Express Pharma April 1-15, 2014

VOL .9 NO.11 PAGES 62

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Cover Story Clinical trials in India: Uncertainty lingers Market Industry, regulators in frank discussion at th 5 India Pharma Summit Pharma Life Merck Serono appoints Meeta Gulyani 1-15 APRIL 2014,` 40

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CONTENTS Vol 9 No.11 APRIL 1-15, 2014

Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury*

Clinical trials: Perception vs reality

BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

As regulators and industry hammer out practical implementation strategies of India’s evolving clinical trial regulations, both sides struggle with their perceptions of what's best for the patient. Will a consensus ever emerge? | P27

Bangalore Neelam M Kachhap Delhi Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Artist Rakesh Sharma Photo Editor Sandeep Patil

P34: REPORT

MARKETING Deputy General Manager Harit Mohanty

Boom in smart pills will reach new peak by 2018-2020: Frost & Sullivan

Senior Manager Rajesh Bhatkal

P38: VENDOR NEWS

MANAGEMENT

Optima to exhibit at Interpack

PRODUCTION General Manager B R Tipnis

P55: CAMPUS BEAT

Manager Bhadresh Valia

Goa College of Pharmacy organises workshop on ‘Science of scientific writing’

Scheduling & Coordination Rohan Thakkar

P56: APPOINTMENT

CIRCULATION Circulation Team Mohan Varadkar

MARKET

Merck Serono appoints Meeta Gulyani as Head of Strategy and Global Franchises

29

13

IDRI AND JUBILANT CHEMSYS EXTEND RESEARCH FOR TB DRUG DISCOVERY

14

URGENT ACTION NEEDED TO PREVENT UNREGULATED SALE OF TB DRUGS IN INDIA: MSF

15

MEDIGENE SIGNS LICENCE AGREEMENT WITH FALK PHARMA

17

PHARMA PRO & PACK EXPO 2014 TO BE HELD IN MUMBAI

18

INDUSTRY, REGULATORS IN FRANK DISCUSSION AT 5TH INDIA PHARMA SUMMIT

19

HIV CONGRESS 2014 DELIBERATES UPON STRATEGIES FOR FIGHTING HIV EPIDEMIC

20

DAIICHI SANKYO INDIA, RANBAXY & ROYAL SOCIETY CHEMISTRY ORGANISE SYMPOSIUM

HARNESSING ASIA’S CLINICAL TRIAL POTENTIAL

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express Limited 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 @ 2011. The Indian Express 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

Walking the talk on GCP

“I

f we are interested in export-

consent process. Registration followed by ac-

ing medicines, we have to

creditation of ethics committees are good steps,

also import the standards.”

but do we have the capabilities right now to roll

This statement from a senior

this out? Sponsors and CROs in India are al-

official of the CDSCO at the

ready shifting trials to other Asian nations, not

recent FICCI Pharma Summit sums up the tough

willing to wait for change.

stance being taken today by India’s regulators, on

maintaining

standards

at

our

The heart of the matter is that different

drug

stakeholders have conflicting perceptions of

manufacturing facilities as well as while conduct-

what clinical research is and how patients can

ing clinical trials and research.

But can we walk the talk? All branches of the pharmaceutical regulatory mechanism in India as well as the industry have been under fire in the last two years. While the US FDA’s warning letters and import bans put a question mark on India’s GMP norms, on the GCP side, a May 2012 report of the Parliamentary Standing Committee on Health revealed a nexus between a host of pharma companies, CROs, clinicians and hospi-

Industry observers allege that many new regulations were knee jerk and poorly structured and as a result,difficult to implement due to the many grey areas

be protected. There are efforts to resolve these differences. Another story in the section (Clinical trials: Perception vs reality, page 27-28) offers a ringside glimpse of discussions between regulators and industry. More like a tug of war, the two sides may seem to be moving in circles and stuck in limbo, but plugging the loopholes is better than allowing rogue elements to exploit them as in the past.

While there seems to be genuine intent to

tals involved in trials and the regulator, the Drug

move forward, there is a huge trust deficit... on

Controller General (India)’s office.

all sides. But there seems to be a consensus: we

The DCGI has since launched into Operation

need clinical research and trials, but they need

Clean Up and 2013 saw many new regulations. In-

to be better regulated. In other words, keep the

dustry observers allege that many new regula-

baby, but replace the bathwater. With a judicious

tions were knee jerk and poorly structured and

dose of tough regulations, clinical research and

as a result, difficult to implement due to the

trials can both safeguard patient safety as well

many grey areas. Our cover story (Clinical trials in

as revive revenues. The answer is not more

India: Uncertainty lingers, page 22-26) presents

rules, but stronger implementation.

some of the issues being faced by industry while trying to implement these notifications like the need for audio visual recording of the informed

10

EXPRESS PHARMA

April 1-15, 2014

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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MARKET COMPANY WATCH

IDRI and Jubilant Chemsys extend research for TB drug discovery The additional grant of $3.4 million will enable development of new drugs to combat tuberculosis JUBILANT CHEMSYS, a wholly-owned subsidiary of Jubilant Life Sciences, announced an extension of collaborative partnership with Infectious Disease Research Institute (IDRI) for TB drug discovery.

The collaboration in chemistry support has been in existence since 2009 as part of a joint effort with the Lilly TB Drug Discovery Initiative (LTI) and so far has generated hundreds of Novel Chemical Entities (NCEs), some of which have now been identified for further exploration. Jubilant Chemsys, under the terms of agreement, so far had been offering philanthropic support and expertise in synthesis of NCEs to support the early research in TB. Commenting on the collaboration, Dr Subir Basak, Presi-

dent, Jubilant Drug Discovery Services, said, “Jubilant is excited to extend the partnership with IDRI in identifying and discovering novel chemical entities in the area of tuberculosis. The collaboration is leveraging our chemistry talent and our experience in anti-bacterial research.

The research outcome will address the current unmet medical need in the field of TB therapy, a growing concern in under developed and developing economies including India.”

“We have been impressed with the commitment and engagement from Jubilant Chemsys in support of TB drug discovery over the past few years. We are excited to expand our efforts with them to access additional synthetic and medicinal chemistry capabilities. This will take

Jubilant Chemsys, under the agreement, had been offering philanthropic support in synthesis of NCEs to support the early research in TB

us another step closer to our goal of developing much-needed new drugs to combat tuberculosis,” Tanya Parish,, Vice President of Drug Discovery, IDRI. With this association, Jubilant will continue to provide chemistry and medicinal chemistry support to IDRI. The company is also evaluating further liaisoning with IDRI in key functional areas like computational chemistry and Drug Metabolism and Pharmacokinetics (DMPK) Services.

IDRI is a founding member of both the LTI and the TB Drug Accelerator, a unique partnership funded by the Bill & Melinda Gates Foundation that targets the discovery of new TB drugs by collaborating on earlystage research. The Foundation recently awarded IDRI $3.4 mil-

lion in additional funding to Parish and supplements an earlier grant awarded in 2010, for a total of $7.8 million. The grant is focused on identifying new leads and drug targets for tuberculosis with the ultimate goal of producing new drugs to treat TB. “Jubilant has been successful in advancing several validated hit series for the Lilly Initiative, and we are pleased to see this progress recognised through the ability to expand the Jubilant collaboration with IDRI. We are grateful to Jubilant for all they have done to get us to this point, and look forward to reaching our goals through this expanded partnership,” said, Dr Philip Hipskind, Distinguished Research Fellow and Leader of the Lilly Initiative, Lilly.

EP News Bureau – Mumbai

US FDA approves Piramal Imaging’s Neuraceq Will help in PET imaging of beta-amyloid neuritic plaques in the brain US FOOD and Drug Administration (US FDA) has approved Piramal Imaging's Neuraceq.

This approval comes only four weeks after receiving marketing authorisation for Neuraceq from the European Commission.

Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive decline.

The Centres for Medicare & Medicaid Services (CMS) has

declared it will cover a betaamyloid PET scan for patients under Coverage with Evidence Development (CED) programmes. The objective of these programmes is to assess the impact of beta-amyloid scans on improving patient outcomes or advancing patient treatment options. “Alzheimer’s disease or any form of cognitive impairment is a daunting diagnosis,” said Dr Ludger Dinkelborg, Director of the Board, Piramal Imaging. “For the patients and caregivers, the concern centres around understanding what the future holds. For physicians, the

challenge is properly assessing the patient and determining the best care path.”

“The FDA's approval of Neuraceq is a significant milestone for Piramal Imaging and demonstrates our dedication to advancing innovation in molecular imaging globally,” said Dr Swati Piramal, Vice Chairperson, Piramal Enterprises. “The rising prevalence of Alzheimer’s disease and cognitive impairment is being felt individually and collectively around the world. Our goal as a company is to usher in a new era of imaging that helps paint clearer pictures of the

physiology of such conditions and help improve patient outcomes.”

The FDA approval of Neuraceq is based on safety data from 872 patients who participated in global clinical trials as well as three studies that examined images from adults with a range of cognitive function, including 205 end-of-life patients who had agreed to participate in a post-mortem brain donation programme. Images were analysed from 82 subjects with post-mortem confirmation of the presence or absence of betaamyloid neuritic plaques. Corre-

lation of the visual PET interpretation with histopathology in these 82 brains demonstrated that Neuraceq accurately detects moderate to frequent betaamyloid neuritic plaques in the brain and is a useful tool to estimate the density of these plaques in life.

Piramal Imaging has partnered with IBA Molecular for manufacturing and distribution of Neuraceq. IBA Molecular owns and operates a network of 49 PET isotope facilities worldwide, a network that is unique in both size and scope.

EP News Bureau – Mumbai

EXPRESS PHARMA

13

April 1-15, 2014

MARKET

Urgent action needed to prevent unregulated sale of TB drugs in India: MSF Strict regulation of first-line TB drug formulations and prescription practices in the private sector is needed in India IMMEDIATE ACTION from the Indian government is needed to prevent the unregulated sale and inappropriate prescription of tuberculosis (TB) drugs in the private healthcare sector, a practice that has had a significant role in the emergence of drug-resistant TB in the country, warned the international medical humanitarian group Doctors Without Borders/ Médecins Sans Frontières (MSF) in a statement released in advance of World TB Day. “It is the patients who suffer the consequences of poor regulation of TB drug formulations in India. An increasing number of our patients are being diagnosed with drug resistant TB (DR-TB).

We encounter a spectrum of resistance patterns which range from monodrug-resistant TB all the way through to extensively drug-resistant TB (XDR TB),” said Dr Simon Janes, Medical Coordinator, MSF in India.

Lack of oversight from the

Lack of oversight from the drug regulatory authority – the DCGI, has made even basic treatment of drug-sensitive TB difficult to monitor drug regulatory authority – the Drug Controller General (India) (DCGI), has made even basic treatment of drugsensitive TB difficult to monitor. In the face of so many different formulations available in pharmacies across the country, ensuring the correct prescription of firstline TB drugs in the private sector is almost an impossible task for the Central TB Division (CTD).

As a result, poor compliance to World Health Organization (WHO) treatment guidelines is common among private doctors. TB patients being treated by private doctors in India might be facing a grave risk of developing

drug-resistant TB due to irrational prescribing practices or indiscriminate use of non-WHO-recommended drug regimens.

“In our experience of working in India since 1999, we have seen prescriptions from private health providers that were completely inappropriate. For example we have seen many prescriptions that prescribe three out of the four first-line TB drugs in combination with a quinalone (antibiotic),” said Dr Homa Mansoor, TB Medical Referent, MSF India. “The alarm on drug resistance has been sounded, and the Health Ministry must act now to address this public health crisis.”

Strict regulation of firstline TB drug formulations and prescription practices in the private sector is needed in India. The long-awaited implementation by the Central TB Division of a standardised first-line daily drug regimen across the public and private sectors could go a long way in simplifying prescription, adherence and drug supply management of first-line TB treatment and prevent further emergence of drug-resistant tuberculosis in the country.

“Other countries have already undertaken steps to control DR-TB, by ensuring drug regulatory authorities strictly regulate the quality and formulations of first-line TB drugs in the private market. Governments like Brazil have even taken the additional step of making the public sector the primary distributor of all TB drugs,” said Leena Menghaney, India Coordinator of MSF’s Access Campaign.

EP News Bureau - Mumbai

Glenmark receives $4 million through Swiss subsidiary GLENMARK PHARMACEUTICALS has informed the Bombay Stock Exchange that the company through its Swiss subsidiary has received $4 million as research fee payment from Forest Laboratories on a collaboration for the development of novel mPGES-1 inhibitors to treat chronic inflammatory conditions, including pain.

Under the terms of the agreement signed in FY 2012-13, Forest made $6 million upfront payment and also provided an additional $3 million to support the next phase of work. In September 2013, Glenmark received an additional amount of $2 million as research fee payment from Forest Laboratories.

Hence, the total amount received by Glenmark from Forest Laboratories towards its novel mPEGS-1 inhibitors programme is $15 million.

EP News Bureau-Mumbai

Novartis bags approval of Xolair Xolair is the first and only licensed therapy in the US for the nearly 50 per cent of patients with CIU NOVARTIS ANNOUNCED that the US FDA has approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria (CIU), an unpredictable and debilitating skin disease that is known as chronic spontaneous urticaria (CSU) outside of the US. In the US, Xolair is indicated for CIU in adults and adolescents who remain symptomatic despite H1-antihis-

14

EXPRESS PHARMA

April 1-15, 2014

tamine treatment. Until now, H1antihistamines have been the only approved therapy for CIU in the US. CIU / CSU is a severe and distressing skin condition characterised by red, swollen, itchy and sometimes painful hives on the skin that spontaneously present and re-occur for more than six weeks. Up to 40 per cent of CIU / CSU patients also

experience angioedema, a swelling in the deep layers of the skin.

“This approval from the FDA is great news for patients in the US suffering from CIU, a skin disease known as CSU in other parts of the world,” said David Epstein, Division Head of Novartis Pharmaceuticals. “Up to 50 per cent of patients do not respond to approved doses of H1-

antihistamines, which up until now have been the only licensed treatment for CIU in the US.” At any given time, the prevalence of chronic urticaria (CU) is up to one per cent of the world's population, and up to two thirds of these patients have CIU / CSU. In the US, it is estimated that approximately 1.5 million people suffer from CIU. Women are twice as likely than men to

have the condition and most people develop symptoms between the ages of 20 and 40.

The US FDA approval is primarily based on positive and consistent results from two landmark phase III studies, ASTERIA I and II, which involved CIU / CSU patients not responding to approved doses of H1-antihistamines.

EP News Bureau - Mumbai

MARKET

Medigene signs licence agreement with Falk Pharma Falk Pharma will initially concentrate on development in primary biliary cirrhosis (PBC) MEDIGENE has signed an exclusive global licence agreement with the company Dr Falk Pharma (Falk Pharma) for the development and commercialisation of its drug candidate RhuDex for indications in hepatology and gastroenterology.

Falk Pharma will assume responsibility and all costs relating to the clinical development and marketing of RhuDex in these therapeutic areas. Medigene will receive an upfront payment and future milestone payments from Falk Pharma, plus doubledigit RhuDex royalties. Falk Pharma will initially concentrate on development in primary biliary cirrhosis (PBC).

Medigene retains the rights for RhuDex in the indication areas rheumatoid arthritis, psoriasis and other autoimmune diseases.

Dr Frank Mathias, Chief Executive Officer, Medigene AG explained, “In Falk Pharma, we have found an ideal partner for RhuDex. Falk Pharma has already successfully developed and launched several drugs to treat diseases of the liver and biliary tract. After the transforming acquisition of Trianta Immunotherapies, this partnership for RhuDex represents another major step in the implementation of our strategy for sustainable growth.”

Ursula Falk, Managing Director, Dr. Falk Pharma commented, “RhuDex possesses an innovative mode of action and complements our existing development and commercial portfolio. We will use our years of expertise in this field to further develop this attractive product candidate to a successful drug.”

Peter Llewellyn-Davies, Chief Financial Officer, Medigene commented, “With this agreement we continue to implement our licensing plans for the advanced product candidates. Yet we will retain the

EXPRESS PHARMA

15

April 1-15, 2014

major part of our rights to RhuDex, e.g. for the treatment of rheumatoid arthritis or psoriasis. This license agree-

ment facilitates the further clinical development of RhuDex and also contributes to the financing of our im-

muno therapy programmes recently acquired which will open up new partnering and financing opportunities.”

Confidentiality was agreed on financial details of the deal.

EP News Bureau – Mumbai

MARKET GROWTH TRACKER

IPM registers 4.5 per cent growth in Feb 2014 Clocks `5902 crores in the same month THE INDIAN Pharmaceutical Market (IPM) clocked `5902 crores in February 2014. It has grown at 4.5 per cent in the month. Amongst the top 10, Sun Pharma grew at 18.1 per cent followed by Lupin at 9.3 per cent and Alkem at 6.7 per cent.

29 corporates have crossed the growth of IPM amongst top 50.

Amongst the top 50 corporates, Biocon has registered the highest growth of 46.7 per cent followed by Ajanta at 42.5 per cent and Eris at 34.9 per cent.

Amongst the 11-20 ranked companies, Aristo showed a growth of 22.4 per cent followed by Torrent at 16.6 per cent and Glenmark at 16.3 per cent.

Sun Pharma has become the second corporate to enter the `4000-crore club. Meyer Organics has also entered the `350crore club.

Indian companies have grown at 6.9 per cent versus -1.7 per cent for MNCs in February 2014. Amongst the top 50 in MNCs, MSD grew the highest at 17.3 per cent, followed by AstraZeneca at 15.3 per cent and Merck at 5.1 per cent. The DPCO 2013 containing molecules market was at –13.6 per cent whereas the non-DPCO market grew by 7.4 per cent resulting in an overall growth of 4.5 per cent. The DPCO 2013 portfolio for GSK degrew at 30.7 per cent and Ranbaxy de-grew by 25.2 per cent, whereas Sun Pharma had the least impact with its DPCO 2013 portfolio degrowing at 6.8 per cent. From the therapy perspective, 11 therapies have outgrown the IPM growth and four therapies have double digit growths.

The respiratory market grew at 6.2 per cent, gastrointestinal market grew at 5.1 per cent whereas the anti-infectives degrew at 0.9 per cent. In the chronic business segment, antidiabetic market grew at 13.3 per cent while the cardiac marketgrew at 5.9 per cent. The derma market grew by 12.5 per cent.

16

EXPRESS PHARMA

April 1-15, 2014

With Bonus Units at Full Value Val in Crs

Rank

CORPORATE

(Val in Crs)

MAT Feb -14

MAT

MTH

Abbott + Abbott HC + Novo

1

1

Sun Pharma

2

Cipla

Feb-14

Val (Cr)

MS%

GR%

Val (Cr)

MS%

GR%

75149

100.00

5.9

5902

100.00

4.5

4857

6.46

5.1

385

6.52

3.4

2

4035

5.37

17.3

333

5.65

18.1

3

3

3743

4.98

5.3

306

5.19

0.6

Zydus + Biochem

4

4

3334

4.44

9.9

269

4.56

1.1

Ranbaxy

5

5

2886

3.84

-0.4

218

3.70

-3.1

Glaxo

6

6

2771

3.69

-15.0

207

3.51

-17.5

IPM

Mankind

7

7

2675

3.56

5.3

207

3.50

4.0

Alkem + Cachet + Indchemie

8

9

2624

3.49

10.8

195

3.30

6.7

Lupin

9

8

2514

3.35

12.6

204

3.46

9.3

Pfizer + Wyeth

10

10

2198

2.92

3.3

173

2.92

0.0

Emcure + Zuventus

11

11

2112

2.81

15.3

167

2.82

7.7

Macleods

12

12

1954

2.60

8.4

163

2.76

15.0

Sanofi-Aventis + Universal

13

15

1924

2.56

2.0

142

2.40

-3.7

Intas

14

13

1885

2.51

9.0

152

2.58

-1.1

Aristo

15

14

1813

2.41

11.6

143

2.42

22.4

Glenmark

16

16

1619

2.15

16.3

133

2.25

16.3

Val in Crs

MAT Feb 14

Month Feb -14

Super Group

VAL IN CRS

Gr%

VAL IN CRS

Gr%

IPM

75149

5.9

5902

4.5

ANTI-INFECTIVES

12591

0.7

945

-0.9 5.9

CARDIAC

9291

8.3

752

GASTRO INTESTINAL

8467

5.7

640

5.1

VITAMINS / MINERALS / NUTRIENTS

6717

4.8

511

4.0

RESPIRATORY

5911

9.3

518

6.2

PAIN / ANALGESICS

5417

3.7

412

2.3

ANTI DIABETIC

5260

14.6

434

13.3

NEURO / CNS

4703

7.8

375

4.3

GYNAECOLOGICAL

4661

1.2

361

-4.0

DERMA

4159

10.6

334

12.5

OPHTHAL / OTOLOGICALS

1360

8.6

105

6.8

HORMONES

1281

5.9

102

1.9

VACCINES

1115

-2.4

75

-19.3

ANTI-NEOPLASTICS

1009

24.9

91

45.8

OTHERS

923

5.5

82

23.1

BLOOD RELATED

898

3.1

67

-0.1

ANTI MALARIALS

621

1.0

35

9.4

SEX STIMULANTS / REJUVENATORS

428

5.4

36

4.6

STOMATOLOGICALS

336

7.5

27

8.7

From a regional perspective, 10 regions have outgrown the IPM growth. Jharkhand market grew the highest at 14 per cent followed by Vidarbha market at 13.2 per cent. Three regions had negative growths. The biggest molecule, Amoxycillin + Clavulanic degrew by 4.4 per cent, whereas Cefixime degrew at 5.7 per cent. The markets of Glimepiride + Metformin grew at 33 per cent, protein supplement by 25.1 per cent, Vitamin D grew by 27.8 per cent, Rosuvastain by 18.9 per cent, Telmisartan by 17.6 per cent and Levocetirizine + Montelukast by 15.9 per cent.

Glycomet-GP and Monocef have registered 23 per cent growth amongst the top 10 brands. Amongst the top brands in the IPM, Lantus grew by 25 per cent, Skinlite by 19 per cent, Aciloc by 15 per cent amongst top 25 brands. A total of 107 brands were launched in February 2014. Buscogast and Ferinject are the top NIs.

About PharmaTrac PharmaTrac is a the secondary sales data audit conducted by AIOCD Pharmasofttech AWACS, a pharma market research company formed by All Indian Origin Chemists & Distributors (AIOCD) in a joint venture with Trikaal Mediinfotech. AWACS (Advanced Working, Action & Correction System) reflects the underlying philosophy behind AIOCD AWACS' research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information.

Terminologies used MAT – Moving Annual Total MTH – Month Val (Cr) – Value in Crores MS per cent – Market Share in Percentage GR per cent – Growth in percentage.

For more information, visit http://www.aiocd.net

MARKET PRE EVENT

PHARMAPro & Pack Expo 2014 to be held in Mumbai Around 20,000 pharma trade professional/decision makers are likely to attend the event PHARMA PRO&Pack Expo 2014 will be held in Mumbai from May 21 to 23, 2014 at the Mumbai Exhibition Centre.

The event is expected to showcase the best of pharma manufacturing technologies and will be co-located with iPHEX 2014, which will be organised by PHARMEXCIL. Around 20,000 pharma trade professionals/decision makers are likely to attend the event. More than 250 industry majors will exhibit their technologies/services.

Exhibitors’ profile include, players in pharma processing, packaging, lab equipment, packaging materials and consumables, lab glassware, labwares, pharma chemicals, API, bulk actives, excipients, lab reagents and chemicals, utilities, consultants, turn key contractors, environment control products and services, pharma manufacturing services, contract manufacturing, CROs, research institutes, testing labs and services, trade promotion activities, trade associations, trade promotion councils, trade publications, etc.

Road shows were organised in Mumbai, Delhi, Pune, Baddi, Panchkula, Hyderabad, Indore, Bangalore, Dehradun and Nepal where pharma professionals were invited for the main event. The Mumbai road show witnessed 95 pharma machinery manufacturers. Similarly, 78 senior pharma professionals attended the road show at Pune. 1The Baddi roadhsow saw the presence of 78 senior pharma professionals while 134 people from Panchkula, Chandigarh, Mohali attended the road show at Panchkula. All these road shows provided indepth information on the benefits of attending PHARMA Pro&Pack Expo 2014.

EP News Bureau-Mumbai

EXPRESS PHARMA

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April 1-15, 2014

MARKET POST EVENTS

Industry,regulators in frank th discussion at 5 India Pharma Summit DoP, WHO and FICCI event focused strengthening infrastruture, clarifying regulations pertaining to APIs, drug trials, R&D

THE DEPARTMENT of Pharmaceuticals (DoP), Ministry of Chemicals & Fertilizers, Government of India, in collaboration with the WHO Country Office for India and Federation of Indian Chambers of Commerce and Industry (FICCI) organised the 5th India Pharma Summit in Mumbai.

The theme for this year’s deliberations was: “Enhancing India’s Global Role in Supply of Generic Medicines — Focus on Strengthening Domestic Landscape of Active Pharmaceutical Ingredients (APIs), Regulation of Drug Trials and Fostering Innovation.”

Aradhana Johri, Secretary, Department of Pharmaceuticals, highlighted that Indian pharma industry exports around $14 billion of pharma products, including vaccines, to most countries in the world.

Pharma market in India is ranked third globally in terms of volume and 13th in terms of value, accounting for about 10 per cent of the world's production by volume, including 80 per cent of global production of antiretroviral medicines manufactured in India.

She said, “At present, there is a significant dependence for intermediates of medicines, which needs to be reduced. There is a need to look at strengthening the development of the bulk drug industry in India. There are various challenges being faced by the Indian pharma industry. Re-

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The summit witnessed a convergence of various stakeholders ranging from the Indian and global pharmaceutical industry, regulators and policy makers. Challenges and gaps for strengthening the domestic landscape of Active Pharmaceutical Ingredients (APIs) were extensively discussed cently, Department of Pharmaceuticals had organised three GMP strengthening for manufacturers in Hyderabad, Ahmedabad, and Chandigarh in collaboration with WHO and FICCI. India has tremendous potential in R&D and research capabilities.” The streamlining of the regulatory landscape of clinical trials is pivotal to create a balance between the growth of clinical trial industry and the ethical issues there-in.

The summit witnessed a convergence of various stakeholders ranging from the Indian and global pharmaceutical industry, regulators and policy makers.

Challenges and gaps for strengthening the domestic landscape of Active Pharmaceutical Ingredients (APIs) were extensively discussed.

“The issues of API’s quality, fostering R&D and innovation, and regulatory issues for clinical trials are key issues facing the pharmaceutical industry today,”

said Dr Nata Menabde, WHO Representative to India. She highlighted the pivotal role being played by Indian manufacturers to the WHO Prequalification of Medicines Programme for increasing access to medicines in both developing and developed countries. “There is a continued need to engage in international processes for convergence towards international standards and a need for self-reliance for domestic production of APIs in India to enable accessibility of affordable medicines. In the clinical trials agenda, the regulatory landscape has undergone dynamic changes for ensuring efficacy, safety and quality of medicines. There is a however a need to strengthen the Institutional Ethics Committees and capacity building of the stakeholders. India has been contributing to the agenda of the Global Plan of Action for Public Health, Innovation and Intellectual property, and there is a need to ensure

that there is a priority setting for the agenda of global health and facilitate developing mechanisms for innovation for diseases prevalent in developing countries including India,” she added.

The deliberations focused on convergence towards international quality standards, streamlining the drug regulatory landscape for the conduct of clinical trials in India, fostering R&D and innovation by the pharma industry.

Habil Khorakiwala, Chairman, FICCI Life Sciences Council, Past President FICCI and Chairman Wockhardt Group highlighted that Indian pharma industry has gone a major transformation over the past several years. “India is expanding into the global markets to provide affordable medicines and have a broad base for manufacturing APIs and finished dosages.

Presently, $2 million is being invested in R&D by the Indian pharma industry and the coun-

try has a capacity to become the global hub of R&D in the world.

We have to create an ambience for research and need to streamline the landscape for clinical trials in India.”

The summit provided a platform to engage at a policy level with stakeholders and chart a policy road map for enhancing India’s global role in supply of generic medicines.

CP Singh, Chairman, National Pharmaceutical Pricing Authority added, “There is a need to strengthen the domestic landscape of APIs in India and develop appropriate mechanisms in this regard to meet the need of country specific regulatory requirements.”

Dr Arbind Prasad, Director General, FICCI said Ïndian pharma industry exports to over 200 countries in the world and is growing at 14 per cent per annum. This is a unique opportunity for the industry and the government to partner for issues related to quality of pharmaceuticals, clinical trials and innovation agenda”.

“There is a need to foster the quality agenda in India including consideration of moving towards convergence towards international manufacturing standards, including PIC/S,” Pankaj Patel, Chairman, FICCI Pharmaceuticals Committee and Managing Director, Zydus Cadila said in his concluding remarks.

EP News Bureau-Mumbai

MARKET

HIVCongress 2014 deliberates upon strategies for fighting HIVepidemic 700 participants took part in the event CLOSE TO 700 participants from across the globe assembled to deliberate upon actionable strategies for fighting the global HIV epidemic, in the three-day long HIV Congress 2014, held in Mumbai. The focus of the HIV Congress 2014 was to disseminate and share knowledge about HIV amongst clinicians, to enable them to devise more effective disease management methods, encourage young physicians to take up HIV as a speciality, and bridge the gap between private HIV physicians and government bodies like Department of

AIDS control (DAC), WHO and UNAIDS, in turn encouraging collaborative research on HIV in India.

Speaking on the occasion, Dr JK Maniar, Organising Chairperson, HIV Congress 2014 said, “The global scenario of HIV is changing day by day.

Until twenty years ago, there was a huge amount of social stigma associated with HIV-patients were sceptical to consult doctors and even doctors had limited knowledge. Earlier, a patient had to consume 20-25 pills a day to survive, and still had to

bear numerous side effects, along with high costs of the medicines. A lot of deaths were due to lack of early detection of the disease and the side-effects of the available drugs.”

Dr BB Rewari, National Programme Officer (ART) WHO/NACO said, “Rolled out in 2004, National ART programme has evolved from eight ART centres to network of 1280 ART service delivery points wherein 7.5 lakh patients are receiving free ART. This has changed the outlook of HIV from a death sentence to

chronic manageable disease.

Recently NACO has also decided to introduce 3rd line ART in addition to 1st and 2nd line ART.” A recent initiative has been to provide multi drug ART to all positive pregnant women to ensure that no child is born with HIV. Oussama Tawil, UNAIDS Coordinator, India said, “An HIV patient in India can now live a healthier life with an almost normal life expectancy. The Department of AIDS Control along with private practitioners is currently expanding access to treat-

ment and working with civil society organisation to ensure continuum of care. Scientists continue to challenge themselves by exploring newer molecules with even lesser side effects and also drug delivery systems that reduce doses.”

The Academic partners of the HIV Congress 2014 were Association of Physicians of India, Centre for the AIDS Program of Research in South Africa (CAPRISA) and University Hospital Bazel, Switzerland.

EP News Bureau-Mumbai

MARKET

Daiichi Sankyo India,Ranbaxy & Royal Society Chemistry organise symposium Declare Research Awards 2012, honour five outstanding scientists and five young science scholars DAIICHI SANKYO India Pharma (DSIN) and Ranbaxy Laboratories (Ranbaxy) together with the Royal Society of Chemistry (RSC) recently organised a symposium titled 'Overcoming the Bottlenecks in Drug Discovery and Development' in Gurgaon. The two-day symposium was attended by over 400 delegates from countries including India, Japan, the US, the UK and Singapore.

The symposium featured lectures from leading researchers on four key pharma R&D themes: biological hit identification, chemical hit identification, pharma research and chemical hit to lead optimisation.

The conference took on the challenge of productivity improvement in pharma R&D. Speakers highlighted recent advances in computational tools for lead optimisation and new methodologies for chemical hit/target identification and delivery of medicines. The journey from lead optimisation to successful commercialisation of the Daiichi Sankyo’s recently-approved drug Edoxaban was shared as a case study.

The symposium also featured a poster session and a student poster competition. The poster entries were judged by an international panel and selected posters were invited for flash oral presentations during the conference.

Speakers who took part in the conference were Abdul Basit, University College London, UK; Ian Collins, The Institute of Cancer Research, UK; Ben Davis, Vernalis, UK; Gautam Desiraju, Indian Institute of Science, India; Ulrike Eggert, King's College London, UK; Paul Gleeson, Kasetsart University, Thailand; Anne Hersey, EMBLEuropean Bioinformatics Insti-

20 EXPRESS PHARMA April 1-15, 2014

Winners of Ranbaxy Research Awards 2012 for excellence in original research work in medical and pharma sciences

tute, UK; Andrew Leach, Liverpool John Moores University/ MedChemica, UK; Masatoshi Nagamochi, Daiichi Sankyo, Japan, William Pennie, Pfizer, US; Ashok Prasad, Delhi University, India; Kunal Roy, Jadavpur University, India; Narahari Sastry, CSIR-Indian Institute of Chemical Technology, India; Ravi Shanker, Pfizer, US; and Fumiaki Yokokawa, Novartis Institute for Tropical Diseases, Singapore.

Ranbaxy Science Foundation (RSF), a non-profit organisation set-up by Ranbaxy Laboratories also announced Ranbaxy Research Awards 2012 at the event for excellence in original research work in medical and pharma sciences. The Foundation also announced the Annual Science Scholar Awards.

The awards were presented by internationally acclaimed scientist, Pierre Alain Clavien, Professor & Chairman, Department of Surgery, University Hospital in Zürich, Switzerland.

Dr Tsutomu Une, Ranbaxy’s Chairman and Dr Nitya Anand, Chairman of Ranbaxy Science Foundation were also present at

the award ceremony.

The awardees were as follows: Medical Sciences - Basic Research: Prof Umesh Varshney, Professor, Department of Microbiology and Cell Biology, India Institute of Science, Bangalore, for his pioneering discoveries in the areas of protein synthesis and DNA repair using Escherichia coli and mycobacteria as model organisms.

Medical Sciences - Medical Research: The award was jointly shared by Prof Kanjaksha Ghosh, Director, National Institute of Immunohaematology, Mumbai and Prof Saumitra Das, Professor, Department of Microbiology & Cell Biology, Indian Institute of Science, Bangalore. Prof Ghosh received the award for his significant contribution in understanding and economic management of congenital bleeding disorders.

Prof Das received the award for his outstanding contribution towards developing novel antiviral agents against Hepatitis C virus.

Medical Sciences – Clinical Research: Prof Parmjeet Rand-

hawa, Professor of Pathology, Division of Transplant Pathology, University of Pittsburgh, US was bestowed with the award for recognising BK virus nephropathy masquerading as rejection in the era of modern immunosuppression.

BK virus PCR initially developed for research is now a routine diagnostic and screening tool.

Pharma Sciences: Prof Sandeep Verma, Deva Raj, Chair Professor, Department of Chemistry, Indian Institute of Technology, UP was given the award for outstanding contribution in creating novel, self-assembling peptide scaffolds to mimic aggregation of amyloidogenic proteins and for using them as screens to discover inhibitors of these processes.

The Science Scholar Awards in the field of Bio-Medical Sciences were given to Kumar Somyajit, Senior Research Fellow, Department of Biochemistry, Indian Institute of Science, Bangalore; Priyanka P Trivedi, Ph.D. Scholar, Facility for Risk Assessment & Intervention Studies, Department of Pharma-

cology and Toxicology, NIPER, Punjab; Pushpa Mishra, Senior Research Fellow, Department of Chemistry, Tata Institute of Fundamental Research, Mumbai. In the field of Pharma Sciences, the awards were given to Priyanka Shreekrishna Gokhale, PhD Student, Department of Infectious Diseases Biology, National Institute for Research in Reproductive Health, Mumbai and Chetan Prakash Yewale, Senior Research Fellow, Pharmacy Department, Faculty of Technology and Engineering, Maharaja Sayajirao University of Baroda.

Earlier during the day, Ranbaxy Science Foundation organised its 20th Annual Symposium on ‘Regenerative Medicine – Current and Future Perspectives’ in association with the Institute of Liver and Biliary Sciences, New Delhi.

The Chief Guest, Dr R Chidambaram, Principal Scientific Adviser to the Government of India delivered the inaugural address followed byProf Pierre Alain Clavien’s key note address. Eminent scientists from India and abroad participated in the symposium and deliberated on the recent advances in regenerative medicine and stem cell therapy and its recent applications in various disease areas such as kidney disorders, type II diabetes mellitus, neuronal disorder, ocular disorders, liver injury, cardiac disorders etc.

Ranbaxy Science Foundation received an overwhelming response when the nominations for Ranbaxy Research Awards opened in May 2013. The nominations were then evaluated by a panel of jury comprising 11 distinguished scientists from all over India.

EP News Bureau-Mumbai

EVENT BRIEF MAY 2014 4

Respiratory Drug Delivery (RDD) USA 2014

RESPIRATORY DRUG DELIVERY (RDD) USA 2014 Date: May 4-8, 2014 Venue: El Conquistador Resort, Fajardo, Puerto Rico Summary: The worldwide symposium about nasal and pulmonary drug delivery will present latest advancements in human genomics, drug design and delivery technologies, drug development, in Vitro and in Vivo testing methods, and regulatory science through podium sessions and debates; scientific poster sessions; technology exhibition and workshop sessions.

Academic, industrial and regulatory scientists involved in the development, investigation, preparation and delivery of existing and therapeutic entities by inhalation will attend the symposium. RDD Online with support from Aptar Pharma will organise the event.

Contact Joanne Peart E-mail : info@rddonline.com Website: www.rddonline.com

DISSO ASIA 2014 Date: May 5 and 6, 2014 Venue: Mumbai Summary: Society for Pharmaceutical Dissolution Science (SPDS) will be conducting its 2nd Annual International Convention DISSO ASIA 2014. The event will promote introduction of new technology, innovation and would have deliberations on various issues faced related to dissolution. DISSO ASIA 2014 event will witness eminent professionals from the pharmaceutical industry. The event will have plenary lecture, poster exhibits and panel discussions. Around 200-250 delegates are expected to participate in this event.

Contact Society for Pharmaceutical Dissolution Science Department of Pharmaceuticals Bombay College of Pharmacy

5

DISSO Asia 2014

Kalina, Santacruz, (East) Mumbai-400098 Phone: 91 22 26670871 email: scientific.committee @spds.in website: www.spds.in

EMERGING TRENDS IN DRUG DISCOVERY: AICADD – 2014 Date: July 23-28, 2014 Venue: AMRITA Vishwa Vidyapeetham - Amrita University, Coimbatore Summary: The emphasis of the conference will be on topics related to the Computer Aided Drug Discovery (CADD). The organisers are expecting more than 500 delegates including nobel laureates/ scientists/researchers/ students and professionals from academia and industries. A few identified thrust areas are: clinical pharmacy and pharmacy practice, natural products chemistry, medicinal chemistry, pharmaceutical technology, CADD, pharmacogenomics, pharmacoinformatics, SAR studies and machine learning, drug delivery system, nanomedicine, personalied drug design, bioinformatics and biomedical engineering.

Contact Dr PK Krishnan Namboori Associate Professor, (Executive Coordinator), AMRITA Insight into Computer Aided Drug Discovery (AICADD) 2014, Computational Chemistry Group (CCG), Computational Engineering and Networking, AMRITA Vishwa VidyapeethamAmrita University, Amritanagar, Coimbatore-641 112 Phone: +91 422 2685000 Extn: 5592 Email: aicadd_2014 @cb.amrita.edu aicadd2014@gmail.com URL: http://www.amritaccg.in/ Conference URL: http://www.amritaccg.in/aicadd2014

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CLINICAL TRIALS IN INDIA

UNCERTAINTY LINGERS As the Indian clinical research industry strives to adhere to the numerous changes announced last year, the delay in clearing up the grey areas is hampering the growth of the industry

BY USHA SHARMA

Clinical trials are an essential component of the drug discovery research process. This is the stage when volunteers or patients are first exposed to the new drug/device on trial so it is only to be expected that the regulatory authorities would want to be very sure that they are well protected.

Consequently, in the past year the Indian contract research organisation (CRO) industry witnessed several new regulatory initiatives and legislative measures all aimed to safeguard the safety and well-being of clinical trial participants But it seems the pace of change has got industry concerned. As Dr Renu Razdan, Vice Chairperson, Association of Contract Research Organisations (ACRO) puts it, “More than 21 orders and 13 notifications were issued by the higher authorities and the industry has been asked to implement them without any lead time. One more bill introduced in the Parliament is the Central Drugs Authority (CDA) bill.” She avers that most of these have already been implemented though in a majority of cases, no lead time was given to the industry.

Since the rules and orders need to be followed and maintained by the industry, the Government did take inputs from industry stakeholders to understand the issues in more detail and continues to do so. Speaking about this ongoing consultative process, Dr Kiran Marthak, Member of Board of Directors and Global Head of Clinical Development, Lambda Therapeutic Research says, “The industry gets an opportunity to interact with the government officials including Drug Controller General (India) (DCGI), Directorate General of Health Services (DGHS), Indian Council of Medical Research (ICMR), Health Secretary to convey the impractical aspects of the new laws.”

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It may be mentioned that India may be the only country in the world where AV recording of each trial patient is mandatory Dr Renu Razdan, Vice Chairperson, Association of Contract Research Organisations

Nearly 50 per cent of the subjects, particularly female patients, have refused to get their consent recorded as per the AV recording norms Dr Kiran Marthak, Member of Board of Directors and Global Head of Clinical Development, Lambda Therapeutic Research

24 EXPRESS PHARMA April 1-15, 2014

Industry accepts the rules but protests the method of implementation. Dr Shoibal Mukherjee, Chief Medical Officer, Quintiles India and Head, Asia Medical Sciences agrees for the need to operate in a system which is safeguarded with regulations and points out, “We are very supportive of the need for a regulatory framework that has its focus quality, ethics and patient safety. However, many of the regulations introduced in 2013, such as the regulation on compensation and on audiovisual (AV) recording of informed consent deviate from global practices and may actually hinder research.”

A hasty reaction?

In the past few years, clinical trials have become the focus of NGOs and activists and this has put the authorities on the back foot. For instance, the Supreme Court of India order mandating AV recording of the informed consent process came in response to a case filed by Indorebased NGO Swasthya Adhikar Manch, Indore along with other like organisations, regarding five global clinical trials approved by CDSCO between January 2013 and August 2013.

The SC passed an order requiring that before clinical trials are conducted, ‘appropriate provision shall be made or administrative direction shall be issued which ensures that AV recording of the informed consent process of the participants is done and the documentation preserved, adhering to the principles of confidentiality.’ The ruling specifies that this is applicable to new subjects to be enrolled in clinical trials, including global clinical trials. The document also provided guidelines for stakeholders for AV recording of informed consent process in clinical trials.

Following the order from the SC, CDSCO issued a directive on November 19 that in all clinical trials, in addition to the re-

Many guidelines and regulations have been introduced to safeguard Indian patients and regulatory agencies are continuously working to address these issues. Still there are a lot of ambiguity present which is leading the industry no where

quirement of obtaining written informed consent, AV recording of the informed consent process of each trial subject, including the procedure of providing information to the subject and his/her understanding on such consent is required to be done while adhering to the principles of confidentiality.

Such AV recording and related documentation would be preserved.

Mukherjee while commenting on the orders, says, “As the order on AV recording is very recent and the number of new clinical trials in India is negligible, it will take a few months before we get a better and deeper understanding of the practical challenges in AV recording of informed consent. In addition, it will be important for them to get a clear guidance on how such materials are stored and how associated data privacy concerns are addressed. Lastly, we are yet to see a perceptible improvement in regulatory approval timelines.”

The order dated November 19 aims to bring more transparency and create confidence among patient groups but appears to be doomed to failure.

Suneela Thatte, President, Indian Society for Clinical Research (ISCR) says, “With the new requirement for AV recording of the informed consent process, patients are refusing to be videotaped due to several reasons. Discomfort with and suspicion of being videotaped as well as hesitancy into entering into a videotaped discussion on a serious illness or

illness with a stigma as the case might be.”

Marthak agrees with Thatte and says, “Nearly 50 per cent of the subjects,particularly female patients, have refused to get their consent recorded as per the AV recording norms.”

Implementation challenges The challenges of implementation become clear during the patient enrollment process.

Some patients have second thoughts about participating in trials when they are informed about the mandatory video tapping of consent. Thatte reveals, “In situations where patients refuse to be videotaped, there is not much one can do, except to disallow such a patient from participating in the trial as the guidance states, 'Only those subjects who give the consent for the AV recording shall be included in the clinical trial process.’”

This reaction from patients has worried investigators too as they face an ethical dilemma.

As Thatte reasons, “Disallowing a patient from participating in a clinical trial and accessing more effective treatment on account of his or her refusal to be videotaped is a violation of medical ethics and the rights of a patient to fair treatment. We therefore hope this will be revoked.”

Though in most cases Indian regulators take their cue from guidelines being implemented in western countries, on this count they seem to have gone a step further. Apart from India,

no other country in the world has mandated AV recording of the informed consent process.

As Razdan reveals, “It may be mentioned that India may be the only country in the world where AV recording of each trial patient is mandatory. Even in the US, this is recommended in extreme situations, for example, for totally illiterate subjects.”

Dr YK Gupta, Professor & Head, Dept of Pharmacology, All India Institute of Medical Sciences (AIIMS) agrees that AV recording is a good step towards empowering clinical trail subjects but there are logistical issues in some cases. For instance, studies related to HIV/AIDS medication, contraceptive methods and consenting in emergency situation like heart attack etc. He reveals that groups of experts across the country are making a case that ethics committees should be empowered to grant waivers (of the AV recording of the consent process) in such situations.

Another major ethical issue posed by the AV recording mandate is the need to maintain confidentiality. Mukherjee stresses that the AV recording of informed consent is a big challenge due to confidentiality and the socio-cultural environment in India. Razdan avers that while all attempts are made to maintain confidentiality, it is not clear how these recordings can be monitored or audited.

Thatte agrees and says, “Confidentiality is a real issue and challenge that investigators are facing. Confidentiality of data is also of prime importance and it is the investigator’s responsibility to ensure that all patient data is treated keeping patient safety, rights and privacy uppermost. Building trust amongst patients in videotaping informed consent is a major challenge particularly where misguided activism and misleading reports have already

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ISCR'S CODE OF CONDUCT created an environment of mistrust amongst the general public. So there are no easy solutions.”

However, Arun Bhatt, President, Clininvent Research differs on this count saying, “There are no confidentiality issues as the information exchange is between the doctor and the patient. No third party, except ethics committee and regulators, can view the video.”

The 12-point code which ISCR members are bound to commit to and comply with while conducting clinical research activities and comply are as follows: ◗ Compliance to all applicable regulations of the country ◗ Confirm scientific merits: ◗ Maximisation of public Interest ◗ Respect and protection of autonomy, rights, dignity and privacy of participants ◗ Consideration to risk – benefit ratio in favor of participants ◗ Stringent monitoring of trial conduct: ◗ Conflicts of interest:

Bottlenecks galore

◗ Support promotion of ethical research

Commenting on the slew of actions being taken by the Ministry of Health and Family Welfare and CDSCO to create a vigorous framework for clinical research, Thatte says, “What has concerned us with the regulatory guidelines and notifications introduced last year is that some of them have been hastily introduced and not well thought through. They have acted as a deterrent to stakeholders and have impacted the willingness and interest of sponsors (who include academic and teaching institutions, NGOs, CROs and biopharma companies) to do clinical research in the country.”

The compensation formula is another well discussed topic among the CRO fraternity.

Mukherjee says, “The compensation regulations contain several clauses that are making sponsors reluctant to conduct clinical research in India.

There have also been recent notifications with regard to the representation of sites in a trial and the number of trials an investigator can undertake.”

Besides the AV recording issue, there are many bottlenecks in the Indian CRO industry today. Listing some of these, Marthak highlights the limitation on number of protocols per investigator, reporting of Serious Adverse Events (SAE) within 24 hours of occurring, and compensation for the SAE even if it is not related to clinical

◗ Accountability and transparency ◗ Post trial access: ◗ Build research capacity ◗ Support research certifications and stakeholder accreditations

trial drug and also for inadequate response to the trial drug. Adding to this list, Thatte spotlights composition of NDACs and pre-determined allocation of trial sites by type of site.

All the above mentioned barriers are prevalent in the system due to less regulated mechanisms. However, investigators also feel that too much regulations will become an obstacle to growth. Razdan enlights, “There have been a number of incidences where leading investigators / doctors have refused to participate in trials due to numerous changes that have been brought in.

While many changes have been good for patient’s welfare, others like putting a cap on the maximum number of trials that an investigator can do, is actually a regressive step. It is actually the ethics committee, infrastructure and investigator’s expertise that should determine the upper limit of trials and can be done by an investigator only. It is important to mention that clinical research involves not only medical but scientific bent of mind and every clinician can under-

take research activities. Hence putting this upper cap is a big bottleneck.”

Hoping for the best Many guidelines and regulations have been introduced to safeguard Indian patients and regulatory agencies are continuously working to address these issues. Still there are a lot of ambiguity present which is leading the industry no where.

As Razdan says, “There are a number of grey areas which need to be addressed. One is the medical management for clinical trial patients. This area is very ambiguous and providing medical management for 'as long as required' is construed in different ways by different people.”

Mukherjee hopes for a balanced work environment and comments, “We hope that equilibrium will soon be brought in balancing the interest of patients and other stakeholders with the national health agenda of the country. We will see a more regulated, but conducive environment created for the conduct of clinical research in our country. We need to secure the progress of an industry

that is committed to drug discovery and development for diseases endemic to our region and the growing lifestyle diseases that are affecting our population.”

Thatte too feels, “We need the ecosystem to be encouraged and motivated to do clinical research in India.”

With the acceptance of recommendations of the Prof Ranjit Roy Chaudhury expert committee submitted to the Union Health Ministry of India gives a new direction to the system.

The committee was constituted by the Ministry and the core function was to formulate the policy and guidelines for approval of new drugs, clinical trials and banning of drugs.

Bhatt anticipates, “Some of the recommendations of Dr Roy Chaudhury Committee will become rules / guidelines. Their impact can be judged only after the rules are framed and implemented.”

In situations where patients refuse to be videotaped, there is not much one can do, except to disallow such a patient from participating in the trial as the guidance states Suneela Thatte, President, Indian Society for Clinical Research (ISCR)

Building trust In western countries there are websites announcing the trials and with this information, volunteers/ patients are comfortable signing up for the trials, whereas in India, patient groups lack confidence in Indian clinical trials and CROs. The few that do, are unfortunately put off.

According to Mukherjee, “Like elsewhere in the world, many patients in India seek clinical trials as they look for different treatment options. It is not unusual for clinical researchers and investigators to receive queries direct from patients seeking access to investigational therapies.”

Unfortunately, he avers that misleading media reports and requirements such as compulsory video recording of informed consent and announcement of large compensation payouts for ‘injuries’ have made patients suspicious of research activities.

There are no confidentiality issues as the information exchange is between the doctor and the patient. No third party, except ethics committee and regulators, can view the video Arun Bhatt, President,Clininvent Research

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cover ) We are very supportive of the need for a regulatory framework that has its focus quality, ethics and patient safety Dr Shoibal Mukherjee, Chief Medical Officer, Quintiles India and Head, Asia Medical Sciences

Looking to the future, he says, “Patients must see the regulatory authorities as a reliable gate-keeper capable of ensuring patient safety without compromising patient access to clinical trials, so that they feel confident that trials approved by the authorities and conducted by doctors are authorised to do so will be safe to participate in. Ultimately all stakeholders involved in the clinical trial process need to be committed to high quality clinical research which has safeguarding patients’ health at its core.”

Razdan feels, “There is a need for education and information which should be transparent with the patients. Regulators and the industry have to ensure that patients are given enough education and information regarding clinical trials so that they opt for participating in these trials.” She further elaborates, “One only

has to look at the advances that medical sciences has made in past few decades and clinical research and trials have become an intrinsic part of this development.”

“Patients coming forward to share experiences of how important clinical research is in addressing their unmet medical needs is also a critical need and would help build greater awareness and credibility. Better governance and action by regulatory authorities with regard to proven irregularities in the conduct of clinical research will also go a long way in instilling confidence amongst the public at large,” adds Thatte.

Resolving the grey areas While individual companies have been complying with all the notifications and guidelines issued by DCGI to the best of their abilities, associations like ISCR and ACRO are working

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towards more long term solutions to address the loop holes.

Thatte informs that there have been and continue to be various stakeholder representations to the regulators to draw attention to the lack of clarity and ambiguity in some of these guidelines. The hope is that the requisite changes will be affected soon in the interest of patients in particular for many of whom participation in a clinical trial is the only hope of cure or a better quality of life. Many organisations and institutions are therefore adopting a wait and watch approach at the moment, according to her.

Similarly, after internal debate, ACRO too has represented the views of its members on the suggested changes through representations to the parliamentary standing committee along with other industry stakeholders. While DCGI has reviewed the timeline for

approval of clinical trials, timeline for Bioavailability and Bioequivalence (BA/BE) studies would be further looked into. ACRO has submitted feedback both from within the CRO community as well as from investigators.

When the Health Ministry was striving to strengthen and streamline the clinical trial regulations in India, industry too has taken steps to self-regulate.

The ISCR released its code of conduct for members earlier this year (see box) and while this is restricted to its members, it is a step in the right direction. This indicates the industry's seriousness and their positive approach to adhere to the regulations for the betterment. Hopefully, such measures will multiply and ultimately form the basis of a more transparent and trustworthy ecosystem for clinical trials. u.sharma@expressindia.com

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C

linical trials conjure up different realities to different stakeholders. To a patient, it could mean life, death or disability. His doctor/investigator sees a trial as his attempt to give his patient the best treatment as well as contribute to medical research. The company whose drug is on trial also has its corporate reputation on line, not to mention its revenues. The media and the lay public have their own take and it is these conflicting perspectives that deepen the divide between the various players.

But the regulator probably bears the heaviest burden, because he has to protect as well as punish all of these stakeholders. Protecting the rights of patients by punishing errant doctors and pharmaceutical companies has to be balanced with the long-term objective of making the best medicines available to Indian patients, at affordable prices. This cannot be met without creating a viable ecosystem for corporates to be profitable.

This balancing act was very much in evidence at this year’s India Pharma Summit. (See report on page 18). In a session moderated by RK Jain, Additional Secretary & Director General (CGHS), Ministry of Health and Family Welfare, he stressed that all the measures taken so far were to bring trans-

REPORT

CLINICALTRIALS:

PERCEPTION vs REALITY As regulators and industry hammer out practical implementation strategies of India's evolving clinical trial regulations, both sides struggle with their perceptions of what's best for the patient.Will a consensus ever emerge?

By Viveka Roychowdhury parency, predictability and reasonability into the clinical trial process; while ensuring patient safety. "We are not against clinical trials but want it to happen in a regulated regime," he said.

For his part, Dr G N Singh, Drug Controller General (India) (DCGI) too stressed that their prime commitment is to patient safety and indicated a willing-

ness to discuss the concerns of industry.

What industry wants ...

The day’s proceedings were a free and frank exchange of views industry representatives highlighted their concern areas and regulators replied with clarifications of the rationale behind each notification.

For instance, Dr Urmila Thatte, Head, Department of Pharmacology, KEM Hospital, Mumbai expressed her concerns over the mandatory registration of ethics committees (ECs).

Firstly, there was a huge skew in the numbers of registered ECs across states, she pointed out, with Maharashtra

at the highest (167), followed by Pune (46) but with large states like Bihar having just three registered ECs. Madhya Pradesh has 16 medical colleges but only six of them have registered ECs. Many independent ethics committees (IECs) ‘vanished’ after the ruling and she wondered about the fate of patients on trials under these IECs. “We must

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cover ) not ‘orphan’ these patients,” she said.

Her point was that registration of ECs was a first step but it still didn’t reveal the level of standards, etc. Accreditation of ECs is the next logical step and is needed, but Dr Thatte cautioned that we needed to think this through carefully and ask if we have the capability and manpower required for this step.

She also related the mixed reactions to the need for AV recording of the informed consent process, highlighting how it would be difficult to get the assent of children or terminally ill patients to this step.

Industry sees a clear dip in the number of trials approved in India vis a vis in other Asian countries (see figure: Impact On India’s Share Of Clinical Research in Asia).

The main grouse of the industry seems to be approval timelines. Dr Surinder Kher, Chair of the FICCI taskforce on clinical research and also CEO, Manipal Acunova, lamented the lack of predictability of the process as well as of the outcome. He pointed out that there is no scientific basis to some of the regulations (like for example there is no need for a post marketing surveillance study to go for approval to the experts committees set up, particularly when it was an observational study of a cough medication in use for many years in the country).

Industry observers opint out that the delays also impact doctors who might have put in place infrastructure for conducting trials but then have to cool their heels waiting for the trials to be approved.

... and the regulator’s rationale The regulators for their part justified each notification released. Jain said that mandatory registration of ethics committees (ECs) was required to bring in some discipline so that only registered ECs could function.

So also the restraint on the number of trials each principal investigator (PIs) could take on was aimed at ensuring that there is no burden on individual PIs and patients are not short-

28 EXPRESS PHARMA April 1-15, 2014

IMPACT ON INDIA’S SHARE OF CLINICAL RESEARCH IN ASIA

Source : US National Institutes of Health, ClinicalTrials.gov Database accessed 11 Feb 2014

changed. The regulators also hoped that this move would encourage more clinicians to turn investigators.

In fact the regulators have addressed some concerns, with Jain clarifying the notification on EC registration applied to future trials and were not retrospective in nature. He also indicated that issues pertaining to placebo arm related injuries would shortly be addressed.

Regulators have tried to meet industry half way but this is a work in progress. For instance, Jain pointed out that the gaps in the medical/scientific expertise within the administration has been met by the therapy-wise expert committees set up but on this count too, industry was not happy with their functioning.

The stipulation that trial sites have to be spread across the country and also include government institutions was irrational because it neglected to weigh the actual quality

Source: Assansa

The March 20 Summit was just one of many formal and informal meetings between regulators and industry; both individual and at an association level that are part of the consultation process of such sites.

Resurrecting clinical research in India Industry’s angst was perhaps best captured by Dr Aamir Sheikh, Founder and Healthcare Consultant, Assansa when he said that clinical research in the country was in dire need of nothing short of an 'Operation Phoenix', to be resurrected from the ashes.

He proposed a streamlining of the regulatory landscape and a three-step approach.

Firstly, crafting a national vision for clinical research, to be followed by creating capacity

at both and individual and institution level, and lastly, cultivating a sound regulatory mindset.

When a regulator objected to the term “promotion of clinical research/trials” saying that thinking of it as an industry led to exploitation of patients, a voice from the audience suggested that the terms were not a contradiction to patient safety, because only if we have patient safety can we have a thriving clinical trials industry. This opposing stance best illustrates the long journey ahead.

The March 20 Summit was

just one of many formal and informal meetings between regulators and industry; both individual and at an association level that are part of the consultation process. With the general elections around the corner, regulators were mindful of the model code of conduct and refrained from giving details of policies being crafted.

But there is a sense of cautious optimism, that regulators are listening and willing to act and even backtrack on key issues. Or is this merely an illusion? Only time will tell. viveka.r@expressindia.com

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INSIGHT

Harnessing Asia’s clinical trial potential Lisa Marie Saldanha, Director, Head of Site Identification Services Asia, Quintiles and Dr Karen Wai, Senior Director, Head, Site Services Asia, Quintiles give an insight about the three key resources to leverage for a comprehensive Asia site strategy

2

013 was a challenging year for the clinical research sector in India, and the situation seems even tougher moving into 2014.

Media reports of a Government ruling in December 2013 that all ethics committees that approve clinical trials need to be accredited as well as registered, is definitely moving clinical research in India in the right direction.

However, in the short term, this will further shrink the currently available site pool and increase start-up timelines in India. Data from the Clinical Trial Registry -- India (CTRI) shows that only 114 of the 228 phase II and III clinical trials that were registered in 2013 are currently open to 1 recruitment. The slowdown in approvals and the newer regulations being imposed are making it next-to-impossible for pharmaceutical firms to complete their clinical development programmes on schedule and is driving them to look at the rest of the Asia Pacific region and even to the West to meet their clinical trial needs.2

LISA MARIE SALDANHA, Director, Head of Site Identification Services Asia, Quintiles

DR KAREN WAI, Senior Director, Head, Site Services Asia

FIGURE 1: THE ASIA SITE STRATEGY

The rest of the Asia Pacific region, with its sizeable population, 3 represents a significant potential patient pool for these clinical trials to tap into.4 The changing burden of disease trends in east Asia and the Pacific region, which are moving away from communicable diseases and more to non-communicable and chronic diseases, mirroring global trend 5, represent opportunities for investigational products aimed at both Asian and global markets and for clinical trial participants, offering them more treatment options.

In the early stages of the clinical trial process, getting off to the right start can translate into dollars on the corporate bottom line. For each day a timeline slips, the estimated loss in operational costs alone is estimated to be around $35,0006. Also any delay will impact on when the new medicine may be available to patients.

Ensuring the best study strategy in a region with diverse healthcare environments from the established

clinical trial systems in Japan, South Korea and Taiwan at one end to the relatively new systems and sites in Vietnam, Indonesia and Cambodia on the other, presents some challenges, but can also bring big opportunities when the potential is effectively harnessed.

Three key resources that can be leveraged to achieve this are: current and comprehensive local intelligence that supports innovative site identification methodologies; qualitative and quantitative data allowing data-driven feasibility assessment at country, site and investigator level; and strategic site relationships promoting operational efficiency and effective site management to ensure data integrity and patient safety.

These resources can support

data-driven decision making to arrive at the best country mix and the right sites and investigators for clinical trials.

Innovative site identification methodology The traditional site identification process involves pinpointing sites once a study protocol is in hand. In a rapidly growing clinical trial environment like Asia, this process can often lead to settling an appropriate combination of ‘currently known and available’ countries and sites for studies, rather than best possible ones.

There is tremendous diversity in experience levels of the countries in the region, with Korea and Taiwan highly sought after for their quality and delivery, while Thailand,

Vietnam and Indonesia, are largely untapped for their clinical trial potential. Knowledge of the available site universe in each country early on in the game can be critical in helping ensure that the most appropriate sites are included in the study, those with promise are considered, and inappropriate ones are excluded. The process involves taking a ‘ground-up’ approach to site identification.

An upfront investment in time and local resources is necessary to map all possible clinical trial sites in a country’s healthcare system and prioritise these sites based on their capabilities and potential to conduct high quality work across the various stages of clinical trials across the therapeutic spectrum7.

The local intelligence

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cover ) generated then helps determine the type of studies the country can do, based on factors such as the type and number of patients accessible, interest levels and infrastructure available at the sites, ethics committee approval processes and their influence on start-up timelines, and other site-specific nuances. This also identifies the maximum number of sites potentially available, and provides a heads-up on any site development activity needed to ensure operational efficiency and patient safeguarding. This is especially important when in bringing down start-up costs and initiating trials in the minimum number of countries necessary.

Using Thailand as an example, the country site mapping methodology was presented at the Drug Information Association (DIA) Annual Conference in Boston in 2013. The poster showcased Thailand’s 1,200 possible clinical trial sites, including the major medical school hospitals in highly populated cities with the capabilities to take on phase II-IV clinical trials across therapeutic areas.

Not surprisingly, 60 per cent of the country’s sites reside in a primary healthcare setting, demonstrating the potential of the country for studies involving chronic illnesses such as diabetes and hypertension, and also vaccine trials6.

In South Korea, on the other hand, the Ministry of Food and Drug Safety (MFDS) approves sites for conducting clinical trials in the country. There are currently 164 sites approved for conducting clinical trials, representing the maximum available number of sites in the country8.

In order to understand the potential at the therapeutic area and indication level, the sites mapped can be further interrogated. If we look deeper at the 164 Korean sites, 74 have conducted an oncology study (phase I-IV) at some time based on data from the Korean Food and Drug Administration (KFDA) Clinical Trial Registry, including 36 in non-small cell lung carcinoma (NSCLC)9.

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FIGURE 2: MAPPING HOSPITALS AND HEALTHCARE CENTRES IN THAILAND TO UNDERSTAND CLINICAL TRIAL POTENTIAL

Source: MOPH=Ministry of Public Health

FIGURE 3: AN EXAMPLE OF THE INDICATION LEVEL SITE MAPPING: NSCLC SITES IN SOUTH KOREA

MFDS=Ministry of Food and Drug Safety

This therapeutic area and indication level mapping provide a clear picture of the available site pool that can then be evaluated by clinical operations teams for their suitability for studies. This also helps the site strategy development during the very early planning and budgeting stages as well as when the sites are actually being assessed at the time of site selection.

Data-driven feasibility assessments (countries, sites and investigators) Data-driven feasibility analysis is an essential step when the study protocol is being drafted and the study site strategy is being developed.

This step involves an initial assessment to determine whether a clinical trial can be executed effectively10. In Asia Pacific, as in other regions, this could con-

sist of assessing a company’s internal database, which includes information from previous clinical trials, investigator outreach and data collected from other public and proprietary sources.

Key considerations for a robust feasibility in a diverse healthcare environment include the protocol’s inclusion and exclusion criteria, regulatory considerations and local nuances, competition from other trials in

the same indication, the marketing strategy of the company, and the clinical site’s access to the target patient population11,12.

As an example, consider an NSCLC study looking for countries within the region.

According to Globocan 2012 data, China ranks first in the world for the incidence of lung cancer13, making it a potentially high priority country for a NSCLC study. However, when

( other factors are taken into account, such as the high number (127) of currently on-going studies14, which often results in lower recruitment rates, and the relatively long start-up time of 12 months that China currently needs to start recruiting4 – then China moves many spaces down the priority list, giving way to countries such as Thailand and South Korea.

Given the limited experience of some countries in the region and the absence of quantitative data, qualitative data such as feedback from potential investigators can be used.

To further aid data-driven decision-making, and to support the experts who provide a critical review of the data and recommendation for actions, quantitative data can be run through customised algorithms and the results suitably visualised, allowing a comparative analysis. Quantitative data could include data from previous clinical trials, prevalence and incidence data, site and country start up timelines, and drug reimbursement regulations. An example of such visualisation is depicted in Figure 5. This process provides the ability to objectively ascertain the best countries, sites and investigators to place a trial in a very dynamic region like Asia.

Performance Index Score (PIS) = Score for each site based on the customised algorithm. In the example above, the site with the highest PSI would be the best site. The three different shades of blue indicate the three levels of sites, the darkest blue (far right) being the priority sites with the highest PSI. Integrating data and technology to provide better insights is the way forward in a ‘Big Data’ world. The Quintiles Infosario system and Pfizer’s TIBCO Spotfire data visualisations are all examples of visualisation tools1.

Strategic site relationships Knowing which are the best sites and having a well-written protocol does not necessarily

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FIGURE 4: AN EXAMPLE OF COUNTRY LEVEL FEASIBILITY ASSESSMENT TO DETERMINE THE BEST COUNTRY MIX

FIGURE 5. EXAMPLE OF SITE SPREAD ACROSS THE REGION FOR A PARTICULAR INDICATION BASED ON CUSTOMISED ALGORITHMS INCORPORATING KEY PERFORMANCE PARAMETERS (SITE PERFORMANCE INDEX)

amount to a good site strategy if the best sites are busy with other competing trials and cannot take on the study. Strategic alliances with high-performing sites provide the opportunity to plan ahead, offering a better chance at securing the studies at these key sites in a highly competitive environment. Seoul National University Hospital (SNUH), one of the premium hospitals and research institutes in South Korea, currently has 380 ongoing clinical trials2.

High-performing sites also need constant coaching and guidance

to stay at the top of their game.

Active site management, focused on engaging with the site’s higher management to drive better productivity, delivery and quality further ensures that these remain the best sites to have in a study. It has been demonstrated that with active management, such sites can recruit 50 per cent more than normal sites3. The biopharmaceutical and CRO industries are both moving in the direction of strategic alliances with key sites in the region4,5, providing opportunities for sites to select the

best studies to offer their patients and for sponsors of clinical trials to improve study startup and recruitment timelines.

As more clinical trials move into the Asia Pacific region over the next few years, it is becoming increasingly imperative to plan ahead and ensure that countries are ready to take on the studies and that studies are designed to fit the region. The importance of the right operational strategy being implemented at the very beginning highlights the importance of a consolidated Asia site strategy.

The three key resources of qualitative and quantitative data, up-to-date local intelligence, and strategic site relationships all help set a solid foundation for the study site strategy. Close collaboration with other operational groups, such as site start up, clinical monitoring resources, project management and central lab services, can ensure the delivery of a successful clinical trial in this region.

References: 1. Clinical Trials Registry – India (CTRI), Accessed on 3Jan2014

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cover ) http://ctri.nic.in/Clinicaltrials/ad vancesearchmain.php

sciences/pdf/change_asia_10_08_ 08.pdf

2. The Financial Times, Pharmaceuticals,’India ruling on drug trials injects fears for industry’s health’, 18Nov2013, Accessed 3Jan2013, http://www.ft.com/intl/cms/s/0/7 6335e22-4d03-11e3-9f40-00144feabdc0.html#axzz2pIM7toOm

5. Institute for Health Metrics and Evaluation, The Global Burden of Disease: Generating Evidence, Guiding Policy, East Asia and Pacific Region Edition, 2013. http://issuu.com/ihme/docs/wb_g bd_report__east_asia___pacific?e=2626063/4701958#search

3. Asia Population 2013, World Population Statistics, 20May2013, http://www.worldpopulationstatistics.com/asia-population-2013/

6. Digitome 2011, Digital Health: Clinical Trials, Accessed 6Jan2014 http://digito.me/resources/clinical-trials-are-going-digital/

10. Turner JR. New Drug Development: An Introduction to Clinical Trials, 2nd ed. New York, NY: Springer; 2010

4. PricewaterhouseCooper, ‘The changing dynamics of pharma outsourcing in Asia - Are you adjusting your sights,’ 2008. Accessed 6Jan2014 http://www.pwc.com/en_GX/gx/ pharma-life-

7. Saldanha LM, Current Scenario of Clinical Research Sites in Thailand: A Ground Up Approach to Clinical Site Selection in Emerging Countries, Poster Presentation Drug Information Association Annual Conference,

11. Wai K, Saldanha LM, Lansang EZ et al Case series of feasibility considerations that impact operational delivery strategy in the highly competitive rheumatoid arthritis space in Asia, Open Access Journal of Clinical Trials

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Boston, 2013. http://www.diahome.org/~/link.a spx?_id=7FA8279B1DC940CA81 09CDF6F0E19B11&_z=z 8. http://www.mfds.go.kr/ index.do?seq=7221&mid=1043 accessed 6Jan2013 9. http:// drug.mfds.go.kr /html/menuLinkBody.jsp?p_men uId=0202#1 accessed 6Jan2014

2013:5 33–38 12. Lansang EZ, Tan K, Nayak S et al Key feasibility considerations when conducting vaccine clinical trials in Asia–Pacific countries Vaccine: Development and Therapy 2013:3 1–9 13. Globoban 2012, ‘Estimated Incidence, Mortality & Prevalence Worldwide 2012’, Accesses 6Jan2014. http://globocan.iarc.fr/Pages/sum mary_table_site_prev_sel.aspx

to-big-insights.pdf Accessed 7Jan2014 16. http://www.quintiles.com/ data-driven-difference/ Accessed 7Jan2014 17. http:// www.snuh.org/english/ snuh/snuh03/sub02/index2.jsp, Accessed 6Jan2014 18. http://www.quintiles.com/ services/capabilities/clinical/ patient-investigator-recruitment/ accessed 03 Jan2014

14. http://www.infinata.com/biopharma-solution/by-product/biopharm-clinical.html Accessed 5Jan2014

19. http://www.quintiles.com/library/press-releases/quintilespartners-with-the-seoul-national-university-hospital/ Accessed 6Jan2014

15. http:// www.intel.sg/ content/dam/www/public/us/en/documents/white-papers/big-datavisualization-turning-big-data-in

20. http:// www.ntu.edu.tw/ engv4/ highlights /2012/he121201_2.html accessed 6Jan2014

MANAGEMENT INSIGHT

Commercial Excellence 2.0 Bart Janssens, Partner and Director, BCG and Rahul Guha, Principal, BCG, in second part of the series, focus on the marketing model, particularly ensuring marketing initiatives are aligned to the state of the market in which the brand competes and outline a concept of an integrated approach to sales and marketing

THE PHARMACEUTICAL selling model has been established for decades. Much has been done on improving the model and squeezing efficiency from the model using sales force effectiveness tools and IT-enabled solutions. The authors propose six tenets to Commercial Excellence 2.0 which will be elaborated in this three part article series. In brief, these six tenets are:

tice sharing is rarely institutionalised, getting teams to learn from each other is key.

In the second part of our series, we focus on the marketing model, particularly ensuring marketing initiatives are aligned to the state of the market in which the brand competes and outline a concept of an integrated approach to sales and marketing.

●

Let the market drive marketing

Move beyond share of voice: Engage with the customer to drive value in his business and ensure the messages delivered are differentiated, relevant and absorbed

● Manage performance, not in-

Return on marketing investment is an interesting concept,

but often times difficult to implement. Companies push back saying the impact of different marketing activities on sales and the direct linkage is often difficult to pin down. Often times, companies under-invest in tracking their marketing spend effectiveness because of these fundamental 'shortcomings' of the marketing process.

On the topic of measuring returns, first we need to look at how spend is determined. Rarely is marketing investment built from a 'zero-based point of view.

Marketing budgets are typically defined as incremental over the

previous year. How often have you heard the justification “last year we spent 12 per cent of sales on marketing, this year we believe it needs to 12.5 per cent because brand x, y are at those levels.” Budgeting processes, for lack of time are typically run as an increment over the previous year. “We did 15 events this year, if we need to sustain a growth of 20 per cent, then we need to do at least 18 in this year” is often the argumentation put forward.

Products, however, are in different lifecycle stages and the marketing deployment needs to evolve throughout the product

BART JANSSENS, Partner and Director, BCG

RAHUL GUHA, Principal, BCG

lifecycle. With an incremental budget, rarely is the deployment checked with a critical eye.

Let us elaborate with an example: Take a brand which has been now in the market for five years in a well established molecule. In the initial lifecycle, marketing spend was allocated to education of the doctor on the brand i.e. awareness generation.

Over time, the brand has been established with newer brands entering the market place. The dynamic has shifted from educating the doctor about the molecule, to a more competitive dynamic both against other

EXHIBIT: MAPPING PRODUCT SPENDS AGAINST PRODUCT LIFECYCLE

centives: Understand the behaviour of the sales force segments and then customise incentives and coaching to address specific patterns ● Let the market drive marketing: Zero-base your marketing spend and then align your initiatives with where your brands are in the product lifecycle ● Integrate to differentiate: Align the commercial model across sales and marketing and close the loop effectively ● Middle managers manage a business: Equip Zonal / Regional managers with the right skills to manage a business vs. just managing sales ● Sharing is caring: Pockets of

excellence exist, but best prac-

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MANAGEMENT molecules and against other molecules within the ATC-3 as well. While marketing spend has probably increased over time to address this shift, how many times has a brand really looked at its promotion spend from a zero-base and re-aligned it to this shift in the market. A rough analysis of marketing spend will reveal awareness based promotions even for brands which have been around for 10+ years or more in molecules where doctors don't really need to know much more about the molecule.

And that is just marketing; sales messaging, detail aids often don't sync up with this change in market either. Take for example iron supplements, almost every doctor today knows about anaemic deficiency in women. Is there a point then in continuing to drive awareness programmes with doctors or is the money better deployed in driving compliance with the patient base that you have already?

To test the effectiveness of your marketing spend we suggest you build a matrix of the product lifecycle (i.e. awareness,

treatment, compliance) and map your marketing spend by marketing levers (i.e. free good offers, sampling, CMEs etc) against these as outlined in the exhibit.

Tracking the spend increase over time in this matrix will reveal much about your marketing spend alignment with market realities. We have found in our experience, taking a zero based view on the marketing budget could optimize spends up to 20 per cent depending on the starting position of the company. In this competitive environment, an extra 20 per cent to deploy against the right levers could certainly go a long way in driving differentiation for key brands.

Sales automation tools can help ensure a coordinated effort and help drive alignment in spend and tracking of the results

Integrate to differentiate Sales and marketing have existing in traditional silos. While much has been done at the organisation structure level e.g. BU structure to ensure alignment, much still remains to be done at the ground level. Aligning an organisation to deliver a seamless approach i.e. aligned strategic priorities and the subsequent al-

location of budgets and activities, timely tight and coordinated execution and feedback and tracking still remains a challenge. Ask yourself this, when the last time availability in the market was was truly synced up with a promotion run at Head Office.

Lack of robust IT systems has truly complicated matters on this front. Do you know today, how much you spend per customer? If you do, fantastic, but then the next question is has this been synced up across BU’s and do you have an integrated view on promotion spend and whom it is targeted to? Do local on the ground promotions and centrally driven marketing events tie up with sales uptick over the promotion horizon?

Very few of the clients we have worked with have established a tight link across the value chain of events, from the fact that promotion has been done, has it effectively reached the right set of doctors, was it executed well and did we track and measure feedback and did the sales force know and refer to it in their next visit.

Practically speaking, having good data in India is tough to achieve. What is a practical model to achieve integration in the sales and marketing approach? Automation tools are touted as the panacea to drive this integration, but as we know

garbage in – garbage out apply.

The place to begin is with the good old fashioned 80:20. Building off the call list with the right segmentation and tracking of a core doctor set is the first place to begin. Aligning this list across the BU’s and working with the sales team to ensure the list is accurate and up to date is important.

Once this is in place, sales automation tools can help ensure a coordinated effort and help drive alignment in spend and tracking of the results. Driving this is critical, ensuring that you have the right deployment will go a long way in ensuring you are able to deploy and track your spend in the right way.

We hope this article compels you to drive a more integrated and zero-based approach to marketing in your organisation.

In the third part of our series, we focus on people, ensuring you build capabilities at the right level for business management and more importantly ensuring pockets of excellence in the organisation are deployed more broadly.

REPORT

Boom in smart pills will reach new peak by 2018-2020: Frost & Sullivan Technological advances in minimally invasive and remote controlled devices drive the market NEW ANALYSIS from Frost & Sullivan, Innovations in Smart Pills, finds a clear trend towards minimally invasive and remote controlled devices for diagnosis and therapy. Smart pills are widely used for gastrointestinal imaging too, replacing invasive endoscopes. Advancements in enabling technologies, such as wireless communications, remote patient monitoring, and miniaturisation, will widen smart pill applications.

An analyst from Frost & Sullivan said that the smart pills industry is likely to experience a

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burst of new products in the next five to seven years, offering tremendous potential for collaboration between the industry and academia. While overarching product designs developed by the industry can lead to breakthrough products such as capsule endoscopes, it is by leveraging ideas from basic and applied sciences at universities and research centres that product differentiation and value enhancement can be achieved.

Being a nascent market there is a need to build confidence among the stakeholders — pa-

tients, physicians, researchers, investors and regulatory agencies. Measures like strategic and business partnerships, as well as scientific and clinical education will help win the trust of regulatory authorities, investors and users. In addition, it is imperative that companies take advantage of the government funding available to universities and small businesses. This is especially vital owing to the uneven distribution of venture capital investment, which prevents startup companies from developing into formidable players.

Besides, company valuations have reduced over the past few years. Collaborating with labs that have access to funds for basic and applied sciences will help secure financial support that can be leveraged into commercial products. In fact, governmentsponsored research projects have given rise to formidable academia-industry research collaboration. Such research consortia are especially common in the European Union, resulting in successful spin-offs that commercialise technologies and further the scope of the smart pills.

The analyst also mentioned that smaller companies that cannot effectively translate a technology into a commercial product can also explore licensing them to companies with established solutions in the market.

Meanwhile, new market participants can rely on technology incubators to ease their technology towards commercialisation.

Moreover, leading companies looking to enter new regions can associate with local medical device companies.

EP News Bureau-Mumbai

RESEARCH CLINICAL UPDATES

Phase III psoriasis data show significant skin clearance with Novartis’secukinumab Patient-reported outcomes from Feature and Juncture show high patient satisfaction with secukinumab PFS and AI self-administration NOVARTIS HAS announced the results from the pivotal phase III Feature and Juncture studies showing secukinumab (AIN457), an interleukin-17A (IL-17A) inhibitor, demonstrated consistent high efficacy when administered with a convenient pre-filled syringe (PFS) or autoinjector/pen (AI). These results, along with patient-reported outcomes showing high patient satisfaction with PFS and AI were presented for the first time at the 72nd Annual Meeting of the American Academy of Dermatology (AAD) in Denver, US. Feature and Juncture are the first phase III studies to evaluate secukinumab in clearing patients' skin with the PFS and AI administration. Both methods allow secukinumab self-administration anywhere (including the workplace or home) versus healthcare professional administration, if allowed by local regulations. This is important because many psoriasis patients prioritise easy self-administration at a location of their choice.

“It is important that people living with psoriasis, a chronic skin disease, have highly effective and safe treatments they can conveniently self-administer,” said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. “These exciting results from our speciality dermatology portfolio show that secukinumab, the first IL-17A inhibitor with regulatory submissions completed, had similar efficacy in clearing skin with a convenient pre-filled syringe and autoinjector pen as in the landmark Fixture study, where it was significantly superior to Enbrel, a biologic psoriasis therapy ap-

The Feature and Juncture results support the head-to-head phase III Fixture data first presented in October 2013, which showed secukinumab cleared skin faster proved 10 years ago.”

Importantly, in both studies more secukinumab 300 mg patients experienced almost clear skin, described as Psoriasis Area and Severity Index 90 (PASI 90), at Week 12 (60.3 per cent for Feature and 55 per cent for Juncture, p<0.0001) compared to placebo. PASI 90 is considered the best evidence of efficacy, and a more robust measure of the extent of skin clearance compared to standard efficacy measures that have been used in most psoriasis clinical studies, such as PASI 75.

The Feature and Juncture

studies met all primary and prespecified secondary endpoints.

Across the co-primary endpoints in both studies, secukinumab 300 mg demonstrated significant improvements in PASI 75 at Week 12 versus placebo (75.9 per cent vs. zero per cent for Feature; 86.7 per cent vs. 3.3 per cent for Juncture, p<0.0001), and was also superior to placebo according to the Investigator's Global Assessment (IGA mod 2011).

Patients also benefitted from rapid and significant skin clearance with secukinumab in both studies. Already by the third

week, patients taking secukinumab 300 mg experienced superior efficacy in clearing skin compared to placebo. In addition, the 300 mg dose showed numerically and clinically relevant improvements compared to 150 mg.

Both studies measured usability and patient satisfaction with secukinumab delivered via PFS and AI. On the first week, all patients successfully self-injected secukinumab by following instructions, with no administration issues observed. Patient satisfaction scores were consistently high, showing

acceptability of the PFS and AI. Satisfaction was assessed using a self-administered Self-Injection Assessment Questionnaire (SIAQ), which measures overall experience, feelings about injections, self-confidence, satisfaction with self-injection, injectionsite reactions, ease of use, and self-image before and after treatment.

Secukinumab demonstrated a positive safety profile consistent with findings from previous studies, with adverse events (AEs) similar between both secukinumab treatment arms (300 mg and 150 mg). In Feature, the most common AEs in any treatment group were diarrhoea, nasopharyngitis and headache. In Juncture, the most common AEs in any treatment group were nasopharyngitis, headache and pruritus. There were no deaths reported during either study, and no new or unexpected safety findings were observed.

The Feature and Juncture results support the head-to-head phase III Fixture data first presented in October 2013, which showed secukinumab cleared skin faster and for longer than Enbrel(etanercept). Clinically relevant differences were observed as early as the second week in Fixture, and by week 16 nearly three quarters (72 per cent) of secukinumab 300 mg patients experienced almost clear skin (PASI 90). Secukinumab efficacy was also sustained over the full one year study, with significantly more secukinumab 300 mg patients experiencing PASI 90 at Week 52 compared to Enbrel (65 per cent vs. 33 per cent).

EP News Bureau-Mumbai

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RESEARCH

Lallemand declares results of on-going AIACE(1) study Prof M Cazzola presents positive immunological study at a workshop on lung health LALLEMAND PHARMA announced that the ancillary results of the on-going AIACE(1) clinical study were presented by Prof M Cazzola, at the international workshop on lung health dedicated to Chronic Obstructive Pulmonary Disease (COPD), which took place in Monaco in December 2013. These results represented a further proof of concept of the immunostimulating effect of PMBL in patients.

COPD is ranked by the World Health Organization (WHO) among the top-10 causes of mortality worldwide, projected to become the fourth one by 2030, and its economic burden has been estimated to €48.4 billion in Europe (2).

Cazzola’s presentation was titled 'Polyvalent Mechanical Bac-

terial Lysate as a Potentially Effective Approach In Preventing Acute Exacerbations of COPD'.

He exposed PMBL activity on both innate and adaptive immune response, linked to a proven clinical efficacy in reducing acute exacerbations in COPD patients. This has been confirmed by a meta-analysis of all randomised clinical trials, indicating that PMBL induced a significant reduction in AECOPDs (RR, 0.83; 95 per cent CI, 0.77–0.89).

In the ancillary clinical study (3) , it was shown for example that during the study, 25 per cent of patients experienced a single acute episode in the PMBL group, while 72 per cent of patients in the placebo group experienced at least one acute

episode (27 per cent of these patients experienced multiple episodes) (p <0.05). The aim of this ancillary study was to get a better insight of PMBL modes of action in vivo: many immunological parameters were monitored.

Interestingly, it was shown that the clinical benefits observed were correlated with serological signs of an efficient specific (memory) and non-specific immune response against bacteria as well as viruses. Moreover, the study also showed that PMBL had a stimulating effect against vaccinal antigens, which can be described a real ‘vaccine boosting’ effect. These results complement previous findings and further indicate that PMBL is able to stimulate both innate and adaptive immune response, even

in elderly COPD patients.

PMBL is a bacterial lysate obtained mechanically for optimal preservation of the antigens structures. PMBL contains a blend of 13 inactivated bacterial strains of the most common pathogens involved in infections of the upper and lower respiratory tract. It is formulated in sublingual tablets, described as an optimal route of administration to stimulate a strong and longlasting immune response and enhance anti-microbial defences. A recent meta-analysis encompassing the data of 15 randomised clinical studies using PMBL in both upper and lower respiratory tract infections concluded that it is effective in both children and adults

in preventing respiratory tract infections.

References (1) Advanced Immunological Approach Against COPD Exacerbations, a Phase IV clinical trial in COPD patients (2) http://www.erswhite book.org/ (3) Ricci R, Palmero C, Bazurro G, Riccio AM, Garelli V, Di Marco E, Cirillo C, Braido F, Canonica GW, Melioli G. The administration of a polyvalent mechanical bacterial lysate in elderly patients with COPD results in serological signs of an efficient immune response associated with a reduced number of acute episodes. Pulm Pharmacol Ther. 2013 Jun 21. pii: S10945539(13)00124-7. doi: 10.1016/j.pupt.2013.05.006.

EP News Bureau-Mumbai

RESEARCH UPDATES

Amgen vaccine triggers immune response in advanced melanoma: Study Melanoma is one of the most aggressive forms of cancer AN EXPERIMENTAL Amgen cancer vaccine used to treat advanced melanoma, the deadliest form of skin cancer, proved effective in a late-stage study in shrinking tumors in a way that suggests the drug triggered the intended systemic immune response, according to data presented. The vaccine shrank tumors that were directly injected with the drug and tumors around the body that were not injected, according to the data.

The drug, talimogene laherparepvec, also known as T-vec, is an engineered virus designed to replicate inside the injected tumor, killing cancer cells there, as

36 EXPRESS PHARMA April 1-15, 2014

well as prime the immune system to attack other cancer cells around body.

Dr Robert Andtbacka, one of the study's lead investigators, called the results "very encouraging."

Amgen last year released initial data from the 295-patient Phase III study showing that Tvec succeeded in demonstrating a significant tumor response that lasted at least six months.

The latest data analysed 4,000 tumor lesions to study the response to the drug in injected versus non-injected tumors. Of the directly injected tumors, 64 per cent shrank by at least half,

and 47 per cent of those had a complete response, meaning the lesion had disappeared, researchers said.

Of the uninjected lesions in the skin or lymph nodes, known as non-visceral tumor lesions, 34 per cent shrank by at least half with a complete response seen in 21 per cent of those. Of those socalled visceral tumors on solid organs, 15 per cent shrank by at least 50 per cent, said Andtbacka, who presented the data at the Society of Surgical Oncology Cancer Symposium in Phoenix. "This is a new generation of oncolytic immunotherapy where you're seeing very robust

responses in injected lesions but also robust responses in non-injected lesions. This bodes well for the future for this product," added Andtbacka, an associate professor in the division of surgical oncology at the University of Utah School of Medicine.

Amgen said it expects to have further data in the first half of this year showing whether Tvec ultimately helped patients in the study to live longer. The company has not yet said when it will apply for approval of the medicine. Andtbacka said he expects the future of the drug will involve its use in combination with other types of cancer im-

munotherapies, especially in treating patients with non injectable visceral tumors. Amgen is already testing T-vec in combination with Bristol-Myers Squibb's melanoma drug Yervoy and has agreed to study Tvec in combination with Merck & Co's experimental immunotherapy from a highly promising class called PD-1 inhibitors. "We are extremely excited about the data and the potential for combinations with other treatments," said David Chang, Amgen's head of global oncology development.

Reuters

RESEARCH

Intercept says liver disease drug effective in trial INTERCEPT PHARMACEUTICALS said its experimental liver disease drug was effective in a third late-stage clinical trial and that the results set the stage for the company to file for marketing approval.

The drug, obeticholic acid (OCA), is designed to treat primary biliary cirrhosis, a disease in which bile ducts in the liver become damaged, allowing harmful substances to build up and scar liver tissue.

It is thought to be an autoimmune disorder, in which the body's immune system mistakenly attacks its own cells.

The findings come roughly

The drug, obeticholic acid (OCA), is designed to treat primary biliary cirrhosis, a disease in which bile ducts in the liver become damaged

gium and the lead investigator on the trial.

Nevens said that a significant proportion of patients

fail to be adequately helped by existing treatments and that new therapies are needed to prevent their disease from

progressing to cirrhosis and liver failure. “I believe that the POISE data indicate OCA will provide a meaningful clinical

improvement in patients,” he said.

these

Reuters

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PHARMA ALLY VENDOR NEWS

Optima to exhibit at Interpack Focus will be on flexibility, high outputs and line solutions offering users best possible RoI OPTIMA WILL exhibit its intelligent process and packaging solutions, with the focus on flexibility, high outputs and line solutions to offer users the best possible return on investment at this yearâ&#x20AC;&#x2122;s Interpack. An overview of important new developments which will be showcased.

Optima consumer Being able to fill and close both bottles and tubes is the advantage of the flexible new Moduline machine type. The installed robot removes the supplied packaging materials from boxes and inserts them into special transport pucks. Although the exhibited version of the filling and closing machine has been designed to process shampoo, shower gel and lotion (cold and warm filling), the complete range of cosmetic products can also be filled using the same equipment. The machine can accommodate PE and laminate tubes up to 60 mm in diameter and glass and plastic bottles up to 100 mm in diameter. Other dimensions can be integrated. The unit has impressive performance even for large volumes, with an output of up to 12,000 units per hour. Format changes, including between tubes and bottles, do not require any tools. Changeover time including CIP is approximately 20 minutes, depending on the product being processed. Modules can be exchanged or added later to the compact monoblock moduline machine.

The new high-performance cartoner OPTIMA CBF is closing the gap between primary and secondary packaging thanks to seamless line integration. The products are oriented and positioned within the cartoner. Flexibility is once again the keyword here: Product

38 EXPRESS PHARMA April 1-15, 2014

grouping devices or a second alignment module can be integrated. The cartoner offers a number of advantages for the customer, including a cassette for blanks that can be removed as a unit when formats are changed. Other benefits include gentle processing (finished boxes are transported in a puck), a large format range, operator ergonomics and hygienic properties.

The OPTIMA MPS is another new modular machine designed specifically for food and chemicals. It can flexibly process cylindrical containers including canisters in the filling range of 500 ml to 30 ml. The version shown at the fair is for filling liquids, but a filling system for powders could also be installed. The mass flow filling system is located on a trolley, which makes switching products fast while reliably avoiding cross contamination. Additional functions such as handling processes, sealing, flushing, inspection and more can be integrated. The highly accessible machine with explosion protection can also be equipped with a CIP unit. Outputs of up to 160 products/min are reached.

OPTIMA FS

Optima pharma Modular systems are becoming increasingly important in special machinery manufacture. The INOVA SV125 exhibited has been further developed into a proven, modular filling and closing machine system.

The INOVA SV is suitable for the range from pilot testing to medium outputs. A maximum output of 18,000 containers/hour is achieved via ten filling points, with a dosing range of 0.1 to 50 ml. The system boasts impressive flexibility. The operator can implement up to three difference

OPTIMA MODULINE

OPTIMA Transport System

filling systems in a single machine while also processing three different container types: nested syringes, carpules and vials (for more information, please refer to page YX in this issue of O-com). Numerous additional modules and functions can be integrated, including filling under vacuum, pre- and post-flushing with gas, and up to 100 per cent in-process control. Upstream, the pre-sterilised containers are manually to fully automatically unpacked and fed to the process. The post-processing section features such modules as backstop locks and safety devices, optical and sensor controls, labellers and track and trace systems. RAB systems and isolators can be deployed for containment.

The company will also be presenting the KUGLER LINOLINE, a monoblock filling and closing machine with an extended format range of 5 ml to 1,000 ml dosed via a peristaltic pump system, allowing for a high output of up to 7,200 products/hour. Up to 4,800 containers/hour can be processed in the 500-ml format. The compact machine also comes equipped with a sophisticated closing system consisting of a stopper insertion station, a sealing station, a screw capper with a final torquing station and a station for attaching a secondary cap and a measuring cup.

Optical inspections and integrated in-process control with tendency control of dosing ensure outstanding product quality and filling accuracy.

The Klee freeze dryer to be presented at Interpack is a pilot unit capable of being retrofitted for production as needed.

It can be manually loaded and unloaded under an isolator with VHP-sterilisation. A special stopper closure mechanism on

the back of the machine makes it possible to close individual vials of a test batch in order to assess how the process is progressing. With countless years of experience, Klee offers a comprehensive portfolio of freeze drying technologies in all capacity ranges, including with automatic loading and unloading.

Metall + Plastic will exhibit one of its models to showcase the advantages of its isolator technology for fair visitors, including highly effective, reliable pneumatic sealing systems and catalytic aeration techniques that massively reduce cycle times. Metall + Plastic will also present e-beam decontamination tunnels and isolators for specific requirements.

In addition to its filling and closing technologies, Optima Pharma will be showing the rest of its product range at Interpack, including washing machines, sterilization tunnels, containment and process technologies, and robotics.

Optima life science Medicon systems from Optima life science are at the cutting edge of modularity. The MEDICON MDC 300 Vario converting unit is ideal for manufacturing and developing advanced wound care products. The process can be very easily changed or expanded.

Operators can configure the modules via ‘plug & play’ – no programming skills required.

Within a very short time, a new manufacturing process under cleanroom conditions has also been brought to production readiness. The machines are thus ideal for developing new products as well as for flexible series production. The biggest advantage: the time to market for new wound care products is massively reduced.

Optima life science will also demonstrate the MEDICON ImmuCoat production line, a modular, scalable system for the automatic coating of microplates for the production of ELISA test kits. The key feature: all base modules can also

Optima INOVA SV 125

OPTIMA OPAL

be combined as desired for true “plug and play” convenience.

MEDICON ImmuCoat allows parallel administration and processing of a practically unlimited number of product batches without mixing them up.

The purpose of the OPAL software solution developed by Optima life science and presented at Interpack is to analyse machines in terms of outputs and potential clusters of errors and to identify potential for improvement, in turn making operational efficiency transparent. OPAL also performs planning and process optimisation tasks. The software communicates with other IT systems that are typically installed in companies, including ERP software such as SAP. A number of the machines demonstrated at Interpack will be networked using OPAL. (Optima at Interpack, 8-14 May, 2014 in Düsseldorf: Hall 16, Booth F25-F26) EP News Bureau-Mumbai

GE Healthcare Life Sciences and NetBio commence independent validation of Rapid DNA system Accredited forensic laboratories to verify accuracy and reliability of DNAscan Rapid DNA Analysis System GE HEALTHCARE Life Sciences and NetBio has commenced an extensive developmental validation of DNAscan Rapid DNA Analysis System.

The studies will evaluate the overall system from swab-in to profile-out, including the instrument, NetBio BioChipSet Cassette, STR chemistry, and data interpretation by the on-board Expert System Software. The software enables fully automated data analysis which will be critical to Rapid DNA Analysis realising its full potential outside the laboratory. This approach to validation will pave the way for future uptake of Rapid DNA by crime laborato-

ries and police stations globally.

Mike Benevento, General Manager, Human Identification, GE Healthcare Life Sciences, said, “Rapid DNA analysis will significantly increase the speed with which DNA supports the investigation of crimes and is predicted to substantially reduce violent and property crime over time. Together with NetBio, we are committed to the responsible adoption of DNAscan Rapid DNA Analysis System which is essential to successfully realising this potential, not just in the US, but globally. We are working closely with the FBI, SWGDAM (Scientific Working

The software enables fully automated data analysis which will be critical to Rapid DNA Analysis realising its full potential

Group for DNA Analysis Methods), and others in the forensic and law enforcement communities to take a considered, step-wise approach to the introduction of the DNAscan System.”

Developmental validation of the system comprises an extensive series of tests to verify that results generated (STR profiles) are reliable and reproducible. A working group which includes five accredited forensic laboratories is independently generating and analysing data from the DNAscan System. This verification process, which includes meeting an extensive set of FBI

Quality Assurance Standards, is expected by the forensic science community for any new scientific technology being introduced into the criminal justice system.

Following analysis, the results will be used to seek National DNA Index System (NDIS) approval which will allow forensic laboratories to submit the STR profiles generated by the DNAscan System to the US national DNA database (CODIS). NDIS approval is also a critical step toward the ultimate goal of obtaining approval for use in the police station.

EP News Bureau – Mumbai

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PHARMA ALLY PRODUCTS

OGTand Emory Genetics Laboratory develop new molecular arrays OXFORD GENE Technology (OGT), the molecular genetics company, has expanded its range of research-validated CytoSure molecular arrays to investigate DNA copy number variation (CNV) underlying a variety of genetic disorders. Designed and optimised in collaboration with experts at Emory Genetics Laboratory (EGL; Atlanta, US), the arrays are the ideal complement to DNA sequencing, providing a particularly powerful tool for investigating the variety of aberrations underlying genetic

disorders.

Comparative genomic hybridisation arrays (aCGH) are the gold-standard for CNV detection and the 60-mer oligonucleotide probes utilised by OGT’s aCGH platform have been shown to deliver superior CNV detection than alternative platforms. The expanded CytoSure molecular array portfolio enables the detection of CNV in genes associated with over 20 genetic disorders, including cardiovascular, inherited eye, intellectual disability and neuromuscular disorders, as well

as a range of inherited cancers.

In addition, genes covering each disorder can be combined to create bespoke custom arrays,

or further customised by the addition of novel content to suit each individual research project.

For the easy extraction of meaningful results from aCGH data, all CytoSure Molecular Arrays are supplied with OGT’s class-leading CytoSure interpret software.

Utilising highly targeted, exon-focussed arrays has been shown to detect CNVs as small as 12 bp in size that were missed by targeted NGS. Whether used alone or alongside sequencing, CytoSure Molecular

Arrays allow researchers to reliably investigate the role of CNV in a wide range of genetic disorders.

Contact details Oxford Gene Technology, Begbroke Science Park, Begbroke Hill, Woodstock Road, Begbroke, Oxfordshire, OX5 1PF, UK T: +44 (0) 1865 856826 F: +44 (0) 1865 848684 E: contact@ogt.com W: www.ogt.com Twitter: @OxfordGeneTech

Eppendorf’s launches Mastercycler nexus X2 EPPENDORF HAS launched the latest range of molecular biology instruments. The new Mastercycler nexus X2 is ideal for researchers looking to carry out two runs of PCR simultaneously, without any compromise on the number of samples.

The instrument consists of two asymmetric blocks, consisting of 64 and 32 wells, which can be programmed and run completely independently, enabling two separate PCR protocols to be run in parallel.

With reduced noise emission (< 40 dB), low power consumption and a small, well-designed footprint, the Mastercycler nexus X2 is perfectly suited for use in busy academic laboratories, or any institution with multiple users or large research groups.

In comparison to other dual block cyclers, it provides an elegant solution for users wishing to run procedures using a large number of samples, without taking up a large amount of bench space.

As the latest addition to the popu-

40 EXPRESS PHARMA April 1-15, 2014

lar Mastercycler range, the Mastercycler nexus X2 continues Eppendorf ’s legacy of exceptional design and ease of use combined with efficiency and accuracy.

Contact details M Anthoni Jai Kumar Eppendorf India, Chennai

Tel: +91 44 421 11 314, Fax: +91 44 421 87 405 email: anthoni.jk@eppendorf.co.in website: www.eppendorf.co.in

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PHARMA LIFE CAMPUS BEAT

Goa College of Pharmacy organises workshop on ‘Science of scientific writing’ Researchers were updated about the skills involved in writing scientific research papers and practical applications involved in writing such papers GOA COLLEGE of Pharmacy recently organised a two-day workshop on ‘Science of scientific writing.’ The workshop was sponsored by AICTE. The purpose of the workshop was to keep researchers updated about the skills involved in writing scientific research papers and practical applications involved in writing such papers.

The workshop was attended by 131 delegates consisting of teaching faculty and PG students from pharmacy colleges in Goa, Karnataka and Maharashtra. The workshop was inaugurated by Prof VP Kamat, Registrar, Goa University, who was also the chief guest, Vivek Kamat, Director, Directorate of Technical Education, Salim Veljee, Director, FDA, Dr SY Gabhe, Chairman, Board of Pharmaceutical Education, AICTE and Arun Naik, Chairman, Management Council of Goa College of Pharmacy. Dr GK Rao, Principal, welcomed the gathering and explained the significance of the workshop.

Dr VP Kamat, Registrar, in his address, appreciated the efforts of the college and stressed on the fact that the institute should organise such national level workshops every year for the benefit of Goan students and faculty. Lectures on various topics were delivered by the faculty in their respective fields.

Dr Shobha Rani RH, Principal, AlAmeen College of Pharmacy, Bangalore and Editor, Indian Journal of Pharmacy Practice, spoke on ‘Selecting Topics for Research Projects.’

Dr SY Gabhe, Professor, Bharti Vidyapeeth deemed University-Poona college of Pharmacy, delivered a lecture

on ‘Writing Scientific Reports,’ Dr N Udupa, Director-Research (Health sciences), Manipal University spoke on ‘Good Practices for Biomedical Publications,’ Dr V Malla Reddy, General Manager, Divi’s Laboratory, Hyderabad and retired Prof Kakatiya University, Warangal delivered a lecture on ‘Salient Features of Scientific/ Technical Research Paper Writing.’

Dr Vadlamudi VSV Rao, Director, St Peter’s Institute of Pharmacy, Warangal and Editor, Indian Journal of Pharmaceutical Sciences highlighted the importance of ‘Scientific Writing and the Impact of Plagiarism’, Dr V Gopal, Principal, Mother Theresa Institute of Pharmacy, Pondichery, Govt of Pondichery delivered a lecture on ‘Scientific Writing – Is it an Art or Skill or Science?,’ Dr Shivaprakash Ratnam, Chief Executive Officer, Synchron, Ahmedabad and Former Editor, Indian Journal of Pharmacology, spoke on ‘Methodology of Writing Clinical Research Protocol.’ Dr S Rajasekaran, Executive Editor, Indian Journal of Pharm.

Education and Research, highlighted the importance of ‘Writing a Good Dissertation/ Thesis,’ Dr Sanjay Pai PN, Goa College of Pharmacy and Former Editor, Indian Journal of Pharmaceutical Education and Research, spoke on ‘Writing Proposals for Funding.’

The lectures were followed by interactive sessions. The workshop concluded with the valedictory function which was graced by Rajendra Naik, Deputy Director, FDA. EP News Bureau-Mumbai

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April 1-15, 2014

PHARMA LIFE APPOINTMENT

Merck Serono appoints Meeta Gulyani as Head of Strategy and Global Franchises Gulyani will lead Merck Serono’s global franchises MERCK SERONO has appointed Meeta Gulyani to the position of head of strategy and Global Franchises as of May 7, 2014. Gulyani will be based in Boston, US and will report to Belén Garijo, President and Chief Executive Officer, Merck Serono.

Gulyani will be leading Merck Serono’s global franchises (multiple sclerosis and immunology, oncology, fertility, general medicine and en-

docrinology, and medical devices), with a strong focus on defining integrated strategies for the different disease areas, ensuring rigorous allocation of resources in line with the strategy, as well supporting drive Merck Serono’s operating performance through marketing excellence.

“I am pleased to have Meeta on board as we are moving into a new phase of

Merck Serono’s transformation, focused on growth, and seek to maximise the value of our current product portfolio and build our future product offering,” said Garijo.

Gulyani joins Merck Serono from Roche where she was most recently general manager for South Asia, covering India, Sri Lanka, Bangladesh and Nepal, and previously Vice President of Global Portfolio Management.

Prior to joining Roche in 2010, Gulyani spent eight years at Sanofi. She holds an MBA from the Asian Institute of Management, Philippines, accompanied by an exchange programme at Wharton, University of Pennsylvania, US, and a BA in Economics from the Shri Ram College of Commerce from the Delhi University, India.

EP News Bureau-Mumbai

AWARD

Quintiles bags ‘Best CRO in Asia’award 2014 BioPharma Asia Industry Awards has recognised Quintiles for its ongoing commitment to improve clinical research in Asia QUINTILES HAS been named as the ‘Best CRO in Asia’ at the 2014 BioPharma Asia Industry Awards. This is the third time in the event’s four-year history that Quintiles has received the honour. The award recognises the contract research organisation that has best demonstrated an ongoing commitment to improve clinical research in Asia and help customers succeed.

“This award reflects Quintiles’ ability to improve our customers’ probability of success by combining market knowledge with superior service,” said Ken Lee, Vice President and Regional General Manager for Southeast Asia, Quintiles,

56 EXPRESS PHARMA April 1-15, 2014

who accepted the award. “For 20 years we have been helping our customers navigate Asia’s complex and changing healthcare environment. It’s wonderful to be acknowledged for our excellence in bringing knowledge and people together for a healthier world.”

Anand Tharmaratnam, Senior Vice President and Head of Asia-Pacific, Quintiles said, “I’d like to dedicate to this to our employees, whose excellence made it possible; to our valued customers; and to patients worldwide whose lives and quality of life depend on new and better medicines.”

EP News Bureau-Mumbai

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