delivered at 2nd open forum on pharmaceutics and biopharmaceutics. Istanbul, Turkey, April 26/27 2012.

[8] M. Copley “Optimizing cascade impactor testing for characterizing orally inhaled and nasal spray drug products” Drug Delivery Technology July/August 2010

97 EXPRESS PHARMA December 1-15, 2013

PHARMA ALLY NEWS

And now,Instacoat Lab: Atablet coating toolkit as a mobile app Encompasses a comprehensive tablet coating toolkit, in the palm of the hand

SIR FRANCIS Bacon first coined the phrase “Knowledge is power” in 1597. The popular spin off of this phrase in the 21st century is “Information is power”. It is hard to underestimate the value/power of accessing the right information at the right time. With this mind, Ideal Cures felt that a tablet coating toolkit, which provides information by the click of a button, would be of immense value to scientists.

Ideal Cures has been a leading player in film coating systems since more than a decade and this experience and expertise has culminated in to a vast knowledge base. Speaking about the idea behind this latest innovation, Suresh Pareek, Managing Director, Ideal Cures says, “It has been our constant endeavour to give our customers quick and efficient technical service. With this end in mind, we wanted to make our expertise available to the customers, and that too at their fingertips!”

This thought process led to the genesis of Instacoat Lab, a mobile-based application which acts as a tablet coating toolkit.

This is the first time that a B2B excipient company has launched a mobile based application.

In the first edition, Instacoat Lab features a colour guide, country-wise colour regulatory information and various interactive tools like time and cost saving calculator when converting to Instacoat, drum pan velocity calculator, tablet surface area calculator, reconstitution calcula-

98 EXPRESS PHARMA December 1-15, 2013

tor. The entire Ideal Cures product portfolio is also included in the app.

An extensive colour guide has around 1000 shades and was designed keeping in mind that faster developed of products can be enabled when the colour guide is available in the palm of the hand.

Pharmaceutical products are regulated in virtually every

aspect of the product life-cycle , different countries have different regulations for permitted colours. Instacoat Lab features a country-wise regulatory information tab, so that the scientists will have access to the complete regulatory information on the go.

Instacoat Lab also has several interactive calculators like a calculator specially designed

to calculate how the use of Instacoat film coating systems can save time and cost. Other calculators act as tools to help the scientists with the day-to-day calculations related to tablet coating like calculating the reconstitution of the coating solution and calculators that aid in the scale up of the coating process. Another interactive tool in is the tablet surface area

calculator. Ideal Cures believes that Instacoat Lab will revolutionise the way scientists use mobile technology.

The company invites users to talk to them about the app and features that they would desire in the app.

To download Instacoat Lab sms Lab to 9322273559 or email info@idealcures.co.in.

PHARMA ALLY

Agilent Technologies inaugurates CrossLab at its Manesar facility CrossLab will deliver solutions that help improve results, reduce costs, and increase the productivity across the organisation

AGILENT TECHNOLOGIES has launched, Agilent CrossLab Laboratory at its Manesar campus. This initiative will further strengthen the company’s CrossLab Enterprise Services, a synchronised laboratory solution by Agilent Technologies, a service model for all instruments regardless of the brand.

CrossLab Laboratory is an investment done by Agilent Technologies to further strengthen the CrossLab Services initiative started in India three years back for providing comprehensive service sup-

port to analytical instrument’s from various manufacturers’ which is used in pharmaceutical, biotech, food and environmental industries across India.

This Laboratory will help increasing the capability of Agilent Service Engineering Team with hands on training on analytical instruments from various manufacturers and thereby developing services protocol to provide comprehensive solution to their customers.

Commenting on the inauguration of CrossLab, Dr Siva

Kumar Pasupathi, Country Head, Life Sciences and Chemical Analysis Unit, Agilent Technologies said, “We are proud of our CrossLab Laboratory which offers industry’s best facilities to our customers. We understand and recognise that laboratories are often equipped with instruments from a range of vendors.

Agilent CrossLab will enable simplification product selections and purchase for our customer. Apart from that, this initiative will also streamline their workday, and improve

Luca Geretto, EMEAI Service Sales Manager alongwith Dr Sivakumar Pasupathi, Country Manager, LSCA India

their overall productivity.”

Luca Geretto, EMEA & India Service Sales Manager, Agilent Technologies said, “With Agilent CrossLab Services customers can reach the highest level of productivity. Cus-

tomers can rely on one highly qualified engineer, who understands their work flow, goals to keep all instruments performing at maximum capacity.”

EP News Bureau-Mumbai

VALUE ADD

Embracing QbD and PAT Tim Freeman, Director of Operations, Freeman Technology says that the advent of Quality by Design (QbD) and Process Analytical Technology (PAT) initiatives will help the pharma industry to transform process operation and efficiency IN RECENT decades the pharmaceutical industry has used innovative, cutting edge technology to research and develop new drugs of immense value to society. By comparison there has been relatively little emphasis on processing, so these products tend to be manufactured using empirically developed, relatively inefficient, batch processes. The advent of Quality by Design (QbD) and the Process Analytical Technology (PAT) initiative invites the industry to use its considerable skills to address this imbalance, and transform process operation and efficiency.

One of the keys to this transformation will be a better understanding of powders since almost all pharma products are handled in this form at some point during manufacture. Mod-

ern powder characterisation methods have an important role to play providing data that can used to convert process- or product-specific experience into more fundamental knowledge.

ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) Guideline Q8: Pharmaceutical Development describes the principles of QbD. It suggests that the industry should switch from an approach that checks for quality by testing, to one that designs quality into the product and manufacturing process. PAT is a Food and Drug Administration (FDA) initiative designed to facilitate the uptake of new analytical technologies. Its aim is to reduce the regulatory burdens that re-

strict innovation in the processing arena to encourage improvements in efficiency.

The underlying message of both QbD and PAT is that the industry needs to improve understanding and adopt a knowledge-based approach to product and process optimisation. QbD and PAT are symbiotic rather than distinct. QbD encourages better understanding of the process at an early stage and the identification of critical process parameters, those that should be closely monitored and controlled. Relevant analytical technologies optimise information gathering during the pilot stage, and enhance understanding throughout the manufacturing life cycle, augmenting the knowledge base.

But neither QbD nor PAT is a

regulatory requirement so why should anyone embrace this new way of working? The simplest answer is that the old ways are not sustainable. The pharma industry needs to bring new products to market successfully and quickly recoup the growing costs of development. Understanding the product and process may involve additional investment in the early stages, but ultimately it accelerates time to market and improves the reliability of scale-up. It also optimises process efficiency, increasing profitability, particularly when patents expire and the growing generics industry exerts intense commercial pressure.

Changes in regulatory approach also provide an incentive.

From necessity the regulators

now have to adopt a risk-based approach, focusing their efforts on products and processes that have the greatest potential for harm. Companies who use QbD and PAT to manufacture products with well-defined performance, using clearly understood processes will therefore ultimately be subjected to a lighter regulatory touch.

So there are good reasons for change but it will require better fundamental knowledge and much improved understanding.

The industry will need to adopt new ways of working and new tools to access the information it requires.

(As seen in the 7/22/08 edition of the Pharmaceutical Online (www.pharmaceuti calonline.comnewsletter.)

99 EXPRESS PHARMA December 1-15, 2013

PHARMA ALLY PROFILE

Spaceage Aquatechs: Ahelping hand to conservation K Amarnath, CEO, Spaceage Aquatechs presents the advantages of a new product in RO technology: the Desalitech CCD-RO system, which will lend a helping hand to water and energy conservation and reuse initiatives

PHARMACEUTICAL WATER is perhaps the most important of all pharma utilities.

It is used as an excipient in many pharma formulations, as a cleaning agent, and as a separately packaged product diluent.

Spaceage is a 11-year-old company with expertise in design, manufacture, installation and validation of pharma water systems. The company’s vision is to serving the cause of the pharma industry focused on pharma water systems. The long-term goal is to become a dynamic, responsive and respectable pharma water systems technology provider that becomes the preferred choice of customers.

The company’s expertise areas are the design, manufacture, installation and operation of purified water generation, storage and distribution system, loop piping, CIP and SIP systems for pharma, food & beverages and healthcare industries.

The company comprises a team of water treatment professionals with expertise in engineering of pharma water treatment systems with vast experience in the field of pharma water. Spaceage designs systems to meet compendial and non-compendial requirements.

Recent projects of Spaceage

100 EXPRESS PHARMA December 1-15, 2013

include Generation, storage, distribution and loop piping at Ms/s.Gland Pharma, M/s Fleming Laboratories , Acacia Life Sciences & Madras Pharmaceuticals.

Services provided by Spaceage include validation and documentation services, system malfunction or breakdown services, annual maintenance contracts, supply of spares and rectification and modification of clients’ existing purified water generation, storage and distribution systems In addition, the company's decade of experience in design and engineering of USP PFW and generation systems has helped them to be in the forefront of the advancement in the system design and engineering aspects in this area. A design that is robust and simple cannot be translated into engineering unless the right instruments and components are sourced to support the design.

The strong sourcing team evaluates all critical component vendors or repute to asses their product models and incorporate into our design.

To design the appropriate generation, distribution and storage systems the company reviews and overviews various options, taking into consideration various operating circumstances, including microbial

control strategies, sanitisation methods and the advantages and disadvantages of each.

To fullfill the company’s environmental and social responsibility and to lend a helping hand to water and energy conservation and reuse initiatives of clients, the company presents a major breakthrough in RO technology: the Desalitech CCD-RO system.

Desalitech CCD-RO Advantages Maximum recovery – CCD-RO unit operates at 90 per cent ++ recovery.

Low operating cost – Desalitech CCD-RO (BW) technology can significantly reduce

the energy consumption, typically 0.5 KWh/M³ *of permeate generated.

Greater reliability – Membrane fouling and scaling are disrupted and reduced by salinity cycling and high cross flow, thereby reducing downtime, reducing CIP requirements, and saving operating costs.

Footprint reduction – The Desalitech CCD-RO can significantly reduce the system footprint by eliminating the need for multiple stages as seen in conventional RO. Accessibility & traceability - Off the shelf equipment e.g. Membranes, pumps, valves and piping, process instrumentation.

RESEARCH CLINICAL UPDATE

Efficacy of PMBLto reduce infection risks in COPD patients by almost three-fold: Study The present ancillary study concerned a subset of 23 COPD patients and is part of a larger multi-centric randomised control trial involving 288 patients in total

ANCILLARY IMMUNOLOGICAL results of an on-going COPD clinical study were recently published on-line(1), indicating a significant benefit of Lallemand Pharma sublingual tablets PMBL to reduce the risk of acute infections in elderly patients with Chronic Obstructive Pulmonary Disease (COPD).

Over the six-month study, 25 per cent of the patients experienced a single acute episode in the PMBL group, while 72 per cent of patients in the placebo group experienced at least one acute episode (27 per cent of these patients experienced multiple episodes) (p <0.05). These results confirmed previous clinical trials in COPD, and, showed an effective and direct immunostimulating activity of the drug.

COPD is ranked by World Health Organisation (WHO) among the top-10 causes of mortality and projected to become the fourth one by 2030.

In its latest White Book released a few weeks ago, the European Respiratory Society estimated the annual economic burden of COPD to at least €48.4 billion in Europe, and has pointed prevention of respiratory infections as one of its key objectives(2).

The present ancillary study concerned a subset of 23 COPD patients and is part of a larger multi-centric randomised control trial involving 288 patients in total. Its aim was to get a better insight of PMBL modes of action in vivo: many immunological parameters were monitored.

common pathogens involved in infections of the upper and lower respiratory tract. It is formulated in sublingual tablets, described as an optimal route of administration to stimulate strong and long-lasting immune response and enhance anti-microbial defences. A recent meta-analysis encompassing the data of 15 randomised clinical studies using PMBL in both upper and lower respiratory tract infections concluded that it is effective in both children and adults in preventing respiratory tract infections.

References

The present ancillary study concerned a subset of 23 COPD patients and is part of a larger multicentric randomised control trial involving 288 patients in total. Its aim was to get a better insight of PMBL modes of action in vivo: many immunological parameters were monitored The six-month study includes a three month treatment period (one daily administration of PMBL or placebo sub-lingual tablet for ten consecutive days at the beginning of each month) plus a three month follow-up period. The benefits reported included a statistically significant reduction of the number of acute infectious episodes in patients (p <0.05).

The clinical benefits were correlated with serological signs of an efficient specific

(memory) and non-specific immune response against bacteria as well as viruses. Moreover, it also showed that PMBL had a stimulating effect against vaccinal antigens, which can be described a real ‘vaccine boosting’ effect.

These results complement previous findings(3) and further indicate that PMBL is able to stimulate both innate and adaptive immune response, even in elderly COPD patients.

To the authors’ knowledge, “These are the first results that show a clear correlation between the loco-regional administration of a bacterial lysate and the laboratory evidence of an efficient and wide immune-response at serological and systemic level.”

PMBL is a bacterial lysate obtained mechanically for optimal preservation of the antigens structures. PMBL contains a blend of 13 inactivated bacterial strains of the most

1 Ricci R, Palmero C, Bazurro G, Riccio AM, Garelli V, Di Marco E, Cirillo C, Braido F, Canonica GW, Melioli G. The administration of a polyvalent mechanical bacterial lysate in elderly patients with COPD results in serological signs of an efficient immune response associated with a reduced number of acute episodes. Pulm Pharmacol Ther. 2013 Jun 21. pii: S1094-5539(13)00124-7. doi: 10.1016/j.pupt.2013.05.006.

[Epub ahead of print] 2 http://www.ers whitebook.org/ 3. Lanzilli G, Traggiai E, Braido F, Garelli V, Folli C, Chiappori A, Riccio AM, Bazurro G, Agazzi A, Magnani A, Canonica GW, Melioli G. Administration of a polyvalent mechanical bacterial lysate to elderly patients with COPD: Effects on circulating T, B and NK cells. Immunol Lett. 2013 Jan;149 (1-2):62-7 EP News Bureau - Mumbai

101 EXPRESS PHARMA December 1-15, 2013

RESEARCH RESEARCH UPDATE

US FDAapproves J&J hepatitis C pill Olysio is a protease inhibitor which blocks a specific protein US REGULATORS approved the use of Johnson & Johnson’s Olysio, also known as simeprevir, as a treatment for chronic infection with the liver-destroying hepatitis C virus. Olysio, a protease inhibitor that blocks a specific protein needed by the virus to replicate, is to be used in combination with interferon, given by injection, and ribavirin, another pill. Hepatitis C affects about 3.2 million Americans, killing more than 15,000 each year, mostly from illnesses such as cirrhosis and liver cancer.

The often-undiagnosed virus is transmitted through contaminated blood. Infection rates have dropped since the early 1990s, due in part to the introduction of blood and organ screening. Still, many older adults remain at risk, according to the Centers for Disease

Control and Prevention, which has called for baby boomers to be routinely tested for the virus. Olysio is a member of the same class of drugs as Merck & Co’s Victrelis and Vertex

Pharmaceuticals' Incivek. The FDA approved both those drugs in 2011.

Olysio was shown in clinical trials to cure patients with a shorter duration of treatment.

Drugmakers have been racing to develop more effective, easier-to-tolerate antivirals to treat hepatitis C. Wall Street analysts have forecast annual sales of billions of dollars for new drugs that would allow doctors to skip use of interferon, which can cause severe flu-like side effects. The FDA is slated to decide by December 8 on Gilead Sciences’ application for sofosbuvir, a member of a different class known as nucleotide analogue inhibitors, or ‘nukes,’ designed to block a different enzyme the virus needs to copy itself.

European regulators recommended approval of the Gilead drug, under the brand name Sovaldi. Other companies working to develop new hepatitis C drugs include AbbVie and Bristol-Myers Squibb.

Reuters

Roche’s Kadcyla wins European approval Zurich ROCHE SAID its drug Kadcyla, a treatment for an aggressive form of breast cancer, had been approved in Europe following US approval in February. Kadcyla treats patients with late-stage disease whose cancer cells contain increased amounts of a protein known as HER2. It works by attaching Herceptin to a drug called DM1, developed by ImmunoGen, which interferes with cancer cell growth. ImmunoGen will receive a $5 million milestone payment from Roche following the approval.

Reuters

FDAdeclines to approve newForest,Richter drug

US FDAapproves Bayer/Onyxdrug for a type of thyroid cancer

US HEALTH regulators have declined to approve a new antipsychotic drug from Forest Laboratories and Richter, citing the need for more information, including additional clinical trial data.

The Food and Drug Administration (FDA) delivered its verdict on cariprazine for schizophrenia and bipolar disorder in a so-called ‘complete response letter,’ the type of letter issued by the agency to convey that it cannot ap-

prove a drug application in its current form.

Cariprazine was discovered

by Hungarian drugmaker Richter and licensed to Forest in the US and Canada.

In its letter, the FDA acknowledged that cariprazine demonstrated effectiveness but the two companies said it appeared regulators wanted more tests on the optimal dose of the treatment to avoid potential side effects.

THE US Food and Drug Administration said it has expanded the approved use of the cancer drug Nexavar to include late-stage differentiated thyroid cancer. Differentiated thyroid cancer is the most common type of thyroid cancer, the FDA said.

The National Cancer Institute estimates that 60,220 people in the US will be diagnosed with it and 1,850 will die from the disease in 2013. The drug, made by Germany's Bayer AG and Onyx Pharmaceuticals, is already approved to treat advanced kidney cancer and liver cancer that cannot be surgically removed. Onyx was acquired by Amgen earlier this year.

Reuters

Reuters

102 EXPRESS PHARMA December 1-15, 2013

RESEARCH

Oral contraceptive benefits outweigh risks, says EMA CHCs carry a well-known but small risk of venous thromboembolism London THE BENEFITS of combined hormonal contraceptive (CHCs) pills such as Bayer's Meliane or Yasmin in preventing unwanted pregnancies continue to outweigh any risk of blood clots, Europe’s drugs regulator said.

Announcing conclusions of a review into the safety of CHCs, the European Medicines Agency (EMA) said they

carry a well-known but small risk of venous thromboembolism, or blood clots in the veins, and a ‘very low’ risk of blood clots in arteries.

But EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded "that the benefits of CHCs in preventing unwanted pregnancies continue to outweigh their risks", the agency said.

The safety review was launched earlier this year after a request by France, where authorities want to reduce use of the contraceptive drugs.

The French government said in Jan-

uary it would stop reimbursing prescription costs of the newer generation CHC pills would restrict their use after a woman sued Bayer over alleged side effects. While all oral contraceptives are associated with some danger of blood clots, a number of scientists studies have suggested that the most recent third- and fourth-generation pills carry a higher risk than their predecessors.

The London-based EMA said its review had “reinforced the importance of ensuring that clear and up-todate information is provided to women who use these medicines and to the healthcare professionals giving advice and clinical care". On the risk of arterial thromboembolism - blood clots in arteries which can potentially cause a stroke or heart attack - the risk "is very low and there is no evidence for a difference in the level of risk between products," it said.

Reuters

103 EXPRESS PHARMA December 1-15, 2013

RESEARCH

Sanofi,Regeneron arthritis drug meets goals in phase 3 trial Sarilumab blocks an inflammationcausing protein called interleukin 6 Paris AN EXPERIMENTAL drug for rheumatoid arthritis developed by French drugmaker Sanofi and Regeneron, when combined with methotrexate, improved symptoms and physical function and slowed progression of the disease in a late-stage clinical trial.

Rheumatoid arthritis is an autoimmune disease in which the body’s immune system mistakenly attacks healthy tissue, causing inflammation and pain in the joints.

Sanofi and Regeneron’s drug, called sarilumab, is an injectable antibody that works by blocking an inflammationcausing protein called interleukin 6. It is similar to Actemra, Roche's fast-growing treatment approved in 2010.

The success of the trial pushes the new drug one step closer to the production line, although it

still to pass further long-term trials and the approval process in particular markets. The 52 week SARIL-RA-MOBILITY Phase 3 trial enrolled some 1,200 patients with active, moderate-to-severe rheumatoid arthritis, who have not benefited from or been able to tolerate the standard oral treatment, methotrexate, whose side effects can include nausea and liver damage.

Patients given a 200 mg dose of sarilumab every other week on top of methotrexate saw a 66 per cent improvement in signs and symptoms of rheumatoid arthritis after six months, Sanofi and Regeneron said. Those given a 150 mg dose saw a 58 percent improvement, while those given a placebo alongside methotrexate saw a 33 per cent improvement. Sarilumab met the other two primary endpoints of the study, improving physical func-

tion at week 16 and inhibiting progression of joint damage after one year, the companies said. Infections were the most frequently reported adverse side effects, as well as increases in ‘bad’ LDL cholesterol and transaminases, they added.

Sarilumab, alongside cholesterol drug alirocumab, is one of the promising products Sanofi is developing under its partnership with US biotech Regeneron to offset the loss of patents on once top-selling drugs like blood thinner Plavix.

Reuters

AbbVie’s hepatitis C treatment helps 96 per cent of patients in trial ABBVIE SAID a late-stage trial of its experimental oral hepatitis C treatment showed about 96 per cent of patients had no detectable levels of the virus after 12 weeks.

The trial is being watched closely because of the potential of the treatment, 3D regimen, to eliminate the need for the injectable drug interferon, which can have debilitating side effects. Analysts said the "high efficacy" seen in the trial was in line with market expectations but underlined the increasingly competitive landscape.

“Thus far AbbVie looks competitive but still key data to come,” UBS analyst Marc Goodman said. AbbVie, the pharmaceuticals business spun off by Abbott Laboratories early this year, said it was on track for regulatory submissions for the treatment in the second quarter of 2014. “We conservatively forecast AbbVie's HCV regimen to produce $192 million

in 2015, and reach peak sales of $950 million in 2018,” BMO Capital Markets analyst Alex Arfaei said. Gilead Sciences Inc's experimental hepatitis C drug sofosbuvir is awaiting a decision from the US Food and Drug Administration.

Bristol-Myers Squibb Co also has advanced all-oral clinical trial programs in late-stage development. But Gilead is widely seen to be leading the race. AbbVie's trial, named Sapphire-I, is the first of six late-stage trials testing AbbVie's interferon-free treatment. AbbVie's 3D regimen combines three drugs along with an existing medicine, ribavirin.

The trial tested the treatment in 631 patients, who had received no prior treatment and had no signs of liver cirrhosis. They had the genotype 1 variant of the infection, which accounts for roughly 70 per cent of hepatitis C cases.

Reuters

Merck trial shows more melanoma cancer patients respond to drug EARLY DATA from a small trial of Merck & Co Inc's experimental immunotherapy cancer drug, known as MK3475, show that about half of advanced melanoma patients treated with the highest dose of the drug experienced tumor shrinkage. Updated results from the early-stage trial are set to be presented at the International Congress of the Society for Melanoma Research

104 EXPRESS PHARMA December 1-15, 2013

in Philadelphia. The antibody drug is part of a new class of compounds designed to block the activity of a receptor on immune cells called programmed death 1, or PD-1. The aim of the drugs is to spur the body's own immune system to attack cancer cells. Merck said results from 135 patients whose melanoma had stopped responding to earlier rounds of treatment showed that 41 per

The company estimated overall survival at a year of treatment at 81 per cent, but said the trial had not yet reached either a median duration of response or median overall survival

cent had tumor shrinkage - the rate was 51 per cent in the high-dose group, and 40 per cent for lowest-dose group.

The company estimated overall survival at a year of treatment at 81 per cent, but said the trial had not yet reached either a median duration of response or median overall survival.

Reuters

WEST BENGAL PHARMA REVIEW

Destinyof pharma industries in West Bengal WEST BENGAL REVIEW

Dr Chintamoni Ghosh THE PHARMACEUTICAL industry is in the front rank of India’s science-based industries with wide ranging capabilities in the complex field of drug manufacturing and technology. The Indian pharma industry can be said to have begun with the setting up of ‘Bengal Chemical and Pharmaceutical Works’ in Calcutta. Subsequently institutes like Kings Institute of Preventive Medicine in Chennai, Pasteur Institute in Coonoor, the Central Drug Research Institute in Kasauli and others were set up.

Post-independence, many other public sector companies such as Hindustan Antibiotics and Indian Drugs and Pharmaceuticals were set up to reduce the imports of important antibiotics and also to meet the county’s demand from indigenous production.

Today India has proved to the world that it can produce world standard quality generic medicines. It ranks very high in the third world, in terms of technology, quality and range of medicines manufactured. From simple headache pills to sophisticated antibiotics and complex cardiac compounds, almost every type of medicine is now made indigenously.

The Indian pharma sector is highly fragmented with severe price competition and government price control. It has ex-

panded drastically in the last two decades. There are about 300 large units that control about 70 per cent of the market with market leader holding nearly seven per cent of the market share and about 8000 small scale units together which form the core of the pharma industry in India. These units produce the complete range of pharma formulations, i.e., medicines ready for consumption by patients and more than 400 bulk drugs, used for production of pharma formulations. Consequently, larger companies are cutting back on outsourcing and shifted to companies with facilities in the five tax-free states: Himachal Pradesh, Jammu & Kashmir, Uttaranchal, Sikkim and Jharkhand. SMEs have been finding it difficult to find the funds to upgrade their manufacturing plants, resulting in the closure of many facilities.

In the year 2005, India introduced product patent recognition to all new chemical entities (NCEs) i.e., bulk drugs developed then onwards. This introduction of product patent regime from January 2005 is leading into long-term growth for the future which mandated patent protection on both products and processes for a period of 20 years. Under this new law, India will be forced to recognise not only new patents but also any patents filed after January 1, 1995. Under changed environment, the industry is being forced to adapt its business model to recent changes in the operating environment. Indian pharma industry is mounting up

ficient in case of formulations.

Some life saving, new generation under-patent formulations continue to be imported, especially

by MNCs, which then market them in India..

Export potential

the value chain. From being a pure reverse engineering industry focused on the domestic market, the industry is moving towards basic research driven, export-oriented global presence, providing wide range of valueadded quality products and services, innovation, product life cycle management and enlarging their market reach. The old and mature categories like antiinfectives, vitamins, analgesics are de-growing while, new lifestyle categories like cardiovascular, Central Nervous System (CNS), anti diabetic and anti-cancer drugs are expanding at double-digit growth rates.

The pharma sector is one of India’s most important sectors in terms of projected revenue growth from exports and for meeting the needs of Indian population. There are a larger number of markets to which Indian pharma companies can now export as a result of global trade liberalisation and capacity building by Indian companies over the last decade. India, considered as a knowledge intensive economy, is looked upon to make available drugs that are affordable to the developing countries.

The recent contribution of Indian generics in fighting AIDS and its contribution to affordable healthcare in the US and elsewhere is widely acknowledged.

Pharma sector in Bengal Domestic market The industry has enormous growth potential. Factors listed below determine the rising demand for pharmaceuticals. ● The large population of over of a billion ● Increasing income capacity ● Demand for quality healthcare ● Change in disease patterns ● Increased demand for new medicines to combat lifestyle related diseases More than 85 per cent of the formulations produced in the country are sold in the domestic market. India is largely self-suf-

The pharma sector is one of India’s most important sectors in terms of projected revenue growth from exports and for meeting the needs of Indian population

Agriculture is the backbone of the West Bengal state economy. Industrial and services sector also contribute in the development of the economy of West Bengal. Pharma industries especially formulation units require less land compared to other heavy industries; return on investment is fast and very good.

The modern pharma industry requires less but highly qualified and skilled manpower, which is available in the state as it is evident from the fact that many of personnel from the West Bengal are holding high position in the pharma industries.

Advantages of pharma industry in West Bengal ● Potential market with a target

large population in the eastern and north eastern states ● Successful implementation of Land reforms, the rural economy has developed resulting in-

crease of purchasing power ● Prime medical facility in Kolkata, Durgapur and Siliguri for patient from neighbouring countries, especially Bangladesh, Nepal and Bhutan ● NIPER campus is established in the state ● A proposed pharma manufacturing zone and chemical hub ● Special Export Processing Zone (SEPZ) at Falta ● NPPA-CIFG in Kolkata for redresse the grievances of consumer ● Biotech Policy is declared ● Country’s main patent office in Kolkata.

The state government is adopting a number of policy measures in order to accelerate the growth of the pharma industry and to make it internationally competitive. The government’s effort is at best directed to facilitate the growth of industries through various measures.

However, the industry requires leadership to galvanise all the efforts at micro level to macro level for intended result.

The Directorate of Drugs Control of the State has extended a helping hand to the pharma producers in meeting global standards in stages.

Since all surviving industries in West Bengal are GMP compliant, requirements of advanced tools and technology, validated and aseptic processing will no more be a problem centres.. A strong motivation within the pharma industry is now required to regain its lost pride and position. The effect was negated in government taxation and pricing policies. The driving factors, however, remained as availability of skilled manpower and Phytochemicals, raw materials and access to different global regions through East.

(The author is Director of Drugs Control, Government of West Bengal)

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WEST BENGAL PHARMA REVIEW

Stadmed Pharma: Diversifying presence WEST BENGAL REVIEW

THE RISE OF the pharmaceutical industry in India took place in Bengal. The dedication and untiring efforts of Prafulla Chandra Roy made it possible to set up the first of its kind pharma company in Kolkata way back in 1901. Later, several pharma companies were set up in Kolkata by entrepreneurs then.

It was in 1940 when the late

106 EXPRESS PHARMA December 1-15, 2013

Gour Gopal Saha, a visionary, started his entrepreneurship with the foundation of Standard Medical Research Institute in Kolkata. Soon, the brands manufactured by the company like Alkasol, Pulmocod and Aminozyme became very popular among the masses. Later, the company was rechristened Stadmed, which went on to spread a strong marketing network across the length and breadth of the country.

The flagship brand of the company, 'Alkasol', remains the first choice for a large section of

medical practitioners. Metabolic acidosis, urinary tract infection, lung diseases, general weakness, nutrition were the primary segments of focus in the company.

Since then, the company has never looked back. Now, with diversification of brands in different segments, and by forming a separate SBU, the company is not only strengthening its ethical general trade market, but also giving much emphasis on institutional sales and sale to corporate hospitals. Today, the company has been able to manufacture quality medicines

to meet the increasing demand by its ISO 9001:2008 certified manufacturing units based in Kolkata and Lucknow.

Asheesh Roy, Director, Stadmed, informs, “We are now focusing on both the acute and

chronic care segment. With more than 100 brands in our portfolio, the company is now aggressively marketing to strengthen its presence in the anti-hypertensive and anti-diabetic ranges. Our recently launched brand ‘Ursolic’ (Ursodeoxycholic Acid) is getting encouraging response from the medical practitioners. Urology, paediatrics and gynaecology remain to be the key strength segments of the company. With a consistent growth rate over the years, the company has crossed the `50-crore mark of turnover.”

WEST BENGAL PHARMA REVIEW

Albert David to launch marketing division (Isoxsuprine Tab / Inj), which it feels will tilt the balance in its favour.

WEST BENGAL

Soon, the company plans to further strengthen its gastro range of products by launching

Rebeprazole and its combination. We also have plan to venture into anti-asthmatic,

infertility, paediatric and nutraceuticals.

Continued on Pg 111

REVIEW

KOLKATA-BASED PHARMACEUTICAL company Albert David, a unit of the Kothari group, has recently undertaken a range of initiatives for development of new products for increasing its market share in formulation segment to achieve sustained growth in the current fiscal year.

“In the current fiscal, we have introduced new products and would be soon adding more brands to expand our product offerings,” said Kamal Prasad Mundhra, Executive Director, Albert David. “We also plan to launch a separate marketing divi-

sion to consolidate our position in the domestic market,” he said.

Albert David, which makes pharmaceutical formulations, bulk drugs and injections, has three manufacturing plants — in Kolkata (for tablets and powder, small volume parenterals, oral liquids, bulk drugs), Ghaziabad (for IV fluids in glass and polythene containers using the latest Form-Fill-Seal (FFS) technology and small volume parenterals) and Mandideep (disposable syringes & needles).

In the last fiscal, the company, touched a turnover of ` 264 crores and is expecting to touch ` 300 crores in the current year. The company has successfully launched Anaflam TH4/TH8 (skeletal muscle relaxant), Alamin RG/RGX (LArginine Sachets) and ADILAN

107 EXPRESS PHARMA December 1-15, 2013

Ursodiol 300mg & Silymarin 140 mg tablets

Isoxsuprine hydrochloride 10mg Tablets, 40mg SR Tablets, 5mg/ml IM / IV

Montelukast 5mg/10 mg + Levocetrizine 2.5/5 mg

B R E AT H E

Tablets

EASY

15, Chittaranjan Avenue, Kolkata - 700 072, Phone: 2212-9700/9637/9592, Fax: 033-2225-8714/2212-9629, E-Mail: adidavid@cal.vsnl.net.in, E-Mail: adldavid@dataone.in, Website: www.albertdavidindia.com

WEST BENGAL PHARMA REVIEW I N T E R V I E W

We plan to increase our production capacity by starting a new plant The United Engineering Company is a leading pharmaceutical packaging player in the country. For the last five decades, it has made its presence felt in this sector. Express Pharma spoke to Debasish Roy, Managing Director and Subhasish Roy, Chief Executive Officer, The United Engineering Company to know more about the company and its future plans

WEST BENGAL REVIEW

First of all, we convey our greetings for completing five decades in this industry.

Today, after so many years, how do you look back to the achievements of the company.

See, United Engineering Company (UEC), which was started in 1963 by GD Roy, from the beginning, attained a high reputation in providing machines and services of highest standards with utmost care.

With the founder’s innovative ideas and unmatched leadership qualities, UEC crossed various boundaries in different fields of work. It has tried to build relationships rather than clients or customers. We have never compromised with the quality in all aspects of the business, be it machines, service or relations.

Today, the list of clients, which include the who’s who of the Indian pharma industry are on our client list and speaks volume of our achievements.

Besides, the hard work and efforts of the members, the company does play a very crucial role in making ‘The United Engineering Company’, what it is today.

108 EXPRESS PHARMA December 1-15, 2013

Which are the major pharma machines manufactured by the company?

We specialise in machinery for packaging ampoules, vials and bottles. We provide a complete solution for the whole production line. UEC has also mastered in providing machines for automatic tablet coating. Our product ranges from semi-automatic (R&D models) to fully automatic machines.

‘UNITED’ machines are versatile in nature and thus can accommodate containers of different shapes and sizes.

UEC also provides customised solutions to its customers.

UEC has always been keen on introducing latest designed machines to the industry. What are the latest products from your basket and what more can we expect in the coming days?

Our latest development is the UNITED ‘EAC’, Automatic External Cleaning & Drying Machine for ampoules and vials. This machine plays a very big role in improving the productivity of an automatic inspection and labeling machine in the production line.

We have also developed High Speed Sticker Labelling Machines for Ampoules and Vials, with special unique features incorporated in it.

Currently, we are working on the development of a High Speed Ampoule Filling and

and utility of the machines.

UNITED machines are equipped with the latest technological trends.

We at UEC, are always keen on upgrading our existing machines in paralance to the new developments. We believe that tomorrow’s technology should be standard in every UNITED machine produced today.

DEBASISH ROY

SUBHASISH ROY

Sealing Machine, which would operate in rotary motion with special liquid dosing capabilities and other unique features. It would be in fact, the first of its kind in the country and the most compact machine for high output productivity. We plan to develop machines for packaging pre-filled syringes and automatic cartoning machines for containers of various sizes in the near future.

before being despatched.

Hence, Quality Control does form a crucial part of our validation programme.

Adhering to strict ‘Quality Control’ parameters, is an important element in today's pharma-production business. Can you elaborate on this?

From a nut to the main component of the machine, we provide the best quality material complying with the highest standards of manufacturing guidelines. We perform regular quality checking programme for each and every machine

How are you currently placed in the Indian and the international market?

In India, we are considered to be one of the best and trusted brands in the industry.

'UNITED' machines also cut a niche for itself in the international markets.

Today, Indian pharma machines are being exported to different parts of the globe. Which countries do you export?

We have a strong foothold in the overseas market. We export mostly to South African and Asian countries.

Yet, we have supplied a few machines to the US and Canada as well. Presently, we are looking forward to extend our horizons to the European and other markets.

Keeping pace with the latest 'technology upgrades' is one of the key attributes for attaining success in today's fast changing world. How is UEC taking care of this aspect?

In the last few years, this field has seen a favourable metamorphosis in technology.

Automation of machines has improved to a new dimension which adds a lot to the productivity of the machines. This also helps the user to get a clear view on the overall performance

Can you please elaborate on your future plans?

We are planning to increase our production capacity by starting a new plant, incorporating modern equipment and state-of-theart facilities.

We have traversed five decades in this business, but for UEC entering the 51st year is the beginning of a new chapter. In the words of Robert Frost: ‘We have miles to go before we sleep.’ We plan to venture into new areas, work harder and excel in what we do.

WEST BENGAL PHARMA REVIEW

Serving the pharma industry for last five decades gious ‘Innovator’s Award’ from the Indian Pharmaceutical Congress for their innovation and development. Today, at UEC,

WEST BENGAL REVIEW

KOLKATA-BASED The United Engineering Company (UEC) with the brand name ‘United’ is known for being the pioneer and commander in packaging machinery manufacturing in India.

UEC, which was started in 1963 by GD Roy, from the beginning, attained a high reputation in providing machines and services of highest standards with utmost care. With the founder’s innovative ideas and unmatched leadership qualities, UEC crossed various boundaries in different fields of work.

Initiating the business with solutions for parenterals (ampoules and vials), UEC has diversified its business into the bottle packaging sector and has also mastered in providing automatic tablet coating solutions. UEC also provides customised solutions for its customers. UEC has ventured into different industries such as distilleries, cosmetics, foods and beverage, paints, chemicals, home care, office and student stationery and others.

The company has expanded its footprints abroad in a large way. ‘United’ machines are exported to more than 21 countries across the globe namely the US, Canada, Bolivia, Nigeria, Kenya, UAE, Iran, Sri Lanka, Bangladesh, Malaysia, Indonesia, Vietnam, Korea and others.

UEC puts in a lot of effort for their R&D and strives to provide the best and optimised solution to its customers. By virtue of dedication and continuous hard work of their R&D team, ‘United’ machines provide technically advanced solution for its customers.

Presently, UEC is having its head office in Kolkata. It has three manufacturing units in West Bengal, covering an area of over 10000 sq ft. UEC is having another office in Mumbai along with a service station. UEC has been honoured by the presti-

109 EXPRESS PHARMA December 1-15, 2013

machines are equipped with the latest technology. For its customers, United machines are cost effective but are guaranteed

with the quality, optimum production and ensured unconditional service. UEC is equally focused on being a corporate

citizen. It has never shirked the responsibility of the society and has always been an active participant in numerous social events.

WEST BENGAL PHARMA REVIEW

Neomachine Mfg Co: Aleader in automatic coating technology WEST BENGAL REVIEW

KOLKATA-BASED Neomachine Mfg Co was started in 1973 with an objective of manufacturing all types of pharmaceutical machinery.

For a decade, the company catered to the requirements of the Indian domestic players by manufacturing pharma ma-

110 EXPRESS PHARMA December 1-15, 2013

chinery like bottle filling and washing machine, tray driers, mechanical sifter, vial filling machine, coating pan, fluid bed drier, pressure vessel, planetary mixer etc.

While catering to this market segment, Neomachine chanced to come across a Kolkata-based pharma producer, who were facing problems in film coating of tablets.

Until then, the tablets were being coated in conventional pans, which were not only

causing health hazards to the coating personnel, but was also a time consuming process. Inspired by this opportunity, Neomachine started the process of developing an automatic coating machine in the right earnest. After, two years of research and development, the first ‘Neocota Automatic Coating System’ was manufactured in 1984.

During the last three decades, Neomachine manufactured and marketed over

500 machines, out of which 50 machines were exported to the US, Australia, China, Jordan, Yemen, UAE, Uganda, Kenya, Sudan, Cyprus, Saudi Arabia, Austria, Brazil, Bangladesh, etc.

Neomachine, a professionally managed organisation now has two manufacturing units in Kolkata, which are equipped with state-of-the-art equipment like fabrication, machining, assembling and finishing.

ANUP MAITRA, MD, NEOMACHINE

The company has been strictly following all the quality control guidelines during manufacturing. The boughtout items are inspected at the manufacturers’ works periodically. The company has a dedicated team of engineers for providing erection and commissioning and prompt after-

WEST BENGAL PHARMA REVIEW sales service to the clients.

The in-house R&D facility is abreast of the latest technology upgradation and the latest developments in 'Coating Technology’. This helps in continuous improvement of the product.

Neomachine also provides

Continued from Pg 107

Albert David to launch ...

Mundhra said efforts are on to generate new scientific data and expand our knowledge base to further substantiate the therapeutic principles of its 56-yearold flagship product – ‘Placentrex.’

He said, “The company has given much thrust on its research and development initiatives. The company has made significant investments in renovating, virtually re-creating, expanded R&D facility at its Kolkata site. Renovated facility meets the current GMP and GLP requirements. The R&D section of the company has been engaged in developing innovative process developments, analytical methods and process validations. It has also been working on development of new products, while at the same time focusing on improving the quality of its existing products.”

In the coming days, the company plans to tap the international market in a bigger way. Exports will remain to be a key driver for growth of the company in the coming years. Last year, our exports touched ` 25crore mark, Mundhra added.

African nations, Vietnam, Myanmar are the major markets of the company.

Commenting on the Indian pharma industry, he said it is an extremely fragmented market with severe price competition and government price control.

But inspite of these, Albert David will continue to grow with the current strategies in place and is equipped to meet any future challenges, he added.

EP Team -Kolkata

111 EXPRESS PHARMA December 1-15, 2013

IQ/OQ/PQ Qualifications for automatic coating system and are in the process of getting CE Certification. Over the years, the company has gained vast experiences in manufacturing 'Automatic Coating System' by interacting with various Indian and multina-

tional pharma and confectionery units based in India.

Products like Cadbury India’s fast-moving product ‘Gems’ and Parke Davis’ ‘Chicklets’ are coated in the systems manufactured by Neomachine. The company also imparts aqueous and

non-aqueous film coating and sugar coating technology to clients, who need the expertise.

Neomachine also supplies Hepa Filter for filtration of incoming drying air and Mobile Bed Wet Scrubber for purification of exhaust air, for these

companies that need these items. Neomachine being a single-product company, manufactures various models of NEOCOTA. The automatic coating machine, gained vast experience in coating technology since the last two decades.

PHARMA LIFE INSIGHT

ALIGNMENTOF HUMAN CAPITAL

A recent study from the Hay Group focuses on the pharma sector across the world and concludes that market access must focus on understand and demonstrating measurable improvements in benefits to customers. According to Ian Wilcox, Global Managing Director â&#x20AC;&#x201C; Life Sciences, this journey will require finding and keeping the right people

IN A HEALTHCARE landscape where value remains a major focus, market access has taken centre stage.

But market access as it has traditionally been pursued will not satisfy the needs of

112 EXPRESS PHARMA December 1-15, 2013

the current value-based landscape. By viewing market access and development as distinct functions, life sciences companies not only risk losing ground in pricing and contracts. They also risk leaving

a potential source of competitive advantage on the table: a market access area aligned with customer needs.

In the wake of rising healthcare costs, the increasing power of payers and other

players has created the challenge of providing a compelling value proposition to stakeholders across the healthcare system. Hay Groupâ&#x20AC;&#x2122;s experience indicates that successful and profitable

development in the life sciences industry will, henceforward, be driven by a clear understanding of what constitutes value for various stakeholders that make up the market.

PHARMA LIFE Clearly, pharma sector has relied on a product-centric mindset for too long. Success today demands a customercentric strategy. However, a customer-centric strategy requires a clear operating model, far different from the one used in the past, and a sound human capital plan to implement it. As a result, ‘market access’ efforts need to evolve from their traditional reliance on pricing, contracting, sales, and account management activities.

This transformation requires a three-step change agenda: ● A mindset shift to a value culture ● The capacity to scan, build solutions, and adapt ● A sound human capital strategy to support new market access capabilities

Committing to a value culture Top science will always be indispensable, but science alone is no longer sufficient.

Companies need a stronger customer focus. To borrow a concept from the consumer goods industry, companies must become adept at ‘design thinking,’ a mindset that has proven successful in other industries in the past decade or so. For instance, when P&G was losing market share in the early 2000s, the company called on employees to build products around the customer’s experience of them.

P&G dubbed this ability ‘design thinking’, and it is credited with reviving a number of flagging brands.

The transformation of market access will require a similar shift from a product focus to a customer focus. It means seeing that innovation does not come from science alone; it lies primarily in the extent to which science enters and influences the value chains of customers.

To view a product in this ‘outside in’ manner, companies need to understand ‘customerness’. In their book MBA Fundamentals: Strategy, Thomas P Ference and Paul

W Thurman developed the idea of ‘customerness’: a concept that does justice to the complex question, ‘Who is the customer?’ The concept of customerness is useful in distinguishing between the multiple parties to a healthcare purchase – including those who use a therapy (patients), those who decide to use it (physicians), those who pay for it (public and private payers), and those who benefit from it, both medically and economically (patients, but also a host of other parties).

Importantly, understanding who benefits from a therapy affects how, and for whom, pharma companies construct value propositions.

Preparing for transformation Scanning: In the quest to transform ‘market access’, scanning becomes the first step, a strategic activity to gauge and anticipate stakeholder needs in the different markets in which a company operates. Scanning involves searching for potential areas of mutually beneficial collaboration, such as collaborations with payers to examine claims data. It also involves seeking new ways to deliver benefits to healthcare stakeholders.

Building Solutions: The next step, building solutions, requires turning the opportunities generated by effective scanning into reality. From a human capital standpoint, it requires leaders to develop winning partnerships, such as customer advisory boards, and to overcome organisational inertia and persuade colleagues who may resist new opportunities for collaboration at the senior level. It entails finding pragmatic ways to partner with the customer, and requires implementing a customer-oriented value focus in R&D. One implication of this new focus is that research should be driven by stakeholder needs as well as by science.

According to Dr Tehseen Salimi, TA Vice President in Global Medical Affairs, AstraZeneca, producing the

kinds of evidence most meaningful to each stakeholder is vital, as is generating the data necessary not only to win approval but also to demonstrate measurable cost and efficiency benefits as science travels ‘from the bench to the bedside.’

Adapting: Finally, adapting, the ability to realign company resources as the market evolves, implies that top management must remain in close contact not only with the science, but also with healthcare stakeholders and the market.

Remaining agile is therefore key. Leaders must be able to manage the tension between efficiency and adaptability as well as between adherence to processes and the flexibility to amend processes in response to opportunities. Collaboration is a much-needed ingredient of adaptability. Leaders should amplify the strengths of their colleagues, work

Life sciences companies will ultimately rely on the strength of human capital initiatives to support the goal of showing value. A sound business strategy ... will underperform unless the human capital and cultural component of change is a top priority

through others, create strong teams, mentor subordinates, and work with the good of the organisation in mind.

These always are good ideas for most businesses. But for pharma in its coming transformational era, they may make the difference between success and failure.

Finding – and keeping – the right people This journey requires hiring and rewarding employees who demonstrate adaptability, resilience, tact, and flexibility.

In addition, the value-based environment calls for new descriptions of roles (some of which have not been invented yet), a new understanding of what success means, and new rewards for leaders.

Market access teams will need to work across more functions than ever before, and this will call for a new set of behavioural skills: the ability to think cross-functionally, to see the business from the outside in, and to act within a dynamic environment. Talent will be required to develop the ability to perceive complexity, to understand products from the vantage points of different stakeholders, and to notice opportunities to drive value for customers and for the company at the same time.

This means that key traits of employees for today and in the future will differ from those previously associated with market access roles— and be less static than they have been in the past decades.

Importantly, it is investment in talent and organisational capabilities that will yield significant competitive advantage—more so than improvements in areas such as sales, payer marketing, contracting, and relationship management. While these areas remain indispensable, in most companies they are streamlined activities where improvements will be incremental. Roles that will become pivotal are those that link the organization to outside stakeholders, such as evidence-based medicine leaders or cross-functional product or

brand leaders.

Rewarding leaders who can align the organisation with stakeholder needs means rethinking compensation at all levels. While there still may be a place for classic measures based on financial performance, hiring, performance management, development, and promotion processes will also need to support the goal of showing value.

Looking ahead Transformed through this three-pronged approach, market access will become a strategic capability. In a previous, less dynamic climate, it made business sense to treat market access as a path to a predictable revenue stream.

But as pharma companies worldwide are experiencing, this is no longer a viable strategy.

The worldwide drive to make healthcare costs sustainable demands that companies shift their market access strategy from one centered on products to one centered on showing value. Focusing on the uniqueness of product attributes is necessary but not sufficient, and a scientifically superior product alone is not enough. It must be supported by a strong health economics case for the value that such superiority can deliver to constituents.

Again, in the context we have described and the future we envision, the bottom line is that life sciences companies will ultimately rely on the strength of human capital initiatives to support the goal of showing value. A sound business strategy, even one supported by well-designed structures and processes, will underperform unless the human capital and cultural component of change is a top priority.

Done well, this realignment of human capital will prepare an organisation for a climate of permanent dynamism—essential in the new landscape where change seems to be in order for years to come.

115 EXPRESS PHARMA December 1-15, 2013

PHARMA LIFE AWARD

BD Biosciences recognises ‘Excellence in Flow Cytometry’in India Reecha Shah from National Centre for Cell Sciences receives 5th BD-TCS Award REECHA SHAH, a research scholar from the lab of Dr Padma Shastry at National Centre for Cell Sciences, Pune, received the 5th BD-TCS Award (2013). This year the award ceremony was held at Bhubaneshwar, which also hosted the first BD-TCS Award function in 2009. Shah won the award for her paper elucidating molecular mechanism of sodium valproate (VPA) potentiating the cytotoxic effects of anti-cancer drugs. The study provides new information on the possible utility of VPA, a commonly used anti-epileptic drug, in combination chemotherapy.

BD Biosciences, India in collaboration with The Cytometry Society – India (TCS), instituted

an award for ‘Excellence in Flow Cytometry’ in 2009 to recognise the creative use of flow cytometry as a tool for addressing problems in the fields of clinical or basic research. The BD-TCS Award constitutes a prize of ` 1,00,000 and a citation. Eligible investigators submit their published papers, which are screened by a national committee constituted by the President, TCS and the shortlisted papers are evaluated by an international jury consisting of eminent flow cytometry experts. The winner is felicitated during the annual meeting of TCS. On receiving the coveted BDTCS Award Reecha Shah said, “It is a great feeling to receive an award from such a prestigious

platform. It is indeed very encouraging to see that our work is getting appreciated by the community and paves way for many more aspirants to participate each year. I hope this award takes me to greater heights as I plan to move to San Jose soon.”

YS Prabhakara, Business Director, BD Biosciences in India, said, “BD Biosciences is proud of its association with TCS. We have teamed with TCS to reward meritorious scientific research in India. We believe this will go a long way in motivating life science research specifically by using Flow cytometry. Flow technology can be gainfully employed much more (than present level) for research or clinical purposes. We are confident that

through interactions with progressive societies of scientists like TCS.” Flow Cytometry has been recognised as one of the important technologies that transformed the face of modern life science and biotechnology research in India. Over the past few years, the technology has witnessed continuous improvement in multicolour analysis, high speed cell sorting, new fluorochromes, innovative reagent portfolios, and new emerging ap-

plications in health care research. Flow Cytometry makes the scanning of millions of cells in minimum time and cells of interest can be further tagged with suitable add-ons to study their various characteristics. Flow Cytometry is a count and measure of the physical and chemical characteristics of numerous biological particles such as cells, cell subsets, DNA, surface antigens and bacteria.

EP News Bureau - Mumbai

INITIATIVE

Sanofi India partners with PVR Nest Healthy Children, happy children’ initiative will jointly reach out to 2,00,000 children SANOFI INDIA has joined hands with PVR Nest, the social programme and registered foundation of PVR, for its ‘Healthy children, happy children’ initiative. The largest in its outreach and scope so far, the programme titled CineArt ‘Healthy children, happy children’will bring together leading Indian paediatricians, with NGOs and artists in the field of creative learning, to mentor 2,00,000 school children

116 EXPRESS PHARMA December 1-15, 2013

from 200 schools (an equal mix between public/privately held schools and NGO/ community schools) in four cities, Mumbai, Delhi, Chennai, and Hyderabad, on critical aspects of children’s health.

The programme endeavours to make children’s health education real, innovative and participatory. 600 health workshops using experiential learning methodologies like puppetry,

theatre, storytelling and capacity building exercises, will be tapped to sensitise children on relevant health topics like hygiene, environment, play and exercise, disability and discrimination, vaccination, ergonomics, among others.

Speaking at the launch event in Mumbai, Joanna Potts, Commercial Operations Officer, Sanofi India stated, “Over the years, Sanofi has provided med-

ication and healthcare tools to address numerous fundamental childhood health issues, from routine to life-threatening.

Through our new ‘Healthy children, happy children’ initiative, we aim to diversify and adapt our healthcare offer to young Indian patients, with innovative products, services and awareness initiatives. We are delighted to partner with PVR Nest for a first-of-its-kind interface be-

tween paediatricians, NGOs and artistes for this innovative, yearlong school awareness programme on health. We are looking forward to seeing children-in-action during the school health workshops, and also, during the making of original ‘Healthy children, happy children’ health films and publication.”

EP News Bureau-Mumbai

PHARMA LIFE BOOK REVIEW

Caregiving simplified Raelene Kambli reviews Amey Goyer’s book- Juggling Work and Caregiving and finds that it makes for an informative and interesting read

CAREGIVING IN reality is an act of love and compassion.

However, it also takes courage to for the old and the ailing loved ones on a daily basis. Especially, if one is a working caregiver-life seems to be extremely difficult. ‘Juggling Work and Caregiving', an ebook developed by the American Association of Retired Persons (AARP), sponsored

by Pfizer and authored by AARP’s Amy Goyer, is a complete guide for people who have been caring for their ailing loved ones at home while having their own careers. The title of the book is self explanatory and it gives a clear understanding to the readers that the book deals with various challenges a working caregiver. The e-book also gives infomration on how one can successful trod over these rough patches in life and handle it with aplomb. The book offers useful tips to people who are caregivers on a day-to-day basis and yet need to maintain a balance with their work.

The book begins with a foreword by Dr Freda LewisHall, MD, Executive Vice President and Chief Medical Officer, Pfizer, a name well known among international pharma and healthcare experts. She writes, “We believe that caregivers are both essential to our society and under-appreciated within it. Whatever your situation, this guide makes it clear: You are not alone”. This show of solidarity raises high hopes from the book and urges you to read it.

“Although caregiving can be a richly rewarding experi-

ence, the role comes with enormous responsibilities — and pressures,” writes the author, while she introduces the subject.

The book has 14 chapters that deal with aspects related to caregiving and managing a paid job. Caregiving is an art mastered by experience and the author explains this well in each of its chapters. The topics covered in each chapter are also very pertinent and comprises issues that may arise on a day-to-day basis in the life of a working caregiver.

Written in simple and lucid language which can be easily understood and comprehended, the book offers great insights and keeps you hooked till the last page. In a time, when there are quite a number of books available on caregiving, the books takes a personal approach in solving various challenges. Apart from this, the author gives a personal touch to book by sharing her own poignant story as a live-in caregiver to her parents.

She also incorporates experiences shared by many working caregivers from America, since this book is written keeping in mind, the working caregivers from the US. Some might wonder that if the book caters to Americans, what will the lure for Indian readers?

Well, the answer is the book itself. Caregiving as an act comes with a set of challenges, issues and solutions which remian similar regardless of the topography.

In the first chapter, the author speaks about understanding a caregiver and the

Title: Juggling Work and Caregiving' Author: Amy Goyer Edited by: C Sampath & Hannah Paul Publisher: Rosetta Books Developed by: AARP Sponsored by: Pfizer Available for download: Kindle, Apple, Barnes and Noble and Kobo e-tailer stores

challenges faced by them. The second chapter deals with the real tough job of a caregiver juggling their work and caring for their loved ones. The third chapter gives tips on how a working caregiver can plan for their ailing loved ones. Moving on, in the fourth chapter, the author touches upon details that usually caregivers overlook while they juggle through these difficult times but can have far reaching consequences, for instance caring

for themselves. Sharing some personal experiences, the author in this chapter helps one overcoming the emotional and physical challenges that a caregiver is bound to face. The author elaborates of this theme in the fifth and sixth chapters as well. Taking a step forward, Chapter 7 and 8 is on how a caregiver needs to manage his/her legal and financial matters. Often, while caregivers are engrossed in providing support and medical

aid to the loved ones they tend to overlook details related to medical insurance settlements and other financial matters.

Here, the author, in a simple way explains how one can efficiently maintain medical bills, settle claims and take care of legal matters while caring for their loved ones.

In the latter chapters 10, 11 and 12, the author gives tips on how to maintain a work-life balance when your ailing loved ones live in a separate facility away from home. She also teaches the caregivers to be prepared for a crisis situation.

In Chapter 12, the author gives tips on how to manage the hospitalisation of a loved one while handling a paid job.

Chapter 13 and 14 deals with life’s most difficult timeswhen caregivers have to part with the loved ones whom they have looked after for a long time. Indeed, this is the time when most caregivers experience an emotional collapse. Often it seems to be the end of the world for them. However, here the author who also experienced the same pain, advises how cope with the situation and move forward. The author sums up the book by providing some interesting ways where people can make a new beginning.

All in all, the book serves as a simple yet effective guide and reference for caregivers while they take on an important role in their lives. The book is available for free download in the Kindle, Apple, Barnes and Noble and Kobo etailer stores. raelene.kambli@expressindia.com

117 EXPRESS PHARMA December 1-15, 2013

PHARMA LIFE NAUKRI JOB SPEAK

Hiring activity in pharma sector increases by seven per cent in Oct’13 over Sept’13 Year-on-year analysis shows seven per cent increase in hiring activity in comparison to last year

NAUKRI JOB SPEAK Index for the month of October’13 has increased signalling better times ahead for the sector. An M-O-M analysis reveals that index has gone up by seven per cent in October’13 as compared to September’13. Yearly comparison shows a 20 per cent in-

crease in October’13 if compared to same month of previous year. Both set of numbers portends an improvement in hiring situation in pharma sector.

About Naukri.com Naukri.com, India’s No. 1 job

site and the flagship brand of Info Edge introduced the concept of erecruitment in India. Since its inception in 1997, Naukri.com has seen continued growth while outperforming its competitors in every sphere. Info Edge was the first internet Company to be listed in India. The site enjoys a traffic

share consistently over 60% as per the Comscore data. Naukri.com is a recruitment platform that provides hiring-related services to Corporates/ recruiters, placement agencies and to job seekers in India and overseas. It offers multiple products like Resume Database Access, listings and Response

Management Tools. With 230000 jobs live at any point and over 33 million CV’s, Naukri.com serviced over 48000 corporate clients in 2012-2013. The company has over 2500 people operating through 57 offices in 36 cities in India and overseas offices in Dubai, Riyadh, Abu Dhabi and Bahrain.

JOBS FROM Naukri.com PACE FIT FACILITATOR Company: Dr Reddys Laboratories Exp: 1-3 Location: Hyderabad / Secunderabad Job Id: 220813000064

MANAGER - OPERATIONS & CONTRACT MANUFACTURING Company: Enovate Biolife Exp: 4-8 Location: Mumbai Job Id: 310713002029

COMPUTER OPERATOR & TYPIST Company: Pharmaffiliates Analytics Synthetics

118 EXPRESS PHARMA December 1-15, 2013

Exp: 1-3 Location: Chandigarh Job Id: 100513001846

SENIOR MANAGER GLOBAL PHARMACOVIGILANCE Company: Wockhardt Ltd. Exp: 10-20 Location: Mumbai Job Id: 260813002759

GM - EXPORTS Company: Anglo French Drugs & Industries Exp: 10-14 Location: Bengaluru/Bangalore Job Id: 300813004223

TECH LEAD STAT PROGRAMMING Company: inVentiv International Pharma Services Exp: 8-12 Location: Gurgaon Job Id: 030413001593

ASSISTANT MANAGER- SALE & BUSINESS DEVELOPMENT Company: GVK Biosciences Exp: 2-3 Location: Hyderabad / Secunderabad Job Id: 210813002875

EXECUTIVE - PHARMA REGULATORY AFFAIRS

Company: PKG International Exp: 2-6 Location: Delhi Job Id: 050913005109

MANAGER - PHARMA FDA LIASONING Company: Naprod Life Science Exp: 5-10 Location: Mumbai Suburbs Job Id: 050913005007

REGD.WITH RNI NO.MAHENG/2005/21398 REGD.NO.MH/MR/SOUTH-77/2013-15, PUBLISHED ON 5TH & 20TH EVERY FORTNIGHLY & POSTED 6-7-8 & 21-22-23 OF EVERY FORTNIGHLY. POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE.