Express Pharma (Vol.14, No. 2) November 16-30, 2018

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CONTENTS Vol.14 No.2 November 16-30, 2018

Chairman of the Board Viveck Goenka

REFORMING PUBLIC HEALTH: LESSONS FROM INDIA PHARMA INC

Sr. Vice President-BPD Neil Viegas Asst. Vice President-BPD Harit Mohanty

The pharma industry, one of the key stakeholders of public health, have a huge responsibility to ‘do good’ and ‘be part of the solution’| P18

Editor Viveka Roychowdhury* BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Swati Rana, Tanuvi Joe New Delhi Prathiba Raju DESIGN Asst. Art Director Pravin Temble Chief Designer Prasad Tate Senior Designer Rekha Bisht

MARKET

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CPHI & P-MEC INDIA TO BE HELD IN DELHI NCR FROM DEC 12-14, 2018

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CIMS MEDICA TO ORGANISE NUTRITION & WELLNESS 2018 CONFERENCE AND AWARDS IN MUMBAI

Graphics Designer Gauri Deorukhkar Senior Artist Rakesh Sharma

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Digital Team Viraj Mehta (Head of Internet )

MANAGEMENT

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'UNDER GDUFA II, FDA HAS COMMITTED TO CLEAN UP INACCURATE, INCONSISTENT AND MISSING INFORMATION AND VERIFY DATA INTEGRITY'

PRODUCTION General Manager BR Tipnis

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LILLY SAYS DIABETES DRUG TRULICITY REDUCES HEART RISKS IN TRIAL

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NOVEL ANTIBACTERIAL DRUGS DEVELOPED AT UNIVERSITY OF EASTERN FINLAND

AI IN PHARMA: A NEW PERSPECTIVE

70TH IPC TO ADD HEALTHCARE AND DIAGNOSTIC TO ITS SPECTRUM

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Photo Editor Sandeep Patil Marketing Team Rajesh Bhatkal Ambuj Kumar Debnarayan Dutta Ajanta Sengupta E Mujahid Nirav Mistry

RESEARCH

CPHI WORLDWIDE RECORDS 44,500 ATTENDEES FROM 164 COUNTRIES

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PANCREATIC CANCER TREATMENT HEADS IN PROMISING DIRECTION

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MANJIRI GHARAT, VICE PRESIDENT, IPA RECEIVES ISHIDATE AWARD

ANESTHESIA IN EARLY CHILDHOOD NOT TIED TO DEVELOPMENTAL PROBLEMS

PHARMA ALLY

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EDITOR’S NOTE

Dipping rupee to boost FY19 pharma revenues but ...

I

t's been more than three years since the Directorate General of Foreign Trade (DGFT), Department of Commerce, Ministry of Commerce and Industry laid down procedures for implementation of the track and trace system for export of pharma and drug consignments. On November 1, the DGFT decided to extend the date for maintaining the parent-child relationship in packaging levels and uploading the data on the central DAVA portal to July 1, 2019, for both SSI and non-SSI units supplying to the export markets. The Pharmexcil site notes that November 15 remains the deadline for barcoding on secondary and tertiary packaging.

Given that the India's pharma sector is a net exporter, this recent DGFT notice should give exporters some leeway as they cope with the increasing price of imported active pharma ingredients (APIs) and increased competition in the ANDA space. Both these trends will be partially offset by the depreciating rupee versus the US dollar.

India Ratings and Research (Ind-Ra)'s latest report also points out that the higher margins for 2QFY19 on a year-on-year basis, largely supported by the nine per cent y-o-y depreciation of the Indian rupee against the US dollar, will be partially off set by the increasing debts of these companies as they have foreign currency-denominated debts .

The impact of imported API prices can be gauged by the 100bp-350bp fall in the gross profit margins of some large players over QFY18-1QFY19.

Thus prices of imported APIs are going to be very crucial, especially for players focused on regulated and fixed -tender markets, as it is fairly certain that prices are never going to reduce to previous levels.

Similarly, a CRISIL report predicts that after two years of single-digit growth, revenues of big pharma companies in India, i.e. those with a turnover of `1,000 crores or more, will be up 10-12 per cent in fiscal 2019; with operating margins seen stable at 18-20 per cent. Besides the depreciation of the rupee against the dollar, a recovery in sales in the US and improving domestic demand will contribute to this return to double digit growth.

The recovery of sales in the US could be linked to improved compliance status of US generic market-

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Smart companies will focus on discovering avenues which lead to long-term sustainable growth

focused pharma companies, with the CRISIL report pointing to establishment inspection reports for facilities of two big players which were under warning letters (Sun Pharma and Dr Reddy’s Laboratories).

But the news on abbreviated new drug approvals (ANDA) front is bitter sweet. The IndRa report points out that while Indian companies received more ANDA approvals, the overall increase in these approvals meant more competition. A slight silver lining could be the fairly significant 30 per cent increase in India's share of first-time generic drug approvals, including gSensipar by Aurobindo Pharma and Cipla, gSuboxone, by Dr Reddy’s Laboratories, and gWelchol by Glenmark Pharma. First-time generic approvals, which do not offer marketing exclusivity in all cases, allow manufacturers to operate in a less competitive environment and are especially positive from the margin expansion perspective.

While the exports market has traditionally offered more margins, the domestic market cannot be ignored any longer. The CRISIL report posits that better access to healthcare, deeper penetration of health insurance are expected to grow domestic revenues of big pharma companies by 12-13 per cent in FY19. The IndRa report says that the domestic market offers a relatively high scope to large-sized players to pass on increased input costs than highly competitive regulated markets such as the US. Thus, while revenues will increase in FY19 (with nearly half of revenue growth likely to be driven by a weaker Indian rupee), smart companies will focus on discovering avenues which lead to long term sustainable growth. Beside ongoing cost optimisation measures, this could be complex generics, as well as balancing focus on key ANDAs and first-time generic drug approvals. The roll-out of India's health assurance scheme, Ayushman Bharat, could see increased demand for medicines, expanding the domestic market but this segment will be under severe price control. All in all, FY19 promises to be no cakewalk.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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MARKET PRE EVENTS

CPhI & P-MEC India to be held in Delhi NCR from Dec 12-14,2018 UBM INDIA is all set to bring in the third edition of India Pharma Week (IPW), a week-long celebration packed with avant-garde events from December 12-14, 2018 alongside its flagship expo CPhI & P-MEC India. CPhI & PMEC India will be held in India Expo Mart, Greater Noida, Delhi NCR. Unlike the previous editions organised in Mumbai across a number of venues, this year all the engagements of the IPW, which is also South Asia’s largest pharma event will be held at the world-class venue the India Expo Mart - Greater Noida, with all its attendant facilities. This will enable all the key stakeholders and professionals of the pharma industry the convenience to congregate, network and celebrate the industry under one giant umbrella for an entire week.

As the pharma industry is increasingly looking towards India for high quality, low cost pharma solutions, CPhI & P-MEC India is the perfect event for companies to pick up on the latest trends and innovations the market has to offer. Apart from India Pharma Week, the 2018 edition will also feature dynamic engagements such as the Pharma Leader’s Golf Pre-Connect Congress, plant visits, Women in Pharma – Power Breakfast, India Pharma Awards, Networking Evening, and a closed-door CEO Roundtable, amongst others. The ultimate goal of all these intertwined events is to help nurture a complete pharma ecosystem in India and better enable networking with the country’s corridors of power. P-MEC India will represent the platform where international and domestic pharma experts meet to to do business, network and shape the future of the Indian and South East Asian pharmaceutical industry.

Key reasons to attend P-MEC India ◗ Meet the biggest representation of pharma ingredients manufacturers in one single location ◗ Source high quality products at the most competitive price

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◗ Network and do business with over 50,000 experts from 120+ countries ◗ Grow your client range and establish new busi-

ness relationships Exhibitor’s profile include analytical equipment, automation and robotics, batching

systems/equipment, cleanroomequipment, filling equipment, filtration/separation/purification, health and safety

products, instruments etc.

Express Pharma is the media partner for the event.

EP News Bureau

MARKET

CIMS Medica to organise Nutrition & Wellness 2018 conference and awards in Mumbai The event will recognise the proactive and innovative approaches that leads to the success thereby raising the standards of nutraceutical industry CIMS MEDICA will organise Nutrition & Wellness 2018 conference and awards on November 24, 2018 in Mumbai. ‘Nutrition and Wellness Awards 2018’ will recognise the excellence in nutraceutical industry under various domains including research and development, manufacturing, packaging, distribution and other support services in the areas of active ingredi-

ents, procedures, practices, technologies and finished products.

The event will recognise the proactive and innovative approaches that leads to the success thereby raising the standards of nutraceutical industry.

It will witness the presence of leading industry brands and stalwarts such as Kaizzad Capadia, Director, K11 Fitness

Management, Dr Shilpa Joshi, Founder Secretary of Indian Association of Diabetes Educators, Celebrity Leena Mogre Leena Mogre’s Fitness, Nazneen Hussain and many more respected personalities from health and wellness industry. Varied associations such as HADSA, AHPI, AFSTI and Express Pharma is the media partner for the event. Par-

ticipation companies include Nestle, Dabur, Danone, Cipla, Sanofi Pasteur and GSK. Manufacturers and distributors of dietary supplements, functional foods, medical foods and pharmaceuticals.

Dr Monica Bhatia, MD, CIMS Medica, “Globally, nutraceuticals are gaining prominence and becoming a part of the average consumer’s daily

diet. In India, the market for dietary supplements, sports nutrition products, food beverages, and weight loss products that are broadly clubbed in nutraceuticals is beginning to pick up speed since the Indians are becoming conscious about their health and external appearance.”

EP News Bureau

POST EVENTS

70 IPC to add healthcare and diagnostic to its spectrum th

This year’s IPC is going to have nearly 100 speakers and they are the cream of the industry. Few of them will be international speakers Usha Sharma Mumbai WITH JUST one months left for the 70th Indian Pharmaceutical Congress (IPC), preparations for the event are in full swing, informed committee members of IPC in its third Indian Pharmaceutical Congress Association (IPCA) meeting held recently in Mumbai.

The meeting commenced with a welcome address by Dr TV Narayana, General Secretary, IPCA wherein he thanked all the members who had joined the meeting. He especially thanked Dilip Shanghvi, President, IPCA and Founder, Sun Pharma. The meeting proceeded with a remark raised by Shanghvi that apart from pharma and academia, there is a greater need for

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MARKET the machinery manufacturers’ fraternity to be part of this edition of the IPC. BR Sikri, LOC’s Chairman informed that this year’s IPC is also focussing on the healthcare sector. Dr Naresh Trehan, Chairman and Managing Director of Medanta – The Medicity, will be the special invitee on December 21 to launch the healthcare chapter at the 70th IPC. The event will also witness attendance by leading experts of the pharma, healthcare and diagnostics segments. He also informed that a Bhoomi Poojan will be held at the venue, Amity University campus, to initiate IPC work in November.

Giving an update on the work initiated by him and Atul Nasa, Organising Secretary, with support with other LOC members, Sikri informed that they have appealed to different industry associations like IDMA, HDMA, FOPE, BDMA, CIPI and Pharmexcil to extend their support and have received positive responses from

TOPICS TO BE COVERED AT 70TH IPC AT AMITY UNIVERSITY, DATE 21-23, 2018 Presidential symposium- Pharma vision 2030 Indian Pharma Industry –A Global Leader Award memorial lectures Track I Industry Session I Session II Session III Session IV Session V Session VI

Discovering Innovative Medicines Global vs India, Trends in Medical technology and Devices in Changing Regulatory Environment for cost effective Healthcare Opportunities & Challenges in development of Similar Biologics, Indian Pharmaceutical Industry can be a global leader, Success Stories, Pharmaceutical Innovations-Out of Box Ideas Missing,

Track II Regulatory Session Session I Pharmexcil & AIDCOC, Seminar on “Indian Pharma Exports-Regulatory Challenges” Session II IPR-Roadmap for Growth through protective innovation in pharma Session III Comprehensive views on OTC product registration , License, Compliance, Safety & Risk Control Session IV Can Industry and Regulators go hand-in hand?, Track III Pharma Academia Session I Redefining the pharmacy Curriculum as per Industrial needs, Session II Research Using Animals Demisting the myth Session III Imparting Quality Pharmacy Education – Challenges?, Session IV Ethno Pharmacology – AYUSH – Traditional Medicines, Session V Women Forum Panel Discussion Track IV Pharmacy Practice Session I e-Pharmacy,Track IV Pharmacy Practice Session II Good Pharmacy Practices in Community & Hospital Settings Session III Pharmacist Yesterday,Today & Tomorrow Session IV Pharmacovigilance Streamlining pharma industry including herbal products

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MARKET them. He also gave an update on the registrations received so far. He revealed that the committee has received 2100 scientific abstracts, of which 1500 have been already evaluated.

Sikri also mentioned that there will be a session on success stories of stalwarts such as Pankaj Patel, Chairman Zydus Cadila; Dilip Shanghvi, Founder, Sun Pharma; RC Juneja, Chairman, Mankind Pharma; J Jayaseelan, National Vice President, IPA (Industry Division); Partha Sarathi Reddy, Chairman, Hetero; and Rajeev Nannapaneni, Director, Natco.

Nasa highlighted key activities related to the event and novel features of the Congress.

He divulged that different topics related to training, placement and entrepreneurship, health startup hackathon, women empowerment, international speakers and delegation, industry – academia discussions, government regulators industry discussions etc will be

This year’s IPC is going to have nearly 100 speakers and they are the cream of the industry. A few of them will be international speakers. In a unique initiative, the present LOC of IPC has constituted 28 different committees and each committee comprises seven to eight members addressed at. He also informed that a special committee has been constituted under LOC to manage industry relations.

Besides these initiatives, under the guidance of Ravi Uday Bhaskar, Director General, Pharmexcil a symposium on ‘Indian Pharma Exports – Regulatory Challenges’ will also be held. It will have key speakers from the industry as well as Indian regulators. The LOC is also trying to get Chinese regulators to attend the event, which would be a firstof-its-kind endeavour. He also

informed that gala cultural evenings, to be held on December 21-22, 2018, will also be a part of IPC this year.

Informing about scientific programmes, Dr Arun Garg, Chairperson, Scientific Committee briefed about the progress on four different tracks and speakers. He also asked the LOC members for suggestions on speakers. Taking over from Garg, Dr Ramkrishnan, Convenor, Scientific Committee provided detailed reports of each track along with speaker confirmation up-

dates. He also informed about the in-principle confirmation of Kiran Mazumdar-Shaw, Chairperson and Managing Director, Biocon for the Women Empowerment session.

It was also revealed that this year’s IPC is going to be different from previous editions, now the ratio is 60 per cent academia and 40 per cent industry. And to add more significant value to the IPC brand, the present LOC committee members are working aggressively on expanding the IPC spectrum and have added

healthcare and diagnostic sectors to it. The aim of increasing industry focus in this year’s edition is to deliberate on key issues of the industry on the IPC platform, wherein all stakeholders of pharma fraternity come together and discuss challenges and solutions. Besides this, it is the only platform where students get the opportunity to interact with industry stakeholders directly and understand the industry’s requirements.

Moreover, this year’s IPC is going to have nearly 100 speakers and they are the cream of the industry. A few of them will be international speakers. In a unique initiative, the present LOC of IPC has constituted 28 different committees and each committee comprises seven to eight members. In his vote of thanks Garg thanked everyone for taking time and sharing valuable suggestions. u.sharma@expressindia.com

CPhI Worldwide records 44,500 attendees from 164 countries CPhI Worldwide pharma survey shows improving outlook for pharma economies globally, with China and India showing the fastest improvement CPHI WORLDWIDE, closes its 29th edition with pre-audit figures showing the most international audience in the event’s history, with a total unique attendance of 44,500 – remarkably, over 39,000 of which were international.

This year’s event highlighted a number of new trends across the industry and collectively with bioLIVE – the bioprocessing and manufacturing exhibition added in 2018 – played host to more than 150+ sessions.

Held at the IFEMA center in Madrid (October 9-11), attendees came from a record 164 countries, with 47 per cent at Clevel or above.

The standout new addition at this year’s event and one of the biggest overall trends to emerge is the integration of small and large molecules – with bioLIVE bringing the biologics supply chain into the wider CPhI family.

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Sessions here highlighted the developments in ‘cell and gene therapies’, ‘biosimilars’ and ‘capacity challenges in Europe, USA and Asia’, as well as new manufacturing and processing techniques – spanning 45 hours of insights over three days.

CPhI Worldwide is widely used as a barometer of pharma’s overall health – as the only platform that brings together global pharma – and a strong event is reflective of a prosperous pharma sector. The industry looks set for an extremely strong 2019, as CPhI Worldwide received more than 103,000 visits over three days.

Emphasising the strength of global pharma over the past year, in the annual survey conducted for CPhI Worldwide, eight of ten top nations improved their overall score across all categories – with table topping nations the USA and

Germany the only countries not to improve. In fact, for the second year running Germany, Japan and the US emerged as the top-ranked, tier-one nations for pharmaceutical quality and overall score – with India and China making dramatic strides in raising their overall reputations. Host nation of CPhI Worldwide 2018, Spain, also made a significant improvement with international perception of ‘innovation emerging in the country’ rising – driven notably by the biotech hubs in both Barcelona and Madrid. However, most promising, was the improvement in growth potential industry-wide, as eight out of ten countries’ scores rose – with only Spain and China marginally lower than in 2017.

Remarkably, since the last CPhI Worldwide was held in Madrid (2015), the industry has grown extremely quickly with

attendee numbers increasing by 9,000 to nearly 44,500. Attendees from the world’s largest pharma economy also continue to grow, with visitors from the US increasing by 8 per cent in the last year, as well as an impressive 27 per cent rise from South America.

The organiser attributes this year’s stellar event to its bespoke customer focus as well as the wider market conditions in pharma. Orhan Caglayan, Brand Director adds, “The 2018 CPhI Worldwide event showcased the incredible strength of pharma, and we are seeing good growth potential across all sectors from API and finished product to bio, generics and NCEs. But what has been most significant is the internationalization of partnering; furthermore we see a wider spread of international attendees year-onyear at CPhI Worldwide. An-

other notable trend and reflected in our content programmes at the event, has been the rise of innovation in the industry, with more new products in development, but also, new technologies that lower overall production costs.”

In total, CPhI Worldwide – along with bioLIVE, ICSE, FDF P-MEC, and Innopack – featured 22 country pavilions and 19 different zones covering the entire supply chain. Finally, 4,300+ attendees viewed the sessions available throughout the event, which included a who’s who of prominent executives and experts exploring the future of the industry. The agenda included keynote speeches on ‘quality by design’, ‘introduction and implementation of continuous manufacturing’, ‘smart-packaging’, and the ‘digital future of pharma’ to name just a few.

cover )

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( mproving public health is a development priority for India, but while the country has made some noteworthy advances in this sphere, mammoth challenges remain to be conquered. And, it is growingly evident that only a strong and sustainable partnership across the entire health value chain can be the solution to tackle them.

Therefore, as India’s focus on health intensifies and the government drafts ambitious plans to make its population healthy, we would also have to take the pharma sector’s perspective to ensure access and quality in public health. Hence, one of the major discussions at the 4th edition of Healthcare Sabha - The National Thought Leadership Forum on Public Health was on ‘The Path Ahead in Public Health – A Pharma Perspective’.

An eminent panel comprising Viveka Roychowdhury, Editor, Express Healthcare and Express Pharma (Moderator); N Rajaram, MD, Sanofi India; Umang Vohra, MD and Global CEO, Cipla; Anuja Kadian, Head, Government Affairs, AstraZeneca Pharma India; AG Prasad, VP - Cluster Head, Sales & Marketing, Glenmark Pharmaceuticals, came together to highlight several pertinent factors such as access to medicines, drug pricing, patents and intellectual property, government policies and means to achieve UHC. Roychowdhury steered the discussion through the companies’ latest initiatives on increasing access, affordability and quality of medicines, healthcare in India; the panelists’ views on Ayushman Bharat and measures to make it successful, and the role of the pharma sector in Ayushman Bharat and other government initiatives.

Let’s examine a few of the most important insights shared by them and how can they be applied effectively to transform our public health system for the better.

I

Strategic investments are key to improve public health – N Rajaram

The pharma industry, one of the key stakeholders of public health, have a huge responsibility to ‘do good’ and ‘be part of the solution’

By Lakshmipriya Nair

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Rajaram was a very strong advocate for investments which would make medicines affordable without compromising on quality, for instance manufacturing technology. He informed that as a company which has been manufacturing in India over several years, Sanofi has invested over `5000 crores in upgrading their existing facilities or acquiring new ones. Hence, falsifying the general belief that MNCs only manufacture expensive medicines, 25 per cent of Sanofi’s portfolio today is priced between `1 to `5. Thus, a therapy or five-year treatment for a patient can be between `5 to `25. However to do that, he stressed on the need to build expertise for developing products at an affordable price without compromising on the quality. And, this can only be done with a capacity for large scale manufacturing.

He also laid emphasis on investments in innovating as well. He explained that it is important to develop solutions and encourage incremental innovations which would bring value to the Indian market. He cited the example of disposable insulin pens which is used all over the world. However, they are priced at `2000 and above and moreover it generates a lot of plastic. Therefore for India, Sanofi developed reusable pens which are priced at 1/10th of disposable ones. This instance is an example of how incremental innovation and out-of-the box thinking is crucial to serve the health needs of the Indian population. However, it also highlights the importance of investing in innovation and human resources to train them to

THE MAIN FOCUS

think differently.

India’s public healthcare can take a leaf out of these measures and ramp up investment in research and infrastructure creation to strengthen its current capacities and build more capabilities.

We have to aim for Universal Care Coverage Umang Vohra Vohra underlined the role of pharma companies in enabling access to medicines and informed that Cipla has always endeavoured and stood for access. He accentuated that enabling access to quality medicines in India was the vision of its Founder KA Hamied and till today, Cipla continues to be driven by this vision. However, he also stressed that now it looks at access differently and believes it to be more than just that affordability. He states that access is more about creating an ecosystem which enables and empowers the citizens to avail good quality healthcare conveniently and affordably.

He advocates that the policymakers and public health sector too should realise this and work towards for a more comprehensive strategy towards expanding healthcare access. Putting it in the context of Ayushman Bharat, Vohra lauded it as a very bold and worthy initiative but he also opined that this should only be a step towards achieving Universal Care Coverage and not just Universal Health Coverage.

Outlining some measures which could help in achieving this larger and more effective outcome, he said that Cipla, in its bid to expand access and its generics business, has ventured into most of the tier II-III areas of India and has realised that the community health centres (CHCs) and primary health centres (PHCs) in these areas could be mobilised in a better manner to enable and expand the reach of quality medicines and healthcare to these regions.

He spoke on how right diagnosis and training is essential to make ambitious endeavours such as Ayushman Bharat successful. Vohra also emphasised on the inclusion of diagnostics in the whole scheme, thus making it more than just about medicines and hospitalisation. He advocated looking beyond just costs and making Ayushman Bharat more outcomes-driven to make it effective and successful.

The public health sector should heed this timely and pertinent insight to create a 360o approach towards serving the needs of its citizens.

Government schemes should be formed in concurrence with all stakeholders - AG Prasad AG Prasad spoke at length about the importance of assuring quality of medicines to build a sustainable and effective public health system. He informed that Glenmark looks at quality at different levels and includes patient safety, environment safety and pharmacovigilance and is not only concerned about the potency of product. He informed that the company also ensures that its raw materials are sourced only from high quality manufacturers. Mirroring this practice, our public health system too needs to assure quality at each level to fortify it and strengthen it from within.

Another point highlighted is that while the government develops public health schemes it should be done with inputs from all stakeholders. He said that often good schemes do not take off and perform as expected due to

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cover ) lack of adequate stakeholder participation. For instance, Jan Aushadhi is a very good initiative taken by the Government of India but the project has not taken up the way it is expected to, primarily, because it has failed to attract reputed pharma companies.

Prasad also pointed out that often lack of clarity and tediousness in government procedures like tendering and procurement dissuade big companies from participating in these schemes.

At the same time, he also lauded AMRIT stores, run through HLL which is very successful.

He cited it as an example of good partnership between private and public institutions, wherein AMRIT stores source branded products from reputed companies with 30-40 per cent discount and offers 20-30 per cent discount to customers. CGHS and many other government sector institutions also prefer procurement through Amrit stores of HLL. He advised applying these learnings while implementing Ayushman Bharat, an insurance and assurance scheme, as its success is dependant on the quality of execution. As public private partnerships (PPP) would be crucial to success for Ayushman Bharat and all other large scale public health schemes, the government should take the views of all stakeholders involved to create a win-win situation for all.

Digital technology can make public health schemes effective - Anuja Kadian As a representative of AstraZeneca she spoke on the Anglo-Swedish company’s 40 years of presence in India and its focus areas. She informed that sustainability is inherent for their global strategy and access to healthcare is key to their sustainability strategy. Their major endeavours include measures for disease prevention, capacity building and access to medicines.

She also spoke on how spreading healthcare awareness is paramount. She stressed on

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We are going to make a very comfortable environment for innovators and manufacturers to carry out their business in India.

We are taking measures to improve ease of doing business in India, be it clinical research or manufacturing in India.

Dr S Eswara Reddy DCG(I)

We need to build expertise for developing products at an affordable price without compromising on quality. And, this can only be done with a capacity for large scale manufacturing N Rajaram MD, Sanofi India

It is important to look at quality at different levels including patient safety, environment safety and pharmacovigilance and not just at the potency of products AG Prasad VP- Cluster Head, Sales & Marketing, Glenmark Pharma

Access is more than just that affordability. It is about creating an ecosystem which enables and empowers the citizens to avail good quality healthcare conveniently and affordably Umang Vohra MD & Global CEO, Cipla

Through effective use and application of digital technologies, it is possible to gather empirical evidences about public health priorities for the country and important clusters of population that need to be served Anuja Kadian Head, Government Affairs, AstraZeneca Pharma India

the importance of not only looking at curing diseases but also encouraging healthy living and elaborated on strategies such as CSR funds effectively to expand access to medicines and healthcare. Throwing more light on AstraZeneca’s efforts in this direction, she spoke on their young health programme which focusses on spreading awareness.

She revealed that till date they have reached 2.5 lakh adolescents directly and intend to set up several centres of excellence to spread access. They also promote healthy living as part of their access programmes.

But, the most important takeaway from her was how the use of digital technologies can help reform and improve public health. She spoke on how it is gradually being implemented in the pharma sector to come up with products and processes which are more efficient and efficacious and recommended using these technologies on a large scale to make public health schemes like Ayushman Bharat more successful.

She opined that robust monitoring systems, gap analysis, creating data sets etc are essential to make an ambitious public health plans successful, including Ayushman Bharat. Through effective use and application of digital technologies and ICT technologies, it is possible to gather valuable data sets which would enable us to gather empirical evidences about the public health priorities for the country as well as important clusters of population that need to be served. This, in turn, would help develop targeted interventions and schemes which would get the desired outcomes.

Role of the regulator Thus, each one of the panelists reiterated and underlined the endeavours of their organisation in creation of value to improve patients’ well-being, and contribute significantly to the quality and protection of life.

At the same time, their insights also carried a lot of learnings to improve public health. They also explained that the access puzzle

( can be resolved only through a mix of measures which would be dependent on medical expertise and good governance as well as efficient healthcare and supply systems.

And, the role of the regulator in ensuring all these and helping the pharma industry live up to its potential in an ethical manner is paramount. Hence, Healthcare Sabha had also invited the Eswara Reddy, DCG(I) to present his vision and objective for the pharma industry and augment its role in ensuring an effective public health system.

He informed that as the DCG(I), one of his major objectives is to build trust and confidence in the public mind about the quality of medicines that are manufactured, distributed, sold and exported from India.

The second objective is to

THE MAIN FOCUS

Be it for research and training personnel or re-evaluating our health policies and effective reallocation of resources, multi-stakeholder approaches will be pivotal to build an effective public health system work towards building a positive image of the Indian drug regulator in the public mind. He also spoke about the measures introduced to ensure quality of the products and to make drug regulators accessible. He further stated that they have a public relations office where manufacturers, start-ups and innovators can visit or call to clarify doubts, get information and resolve their problems. Measures are also being into place to assure quality,

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fight counterfeits and make our systems more transparent.

He said, “We are going to make a very comfortable environment for the innovators and manufacturers to carry out their business in India. We are taking several measures to improve ease of doing business in India, be it clinical research or manufacturing in India. We are also open for any national and international audits to ensure that we are fully compliant with the

Drug & Cosmetics Act. ”

Going forward In the past 60 years, innovation and technology have driven huge improvements in global health. However, be it for research and training personnel or reevaluating our health policies and effective reallocation of resources at national and local levels, multi-stakeholder approaches will be pivotal to build an effective public health system

which can serve our present and future needs.

And, the pharma industry, generally acknowledged to be one of the most powerful economic sectors across the globe, is also one of the key stakeholders of public health with a very significant role to play alongside governments, international organisations, (NGOs) and others.

So, the companies themselves also have a huge responsibility to ‘do good’ and ‘be part of the solution.’ This would mean putting systems in place to enable compliance to national laws, protecting the environment, monitor performance, encourage transparent communication and enhance accountability. lakshmipriya.nair@expressindia.com

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MANAGEMENT I N T E R V I E W

'Under GDUFA II, FDA has committed to clean up inaccurate, inconsistent and missing information and verify data integrity' DuPont Nutrition & Health's regulatory team, from direct participation on joint IPEC and FDA working groups, has the expertise to assist its customers with understanding the FDA requirements for using the IID and developing bridging justifications, informs Priscilla Zawislak, Global Regulatory Affairs Advocacy Manager & Tejas Gunjikar, South Asia Technical Application Leader at DuPont Nutrition & Health, in conversation with Usha Sharma Tell us about the complexities and challenges associated with the US FDA Inactive Ingredient Database (IID).

The change in 2011 to list each excipient grade and UNII code with information from the GSRS has created a lot of confusion in the industry. The current database is incomplete and has missing information.

Under GDUFA II FDA has committed to clean up inaccurate, inconsistent and missing information and verify the data integrity. FDA has been updating the IID on a quarterly basis. Users are recommended to check items of interest each time since information can change.

Maximum potency is a source of confusion, it is not a MDI.

FDA has also committed under GDUFA II to adding a column in the database for MDI and will eventually populate it.

Nomenclature in the IID comes from the GSRS which is the ‘preferred name’ and may not be the compendial name.

Tradenames, sometimes referenced in the IID are being removed. The GSRS has a listing of synonyms for the preferred name which may include the compendial name and trademarks.

US FDA has revised Refuseto-Receive Guidance for ANDAs submission, tell us about the revised guidelines and their impact on the pharma industry?

If the excipient being used is

not listed in the IID based on the route of administration and dosage form it is considered a novel excipient by FDA and a bridging justification is needed in the ANDA to use the information in the IID to support other grades, route of administration, dosage form or level of use. The bridging justification must include the context of use in the specific formulation and this information must come from the drug product manufacturer.

The excipient supplier usually can only provide safety and toxicology information for the excipient. FDA requires that the bridging justification ‘tell the story’ which includes the context of use of the excipient in the specific drug product

formulation. It is recommended to submit a Controlled Correspondence to request information about MDI. The CC must include details of the specific formulation, excipient, route of administration, dosage form and level of use.

Providing the bridging justification in the CC is often recommended before submitting the ANDA. FDA has been asking for toxicology studies for each grade of excipient but toxicology is typically the same within a polymeric excipient family.

Studies are not conducted in individual grades. Rather, a ‘bracketing’ approach is used that is representative of all grades within the family. This is one of the reasons a bridging

justification must be provided to ‘bridge’ the information between grades.

How does DuPont Nutrition & Health support customers on the use of excipients in oral solid dosages?

DuPont N&H has toxicology summaries for many of our excipient products that can be used to support bridging justifications. Our regulatory team, from direct participation on joint IPEC and FDA working groups, has the expertise to assist our customers with understanding the FDA requirements for using the IID and developing bridging justifications. u.sharma@expressindia.com

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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. ❒ We welcome information on new products and services introduced by your organisation for our various sections: Pharma Ally (News, Products, Value Add), Pharma Packaging and Pharma

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AI in pharma: Anew perspective Dipankar Kaul -Head GMP Audits, Asia-Pacific- Novartis Technical Operations, envisages the many ways in which AI can transform pharma manufacturing operations and the present perspective of the science of pharma development, manufacturing and quality assurance AS THE pharma manufacturing plants operate on computerised/programmable logic-controlled machines, instruments or technologies within fixed operating parameters to produce products of standard quality and specifications, compatibility towards highly automated and robotic machineries is evident.

Through integration with AI self-learning machines, these complex operations can be simplified to a greater degree.

The further development of these technologies will facilitate ensuring that these operations become more intelligent and efficient; however, they pose a challenge for the policy makers and regulators to redefine our knowledge of the current good manufacturing practices.

Some of the AI applications useful in text, speech, and video recognition can be utilised further to interpret the pattern and convert it into a meaningful and chronological script of events. While this will certainly reduce the time and increase the efficiency, it will also enhance the reporting quality. Machine learning thus employs statistical applications to identify patterns in the data then make predictions using those patterns. The AI lead machine-learning processes are capable of reading and recognising the key process parameters responsible for raising product quality.

Academics, researchers and a few industry players have been working on AI for several decades now, from as far back as 1955 when John McCarthy coined its definition. [1] Substantial material has already been published on AI and its prospects; however, its usability in various industrial and commercial applications is yet to be fully applied

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MANAGEMENT and benefitted. As stated, not all technological revolutions are straightforward and thus, in like manner concerns continue to arise on the ways that AI will integrate within the domain of pharma engineering and regulatory compliance. At least, this is the dilemma confronting the current pharma scientists, engineers and manufacturers. There is an interesting cultural challenge to overcome, which is technological innovation that supports AI, while the pharma industry has been built on a strong backbone of ‘traditional’ science that the regulators expect.

A cautious approach has been made by data scientists from various tech giants, who are continuously engaged in constructing some of the AI systems for the pharma industry which has a necessary fence of regulations and is controlled by the health authorities. The present need is to determine that AI solutions are both feasible for use, and safe for adoption.

Perhaps many such technologies had existed earlier, but today they are poised to become mainstream systems with advancements in technologies brought in by IT giants. At the same time, the increase in automation and emergence of new technologies within the pharma industry over the last decades have altered our perspective of the science of pharma development and manufacturing operations. Also, the global expectations of the health authorities, to rationalise and validate pharma processes right from the moment of their development and establish scientific rationales undergirding the principal quality attributes and controlling measures are gaining greater acceptance. Consequently, the systems used to automate the process steps during manufacture, which are uninterruptedly evolving with the implementation of new instrumentation, are well within the gamut of regulatory compliance and this further diversifies the need for various autonomous technologies.

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Integrating machine learning with pharma operations Plant efficiency and reliability are often cited as the potential reasons for developing and applying AI techniques, developing a variety of algorithms and expert systems to the control and operations. [2] AI is otherwise referred to as a process of evolving machines or a device to communicate, learn, plan and solve problems in a manner similar to the ways humans do.

Machine learning lies at the core of AI. Learning in the absence of any kind of supervision requires an ability to identify patterns in the streams of inputs, whereas learning with adequate supervision involves classification and numerical regressions. [3] Although, over time, machines become increasingly capable, and some of the tasks are removed from the list of ‘intelligence’, for e.g. playing chess is no more considered by some as AI which continues to be debatable as AI continuously evolves. However, with various technology giants, robotics companies and IT start-ups expressing greater interest and venturing into AI, the boundary between automation and AI appears to be more

distinct. Therefore, innovative ideas continue to appear almost every year, and inventing autonomous machines is signaling the beginning of the AI revolution.

AI and pharma product development AI applications have already been established and proven for pharmaceutical development. There are various publications demonstrating successful AI interfaces to develop pharmaceutical formulations or predict high yielding combination of chemical reactions. Utilising AI in technology can save time, money and resources, while providing a better understanding of the relationships between the different chemical reactions, physical processes and other related process parameters.

The right algorithms, which are a set of rules to be followed in order to calculate or perform problem-solving operations using computing devices, are fundamental to the designing of the AI architecture for a process industry.

Neural networks are such rapidly growing technologies that can be applied to the development and processing of pharma substances and

products. Neural networks are the learning algorithms used within machine learning. In the recent years, neural networks have been demonstrated to be able to offer an alternative approach. Neural networks are mathematical constructs with their capacity to “learn” relationships within data, with no prior knowledge required from the user.

The current trends in pharma sciences portend a good outcome with the developments of information technology and AI. The “Quality by Design” cited in the ICH Q8 Guideline, provides enhanced scientific understanding of critical process and product qualities using the knowledge obtained during the life cycle of a product. In light of this development, “design space” is the area in which a product can be manufactured within acceptable limits.

The Neural Network generates and assesses a range of models to identify the one that will best fit the experimental data provided to it. As such, increasingly, artificial neural networks (often termed ANNs) are used to model complex behaviors in issues like formulation and processing of pharmaceuticals. [4] To create these spaces, artificial neural networks (ANNs) can be trained to emphasise the multidimensional interactions of the input variables and closely bind these variables to a design space. This assists in guiding the experimental design process to include interactions among the input variables, together with the modeling and optimisation of the pharma formulations. [5] There are various machine learning algorithms viz. genetic algorithms or fuzzy logic which have proven to be effective and useful tools in predicting the results that arise from alterations in the input parameters, such as the formulations. Using this approach with neural networks can be productive as it provides “what if” predictions and optimisations. [6] The objective of this paper is to develop an integrated multivariate approach to obtain quality products based on a sound

understanding of the cause–effect relationships between the formulation ingredients and product properties, employing trained ANNs and genetic programming. The data are generated through the systematic application of the principles of the design of experiments (DoE) and optimization studies using artificial neural networks and neuro-fuzzy logic programmes. [7] The functioning supporting AI in product development arises from the predictive and deep learning algorithms which recognise patterns and continuously track the input versus output data and accordingly regulate the most suitable design space. This approach generates experimental data within all the possible sub-sets of the variables which could be referred to later on during the entire lifecycle of the product. This approach of using trained algorithms maps dealing with an input to an output and developing knowledge-space (a summary of all the knowledge obtained during product development) is in accordance with the approach of quality by design.

AI and pharma manufacturing operations The pharma manufacturing plants which operate on computerised/programmable logiccontrolled machines, instruments, gadgets or technologies are gearing up to incorporate innovations in therapies and new drug delivery systems. These plants operate within fixed operating parameters to produce products of standard quality and specifications, compatible with highly automated and robotic machineries. These complex operations can be further simplified by integrating with the AI-driven technologies or self-learning machines. These developing technologies will enable operations to become intelligent and efficient, although they pose a challenge for the policy makers and regulators to redefine the way we understand the current good manufacturing practices (cGMPs). As the GMPs require manufacturers of drugs

MANAGEMENT and medical devices etc., to take proactive measures to ensure that their products are safe, pure, and effective, these pharma manufacturers are accountable to demonstrate that their technologies are suitably qualified and validated to consistently produce products of standard quality and efficacy.

Therefore, machine learning involves connecting good manufacturing practices (GMPs) with AI, in a way that the algorithms can recognise any inconsistency within the process and accurately detect them. A variety of sub-process viz. granulations, compression, blending for formulations and chemical synthesis for API manufacturing can be optimised on real-time basis to get standard quality of the inprocess bulk. These machines will continuously track and control the process attributes and retain the right recipe for the formulation to maintain the dosage accuracy. What characterises these machines as being different from the present automated machines are the machine learning algorithms or mechanisms by which the continuously collected data will be utilised to make informed decisions on real-time basis. The synergy of robotics and AI can therefore revolutionise the entire spectrum of pharma operations as is possible in any other manufacturing sector.

Therefore, conventional manufacturing processes may undergo a paradigm change.

Processes like granulation or compression of tablets or a progressive chemical synthesis in a chain of reactors can be rapidly achieved by eliminating or combining specific processing unit operations.

This could involve either simply eliminating tasks that are no longer necessary or using deep learning machine algorithms for equipment that can operate machines to simultaneously perform more than one unit of operation at a time (multi-tasking).

While machine manufacturers mainly focus on eliminating the ‘Out-of-Specification’ (OOS) products, the AI-enabled machines will emphasise a means of rejecting

the root-cause(s) for the output going ‘Out-of-Specification’. Understanding the logics and patterns, predicting the variations and adjusting the

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process beforehand will preempt unnecessary product failures. This will also minimise any redundancy in the process, improve the yield,

ensure consistency and stabilise quality.

Besides these operational benefits, the AI-enabled processes will exhibit

complete regulatory compliance. Regulatory compliance can be achieved and established through continuous monitoring, tracking not

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MANAGEMENT merely for the key process parameters alone but also by generating, compiling and evaluating the online process data. The challenge for the future is to first integrate the AI technologies with the existing machines so that the process data can be collected online, evaluated and the precise decision-set applied on a realtime basis.

As an intelligent machine which actively participates in the production process, in this context, should be able to exchange information and control these processes in real time, thus enabling the production to run in a fully automatic and compliant manner.

The machine controls the digital receipt of the incoming order, and even the individual if necessary, as well as the product planning, request for the materials required, production as such, order handling and even product shipment.

Once done, these intelligent machines will be able to take complete control of the pharmaceutical manufacturing operations such as: ◗ Data acquisition and supervisory controls for real time assessment of unit operations in compliance with Process Analytical Technology (PAT) – no destructive testing and continuous quality assurance for individual units (in case of formulations). ◗ Process forecasting and predictive maintenance, with sensors tracking the operating conditions and performance of tooling, to predict breakdowns and malfunctions and track or recommend preemptive actions. [8] ◗ Simple and easier investigations for non-compliances and out-of-specifications tests using intelligent algorithms that identify the root-cause(s) and take macro- or micro-decisions which may rectify or reboot the process, while generating the complete record of historical events or troubleshooting. All the related processes – from manufacturing and packaging to warehousing and shipment – are consolidated within minutes to analyze and determine noncompliance to business and quality rules and procedures.

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The challenge for the future is to first integrate the AI technologies with the existing machines so that the process data can be collected online, evaluated and the precise decision-set applied on a real-time basis ◗ Auto-controlled processes will involve negligible chances of human intervention resulting in the reliability of processrelated data.

The next challenge is to validate these systems and integrate the technologies to the total satisfaction of the individual manufacturer and of the health authorities, such as the US Food and Drug Administration.

Process validation for drugs involves legally enforceable requirements under CFR 501 (a) (2) (B), required by the GMP regulations in parts 210 and 211. Regulatory requirements require manufacturers to design a process, including operations and controls, which will result in a product fulfilling its critical quality attributes.

As an alternative technique for process validation where the manufacturing process performance is continuously monitored and evaluated and further tracked after performance qualification, there is a continuous quality verification (CQV) in which the manufacturing process (or supporting utility system) performance is uninterruptedly monitored, evaluated and adjusted as necessary. The CQV moves away from validation as a discrete exercise and is consistent with a lifecycle approach to process validation. These expectations of the regulatory agencies will evidently be satisfied by AI and its applications through machine learning tools.

Therefore, the innovations in AI, the cutting edge scientific and engineering knowledge in pharmaceutical manufacturing, together with the principles of quality management will be incorporated within the framework built on process understanding and risk-based regulatory decisions by the industry and

health authorities.

Enabling AI in quality assurance & regulatory compliance Based upon its wide scope as a human-technology interface (HTI), either through predictive text, speech, gesture or pattern recognition, AI finds use in diverse applications for quality assurance and quality systems management. These applications can come from real-time detection of noncompliances, risk assessment, implementing remedial actions or predicting variations and thereafter via reporting of these facts.

Different types of rapidly emerging AI technologies have further appeared to contribute to communication with machines, computers or other objects. Some of these technologies are beginning to transform the ways humans track, use and manage anything from match commentaries in sports, interpretation of legal judgment to product quality and customer outcomes. AI is becoming a popular means of making more informed decisions. Here, it is worth sharing one of the interesting cases during the 2015 Wimbledon Tennis Championship, where machine learning algorithms were used to automatically turn match statistics and sensor data collected during each game into automated news stories which read as if sports journalists had written them. [9] Such applications which are useful in text, speech, and video recognition can be further utilised to interpret the patterns and convert them into chronological and meaningful script of events. While this certainly minimises the time and increases the efficiency, it also improves the reporting quality. Machine

learning thus utilises the advanced applications of statistics to identify patterns in the data and then make predictions from those patterns. AIdirected machine learning processes have the capacity to read and recognise the principal process parameters responsible for building product quality.

A long time ago Google proved the value of a program me that can read text. Their search engine algorithm revolutionised internet search, and continues to do so with every advancement. However, it is one thing to detect whether a document contains a certain word or phrase and quite another to understand its context. The newer AI technologies are capable of accomplishing such deep learning, enabling the machines to understand the context and accordingly respond.

Investigations and root-cause identification through pattern detection algorithms According to Carmelo Rosa, Director Division of Drug Quality, US FDA, since the last 10 years, inadequate or the complete lack of thorough investigations have been true of the fiver top-most GMP violations / deficiencies cited during FDA inspections. The deficient Out-of-Specification (OOS) investigations represent risk to patients and thus compromise either safety or efficacy. The FDA continues to observe a lack of scientific rationale to support the investigative conclusions which primarily are as listed: ◗ Insufficient knowledge to support conclusions and decisions not readily available or not clearly communicated. ◗ No additional understanding or insights are available regarding the reason the prob-

lem may have occurred and thus offers no hope for prevention. ◗ The CAPAs are not evaluated and are often ineffective.

[10]

Algorithms are being developed which can determine whether a sentence is positive or negative, and its context within a document, besides other information. [11] Due to these developments in personalization and machine-human interactions, AI is more efficient than ever in pattern recognition, in which friendly machines mimic human investigation patterns to provide fast, easy and authentic service for the senior management. These applications, can thus be utilized for various routine investigations in the pharmaceutical operations during product failures, noncompliance or for Out-of-specification test results.

In order to automate processes involving human level of intelligence, some algorithms and technologies necessitating human-level intelligence are needed. These new algorithm-enabled machines will have the capacity to more accurately capture the events, key process attributes on a real-time basis and speedily identify the areas of anomalies in the process. Fortunately, researchers and companies have developed a myriad of techniques that can dramatically improve automation which is the strong point of AI – viz., business decision making.

Such information will be chronologically transcribed, as well as have captured even minute technical details of the root-cause to create comprehensive and scientifically valid investigation reports.

Therefore, the organisation that implements meaningful real-time process surveillances and processes for their investigations will both strengthen their business base, as well as produce sustainable improvements in their productivity, regulatory compliance and product quality.

AI in pharma process risk assessment AI advance technology platforms — in fact, cognitive

MANAGEMENT computing, in particular, can address complex situations that are defined by ambiguity and uncertainty. Cognitive computing has commenced to make inroads into augmenting business decisions and power performances alongside with human thought process and traditional analytics.

In fact, the domain of risk management relates well to cognitive computing capabilities, as typical risk issues often include unlikely and/or ambiguous events. The cognitive capabilities, including data mining, machine learning, and natural language processing, are replacing traditional analytics and being applied to these massive data sets to enable indicators of known and unknown risks to be identified.

As the pharma products or processes include their own associated intricate risks, clearly evident from the fact that manufacturing involves various components, there is necessarily a certain degree of risk. This quality risk is only one component of the overall risk. Therefore, product quality must essentially be maintained throughout the lifecycle of the product in a manner that the attributes crucial to the quality of the drug product remain consistent with those used in clinical studies. [12] Patient protection, performed by risk management in the quality system and manufacturing process, is being allocated supreme significance in the pharma industry. As revealed by the ICH Q9, several components are involved in the overall risk assessment model – risk identification, risk analysis, risk evaluation, risk control (risk reduction / risk acceptance), output after which a continuous review of events is performed as the risk review. Each component is evolved by utilising the massive data gathered from several different permutations and a combination of the process parameters, machine settings and associated variables. The pharma manufacturers simultaneously employ several quality management tools to produce an appropriate risk-assessment model for both their products and

processes. Therefore, for patient protection, enormous amount of data is compiled and meaningfully evaluated through scientific knowledge.

The degree of effort and documentation of the quality risk management processes must be commensurate with the level of the risk.

Using AI to manage risk is especially beneficial when unstructured data needs to be handled and evaluated. This implies the type of information

that does not fit neatly into structured rows and columns.

Cognitive technologies, like natural language processing (NLP), use advanced

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MANAGEMENT algorithms to analyse the text to draw insights and direction from unstructured data.

Conclusion To summarise, at the present time a paradigm change is being observed, with engineering principles and productprocess design becoming the main principle guiding pharma development and manufacturing. This implies, we are adopting a pattern of thinking, based on which pharma operations and related manufacturing processes are simultaneously and quantitatively being considered. However, we continue to be in the process of understanding and integrating various technologies currently available which can learn, predict and/or measure compound properties, operational attributes, and define and characterise their constitutive behaviour.

Although, the conclusion drawn is that a large part of

the fundamental knowledge and technical tools in the AI space exist for the implementation of innovative pharma manufacturing operations, further work is definitely required, particularly at the interfaces between the pharma sciences, regulatory compliance and software engineering, in order to make substantial contribution to the successful operation of the pharma and chemical industries.

Bibliography & References [1] What is Artificial Intelligence Exactly? Video presentation by Cold Fusion, YouTube.

[2]Applications of Artificial Intelligence to reactor and plant control, John A. Bernard, Elsevier Science, Nuclear Engineering and Design 113 (1989) 219-227.

[3]What does Artificial Intel-

ligence (AI) mean? [Definition] https://www.techopedia.com/definition/190/artificial-intelligence-ai [4]Artificial intelligence in pharmaceutical product formulation neural computing.

S. IBRIC, Z. DJURIC, J. PAROJCIC, J. PETROVIC. Chemical Industry & Chemical Engineering Quarterly 15 (4) 227-236 (2009). [Page 227228] https://www.researchgate.net/publication/41137691_Artificial_intelligence_in_pharmaceutical_p roduct_formulation_Neural_ computing [5]Quality by Design Approach: Application of Artificial Intelligence Technique of Tablets Manufactured by Direct Compression. B Aksu, A Paradkar, M de Matas, Ö Özer, T Güneri, and P York.

AAPS PharmSciTech. 2012 Dec; 13(4): [1138–1146] https://www.ncbi.nlm.nih.gov /pmc/articles/PMC3513460/

[6]Quality by Design Approach: Application of Artificial Intelligence Technique of Tablets Manufactured by Direct Compression. B Aksu, A Paradkar, M de Matas, Ö Özer, T Güneri, and P York.

AAPS PharmSciTech. 2012 Dec; 13(4): [1138–1146] https://www.ncbi.nlm.nih.gov /pmc/articles/PMC3513460/ [7]Quality by Design Approach: Application of Artificial Intelligence Technique of Tablets Manufactured by Direct Compression. B Aksu, A Paradkar, M de Matas, Ö Özer, T Güneri, and P York.

AAPS PharmSciTech. 2012 Dec; 13(4): [1138–1146] https://www.ncbi.nlm.nih.gov /pmc/articles/PMC3513460/ [8]3 Advances changing the future of artificial intelligence in manufacturing, by Peter Dorfman, https://www.autodesk.com/r edshift/future-of-artificial-intelligence/

[9]5 Ways Machine Learning is reshaping our world, Bernard Marr, Oct 22, 2015, Forbs, https://www.forbes.com/sites/ bernardmarr/2015/10/22/5ways-machine-learning-is-reshaping-ourworld/#76960a13641a [10]Laboratory OOS investigations The Missing Link.

Carmelo Rosa, Director Division of Drug Quality I, http://www.ipaindia.org/staticfiles/pdf/event/Session10-Laboratory-OOS-Investigations.pd f [11]5 Ways Machine Learning is reshaping our world, Bernard Marr, Oct 22, 2015, Forbs, https://www.forbes.com/sites/ bernardmarr/2015/10/22/5ways-machine-learning-is-reshaping-ourworld/#76960a13641a [12]ICH Q9, Quality Risk Management, www.ich.org

REPORT

Pancreatic cancer treatment heads in promising direction Despite the disappointing history of drug development in pancreatic cancer, the current therapeutic pipeline and clinical development is headed in a promising direction, according to GlobalData, a leading data and analytics company DRUG DEVELOPMENT has been highly challenging and replete with failure stories of pipeline agents investigated in pancreatic cancer, despite treatment algorithms being dramatically improved in many oncology indications. The very low success rate in clinical development stems to a great extent from pancreatic tumours being highly resistant to treatment. This is attributed to thick stromal tissue within pancreatic tumours which in turn contributes to immunosuppression and limited access

28 EXPRESS PHARMA November 16-30, 2018

of therapies to the tumour site.

Volkan Gunduz, Oncology and Hematology Senior Analyst, GlobalData, says, “While previous clinical development programmes directly targeted tumor cells, current clinical development includes Phase III programmes which are specifically or co-targeting stromal tissue along with the tumour itself.”

Among these agents is AbbVie and Johnson & Johnson’s Bruton’s tyrosine kinase (BTK) inhibitor Imbruvica (ibrutinib), which eliminates tumour pro-

moting survival signals from the tumour microenvironment.

Another therapeutic candidate, Halozyme’s PEGPH20 (pegvorhyaluronidase alfa) degrades hyaluronan, a component of the tumor stroma and thereby makes the tumor tissue more permeable to drug delivery.

Meanwhile, preclinical research is identifying novel targets that could inspire further clinical development. Recently, emerging research from University of Texas MD Anderson Cancer Center in Houston

identified Dickkopf-3 (DKK3) protein to be highly abundant in pancreatic tumour stroma.

Targeting DKK3 in mouse models of pancreatic cancer resulted in immune cell infiltration and prolonged survival.

Compared to healthy individuals, DKK3 levels are four and a half times higher in people with pancreatic cancer, making it a feasible therapeutic candidate.

Gunduz continues, “While pancreatic cancer progresses rapidly following diagnosis, it is estimated that it takes an average of about ten years from the

initiating tumorigenic mutation to formation of a sizable tumour and metastatic spread to other parts of the body.”

“There is a large window of opportunity here, where a better understanding of the disease evolution in this time frame could lead to development of more specific early diagnostic techniques, more effective novel treatment approaches, and identification of patient populations that will benefit most from novel therapies.”

EP News Bureau

RESEARCH UPDATES

Lilly says diabetes drug Trulicity reduces heart risks in trial The company did not provide any details on the magnitude of risk reduction seen in the so-called outcomes trial li Lilly and Co said that its topselling diabetes drug Trulicity significantly reduced the risk of heart attack, stroke and heart-related death in a broad range of people with type II diabetes, according to results of a large clinical trial.

The company said Trulicity is the first type II diabetes medicine to show this sort of statistically significant heart risk reduction in a clinical trial in which a

E

can begin to promote its heart safety benefits.

Trulicity belongs to a class of drugs called GLP-1 analogues that stimulate insulin production.

Other drugs in the class, including Novo Nordisk’s Victoza and GlaxoSmithKline’s Tanzeum, have also shown they reduce cardiovascular risks in diabetes patients. But those trials had a significantly higher percentage of high-risk

majority of patients did not already have heart disease.

“The population that we’ve studied, with and without cardiovascular disease, certainly makes these results interesting and applicable to a broad population,” Brad Woodward, senior medical director of Lilly Diabetes, said in an interview.

The company did not provide any details on the magnitude of risk reduction seen in the so-called outcomes trial. It said it will disclose the full results at the American Diabetes Association meeting in June, and plans to submit the data to regulators for review next year.

Once regulators agree to allow the data to be added Trulicity’s label, Lilly

patients with established heart disease.

Only 31 per cent of those in the 9,901patient study had heart disease, the company said.

The trial compared 1.5 milligrams of Trulicity once a week to placebo, with the primary goal a reduction in a composite of major adverse events that included non-fatal heart attack, non-fatal stroke and heart-related death.

Trulicity is expected to generate more than $3.1 billion in sales for Lilly this year, according to analyst estimates.

Lilly said the safety profile of Trulicity observed in the study was generally consistent with drugs in the class.

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Reuters

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RESEARCH

Novel antibacterial drugs developed at University of Eastern Finland In the era of increased antibiotic resistance, it is necessary to focus on developing new antibacterial agents

RESEARCHERS AT the University of Eastern Finland have developed novel antibacterial compounds, focussing on the role of LsrK kinase. LsrK kinase is a protein involved in bacterial communication. In a new study published in ChemMedChem, the researchers explore LsrK kinase as a target in antibacterial drug design.

In the era of increased antibiotic resistance, it is necessary to focus on developing new antibacterial agents. Rising resistance alarms us following the traditional mechanisms of antibiotics for drug development. Addressing this, the INTEGRATE consortium focussed on validating novel targets that can be used in future antibacterial drug development. Quorum sensing (QS) is a process of bacterial communication involved in the host

30 EXPRESS PHARMA November 16-30, 2018

colonization, virulence factors production, biofilm formation and infection establishment.

Consequently, the investigation of quorum quenching and inhibiting agents, which would interfere with the production and processing of QS mediators, has become a new strategy for developing antivirulence agents.

QS is mediated by signalling molecules called autoinducers (AI) in a population density dependent manner. The AI-2 signalling molecule is, derived from precursor 4,5-dihydroxy2,3-pentanedione (DPD), involved in both intraspecies as well as in interspecies communication. LsrK is a kinase involved in the phosphorylation of AI-2 molecules, which (i.e. the phosphorylated form of AI2) further regulates the QS pathway. Thus, inhibiting LsrK can lead to quorum sensing

inactivation and interfere with the pathogenesis.

There are no reported inhibitors or protein structure of LsrK (until 2018). Thus, University of Eastern Finland researchers initiated the drug design efforts by modelling the LsrK protein structure using computational methods. The modelled protein structure was used for the screening of the compound library available at the Institute for Molecular Medicine Finland. The prioritised hits were tested in experimental assays for LsrK inhibition at the University of Helsinki. This study resulted in two primary hits, which were further confirmed by an analogue based approach. This analogue approach resulted in four more hits of micromolar activity against LsrK. The identified LsrK inhibitors through this study are the first class of LsrK inhibitors reported to date. These hits will be further optimised to achieve high affinity and function as useful tools for improving our understanding towards inhibition of LsrK in the AI-2 pathway and its significance as a potential antivirulence strategy. Considering the limited knowledge about LsrK structure, our study offers a great overview of the behaviour of the protein and a perfect starting point to better understand the protein-substrate dynamics and how to interfere with it.

The study was conducted in collaboration with the University of Helsinki. Computational resources were provided by the CSC – IT Centre for Science.

EP News Bureau

Novartis abandons effort for US approval of biosimilar rituximab The decision comes after the US Food and Drug Administration (FDA) sought additional information to support the company’s application for the drug NOVARTIS International said that its Sandoz division is abandoning an effort to gain US regulatory approval for a biosimilar of rituximab, a medication used to treat certain cancer

monoclonal antibody used in non-Hodgkin’s lymphoma and rheumatoid arthritis, had more than $4 billion in sales in the US in 2016.

A biosimilar is a biologic

and rheumatoid arthritis.

The decision comes after the US Food and Drug Administration (FDA) sought additional information to support the company’s application for the drug, which is approved already in the EU, Switzerland, Japan and Australia, the company said in a statement.

“We are disappointed to have to make this decision and stand behind the safety, efficacy and quality of our medicine,” said Stefan Hendriks, global head of biopharmaceuticals at Sandoz.

Rituximab is a biosimilar drug referencing a Roche Holding medication marketed as Rituxan in the United States, Japan and Canada and as MabThera elsewhere. According to analysts, Rituxan, a

drug that is virtually identical to the reference product.

An FDA committee in October recommended approval of Truxima, another biosimilar for rituximab, from South Korea’s Celltrion and Israel’s Teva Pharmaceutical Industries. Approval is expected in late November or December.

Sandoz said it is committed to a robust biosimilar portfolio.

It has seven approved biosimilars worldwide, three of which are approved in the US. Sandoz received a complete response letter from the USFDA, a communication that tells a company that its application cannot be approved in its current form - for biosimilar rituximab on May 2.

Reuters

RESEARCH

Anesthesia in early childhood not tied to developmental problems YOUNG CHILDREN who had surgery under general anesthesia were no more likely than their siblings who weren’t exposed to anesthesia to experience developmental challenges that impair school readiness, a Canadian study found.

Some previous studies suggest that the opposite might be true: that the developing brain might be injured by anesthesia drugs early in life, researchers note in JAMA Pediatrics. But much of that research has been based on studies in animals and in labs, not in children having surgery.

For the current study, researchers examined data on almost 11,000 pairs of siblings, including about 370 pairs with both siblings exposed to surgery under general anesthesia

and roughly 2,350 pairs with only one sibling with anesthesia exposure.

While children exposed to anesthesia did appear to have a slightly higher risk of developing physical health issues or challenges in social, emotional or communication skills than their siblings who didn’t have surgery, these differences were too small to rule out the possibility that they were due to chance, once researchers accounted for kids’ age at surgery and other factors that might also impact development.

“The findings of the current study should reassure parents of young children who require anesthesia for surgical procedures,” said lead author Dr. James D. O’Leary, an anesthesiologist at the Hospital for

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Sick Children (SickKids) in Toronto and the University of Toronto.

“However, interpreting the clinical implications of anesthesia-related neurotoxicity is challenging, and more definitive clinical studies providing high-quality evidence of a relationship between exposure to anesthesia and neurological in-

jury are still required to guide treatment decisions,” O’Leary said by email.

Most of the kids who had surgery - about 60 percent were at least two years old at the time of their operations and the majority - almost 80 percent - didn’t have overnight hospital stays.

The most common procedures included operations to fix problems with the ears, mouth and throat, male genital organs or musculoskeletal system.

In the pairs with one sibling who had surgery and one who did not, there was no difference in the proportion of kids who had delays in language and cognitive development, social skills, emotional health and maturity, or communication skills.

The study included all chil-

dren eligible for public or Catholic schools in Ontario, Canada, from 2004 through 2012.

Researchers examined data a questionnaire that teachers completed to assess child development before children entered primary school when they were five to six years old.

One drawback of the study is that it wasn’t a controlled experiment designed to prove whether or how exposure to general anesthesia during surgery might directly impact brain development in early childhood. Another limitation is the analysis excluded kids with assessments that pointed to potential behavioral, learning or developmental problems.

Reuters

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PHARMA ALLY VENDOR NEWS

Lonza in agreement with Platinum Equity Platinum Equity will acquire Lonza’s Water Care business and operations for $630 million

L

onza and Platinum Equity jointly announced that Platinum Equity has entered into a definitive agreement with Lonza to acquire Lonza’s Water Care business and operations for $ 630 million. The inclusion of the French business in this transaction is still under discussion.

With headquarters in Alpharetta, Water Care has six manufacturing facilities in key regions, including North America, South America, EMEA and South Africa, with sales locations in all regions globally and with approximately 1,200 employees. The business is a leading provider of innovative water treatment solutions and a top global consumer brand in residential pool care and key positions in high-growth industrial and municipal water care markets. The agreement is expected to close in the first quarter of 2019, subject to custom-

ary closing conditions.

“We are putting the Water Care business in the hands of an experienced owner who will develop Water Care as a standalone business while focusing on innovation and further growth. We believe that we have found the optimal partner for the business to give new perspectives to the global sites and its employees,” said Richard Ridinger, CEO, Lonza.

“The divestment further strengthens our strategic focus on our three core pillars – Pharma & Biotech, Consumer Health and Consumer & Resources Protection – within the healthcare continuum.”

Lonza already announced in May this year that it had retained an investment bank to advise on all strategic options regarding its Water Care business as part of an active portfolio management approach. The strategic review was publicly

confirmed at Lonza’s Capital Markets Day in September 2018. After a robust analysis of options, Lonza decided now to divest the Water Care business as part of its long-term strategy to grow sustainably along the healthcare continuum and to focus all growth initiatives and investments on its core businesses.

Lonza acquired the Water Care business as part of its acquisition of Arch Chemicals in 2011 and developed it as part of the Specialty Ingredients segment. The business provides offerings for recreational water, as well as for industrial, municipal, commercial and surface water treatments and has leading positions in several markets worldwide.

Platinum Equity is a global private equity firm with approximately $13 billion of assets under management and a highly specialised focus on

business operations. The firm has substantial carve-out expertise, with more than 20 years’ experience acquiring and operating businesses that have been part of large corporate entities.

“We are looking forward to working with Water Care's experienced management team to further grow the business and strengthen its unique positioning in residential pool care and industrial water markets around the world,” said Platinum Equity Partner Jacob Kotzubei. “Lonza's Water Care business has tremendous value as a standalone company.”

Platinum Equity operates each of its portfolio companies independently and will apply this approach to the Water Care business with the goal of creating long-term, sustainable value. Lonza's Water Care business has already been focusing on brand restaging, innovation

and e-commerce; and this agreement now provides the team the opportunity to fully focus on further growing its business, innovative product portfolio and global footprint in both residential and industrial water treatments. Water Care's business unit head Christian Wichert and his experienced management team will continue to lead the business.

The carve-out and ownership transfer process is expected to be seamless to customers. Platinum Equity said that ensuring consistency, continuity and quality will be a priority following closing.

Citi is acting as financial advisor and Jenner & Block as legal advisor to Lonza. Gibson, Dunn & Crutcher is acting as legal advisor to Platinum Equity on the acquisition.

EP News Bureau

Elgi’s oil-free, fuel-efficient compressed air powers the pharma industry Exhibits state-of-the art air compressor range at the 9th edition of Pharmac India 2018 ELGI EQUIPMENTS, a leading air-compressor manufacturers displayed its stateof-the-art range of air-compressors at stall number A 05 at the 9th Edition of Pharmac India 2018. The exhibition, witnessed over 150 exhibitors and over 5,500 visitors from the pharmaceutical industry.

The compressed air used in pharma manufacturing must be free of microbial contamination and oil in micronising operations. In some applications

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pure oxygen or nitrogen may be required and the moisture content of the air should be below a specified level, such as 50 ppm. Elgi offers a wide range of air compressors to address these requirements. This includes lubricated compressors with a combination of driers and filters, as well as oil-free compressors (up to 2500 cfm).

ELGi’s oil free screw compressors offer oil-free air that adhere to the ISO 8573 Class ‘0’ certification, a wide operating

temperature range (-5 deg to +50 deg Celsius) and a quicker return on investment with increased reliability and energy efficiency across pharma installations.

Ramesh Ponnuswami, Executive Director, ELGi Equipments says, “In India, there is a growing focus on the quality standards in the pharma and healthcare industry. Compressed air is used in the production of many healthcare industry products and also the

delivery of healthcare to patients. At ELGi, our core focus is to create world-class products that will ensure high efficiency and eliminate air contamination completely. Some of the world’s leading pharma companies are our customers today and this stands testimonial to our innovation and focus on building highly energy efficient compressors, the best in the world.”

In 2013, ELGi acquired Pattons, headquartered in

Charlotte, North Carolina. Pattons Medical, a division of Pattons is primarily engaged in the business of producing high quality medical air products which include compressors, vacuum systems, pipelines and the control elements, used in hospitals to deliver high quality air and gas to patients. ELGi is currently the number 2 player in the US in the medical air market.

EP News Bureau

Kappa Bioscience announces first-ever India drug import license for Vitamin K2,and K2VITAL DELTAdrug approval The approval of Kappa’s K2VITAL DELTA with registration certificate and import license from the Indian authorities significantly impacts the Indian vitamin K2 market KAPPA BIOSCIENCE has announced the approval of a first-of-its-kind drug import license for vitamin K2 for the Indian market. Kappa’s K2VITAL DELTA product was granted a drug import license following a comprehensive regulatory approval process.

The approval of Kappa’s K2VITAL DELTA with registration certificate and import license from the Indian authorities significantly impacts the Indian vitamin K2 market.

DELTA enables the expansion of K2 into the Indian pharmaceutical market and opens new market channels to consumers. Kappa, working with K2VITAL distributor SA Pharmachem of Mumbai, secured this first-and-only drug import approval to increase K2 quality and stability options in India, and offer manufacturers options to reduce costs.

These approvals are specific to Kappa’s microencapsulated K2VITAL DELTA vitamin K2 MK-7 product.

Unprotected vitamin K2 is not stable in formulations with

minerals such as calcium and magnesium, and microencapsulated DELTA ensures that finished products meet label claim and shelf-life requirements. With these drug approvals, brands and manufacturers in India can now include K2 in a wider range of product formulations, including the large calcium supplements market category.

DELTA is the only microencapsulated K2 with Indian drug approval.

These approvals are significant because K2VITAL DELTA can now be used as an important constituent of pharma products. Pharma products serve a wider consumer segment compared to food ingredients products, with more extensive distribution including pharmacies.

DELTA drug-approved status, plus documented stability with minerals, is projected to influence how doctors and practitioners within the Indian medical community approach K2. Osteoporosis is a significant problem within India’s large and growing elderly

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Vitamin K2 is essential to bone and cardiovascular health because it mediates calcium use in the body population, and calcium supplementation is a common prescription.

Vitamin K2 is essential to bone and cardiovascular health because it mediates calcium use in the body. K2 activates osteocalcin enzymes which incorporate calcium into bone, and matrix Gla proteins (MGP) which bind excess calcium to prevent deposit in the arteries. Bone health products containing

calcium and vitamin D3 are widely available in Indian markets, providing a strong platform for K2 consumer adoption.

K2VITAL is pure, crystalline >99.7% all-trans MK-7 produced in Norway. K2VITAL DELTA provides commercial opportunities in eight different supplement categories, and synergistic health effects to four of the five topselling ingredients: calcium, magnesium, omega-3 and multivitamin blend. The launch of DELTA as a drug in India will be accompanied by Kappa’s full ToolBox of educational materials and nearly 150 license-free product formulations that customers can leverage for fast-launch K2 products.

Egil Greve, President and CEO, Kappa Bioscience, Norway, said, “Kappa identified India as a very significant opportunity for vitamin K2 and we invested heavily in the drug approval and import license process.” He continued, “We are pleased to finally receive this drug recognition for a

K2VITAL vitamin K2 by the Indian regulatory authorities.

This serves as a strong reference case similar markets and is a good first step toward global OTC markets.”

Mayur Anant Mhadeshwar of SA Pharmachem. said, “These K2VITAL DELTA drug import and approval licenses for a microencapsulated K2 will revolutionise the bone health market category in India.” He continued, “We have seen substantial growth and interest from the medical community regarding K2’s critical role in bone health. A protected K2 that can tolerate mineral salts opens the drug and pharma market to the full range of vitamin K2 benefits, while ensuring legal stability requirements are met.”

Kappa and SA Pharmachem will be present at the CPhI India Exhibition in December, scheduling meetings the exciting commercial opportunities that are now open with approval of K2VITAL DELTA in India.

EP News Bureau

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PHARMA ALLY PRODUCT

Refrigerated warehouse makes every doorway count GANDHI AUTOMATIONS is one of the leading diversified suppliers to the pharma sector, serving pan India customer accounts in more than 23 cities.

Clean room doors (Prime Clean Reset) are designed for inside applications requiring limitation of leak flow. The perfect sealing properties of Prime Clean Reset provide environmental control and protect the inside environment against draughts, dust and dirt. Clean room doors provided by us also has self- repairing system.

One of the most imperative aspects of clean rooms is the door you choose for clean room facility. Time for which door is open will play a critical factor in avoiding dirt, temperature, humidity etc. Opening and closure of door has to quick enough to isolate the two areas.

At Gandhi Automations, we provide clean room high speed doors specifically designed for above purpose. Our clean room high speed doors are best suited for pharma industries where you need to have controlled environment. The opening and closing of door is fast enough to separate two areas.

In the high-volume, 24/7 facility, turns in the cooler happen twice a day and, in the freezer, inventory turns occur every day and a half. With traffic streaming in and out of the building through 47 dock doors, losing a single high-traffic door could severely jeopardise deliveries.

Prime freeze high speed doors are a perfect solution where cold storage with negative temperatures to as low as – 22°F is required. The curtain is made of reinforced PVC vinyl with heated side guides. Optionally a special and innovative insulated flexible curtain is also available.

High Speed freezer doors are the solution when temperature control is critical and where

34 EXPRESS PHARMA November 16-30, 2018

forklift traffic is high.

“If a cooler door is down, that could be detrimental to our operation,” says warehouse manager, who notes that a single inoperable door could cost 30 per cent of shipping capacity. “We cannot afford to lose an opening.

We are hard on things, and that’s why we need durable doors.”

High-speed freezer duo not only helps maintain temperature but also in human safety. Highspeed freezer doors have a revolutionary soft bottom edge and sensor combine to ensure operator safety at all times. Highspeed freezer duo doors curated

by Gandhi Automations are sturdy, dependable and an ideal fit for maintaining temperature control. To prevent ice formation during intensive cooling, the high-speed freezer duo doors

have a functionality of partial and full opening. Its intelligent dual curtain technology - simultaneous open-and-close operation has blower/dryer to maintain temperature balance.

Fast door speed also reduces the likelihood of panel collisions with tall-mast forklifts. In the event of a collision, the self-repairing system automatically resets the panel back into its guide without human intervention.

To avoid accidental contact with door panels, an LED safety light system along the door columns warns employees when the door is about to close and when it is actually closing. Two photo eyes, (cells) a dual-pneumatic reversing edge and threshold warning lights will reverse the descending door panel if an employee is in the doorway.

Contact details Gandhi Automations Chawda Commercial Centre, Link Road, Malad (W) Mumbai – 400064, Off: +91 22 66720200 / 66720300(200 Lines), Fax: +91 22 66720201 Email: sales@geapl.co.in, Website: www.geapl.co.in

PHARMA ALLY

Optima to present MultiUse concept during P-MEC India AT P-MEC India, Optima will present the MultiUse concept. The fully automated and flexible machinery can process different types of containers. Another key feature of the company’s exhibition presence will be the modern engineering technologies that enable Optima Pharma to complete complex turnkey projects on budget and on schedule.

Vials, pre-filled syringes, and cartridges can be processed in one machine: Optima Pharma will present the MultiUse Filler as the ideal solution for small batch sizes and different container types. This type of machine can be used for production in a laboratory for up to medium-sized batches. The MultiUse Filler is fully automated and highly flexible. It can be adjusted quickly for different format sizes and container types.

Comprehensive Scientific Process Engineering (CSPE) has revolutionised the planning and implementation of pharmaceutical filling machines. A combination of scientific methods and technological processes ensures that the time from the order being placed to the start of production is as short as possible. At P-MEC, Optima Pharma will present CSPE together with the latest engineering technologies for turnkey projects.

The turnkey experts will inform visitors about complex projects involving filling and sealing, isolator technology, and freeze-drying. Optima Pharma takes overall responsibility for developing and implementing projects of this kind, from online planning and design through integrated factory acceptance tests (iFATs), building site management, site acceptance tests (SATs), and a comprehensive range of services using the latest engineering technologies such as flow visualisations, which will be also presented at P-MEC. Experts from Metall+

The MultiUse concept allows for the flexible production of small batches in a wide range of different format sizes and container types

The MultiUse filler is one of Optima Pharma’s most recent developments

Plastic – a company of Optima Packaging Group – will inform customers about the portfolio of isolators and latest technologies. Extremely reduced cycle times as well as the user friendly, modular STISO sterility test isolator are among them.

Cost-effective freezedrying in a small space

At P-MEC, Optima will present the new, flexible and compact freeze dryer OPTIMA CS

The sterility test isolator STISO from Metall+Plastic comes with a variety of new user-friendly developments including a well-designed operator ergonomic concept

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Optima Pharma is also known as a technology leader within pharmaceutical freeze-drying. One of the company's most recent developments is the CS freeze-dryer. It is designed for products that are new on the market and are initially being produced in small and medium-sized batches. The CS freeze-dryer is ideal for installation in existing buildings and can easily be configured to ensure an efficient overall layout for the production system. Its spacesaving design also makes it highly cost-effective.

Contact details Member of Steinbeisweg 20 Phone +49 791 506-0 Managing Directors Commercial Register 74523 Schwaebisch Hall Fax+49 791 506-9000 Hans Bühler, HRB 571090 Stuttgart

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PHARMA ALLY VALUE ADD

Overview of hybrid column technology Dr Nishchal Sharma, Business Development Manager- Columns, gives an insight on how Waters has been able to address the needs of scientists using reversed-phase chromatography for improved, efficiency, resolution, selectivity, speed and peak shapes

MANY RESEARCH and development (R&D) groups worldwide are focussing on new development of column packaging material. The result of these efforts is introduction of new chemistries and columns each year. Every new column technology introduced at market place claims to have improvements over the prior technologies. Scientist/users may ponder why they need so many different column brands and phases/ chemistries.

The question asked, how can a new family of column packings be different from others in the marketplace?

For successful product, R&D efforts need to be focussed on user needs. There are a num-

Waters develop hybrid particles to be high performance materials that are well suited to meet the needs of scientists. It introduced first generation hybrid in 1999 as brand name of XTerra columns

36 EXPRESS PHARMA November 16-30, 2018

ber of user considerations for new separation columns. A new column family may try to differentiate on one or more of these user needs.

In early 1990s, scientists/ users were struggling with column reproducibility and as a result, R&D efforts focussed on improving the reproducibility and purity of silica packing materials. Late 1990s, there was ahuge demand for scientists. They started looking for selectivity options and R&D groups addressed that need with the development of new stationary phases.

Waters started investigating hybrid inorganic–organic materials (hybrids) started in the mid-1990s to address the needs of scientists using re-

Dr Nishchal Sharma, Business Development Manager- Columns

versed-phase chromatography for improved, efficiency, resolution, selectivity, speed and peak shapes.

Waters develop hybrid particles to be high performance materials that are well suited to meet these needs of scientists.

Waters introduced first generation hybrid in 1999 as brand name of XTerra columns. It also introduced patented organic/inorganic Hybrid Particle Technology [HPT] to overcome significant shortcomings of silica-based reversedphase packing materials, particularly their hydrolytic instability at high pH ie PH 8 and above. In 2005, Waters introduced second generation HPT, branded as BEH Technology, assimilate in new ACQUITY UPLC BEH Columns and in Waters XBridge HPLC columns, and

mark a new milestone in chromatography.

BEH Technology columns show outstanding capability, especially for basic compounds, using traditional conditions.

With the introduction of BEH Technology scientists have freedom to work on wider pH range of 1–12. BEH Technology retention properties and high temperature stability equal to, or better than, that of the best silica-based reversed-phase columns.

BEH Technology columns define the new benchmark for LC method development.

Later BEH Technology has expanded into hydrophilic interaction HILIC and size-exclusion chromatography (SEC).

PHARMA ALLY VALUE ADD

Hardness testing: Determine tablet breaking force Aditya Marfatia, Director, Electrolab and Dr Namita Varde, Application Scientist, Electrolab, give an insight on hardness testing which plays an integral role in guiding product development as well as ensuring finished product quality and stability Hardness testing plays an integral role in guiding product development as well as ensuring finished product quality and stability. It provides assurance to whether a dosage form can withstand stresses encountered during development, manufacturing, packaging, storage and shipping.

Based on results obtained from hardness testing, major modifications can be brought about in the composition of the dosage form as well as in compression pressures utilised during tableting to achieve the desired disintegration and dissolution.

A hardness tester is used to determine the tablet breaking force, also known as the tablet hardness. The tablet breaking force is the force required to fail or break the tablets. Tablet hardness testers were first introduced in the mid 1930s. They were mostly mechanical testers and were hand operated.

Monsanto (or Stokes), Strong Cobb and Pfizer hardness testers are few examples of the early testers. In the Monsanto tester, a tablet in placed between two faces and the plunger is rotated in a clockwise manner until the tablet breaks and the pressure is recorded in kg/cm2. The Strong Cobb tester utilizes pneumatic systems for measuring hardness, which initially were manually operated but later were motorised. The Pfizer tester utilises the mechanical principle of pliers, where the tablet is crushed in the jaws of the device and the force is recorded in the dial indicator. The current tablet hardness testers use electromechanical equipment.

Typically, in any hardness tester, the tablet is placed be-

Aditya Marfatia, Director, Electrolab

Dr Namita Varde, Application Scientist, Electrolab Figure 3. Effect of lubricants on tablet hardness

Figure 1. Schematic representation of a hardness tester

tween two platen (or jaws)one of which is stationary while the other moves to apply force to fracture the tablet. The breaking force measurements can be determined by either maintaining the platen movement or the compressing force applied (loading rate) constant. Hardness is measured in kiloponds (kp), newtons (N) or StrongCobb (SC) in the current hardness testers. 1kp= 1 kgf= 9.80 N whereas 1 SC= 0.7 kgf= 7 N. Key factors influencing hardness testing:

Tablet geometry and dimensions Hardness testing does not take into account the tablet shape or dimensions. Tablets with different thickness or shape prepared with the same material will have different hardness. Comparison of results should be conducted on

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across the diameter. For scored round tablets two orientations are possible- one where the scored line is kept parallel to the plate surface whereas other, in which the score line is perpendicular to the plate surface. The tablet hardness does not change in either orientation. For other unique shaped tablets, there is no obvious orientation as per guidelines. However, the current testers measure hardness along the long axis

(Figure 2) of such tablets. It is required that standard operation is followed to ensure reproducibility in results for all dosage forms.

Tablet formulation Lubricants are used in the formulation to facilitate reduction of friction between die and tablets. This allows for minimisation of picking, chipping, capping, sticking, etc phenomena. However, increasing concentration of lu-

Figure 2. Tablet orientation of a unique shaped tablet

tablets having same shape and dimensions.

Tablet orientation Tablet orientation during hardness testing should be consistent for every run as breaking force determination may differ based on the orientation. In the case of round tablets with no scoring, diametral compression occurs, wherein the tablet breaks

Figure 4. Effect of binders on tablet hardness

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PHARMA ALLY bricants may have an adverse effect on tablet hardness, eventually affecting disintegration and dissolution.

Figure 3 demonstrates how two lubricants- magnesium stearate and sodium stearyl fumarate affect hardness.

Upon increasing concentration of both lubricants, hardness decreased; however, sodium stearate fumarate was determined to have a lesser effect on hardness compared to magnesium stearate.

Binder imparts cohesiveness to the tablet and ensures tablet strength post compression. Binder associated moisture and moisture loss during storage may have a direct impact on tablet hardness.

Figure 4 demonstrates the increase in tablet hardness with increasing binder concentration. In this particular example, no significant difference was observed between acacia and gelatin, which are two commonly used natural binders.

Tableting process The forces used during tablet compression may have a huge impact on tablet hardness.

Figure 5 demonstrates that increase in compression force increases hardness further increasing the disintegration time of dextromethorphan hydrobromide tablets.

Tester mechanical structure The hardness tester design should be robust. The platens should not demonstrate any type of bending or torsion displacement in the entire force range (specific for each instrument) used. In addition, the faces of the plates should be flat, polished and smooth to ensure result reproducibility.

Rate and uniformity of loading The force applied to the tablet can be controlled by either maintaining the platen movement per second constant or by applying a defined force (or load) per second. The current hardness testers employ one of these measuring principles to measure hardness. The guidance states that the

38 EXPRESS PHARMA November 16-30, 2018

Key features of EHT - 5PR

Figure 5. Effect of compression force on the disintegration time and hardness of dextromethorphan hydrobromide oral disintegrating tablets

tester should have a constant platen movement of 3.5 mm or less per second or a constant force of 20 N or less per second. Time taken for measurement using both measuring principles is variable. The constant force per second (considering 20 N/sec) takes

longer compared to the constant platen movement (considering 3.5 mm/sec). Therefore, in order to compare results (obtained from different instruments, batches, etc.), it is required that test should be performed using identical measuring principle.

EHT-5PR is a 21 CFR compliant 5 parameter tablet tester that measures hardness, thickness, width, diameter and weight. It has a 7” colored intuitive touch screen display. It has programmable calibration and verification modes, within which, reminders can be set for calibration and verification. The body is made up of stainless steel to comply with cGMP regulations. The small compact nature of the tester makes it a perfect fit for IPQC cubicals. The tester has a tablet manager tray for carrying tablets back and forth from the weighing scale. In addition, the tester provides programmable tolerances and plausibility limits. The tester routinely prompts audio-visual alerts about the instrument status (D’light technology). The tester has an electronic logbook. In addition, data can be

printed on user selected templates.

References: 1. <1217> Tablet breaking force chapter- USP 2. Katewongs P et al. Spatial distributing lubricants from Raman mapping and scanning electron microscopy–energy dispersive X-ray spectroscopy on cetirizine dihydrochloride fast disintegrating tablet properties, Journal of Pharmaceutical Investigation 3. Salome C et al. Formulation and evaluation of Cymbopogon citrates dried leaf-powder tablets, African Journal of Pharmacy and Pharmacology Vol. 6(48), pp. 3274-3279, 29 December, 2012 4. Mostafa HF et al.

Development and optimization of dextromethorphan hydrobromide oral disintegrating tablets: effect of formulation and process variables, Pharmaceutical Development and Technology, 2013; 18(2): 454–463

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