Express Pharma (Vol.12, No.10) March 16-31, 2017

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‘We need to encourage more manufacturers to enter and stay in the (vaccines) market’

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CONTENTS Vol.12 No.10 March 16-31, 2017 Chairman of the Board Viveck Goenka

MARKET

THE SOCIALWAYTO SUCCESS

Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja New Delhi Prathiba Raju DESIGN

National Design Editor

12 India Pharma Inc needs to leverage the potential of social media to up its game in times to come | P18

'WE NEED TO ENCOURAGE MORE MANUFACTURERS TO ENTER AND STAY IN THE (VACCINES) MARKET'

Bivash Barua Asst. Art Director

MANAGEMENT

PHARMA ALLY

Pravin Temble

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Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar Senior Artist

WATERS HONOURS SINGAPORE’S BIOPROCESSING TECHNOLOGY INSTITUTE FOR GLYCOSCIENCE RESEARCH

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PMMI MEMBERS TO SHOWCASE GLOBAL PROCESSING AND PACKAGING MACHINERY SOLUTIONS AT INTERPACK

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E-THERAPY TIED TO BETTER BODY IMAGE, INTIMACY FOR BREAST CANCER SURVIVORS

Ajanta Sengupta Ambuj Kumar E Mujahid Mathen Mathew Nirav Mistry Rajesh Bhatkal PRODUCTION General Manager BR Tipnis Manager

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EXPRESS PHARMA

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March 16-31, 2017

EDITOR’S NOTE

Collaborate to conquer

T

wo rulings in the space of as many days demonstrate the fine balance required of India’s legal system when it comes to the pharmaceutical sector.

The first ruling on March 8 went in favour of Natco Pharma (Natco) and Alembic Pharmaceuticals (Alembic) while the second one a day later favoured Novartis over Cipla.

Beyond the immediate results, what do these cases reveal about the legal strategies being deployed by pharma companies in India?

On March 8, Justice Rajiv Sahai Endlaw of the Delhi High Court ruled that Natco and Alembic could make and export generic versions of Bayer's kidney and liver cancer medicines, sorafenib tosylate, provided the exported consignments were not for sale but for development/clinical studies and trials. This is a provision under Section 107A of the Patents Act, 1970. India’s version of the Bolar exemption, it allows export of patented medicines provided it is used for experimental purposes, to generate data for regulatory approvals, etc.

In Natco’s case, Bayer held that since it held a compulsory license (CL) allowing sale only within India, it could not apply under Section 107A. But Justice Endlaw ruled that 'the grant of Compulsory Licence would not come in the way of Natco exercising its rights under Section 107A as a non-patentee.'

Bayer argued that the quantities being exported (Natco had applied for permission to export 1 kg to China for conducting development/clinical studies and trials) were much more than that required for activities covered by Section 107A. Further, exports were to countries which permit approval to be applied for only two years before expiry of patent and Bayer argued that once exported, Indian courts had no jurisdiction to prevent sale of their patented products in the destination country.

To deal with this contention, Justice Endlaw directed Natco and Alembic to file affidavits that during the life of the respective patent, they would not export the patented medicine for purposes other than those specified in Section 107A of the Patents Act. And if Bayer felt that the exports were used or to be used for purposes other than specified in Section 107A, it would have to specially make out that case in another suit.

A day later, a division bench in the same court, headed by Justice Badar Durrez Ahmed, dismissed Cipla's appeal against a judgment of January 2015, which prevented it from making and marketing Novartis' Onbrez, its patented COPD medicine indacaterol. Cipla had launched its version as Unibrez in October 2004, but Novartis filed a suit on January 9, 2015 on

10 EXPRESS PHARMA March 16-31, 2017

With litigation only set to increase, legal costs will also escalate.

Pharma companies will have to carefully plan their strategies.

Perhaps the way forward is to collaborate and present a common front

grounds of trademark infringement. Cipla undertook to change the brand name of the drug from Unibrez to Indaflo.

Having won the trademark infringement battle, Novartis sought to prevent Cipla from infringing on its patent and got an injunction on the manufacture, sale or manufacture of any form of indacaterol. Cipla contested this, alleging that Novartis imported the medicine and sold it in India through a marketing agreement with Lupin.

Therefore Novartis did not work the patent in the country, a key requirement of patentees. However the court disagreed with this interpretation.

Cipla also sought to prove that there was a huge unmet need and it would be in public interest that the injunction be lifted so that patients in India could have an affordable version of Onbrez. The March 8 ruling dismissed Cipla's plea and upheld Novartis' rights as a patentee, ruling that Cipla's estimates of the size of the patient population was disputed by Novartis and there were alternative affordable treatments available. Thus the 'public interest' argument was shot down.

With litigation only set to increase, legal costs will also escalate. Pharma companies will have to carefully plan their strategies. Perhaps the way forward is to collaborate and present a common front. This was a point well brought out at a recent industry meet, when one of the speakers cautioned that more than 40 quia timet injunctions had been filed by pharma companies, which allowed them to block competitors based on perceived threat of possible future threat/injury (patent or trademark infringements in the case of the pharma industry). The speaker said it was time generic companies came together to opposed quia timet injunctions so that a common strategy could be evolved.

Even as business realities require generic and innovators to collaborate (the Novartis-Lupin collaboration for Onbrez, for example), the case for a united front goes beyond the innovator vs generic saga. When the Ministry of Health and Family Welfare (MoHFW) banned the manufacture, sale and distribution of 344 fixed dose combinations (FDCs) last year, the affected companies filed individual petitions, totalling over 450 connected petitions. Each petition varied in strategy, and entailed considerable expense to the petitioners. Legal costs could have been considerably reduced had they decided to club their petitions. Let us hope that a more mature mindset prevails the next time around.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

‘We need to encourage more manufacturers to enter and stay in the (vaccines) market’ Serum Institute of India is one of the eight key vaccine companies covered in the recently released first Access to Vaccines Index. In an exclusive interaction with Viveka Roychowdhury, Jayasree K Iyer, Executive Director, Access to Medicine Foundation, touches on the success of Pune-based company’s high volume-low revenue model and why local and international players should be willing to partner in global agendas like health security and child health for patients in terms of affordability and accessibility?

What we have seen in the past few years points towards more consolidation, especially as many local players, with important products and innovations struggling to compete in this market. It’s important that local and international players reach out and are willing to partner in global agendas, such as global health security and the child health agenda. We need to encourage more manufacturers to enter and stay in the market (including incentivising biotechs). Consolidation means there may be less

manufacturers supplying vaccines, and this can lead to problems in affordability and availability, especially in times of shortages. Having prequalified manufacturers is critical, whether its few or many manufacturers in the market as having reliable quality of vaccines available globally is critical for proper protection.

towards this cause, and are in conversations with some of them.

Will the Vaccine Index consider expansion to include other vaccine manufacturers like Bharat Biotech etc?

Yes. We welcome manufacturers who are interested in engaging with us

Beyond the Vaccine Index, what is the progress on the index of generic manufacturers?

We are in discussion with several generic medicine manufacturers as part of our benchmark to combat antimicrobial resistance coming out by January 2018.

And we are fundraising to create a dedicated generic medicine manufacturer benchmark highlighting good practices. viveka.r@expressindia.com

Looking beyond revenue: Variations in portfolio and pipeline size signal potential for decreasing consolidation

Serum Institute of India has chosen the high volume, low revenue business model. Will this be sustainable going forward?

Will the company have enough revenues to invest in R&D? It is difficult to determine what an ‘appropriate’ revenue amount would be to invest in R&D. The high volume, low revenue model has worked for Serum so far, and we see that they have invested into a rather substantial and important pipeline, so they do indeed know how to be cost effective in R&D, while ensuring affordable prices of products on the market.

As cost and hurdles in

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R&D increases due to, for example technically challenging vaccines that need to be developed, more money may need to be invested, so there will be limits of what companies can do. Collaborative partnerships help mitigate risks and share resources, and we have seen these work in e.g. malaria, meningococcal vaccine development.

Do you forecast further consolidation among vaccine manufacturers?

For example, global players looking for local buys, for example, Sanofi’s acquisition of Shanta Biotech? Would this be good

Source: Access to Vaccines report

● Number of projects in pipeline ● Number of vaccines on the market ● Vaccine revenue (2014 + 2015)

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Indian pharma cos need to join forces to counter IP threats A key takeaway from the 6th Annual Pharma IPR Indian 2017 was the need for concerted action among Indian pharma peers on domestic IP and legal issues, even as they explore how recent amendments from the US FDA, EPO will impact them. By Viveka Roychowdhury EXPERTS ON global pharmaceutical patent laws from five important geographies — the US, Europe, the UAE, Japan and China — as well as IP experts from India, gave an overview of recent and upcoming patent litigation and regulatory trends at the recently held 6th Annual Pharma IPR Indian 2017.

The audience, comprising representatives mostly from the IP cells of pharma companies, took the opportunity to clarify grey areas of recently amended guidelines as well as to compare the regulatory systems across these geographies, which are important export destinations. The first day of the three-day event, organised by the CPhI Conferences, division of UBM, was devoted to a review of the scenario in the US, followed by the rest of the countries on the next day while the last day was reserved for new developments in India.

Speaking on Indian patent law issues, Saya Choudhary Kapur, Partner, Singh & Singh Lall & Sethi appealed to the industry to come together to counter the rising incidence of quia timet injunctions, of which more than 40 have already been filed. These are injunctions filed to prevent a possible future injury (infringements in the case of pharma industry), and as she explained, could hinder R&D. She also updated the audience on the seriousness of the government on efiling and other initiatives like the new Intellectual Property Rights policy.

Archana Sahadeva, Associate Partner, Singh & Singh Lall & Sethi spoke about litigation arising out of the ban on FDCs. Like Kapur, she too rued that the

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The first day of the three-day event, organised by the CPhI Conferences, division of UBM, was devoted to a review of the scenario in the US, followed by the rest of the countries on the next day while the last day was reserved for new developments in India

Indian pharma industry was not united in countering these legal issues.

The highlight of the conference were two panel discussions.

The first one moderated by Taranpreet Singh Lamba, VP intellectual Property and Global Product Portfolio, Glenmark agreed that the Indian pharma industry should look towards to innovation. Dr Eswaran Iyer, Associate VP, IP and Senior Counsel, Sun Pharma, spoke of the steps taken by the sector to move from generics to innovation. Underlining this imperative, Paras Vasanani, Assistant General Manager-Global IP, Amneal Pharmaceuticals quoted the diktat, ‘publish and perish, patent and prosper,’ propagated

by Dr RA Mashelkar.

Speaking about the need to balancing innovation and accessibility, Mahalaxmi Andheria, VP IPR, Panacea Biotech, argued that India was currently still at the stage of ensuring accessibility and affordability and there were many challenges to be overcome.

This was followed by a panel discussion on biosimilars. Mod-

erated by Dr Mandar Kodgule, Former Senior VP IP, Wockhardt, the panel examined the potential of biosimilars to be the next big thing for Indian pharma. From a legal point of view, Ranjna Mehta-Dutt, Partner, Remfry & Sagar cautioned that unlike generic copies of chemical drugs which could be made at a much lower cost than innovators, biosimilars, though copies of innovator biologics, were still quite expensive to make. He asked the industry on how it would balance cost with affordability.

Looking at the situation from both the western and Indian point of view, Dr Bhaswat Chakraborty, Senior VP and Chair, R&D core committee, Cadila Pharma, opined that the Indian biosimilar ecosystem was quite robust but admitted that the timelines were long and sometimes regulators needed to be informed and educated about certain developments, like a new test required for a particular biosimilar.

Pointing out the variations between the way biosimilar regulations have evolved in different

countries, Dr Ambrish Shrivastava, VP Medical Affairs, Clinical Research, Regulatory, Alkem, said India uses the term ‘similar biogenerics,’ while the US calls them follow on biologics, and the EU refers to them as biosimilars. His opinion was that the Indian biosimilar regulations were rigid and stringent that the US FDA’s. In terms of future biosimilar strategies, Chakraborty applauded the fact that Indian regulations are getting harmonised with the rest of the world. He cautioned that China was a competitor, while innovators too are planning to make biosimilars, adding to the intense competition in the field.

Changes in US laws The US focussed sessions did a deep dive into the implications of recent changes in laws like the implications of US FDA’s final rule to amend regulations governing 505(b)(2) applications and abbreviated new drug applications (ANDAs) published on November 26 last year and the impact of the Federal Rules of Civil Procedure (FRCP) Amendments and strategies to make

their Hatch-Waxman litigation more cost effective.

Speaking on the strategic use of IPRs to challenge pharma patents, Mark Remus, IP attorney, Brinks Gilson & Lione pointed out that while the pharma and biotech sectors tended to have the lowest number of claims compared to other industries, the rate of patentability was better than other sectors. He gave examples of successful strategies as well as a list of IPR mistakes to avoid.

Expanding on the implications of Para IV filings for US markets, John W Bateman and Jeffrey A Wolfson, both partners at Haynes and Boone took many queries from the audience, especially on the implications of US FDA’s final rule to amend regulations governing 505(b)(2) applications and abbreviated new drug applications (ANDAs) published on November 26 last year.

The speakers stressed on time frames and ways to reduce cost while filing accurate Para IV for ANDAs. Derek Duarte, President, Blackstone Discovery advised the audience on the impact of Federal Rules of Civil Procedure (FRCP) Amendments and strategies to make their HatchWaxman litigations more cost effective. The FRCP Amendments dealt with replacing the former relevance standard for discoverable information with a new proportionality standard, speeding up the litigation process with earlier initial case deadlines and the potential for more active case management, and consequences for failing to preserve electronically stored information. Companies could explore

MARKET using the implications of the FRCP Amendments to be more cost effective as it could limit the document preservation requirement. These moves are being seen as attempts by the US FDA to reduce unnecessary litigation that delay availability of generic drugs Speaking about recent FDA guidelines on Hatch Waxman Act and its implications, Paul Braier, Partner, Greenblum cautioned companies to understand FDA guidelines on refusal to approve an ANDA. Dr Alpesh Pathak, Global IP head, Intas Pharmaceuticals, examined the biosimilars scenario from the US perspective, giving an overview of the steps in the ‘patent dance.’ He reviewed pertinent ongoing cases like the Novartis/Sandoz vs Amgen case, where Sandoz launched a biosimilar version of Amgen’s Neupogen in 2015. The case, which is set for the next hearing in July this year, is being closely watched as the decision will clar-

ify the court’s stance on certain aspects of the Biologics Price Competition and Innovation Act (BPCIA), specifically when biosimilar companies need to notify originators about their biosimilars which would trigger a six-month waiting period. Intas and Apotex are also involved in a patent dispute for their biosimilar version of pegfilgrastim, a biosimilar version of Amgen's Neulasta.

Srikant Reddy, Partner, Goodwin Procter highlighted the strategies related to settlement of Hatch-Waxman and biosimilars litigation, including recent FDA developments and reverse payments. An interesting session deliberated on the impact of the Trump administration on US patent law. A panel discussion on the Indian IPR scenario, saw patent attorneys and IP heads of pharma companies deliberate on how Indian companies can think beyond patents, as the declining patent cliff will negatively impact the generic

market in India. They looked at the challenges posed by trademarks and copyrights and strategies to cope with them.

Impact of Brexit and UPC Day two started with an update on recent developments in the European Patent Office by Dr Dieter Tzschoppe, Director, European Patent Office followed by a presentation on the impact of Brexit. Dr Jonathan DM Atkinson and Martyn Fish, both partners with HGF, spoke about the implementation of the Unified Patent Court (UPC) and how this would impact IP strategies of pharma companies applying for patents in the EU. As Fish said, the decision to file for a Unified Patent is a choice and an opportunity, but it would be a cost versus coverage consideration that each company would have to analyse on a case to case basis.

Evaluating the recent and upcoming reforms in Supplementary Protection Certificate

regime (SPCs) in the EU, Dr Ludwig Englmeier, Head Patents Early Opportunities, Sandoz International reviewed major cases which had defined the court’s treatment of SPCs, which is an extension of patent period, awarded by courts for a lengthy regulatory review period to compensate for extra research.

The biosimilar regulatory pathway is better defined in the EU but as Dr Alexander Wittkopp, Partner - Patent Attorney - US Patent Agent, Hamm & Wittkopp pointed out, there are still areas like secondary biosimilar patents which are uncharted territory.

IP strategies for the Middle East, Japan and China Comparing the patent filing strategies in the Middle East, Nevin Jacob Koshy, Head, United Trademark & Patent Services reviewed the patenting and patent filing system in each country in the region, and

touched upon issues that need to be resolved for an effective patent regime. He highlighted that besides the usual three principles for deciding patentability, (novelty, non-obviousness, and industrial application) a fourth principle required in the Middle East was that the underlying principle of the patent has to be in line with Sharia law. According to him, many companies like Pfizer are setting up plants in this region as many of their brands were being infringed upon by generics.

Kuzuwa Kiyoshi, President, Kuzuwa & Partners gave an overview on pharma IP and regulatory issues in Japan while a comparison of the IP practices in China and the rest of the world, particularly the US, was presented by Dr Toby Mak, patent attorney, Tee & Howe, who pointed out that the Chinese IP system was relatively hostile to the applicant/ patentee. viveka.r@expressindia.com

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THE SOCIAL WAYTO SUCCESS India Pharma Inc needs to leverage the potential of social media to up its game in times to come

BY LAKSHMIPRIYA NAIR

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ocial media, a confluence of technology, data and relationships — the powerful triad for value creation, is helping organisations across sectors create exponential value and causing the emergence of new business models.

Recognising its tremendous potential, global pharmaceutical giants like Boehreinger Ingelheim, Pfizer, Novartis, Eli Lilly, AstraZeneca, GSK and others are also investing a huge chunk of money and leveraging social media to obtain market intelligence, acquire real time customer feedback, disseminate disease awareness and measure brand equity with healthcare professionals. A survey from Indegene titled, 'The Digital Savvy Pharma Marketer, 2016' predicts that 19 per cent of the global pharma marketers' budget would be reserved for spending on non-personal digital channels with social media, mobile apps, and HCP portals topping the list. The study also foretells an increase in social media preference by 38.2 per cent by 2018.

Wariness prevails The story seems to be slightly different on the domestic front.

'The Indian Pharma Digital Health Report 2015', high-

THE MAIN FOCUS

lighted that despite maintaining presence in various social media platforms, the level of consumer engagement was quite low among the Indian pharma majors. The study by a digital agency called D Yellow Elephant, which analysed 40 pharma companies in India across 10 key digital parameters, ranging across websites, apps and social media platforms, also pointed out: ◗ Just nine out of 40 companies had score above 50 out of 100 ◗ India-specific Facebook page was being operated by only eight companies ◗ Despite a high presence on Google+, only one company was active ◗ Twitter showcases 52 per cent active management (India and global handles) ◗ LinkedIn emerged as the most popular social media platform, but only 14 companies were active

Shackles to break Thus, it is clear that the pharma industry in India is yet to unlock the full potential of social media. So, what have been the deterrents? To name a just a few: Stringent regulatory framework: The constraints of operating in a regulated environment is another major reason why India Pharma Inc is wary of taking the plunge into social

media despite wetting its toes.

As Chandu Mukkavalli, Partner-Advisory Services, EY points out, “It (the pharma industry) is highly regulated with tight guidelines on advertisement of drugs, essentially it shouldn’t violate ‘Drugs and Magic Remedies Act’, and ‘Code of Marketing Practice’.”

Uncertain RoI: Another significant hurdle in the adoption of the medium has been the inability to adequately measure return on investment (RoI) after using these new channels. It is difficult to gauge the value of a tweet or a post shared as compared to clicks on an ad. It makes an industry as traditional as pharma, reluctant to invest in channels which do not offer clear RoI. The Indegene study also points out the difficulties faced by pharma companies in implementing multichannel marketing campaigns.

Lack of tech savviness: A PwC report points out, “the acceptance of the digital platform for marketing purposes has been rather high in other industries, in comparison to pharma industry. This can be assumed as the reason why the pharma industry is being cautious in its use. Mukkavalli also states, “Technology adoption by physicians, patients, and communities needs to significantly improve to optimise the value of

DIGITALISATION ADOPTION

Source: PwC analysis

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Right from awareness campaigns that can help build a category, to seeking insights about consumer mind set, a lot of things can be achieved through social media Dinesh Chindarkar Co-Founder & Director, MediaMedic Communications

social media platforms and engage effectively. Safeguarding personal information is of key importance that could be between pharma organisations and healthcare institutions, patients and physicians among others. This would include cyber challenges posed by social engineers and other variants.”

Lack of trust: Dinesh Chindarkar, Co-Founder and Director, MediaMedic Communications lists the conservative mindset of the pharma industry coupled with fear of regulatory as the main deterrent. Industry sources also reveal that the pharma industry is leery of data provided on social media being misused or used out of context.

At the same time, there are many studies which highlight that the information provided by pharma companies has traditionally not been (and is still not) trusted. Thus, trust deficit is another deterrent in the adoption of social media.

Thus, major challenges continue to hinder the growth of social media in the pharma industry. Mukkavalli gives an overview of the situation and

says, “Majority of the pharma companies in India, both multinational as well as domestic are yet to see the light at the end of the tunnel with regard to effectively leveraging digital and social media platforms. Most of the Indian pharma majors have a digital presence, however there are ample opportunities that are yet to be explored. For example, a recent study suggests that, only 30 per cent of total Indian pharma companies have an India-specific website.”

Unleashing its true power Yet, the benefits of engaging this medium cannot be underestimated. Chindarkar elucidates, “Right from awareness campaigns that can help build a category, to seeking insights about consumer mind set, a lot of things can be achieved through social media. So, social media is here to stay, but how do pharma marketers decide to take advantage of it, is for them to decide.”

So, how pharma companies go about designing their strategy is key to unleashing the true potential of social media

for optimal benefits. Let's take a look at the major advantages that can be gained through a well-charted course.

Collecting insightful data: One of the major benefits offered by social media are the insights about customer needs, changing demands, behavioural patterns and new perspectives.

“Social media analytics gives you the pulse of what consumers are thinking. So while traditional market research responses have limitations, spontaneous reactions, tweets and expressions on social media provides deeper insights into the consumer mindset, which are contextual too,” explains Chindarkar. “This medium will help in gaining consumer/patient sentiment insights, overall categories - specific products, obtain competitive intelligence, improve brand perception and market share,” informs Mukkavalli.

Building a community: Social media offers the advantage of building a community which can become the “public voice” as pharma businesses continue to expand. “Develop a stronger

social media presence in collaboration with key opinion leaders to educate communities in therapeutic areas which they did not have access to before the dawn of social media,” advises Mukkavalli.

Tracking the trends: It is one of the best mediums to be at par with the trends and shifts in the pharma industry. It is also a legit way of keeping track of competition. Thus, social media can serve as a compass which can lead businesses in the right direction for growth.

“The pharma industry is witnessing major transformations day in and day out, with revelations and cures that are dynamic. Prevailing models are hospital and physician-driven but they also present an opportunity to revolutionise and create more effective healthcare solutions by leveraging the power of digital and social media channels,” opines Mukkavalli. He further states, “Social media listening during the product launch will help understand patient and physicians expectations for safety and pricing. This would also

A GRAPHICAL REPRESENTATION OF 40 COMPANIES RESEARCHED, ACCORDING TO THEIR PRESENCE AND ENGAGEMENT LEVEL ACROSS VARIOUS SOCIAL MEDIA CHANNELS

Source: Indian Pharma Digital Health Report 2015

20 EXPRESS PHARMA March 16-31, 2017

◗With about 38 companies present on LinkedIn,it's the most used social media platform by pharma companies. ◗ Facebook comes next with about 36 companies onboard and so on. ◗ Other social media platforms like Vine and Instagram have much less presence compared to the established platforms. ◗ Based on the research we have designated 4 social media platforms* as the 'Big 4',namely

( day's age. “Social media is about people and their emotions, so within healthcare how can pharma companies think beyond the pill and look at supporting and actively engaging with its customer - the doctor,

Chandu Mukkavalli Partner-Advisory Services, EY

help in managing stakeholder expectations and effectively engage with them.” Chindarkar reiterates, “Social media listening is an exciting initiative that a lot of pharma companies are getting into. The ‘SoLoMo’ concept, which is ‘Social’, ‘Local’ and ‘Mobile’ context will play a key role in developing relevant information from the data derived from analytics.”

Engaging the customers: Companies can gather data about demographics and customer preferences to create targeted growth strategies. Social media is also the right platform for targeted advertisements towards the right audience. Thus, it also offers a lot of business intelligence which could be priceless in to-

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® Registered trademark, Ashland or its subsidiaries, registered in various countries ™ Trademark, Ashland or its subsidiaries, registered in various countries / ©2016, Ashland AD-13749

The pharma industry is witnessing major transformations day in and day out, with revelations and cures that are dynamic.

Prevailing models are hospital and physician-driven but they also present an opportunity to revolutionise and create more effective healthcare solutions by leveraging the power of digital and social media channel

and the end consumer – the patient (without directly promoting the brand), is the real key,” points out Chindarkar.

Thus, if leveraged well, market intelligence garnered by monitoring and analysing user-

THE MAIN FOCUS

generated content, can initiate a strategic shift in the operational model of pharma companies which would be beneficial for the industry and the consumers.

Fortunately, while there is a

long way to go as far as tapping its true potential is concerned, there have been some excellent examples of deploying social media to very good effect, both globally and in India. Let's take a look at some of these examples;

Are you always solving?

We are.

We are passionate, tenacious solvers who thrive on developing practical, innovative, and elegant solutions to complex problems in drug delivery, always pushing the boundaries of what’s possible, and advancing the competitiveness of our customers. ashland.com/pharma

For more information, please contact us: Rohan Rastogi / +91 40 4474 8804 / rrastogi@ashland.com Ninad Kellar / +91 22 6148 4646 / nkelkar@ashland.com

efficacy usability allure integrity profitability™

cover ) Boehringer Ingelheim: #COPDChat B

oehringer Ingelheim(BI), a leading biotech company has been at the forefront when it comes to embracing social media. Active on eight out of the 10 social networks, the company has earned the distinction of being a leader in the social media space. Its social media strategies have earned accolades from different quarters. A recent one has been the award as the Social Media Pharma Company of the Year at the PM Society's Digital Awards 2016 at The Brewery in London.

Campaign: Tweetchats hosted by the company with specific topics and hashtags, including #COPDchat and #ChatAFib won widespread attention. #ChatAFib, its first tweet chat, was held at the European Society of Cardiology Congress in September 2013. HCPs, patients and patient groups and the company participated in the initiative which was repeated in 2014 with increased levels of participation. Several #COPDChat chats, were held in collaboration with Professor Andrew McIvor, a key opinion leader during the European Respiratory Society Congress (ERSC) in 2013.

Impact: Twitter itself highlighted one of them as good business practice.

The popular social media platform highlighted that BI gained recognition as an industry leader in the digital arena. Reportedly, the strategy resulted in a seven per cent jump in the number of people following the company and in the course of the ERSC campaign, the company received tweet chat impressions of 1.7 million. The case study also demonstrates how the company effectively leveraged the platform to engage medical journalists, pulmonologists, general practitioners and digital opinion leaders in conversations on chronic obstructive pulmonary disease (COPD). Thus, the company effectively used Twitter to trigger conversations, spread health awareness and engage a niche audience.

The success of the campaign rests on the fact that key stakeholders were the pivot around which it revolved and this made it a very successful solution in the highly regulated biopharma industry.

Dr Reddy's Laboratories: #DontQuit D

r Reddy’s Laboratories, a leading Indian pharma company are one of the companies mobilising the power of social media to engage with their various stakeholders globally. Active on most of the key platforms including Facebook, Twitter, LinkedIn, YouTube and Instagram, the company talks about latest updates and innovations, awards, employee stories, health information, disease awareness, etc. it utilises formats such as Twitter polls, employee testimonials, Facebook tagging and story sharing to spread its messages.

on the importance of quitting tobacco in a counter-intuitive way. The communication used for the campaign highlighted the benefits of ''NOT QUITTING'' on life by QUITTING TOBACCO. To back the campaign, quotes from doctors in different regions were included in the communication that was geo-targeted to different areas. Every piece of communication was clubbed with different messages in order to make it resonate with the relevant target audience.

For eg: #DontQuit on Loved ones, Quit Tobacco.

Impact Campaign Dr Reddy's initiated a campaign called #DontQuit to observe World No Tobacco Day and sought to sensitise people

22 EXPRESS PHARMA March 16-31, 2017

Reportedly, the campaign saw more than 50,000 impressions over a span of two days in the southwest region of the country with more than 7000

(

THE MAIN FOCUS

We see a growing trend of loyalty and appreciation for our senior leadership and company related updates which proves that our communities on the platforms are accurately populated with relevant stakeholders interested in the business.

CALVIN PRINTER VP & Global Head, Corporate Brand & Communications, Dr Reddy’s Laboratories post engagements. The NorthEast region also saw more than 85,000 impressions and more than 9,000 post engagements. While this was backed by minimal media spends on Facebook, the campaign was well received with high interactions on all platforms. This campaign also served as a prelude to a more detailed campaign focussing only on lung cancer a few months later. The nature of this campaign was, once again, a series of geo-targeted videos reaching out to educate the audience on myths, facts and a more in-depth understanding of lung cancer. This campaign spanned over a period of three weeks and lead to more than 10,00,000 impressions in the period with almost 3,00,000 interactions. The primary intent of our presence on social media is to keep our stakeholders informed and engaged in a way that it provides them a clear understanding of who we are as a company, and about the work we do. Our Facebook page has grown over the last year, with a 200% growth in reach and in engagement of posts. Our Twitter and LinkedIn handles have also seen an exponential growth of almost 600 per cent and almost 60 per cent respectively.

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cover ) Cipla: #UquitIQuit C

ipla is another Indian pharma major making serious inroads into social media.

It has an active presence on Twitter, Facebook, LinkedIn and YouTube. The company's social media architecture has interesting diversity as it has dedicated handles for businesses (Cipla South Africa, Cipla Biotec), Corporate Social Responsibility (Cipla Foundation), (Cipla Archives) and long-running awareness/education campaigns (Breathefree).

Spearheaded by Prabir Jha, Global Chief People Officer, Cipla, a leading exponent of digital platforms in communications, the company is harnessing the strength of social media to make it a pillar of its communications strategy.

Campaign An interesting example of their initiatives would be the #UQuitIQuit campaign led by the Cipla Nicotex team. Its success is evident from the fact that it won Gold at the 2015 Effie India Awards in the Healthcare category beating off strong competition. The company took a lot of pride in the achievement as it was Cipla Consumer Healthcare Division’s first marketing campaign for its very first product. #UQuitIQuit was conceptualised as an initiative to get India to quit smoking, where participants helped

Looking ahead Each of these examples served to highlight effective use of social media forums to educate, inform and engage their target audience about worthy causes. At the same time, these campaigns helped to build conversations, create a connect with their consumers and increase their followers across various platforms.

They clearly demonstrate the

24 EXPRESS PHARMA March 16-31, 2017

PRABIR JHA Global Chief People Officer

their loved ones in their journey to quit smoking by quitting a bad habit of their own. This movement was planned and executed on social media platforms such as Facebook, Twitter, YouTube, etc. This, along with celebrity endorsements and activations, drove awareness and generated high participation. It was also supported

by communication on various touch points such as the TV, the radio, the news, etc.

Impact The response to the initiative

was overwhelming with 80,000 users joining the movement from across the country and 1.8 crore views of the communication, strongly reinforcing Cipla’s efforts to

make India smoking-free.

Nicotex has made a huge impact on the markets where it has been launched, and is now helping thousands to quit smoking.

Adoption of digital platforms in communications is key to ensuring that our messages get out to the widest possible audience and receive maximum possible amplification. Through a variety of formats, the latest and most pertinent information is disseminated to achieve maximum effectiveness whilst keeping them crisp and attractive

power and the potential of social media to drive consumer behaviour and shape opinions.

Moreover, experts point out that challenges faced by the industry can actually be negated through social media. For instance, to improve pharmacovigilance, by encouraging sharing and analysis of information on platforms like LinkedIn and Twitter. These platforms can

also help to encourage adverse effect reporting of medicines and thereby lead to enhancement of quality in the processes of the pharma industry.

Luckily, it seems that the industry is cautiously but definitely edging towards widespread adoption of these platforms, especially because of growing patient-centricity in the life sciences sector. As Chin-

darkar highlights, “Pharma companies are now a lot more open to newer media and are shedding their traditional mindset.” Printer also opines, “I believe that there is a lot of interesting work that pharma companies globally are doing in the area of patient awareness and disease management. This trend is on a rise.”

Thus, it is clear that social

media is here to stay and the pharma sector in India should responsibly engage in it with the the right tools and analytics capabilities, to enter the next sphere of growth. Moderating the content, creating a sound social media policy, being creative etc would be key to emerging as leaders in this space. lakshmipriya.nair@expressindia.com

MANAGEMENT INSIGHT

Partnerships with healthcare organisations, government aid disaster management Shripad Desai, MD and Country Director , Americares India Foundation, Mumbai, explains how synergy between NGOs, pharmaceutical companies and government can help reduce the community burden during disasters

Shripad Desai, MD and Country Director, Americares India Foundation

P

harmaceutical and healthcare organisations have a vital role to play during all phases of disaster management. During a disaster, communities are at risk of infectious diseases, water borne diseases and a potential disease outbreak. Access to healthcare facilities and medical supplies is disrupted and

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MANAGEMENT

CASE STUDY N

agamal, mother of two young children, faced the wrath of nature second time in December 2016, when Cyclone Vardha’s forceful winds blew away the makeshift rooftop of her small hut.The heavy rains that accompanied the cyclone, not only flooded her house, but also revived the terrifying memories of the previous year’s massive Tamil Nadu floods, which had inundated her entire neighbourhood of Annai Anjugam Nagar, a slum hamlet which lies on the bank of Adyar River in Tambaram district of Tamil Nadu.

Nagamal and her family were evacuated and taken to a community shelter, where they spent several days amidst suffering and shortage of resources. Unlike in December 2017, Nagamal was not scared to return home since she knew that in times of major crisis, Americares India provides vulnerable communities, such as hers, access to healthcare, relief material and humanitarian aid.

Nagamal was especially vulnerable, being a few months into pregnancy with her second child. By the time Nagamal sought antenatal care at General Hospital Tambaram,Americares had donated vital medical equipment to replace the ones that were damaged in the flood.

Nagamal’s pregnancy had been stressful and her baby needed special care at birth. Fortunately the New-born Safety Unit, with support from Americares, was ready and Nagamal’s baby received the care she needed.

General Hospital Tambaram was just one of more than 30 health facilities across four districts of Tamil Nadu which Americares supported after the floods.

Americares collaborated with the local government for speedy recovery of health infrastructure in flood affected regions.Twenty seven Primary Health Centres and four General Hospitals that we supported through replacement and upgradation of high-end medical equipment are geared to serve the communities for years to come

can take days to restore. Patients suffering from chronic diseases, terminal illnesses and populations requiring special attention (the elderly, disabled, pregnant women and children below five years) are at a higher risk.

Healthcare players have a catalysing role The three phases require active participation by the healthcare providers.

Response: Immediately after a disaster, pharma companies can mitigate the healthcare

hazards through product donations of medicines, vaccines, IV fluids, etc. to NGOs like Americares that partner with government, charitable hospitals and health camp organisers. Medical doctors and other employees also have the opportunity

Health camps conducted post-disasters help provide primary care to survivors from low-income communities Photo credit: Americares India, Tamil Nadu Response 2015

When disaster strikes, it is vital to provide immediate access to health care to prevent and cure diseases Photo Credit: Americares India, J&K Response 2014

26 EXPRESS PHARMA March 16-31, 2017

to volunteer for health camps conducted during the response phase.

When disaster strikes, it is vital to provide immediate access to healthcare to prevent and cure diseases.

Relief: During the second

MANAGEMENT phase, the focus is on providing relief support to the affected communities. As families return to their homes, they need support to rebuild their lives.

Pharma companies can partner with NGOs to ensure families have access to vital relief materials including health and hygiene kits, warm clothing, kitchen sets, mosquito nets and safe drinking water, among other items.

Recovery: During the recovery phase, Americares focuses on speedy recovery of damaged health infrastructure like health centres and hospitals.

Pharma organisations can focus on supporting replacement and upgradation of damaged equipment and facility.

Long-term impact is created by repairing, restoring and upgrading medical equipment in health facilities postdisasters The CSR Bill 2013 recognises the support provided during disaster relief under section VII and pharma companies can dedicate a portion of their CSR budget towards disaster relief activities.

Americares partners with leading Indian and global multi-national pharma companies, towards emergency response and ongoing health programmes. Americares India is the emergency response partner to the member organisations of the Organisation of Pharmaceutical Producers of India (OPPI).

Government efforts need boost from NGOs and healthcare players Government plays a crucial role during disaster relief and recovery. During the December 2015 Tamil Nadu flood, Americares worked closely with the local and state government to identify areas where intervention was most crucial and to meet the governments’ immediate needs for conducting effective relief and response.

In times of crisis, governments are under immense pressure to deliver aid to everyone affected. Many times, they are prepared with pre-positioned relief material which can be distributed whenever an emergency occurs. To be better prepared to tackle crisis situa-

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tions, governments can build capacity of the local communities by training first line responders in disaster response, administering of first aid etc.

This can help save numerous lives before the government or any agency can reach the location and provide relief.

Government can also prevent health emergencies by

closely monitoring the trends in their communities and taking the right measures to curb major outbreaks of diseases. In a situation where an emergency has already taken place, the focus should be on establishing partnerships with healthcare players and NGOs that can provide adequate medicines to meet the needs of

the communities.

Access to information through rapid assessment is crucial for an effective response by any agency. In disaster-prone areas, the local government should invest in infrastructure to facilitate information flow using modern technology. This information and assessment should

be made available to development sector organisations for rapid mobilisation and appropriate resource allocation. The local government can make a huge difference in relief and recovery efforts by ensuring appropriate and methodical co-ordination of relief efforts. This would optimise the resource

MANAGEMENT utilisation and enhance the response efficiency of all stakeholders.

Americares works across the continuum of disaster management Americares India responds to natural disasters and humanitarian crises, establishing longterm recovery projects and bringing disaster preparedness programmes to vulnerable communities. With a robust pre-positioning plan and strong pan-India network of partners, Americares is among the first to respond to emergencies.

Working through readiness, response and recovery, Americares stay as long as needed, helping to restore health services for survivors.

When Tamil Nadu was inundated by one of the worst floods, Americares’ medical teams were swift to provide primary care for more than 30,000 survivors. Americares donated essential medicines and medical supplies to ensure uninterrupted access to healthcare. More than 10,000 families received essential relief materials that helped them rebuild their homes and lives.

Distribution of essential relief material in the aftermath of disasters Photo credit: Americares India, Assam & Bihar Relief 2016

Health camps conducted post-disasters help provide primary care to survivors from low-income communities.

Americares continues to work in Anjugam Nagar to ensure the community has access

to safe drinking water, sanitation and hygiene. Its team of doctors and health workers will provide health education in the community, helping protect families from illness and diseases.

At Americares, the goal is to empower communities and frontline health workers across the continuum of disaster management.

Americares works towards improving survival rates and health out-

comes by strengthening the speed, scale and quality of available medical aid and health services. This is only possible through partnerships with our healthcare partners and the local government.

REPORT

Head and neck cancer market offers fertile ground for investors as disease understanding improves According to GBI Research, there are 112 first-in-class programmes in the head and neck cancer pipeline, acting on 87 distinct first-in-class molecular targets A SUBSTANTIAL number of first-in-class products in the head and neck cancer pipeline will reach the market over the coming decade, potentially transforming the clinical and commercial landscape, according to business intelligence firm GBI Research.

The company’s latest report finds that there are 112 first-in-class programmes in the head and neck cancer pipeline, acting on 87 distinct first-in-class molecular targets. This accounts for 39.2

28 EXPRESS PHARMA March 16-31, 2017

per cent of all products with a disclosed molecular target and reflects the high degree of innovation in this indication.

Adam Bradbury, Associate Analyst, GBI Research, explains, “Factors driving the pipeline size include the limited efficacy of current treatments for refractory patients and a lack of approved targeted therapies in the market landscape, facilitating the development of novel compounds. These factors have far-reaching strategic impli-

cations for all market participants, as it is likely that numerous first-in-class products, many of which are supported by promising preclinical data, will reach the market over the coming decade, potentially transforming the clinical and commercial landscape.”

Despite risks associated with developing first-in-class products, they have still proven to be a highly desirable investment option. Indeed, the high level of deal-

making activity within the head and neck cancer space is indicative of a strong willingness on the part of pharmaceutical companies to engage in strategic consolidations to mitigate some of the risks associated with drug development, such as the high attrition rates exhibited by oncology indications.

Bradbury notes, “Proprietary data show evidence of a promising number of products in the head and neck cancer pipeline, approximately a

third of which are first-inclass targets, across all stages of development. These target a wide range of known cancerrelated cellular processes and signaling pathways, through a number of different therapeutic approaches. On the whole, there is no shortage of developmental programs that display both incremental and disruptive innovation, warranting an optimistic outlook for patients, companies and investors alike.”

EP News Bureau

MANAGEMENT

The data integrity triad Chinmoy Roy, Data Integrity SME, US and Arjun Guha Thakurta, Director, Life Science Consulting, a ConvalGroup Company, India, explain that data integrity hinges on a multi-faceted approach comprising the triad of management controls, procedural controls and technical controls THE RISE in data integrity warning letters are forcing companies to make a beeline for obtaining an understanding of data integrity. A close examination of management objectives where data integrity issues have unravelled indicates that they have been driven by the selfinterest of profit. They hesitate to switch out older equipment for newer ones with technical controls to enforce data integrity.

They also hesitate to provide the required level of personnel resources for regular audit trail reviews, investigation of data integrity issues etc.

While regulatory agencies are actively hiring computer savvy personnel familiar with the intricacies of electronic data, business expediency dictates pharma industry management to shadow those efforts by ensuring that adequate budgets are allocated to hire personnel with the right blend of IT and compliance expertise.

Contaminated data MHRA’s July 2016 draft version for GxP Data Integration Definitions and Guidance for Industry defines data integrity as “the extent to which all data are complete, consistent and accurate throughout the data lifecycle.”

We may consider data integrity as synonymous with product purity wherein the product is either contaminated or not contaminated. So too with data integrity where the metric is binary in nature. Data is either contaminated or not contaminated. There is no in between to signify a ‘degree of breach or contamination.’

So what is data integrity?

Data integrity may be appropriately defined as ‘the state of completeness, consistency, timeliness, accuracy and validity that makes data appropriate for a stated use.’ It is a data

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MANAGEMENT characteristic that lends it the assurance of trustworthiness.

It is defined by the oft-mentioned ALCOA+ attributes.

NIST SP 800-33 defines data integrity as the state when data has not been altered in an unauthorised manner. It covers data in storage, during processing and while in transit. Data integrity’s guiding principles include: ◗ The care, custody and continuous control of data ◗ Measures implemented to ensure that GxP regulated computerised systems and paper based as well as computerised data are adequately and securely protected against willful or accidental loss, damage or unauthorised change. ◗ Such measures should ensure the continuous control, integrity, availability and where appropriate the confidentiality of regulated data.

Thus, data integrity is a process wherein data is not modified in an uncontrolled manner as it progresses through several operations within an operation to undergo any number of operations such as capture, storage, retrieval, update and transfer. It is a measure of the validity and fidelity of a data object.

Assuring enterprise wide data integrity When it comes to assuring data integrity, the situation is more complex because words mean different things to different people. To the IT Security group it is the assurance that information can be accessed and modified only by those authorised to do so. To the database administrator it is about data entered into the database are accurate, valid and consistent. To the data owner it is a measure of quality, with existence of appropriate business rules and defined relationships between different business entities and to the regulator, data integrity is the quality of correctness, completeness, wholeness, soundness and compliance with the intention of the creators of the data. This difference in meaning creates a fertile ground for miscommunication and misunderstandings, with the risk that the activity will not be done well enough because of unclear accountabilities.

30 EXPRESS PHARMA March 16-31, 2017

Chinmoy Roy, Data Integrity SME, USA

Arjun Guha Thakurta, Director, Life Science Consulting, a Convalgroup Company, INDIA

values and philosophy. Code of conduct is a set of rules according to which people in the company are supposed to behave and the consequences they would have to face for failure to do so.

Control activities are captured in a data governance programme. It includes items such as data ownership, data stewardship, roles and responsibilities of different groups, risk assessment and alignment, controls performance metrics etc. Gartner describes information/data governance as follows: The specification of decision rights and an accountability framework to ensure appropri-

some of the items that data governance programme should identify.

Monitoring is one of the most critical but often misunderstood process. It involves regular reviews of performance of data integrity. It helps to identify and remediate deficiencies in the controls. It also determines if and when data integrity directives need modification in order to meet changing business needs.

Procedural controls Procedural and administrative controls are guidelines that require or advise people to act in certain ways with the goal of pre-

DIMENSION

DIRECTIVE

Attributable

Access Control,Audit Trail Design, Date and Time

Legible

Good Document Practices

Contemporaneous

Date and Time, Good Documentation Practices

Original

Raw Data and Metadata retention

Accurate

Calibration, Laboratory controls, Change Control, Deviation and Incident management,Validation, Out-of-Specification directive

Complete

Laboratory Controls, Good Document Practices, Manual data entry

Consistent

Validation,Audit Trail Review, SDLC, GxP Records management, Manual Integration guidance

Enduring

Data Backup & Recovery,Audit Trail Design, Building Monitoring System design, Data Migration and Archiving

Available

Data Backup & Recovery, Data archiving, Building Monitoring System design

Notwithstanding the impossibility of eliminating all vulnerabilities to data integrity in the organisation, controls should be established to reduce the propensity for data integrity errors and vulnerabilities. Such controls should integrate and coordinate the capabilities of people, operations, and technology through a data integrity assurance infrastructure. It hinges upon a multi-faceted approach consisting of the following triad components: ◗ Management controls ◗ Procedural controls ◗ Technical controls

Management controls Management controls address the people and business factors of data integrity. They describe the means by which individuals and groups within an organisation are directed to perform

certain actions while avoiding other actions to ensure the integrity of data. These controls are enumerated in the company’s Ethics Policy, Code of Conduct directive, Data Governance program etc. They serve as the enabler of a collaborative approach for governance of data that affect product quality and patient safety. The four key areas that management controls should address are: 1. Control environment 2. Control activities 3. Information and communication 4. Monitoring Control environment is the establishment and maintenance of a working environment also called the company’s culture. It is the declaration of the company’s ethics and code of conduct for all employees. Ethics is management’s declaration of their moral

ate behaviour in the valuation, creation, storage, use, archiving, and deletion of information (or data).

The processes, roles and policies, standards, and metrics that ensure the effective and efficient use of information (or data) in enabling an organisation to achieve its goals.

Information and communication is management’s commitment to encourage all to communicate data integrity failures and mistakes. This may be accomplished through a regularly scheduled reporting mechanism wherein stakeholders receive reports on data integrity controls’ Key Performance Indicators (KPIs). These reports enable stakeholders to direct their business to achieve the desired data integrity goals. The KPI details, frequency of issuing reports, typical report contents etc. are

serving data integrity. They are embedded in the company’s core business activities. They consist of a suite of approved documents that provide company personnel specific directives for activities that preserve and protect the integrity of data. These controls fulfill the ALCOA+ dimension of data integrity. The following is a non-exhaustive list of directives for the respective ALCOA+ dimensions:

Technical controls Technical controls are controls or counter measures that use technology-based contrivances in order to protect information systems from harm. These can include mechanisms such as passwords, access controls for operating systems or application software programmes, network protocols, firewalls and intrusion detection systems, encryption

MANAGEMENT technology, network traffic flow regulators, and so forth. When used together, the adoption of these different types of controls allows for the establishment of a layered defense, and provides the best chance possible of preventing data from integrity breaches. Whereas procedural control is primarily applied to practices and procedures during data’s lifecycle, technical control is designed into products to preserve data integrity during the three data states, which are as follows: ◗ Data at rest ◗ Data in motion ◗ Data in use Some consider 21 CFR Part 11 and Annex 11 regulations as the ‘data integrity’ regulation. This is partially true. These regulations primarily address the technical controls that address data security. They should be de-

signed into products and include features like role-based access control, audit trail capture and storage, capability to accept global reset of clock time etc.

Design consistency, an ALCOA+ attribute, is also a manifestation of technical control. An example of such a realisation of consistency is through an enterprise IT architecture design centered on a SOA (service-oriented architecture). Such a design provides a common standard for data interchange and along with a common information model provide the boost to data consistency during ‘data in motion’ state. Besides system architecture, design controls are also realised via Master Data Management (MDM), Common Data Model (CDM). Data integrity benefits accruing from a consistent design philosophy enhances data integrity in the fol-

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lowing ways: ◗ Ease of engineering design and development of IT systems requiring data exchange. Adhering to a standard provides for significant decrease in the proneness for data exchange errors during ‘data in motion’ state. ◗ New systems can now be introduced with the least amount of disruption to other systems This insularity maintains the validated state of other systems to a significant extent and their revalidation requirements when new systems are introduced are minimised The following is a non-exhaustive list of directives for technical controls. ◗ Engineering design directive ◗ Enterprise IT architecture ◗ Computer systems security management ◗ System design, includes audit trail design

◗ Master data management ◗ Data model ◗ Computerised systems control ◗ GxP records management

Management’s pivotal role for triad’s success Data integrity efforts’ success in an organisation is largely dependent on it’s culture. Since executive management primarily influences company culture, it is their ultimate responsibility to ensure data integrity. They should not delude themselves into a false sense of complacency and pretend they do not have any data integrity problem. Instead, they should prioritise their company’s efforts towards establishing a data integrity infrastructure and provide the leadership by allocating necessary funds and resources to developing the infrastructure.

To fulfill the leadership role, executive management should be familiar with the following key data integrity concepts: ◗ Data integrity context ◗ Obligation ◗ Ramification ◗ Controls Data integrity context has been defined in various ways by different regulatory agencies.

All those definitions coalesce to ‘the assurance of trustworthiness of data.’ Management should not labour under the impression that data integrity is limited to falsification or fraud but that inadvertent error in capturing and recording of data, lack of data integrity training are also some of the reasons that data integrity issues occur.

Obligation is a management responsibility to establish a work culture wherein employees are sensitised to treating data as a

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MANAGEMENT valuable company asset. It also includes an obligation for establishing robust systems and processes to ensure data integrity. Also included is the creation of a work culture where data integrity is incentivised and lapses are not dealt with in a punitive manner but instead with increased level of training and supervision.

Ramification is a management awareness of legal consequences for presenting untrustworthy data to regulators.

Other consequential impacts of data integrity lapses include patient safety, employee morale, decrease in stock value etc.

Awareness of these consequences serves as the management’s driver to provide the leadership to establish the triad controls.

Controls are the triad

controls mentioned above.

They are mechanisms, which prevent data integrity issues from occurring. They also address how to avoid future occurrences of issues that may crop up in spite of the controls being in place.

In addition to the leadership role that executive management provides, they also serve as the driving force for developing and implementing management controls while delegating the leadership role to middle level management to develop the procedural and technical controls.

When establishing management controls, they should seek the expertise of outside consultants. These consultants provide the data integrity expertise along with valuable external perspectives on the company’s dynamics that can be difficult to

see from the inside. The consultants also help in negotiating differences of opinions among team members by providing their valuable opinions based on their experiences with other companies.

Executive management should also recognise the contributions of all their employees. As a result, they should empower them with decision-making and encourage them to be critical and divergent thinkers. Towards that end, they need to provide the necessary funding and hire the right people to develop the procedural and technical controls while they and their consultants develop the management controls.

Conclusion A pharma company’s supply chain consists of business

processes that produce and use regulatory data. Consequently, the triad controls along with the company’s Quality Management System (QMS) are applicable to all these processes. Hence, business expediency dictates that the triad controls are integrated with the QMS. Accordingly, the same managers who are responsible for dayto-day operations and product quality decisions should also be responsible for ensuring the integrity of data they use or create.

The triad controls should be designed to complement one another with no overlaps.

Since management controls consists of a Data Governance program, which is the company’s overarching programme to ensure data

integrity, the program elements must be traceable to the procedural and technical control elements. This triad interdependency is the key to ensuring an effective data integrity assurance infrastructure. The developers of triad controls cannot effectively judge the data integrity safeguards that the controls represent. Experienced data integrity consultants routinely find issues with the controls that are unknown to management or has eluded their attention. Nor were these detected during management oversights and internal audits. A fresh set of eyes of experienced consultants could significantly enhance the assurance of trustworthiness of data that triad controls are designed to achieve.

REPORTS

Russia’s pharma market to double to $39 bn by 2021 Implementation of a state programme to improve the healthcare industry has also had a positive impact on domestic production THE PHARMACEUTICAL market in Russia is one of the fastest growing globally and is set to rise from $20.91 billion in 2016 to $38.56 billion by 2021, representing a compound annual growth rate of 13 per cent, according to research and consulting firm GlobalData.

The company’s latest report states that key drivers of the Russian healthcare market include improving regulatory guidelines and government initiatives to develop the domestic pharma industry. The Federal Drug Reimbursement Program, for example, provides uniform, free access to over 350 drugs for the most vulnerable social groups of the country.

The implementation of a state programme to improve the healthcare industry by the Russian Ministry of Industry and Trade has also had a positive impact on domestic production.

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The programme’s main goals are developing domestic medicine production, developing the domestic production of medical devices, and improving state regulations for the circulation of medicines and medical devices.

In 2015, the domestic market share of medicine was 27.2 per cent, and the government aims to increase this to 50 per cent by 2020.

A competitive generics market will also drive pharma sales.

In 2015, the market share of generics, by value, was 59 per cent of all drugs in Russia. By volume, generic drugs accounted for 85 per cent of marketed drug sales. Russian-based Pharmstandard is one of the leading generic manufacturers in the country, producing and marketing a range of generic and branded pharma, biogenerics, and active pharma ingredients.

For pharma companies hop-

ing to profit from the Russian market in coming years, the country’s increasing focus on biotechnology may provide ample opportunity. In 2012, the government adopted the Comprehensive Program for Development of Biotechnology in the Russian Federation through 2020. The programme sets targets for the development of the biotechnology market and will require $31.8 billion in financing from 2012 to 2020.

The government is planning to construct 10 factories for the manufacturing of biosimilars by 2020, with an additional investment of $265.3 million. Russia is currently developing its biosimilars guidelines. Draft guidelines were prepared in 2014 by the medical and pharmaceutical industries and submitted to the Ministry of Health, and are expected to be enacted this year.

EP News Bureau

French pharma market to stagnate as govt embraces generics to cut health expenditure The market is set to decline from $35.5 bn in 2017 to $34.16 bn in 2021 THE PHARMACEUTICALS market in France is set to decline from $35.5 billion in 2017 to $34.16 billion in 2021, representing a negative compound annual growth rate of one per cent, according to research and consulting firm GlobalData.

Despite France’s robust public health insurance system and rising elderly population, increasing pressure on pharma selling prices, patent expiration of branded drugs and foreign exchange fluctuations are stifling growth. The government is currently focussing on the use of generics as a cost-containment tool to reduce healthcare expenditure. Indeed, the generics market is mainly driven by a favourable regulatory regime and a continuous wave of patent expiries, acting as a barrier to pharma market growth.

France follows external reference pricing, which is linked with other European countries such as Germany, Spain, Italy, and the UK. A price cut by any of these countries’ governments will quickly translate into price reductions in France, and repeated price cuts have curtailed the rise in healthcare spending.

France’s reimbursement policy is grounded in clinical effectiveness rather than the costversus-benefit approach that other countries such as the US and the UK employ. This means that pharma companies take a higher risk in order to see returns on innovative products, and new drugs have to demonstrate a level of improvement over existing products, which can be seen as a deterrent to investment.

EP News Bureau

MANAGEMENT

Indian pharma industry continues to face headwinds: ICRA Increased regulatory scrutiny and consolidation of supply chain in the US market resulting in pricing pressures along with increased R&D expenses will have an impact on profitability of Indian pharma companies ICRA EXPECTS growth trajectory for Indian pharmaceutical industry to moderate on back of slowing growth from the US, increased competition, and regulatory overhang along with base effect catching up.

As per ICRA’s sample study, revenue growth from US during FY11-15 period, experienced CAGR of 33 per cent though growth from US has come down to 15 per cent in FY2016 and 12 per cent in 9M FY2017 despite consolidation and currency benefits. In ICRA’s view, going forward the growth momentum is likely to face further pressure. Increased regulatory scrutiny and consolidation of supply chain in the US market resulting in pricing pressures along with increased R&D expenses will have an impact on profitability of Indian pharma companies. In spite of these ongoing challenges, several Indian pharma companies have ramped up their R&D spend, targeting pipeline of speciality drugs, niche molecules and complex therapies. The domestic pharma industry has gained adequate scale and drug development capabilities over last decade of growth which will keep them in good stead to capture new opportunities in the US market.

Aggregate revenues of ICRA sample of leading players grew by 9 per cent in Q3 FY2017 y-o-y with 9M FY2017 growth at 8.9 per cent as against 10.1 per cent growth in FY2016.

Subrata Ray, Sr Group Vice President, ICRA, “The revenue growth for Indian pharma industry remains moderate for US, with base business in US continuing to face high single digit price erosion, regulatory overhang for select companies and temporary impact of demonetiation on domestic growth to an extent. The domestic formulations business of companies within our sample registered growth of 9.3 per cent in Q3 FY2017 as against 14.1 per cent in Q2 FY2017 with demonetisation resulting in channel de-stocking though the growth should come back in the next few months.”

Growth from key emerging markets benefitted from currency tailwinds though macro-economic challenges remain. In ICRA’s view, continued regulatory interventions in domestic market are expected to put some pressure in near term though

long-term growth prospects for domestic pharma market remain healthy given increasing penetration, accessibility and continued new launches. There are limited major FTF launches in US market in near term and base business is expected to continue to face competitive pressures affecting growth from US market. Aggregate revenue growth for ICRA’s sample is projected at 9-11 per cent over FY2017 to FY2019 after mid to high double digit growth over last five years.

Despite growth pressures along with increased R&D and compliance related investments, profitability for the industry has remain relatively stable with aggregate EBITDA margins for ICRA’s sample at 24.8 per cent for Q3 FY2017. Certain companies has been facing margin pressure on back of slowing growth in US along with remediation costs though improving product mix and productivity improvement has provided overall cushion to margins.

Over the past few years, pharma companies have increased their R&D budgets significantly in view of their growing focus both on regulated markets and complex molecules/therapy segments. The aggregate R&D spends of top few companies in domestic pharma market have increased from 6 per cent of sales in FY2011 to close to 9 per cent now. ICRA expects this trend to continue as most of the leading companies are in the midst of expanding their presence in complex therapy segment such as injectables, inhalers, dermatology, controlled-release substances and biosimilars.

The credit metrics of leading pharma companies are expected to remain stable in view of steady growth prospects in regulated markets and relatively strong balance sheets. The capital structure and coverage indicators are expected to remain strong despite some pressure on profitability and marginal rise in debt levels given inorganic investments. The key sensitivity to ICRA’s view remains productivity of R&D expenditure, increasing competition in the US generics space and operational risk related to increased level of due diligence by regulatory agencies.

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EP News Bureau

EXPRESS PHARMA

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RESEARCH UPDATES

Older women reduce their endometrial cancer risk with weight loss Women who intentionally lost five per cent or more of their body weight had 29 per cent lower risk of developing endometrial cancer during the study period

P

ostmenopausal women who intentionally lost weight over the course of three years had a much lower risk of endometrial cancer up to 11 years later compared to women whose weight didn’t change, a US study finds.

Overall, women who intentionally lost five per cent or more of their body weight had 29 per cent lower risk of developing endometrial cancer during the study period, and the effect was most pronounced for obese women, whose risk dropped by 66 per cent with weight loss.

“We decided to do the study because we realised that, although obesity increases the risk of endometrial cancer, research couldn’t say if intentional weight loss, especially among older persons, could reduce that risk,” said lead author

34 EXPRESS PHARMA March 16-31, 2017

Juhua Luo, School of Public Health at Indiana University in Bloomington.

Endometrial cancer is the most common gynaecologic cancer in the US and the fourth most common cancer among women. About 2.8 per cent of American women will be diagnosed with endometrial cancer at some point during their lifetime, according to the National Cancer Institute. Body fat is thought to increase risk of this hormone-sensitive cancer by increasing the amount of estrogen a woman produces, the researchers write in Journal of Clinical Oncology.

For their study, Luo and her colleagues analysed data on more than 36,000 women between the ages of 50 and 79 who participated in the larger, long-term Women’s Health Initiative study.

All the women were weighed at the beginning of the study period and again three years later when they were also asked if they had intentionally tried to lose weight in the previous few years. The study team followed the women for an average of 11 more years and found that 566 women were diagnosed with endometrial cancer during that time.

With women whose weight remained stable as the reference point, researchers found that women who dropped pounds were significantly less likely to develop endometrial cancer, and those who gained weight saw an 8 per cent to 23 per cent increase in risk. For women who had not used hormone replacement therapy for menopausal symptoms and gained weight, risk rose by 30 per cent.

“It is not too late to lose weight to reduce cancer risk, even if you are older,” Luo said.

The study only looked at older women, but Luo said she thinks it is reasonable to think the effects might apply to younger women too, and more research is indicated.

“The majority of women with endometrial cancer are diagnosed with earlystage tumours that are associated with a high cure rate. However, despite this paradigm, not only is the incidence of endometrial cancer increasing, but the number of women who die as a result of the disease also is increasing,” said Dr Jason Wright, Chief of Gynaecologic Oncology at Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital.

In 2016, the number of deaths from endometrial cancer in the US reached 10,170, which is a 25 per cent increase compared with just five years earlier, he writes.

Luo’s findings suggest that weight loss, even by a modest amount, can lower a woman’s risk of endometrial cancer, Wright said.

“Fatty tissue releases estrogen which can stimulate the endometrium and increase a woman’s risk of endometrial cancer,” Wright said.

At present, the only women for whom screening is recommended are those with Lynch syndrome, a genetic abnormality that predisposes women to the development of endometrial and colorectal cancer among other cancer types, Wright noted.

“Most endometrial cancers will have symptoms early such as vaginal bleeding.

Women with vaginal bleeding should consult with their physician for evaluation,” he said.

Reuters

FDA approves Valeant’s drug to treat plaque psoriasis The US Food and Drug Administration approved Valeant Pharmaceuticals International’s Siliq to treat adults with moderate-to-severe plaque psoriasis.

Psoriasis is an autoimmune disorder that occurs more commonly in patients with a family history of the disease, and most often begins in people between the ages of 15 and 35.

Plaque psoriasis, in which patients develop thick, red skin with flaky, silver-white scales, is the most common form of the disease.

The approval for Siliq injection includes a labelling with boxed warning to mitigate the risk of suicide. Patients treated with Siliq during clinical trials had shown suicidal behaviour, the FDA noted.

Reuters

Muslim prayer movements may reduce back pain: Study Bowing is the most stressful on the lower back, but for individuals with low back pain, using proper knee and back angles during the ritual can reduce pain COMPLEX PHYSICAL movements involved in the Muslim prayer ritual, such as bowing and kneeling, may reduce lower back pain if performed regularly and properly, a new study has claimed.

While the research focused specifically on Islamic prayer practices, similar movements are also found in Christian and Jewish prayer rituals along with Yoga and physical therapy, researchers said.

“One way to think about the movements is that they are similar to those of yoga or physical therapy intervention exercises used to treat low back pain,” said Professor Mohammad Khasawneh from Binghamton University in the US. “Prayer can eliminate physical stress and anxiety, while there is also research that indicates prayer rituals can be considered an effective clinical treatment of neuro-musculoskeletal dysfunction,” said Khasawneh.

Researchers analysed statistics based on the movements of computer-generated digital human models of healthy Indian, Asian, and American men and women, and models with lower back pain.

They found that the bowing is the most stressful on the lower back, but for individuals with low back pain, using proper knee and back angles during the ritual can reduce pain. The angles are based on individual body shapes. “The maximum compression forces created during prayer postures is much lower than National Institute for Occupational Safety and Health (NIOSH) safety limits, and the movements can be safely considered a clinical treatment for low back pain, as it requires different movements of the human body on a regular basis,” Khasawneh said.

“The kneeling posture (sujud) increases the elasticity of

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joints. It is recommended for these individuals to spend

more time in the kneeling posture," Khasawneh added. The

study was published in the International Journal of Industrial

and Systems Engineering.

PTI

RESEARCH

OncoCyte says study confirms accuracy of lung cancer blood test OncoCyte plans a commercial launch of the test as early as the second half of this year ONCOCYTE CORP, which is developing diagnostics in the fledgling field of liquid biopsies, said a 300-patient validation study of its blood test for early detection of lung cancer has confirmed the accuracy reported from a prior trial.

OncoCyte said it was preparing for a commercial launch of the test as early as the second half of this year and expects it will be the first product of its kind for lung cancer to reach the market.

Liquid biopsies use blood or urine to determine the presence of cancer and can help spare patients from unnecessary invasive biopsies, that are risky, expensive and most often find tested tissue to be benign.

With a traditional lung biopsy, a needle is plunged into the lung to remove part of a nodule or suspect tissue for laboratory testing. It can cause serious complications requiring hospi-

talisation, including collapsed lungs, infection and in some cases death.

OncoCyte said it would price its test at about 20 per cent to 25 per cent of the cost of a standard of care lung biopsy, which can run about $15,000.

The test is being developed at a time when people at high-

risk for lung cancer, such as long-time heavy smokers, are being encouraged to get annual CT scans aimed at catching the deadly disease early, when favourable treatment outcomes are far more likely.

Currently, when CT scans reveal suspicious lung nodules larger than about five millime-

tres, the next step is a needle biopsy that could be avoided with a reliable non-invasive test showing the nodule to be benign.

OncoCyte said about 1.4 million US patients a year are found to have lung nodules 5 mm or larger, making for a sizable market for alternative diagnostics.

A previously-reported study of more than 600 patients found the OncoCyte test had a sensitivity of 90 per cent and specificity of 62 per cent. That means it accurately detected cancer 90 per cent of the time, while demonstrating an ability to identify false positives 62 per cent of the time. The latter is the key measure that could help spare many patients from unnecessary biopsies and health insurers from paying for avoidable procedures and potential complications.

OncoCyte said it believes the

data provides a level of accuracy well above what is necessary for a commercially successful test.

“If the assay continues to perform at these levels, it could create a significant improvement in the standard of care in lung nodule management,” Dr Anil Vachani, the study's lead investigator, said in a statement.

Vachani, from the University of Pennsylvania, will present details of the latest findings at a medical meeting in late May, the company said.

OncoCyte said it was taking steps to have its testing laboratory certified by regulators, after which it must do one more 300-patient confirmatory study to demonstrate tests performed in that lab provide similar accuracy to those done at its research facility.

Chief Executive William Annett said he believes that can all be completed this year.

Reuters

Roche trial finds new drug cocktail cuts breast cancer deaths Combining its drug Perjeta with Herceptin and chemotherapy after surgery cut recurrence of an aggressive type of early breast cancer or death compared to Herceptin and chemo ROCHE’S BID to shield its ageing but lucrative oncology franchise from cheaper copies got a lift from a trial showing a new drug cocktail kept breast cancer patients alive longer.

Combining its drug Perjeta with Herceptin and chemotherapy after surgery cut recurrence of an aggressive type of early breast cancer or death compared to Herceptin and chemo, the Swiss pharmaceuticals giant said in a statement.

Herceptin, approved in 1998, is losing patent protection, exposing it to competition

36 EXPRESS PHARMA March 16-31, 2017

from a biosimilar version that Mylan and Biocon may introduce in Europe this year.

By showing the addition of Perjeta improved results over the previous regimen, Roche aims to make the case to regulators and doctors that it will keep more patients alive longer.

“These results from the positive Aphinity study represent an important addition to the body of data for Perjeta in the treatment of people with HER2-positive early breast cancer,” Sandra Horning, Roche’s, Chief Medical Officer, said.

About a third of HER2-positive breast cancer patients have historically suffered a relapse after successful initial therapy.

Herceptin and chemotherapy have helped keep cancer from returning in more than 80 per cent of these patients.

With Aphinity, the goal was to show adding Perjeta would

improve invasive disease-free survival rates significantly.

With Aphinity’s ‘commercially significant’ outcome, Zuercher Kantonalbank analyst Michael Nawrath expects revenue of 9 billion francs from the Perjeta-Herceptin franchise by 2021.

Still, analysts from Baader Helvea told investors to ‘beware,’ as Roche released only the trial’s positive headlines.

“We see the limited released information regarding the Aphinity study leading to potential confusion and recommend waiting until the dust

settles,” wrote Baader’s Bruno Bulic. The drugs are already approved in combination with chemotherapy for those suffering from metastatic disease, but Aphinity tested Perjeta’s ability to keep tumours from returning in breast cancer patients after surgery.

Vontobel analyst Stefan Schneider boosted his share price target to 301 Swiss francs from 292 francs and lifted his forecast for the probability of Perjeta winning expanded approval to 90 per cent from 60 per cent.

Reuters

RESEARCH

E-therapy tied to better body image,intimacy for breast cancer survivors According to a researcher, one potential downside to web therapy could be the lack of a therapist to visit in person when problems arise INTERNET-BASED psychotherapy focussed on changing behaviour may be tied to improved body image and sexual functioning in breast cancer survivors, a recent study suggests.

Researchers randomly selected 169 breast cancer survivors diagnosed with sexual dysfunction to receive either online cognitive behavioural therapy for up to 24 weeks or to join a control group of people on a waiting list for therapy.

After 10 weeks, women in the therapy group reported bigger improvements in sexual desire and pleasure and less discomfort during sex than women on the waitlist, the study found. By the time treatment ended, women who got online therapy also reported greater improvements in desire and overall sexual functioning than women on the waitlist.

“Several studies have demonstrated the efficacy and applicability of Internetbased cognitive behavioural therapy for female sexual dysfunctions in the general population,” said Senior Study Author Neil Aaronson of the Netherlands Cancer Institute in Amsterdam.

The current study, however, is the first to evaluate and confirm the effectiveness of this type of treatment for sexual dysfunction in female breast cancer survivors, Aaronson added by email.

“This is particularly important because the prevalence of sexual dysfunction in this population is two to three times higher than in the general population,” Aaronson said.

For the study, women in the treatment group could participate in up to 24 weekly sessions guided by a therapist. Researchers surveyed all of the participants at the start of the study, after 10 weeks and after therapy sessions concluded, with a similar schedule for women on the waiting list and patients in therapy.

Participants were 51 years old on average and most of them had a romantic partner. Slightly more than half of the women had undergone breast-conserving treatment, with a majority getting chemotherapy, radiation or hormones.

The most common type of sexual dysfunction was low desire, which affected about 83 per cent of the women, followed

by sexual arousal disorder, which impacted 40 per cent of participants.

Overall, the odds of improved sexual functioning were more than tripled with therapy, compared with women on the waiting list. Researchers didn't find any meaningful differences between groups in orgasmic function, sexual satisfaction, intercourse frequency, relationship intimacy, psychological distress, marital satisfaction or health-related quality of life.

One limitation of the study is that it wasn't designed to show whether webbased treatment might be any better or worse than in-person therapy sessions, the authors note. Another drawback is that only 62 per cent of women in therapy completed the treatment cycle.

In addition, researchers didn't have clinicians examine women at the end of the study to see how many participants still had a diagnosis of sexual dysfunction, the researchers note. A goal of treatment would be to help women improve enough to no longer meet the criteria for this diagnosis. While the Internet doesn't allow patients to develop the same personal relationships with therapists that they can establish in the same room together, online treatment may be a more convenient and private option that some women may prefer, Aaronson said.

One potential downside to web therapy could be the lack of a therapist to visit in person when problems arise, said Dr Christine Rini, a researcher at Hackensack University Medical Center in New Jersey who wasn't involved in the study.

“People using the therapy may be less likely to get help for problems such as distress or relationship conflicts caused by completing the therapy,” Rini said by email. “In an emergency, that could be a real problem."

But web-based therapy could make treatment available to far more patients, and be more affordable than in-person visits, Rini said. “Using the web should allow people to get this therapy even if they could not or would not attend in-person therapy,” Rini added. “People need to decide whether they prefer in-person versus web-based therapy.”

Reuters

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EXPRESS PHARMA

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PHARMA ALLY VENDOR NEWS

Waters honours Singapore’s Bioprocessing Technology Institute for glycoscience research

Q A &

W

aters Corporation welcomed into its Centers of Innovation Program the Bioprocessing Technology Institute (BTI), a research institute under Singapore’s Agency for Science, Technology and Research (A*STAR). BTI is the first research institute focussed on glycobiology to participate in the Waters Centers of Innovation Program.

Glycans, or sugars, are one of the four fundamental classes of macromolecules that comprise living systems. BTI’s glycan research is aimed at finding novel cancer markers and elucidating glycosylation pathways that could pave the way for new therapeutic strategies.

“I am delighted that BTI has been recognised by Waters for its expertise in glycomics. Through this collaboration, BTI will be able to advance cancer biomarker research and further cement Singapore’s position as a key player in biologics,” said Professor Lam Kong-Peng, Executive Di-

38 EXPRESS PHARMA March 16-31, 2017

rector, BTI. “This award also recognises the importance of the integrated research programmes that are fundamental to the success of BTI,” added Lam. “It’s truly a pleasure to have BTI participate in our COI Program,” said Dr Mike Harrington, Senior Vice President, Global Markets for Waters Corporation. “BTI’s research in glycobiology is world-class and we wish to help it realise the enormous potential of this very important area of science through the application of Waters analytical technologies and expertise.”

Waters Corporation is supporting The Next Frontier of Glycobiologics, a symposium featuring keynote presentations from Professor Raymond Dwek, Glycobiology Institute, University of Oxford, UK and from Professor Nico Callewaert, VIB Medical Biotechnology Center, University of Ghent, Belgium.

EP News Bureau

SCHOTT GLASS INDIA

Q

What is delamination and when does it occur?

A

Delamination is a process where thin glass flakes detach from the inner glass surface. The process is already known since the 1950s. Unfortunately, it can not reliably be predicted if and when delamination will occur because the factors influencing this are too many and too complex. There is e.g. the converting process which with hotter converting has a bad influence. But also the drug solution has an important part in this. The buffer or even the drug itself can accelerate the process by attacking the glass and complexing selectively certain elements, e.g. aluminum. If this is the case, it can be seen from the composition of the flakes as they also contain elements from the solution.

As this topic became quite prominent in the pharmaceutical industry, the USP released a guideline in Chapter <1660> proposing different methods with which the propensity to delaminate can be investigated. But as mentioned already, this can only be hints but not reliable information. If one had a delamination case, the best thing to do is to have investigated by an experienced lab (e.g. SCHOTT Pharma Services) who can tell exactly if it was only the glass or also the drug solution being involved in the reaction. This is a valuable information according to which the whole process has to be evaluated and if needed changed.

Q

How temperature resistant are glass containers, e.g. in the depyrogenation oven?

A

Borosilicate glasses usually are good heat resistant. In the converting process they undergo temperatures of above 100°C without changing the chemical composition. After converting they go through the annealing oven at around 600°C. In the filling process, the temperature of around 300°C is easily bearable for them even if they are standing there for a few hours.

The point is not so much the temperature itself but rather the temperature difference if they are exposed to heat and cold at the same time. Here the strength depends on the the Coefficient of Thermal Expansion (CTE). The lower the CTE is, the higher is the temperature shock resistance. E.g. a FIOLAX(R) container (CTE of 4.9) with a wall thickness of 1.0 mm can bear a temperature difference of around 200°C meaning the container can be thrown from 200°C into cold water without bursting. A soda-lime container (CTE of around 9) with a wall thickness of 1.0 mm e.g. can only bear 110°C. This is important for the lyophilisation process where the glass is frozen inside and at the same time heated from the bottom. It should be kept in mind that this relates to a container without any defects on the glass surface. Any defect lowers the resistance. The temperature shock resistance can be influenced by the wall thickness. As glass is a bad conductor of heat, the temperature shock resistance increases with decreasing wall thickness.

BTI is the first research institute focussed on glycobiology to participate in the Waters Centers of Innovation Program

(L-R) Dr Benjamin Seet, Executive Director, Biomedical Research Council, Agency for Science, Technology and Research, Singapore; Professor Kong Peng Lam, Executive Director, Bioprocessing Technology Institute (BTI); Eric Fotheringham, Senior Director, Waters Centers of Innovation Program and Mathieu Laouenon, General Manager, South Asia, Waters Corporation

WITH

PMMI members to showcase global processing and packaging machinery solutions at interpack PMMI’s Business Intelligence will release its 2017 Global Packaging Trends report MORE THAN 165 members of PMMI, The Association for Packaging and Processing Technologies, will represent the North American market, while showcasing global processing and packaging machinery solutions at interpack, to be held in Düsseldorf, Germany from May 4–10, 2017.

A triannual international trade fair for packaging and related processing industries, interpack serves the food, beverage, confectionery, bakery, pharmaceutical, cosmetics, non-food and industrial goods sectors.

As the biggest and most influential packaging and processing association in the largest economy in the world, PMMI is the strongest partner to facilitate North American business through its PACK EXPO portfolio of trade shows, PMMI Media Group and business drivers that equip the industry to succeed in a global marketplace.

“PMMI offers invaluable resources to manufacturers wanting to do business in North America,” says Charles D Yuska, President and CEO, PMMI. “Our three business units work together to connect suppliers with customers yearround and drive the innovation needed to move the industry forward. We do this through our PACK EXPO portfolio of trade shows, PMMI Media Group and business drivers that provide the industry tools to succeed in a global marketplace.”

At interpack, PMMI’s Business Intelligence will release its 2017 Global Packaging Trends report. This report explores key trends driving packaging innovations such as increasing awareness of health and wellness and growing concerns about environmental impact while identifying hot spots for packaging growth in all regions of the world.

The PMMI booth will also offer a thorough primer on its world-class PACK EXPO portfolio of trade shows.

As the leading processing and packaging shows in North America,

2017 Global Packaging Trends report will explore key trends driving packaging innovations like increasing awareness of health and wellness each is designed to connect consumer goods companies with manufacturing solutions.

In addition, representatives from PMMI’s Media Group will be on-hand to showcase its leading publications, events and online media connecting the global supply chain. PMMI’s Media Group produces information for processing and packaging professionals, bringing together solution providers and end users of packaging, processing and industrial automation.

The PMMI booth (Hall 12; Stand F01) will have pocket guides readily available that attendees can use to locate PMMI member companies exhibiting at the show. The pocket guide identifies these members alphabetically, cross-referenced by the types of machines they produce.

“PMMI members are globally renowned for making the highest quality equipment, offering responsive service and committing to meeting their customers’ needs,” Yuska says. “Their active participation at interpack is a testament to the robust North American market and the innovations offered by our members designed to serve the international marketplace.”

EP News Bureau

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EXPRESS PHARMA

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PHARMA ALLY PRODUCTS

Bosch to showcase new products at Interpack 2017 BOSCH PACKAGING Technology will present its new developments from its comprehensive portfolio for liquid pharmaceuticals at Interpack 2017. The Bosch subsidiary Pharmatec already supports customers with suitable equipment during biotechnological drug production. The pilot fermenter on show at Interpack is suited for both laboratory and industrial manufacture of pilot batches for cell cultivation, for instance for the use in cancer medication. Thanks to different mixing technologies, it processes batches between eight and 50 litres. Via scaleup, batch sizes can even be increased to 200 litres.

For production-scale filling and closing of liquid pharma, Bosch will showcase the ALF 5000 vial version for the first time. To date, customers could fill either ampoules or vials and ampoules on one machine.

Now the proven platform is also available for vials only.

The machine to be shown at Interpack is equipped with 100 per cent in-process control and a carrying rake transport system, which provides an even gentler handling. The ALF 5000 achieves an output of up to 600 containers per minute and can be combined with different barrier systems a competence, which Bosch also demonstrates at Interpack.

Apart from proven isolator technology and open Restricted Access Barrier Systems (RABS), closed RABS and the newly developed return air filter for highly potent products now complete the portfolio. In contrast to the commonly used safe change filters, which are situated in the technical area, the new re-

40 EXPRESS PHARMA March 16-31, 2017

Line competence for liquid pharmaceuticals

Portfolio for barrier and isolator technology completed

turn air filters are integrated into the machine. This saves time and facilitates cleaning, because the highly potent substances are already filtered at point of use. Moreover, the filter exchange is particularly easy and safe: there is no contact between the operator and the contaminated filter medium.

Containment and operator safety are also the focus of the down flow booth. Usually, the booth is used for manual weighing and dosing of pow-

ders. By supplying fresh air from the ceiling and drawing dust away from the operator, one can work with the substances in the closed space without safety concerns. As a tradeshow highlight, the downflow booth is converted into a meeting room for customers.

When it comes to the inspection of filled containers, Container Closure Integrity Testing (CCIT) is becoming increasingly important. With the KLV 1360, Bosch presents a new development for vacuum

leak detection of rigid containers, which combines the highest inspection accuracy with maximum output. Together with fully automated solutions for high-volume leak detection and laser-based headspace analysis (HSA), Bosch can now offer an entire portfolio of CCI technologies. Benchtop devices for visual inspection, HSA and vacuum leak detection provide an additional overview of the broad inspection portfolio.

The semi-automated MSA from the Bosch subsidiary Moeller & Devicon is designed for the assembly of multi-part single-use auto injectors or pens, which are used for the treatment of autoimmune diseases or in emergency care.

With its compact and hygienic design, the MSA platform is suited for the assembly of small volumes between five and 15 pieces per minute.

Thanks to standardised modules it can also be upgraded for larger batches and fully automated production, offering drug producers the flexibility to adapt quickly to new market demands.

Further technologies, such

as product and equipment sterilisation from the Bosch subsidiary Schoeller-Bleckmann Medizintechnik (SBM) complete the equipment portfolio for liquid pharma. These lines can be further extended by adding secondary packaging solutions, as well as platforms and industry 4.0 technologies for serialisation and aggregation. A comprehensive range of services to improve machine efficiency and productivity completes Boschâ&#x20AC;&#x2122;s line competence. The focus is on solutions for preventive maintenance as well as services to eliminate unwanted machine conditions as quickly as possible. To this end, Bosch provides a worldwide service network with qualified field service technicians who offer regional support. Thanks to digital services such as Remote Service, which is now supported by a visualisation and chat feature, or the mobile version of the E-Portal, which will be presented at Interpack 2017, customers receive targeted support regardless of their location. Bosch will further showcase the versatile training portfolio of the Bosch Packaging Academy. Apart from new assistance solutions, Bosch will demonstrate virtual training concepts enabling manufacturers to acquire demand oriented know-how for machine operation and maintenance. Bosch will also illustrate how preventive maintenance parts kits and tailor-made maintenance agreements help to proactively minimise unplanned downtime.

Contact details Christian Treite phone: +49 7951 402-875

PHARMA ALLY

Gandhi Automations launches high speed self repairing door PRIME RESET is a unique high speed self-repairing door with the latest technology that prevents downtime of the door system. In case the curtain is impacted accidentally it will cause the curtain to move out of the guides without damage. The movement of the door is designed in such a way it can be recovered with a simple opening and closing operation. Gandhi Automations manufactures doors of the highest quality that meet the issue for greater flexibility desired by clients. High speed selfrepairing door in PVC is the most suitable solution in the field industries, it lowers the time of transition from one facility to another, avoiding any human error which can cause damage to the high speed door and all this thanks to the innovative anti-crash system.

Gandhi Automations provides a world class product with great security.

Below are the features of self-repairing high speed doors offered by Gandhi Automations: ◗ Flexible and self-repairing door ◗ Functional, safe, quick and resistant

◗ Innovative anti-crash system ◗ Can be equipped with PVC vision windows ◗ Self-lubricating maintenance free guide ◗ Smooth and silent opening and closing ◗ Protects traction unit, enables rapid wiring and safety photocell ◗ Flexible curtain in self-extinguishing material ◗ Self-resetting without intervention ◗ Quickly back to operation ◗ Control panel designed for an intensive continuous service Contact details Gandhi Automations Chawda Commercial Centre, Link Road, Malad (West) Mumbai – 400064 Off: +91 22 66720200 / 66720300 (200 lines) Fax: +91 22 66720201 Email: sales@geapl.co.in Website: http://geapl.co.in/highspeed-self-repairing-doors.html

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March 16-31, 2017

PHARMA ALLY

Virosil Pharma launches eco-friendly disinfectant SANOSIL BIOTECH, a Mumbai-based company is the first company to pioneer the novel concept of eco-friendly fumigation in sterile areas completely replacing the use of carcinogenic proven formalin. The product Virosil Pharma is based on Hydrogen Peroxide (H2O2) with silver ions. The combination of these two ingredients gives a synergistic broad spectrum of activity on all kinds of viruses, bacteria, fungi, yeasts, molds, protozoa and algae. It is a clear, colourless, odourless, tasteless disinfectant which is non-carcinogenic, non-mutagenic, revolutionary and can be used where other chlorine-based disinfectants have been feared.

Virosil Pharma is presently being used in organisations and institutions such as Pfizer, Cipla, Dabur, Ranbaxy, J&J, Abbott, Serum Institute, Dr Reddy’s, Lupin Labs, Cadila Healthcare, Wockhardt, Biocon, Astrazeneca, Reliance Life Sciences, etc., as a very effective fumigant and disinfectant providing an environment with microbial containment and a completely safe and sterile environment Virosil Pharma effectively

MIC DETERMINATION - METHOD BASED ON MODIFIED BSEN13704 (SPORICIDAL) TEST ORGANISMS: 1) BACILLUS SUBTILIS ATCC 6633 RESULTS - COUNT OF STANDARD CULTURE B SUBTILIS USED Standard Culture

CFU/ml

Log Value

B subtilis

270000000

8.4313

RESULTS - MICROBIAL COUNTS POST DISINFECTANT EXPOSURE IN CFU/ML

B subtilis

Microbial Counts in CFU/ml

Microbial Counts in Log Values

Log Reductions

Log Reductions

Virosil l0%

Virosil l0%

Virosil l0%

Virosil l0%

5 mins

30 mins

60 mins

5 mins

30 mins

60 mins

5 mins

30 mins

60 mins

5 mins

30 mins

60 mins

4900

2300

310

4.7411

5.0696

5.9400

3.6901

3.36178

2.4913

99.9981

99.9991

99.9998

protects critical surfaces that come in contact with pharma products. Manufacturing, filling, packing and storage areas; instruments, equipment, water tanks and pipelines – can now be pathogen free.

There is no need to re-wash disinfected surfaces or instruments since H2O2-based Virosil Pharma safely

decomposes into water and oxygen. The formulation has been tested in various reputed institutions in Switzerland, France, Germany, Australia and India.

Disinfecting Biofilms using Virosil Pharma Virosil Pharma not only successfully penetrates bio-films and eliminates bacteria but

also maintains a long residual level of disinfection in water tanks and pipelines.

Using Virosil Pharma overcomes the disruption problem because it is absolutely safe to leave it in the water. Better still, the longer it’s in the water, the better the results since it will attack the biofilms which harbour most of the bacteria

populations.

Contact details Dev Gupta, CEO, Sanosil Biotech Warden House, 1 st floor, Sir PM Road, Fort, Bombay 400 001 Tel No. 022 22872295 / 43112700 / +919820016292 email: info@sanosilbiotech.com

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

❒ We welcome information on new products and

regular columns and from pre-approved contributors / columnists. ❒ Express Pharma has a strict non-tolerance policy of plagiarism and will blacklist all authors found to have used/refered to previously published material in any form, without giving due credit in the industryaccepted format. All authors have to declare that the article/column is an original piece of work and if not, they will bear the onus of taking permission for re-publishing in Express Pharma. ❒ Express Pharma's prime audience is senior management and pharma professionals in the industry. Editorial material addressing this audience would be given preference. ❒ The articles should cover technology and policy trends and business related discussions. ❒ Articles for columns should talk about concepts or trends without being too company or product specific. ❒ Article length for regular columns: Between 1200 1500 words. These should be accompanied by diagrams, illustrations, tables and photographs, wherever relevant.

services introduced by your organisation for our various sections: Pharma Ally (News, Products, Value Add), Pharma Packaging and Pharma Technology Review sections. Related photographs and brochures must accompany the information. ❒ Besides the regular columns, each issue will have a special focus on a specific topic of relevance to the Indian market. ❒ In e-mail communications, avoid large document attachments (above 1MB) as far as possible. ❒ Articles may be edited for brevity, style, and relevance. ❒ Do specify name, designation, company name, department and e-mail address for feedback, in the article. ❒ We encourage authors to send their photograph.

Preferably in colour, postcard size and with a good contrast.

42 EXPRESS PHARMA March 16-31, 2017

Email your contribution to: The Editor, Express Pharma, Business Publications Division,

The Indian Express (P) Ltd, 1st Floor, Express Towers, Nariman Point, Mumbai - 400 021.

Tel: 91-22-2202 2627 / 2285 1964/ 6744 0000 Fax: 91-22-2288 5831 viveka.r@expressindia.com

PHARMA ALLY VALUE AD

Cleanroom gloves or medical gloves?

Derek Watts, CEO, Nitritex, chalks out the reasons on why medical gloves are not suitable for cleanroom use SUPPLIERS OF specialist gloves are often asked to supply medical gloves for use in cleanroom applications. On the face of it, this doesn’t seem unreasonable, however, the introduction of medical gloves into a cleanroom could have serious repercussions. A quick conversation is usually enough to help the customer to specify an appropriate product, but why does the misunderstanding arise in the first place? The following article sets out to explain why the two applications are often incompatible.

Perceived wisdom is that gloves used in medical environments are sterile, as the purpose of medical gloves is to prevent cross-infection from the clinician or surgeon to the patient. Surely, therefore, medical gloves must be very clean. This is a misconception and only partly true. The ultimate purpose of sterilising surgical gloves to be used in operating theatres is to prevent infection from bacteria which would otherwise be present on the gloves. Contrary to the belief of many, the standard dispenser boxed examination gloves used in medical and dental environments are not sterile, and all they can do is prevent cross infection spreading from the wearer of the gloves to the patient.

The patient is not protected from the multiple bacteria that are already present on the gloves.

Dentists are still allowed to use powdered gloves but all medical gloves used in hospitals in the UK have to be powderfree. The traditional way to make a glove powderfree was for it to be put through a process of chlorination after it had been removed from the production line. The process of chlorination not only removed all the powder but it also killed

TABLE 1. RELATIVE PERFORMANCE OF THE FOUR MAIN GLOVE MATERIALS Comfort

Elasticity

Strength

Durability

Latex

Excellent

Excellent

Excellent

Good, but Very poor. Latex is an punctures can be excellent insulator hard to spot

Polychloroprene

Good; very close to Latex

Good

Good

Good

Nitrile

Good; comfort improves with wearing

Medium

Medium Good

Good. Static dissipative and improves with wearing

Vinyl

Fair; relatively stiff

Low

Low

Medium

the provided the packers of the exam gloves wore clean gloves, one could be reasonably assured that the examination gloves would have a very low bacteria count.

Nowadays, however, powderfree medical gloves are\ rarely made through a process of chlorination (inside and out), as in the interests of economy, other manufacturing methods for these gloves have been developed and established. Most powderfree medical examination gloves are now either produced on-line by dipping them into a polymer coating or by chlorinating them on-line prior to stripping them off the glove formers. Because gloves are moulded inside out, chlorination takes place ONLY on what is ultimately the inside of the glove. The outside does not come into contact with the chlorine and therefore the gloves will be prone to having a lot more bacteria as compared with off-line chlorinated gloves.

Pharmaceutical manufacturers will normally require sterile gloves, but in addition to the sterility, they also require the gloves to be low in particulates, especially if they are making injectables. There are

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many ways that particles get on the gloves.

The main origin of the particles is human cells, followed by tiny fibres from clothing.

There is little emphasis during the production and packing of surgical gloves on the minimisation of either of these, and as a result sterile surgical gloves frequently have high particle counts, albeit of sterile particles.

As a further indication of the lack of concern for particles in medical environments, you just have to look at the packaging of standard surgical gloves.

They are packed in paper inner wallets which are then, traditionally, sealed into paper pouches that have a tendency to shed particles when peeled open. The sealed pouches are then further packed into cardboard boxes. Paper is a no-no in all non-medical cleanroom environments, so all of this packaging is unacceptable. In contrast to the paper packing of surgical gloves, sterile cleanroom gloves are packed using non-particulating materials such as polyethylene inner wrappers and easy-tear pouches. All this packaging is itself manufactured in a clean-

ESD performance

Poor – good insulator

Good. Static dissipative and improves with wearing

room to ensure its cleanliness, and comes technically specified.

In some cases, it will not be necessary for pharma manufacturers to use sterile gloves, for instance if making tablets.

However, it is still important that the particulates on the gloves are low. Not only do the particulates need to be low, but the bacteria count on the nonsterile gloves will also need to be very low. This is why it is important that cleanroom gloves are used for this application.

All good cleanroom gloves are chlorinated off-line, meaning that both the inside and the outside of the gloves are thoroughly dosed in chlorine. They are then washed in highly filtered water to remove the residual chlorine and other particles.

Whilst the removal of particles is important for gloves used in the manufacturing of pharma products, removal of ionic contamination is not of importance. However, for the micro-electronics industry, whilst a low particle count is extremely important, in addition to this, many manufacturers also consider low ion counts to be a critical requirement.

Ionic contamination can greatly reduce the yields in the manufacture of electronic products such as hard disk drives, printed circuit boards and silicon wafers.

Ions such as chlorides, nitrates, sulphides, sodium, potassium, etc are by-products of the chemicals used in the manufacturing process.

All of these particles rest on the surface of the glove and require mechanical removal. This is achieved by washing the gloves in ultra-pure, de-ionised water, and then drying just before packing.

Having demonstrated that medical gloves are not suitable for cleanroom use, we have to ask “what actually are the important characteristics of cleanroom gloves”. The number one characteristic, which has already been established, is the cleanliness of both the glove and its packaging. However, beyond that, users have a wide selection of gloves to choose from to match their application. It is probably true to say that for every cleanroom application there will be a number of options available to the purchaser, and that final selection frequently comes down to the preference for one glove over another based on purely subjective criteria such as fit and feel, level of grip etc.

One thing that the user should be able to take for granted, is that the physical properties of the gloves should reach minimum standards.

However, the cleanroom glove community has evolved without defining exactly what the minimum standards should be.

This void has been partially filled by glove manufacturers using the existing medical glove EN 455 standards1-3, to define dimensions, strength and limits on the numbers of pinholes as a basis for quality

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PHARMA ALLY assurance and quality control in their factories.

What is equally important is that glove manufacturers specify the cleanliness class for which the glove is suitable, as defined in EN ISO 14644-14, e.g.

ISO Class 4 or ISO Class 5. It should be noted that some cleanroom gloves are also specifically chosen because they protect the wearer from harm from chemicals. These gloves are classed as Personal Protective Equipment (PPE) and are regulated under the European PPE Directive5 and its associated standards6. Obviously such gloves must at the same time comply with cleanroom requirements.

The other issues that the specifier needs to consider are the shape of the gloves and the type of rubber used for their manufacture.

Lower cost bulk packed non-sterile gloves are normally flat form, ambidextrous, with the thumb emerging at the side, allowing the glove to be donned on either hand.

These gloves are excellent for general purpose use in the cleanroom, but every movement of the fingers and thumbs

has to overcome the resistance of the glove material, which has a natural tendency to maintain its original shape. In most applications, this will not present a problem, however, if the wearer is constantly engaged in very fine work, requiring precise movements, then the resistance of the glove can cause fatigue in the hand and, in particular, the finger muscles. For precision work, hand specific gloves are a much better option.

Hand specific gloves are moulded with a slight curve to the fingers, and with the thumb offset to the front in a much more natural position than ambidextrous gloves.

These design features mean that the wearer is not fighting against the natural behaviour of the rubber and instead the rubber is assisting the wearer where fine control is required. If operators are involved in very fine work, the thickness of the glove becomes important, as does the level of grip and the texture of the fingertips and palm.

In terms of wearer comfort, natural rubber latex (NRL) is probably the best option because of its elasticity and strength.

Pharma manufacturers will normally require sterile gloves, but in addition to the sterility, they also require the gloves to be low in particulates However, there are concerns surrounding latex allergies which can affect the wearer and also make the gloves unacceptable in some pharma manufacturing applications where possible contamination with NRL proteins would render the processed drugs unusable. The alternative synthetic rubber materials are Polychloroprene, Nitrile and Vinyl.

Amongst the synthetic

rubbers, Polychloroprene has the characteristics closest to NRL and provides a very good alternative.

Nitrile and Vinyl are stiffer materials with vinyl being the least elastic; however, both nitrile and vinyl have good electrical conductivity properties making them ideal for use in electronics manufacturing or other staticsensitive environments such as explosive or combustible atmospheres.

In conclusion, it is simple to state that medical gloves should not be used in a cleanroom environment. Medical gloves may appear to be clean (and might even have been sterilised), but in cleanroom terms they can be very dirty.

Cleanroom gloves are available in different materials, different shapes, different lengths, different thicknesses and different textures and levels of grip.

It is, therefore, important that the person specifying the gloves knows a) what level of performance is required to match their process, and b) what the requirements of the wearers are.

For some applications, the selection of the correct glove

will be straightforward, but for others a bit more work may be required.

Any good manufacturer of cleanroom gloves will be able to provide written specifications, advice and samples to aid the decision making process.

References 1. EN 455-1: 2000, Medical Gloves for single use – Part 1: requirements and testing for freedom from holes.

2. EN 455-2: 2009, Medical Gloves for single use – Part 2: requirements and testing for physical properties 3. EN 455-3: 2006, Medical Gloves for single use – Part 3: requirements and testing for biological evaluation.

4. EN ISO 14644-1:1999, Cleanrooms and associated controlled environments, Classification of air cleanliness 5. 89/686/EEC, Council Directive on the approximation of the laws of the Member States relating to personal protective equipment 6. Gloves as PPE: Standards for permeation and penetration, Derek Watts, Clean Air and Containment Review, Issue 2, April 2010

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HEAD OFFICE MUMBAI Rajesh Bhatkal The Indian Express (P) Ltd. Business Publication Division 2nd Floor, Express Tower, Nariman Point, Mumbai- 400 021 Board line: 022- 67440000 Ext. 527 Mobile: +91 9821313017 Email id: rajesh.bhatkal@expressindia.com BRANCH OFFICES NEW DELHI Ambuj Kumar The Indian Express (P) Ltd.

Business Publication Division Express Building, B-1/B Sector 10 Noida 201 301 Dist.Gautam Budh nagar (U.P.) India.

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KOLKATA

IMPORTANT Whilst care is taken prior to acceptance of advertising copy, it is not possible to verify its contents. The Indian Express (P) Ltd. cannot be held responsible for such contents, nor for any loss or damages incurred as a result of transactions with companies, associations or individuals advertising in its newspapers or publications. We therefore recommend that readers make necessary inquiries before sending any monies or entering into any agreements with advertisers or otherwise acting on an advertisement in any manner whatsoever.

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Pharmalab India Private Ltd., Registered Office: Kasturi, 3rd, floor, Sanghavi Estate, Govandi Station Rd, Govandi (E), Mumbai 400 088, INDIA. • E-mail: pharmalab@pharmalab.com • Website: www.pharmalab.com CIN No. U29297MH2006PTC163141.

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March 16-31, 2017

63

PHARMA LIFE APPOINTMENT

KPMG in India appoints Dr Ajaz Hussain as Senior Advisor K PMG in India has appointed Dr Ajaz Hussain as Senior Advisor to the firm from January 1, 2017. Changing regulations, adoption of new technologies and increasing demands across geographies around compliance have compelled KPMG in India to bring forth a proactive and continuous quality compliance programme which aims to deliver effective results.

Dr Hussain will be guiding the KPMG risk consulting practice as an industry and regulatory specialist while defining a compliance roadmap for KPMG clients.

On his appointment, Dr

Hussain said, “I am excited and looking forward to working with KPMG in India to build dynamic progressive service offerings for the pharma sector that will reduce regulatory uncertainty and business complexity to create a competitive advantage for KPMG’s clients.”

Dr Ajaz Hussain brings a wealth of international pharmaceutical regulatory and business experience to KPMG in India, including his decadelong tenure with the United States Food and Drug Administration (US FDA), Center for Drug Evaluation and Research (CDER).

He has led some of the US

S N A P S H O T

Food and Drug Administration’s major initiatives to develop regulatory policies that already have and are likely to continue to have a significant impact on product development and approval in many geographies.

He has been honoured by the US FDA on multiple occasions for his contribution and insights.

Dr Hussain is currently serving as the President of The National Institute for Pharmaceutical Technology and Education, a not-forprofit educational organisation which is a collaboration of 17 major universities in the US. Grants from US FDA pri-

marily fund the research programmes at the institute. He also serves as an advisory to multiple pharma companies around the globe and also supports several regulatory agencies by conducting training programmes.

Dr Hussain has over 80 publications to his credit. He is a Fellow of the American Association of Pharmaceutical Scientists and the Swiss Society of Pharmaceutical Sciences. Dr Ajaz has also worked with Sandoz and Philip Morris International in the US, and Wockhardt in India.

EP News Bureau

CAMPUS BEAT

Sinhgad College of Pharmacy organises series of events Two teachers bags recognition at Research Project Competition

Alkem Laboratories won the EY Entrepreneur of the Year (EoY) 2016 in the Life Sciences and Healthcare category. Seen in the image are Basudeo Narain Singh, Executive Chairman, Alkem Laboratories receiving the Award from Piyush Goyal, Minister of State (Independent Charge) for the Ministry of Power, Coal, New and Renewable Energy and Mines and Nirmala Sitharaman, Minister of State (Independent Charge), Ministry of Commerce & Industry

64 EXPRESS PHARMA March 16-31, 2017

SINHGAD TECHNICAL Education Society’s Sinhgad College of Pharmacy (SCOP), Vadgaon, Pune organised a state level seminar on 'Recent advances in Research, Development and Testing of anti cancer agents.' The seminar was aimed to apprise different aspects of research and development in the area of novel anti-cancer agents. Faculty members from all over Maharashtra and PG students participated in the event. A two-day national level seminar was also organised on 'Advances in molecular biology

& Biotechnology.' The seminar explained various aspects of Pharmacogenomics and Proteomics. Shilpa N Shrotriya, Asst. Professor, Department of Pharmaceutics and Smita S Kale from Sinhgad College of Pharmacy were shortlisted in the teacher's category at the recently held Research Project Competition 'AVISHKAR' held at Swami Ramanand Tirth Marathwada University, Nanded. Shrotriya was declared as the runner up in teachers category.

EP News Bureau

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