Express Pharma (Vol.11, No.23) October 1-15, 2016

VOL. 11 NO. 23 PAGES 56

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Market ‘Urgent need to cater to large unmet needs in dermatology’

Management 'GDP is the heart of the quality system' 1-15 OCTOBER 2016,` 40

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CONTENTS

BOLSTERING DATA INTEGRITY

Vol.11 No.23 OCTOBER 1-15, 2016 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty

Pharma companies need to fine-tune their security policies and implement best practices to safeguard data integrity | 16

BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das New Delhi Prathiba Raju DESIGN

National Design Editor

MARKET

08 12

Bivash Barua Asst. Art Director Pravin Temble Senior Designer Rekha Bisht Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Ajanta Sengupta Ambuj Kumar Arun J Debnarayan Dutta E Mujahid Mathen Mathew Nirav Mistry Rajesh Bhatkal PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

P10: PRE EVENT CubeX to host conference on consumer healthcare in Mumbai

MANAGEMENT

URGENT NEED TO CATER TO LARGE UNMET NEEDS IN DERMATOLOGY UK-INDIA WORKSHOP ON INDUSTRIAL BIOTECHNOLOGY HELD IN MUMBAI

P LIFE

P24: INTERVIEW 'Doctors are highly motivated to know about clinical insights from the pharma industry'

P32: REPORTS Asia-Pacific gastric cancer market set to experience strong growth to $2.7 billion by 2022: GBI Research

P33: UPDATE Novartis says experimental drug helps chronic migraine sufferers

P35: VENDOR NEWS Perlen Packaging (Suzhou) Co opens news facility in China

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'GDP IS THE HEART OF THE QUALITY SYSTEM'

RESEARCH

34

51

BIOCON APPOINTS SURESH SUBRAMANIAN AS HEAD OF BRANDED FORMULATIONS (INDIA) BUSINESS

NOVO NORDISK PLANS LARGER STUDY AFTER ENCOURAGING SEMAGLUTIDE RESULTS

Express Pharma® Regd. with RNI No. MAHENG/2005/21398,Postal Regd. No. MCS/164/2016 – 18. Printed for the proprietors, The Indian Express (P) Ltd. by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright © 2016. The Indian Express (P) Ltd. All rights reserved throughout the world.

Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

EDITOR’S NOTE

Opportunities amidst challenges

M

SF’s seven-year-old appeal campaign to reduce flu vaccine prices has finally borne fruit.

While Pfizer has not responded to the pleas to reduce the price of its pneumococcal conjugate vaccine (PCV) for humanitarian organisations like MSF, GSK has announced that it will sell its vaccine to MSF and other such organisations at the lowest global price.

According to an MSF release, it paid 60 euros ($68.10) per dose for Pfizer’s PCV to vaccinate refugee children in Greece earlier this year, which is 20 times the lowest global price. But GSK’s response means nothing to children in developing countries, unless, as MSF urges, it prices the flu shot at $5 per child, for the three recommended doses, for all developing countries.

Pfizer’s PCV brought in revenues of $30 billion in the past seven years. With such earnings at stake, escalating research budgets and no new products in the pipeline, is it realistic to expect pharma companies to concede ground? GSK’s announcement is a ‘positive and critical step forward for children in emergencies’ but this is a long journey towards giving “every child ... a fair shot at being protected against pneumonia,” as Vickie Hawkins, Executive Director, MSF UK puts it.

In mid September, the United Nations Secretary-General’s High-Level Panel (UNHLP) on Access to Medicines’ report on promoting innovation for, and access to, health technologies highlighted the severe deficit of new medicines.

The report also highlighted the vast difference in reported costs of R&D. While a 2016 study

GSK’s announcement is a ‘positive and critical step forward for children in emergencies’

conducted by the industry-funded Tufts Centre for the Study of Drug Development pegged the average total cost of bringing a new medicine to the market at $2.56 billion to $2.87 billion. Even after adopting the pharma industry practice of adjusting for risk of failure, the non-profit DNDi analysed its own R&D costs for developing a new chemical entity at $130 million to $195 million. The report concedes that R&D costs will vastly differ between molecules/ technologies and apple-to-apple comparison is not possible but calls for more transparency from pharma companies when declaring the costs of R&D. The need for speedy implementation of these recommendations can be gauged by the increasingly frequent outbreaks of epidemics.

For instance, a time-based analysis of the pattern of emerging infectious disease (EID) over the last six decades predicts that five new EIDs will emerge each year if no mitigation policies are adopted now. Hence, priority setting and coordination by global non-profits and governments will be important.

There are signs that pharma companies are also recognising the opportunities amidst the challenges. For instance, Zydus and Takeda have come together for development and commercialisation of a vaccine for chikungunya.

India is one of the 60 countries where EIDs like chikungunya, Zika and dengue, are becoming increasingly common. The future lies in such partnerships so let us hope they deliver the results.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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October 1-15, 2016

Instructor-led courses In-house company trainings Certificate programs Distance learning courses Online trainings Fast-track programs

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MARKET I N T E R V I E W

‘Urgent need to cater to large unmet needs in dermatology’ Fresh from a $14 million series C financing round, Venkateswarlu Nelabhotla (N Venkat), Co-Founder & CEO, Vyome Biosciences tells Viveka Roychowdhury that their’s is the only company addressing topical antibiotic resistance issue, even though current treatment has been witnessing increased resistance rates

Vyome Biosciences recently closed a $14 million Series C financing round. The US FDA accepted the Investigational New Drug (IND) Application for the initiation of clinical studies of the lead product VB 1953 this January, so by when do you expect the product to go into Phase 1 clinical trials?

How long will these trials run? Will India be part of these trials?

The dosing in humans for VB 1953 is planned in October 2016, we will talk about this separately few days prior to it.

We are conducting this trial with a reputed CRO of the US so as to ensure high quality as per US FDA guidelines. Our programme is focussed on the US market therefore India will not be a part of these trials.

With the rise of antibiotic resistant pathogens, many companies are looking at developing drugs which address antimicrobial resistance. Why did your company choose to focus on the dermatology segment?

Which other products are in your pipeline?

Dermatology is one therapeutic area where scientific innovation has been very less since last many years. Because of this, most of the antimicrobial drugs for skin pathogens have

8

EXPRESS PHARMA

October 1-15, 2016

developed resistance or nonresponse. Therefore, there is an urgent requirement to cater to large unmet needs in dermatology. After rigorous scientific research and thorough understanding, Vyome’s team has specialised in understanding the skin microbiome and its molecular level mechanics as well as the global issue of antimicrobial resistance, particularly those caused by skin opportunistic pathogens.

We have clinically-tested products based on our breakthrough technology platform targeting antifungal indications Molecular Replacement Therapy (MRT), for which we are currently pursuing commercialisation discussions with multiple partners in various countries.

We also have preclinical stage products based on MRT which target multiple skin fungal infections. In addition, we are also developing New Chemical Entities (NCEs) broad spectrum antibiotics based on our innovative technology platform Dual Action Rational Therapeutics (DARTs), which target the antimicrobial resistance caused by skin opportunistic pathogens.

VB 1953 is both a nextgeneration antibiotic as well as has an IP-protected

Vyome’s team has specialised in understanding the skin microbiome and its molecular level mechanics

microtechnology gel system. Could you explain more and are there other clinical candidates in research elsewhere? How does VB 1953 measure up to these future competitors?

Vyome’s product VB 1953 is targeted towards prescription based treatment of antibiotic resistant acne, which constitutes the major patient population suffering from moderate to severe acne.

Topical antibiotics are being used as first line therapy by doctors to treat acne. However, current antibiotic treatment has been witnessing increased resistance rates, at present approximately 40-90 per cent patients for topical antibiotic Clindmaycin varying by countries. This reduces the response rates and leads to dissatisfaction with dermatologists as well as patients. Doctors then prescribe oral antibiotics for treatment of moderate to severe acne which have significant side-effects in patients. Even the response rates of oral antibiotic treatment of patients is ~50 per cent, which leads to worsening of the condition of the patients.

No company apart from Vyome, is addressing the topical antibiotic resistance issue, which is a unique space based on huge unmet need, as

there is only one topical antibiotic available for treatment. Clinicians are looking for first in class new topical antibiotic that works on resistant P. acnes. Our product VB 1953 addresses this unmet need and in addition to this, it has antiinflammatory effect and is less prone to develop resistance.

Vyome Biosciences' platform strategy seems to offer differentiated new generation antibiotics combined with either better delivery systems as with VB 1953 or dual action (DARTS Platform Strategy) or changing the tissue microenvironment so that the infecting microbe is killed (Molecular Replacement Therapy (MRTTM)). All these are patentable platforms so while being an excellent R&D risk mitigation strategy, will it add to the cost of the therapy?

This is one unique proposition of Vyome’s R&D strategy and programmes such as these platforms create IP value and have different possibilities for commercialisation. However, we are currently focussed on VB 1953 programmes’ clinical development in terms of fund utilisation. viveka.r@expressindia.com

MARKET PRE EVENT

CubeXto host conference on consumer healthcare in Mumbai It would cover diverse topics such as building mega brands to penetrating unchartered territories, creating multiple touch points for consumers and devising collaborative strategies through multiple stakeholders CUBEX, A division of Sorento, in association with Nicholas Hall & Company, will organise a conference titled, ‘Achieving Scale in Consumer Healthcare’. It will be held on December 9, 2016 at Sofitel, Mumbai.

Along with global OTC expert Nicholas Hall, prominent industry experts who have led the path for their companies, will share their success stories on this single platform. They will throw light on various facets ranging from building

Along with global OTC expert Nicholas Hall, prominent industry experts who have led the path for their companies, will share their success stories on this single platform mega brands to penetrating unchartered territories, creating multiple touch points for consumers and devising collaborative strategies through multiple

stakeholders.

Reportedly, some of the speakers at the conference will be Susan Josi, Managing Partner, Sorento Healthcare Com-

munications; Kedar Rajadnye, COO, Piramal Enterprises; Prof.Piyush Kumar Sinha, IIMA; Swapneel Naidu, VP, Glenmark Pharmaceuticals; Sub-

odh Marwah, Head, Consumer Healthcare, Sun Pharmaceutical Industries T; Gangadhar, MD, MEC-South Asia; Dalveer Singh, CEO, GroupM Dialogue Factory; Dinar Mhatre, Head Integration, Johnson and Johnson Consumer; N Rajaram, Country Head & GM – Pharmaceutical Operations, Sanofi India and K Ganapathy Subramaniam, Head – OTC category, Dabur India.

EP News Bureau

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October 1-15, 2016

MARKET POST EVENT

UK-India workshop on industrial biotechnology held in Mumbai The workshop facilitated discussions having a common interest in industrial biotechnology and to explore possible partnerships Sachin Jagdale Mumbai THE UK Science and Innovation Network of British Deputy High Commission recently conducted a workshop on industrial biotechnology in Mumbai.

The UK-India workshop facilitated discussions among researchers, funding agencies, companies and government officials, having a common interest in industrial biotechnology and to explore possible partnerships. The key topics that were discussed during the workshop were enzymes, fermentation, bio-resources (biofuels), biopharmaceuticals (drugs, vaccines) and bio-process engineering.

Colin Wells, Deputy Head of

Mission, British Deputy High Commission, Mumbai, gave the opening remarks. He categorically mentioned Prime Minister Narendra Modi’s visit to England, which has propelled confidence building measures be-

tween both the countries. Such steps are going to pave a way for collaborations in the field of industrial biotechnology.

Ian Stanton, Biotechnology and Biological Science Research Council (BBSRC), UK, briefed

aim to provide strategic solutions to key issues faced by the manufacturers around the regulatory guidelines of FDA, EMA, upstream, downstream processing, identifying critical quality attributes and statistical approaches to demonstrate biosimilarity.

Contact details: E: Drashti.shah@ubm.com T: 91-22-61727381

Description: CPhI's 3rd Annual Data Integrity, Reliability and Quality Metrics a case study- led two-day workshop will cover the latest draft guideline on quality metrics and critical topics related to overcoming data integrity issues.

Contact details: E: Purvai.gupta@ubm.com T: 91-22-61727077

the audience about BBSRC's support for industrial biotechnology and opportunities for UK-India collaboration. He discussed how industrial biotechnology and bio energy are important for environment, economy and health.

Dr Arvind Lali, Centre of Energy Biosciences, Institute of Chemical Technology, Mumbai, informed the audience about Institute of Chemical Technology's platforms for bio-based bio-refineries to convert waste into value. Nigel Minton, BBSRC, Engineering and Physical Sciences Research Council (EPSRC), Synthetic Biology Research Centre (SBRC), Nottingham, UK, talked about sustainable production of chemicals and fuels through synthetic biology.

Dr Sanjay Nene, CEO, Innovation Biologicals, Pune, gave a speech on experiences on using integrated membrane bioprocess which generated enough curiosity among the audience.

Dr Richard Alldread, The Centre for Process Innovation, UK, talked about the technologies used to manufacture new generation bio-pharma. Alldread said, “Geography, product diversity, time and cost are forcing change in biopharma manufacturing.

Future manufacturing is driven by innovation. Technologies are going to significantly impact manufacturing processes. There is an increased pressure on biopharma industry to manufacture products in a different way.”

trade fair for the analysis, laboratory-technology and biotechnology sectors. As the industry's leading marketplace, it brings together scientists, entrepreneurs and users from around the subcontinent. At the analytica Anacon India and India Lab Expo Conference, scientists from around the world will present their innovative analysis solutions.

Contact Email: info@analyticaindia.com

Description: A strategic conference series that will address the most critical issues in pharmaceutical and biopharmaceutical manufacturing in India Contact details: E: sean.palanna@ubm.com T: 91-22-61727072

sachin.jagdale@expressindia.com

EVENT BRIEF CSV WORKSHOP Date: October 6 - 7, 2016 Venue: Mumbai Description: A two-day in depth workshop designed to provide unique insights and authoritative debate into CSV models, validating data integrity, CSV metrics, network validation and cloud validation.

Contact details: E: sean.palanna@ubm.com T: 91-22-61727072

BIOSIMILARS CONGRESS INDIA 2016

PHARMA DATA INTEGRITY, REGULATORYAND QUALITY CONFERENCE

Date: October 13 – 14, 2016 Venue: Hyderabad Description: Biosimilars Congress India 2016 will

Date: October 18 - 19, 2016 Venue: Mumbai Date: October 20 - 21, 2016 Venue: Hyderabad

12

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ANALYTICAANACON INDIA AND INDIALAB EXPO 2016 Date: October 20-22, 2016 Venue: HITEX Exhibition Centre, Hyderabad Summary: analytica Anacon India and India Lab Expo happens to be India's largest

PHARMA CONFERENCE SERIES Date: November 3-4, 2016 November, 2016 Venue: Mumbai

CPHI PRECONNECT- DAY ZERO Date: November 17, 2016 Venue: Mumbai Description: CPhI's Pre Connect Congress will bring together thought leaders under one roof to discuss on the latest trends and advancements in the Indian pharma industry. Discussions will be

MARKET held on key topics such as M&A, regulatory challenges, drug discovery and other critical topics which are a burning issue in the pharma industry.

Contact details: E: sean.palanna@ubm.com T: 91-22-61727072

CPHI AND P-MEC INDIA Date: November 21 – 23, 2016 Venue: Bombay Exhibition Centre & MMRDA Grounds, BKC, Mumbai Summary: The event will be an ideal congregation for companies to pick up on the latest trends and innovations the market has to offer. CPhI India is also co-located with PMEC India, the pharma machinery show in Asia. This year, the expo has grown from a three-day exhibition to a show spanning a week, Pharma Week, (November 17

to 23, 2016). The Pharma Week will hold more than 12 events that will take place across the city of Mumbai focusing on business, knowledge, leadership, innovation and recognition in the field of pharma.

With two venues this year, Bombay Exhibition Centre and Bandra Kurla Complex in Mumbai, CPhI & P-MEC 2016 will include exhibitor showcase, innovation gallery, speed meetings, live entertainment and much more.

Contact details UBM India TIMES SQUARE Unit No 1 and 2, B Wing, 5th Floor, Andheri Kurla Road, Marol, Andheri (East) Mumbai - 400 059 Tel: +91 22 61727272 Fax: +91 22 61727273

IPC EXPO 2016 Date: December 16-18, 2016 Venue: Visakhapatnam The 68th Indian Pharmaceutical Congress (IPC) will host IPC Expo 2016, which will be jointly organised by the Indian Pharmaceutical Association (IPA) and Orbit Exhibitions. The expo will see a congregation of business delegates from all parts of the world. Visakhapatnam, the upcoming pharma hub will host the fair under the patronage of N Chandrababu Naidu, Chief Minister, Andhra Pradesh.

With India’s new initiative of ‘Make in India’ campaign, the show will witness a huge boost with national and international participation.

Contact details University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam,

Andhra Pradesh-530003 Ph: 0891 2526143 Mob: 7036164555 Email: loc@68ipc.com Website: www.68ipc.com

INDIA PHARMA 2017 Date: February 9-11, 2017 Venue: Bangalore International Exhibition Centre, Bengaluru Summary: India Pharma 2017, an international exhibition and conference on pharmaceutical industry is a joint initiative of Department of Pharmaceuticals, Government of India and Federation of Indian Chambers of Commerce & Industry (FICCI). It will provide a common platform where all the participants will get an opportunity to enhance their brand value by displaying their product and the capabilities among the conference delegates and

business visitors provided by the event.

India Pharma 2017 will cover all the sectors of the pharmaceutical industry starting from finished formulations, APIs, biopharmaveuticals, fine chemicals and intermediates, natural extracts, excipients and many more.

Latest pharmaceutical machinery, plants, laboratory equipment, analytical instrument and cleanroom equipment will be showcased.

Contact details Kamal Bhardwaj Deputy Director Mob: 9899392930 Email: kamal.bhardwaj@ ficci.com Federation of Indian Chambers of Commerce & Industry (FICCI) Federation House, Tansen Marg, New Delhi 110001

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October 1-15, 2016

MARKET GROWTH TRACKER

IPM clocks ` 10426 crores in August 2016 Domestic companies continued to dominate the market with a 79 per cent share THE INDIAN Pharmaceutical Market (IPM) was valued at ` 10,426 crores in the month of August 2016 clocking a strong 18 per cent growth over same period last year (SPLY).

This was the second consecutive month where the IPM crossed the ` 10,000-crore mark. On a MAT August 2016 basis, the industry was valued at ` 110,025 crores and reflected a 14 per cent growth with volumes contributing around 35 per cent of this growth.

The retail channel remained the largest channel in IPM contributing 84 per cent of the overall sales and reflected a 13 per cent growth.

The hospital and doctor channel contributed to 16 per cent of the overall sales and reflected a growth of 17 per cent on a MAT August basis. It is expected that the hospital channel will continue to report robust growth rates due to rapid capacity expansion in this space. As per IMS Health data which captures sales from trade stockists, more than 10 therapy areas in the IPM have already crossed a sale of ` 500 crores in the hospital segment viz. anti infectives, cardiac, gastrointestinals, pain, neuro, VMN, gynaecology, anti-diabetics, vaccines and respiratory.

IPM continued to remain fragmented with top 10 companies occupying 42 per cent of the share and companies across value buckets reflecting strong double digit growth. Top 10 companies grew at 19 per cent while companies in the 11-20 and 21-30 slabs grew at 17 per cent each.

Among the top 10 companies, Cipla (20 per cent), Mankind (21 per cent), Alkem (28 per cent), Macleods (30 per cent), Lupin (24 per cent) and Aristo (38 per cent) grew faster than IPM for the month while in the 11-20 companies,

14 EXPRESS PHARMA October 1-15, 2016

Company

No of brands in Top 300 for August 2016

Value of brands in Top 300 for August 2016 (Rs crores)

2015

2016

2015

2016

Abbott

25

28

255

328

29 per cent

Sun

29

28

234

271

16 per cent

Cipla

22

23

176

227

28 per cent

Pfizer

17

16

169

191

13 per cent

Glaxosmithkline

13

15

165

201

22 per cent

Alkem

14

15

146

194

33 per cent

Mankind

9

12

69

104

52 per cent

Aristo Pharma

10

11

102

157

54 per cent

Sanofi

12

11

111

120

7 per cent

Zydus Cadila

13

11

85

86

1 per cent

Note: Companies have been ranked as per the number of brands which feature in top 300 brands in IPM

Table 1: Pharma market size in million USD by country All values in million USD

Month July 2016

Month growth per cent

MAT July 2016

MAT growth per cent

Global Pharma Mkt

71912

-4.7

951383

3.0

US

33684

3.2

441771

8.2

Japan

6405

7.5

77912

6.1

China

5949

-8.1

73558

0.1

Germany

3384

-1.8

39878

-2.4

Brazil

1890

6.4

18731

-15.8

UK

1858

-19

25437

1.1

France

1759

-35.5

31688

-7.3

Venezuela

1727

52.2

14650

30.6

Canada

1541

-5.2

18965

-5.9

India

1363

8.5

14871

6.1

Australia

1113

20.5

11717

2.3

Italy

940

-60.4

26924

0.2

Spain

891

-51.4

20107

0.2

Table 2: Indian companies market size in the global market All values in million USD

Month July 2016

Month growth per cent

MAT July 2016

MAT growth per cent

Indian companies market size

2045

0.9

25393

6.4

Sun Pharma

318

13.7

3704

1.9

Lupin Lab

270

32.8

3233

20.4

Dr Reddy's Labs

190

-12.1

2573

-4.8

Aurobindo Pharma

126

-6.9

1860

6.2

Zydus Cadila

109

-15.6

1514

-2.6

Glenmark Pharma

107

-1.4

1341

3.1

Torrent

97

-5.2

1164

8.5

Cipla

87

13.6

981

8.7

Intas

79

-19

1256

14.5

Alkem

60

16.9

646

12.4

MARKET Glenmark (26 per cent), Micro labs (20 per cent) and IPCA (27 per cent) outpaced the market.

Among top 25 companies, Aristo gained two ranks and moved to 10th rank for the month while Macleods, Lupin, Glenmark and Ipca gained one rank each and moved to sixth, seventh, 15th and 20th rank respectively vis-Ă -vis July 2016.

Domestic companies continued to dominate the market with a 79 per cent share in August 2016 with a growth of 20.1 per cent. MNCs continued to reflect an improvement in growth, clocking a 12.4 per cent growth vis-Ă -vis a 9.3 per cent in July 2016. Large MNCs like Abbott, GSK and Pfizer which contributed around 57 per cent of the total MNC share in the month reflected growths of 16 per cent, 13 per cent and 10 per cent respectively. GSK growth stabilised after a spurt last month while Sanofi reflected a 6 per cent growth reflecting a slowdown.

Acute therapies remained the strongest pillar of IPM with a 68 per cent contribution to the total market; acute therapy areas (19.6 per cent) continued to outpace chronic therapy areas (15.9 per cent) in terms of growth carrying forward the momentum from last month. Anti-infectives (30 per cent), cough preparations (59 per cent), pain and analgesics (17 per cent) spearheaded the growth in the acute space while anti-diabetics (20 per cent) and urologicals (17 per cent) were the fastest growing chronic therapy areas.

Anti-infectives was by far the largest therapy area for the month with a revenue of ` 1600 crores reflecting a 30 per cent growth on the back of a good monsoon witnessed across the country. This was an impressive performance considering 14 per cent of the portfolio impacted by the FDC ban consisted of anti-infectives while it was also one of the largest therapy areas to be affected by the NLEM notification. Top 10 anti-infective molecules reflected an average growth of 38 per cent for the month with Cefpodoxime, Ceftriaxone injectables and Amoxyclav liquids reflecting

Source: IMS Health TSA & SSA, Aug 2016

Source: IMS Health TSA & SSA, Aug 2016

growth of 54 per cent, 51 per cent and 53 per cent respectively.

Cardiac therapy area regained its number two position in IPM for the month of August 2016 clocking a revenue of ` 1127 crores growing at 11 per cent. The therapy area was driven by Rosuvastatin (17 per cent growth), Amlodipine+ Telmisartan (20 per cent growth). Telmisartan which recently came under price control reflected a zero per cent growth which was an improvement over the -3 per cent growth it reflected

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last month.

Gastrointestinals was the third largest therapy area for the month garnering a revenue of ` 1097 crores with a growth of 13 per cent. PPIs and their combination with Domperidone reflected strong double digit growth. Rabeprazole + Domperidone, Pantoprazole + Domperidone and ranitidine were among the fastest growing molecules with a growth of 17 per cent, 16 per cent and 14 per cent respectively. Digestive enzymatic liquids reflected a 19 per cent growth driven primarily

by the east zone.

Respiratory emerged to be the fourth largest therapy area for the month gaining three ranks over July 2016 and clocked a 38 per cent growth over SPLY. Cough preparations, Levosalbutamol combinations and cold preparations (liquids and solids) were among the fastest growing categories in the respiratory space reflecting growth of 59 per cent, 154 per cent, 52 per cent and 38 per cent respectively.

Among chronic therapy areas, anti-diabetic, urology and

neurology were among the fast growing therapy areas, growing at 20 per cent and 17 per cent and 15 per cent for the month respectively.

DPP4 inhibitors driven by teneligliptin and the unprecedented number of players it has got into the market and glim+ met formulations spearheaded growth for the AD market. In the neurology space Levetiracetam continued to be the fastest growing molecule in neuro psychiatry for the month clocking a value of ` 43 crores with a growth of 24 per cent in August 2016. Escitalopram plain and its combination with Clonazepam found place among the fastest growing CNS molecules for the month with a growth of 14 per cent and 16 per cent respectively.

Brand building efforts across top companies continued to be evident with eight out of top 10 companies driving robust double digit growth for their portfolio falling under top 300 brands with only Sanofi and Zydus reflecting single digit growth. Clavam, Pan and Taxim-O drove Alkem performance for the month while Augmentin and Calpol propelled GSK. Moxikind-CV and Manforce spearheaded growth for Mankind. Clexane, Cardace and Targocid performance led to sluggish growth for Sanofi while Atorva, Aten & Skinlite led to near stagnancy for Zydus.

The global pharma market is valued at $951 billion growing at three per cent. The US continued to dominate the market with 48 per cent market share with growth of eight per cent.

Amongst the top market, India is ranked 10th in the month of July and growing at 9 per cent.

Indian companies holds 2.8 per cent share in the global market and growing faster than the global market.

Amongst the top five Indian companies, Sun, Lupin, Cipla and Alkem are growing on MAT as well as on month basis.

(IMS Health is a leading global information and technology services company providing endto-end solutions to the life sciences and healthcare industry).

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cover )

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(

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BY PRATHIBA RAJU

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cover )

While companies do maintain and implement their set of Standard Operating Procedures (SOP), it should be dynamically aligned with the US FDA requirements. The investments towards regulatory compliance warrant a holistic and root-cause based approach rather than a piece-meal approach that only addresses specific regulatory observation Akshay Chitgopekar Director, CRISIL Ratings

M

aintaining data to ensure traceability of a drug batch to its origin is the most important responsibility of a pharmaceutical company. Data integration asserts that medicines are accurate, complete, attributable, legible, intact and maintained within their original context, including their relationship to secondary data records. It is a worrying trend that Indian pharma companies have been regular defaulters.

Between 2004 and 2012, there has been a seven-fold rise in issuance of warning letters by the US Food and Drug Administration (US FDA) to Indian companies and the trend continues even now.

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Data integrity is fundamental in a pharmaceutical quality system, as it ensures that medicines are of the required quality. Lack of data integrity can have an adverse impact on manufacturers, stakeholders but above all on the patients who consume the drugs

Like people mature, so do regulations.

Increasing visibility into the coverage and frequency of inspections and training our inspectors on focussed data integrity checks is need of the hour Sudesh Anand Shetty Partner, Lifesciences Head, KPMG

Before Ranbaxy issue flared up, regulators in the USA and Europe accepted the data submitted by an Indian pharma company at the face value. After Ranbaxy episode in 2013 what was euphemistically called as ‘data documentation issue’ was actually a case of systemic manipulation of manufacturing records

Rajiv Joshi Partner, Fraud Investigation and Dispute Services, EY India

The CRISIL analysis of the FDA warning letters reveals that there has been an increase in letters being issued to India which was nearly 70 per cent in 2015 and around 37 per cent till August, 2016. Additionally, 14 per cent of the FDA-approved plants in India were on import alerts. Since January 2010, there have been 65 regulatory actions such as issuance of warning letters and import alerts on domestic drug makers.

Noting that the pharma industry has to strengthen its systems and controls to address data integrity issues effectively, Akshay Chitgopekar, Director, CRISIL Ratings, said, “Analysis of warning letters in the last six years shows that data integrity issues are cited in more than 85

per cent of cases relating to domestic plants compared to less than 25 per cent for Canada and Germany.”

Further, the CRISIL ratings on 283 pharma companies indicated that in past three years, 16 of them have been under regulatory scrutiny. This has reduced their exports to the developed markets, leading to a slowdown in revenue growth and dipped it to single digits in two years from over 20 per cent earlier, resulting in a sharp fall in the operating profitability as well. However, ratings on more than 80 per cent of these pharma companies have remained unchanged.

Apprising that the data integrity is fundamental in a pharma quality system, as it ensures that medicines are of the

Anil Khanna Independent Strategic Consultant and Investment Banker

required quality, Rajiv Joshi, Partner, Fraud Investigation and Dispute Services, EY India, said, “It's evident from regulatory actions worldwide that the lack of data integrity can have an adverse impact on manufacturers, stakeholders but above all on patients who consume the drugs. Hence, it is of paramount importance to ensure robust and continuous compliance with data integrity norms by the pharmaceutical sector, to boost regulatory confidence and regain patient trust.”

When it comes to pharma, data integrity is a requirement throughout a product’s lifecycle — from R&D to product development, clinical trials, manufacturing, testing and dispatch.

A company that is desirous of manufacturing and exporting

to any regulated market must comply with data integrity norms, which is an inherent subset of current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP) and Good Clinical Practices (cGCP) norms.

Spelling out the importance of data integrity further, Anil Khanna, Independent Strategic Consultant and Investment Banker, suggested that it impacts the quality, efficacy and safety of the drug that a consumer takes with a blind faith in the company it belongs to.

“When it comes to safety, quality and data integrity issues, before Ranbaxy issue flared up, regulators in the US and Europe accepted the data submitted by an Indian pharma company at the face value. They

( never questioned it. However, Ranbaxy episode in 2013 changed the scenario. What was euphemistically called as ‘data documentation issue’ was actually a case of systemic manipulation of manufacturing records. Ranbaxy was the tipping point,” Khanna said.

Three years ago India-based Ranbaxy Laboratories had to pay a fine of $500 million for gross violation in methods of testing medicine and for manufacturing substandard drugs in a settlement agreement with the US Department of Justice.

“Though the issue of data integrity is a worldwide issue, Indian pharma is under an increased scrutiny by the regulators, after the Ranbaxy episode,” Khanna informed.

This is a clear indication that increased awareness for data integrity norms is the need of the hour for both regulatory authorities as well as pharma manufacturers. Timely enforcement by Indian regulators will definitely help the Indian pharma sector.

Need of concerted efforts Improving data integrity requires concerted effort as it's vital and needs continuous recording of information which is getting generated within the lifecycle of a new discovery, a new cure and its translation from the lab into a patient’s body; be it oral dosage, injectable or otherwise. Hence, the integrity of this record or data is critical to ensure if at a later point there is a need to validate potential gaps. This is evident from the spate of regulatory inspections and resultant regulatory actions that pharma and medical device companies globally are experiencing.

“A proactive approach to assess the quality systems is recommended instead of reactive approach which may involve remediation activities undertaken after possible backlash from regulators. A proactive approach also helps in managing the opportunity cost and unnecessary business distractions, resulting from the remediation

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efforts,” Joshi said.

Informing that documentation should be clear, accurate and identifying the ‘who-whatwhen-where-why-how’ along

with anomalies, Sudesh Anand Shetty, Partner Lifesciences Head, KPMG, shared that the data integrity should follow ALCOA — attributable, legible

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long lasting, complete, original and accurate —method as the data integrity needs to be both inherent and explicit.

“Like people mature, so do

regulations. Perhaps, we need increased visibility into the coverage and frequency of inspections, as also train our inspectors for focused data integrity

cover ) checks – which our industry is being beaten up for in the recent past. Indian regulatory bodies like Central Drugs Standard Control Organisation (CDSCO) and Drug Controller General (India) (DCG(I) are now defining clear inspection checklist for inspectors – which will provide guidance on how inspections are to be conducted, which aspects are to be seen, etc. Indian Pharmaceutical Association (IPA) is also in the process of defining data integrity guidance for the Indian pharma industry. So while the impetus and initiative are there, combining these with hands ontrainings conducted by experienced data integrity personnel will bolster our norms and implementation far more than ever before,” says Shetty.

A senior official from CDSCO requesting anonymity informed Express Pharma that data integrity is crucial, but such problems need to be focused. For that they are upgrading the skill of the employees working in pharma manufacturing companies via a certification programme, which will help them to understand the importance of data integrity and IT integration.

“The certification programme developed by Lifescience Skill Sector Development Council will be effective from 2018. The objective of the course will be to enhance and enable organisations to effectively meet quality standards. It will help and improve domestic drug makers to come out with quality pharma products and be aware and comply with the procedures. The course is mandatory as no person can be employed without a formal diploma or degree,” the senior CDSCO official stated.

The EY survey 'Analyzing the state of Data Integrity Compliance in the Indian pharmaceutical industry' notes that Government of India is more vigilant and is emphasising on GMP compliance guidelines as it focuses on the 'Make in India' initiative, and commitment to battling fraud and corruption,

20 EXPRESS PHARMA October 1-15, 2016

Source : IPQ.Pubs.com which tracks CMC and GMP developments

KEY ROOT CAUSES OF DATA INTEGRITY ISSUES Shortage of manpower: Shortage of staff and excessive work pressure can lead to inaccurate and incomplete documentation.

Quantity over quality: Employees may be forced to compromise the acceptable quality levels in order to meet production targets or dispatch timelines.

Lack of awareness: Often, employees are not trained or inadequately trained to understand GMPs.This causes employees to consider activities as a chore rather than understanding their relevance in light of GMP. Effectiveness of trainings: While the company may hire the best international trainers, employees mentioned that there were language and accent barriers, which prevented the employees from understanding the content, thereby making the training redundant.

Source : EY survey titled, “Analyzing the state of Data Integrity Compliance in the Indian pharmaceutical industry”

the pharma industry is being watched very closely to recoup and lead the initiative.

“The government is more vigilant and is emphasising on GMP compliance guidelines set by global, central and state regulators. While the pharma industry is committed to gear up on quality and compliance, the remedy for the industry now is to get more proactive in its quality compliance drives. The same can be done by adopting regular internal and external

data integrity assessments to identify gaps if any, such as to identify if laboratory test data files have been deleted outside of routine archiving process, monitor data to identify potential trial runs, re-processed files and use of common or shared login ID and password. The company will then have to get into the root cause of these issues and address the gaps without camouflaging or hiding facts, as data integrity essentially is, “do as you say, and say

as you do,” the EY report says.

The report further adds that even companies with a good track record with regulators and regardless of the existing or anticipated GMP compliance concerns should initiate periodical proactive data integrity assessments to assess their current state of quality compliance.

This not only acts as self-assurance, but may also provide comfort to regulators, customers, investors on the management’s commitment to quality and

compliance.

According to Chitgopekar, regulatory mechanisms and regulations differ across regulators as regulations are constantly evolving. He says there is also an increasing talk of greater coordination between regulators of different countries on some key aspects. “Convergence of key regulatory standards across regulators over a period of time can strengthen regulatory oversight, lower cost of compliance for companies

( and get access to highest quality drugs for patients irrespective of their location,� he said.

According to CDSCO, there has been a subsequent rise in inspections by local regulatory bodies in India. In December 2014, Maharashtra FDA inspected more than 50 facilities to assess compliance with GMP requirements. It has been reported that representatives of the State FDA have identified 250 companies certified by the CDSCO for conducting surprise checks.

As per EY reports, recently the US FDA has invited Indian officials, both at Central and State government levels, to accompany its team while

In December 2014, Maharashtra FDA inspected more than 50 facilities to assess compliance with GMP requirements inspecting pharma units within the country. This will help Indian regulators mature with respect to conduct inspections, liaise with international regulators, and communicate GMP compliance expectations of international regulators to the Indian pharma industry.

To improve data integrity issues, more senior management intervention, stronger quality culture and strong reporting hierarchy at the plant level is required.

Drug makers vs regulations Despite scrutiny, drug makers still have been able to hold on to their ratings. Things could change if pharma companies enhanced its capabilities in

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managing data, processes, and compliance. Remediation time for these regulatory actions should be judiciously completed to avert warning letters

and import alerts.

As per CRISIL ratings of the 54 warning letters issued to India between January 1, 2010 and August 9, 2016, only three

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warning letters were resolved and closed. In the case of Germany, of the 10 warning letters issued, four are already closed and six out of 12 warning letters

are already closed for Canada. “Inadequate data control, data deletion and un-investigated out-of-specification results have been some of the

cover ) serious observations commonly raised by the US FDA over the past several years. Companies need to regularly invest to stay abreast of cGMP requirements.

They need to keep learning from ongoing inspections and regulatory actions and are invest in ramping up their facilities to meet the expectations of the regulators. While companies do maintain and implement their set of Standard Operating Procedures (SOP), what is required is to align them dynamically with the US FDA requirements. The investments towards regulatory compliance warrant a holistic and root-cause based approach rather than a piece-meal approach that only addresses specific regulatory observations,” informed Chitgopekar.

Industry experts also highlight that compliance with essentials of 21 CFR 11 is necessary, as it enables audit trail of laboratory systems, respect unique user ID and password at all times, ensure that administration rights are with the right people and department and computer systems are validated and so on.

“Having an integrated periodical proactive data integrity assessment programme, accompanied by upgraded computer systems in line with 21 CFR 11, will not only aid the progress of Indian pharma companies, but also improve the industry’s tarnished image,” the EY report underlined.

Nevertheless, the heightened regulatory scrutiny and programme by regulators help Indian pharma companies improve quality standards and compliance in long term even though it’s a pain to endure in the short to medium term, particularly for those under scrutiny. And as it spruces up amid regulatory glare in the road ahead, it will emerge structurally stronger.

Smooth road ahead A majority of the large Indian pharma companies, particularly those exporting to the US, are aware of the prescribed standards. Data integrity is not

22 EXPRESS PHARMA October 1-15, 2016

Souce : FDA shared by CRISIL Ratings published on August 2016

STATUS OF WARNING LETTERS ISSUED TO VARIOUS COUNTRIES

FDA shared by CRISIL Ratings published on August 2016

just an Indian phenomenon, but a global issue many countries grapple with. The compliance

with regulatory requirements needs to be bolstered, with India’s share of scrutiny being dis-

proportionately high as its share of US FDA approved plants is high.

Data integrity is a serious infraction, remediation time tends to be longer and there is

( a risk of future scrutiny unless quality systems are spruced up.

Players under scrutiny are likely to see some impact on revenue and profitability. Depending on the severity of issues/regulatory action, experts opine that it is hurdle which Indian pharma companies would surpass.

Terming data integrity as a global challenge-cum-opportunity, Shetty said, “I say opportunity because it is human behaviour to remain in our comfort zones. If we get pushed beyond that limit we feel uncomfortable – but growth in fact is beyond that zone. Do we need to do a lot of work to become compliant? Yes, I suppose we do. Reports indicate that we have lost trust of regulators and perhaps even of patients. Hav-

Data integrity and compliance is a cycle which will help win back trust of all stakeholders – patients, regulators, employees and shareholders ing said that, I am confident that Indian pharma industry will emerge out of this situation successfully demonstrating to the world that we are most committed and disciplined to our mission. It is a matter of time and with sincere intent. we will be out of the situation of non-compliance,” he said.

Companies should invest in data integrity for survival and growth, the way they do for R&D. Data integrity and compliance is a cycle which will help to win back trust of all stakeholders – patients, regulators,

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employees and shareholders, eventually yielding immediate benefits. Patient’s preference on the company’s drugs and market share increase will be the immediate outcomes.

Employees will feel more confident about their product and perform better with performance bonus. Finally, regulators will be assured of management’s commitment

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on quality and compliance.

As a result, pending and future application approvals will become more promising. This will boost the management’s morale that doing the right

thing and developing safe and effective products only guarantees success. Clearly, it’s a good cycle to be in. prathiba.raju@expressindia.com

cover ) I N T E R V I E W

'Doctors are highly motivated to know about clinical insights from the pharma industry' DocPlexus, an online community for doctors, is building a bridge between pharma companies and doctors to improve clinical outcomes. Phanish Chandra, CEO, Docplexus, shares more details about the platform, role of technology in the lifesciences industry, differentiators offered by his platform for both the pharma and healthcare sectors and more, in an interaction with Lakshmipriya Nair What does Docplexus seek to achieve? What are the objectives/rationale behind setting it up?

Doctors play the most critical role ensuring that the general population receives care and treatments for various diseases. However, the statistics from the government suggests that seamless connectivity between the doctors across India has been a biggest hurdle in ensuring the delivery to achieve national goals. Docplexus is solving exactly that problem.

Docplexus is a community of over 1,50,000 practising Indian doctors. The doctors from all over India are joining Docplexus to stay updated with clinical information, to know more about new treatments and drugs, and get insights about policies that are related to medical community.

Over 6000 doctors are joining Docplexus every month making us India’s largest and fastest growing platform.

By providing doctors with updated clinical knowledge, we are helping patients to get most effective and recent treatment. Every day over 12000 doctors log on to Docplexus and over 10,000 patient cases have already been shared and solved by the doctors. Each doctor comes in contact with an average of 25 patients per day. That means Docplexus is helping to achieve better patient outcome for

24 EXPRESS PHARMA October 1-15, 2016

over 2,50,000 patients every day. Our ultimate vision is to empower each and every doctor in India so that they learn something new every day and treat their patients well.

Our aim is to create a difference in healthcare by improving patient outcomes for at least 100 million patients every year.

How will Docplexus encourage/promote ethical marketing of pharma products?

At Docplexus, we are collaborating with pharma and medical devices companies.

Pharma industry’s reputation has been tainted in the past due to some pharma companies marketing their products with unethical practices. In the last few years, since the introduction of Uniform Code of Pharmaceuticals Marketing Practices (UCPMP), many pharma companies have woken up after anticipating the effects of this law. However,

they did not have any new means to communicate the message about their products and services to the doctors. We have provided both the pharma industry and doctors with an unbiased platform to interact in an ethical manner.

We help pharma companies to connect with over 1,50,000 doctors with the most important offering they have, their proprietary clinical insights.

Through various means such as articles, webinars, CMEs and interviews, pharma companies can communicate this information and knowledge to the doctors. At the same time, doctors have a complete control of whether they want to consume the communication from pharma firms. So far, we have seen that doctors are highly motivated to know about clinical insights from the pharma industry and Docplexus is their most trusted choice due to our reputation as an unbiased, trustworthy and ethical platform. Pharma companies too have recognised the opportunity to reduce cost and improve the effectiveness of their marketing activities that our platform offers. Overall, it is a win-win situation.

Data security is a growing concern especially in healthcare and pharma.

What measures have been taken by Docplexus?

Data security is one of the biggest concern, especially in the life sciences domain. We have multi-layered security measures to ensure privacy and data security.

First of all, we have a strict registration process where only verified registered Indian doctors can join Docplexus.

Our team ensures that each registration is genuine in multiple ways. This reduces the risk of unscrupulous activities that can become a risk for the platform.

We also have the most sophisticated, state-of-the-art technology to prevent any breach in the system.

Secondly, the patient’s private information is never made public on Docplexus.

Our team has ensured that all private information is masked before the cases are made public. This prevents any breach of privilege or information or identity theft.

Explain the technology you have used to build this platform.

We are using one of the most secure and latest technology, Amazon Cloud. Our core technology is chosen considering user's need and best experience. We are giving that experience through a variety of advanced coding languages for quick response and more secure, scalable solution.

We are agile and we

( continuously test and improve our technology for secure, seamless and efficient experience for our users.

What is the revenue model of Docplexus. How does the business operate?

We do not charge doctors for membership on Docplexus.

For some additional benefits such as certification for CMEs, we charge them a nominal fee.

On the other side, we do charge pharma companies a subscription fee to market their products on Docplexus.

Being a lean organisation, our capital is enough to sustain us.

What are your growth plans for the next three years?

What is your strategy to achieve your goals?

As mentioned earlier, in the next few years, we want to connect all Indian doctors with each other. In addition, we want to bring onboard various professional organisations of doctors to ensure their communication have reached to all their members. This will surely ensure improved patient outcomes. Our aim is to improve patient outcomes for 100 million patient outcomes every year.

In addition, we will be connecting with top global medical institutions to bring best clinical information to Indian doctors through webinars and CMEs. We have already worked with various professional organisations in India and we will ensure most of the bodies are present on

To subscribe: bpd.subscription@expressindia.com

Docplexus.

Being a tech-enabled company, we always focus on how best we can provide solutions to our members. It is easy to get carried away with the technology but our focus will always remain on 'healthcare problems.' This ensures that we stay ahead of the curve.

How would the funds be raised to put the growth plans in motion?

We have raised $750k in the past and have raised another $500k with the same investors. With the raised money, we are going to invest in creating better and more useful content for the doctors.

What are the unique

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opportunities for growth in India’s healthcare IT segment? How are you positioned to leverage them?

The healthcare sector in India has a lot of opportunities for IT companies. Be it ensuring healthcare delivery to patients, hospital management software suits or ensuring the delivery of the medications.

The options are limitless for IT firms to explore. However, healthcare in India is Pandora’s Box. For any IT company who wishes to be successful in healthcare sector in India, working in a silo is not an option. Indian healthcare is very fragmented and firms who give any kind of connectivity between the players in this area can become successful provided

they employ the right manpower who brings a lot of experience but still dare to think differently about this sector.

Unlike developed countries, every single area of healthcare sector poses a unique challenge and ofcourse varied opportunities.

Docplexus is very well positioned in the healthcare sector as we are in a constant dialogue with biggest stakeholders; doctors and pharma and medical devices companies. Through our experience for over 2.5 years as company, we have learnt a lot about the healthcare in India that can be improved and we are working on making the difference from the core. lakshmipriya.nair@expressindia.com

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cover ) Assurance and improvement in pharma ITthrough internal audits and assessments Sambit Mohapatra, Senior Associate Consultant, Infosys and Prasenjit Sen, Senior Consultant, Infosys, in this white paper provide a framework for effective utilisation of the second line of defense (integrated assurance) for effective risk management

E

ffective Risk Management in a pharmaceutical organisation involves the strategic implementation of three lines of defense. Each line of defense provide risk governance guidance to support the ERM framework. Management control and internal sustenance forms the first line of defense in risk management, the various risk control and compliance oversight functions established by management are the second line of defense and independent assurance along with corporate audits is the third. Each of these three ‘lines’ play a distinct role within the organisation’s wider governance framework.

The purpose of this paper is to provide a framework for effective utilisation of the second line of defense (Integrated assurance) for effective risk management. It defines holistic and comprehensive audit approach of computerised systems using pharma industry’s best practices and compliance controls to demonstrate adherence to regulatory directives and guidelines. As FDA has increased focus on CSV-related inspections, CSV audits and assessments have a key role in the corporate governance structure to assure on the effective management of risk. It is not only sufficient to ensure assurance, but also to identify

26 EXPRESS PHARMA October 1-15, 2016

compliance gaps and derive insights about the compliance health. This in turn is used to strengthen the risk management controls which are the focus of this whitepaper. This whitepaper outlines our thoughts on effective audits and continuous improvements.

Business problem Computerised systems used for supporting pharma business processes are subject to numerous regulations (like 21 CFR Part 11, EMEA Annex 11) and industry guidelines (including PIC/S, ASTM 2500 and GAMP Guidelines for computerised GxP systems).

While FDA was quiet about software and computer system validation between 2002 and 2006, this has

changed significantly since 2006. Software and computer system validation has become an inspection focus for pharma, API and device industry. Deviations have been cited related to all steps of computer validation from writing specification and risk assessment to IQ/OQ/PQ, revalidation, reporting and change control. Just from 2007-2010, there have already been more than 30 such warning letters, some with disastrous consequences for inspected companies. Since 2010, FDA’s observations related to 21 CFR 11 non-compliance cover laboratories, manufacturing and clinical trials: the entire product lifecycle.

The core commonality is a lack of control that calls into question the reliability of a

company’s information used to make decisions around product safety and/or efficacy (or otherwise to ensure compliance with predicate rules).

Since then, the number of warning letters related to CSV have seen an upward trend. As the industry evolves, the complexity around achieving compliance has grown due to a number of factors – outsourced development and support, global infrastructure, adoption of cloud, to name a few.

Looking at Indian context, FDA has issued warning letters to atleast five Indian firms in 2016 and four out of them had some form of violations related to computerised system. It is evident that almost 80 per cent of the warning letters related to comput-

SAMBIT MOHAPATRA, Senior Associate Consultant, Infosys

PRASENJIT SEN, Senior Consultant, Infosys

erised systems. Clearly, it is high time for all small and large Indian pharma firms to put proper processes in place if not already done.

In response, most pharma sponsors have put in place robust IT risk management controls and procedures. The efforts to strengthen the first line of defense have matured in line with regulatory and industry guidance. From a regulatory compliance perspective, it is more pivotal to strengthen the second line of defense which can proactively identify issues.

The second line of defense is implemented with internal quality assurance audits and periodic review procedures.

However, in IT divisions of many pharma companies, there is a lack of integration between these processes.

Thus the related information is not being leveraged to gain valuable insight that drives more rapid improvements in processes, solutions and compliance.

Often audits are performed by multiple teams based on their area of responsibility with inadequate coordination and consolidation of findings. Audit and review has intended to be driven from a desire to achieve and demonstrate compliance with regulatory requirements, rather than to find actual gaps, continuously improve and achieve

(

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An integrated and comprehensive audit framework not only provides a high degree of assurance but also provides a detailed feedback to strengthen the first and second line of defense greater efficiency in the operation of systems. Here lies the potential for significant value addition in deriving insights for process improvement and maturity by analyzing the audit observations and periodic review findings and having a feedback process which is integrated, comprehensive and aligned to the process control effectiveness.

Regulatory requirement for defining audit approach Before defining the audit approach, there needs to be a clear understanding of the audit requirements as mandated by regulatory guidelines. Most of the audit requirements are derived from GxP, SOx and privacy regulations like the ones mentioned below: ◗ GxP requirements: GxP is based on guidelines for the pharma industry and covers all steps from drug development to production. It is enforced by industry regulations such as 21 CFR Part 11 and predicate rules, EMEA Annex 11, 21 CFR Part 820, IEC 62304 & 60601 and ISO 14971 & 13485. ◗SOX Section 404 (Sarbanes-Oxley Act Section 404) Controls: This mandates that all publicly-traded companies must establish internal controls and procedures for financial reporting and must document, test and maintain those controls and procedures to ensure their effectiveness.

Major IT SOx focus areas are: ◗ Management of change including development projects ◗ Management of change includ User access management to application, database and operating system, and finally ◗ Management of change includ Computer operations and configuration management The operational GxP audits include change and configuration

management, incident management, security management including data integrity checks, back up, restore and business continuity.

Computer operations sox audits consists of back up and monitoring controls.

Infosys solution framework The integrated risk management solution approach provides high focus on the second line of defense. An integrated and comprehensive audit framework not only provides a high degree of assurance but also provides a detailed feedback to strengthen the first and second line of defense.

The second line of defense encompasses both monthly audits and yearly periodic reviews. The monthly audit involves assessment of a specific operational process area for planned applications while the periodic review covers all process areas for the respective applications. The audit process starts with defining a risk-based audit approach with inputs from all the stakeholders including process owners, system owners, service managers, BAU teams, Site IT Lead.

Based on that an audit plan and periodic review plan are prepared which are streamlined at the planning level.

Audit and periodic review are conducted as planned based on a comprehensive checklist as per applicable GxP good practices, sox controls and internal guidelines. The observations and suggested corrective and preventive actions are then published in audit reports. While the corrective and preventive actions are tracked to closure, the audit and periodic review observations are used to prepare a live dashboard with compliance health information for all critical and regulated applications. The observations are also used as an input for preparing the

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EXPRESS PHARMA

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cover ) consolidated audit analysis report. Based on the analysis, gaps are identified which are remediated using continuous improvement plans. The process gaps are also taken as inputs for design effectiveness reviews.

Any new control/process established as part of the improvement process is checked for proper implementation during next audit cycle.

the audit analysis. The update also covers any new processes/controls established as part of continuous improvement plans.

Audit and periodic review planning: Audit planning and periodic review assessment tracker follows the audit approach. Proper planning for each category of audit is essential to ensure smooth conduct of audit. This includes defining which processes/subprocesses is audited, defining the timelines, schedule, specifying the auditors, determining the resource requirements from audited team.

The audit plan and the periodic review assessment tracker are streamlined at the planning level. This alignment ensures that no application/process combination is audited twice. If a process for a particular application is audited as per plan, the same is taken as an input for the periodic review assessment. If a periodic review assessment of last year requires a follow up audit for verifying remediation action that is incorporated in next year’s audit plan.

Detailed audit framework Audit approach: The starting point for the framework is definition of an audit approach. The audit approach defines the scope and level of audit required based on risk assessment and projected benefits. This is defined based on risk assessment and feedback from IT Strategy and Continuous improvement plans. This defines the overall scope and objectives of the audits.

This is aligned with the overall IT strategy and takes feedback/input from audit analysis of previous year. It forms the basis for audit requirement defined in the audit plan. For e.g., if there are many audit observations in the change management process, it may need more frequency of change management audits.

Furthermore, the input of all stakeholders (including functional process managers, quality process leads, system owners, service managers, BAU teams, Site IT Lead etc is taken at this phase. This is essential to understand the audit needs based on future plans like migration, upgrade, infra migration or other major changes and activities that may affect the compliance status.

The audit is conducted based on a comprehensive checklist as per applicable GxP processes and SOx controls. The checklist is customized based on internal guidelines of the pharma company. It is periodically updated based on feedback from

28 EXPRESS PHARMA October 1-15, 2016

The above picture describes an Infosys standardized and comprehensive framework for preparing a consolidated continuous improvement plan from an extensive and comprehensive analysis of audits, periodic reviews and compliance incidents

Definitions / Acronyms / Abbreviations Terms

Description

ERM

Enterprise Risk Management

CIP

Continuous Improvement Plan

CAPA

Corrective & Preventive Actions

CI

Compliance Incident – Any deviation from standard Quality Management System Processes.

DER

Design Effectiveness Review

QCS

Quality , Compliance & Security

Audit and review process: Based on the audit plan and periodic review tracker, audit and periodic review is conducted and observations are noted in audit report. Proper CAPA is suggested for remediation.

At this phase, some audit findings are taken as an input for the periodic review. As audits are conducted monthly, they can be easily taken as input for the yearly periodic reviews. For e.g. if an audit of change management controls for application is done in February, the same can be used as input for the periodic review of the application. There is no need to conduct change audit again during the periodic review.

The observations also go directly into the live compliance dashboards which displays the compliance health of

(

THE MAIN FOCUS

Sample Audit Dashboard as case study'

each application. The dashboards have multiple filters to view the compliance status for each application or each process area.

Analysis: Rather than limiting the audit process with remediation actions, analysis of the audit observations and of the periodic review observations is done. The includes observations across all IT audits conducted in the organisations. The audit analysis is based on audit reports for the audit period which provides insights for QMS areas across all applications. The periodic review analysis includes application specific analysis. There can be gaps or deviations specific to the particular

application teams in terms of lack of process or technical knowledge.

Analysis report and insights: Based on the analysis, a consolidated analysis report is prepared.

The report also incorporates an analysis of compliance incidents, process gaps and deviations. It has the details on process, knowledge and technical gaps. â—— Process gap: The audit analysis identifies gaps specific to any QMS process. â—— Knowledge gap: There can be process specific knowledge gap

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cover )

Sample /Indicative analysis as case study across the organisation or specific to a particular application team. Analysis of yearly audit observations identifies the organisation wide knowledge gap and analysis of periodic review observations identifies application specific gaps. ◗ Technical gap: Identification of technical gap is very essential as technical issues in regulated systems cause a corresponding compliance impact. ◗ Continuous improvement: Based on the insights, a comprehensive continuous improvement plan is prepared.

All the process related gaps are first used as an input for design effectiveness review (DER). The DER entails review of all applicable control to verify if the existing controls are sufficient for a compliant QMS process. Identified gaps may require

30 EXPRESS PHARMA October 1-15, 2016

establishing new controls and thus the update of SOP’s and guidelines. Any required updates for Sop’s/guidelines forms a part of the CIP. Similarly, the CIP plan includes conducting training sessions to address identified knowledge gap and Technical automation/bug fix to address any technical gaps.

Case study A top pharma company wanted to streamline its audit and review process and somehow integrated that with the continuous improvement process. We started with defining an audit approach based on discussion with all the stakeholders and then the audit plan. Audit and review were conducted as per the plan and at the end of audit period, the observations were analysed to derive insights and integrate that into the continuous improvement programmes.

The numbers and percentage below are only indicative.

The audit finding are also indicative and do not directly correlate to any particular firm.

have an extensive overview of the compliance health of the entire organisation and can take informed decisions on audit requirements and control frameworks.

Industry benefits This framework offers a full proof approach for pharma firms and especially can be used as guidance by Indian pharma companies to streamline their process to meet global regulatory requirements. As a leading IT vendor with global experience, this is an attempt by Infosys to help the promising Indian pharma industry to cope with changing regulatory framework challenges. It offers the following key benefits: ◗ Integrated audit approach The framework covers all the audit processes as required by regulatory guidelines. Furthermore, the entire framework is handled by a dedicated team of audit champions who

◗ Extensive compliance monitoring and external inspection preparedness The integrated audit approach comprehensively monitors and evaluates the effectiveness of internal controls and risk management which in turn also helps to identify and mitigate non-compliance and potential risks to ensure preparedness for external inspections.

Based on the insights, comprehensive continuous improvement plan is prepared to reduce the compliance incidents/ deviations/process gaps to zero by executing a series of targeted systematic improvement plans

References http://www.rsc.org/events/ detail/4529/learning-fromrecent-fda-warning-letters-related-to-computer-validationand-part-11-prepare-yourselffor-the-upcoming-fda-part-11inspections-webinar-by-globalcompliancepanel

◗ Consolidated audit analysis and insights Consolidated insights, analysis and trend reports for senior management to track compliance health

http://ceruleanllc.com/wpcontent/articles/CERULEAN_ FDA_21cfr11_Enforcement_Co ntractPharma092011.pdf http://www.labcompliance.com /solutions/expert_advice/ computers/4103-warningletters-csv.aspx

◗ Comprehensive continuous improvement

Views expressed by the authors are personal

MANAGEMENT I N T E R V I E W

'GDP is the heart of the quality system' Any inaccuracies in Good Documentation Practice (GDP) can have an adverse impact on auditing process. Bhavan (Bob) Mehta, Principal Consultant and Recruiter, GMP ISO Expert Services, explains more about the need for GDP and its impact on auditing process in discussion with Sachin Jagdale Why is it necessary to keep the written records of pharmaceutical operations?

For pharma operations regulated under 21 CFR Part 211 regulations, it is critical to maintain written records to serve as objective evidence during an audit to demonstrate that regulatory requirements were met and products manufactured are in strict compliance to cGMP norms. Some of the applicable requirements that require written records are 21 CFR Part 211.68, 211.180, 211.182, 211.192, and 211.198.

Which are the commonly observed errors in Good Documentation Practice (GDP)? How do they impact the auditing process?

Commonly observed errors in GDP are: a. Records are not filled accurately b. Over-writing c. Cross-outs without explanation or justification, initial and date d. Entries not made when tasks are performed e. Backdating f. Document is not legible and complete g.Records are approved by a second reviewer and errors are not identified during the review h.Use of white-out or correction tape i. Writing an explanation for one’s own understanding that can’t be understood by others GDP is heart of the quality system. When records with any of the above errors are given to auditors, it proves that either the organisation

has a lack of understanding of GDP requirements or does not have control over its quality system. When I say control over quality system, I mean a culture has not been created and supported by providing a robust training and identifying GDP-related issues during internal audits. A number of organisations have received warning letters for not having accurate and complete written records that are free of GDP errors.

What sort of training should pharma companies impart to their employees for the same?

Pharma companies should create a robust training programme to show how GDP directly impacts 21 CFR Part 211 regulations and share warning letters for learning and growth of their employees to minimise the number of errors. In addition, pharma companies should create a programme to qualify reviewers by providing extensive training to ensure that all GDP-related issues are identified by the primary and secondary reviewers. Lastly, organisations should train their internal auditors to focus on the areas of GDP by aligning requirements to the regulations (21 CFR Part 211).

What types of documents come under GDP? The documents that should be considered for GDP are many.

A few examples are manufacturing batch records, laboratory records, Out-ofSpecification (OOS) investigations, cleaning logs, calibration logs, preventive

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Each employee shall be incharge of GDP. The goal of the pharma company should be to have ‘Zero GDP-related errors’ maintenance logs, validation records, complaint and CAPA investigations.

Who is usually in-charge of GDP and what kind of qualification he/she needs to have?

Each employee shall be incharge of GDP. The goal of the pharma company should be to have “Zero GDP-related errors”. This is possible only when each employee fully understands the GDP

requirements and takes ownership of tasks. The employee should understand that by saving five minutes, they are seeding a bad practice while not meeting regulatory requirements.

Ultimately, leads and supervisors should provide resources, training, and create a culture where their departments support GDP. Qualification of the individual should be done by an expert who has experience working for the previous employer or supported FDA’s warning letter related remediation projects to fully understand how to establish a robust GDP programme and to be vigil by reviewing random records in addition to ensuring adherence to requirements during an internal audit.

Explain the role of technology in maintaining GDP. The role of technology is critical. If an organisation can afford implementing electronic batch records rather than having a paperbased documentation system, it is a much more efficient way to tackle GDP-related issues.

The system can detect fields not completed by an operator and requires the operator to complete the documentation accurately before submitting the document to the second reviewer. Electronic records also keep traceability of changes assuming that it is validated and compliant to 21 CFR Part 11 regulations.

Cite a few examples where pharma companies have been punished by regulatory

authorities due to GDP related issues in India?

Many pharma companies in India received warning letters for not having a robust GDP programme which ultimately contributed to data integrity issues. For example, when using a paper-based system, if the operator intentionally or unintentionally does not enter critical information, the field can be filled by someone else on a later date and this creates a data integrity issue. Going back to 2014, a number of large and small pharma companies received warning letters from the FDA. A few of the companies are Cadila Healthcare, Sun Pharma, Sri Krishna, Micro Labs and Megafine Pharma. Since GDP and data integrity are interrelated, GDP issues require regulators to review additional records and organisations spend significant resources by flying in highly-skilled consultants from the US for remediation projects to meet the FDA commitments. In addition, FDA holds approval on new drugs until pharma companies fix issues fundamentally and submit evidences to the FDA. Lastly, pharma companies aren’t allowed to sell products to US customers before warning letter related remediation is completed.

Altogether, it is a significant loss for pharma companies.

As a result, senior management shall use a proactive approach rather than a reactive approach to avoid issues during regulatory inspections. sachin.jagdale@expressindia.com

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MANAGEMENT REPORTS

Asia-Pacific gastric cancer market set to experience strong growth to $2.7 billion by 2022: GBI Research Market will be driven by the increasing prevalence of gastric cancer, higher levels of health insurance coverage, and improving disease awareness THE ASIA-PACIFIC (APAC) gastric cancer market is set to rise from $1.3 billion in 2015 to $2.7 billion by 2022, at a strong compound annual growth rate of 11.4 per cent, according to business intelligence provider GBI Research.

The company’s latest report states that the market will be driven by the increasing prevalence of gastric cancer, higher levels of health insurance coverage, and improving disease awareness.

Indeed, strong awareness of the disease and a widespread screening programme in Japan have already led to a higher number of cases being diagnosed at Stage I, increasing the treatment-receiving population.

Gayathri Kanika, Analyst, GBI Research, states, “In line with improved diagnosis rates, the anticipated approval of various monoclonal antibodies (mAbs) over the forecast period will drive treatment rates across all lines of therapy and generate higher sales in the gastric cancer market. Currently, the gastric cancer treatment landscape

largely comprises generic chemotherapies, which provide limited clinical benefit and cause serious side effects.

However, the current pipeline is strong, with targeted therapies expected to be launched during the forecast period.”

A new class of drug, which approved for the treatment of gastric cancer, targeting vascular endothelial growth factor receptor, is Cyramza (ramucirumab), a mAb used for second- and third-line therapy for gastric cancer.

GBI Research expects Cyramza to garner rapid uptake, as it is being established as the standard of care for the second-line advanced setting, with its label expected to expand to cover the HER2-negative first-line setting within the forecast period.

Perjeta (pertuzumab) is being developed in combination with Herceptin for the treatment of gastric cancer, on the assumption that the combination will yield superior results. The response rate shown in a Phase II trial – which compared the efficacy of

Herceptin/Perjeta combination with that of Herceptin plus chemotherapy – was higher for the Herceptin/Perjeta combination. Perjeta, once approved, will likely replace the current standard of first-line treatment for HER2-positive gastric cancer.

Kanika concludes, “Despite their promise, the anticipated premium pricing of mAbs will make affordability a barrier for the marketing of these drugs in India and China, where there are no strong reimbursement frameworks and most expenses are paid outof-pocket by the patient. Moreover, increasing cost-consciousness in the other major Asian markets, such as Japan and South Korea, will limit premium pricing opportunities for pipeline agents. Drug companies will need to consider the changing reimbursement landscape when determining the pricing strategies for their drugs in these markets.”

EP News Bureau

Infectious diseases POCT market will rise to over $1.17 bn by 2022: GlobalData It will be driven by factors including increasing prevalence of infectious diseases, the emergence of more accurate molecular point-of-care technologies etc THE INFECTIOUS diseases point-of-care testing (POCT) market is set to rise from $696.1 million in 2015 to just over $1.17 billion by 2022, representing a compound annual growth rate of 7.7 per cent, according to research and consulting firm GlobalData. The company’s latest report states that this relatively strong growth, which will occur across the 10 major markets of the US, France, Germany, Italy, Spain, the UK, Japan, China, India, and Brazil, will be driven by factors including the increasing

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prevalence of infectious diseases, the emergence of more accurate molecular point-of-care (POC) technologies, advancing POC technology, and the growing home-testing market which encourages further adoption of POC devices.

Wenlu Hu, Analyst, GlobalData covering medical devices, explains, “The main barrier to the acceptability of infectious disease POC tests has been their relatively low accuracy. The sensitivity and specificity achieved with the currently available lat-

eral flow technologies at the POC is, at present, inferior to those achievable in central labs utilising nucleic acid methods.”

Hu further said, “Recent technological innovations have enabled nucleic acid testing improvements that make POC molecular diagnostics possible. Notably promising technological advances include the loop-mediated isothermal amplification (LAMP), which allows for the rapid detection of DNA/RNA without the requisite for thermal cycling, and the amplified redox

assay, which can yield a highly multiplexed 20-minute nucleic acid test result using room-temperature-stable consumables.”

In addition to improving technologies, a rising prevalence of infectious diseases in developing countries has shifted focus towards preventive care and early diagnosis. Early disease diagnosis is crucial to reducing healthcare cost, and POC technology will play a vital role in treating patients in the most cost-effective manner.

Hu continues, “Infectious dis-

eases are still the primary cause of mortality globally, and according to figures from the Clinical Microbiology and Infection journal, they claim approximately 14 million lives annually, making up around 25 per cent of the 56 million deaths recorded worldwide.

The unprecedented increase in infectious diseases is a foreseeable long-term trend that is expected to result in a dramatic increase in the demand for cost-effective diagnostic techniques such as POCT.” EP News Bureau

RESEARCH UPDATES

NOVARTIS SAYS EXPERIMENTAL DRUG HELPS CHRONIC MIGRAINE SUFFERERS The drug has achieved its main goal of reducing the number of monthly attacks, regardless of dosage, compared to a placebo

A

bout 40 per cent of chronic migraine sufferers taking an experimental drug developed by Novartis and Amgen saw the number of days they suffered a migraine cut by at least half, beating the placebo in the trial. The latest analysis from the mid-phase study amounted to a 'statistically significant reduction in monthly migraine days,' Novartis said about the experimental

AMG 334 compound.

Novartis has struck pacts with its US-based rival Amgen to develop migraine and Alzheimer's treatments as it seeks to bolster its neuroscience portfolio. "These important data further support the efficacy of AMG 334 in patients who currently have limited therapeutic options," said Vasant Narasimhan, Global Head of Drug Development and CMO,

Novartis. The release follows data from June showing AMG 334, whose generic name is erenumab, had achieved its main goal of reducing the number of monthly attacks, regardless of dosage, compared to a placebo.

According to the latest analysis of the 667-person phase II study, 40 per cent of those taking a 70 milligram (mg) dose and 41 per cent of those on a 140 mg dose saw the number of days

they suffered a migraine cut by at least half. Only 24 per cent of those getting the placebo drug had a similar reduction.

“This is part of ongoing research,” a Novartis spokesman said. "We are continuing to analyse the data from the chronic migraine trial and across the entire AMG 334 (erenumab) programme in an effort to better understand who will respond." Novartis is also

studying AMG 334 in people suffering from episodic migraines.

The safety profile for erenumab was similar to the placebo group.

Under the collaboration agreement with Novartis, Amgen holds sales rights for the US, Canada and Japan, while Novartis would sell the drug in Europe and the rest of the world, if it wins regulatory approval.

Reuters

FDA approves Heron’s therapy for chemotherapy-induced nausea Heron’s Sustol can protect patients for five days HERON THERAPEUTICS’ twice-rejected long-acting injection to prevent chemotherapy-induced nausea and vomiting was finally approved by the US Food and Drug Administration, marking the biotech's first regulatory approval. Nausea and vomiting, one of the most acute side effects of chemotherapy, occurs in up to 80 per cent of patients and is the leading cause of patients discontinuing treatment, according to the National Institute of Health.

Other chemotherapy-in-

duced nausea and vomiting (CINV) treatments, including Eisai's Aloxi injection, are generally effective for 48 hours or less, but Heron's Sustol can protect patients for five days, the company said. “Sustol appears to have gotten a favourable label ... and the approval removes a major overhang on the stock,” Leerink’s Jason Gerberry said. The FDA said in April it found no deficiencies in Sustol’s marketing application, after postponing its decision on the drug first in

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January and then in late February.

Sustol was approved in combination with other agents to prevent nausea and vomiting associated with some forms of chemotherapy, excluding platinum-based regimens, Heron said. The absence of platinumbased therapies from the label is a bit disappointing, given that Sustol showed a strong response in patients in this class of chemotherapy, Cowen & Co's Boris Peaker said. This exclusion reduces Sustol's address-

able population by about seven per cent, company executives said on a conference call.

Heron did not disclose Sustol's price, but said it would reference recently approved CINV treatments. Cowen's Peaker estimates a price of $200 per patient. Tesaro’s oral CINV treatment, rolapitant, was approved last September and works by blocking the activation of neurokinin (NK)-1 receptor. Sustol, like Aloxi, targets the serotonin3 (5-HT3) receptor, which plays a role in nausea and vomiting.

Sustol, which is an injectable version of the generic granisetron, will be launched in the fourth quarter. Heron said it had a support plan in place, consisting of co-pay assistance, extended financing until practices receive reimbursement, and would potentially reimburse patients if insurance claims are rejected. The treatment is expected to generate peak sales of $306.3 million by 2021.

Reuters

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RESEARCH

Novo Nordisk plans larger study after encouraging semaglutide results

Lilly breast cancer drug stumbles, but trial continues

Semaglutide has been proved highly effective in reducing glucose levels in patients with type II diabetes NOVO NORDISK'S experimental injectable diabetes drug semaglutide reduced cardiovascular risk by 26 per cent, according to results released, paving the way for a new and bigger study on the drug's benefits.

Semaglutide is the third diabetes drug to show such heart benefits, after Novo's Victoza injectable and Eli Lilly and Boehringer Ingelheim's Jardiance pill. Semaglutide, which has proved highly effective in reducing glucose levels in patients with type II diabetes, is viewed as a pivotal product for Novo Nordisk, which competes in the GLP-1 market against several rivals including Eli Lilly's Trulicity.

Novo Nordisk's so-called

SUSTAIN 6 study, presented, showed that semaglutide significantly reduced the risk of heart complications in patients. Because about half of the deaths in people with diabetes are caused by heart disease, reducing the risk such as heart attacks and strokes is seen as essential. Novo Nordisk announced in April that the SUSTAIN 6 trial had significantly cut the risk of major adverse cardiovascular events, but the scale of the benefit was only disclosed this week at a meeting of diabetes experts in Munich.

The study also found that semaglutide caused an 'unexpected higher rate' of retinopathy complications, such as blindness. Semaglutide, which is designed to be given once a

week, belongs to a class of medicines known as GLP-1 analogues that increase the body's insulin production when blood sugar levels are raised. The excessive blood sugar levels that come with diabetes can cause longterm damage to blood vessels, increasing the risk of heart attack, heart failure or stroke.

Novo Nordisk intends to file for regulatory approval of semaglutide in the US and Europe in the final quarter of 2016.

Consensus analyst forecasts suggest annual sales could reach $2.2 billion in 2022. Jefferies predicted an approval decision on semaglutide in the second half of 2017.

Reuters

US DRUGMAKER Eli Lilly and Co said it would continue a latestage trial of its experimental breast cancer drug in combination with a widely used treatment even though an independent panel determined the combination therapy failed to meet its interim effectiveness goal. The independent data monitoring committee recommended the trial continue without modification through the first half of 2017 despite the fact that its interim look at the data suggested the combination treatment was not delaying progression of the disease.

Leerink analyst Seamus Fernandez said continuation of the study, called Monarch 2, would allow Lilly to better understand abemaciclib, which is also being tested in a variety of other trials.

The Monarch 2 study included 669 patients who had previously failed to benefit from anti-estrogen treatment for metastatic breast cancer. It compared combined use of abemaciclib and anti-estrogen therapy fulvestrant with fulvestrant alone.

Lilly's drug is from the same new class of breast cancer treatments as Pfizer’s recently approved Ibrance, which brought in more than half a billion dollars in second-quarter sales. They work through a new mechanism, by blocking the proteins CDK 4 and CDK 6.

Lilly is evaluating abemaciclib as a single agent in breast cancer patients who have not derived enough benefit from prior treatments. Three other studies are testing abemaciclib with other drugs. Abemaciclib, which was granted the US Food and Drug Administration's (FDA) breakthrough therapy status for breast cancer last year, is also being tested for use in lung cancer. After skin cancer, breast cancer is the most common cancer among women in the US, according to the US Centers for Disease Control and Prevention (CDC). About 40,000 of the 220,000 American women diagnosed with breast cancer die each year, the CDC estimates.

Reuters

Mesoblast cell treatment shows promise in rheumatoid arthritis: Study The cell treatment also led to improvements in measures of physical function and overall disease activity versus placebo MESOBLAST SAID its experimental stem-cell treatment led to significant improvements of symptoms and disease activity in patients whose rheumatoid arthritis had stopped being helped by widely used biotech medicines, according to data from a mid-stage trial. Treatment with the Australian company's mesenchymal precursor cell (MPC) product, MPC-300IV, was deemed well tolerated with no serious side effects or infusion-related adverse events in the 48-patient, 12-week Phase II study, the company said.

Among patients previously treated with at least one biologic drug, the common measure of 20

34 EXPRESS PHARMA October 1-15, 2016

per cent relief of signs and symptoms of the arthritis, known as ACR20, was achieved by 55 per cent of those who received an infusion of two million cells per kilogram of weight. That compared with 33 per cent in the placebo group who achieved ACR20. The higher bar of ACR70, or 70 per cent improvement, was achieved by 36 per cent after one infusion of the Mesoblast treatment, compared with no patients in the placebo group who reported such an improvement.

The cell treatment also led to improvements in measures of physical function and overall disease activity versus placebo, the

company said. "The safety and efficacy results of this study are very encouraging and suggest that Mesoblast’s cell therapy has the potential to fill the major unmet medical need" for patients who cannot take biologic treat-

ments, Dr Allan Gibofsky, rheumatologist at Hospital for Special Surgery in New York, said.

Rheumatoid arthritis is a chronic, often painful autoimmune disease affecting about

one per cent of the global population. It causes inflammation and potentially destruction of multiple joints. Mesoblast, which is 14.6-per cent owned by Teva Pharmaceutical Industries, said it plans to line up a partner to help it move the treatment into larger Phase III trials.

About one third of patients either do not respond sufficiently or cannot tolerate popular biologic treatments for rheumatoid arthritis, such as AbbVie's Humira, the world's top-selling prescription medicine, creating a need for new therapy options.

Reuters

PHARMA ALLY VENDOR NEWS

Perlen Packaging (Suzhou) Co opens news facility in China Optimised to produce medium barrier blister films, the new coating line in Suzhou is equipped with the best available technology PERLEN PACKAGING has opened a pharmaceutical film coating facility in China.

Zhang Jingzheng, Deputy Chief of Administrative Committee of WETDZ, Governor of Tongli Town along with 70 guests took part in the opening ceremony.

“The goal to cater to the expected growth in Asia and to better serve these markets from a local site moved us to invest in a state-of-the-art coating plant in Suzhou. When

fully operational, the new plant will double our coating production capacities,” said Wolfgang Grimm, CEO, Perlen Packaging.

Optimised to produce medium barrier blister films, the new coating line in Suzhou is equipped with the best available technology. Core parts of the coating stations are a joint development between Perlen’s coating and engineering experts and the machine supplier’s engineering teams.

Perlen Packaging (Suzhou) Co, now has the largest and technologically most advanced PVdC coating line in Asia.

The camera detection system inspects 100 per cent of the coating surface and guarantees maximum product safety. Achieving the highest GMP standard, cleanroom class D, underscores this centre of excellence for pharmaceutical barrier films.

EP News Bureau

LANXESS closes acquisition of Chemours' clean and disinfect business Antitrust authorities approve LANXESS’ first acquisition following realignment SPECIALTY CHEMICALS company LANXESS closed the acquisition of the Clean and Disinfect business of US-based chemicals company Chemours.

LANXESS has paid around EUR 210 million for the clean and disinfect business, which comprises various active ingredients and specialty chemicals especially for disinfection and hygiene solutions. The company has financed this first post-realignment acquisition from existing liquidity.

“The acquisition is the first milestone on our path of growth and a further step toward strengthening our business in North America,” said Matthias Zachert, Chairman of the Board of Management,

LANXESS. The acquisition will be accretive to the company’s earnings per share (EPS) in the first fiscal year. The acquired business is expected to deliver an annual EBITDA contribution of around EUR 20 million, which will be gradually increased by synergy effects to about EUR 30 million by 2020.

The new business is to be integrated into LANXESS’ Material Protection Products business unit, not only expanding its active ingredients portfolio but also extending the value chain in the veterinary disinfection segment through to the end market. The acquired business has three production sites in Memphis and North Kingstown

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(US) and Sudbury (UK). It achieved 2015 sales of around EUR 100 million, with about half accounted for by the US. The business comprises three product lines: disinfectants, potassium monopersulfate and chlorine dioxide.

The disinfectants are marketed for biosecurity applications in the veterinary segment.

The core product brand is Virkon S, the world’s leading powder disinfectant with proven performance against a broad range of viruses, bacteria and fungi. It is used, for example, to combat Foot-and-Mouth disease and Avian Influenza.

The second segment focuses on the production and marketing active ingredient potassium

monopersulfate with its core brand Oxone. It is used in pool and spa applications, personal hygiene products and electronics applications and as an active ingredient in the formulation of disinfection products, especially in Virkon branded products.

Thirdly, chlorine dioxide is a proven package solution provider for industrial water treatment applications.

The LANXESS Material Protection Products business unit currently has a workforce of around 350, with production sites in Krefeld-Uerdingen and Dormagen (Germany), Pittsburgh (United States), Jhagadia (India), Changzhou (China) and Singapore. It is part of the Per-

formance Chemicals segment, which posted 2015 sales of around EUR 2.1 billion.

The business unit’s products are used worldwide in many different applications. With its broad portfolio of antimicrobial active ingredients and preservatives, the business unit offers tailored solutions for customers in many industrial sectors. In addition to disinfection, these include the wood protection industry, the paint and coatings industry as well as the construction sector and the beverage industry. Material Protection Products also offers extensive technical service, regulatory support and project-specific research and development.

EP News Bureau

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PHARMA ALLY PRODUCT

Optel Vision launches Open SiteMaster OPEN SITEMASTER (OSM) 2.0 is Optel Vision’s new interoperable site server software for serialisation data management. Located at the plant level, OSM masters the entire serialisation process, streamlining the data exchanges between various systems, while adapting to your specific IT environment and business logic.

Expert serialisation functions OSM offers all the features and capabilities a branded or generic pharma may need, and takes them to the next level, allowing you to fully control and oversee all serialisation actions. ◗ Process order repository: OSM can request or directly receive process orders from the ERP system to handle and allocate them for local packaging. ◗ Serial number management: Right out of the box, OSM supports several types of coding: SGTIN, SSCC and custom serial numbers, as well as barcodes such as GS1 Application Identifiers, Chinese ECode, Brazil IUM, Data Matrix, etc. Moreover, OSM can allocate serial numbers in different ways—sequential, random, prerandomised, or shuffled. It can also cache serial numbers for multiple lots; restock when set threshold is reached; obtain serial numbers on a lot basis; and even generate numbers locally. ◗ Serialisation Reporting (EPCIS): After a serialised batch, OSM can locally store and display various reports—reconciliation, performance, inspection, batch, audit—for all lines and send them to the serialisation database or corporate EPCIS repository. Plus, OSM has the unique ability to act as a temporary in-batch EPCIS repository for a broken flow or a palletising room. ◗ Production Master Data (Recipes): With OSM, production parameters can originate

36 EXPRESS PHARMA October 1-15, 2016

OSM encapsulates all of OptelVision’s proven expertise in serialisation and aggregation,complying with the numerous laws and legislations around the world.

Acting as a hub that coordinates actions for your plant,OSM gathers data from the packaging lines and communicates information and workorders through the existing ERPand up to the corporate level,getting serial numbers and sending back EPCIS reports.

In addition,OSM can be customised as needed and can connect to anysystem and anypackaging line — which means no vendor lock-in!

from the ERP, OSM master data, or a combination of both. ◗ Central Configuration Point: OSM can be a single point of entry for all line set ups — no need to go from line to line. One can create recipes; establish batch flow configurations; set up multiple flows; assign recipes to customers or markets; set triggers; add more steps to your process (e.g., pallet, shipping); select report

formats, etc.

Plus, the agility of open scripts To maximise customisation, OSM includes an exclusive open scripting feature that allows it to accommodate each and every unique process and IT environment. This includes connecting to any system and any vendor, allowing you to control all the different applicable

machines on your lines, under one serialisation umbrella.

In addition, these opensource script files enable you to extend OSM's functionalities and IT connectivity as required.

Using Python, your IT professionals can create all the scripts needed for OSM to run according to your specific infrastructure. There is one script per connection, and an unlimited number of connections are

permitted, allowing you to interface with as many corporate repositories as you need. And the best part is that any time an IT interface changes, only the associated script must be updated—not the entire system.

Contact details http://www.optelvision.com/ solutions/open-sitemaster/ http://www.optelvision.com/ contact/

PHARMA ALLY

Dock levellers by Gandhi Automations GANDHI AUTOMATIONS India, a certified ISO 9001: 2008 company, offers complete logistics solutions by providing dock levellers, dock shelters, sectional overhead doors and dock houses.

Electro-hydraulic, mechanical and air-powered dock levellers offered by Gandhi Automations are not only 'a bridge for connecting a vehicle', but also facilitate fast, smooth and safe transition by compensating the difference in heights between the loading bay and the vehicle. This contributes to minimising energy used and savings on heating and chilling costs resulting in maintaining the quality of the transported goods. Dock levellers offered by Gandhi Automations are designed as per EN 1398 standard for the most demanding loading and unloading operations.

The cost of loading and unloading the goods can be calculated precisely and is exactly definable, which allows for a scientific approach to find out the investment that goes into the process. The dock levellers offered by the company ensure loading and unloading with lesser effort and minimal cost.

Radius lip dock levellers allow the dock to connect with the truck bed, thus making it possible to drive directly on and off with forklift trucks etc.

The self-cleaning lip hinging system does not retain rubbish with automatic end-ofrun, so as to keep the 25 mm security distance between the folded lip and structure as per EN 1398 & EN 349.

It is possible to load and unload your products in a safe way and in the process obtain remarkable energy savings.

The loading bay remains with the dock levellers in rest position and the sectional overhead door closed, until the vehicle is positioned. The driver drives back centring to the dock shelter and stops the vehicle the moment it gets in contact with the bumpers.

The sectional overhead door is then opened only when the vehicle is positioned, brakes applied and engines shut off .This eliminates the exit of hot air, intake of cold air (or the opposite in hot and inside conditioned places) and intake of exhausting gases in the warehouse. After the sectional overhead door opens, the lip of the dock leveller connects to the truck bed for load-

ing / unloading to take place.

At the end of the loading/unloading the dock leveller is put in rest position and the sectional overhead door is closed, without moving the vehicle. The vehicle then departs at the end of the process.

Following are the two types of Dock Levelers ◗ Radius lip dock levellers

◗ Telescopic lip dock levellers Telescopic lip dock levellers are ideal for connecting vehicles unable to drive near dock i.e. sea containers, side loading railway wagons etc.

These types can be supplied with a lip extending up to 1 m.

Gandhi Automation’s dock levellers are equipped with the most secure safety devices and accessories.

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

Phenomenex introduces Lux i-Cellulose-5 chiral columns PHENOMENEX, A leader in the research and manufacture of advanced technologies for the separation sciences, has launched Lux i-Cellulose-5 chiral columns, offering a new selectivity to the company’s highquality LC/SFC media for chiral separations. This new Lux media is more robust than other chiral offerings on the market thanks to a manufactured chemical cross linking between the polysaccharide and silica supports. This enables use of the i-Cellulose-5

columns with even the strongest organic solvents, and offers greater sample loading and method development flex-

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ibility. The dichlorophenylcarbamate selector of the new media combines well with Phenomenex’s other Lux chiral stationary phases to provide an even more comprehensive

toolkit for chiral separations.

Lux i-Cellulose-5 is an affordable alternative to other selectivities on the market, and is available in both 3μm and 5μm particle sizes to meet the needs of analytical and preparative applications.

The Phenomenex Lux chiral column line of seven selectors comprises an affordable and complementary kit for chiral separations, featuring high efficiency, excellent loading capacity and pressure stability up to 300 bar in a wide range of

conditions. Ideal applications for Lux columns include the separation of drug enantiomers from the pharmaceutical sector, chiral pesticides in agrochemical settings, and a range of other chiral-chemicals such as raw materials, intermediates and finished goods.

Contact details Simon Lomas, Phenomenex Phone: (310) 212-0555 Ext. 2267 E-mail: simonl@phenomenex.com

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PHARMA ALLY

Agilent Technologies launches spectrometer AGILENT TECHNOLOGIES has introduced a new spectrometer that will enable laboratories to run more samples and generate more revenue.

The new Agilent 4210 microwave plasma-atomic emission spectrometer runs on air rather than flammable gas, a feature unique to Agilent MPAES systems, making it both safer and less expensive to operate. This is especially important to laboratories in the food, agriculture, petrochemical, environmental and mining industries.

The 4210 features an advanced valve system, an inert torch, a humidifier, a temperature-controlled spray chamber, a multimode sample-introduction system, and

38 EXPRESS PHARMA October 1-15, 2016

tion software enables remote elemental analysis. This flexibility opens up new possibilities for applications such as on-site process stream monitoring and environmental monitoring.

Analysis of heavy metals, micro nutrients and precious metals is critical in food, agriculture, petrochemical, environmental and mining industries. This unique system will take multi-element analysis to labs that may not even have access to regular supply of gases at remote locations, enhance lab safety and considerably reduce the cost per sample. enhanced diagnostics software, all of which extend the

instrument’s analytical performance, sample throughput

and ease of use.

In addition, new automa-

Contact details Website: www.agilent.com

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Dynamic Image Analysis with CFR 21 Compliance

State-of-the-art optical particle analyzers with patented dual camera technology, based on Dynamic Image Analysis. n Reliable detection of oversized and undersized particles down to 0.01% Vol n Particle shape analysis n Unique, almost 100% agreement with sieve results (option) n Fast, time-saving, easy to operate

n With CFR 21 Compliance

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PHARMA LIFE APPOINTMENT

Biocon appoints Suresh Subramanian as Head of Branded Formulations (India) Business Over 30 years of experience in the pharma market, he has worked with MNCs such as GlaxoSmithKline, Novartis, AstraZeneca and Pfizer

B

iocon has announced the appointment of Suresh Subramanian as Senior Vice President & Head of the company’s branded formulations (India) business.

Subramanian has over 30 years of experience in the pharma market, having worked in India and Thailand for MNCs such as GlaxoSmithKline, Novartis, AstraZeneca and Pfizer. Over the years, he has played multiple leadership roles in business development, marketing, sales and strategy.

He has experience in multiple

product launches, business optimisation, cost control, talent

development and performance management.

Subramanian has managed a wide portfolio spanning diverse therapy areas such as neurosciences, respiratory, cardiology, oncology, critical care, gastro-intestinal, ophthalmology, pain & inflammation and women’s health in the Indian market. He has also been a part of the Steering Committee for McKinsey’s India Pharma 2020 report.

Kiran Mazumdar-Shaw, CMD, Biocon said, “We are extremely delighted to have Suresh Subramanian lead our Branded Formulations busi-

ness in India. Suresh has deep expertise in diverse therapy areas including oncology, cardiology and critical care and has a proven track record of delivering robust business growth. We are sure, under his leadership, our branded formulations business will evolve further and become a strong value builder for Biocon.”

Suresh Subramanian is a Physics graduate and has a Masters degree in Marketing Management from Mumbai University.

EP News Bureau

AWARDS

Spirit of HumanityAwards 2016 felicitates NGOs The awards identified and honoured excellence by NGOs working for the underprivileged, especially in the healthcare sector THE SEVENTH edition of Spirit of Humanity Awards was recently held in Mumbai. The event, an initiative by Amricares, gave away awards to six NGOs. A total of 26 NGOs were finalised from over 300 entries, including four finalists from Maharashtra. The impact sectors included child care, disability, education, health, livelihood and women empowerment. The participating organisations went through three levels of shortlisting. The winners received a prize amount, a trophy and certificate of excellence

from the esteemed organisers.

Sankalp India Foundation from South zone received an award in Childcare category followed by Youth4jobs Foundation from South zone in Disability and in Livelihood, Vidya Poshak from North zone in Education, Bangalore Hospice Trust from South zone in Health and Rescue Foundation from the West zone in Women Empowerment.

Spirit of Humanity is a national level platform for collaboration, capacity building and recognition within the social

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sector in India. The finale of The 7th Spirit of Humanity brought together not-for- profit

organisations, academia, government authorities, thought leaders and corporations for

sustained engagement and cross learning.

EP News Bureau

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