BBaannggaalloorree IInnddiiaa BBiioo –– JJuunnee 0022--0044,, 22001100

 

S.NO ARTICLE Date PUBLICATION

1 Biotech Investment Pays off 03-June-2010 The Times of India

2 Bangalore India Bio Kicks off 03-June-2010 Deccan Herald

3 Biotech Flexes its muscle 03-June-2010 DNA

4 Biotech sector likely to pierce $5billion mark by fiscal end 03-June-2010 Financial Express

5 Biotech sector set to grow 20% to $5bn 03-June-2010 Mint

6 Biotech swings past slump, eyes $5bn-mark 03-June-2010 DNA

7 Clinical trials beckons India with a $26 billion purse 03-June-2010 DNA

8 ‘It’s not just a business, but a chance to help the poor’ 03-June-2010 DNA

9 When will biotechnology in India be properly regulated? 03-June-2010 DNA

10 Quick diagnostics key to control pandemic 04-June-2010 DNA

11 Biosimilars hold big opportunity bigger hurdles 04-June-2010 DNA

12 Biosimilars to be next growth area for BT firms 04-June-2010 Business Standard

13 Lab-on-a-chip concept catching on 04-June-2010 The Times of India

14 Shift in parenting trends brings R&D tie-ups to the fore 04-June-2010 DNA

 

India's vaccinedraws world

attention

Bangalore: India's vaccine pro-duction and its vaccine inno-vation pipeline is drawing ma-jor global attention.

Pune-based Serum Insti-tute's swine flu vaccine will hitthe market in the next coupleof weeks. According to Dr S DRavetkar, senior director, serumInstitute of India, the future forinnovations looks bright asmore and products are manu-factured in India and sold in theoutside world. "India's entirelandscape for vaccines anddrugs is changing. The countryis gearing to manufacture notjust affordable medicines, butthe best quality ones," he said.

Delhi-based biotech majorPanacea Biotech is coming outwith a vaccine for dengue andJapanese encephalitis in thenext 5-6 years. "These are thevaccines with which India canenter the developed world in-cluding the US and Europe. Thevaccines industry is now buoy-ant:' said Rajesh Jain, joint MD,Panacea Biotech.

Last year the company hadreceived a Rs 1,067 crore (about$222.37 million) UNICEF con-tract for the supply of its Easy-Five (pentavalent vaccine).EasyFive is a liquid pentavalentvaccine that immunizes chil-dren against five dreadful dis-eases - diphtheria, tetanus,wholecell pertussis, hepatitis Band hemophilus influenza Typeb - of early childhood.

Publication The Times of IndiaEdition BangaloreDate June 03, 2010, p.22

Biotech investments payoffBangalore: With India's biotechnology sectorscaling the $3 billion mark on a standalone ba-sis and the $4 billion mark including ancillaryindustries (data management and equipmentmanufacturing), the industry is in a buoyantmood. Hopes are that by the end of this finan-cial year the industry would have crossed $5 bil-lion in revenues.

Though the years of 00%growth seem to be overfor the industry, the fact that the sector successful-ly emerged out of the global economic turmoil hasboosted the confidence of industry players.

"The biotech industry holds a lot of promise.As the pipeline of drugs of multinational com-panies is drying up, they are looking at India asthe new Mecca for cash:' says Villoo Morawala

An exhibitor explains the disposable bio-reactorsystem to visitors at Bangalore India Bio2010

Patell, founder and MD of Avesthagen.The industry rammed into speed breakers

in 2007-{)8,when growth came down to 21 % fromthe previous five years' average growth of over30%. The trend continued in 2008-09, when itgrew 18 %, with revenues of Rs 12,137 crore. But2009-10 saw the growth rates bounce back over20% , and is expected to continue in this rangeover the next few years, say industry experts.

Public-private partnerships, industry-aca-demia collaborations and government supportare expected to steer the industry on to a steadyand strong growth path. Global partnershipsbetween Indian and foreign companies is said

Chief minister BSYeddyurappa along with KattaSubramanya Naidu, minister of IT&BT,and KiranMazumdar-Shaw, chairperson of Karnataka VisionGroup on Biotechnology, at the inauguration ofBangalore India Bio2010 on Wednesday

to be another key growth driver. Some 800 oddbio-partnering meetings are taking place be-tween Indian and foreign companies over the

three-day event India Bio.Says Kiran Mazumdar-Shaw, CMD, Biocon,

and chairperson of the Vision Group on Biotech-nology in Karnataka, "I think the current moodis very positive and there is enough work com-ing India's way. Besides, the gestation period isover, and the investment the industry made inthe past decade is beginning to payoff."

CHALLENGESBut the industry still has big challenges. "Ourindustry is very fragmented. We need to grouptogether to bring a breakthrough drug to mar-ket:' says Patel!.

An investment banker with a biotech focusedPE fund adds, "Indian companies still don't havethe muscle and money to discover a drug andtake it to market at a global level. That's whywe are seeing buyouts happen like that of Pi-ramal. It will take some more time for Indiancompanies to reach that scale."

Shaw sees fmding employable and industry-ready manpower a challenge. The country's reg-ulatory framework is a bone of contention. SaysShaw, "Today the patent rulings always favourthe imitator. They don't protect the innovatorsenough. So today any company can say I'm go-ing to copy this drug and I don't care aboutpatents because our country needs cheap drugs."

IS IT STILL ADVANTAGE BANGALORE?Though the biotech sector in Bangalore saw in-vestments worth Rs 1,500 crore in the last 12months, neighboring cities like Pune and Hy-derabad are attracting biotech funding fromglobal companies.

"Karnataka today is becoming extremelykey in the emerging trends that we see in thebiotech world globally," claimed Shaw in herinaugural address at India Bio, adding that thestate has become a global hub for clinical data -management. However some in the industryfeel that Bangalore is slowly losing its hold onthe biotech space. This despite the fact that thestate's exports in the sector stood at Rs 3,650crore in 2009-10 and is expected to cross the $1billion mark by the end of 2010-11.

Says Patel!, "In Andhra Pradesh, the gov-ernment gives you land and says 'go get on withit'. Their approach is more business orientat-ed, which is not quite the case in Bangalore."

Biotechnology conclave: Karnataka rolls out red carpet

B'lore India Bio kicks offBANGALORE: The tenth edi-tion of Bangalore Bio, annualbiotech conference in India,Bangalore India Bio 2010,was inaugurated by ChiefMinister B S Veddyurappahere, on Tuesday.,

Yeddyurappa said "The year2010 is very significant for theconference as we are celebrat-ing the 10th anniversary ofBan-galore Bio. The event has pan-India significance and the newname 'Bangalore India Bio' it-self indicates the same."

Further, he said, the biotechsector in Karnataka enjoys com-fortable position in terms ofgrowth and revenues. The gov-ernment has already an-nounced several fiscal incen-tives and concessions for thesector in the 'MillenniumBiotech Policy.' "We have alsoproposed a Bio-Venture fund of$10 million and also plan to start10 BT finishing schools togroom the industry readybiotech professionals."

The State government wouldset up biotech parks in Mysore,Mangalore, Dharwad andBidar. Bio-cluster part of Bang a-lore Biotech Park would be de-veloped in the PPP (Public Pri-vate Partnership) mode and theprocess of selecting the develop-er is in the final stage, he added.

Kamataka had added 11BTfirms over the 12 months whilerest of India added 32 firms.The state attracted investmentsofRs 1,500 crore in the last oneyear. The chief minister alsohanded over letter of intent toManipal Institute of Life Sci-ence and Dayanada Sagar Insti-tute to start Biotech finishingschool.

Steady growthBiocon CMD Kiran MazumdarShaw said the country's biotechindustry is on its growth trajec-tory. In the financial year 2010the revenue from biotech sector

was around was around $3 bil-lion and the ancillary industriesregistered revenue of around$1 billion. She said the overallrevenue from the sector wasabout Rs 18,500 crore which isabout $4 billion and expect tocross the $5 billion mark soon.

Further, she said, climatechange and clean energy wereturning out to be huge opportu-nities for the sector. Kamatakaconstitutes 50 per cent of BTfirms in India. Out of 380 BTcompanies in India, 198 are inKamataka, she added.DH News Service

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C-DACdevelopingnew technologiesCentre for Development ofAdvanced Computing (C-DAC) R&D organisation ofDepartment of InformationTechnology (D11), seeshigh end computing cut-ting drug discovery time,reportsDHNS from Banga-lore.The bioinformaties groupin C-DAC is developingtechnologies and applica-tions that can reduce drugdiscovery time. The centreis also developing software

. which can help the data in-tensive clinical researchwork much simpler.CDAC Group Coordinatorfor Bioinformatics Rajen-dra Joshi said "We developtechnologies to speed upgenome analysis and mo-lecular studies, primarilyfocused on Indian health is-sues." The bioinformaticsdivision of CDAC has devel-oped Genome Grid solu-tion for sharing bioinfor-maties data from differentsites to help in combiningdata at a single location.

EUsetsup€20 m businesscentre in India to boost ties13ANGALORE: In an effort tohelp business and researchhouses, specially small andmedium enterprises from Eu-ropean Union (ED) to enter In-dia, the EU has set up a Euro-pean Business & TechnologyCentre (EBTC) with an initialinvestment of €20 million.

The Centre will focus on de-veloping new technologies inthe areas of biotechnology,transport, energy and environ-ment. Director Poul V Jensentold Deccan Heraldthat EBTC isan initiative which helps SMEsconnect with local partners inIndia and overcome challengesthey face in expanding into In-dian markets.

"We are helping companiesovercome market access issues

and are particularly focused onbusiness and research. Our taskis to connect European firmswith partners in India. Ulti-mately, EBTC - which has 16consortium partners - will beself-sustainable," he added.

Besides trade facilitation, thecentre is also an intelligencehub, producing reports and pro-

viding information to compa-nies and is already in theprocess of developing sector-wise reports, he said.

Stating SMEs wanting tocome to India need hand-hold-ing he said EBTC helps by pro-viding office space, contacts andinformation on the market,adding this can help lower thecost of market entry - whichcan be a barrier to SMEs ex-panding into India.

The centre has close-knit tiesto EU member-state organisa-tions and missions and is in theprocess of establishing formalpartnerships with organisationslike crr, Ficci and others in In-dia. He said once the centrefinds success in India the EUplans to replicate the project inother countries.DH News Service

Biotech flexes itsmuscleThe three-day Bangalore India Bio 2010began on Wednesday evoking a response surpassing theexpectations of the organisers. The event was launched in a celebratory mood as the Indian biotechindustry is on track to achieve a decade-olq dream of crossing the $5 billion mark in 2010-11At least 750 delegatesfrom 20 countries areparticipating In 20programmes crammedinto three days of theevent. The biotechIndustry is on track totoudl $S bi1lion In 2010-11, a dec:ade-okl dream

The biotechnologysector records a rev·enue growth of S4 bil-lion (RsI8,SOO core) in2009-10 - 52% revenuegrowth over the previ-ous fiscal, says KiranMazumdar-Shaw, chair-person of Karnataka'svision group onbiotechnologyOut of the 380 biotechfirms in India, 198 arelocated In Kamataka,and 191 In sangaJorewhich accounts for 27%or $81. million(Rs.3.888 core),contributing $750million (RS3.650 core)In exportsWith focus on biophar-ma, Bangalore India Bio2010 receives 2,300business requests onthe first of the three-day mega event. This is1,100 more thanBangalore 8io 2009 SMILES TO GO: Biocon chairperson Kiran Mazumdar-Shaw and British deputy high commissioner Richard Hyde (second right) inau-

"FULL COVERAGE I PZ gurate the Bangalore India Bio 2010, India's premier biotech event, in the city on Wednesday. The event will be on till Friday

:Biotech sector likely topierce~$5-billionmark byfiscal-end1>,,,feBureau

lc·Bangalore, Jun 2: The do-.~,mesticbiotechriology sedor,3f viewed as one of the top five

biotech destinations global-~}ly;is likely to touch $5-billiono mark at the fiscal-end owing.;;to robust growth in ancillary["segments such as data and[f'equipment management ,t saidKiranMazumdar-Shaw,.~chairperson of the Vision

Group for Biotechnology(Karnataka).

Inaugurating the Banga-_'10re-IndiaBi02010, Mazum-

dar-Shaw said that theindustry had seen growth

at the rate of 20% in the fis-cal 2009-10to reach $3 bil-lion, while exponentialgrowth in ancillary indus-tries added to the figure totakeitpast$4 billion.

'~s against a decline to18% in 2008-09,the bio-techindustry has grown remark-ably well in 2009-10.Youtakeinto account clinical trial, da-ta management, equipmentmanagement and other an-cillary segments, the bio-techsectortouched$4 billionoverthepastyearandIwouldsay that puts us well on tracktoachievethetargetofreach-ing $5billion this year," said

Mazumdar-Shawwho is alsothe CMD of India's biggestbiotechfirmBiocon.

During2008-09,the gmbalfinancial crisis restrictedthe sector's growth to 18%asagainst a 34% year-on-yeargrowthin2007-0a.

Ancillary segments hadgrown at close to 40% dur-ing the fiscal, while biotechsegments like bio-pharmacontinued to beamajordri-ver, followed by servicesand agri-biotech, whichwas expected to grow as amajor contributor thisyear as well.

With a steady growth mo-

mentum gathering ill bio-tech sector,Mazumdar-Shawsaid thatthe industry was op-timistic _ot .douJ:!.liIJ..g_ itsstature in the coming years,aiming at reaching $10 bil-lionbytheyear2020.

While bio-manufactur-ing, clinical developmentand service based offeringswere seen as some of the keysegments to drive growth,climate change and cleanenergy were also. beingviewed as huge opportuni-ties for the Indian bio-techsector, which presentedgreat cost and man poweradvantages.

Biotech sector set togrow 20% to $5 bnBy K. RAGHU

raghu. k@livemint.com

BANGALORE

India's biotechnology in-dustry is expected to grow

20% this fiscal to $5 billion(Rs23,600 crore) as the coun-try becomes a low-cost re-search hub for global agricul-tural and pharmaceuticalfirms.

The nation's 380 biotech-nology firms reported reve-nue of $4 billion for fiscal2010, said Kiran Mazumdar-Shaw, chairperson of the vi-sion group on biotechnologyfor Karnataka. Of this,around $1 billion was con-tributed by the equipmentand an cillary segment of theindustry.

Bangalore is home to halfthe biotechnology companiesin the country.

"Having come a long way,now is the time to shift fromwestern-centric models. In-dia and China can playa leadrole in the world in the areasof food security and health-care," said Mazumdar-Shaw'at the inaugural of the 10thedition of Bangalore IndiaBio, the annual biotechnolo-gy event of the state.

"New challenges, such asglobal warming, energy,health and food security offerhuge opportunities for the bi-otech industry," she said.

Of the 32 new foreign firmsthat have invested in India inthe past year, 11 are locatedin Bangalore, with an invest-ment of Rs1,500 crore.

They include a Rs500 croreresearch unit for clean ener-gy and biofuels from Hindu-stan Petroleum Corp. Ltd anda Rs250 crore contract manu-facturing unit to make en-zymes, proteins and DNA

vaccines by Kemwell Pvt. Ltdin collaboration with Boe-hringer Ingelheim Pharma-ceuticals Inc.

"Our plant will be opera-tional by next year," said An-urag Bagaria, vice-presidentat Kemwell.

Biocon Ltd, of which Maz-umdar-Shaw is the chairper-son and managing director, isinvesting Rs200 crore in anew facility to make drugs.

Clinical data management,drug discovery and low-costproduct manufacturing arethe advantages Indian firmsenjoy in the global market.

"India has shown its com-petitiveness in the past twodecades and now it is time towork towards R&D (researchand development) leader-ship. We can achieve this byremoving hierarchical bu-reaucratic and academicstructures. From next year,India will produce about amillion engineers and if we Ideploy them in the R&D pro-jects even for few months, wecan do wonders," said SamirBrahrnachari, director gener-al of Council of Scientific andIndustrial Research (CSIR).

Of CSIR's 37 laboratories,India's largest public-funded Iresearch agency, about 10 arededicated to biotechnologyresearch.

CSIR has developed an en-hanced aswagandha, theequivalent of Chinese gin-seng, for farmers in six states,Brahmachari said, addingthat biotechnology can playakey role in promoting inclu-sive growth.

Karnataka plans to set upsector-specific biotechnologyparks in Mysore, Dhar-wad, Mangalore and Bidar,chief minister B.S. Yeddy-urappa said.

BANGALORE INDIA B10-2010 OFF TO A COLOURFUL START AS THE VERTICAL RECOUPS FROMTHE 18% TUMBLE IN FY2008-09 TO POST 52% Y-O-Y IN THE PREVIOUS FISCAL

Biotech swings pastslump,eyes S5-bn mark

The celebratory mood was quite palpable atthe 10th edition of Bangalore India Bio-201O,India's premier Biotech event, inauguratedon Wednesday;on achieving the growth ratedreamt ten years ago.

It seems global economic recession couldnot have any effect on biotechnology sector,as it recorded an estimated revenue growthof $4billon (Rs18,500crore)in 2009-10,an-nounced Kiran Mazumdar-Shaw, chairper-son of Karnataka's Vision Group on Biotech-nology at the inaugural session.

The revenue growth is a whopping 52%over the previous fiscal year.

'~s against a decline of 18%in 2008-09,thebiotech industry has grown remarkably wellin 2009-10and we are on track to achieve $5billion this fiscal (2010-11),"said Shaw,also

. the chairman and managing director of In-dia's leading biotech firm Biocon.

While bio-pharma and agri-biotech, ac-counted for $3billion (Rs14,4oocrore), theequipment and ancillary segments con-tributed about $1billion.

"Ten years back, we had dreamt of achiev-ing a $5billion industry size, which1we'1lachieve by 2010-11,"Shaw said.

"India has emerged as an attractive mar·ket for the global pharma sector, as evidentfrom increasing investment flow into thecountry. Weoffer huge cost advantages withhigh value of services. Several countrieswant to build long lasting partnership withus," she added.

Around 700delegates from 20countries,

who are part of the three-day event, are hope-ful of creating several business deals withthe host country. The visiting delegates aremostly looking at fostering partnership withvarious Indian companies in biotech sector.

The event has been organised by the De- .partment of Information Technology;Biotechnology and Science & Technology;Government of Karnataka, Vision Group onBiotechnology and MMActiv Sci-TechCom-munications Co.

The focal theme of this year's biotechevent is Biotech For a Better Tomorrow.

Inaugurating the three-day event, chiefminister BS Yeddyurappa said the statewas helping in the growth of the industry.

"The state government is continuouslyworking towards the industry's needs. TheMillennium Biotechnology Policy of 2001has given many incentives and conces-sions. As a result, the state has accountedfor $810million (26%) of India's biotechmarket of $3billion," said Yeddyurappa.

In order to produce employable and

skilled manpower to the industry; thestate government is encouraging biotechfinishing schools, of which ten will comeup this year. Government has also pro-posed to set up bio-venture fund of $10 'million. Sector specific Biotech Parkswould be set up in Mysore, Mangalore,Dharwad and Bidar.

Over the years, Bangalore has trulyemerged as the hub of biotech sector in thecountry. Out of the 380biotech firms in In-dia, 198are located in Karnataka, and 191in Bangalore, which accounted for 27% or$810million (Rs3,888crore), with exportsto the tune of $750million (Rs3,650crore).

Richard Hyde, British Deputy Commis-sioner, said the UK was a very importantpartner for India, as it accounted for 20%of the biotech medicines of the world.

'~cting in accordance with the edition'stheme of Biotech For A Better Tomorrow,the UK has signed for a $ 160million vac-cine development scheme with India,"said Hyde.

Clinical trials beckon India with a $26 billion purse

MATTER OF CONCERN: Experts expressed their coocern over the lack ofresearch culture in Indian medical colleges and hospitals. They called foran interface between the academia and industry

THE NUMBER OF CLINICALINVESTIGATORS IN INDIAIS TOO SMALL WHENCOMPARED TO OTHERS

Experts and investors at the BangaloreIndia Bio-2010 on Wednesday made astrong plea for a strong interface be-tween the academia and industry to en-able the country to grab huge opportuni-ties in Biotechnology research, especial-ly in clinical trials.

Dr Moni Abraham Kuriakose fromNarayana Hrudayalaya, participating ina panel discussion on the issue, said,"India has highly trained work force,world-class health facilities, 221medicalcolleges and a huge cost advantage inclinical trials. But still, the potential.has

not been fully utilised."India has 50% to 75% cost advantage

in clinical trials and "we have a great op-portunity to bag a huge share of the $26billion clinical trials market in theworld. India has just about 500 to 1,000clinical investigators and it is too small,when compared with countries like theUSA which has 50,000of them. India istraining about 1,000clinical investiga-tors each year and it should be rampedup to at least 10,000,"he said.

Dr Kuriakose wanted the governmentand private sector to initiate measuresto develop research culture in medicalcolleges and hospitals, and encourage .research as a career.

Dr Ravi Kumar Banda, managing di-rector of Xcyton Diagnostics Ltd, said"There are large gaps between the indus-try; academia and investor that need to bebridged. Institutes and research facilitiesshould develop technology platforms or

proof of concept for a product to show-case to the industry. Most collaborationsfail because of the way the academia ap-proach the industry. Some of the academ-ic institutions like the Indian Institute ofScience have good infrastructure. But noteven 20% of its potential is being used forresearch and development."

Prof Gayatri Saberwal, scientific offi-cer, Institute of Bioinformatics and Ap-plied Biotechnology (IBAB), said "75%of the students passed out from IBABhave been placed in premier organisa-tions such as Biocon, BrickWood, IBM,etc. IBAB is a novel private academic in-stitute of the Govt of Karnataka andICICI Bank. One of the challenges facedby the institute is the funding scheme ofthe Central government.". Dr SR Rao, adviser, Department of

Biotechnology under the Central gov-ernment, said, "There is very little insti-tutionalised relationship between indus-

try and universities and only about 1,500projects have been funded so far. Thebarriers in linkages and partnership arelack of mutual trust and appreciation,lack of financial gains, lack of infra-structure facilities,lack of frame workand different norms of evaluation."

Dr Sunny Sharma, senior managingdirector (Asia), OrbiMed Advisors, IndiaPvt., Ltd., said, "The role of venture cap-ital in life sciences is very much needed.Access of capital is important for re-search and development. What OrbiMedlooks for are novel products and technol-ogy, technological breakthrough, strongmanagement team, and growing market.Investors like OrbiMed can help in cer-tain areas such as providing a long-term, value-added, strategic source ofcapital helping management achievestrategic, fmancial and operational ob-jectives via participation at the boardlevel." k_hemanth@dnaindia.net

STRAIGHT TALK: If there is no inclusivegrowth, there is no meaning to the greatachievements on the technology front

'ItS notjust biz;but a chanre·tohelp the IIDfFor eminent Indian scientist Prof Samir KBrahmachari, Biotechnology is not onlyabout business, but an opportunity to help800 million poor people of the country.

"Biotechnology is not about business, butan opportunity to help poor population ofthe country by bringing them affordablehealthcare facilities, sustainable energy andfood security," said Brahmachari, director-general of Council of Scientific and Indus-trial Research (CSIR) on the first day of Ban-galore India Bio-20l0 on Wednesday.·

Strongly espousing the cause of under-privileged section of the society, Brah·machari said that there was an urgent needto solve the problem of hunger and health-related issues.

"If people are healthy, and we can solvethe problem of hunger the world over, big-ger issues like terrorism would be take careof on its own. Biotechnology has the poten-tial to solve these pertinent issues," addedBrahmachari, who is also the secretary, De-partment of Scientific and Industrial Re-search (DSIR).

Out of its 37 laboratories, CSIR has 10 lab-oratories dedicated to biotechnology. Theselaboratories work to focus on CSIR 800, aprogramme focusing on the issues of 800million people at the bottom of the pyramidin the country.

'1f there is no inclusive growth, there isno meaning to the great achievements on thetechnology front," said the veteran scientist.

"CSIR has given an enhanced Aswagand-ha to the farmers of six Indian states. Thebiotech sector has lots of such opportunitiesto participate in India's inclusive growth."

Brahmachari's who has extensivelyworked in DNA and its structure, felt thatIndia's young talent pool should be used ef-fectively in the scientific field.

"From next year, India will produce abouta million engineers and if we deploy themin the R&D projects even for a few months,we can do wonders. We need to empower theyouths. We can achieve this by removing hi-erarchical bureaucratic and academic struc-tures," said the scientist who has to his cred-it discovering two genes linked to bipolardisorder and schizophrenia.

When will biotechnology in India be properlyTHE MINISTRIES OF HEALTH, S&T ANDAGRICULTURE HAVE BEEN UNABLE TOREACH AN AGREEMENT ON NORMS

NEED OF THE HOUR: India produces 8% of the world'smedicines. Experts feel there is need for uniform regula-tions in Europe and India

Who regulates research in biotechnology inIndia? Who takes care of discrepancies indrug pricing, genetic engineering in plants,or the safety of clinical trials? The answer,at present, is: Nobody.Different ministriesat the Centre have still not arrived at a con-sensus on the nature of regulations neededin the area, and the functions that will fallwithin the jurisdiction of the proposed Na-tional Biotech Regulatory Authority(NBRA).A draft bill on the regulatory bodylies in cold storage.

The delay :iffectsbio-safety and a slew ofother issues, many too complicated for a layperson to even understand. At the Banga-lore India Bio-2010,discussions occurredaround, significantly, the need for a fool-proof regulation of the emerging industryof 'biosimilars'.

The biosimilar is a term used to describeofficially-approved new versions of innova-tor biopharmaceutical products after thepatent of a similar older product has ex-pired. Simply put, these are pharma prod-ucts developed using the latest technology,including gene therapy. They speed up and

mimic a drug discovery method, to fasterachieve a better, but similar, drug. "Therehave been differences between variousunion ministries and agencies concernedwith health, science and technology, foodand agriculture," an'expert privy to the gov-ernment's efforts to set up the authority,who also participated in the session, toldDNA on condition of anonymity. .

KK Tripathi, adviser and member-secre-tary of the review committee on genetic ma-nipulation, union department of biotechnol-ogy,under the ministry of science and tech-nology,admitted to DNA that fast-progress-ing technology had remained outside regu-latory cover.The sheer pace of develop-ments made legislation quickly obsolete,leaving it in a constant state of contentionbetween different players.

The pace of technological advancementin the field also comes as a stumbling blockin the formulation of guidelines for the reg-ulatory authority. The absence of a regulato-ry authority, however, could pose problemsthat cannot even be properly anticipated, aslegal loopholes could be abused and new andinsufficiently researched pharma productscould be introduced in the market.

led?a .IT'S A LONG PROCESS, ONE STILL TO BEGIN

~ -- - --so when can we expect to have anational-level biotech regulatory

authority? KKTripathi, adviser andmember-secretary of the review com-mittee on genetic manipulation, underthe ministry of science and technology,did not know quite how long the set-ting up of the NBRAwould take. "First,there needs to be a consensus. Then,we have to formulate the guidelines.After that, the bill will have to be putthrough discussion in Parliament.Public opinion on it should be soughttoo. All that takes a long time," he said.At the meet on Wednesday, Martin Cox,a business development manager andfaculty member in medical science atthe Newcastle University, UK,in hispresentation at the session on'Regulatory issues for biopharmaindustry' highlighted the problemsfaced by regulatory bodies in his coun-t~y, on account of the rapid advances in

technology. Tripathi said that Indiashould learn from such experienceselsewhere in the world.

Publication DNA

Edition Bangalore

Date June 03, 2010 p.04

ONE OF THE PRIMARY GOALS FOR FUTURE IS TAilORING DRUG TREATMENT TO A PERSON'SGENETIC PROFILE, SUCH PERSONALIS ED MEDICINE HOLDS HOPES FOR CANCER PATIENTS

Quick diagnostics keyto control pandemic

SOumita Majumdar and Maitreyee Boruah............................................................................................................. -BANGALORE

The year 2009will be remembered for thedeadly disease swine flu Influenza A (H1N1)which took the entire world by storm. In-dia, including its tech hub Bangalore, toowas not immune to the deadly virus, result-ing in thousands of deaths.

Taking a closer look to deal with pandem-ic like H1N1virus, experts across the coun-try brainstormed at the ongoing three-day10th edition of Bangalore India Bio-2010,In-dia's premier Biotech event, on Thursday.

A more advanced diagnostic kit for H1N1is on its way to the market. Defence Re-search and Development Organisation(DRDO)has developed the simplest kit forswine flu screening and the kit is nowawaiting approval from Indian Council ofMedical Research (lCMR).

"This kit will enable naked eye visualisa-tion and identification of H1N1virus. Tri-als have been done on this kit with samplessourced from centres including NIMHANS,Bangalore, SMSMedical College, Jaipur,and Post Graduate Institute of Medical Ed-ucation and Research (pGI), Chandigarh. Ithas been inferred that diagnosis throughthis kit can be highly specific, simple, rapidand effective," said Dr PVL Rao, joint direc-tor and head, division of virology and bio-process scale-up facility, Gwalior.

"ICMR has already appreciated this kitand soon after getting clearance from ICMRand the government, this kit will be intro-duced to the hospitals," he said.

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The session titled 'Future of Diagnostics'looked deep into issues like how pandemicdiseases could be managed by using quick,affordable and easy-to-use diagnosticsolutions.

"The current system of diagnosis istime-consuming. The problem is that thetime taken to move from presumptive/pro-visional stage to final diagnosis is quitelong," said Chandrasekhar B Nair, founderdirector of Bigtec Private Limited, Banga-lore.

"This is especially true for infectious dis-eases where there is a special need to diag-nose quickly. For instance in H1N1sce-nario, point of care (POC) diagnosis is re-quired. The challenge lies in making labo-ratories go to the patient. An affordableand easy-to-use solution is the need of thehour," he said.

Talking about the solutions to deal withpandemic diseases, Nair said special solu-tions like lab-on-chip were the best way totackle H1N1virus.

"Such products need to be mass pro-

duced to make them affordable. Theyshould be portable and faster but should bereliable," he said.

The session was chaired by Dr ShamaBhat, founder, chairman & MD,Bhat Bio-Tech India (P) Ltd, Bangalore.

Elaborating on the importance of phar-macogenomics, Shama Prasada K, of divi-sion of biotechnology, Manipal Life Sci-ences Centre, Manipal University, said itdeals with identifying drug response on thegenetic make-up of individuals to achieve apersonalised treatment.

"One of the primary goals for future is tohave personalised medicines. With phar-macogenomics, we are working on develop-ing personalised medicines for ovarian,cervical, breast and oral cancer," he said.

Prof AQ Contractor of lIT Bombay spokeon the platform for low-cost electronic diag-nostic systems. The issues discussed atlength had direct and immediate implica-tions to common people, who are mostly de-prived of medical aid in time during thespread of pandemic diseases.

Publication DNA

Edition Bangalore

Date June 03, 2010 p.04

NEW THEME: The focal theme of thisyear's event is 'Biotech for a bettertomorrow'

Biosimilars holdbig oPJX)rtunity,bigger hurdles

Discoverer, 9th FI<Te

While biosimilars hold big opportunity amidhurdles, its competitive advantages willhinge on quality, cost, timelines, and regu-lated market access, an expert said.

'Biosimilars' isa term used to describe of-ficially approved new versions of innovatorbiopharmaceutical products, followingpatent expiry,

Participating in a discussion on 'Success-fully Negotiating the Biosimilars Landscape'at Bio India-2010,Dr KVSubramaniam, pres-ident and CEO,Reliance Life Sciences, said:"The global biosimilars opportunity is sig-nificant, valued at $ 70billion covering 25products. An integrated biosimilars initia-tive requires several competencies workingseamlessly across the value chain. Hence,competencies are required. Competitive ad-vantages in biosimilars will hinge on quali-ty, cost, timelines, and regulated market ac-cess."

"The technology hurdles, significant costsand regularity pathway in development mar-kets are major challenges we face. The righttalent and partnership playa key role in ad-dressing challenges in biosimilars," he said.

"Reliance life science is building a re-search-led, diverse and integrated biotech-nology business. They have five biosimilarsin the semi-regulated market and 17biosim-ilars under development. The biosimilarslandscape is attractive but marked by sever-al formidable challenges." he added.

Dr KK Tripathi, member secretary of theReviewCommittee on Genetic Manipulation,said: "Biopharmaceutical term can be usedwidely and is hardly dermed by users over 4million entries on Google, involves use ofbiotechnology and pharmaceutical comparedto drugs. Biopharma is complex on how wethink of,derme,name and regulate these prod-ucts. Biopharma industry is more than 25years old and has 350products in the market."

Dr Eric Grund, senior director, Biophar-ma Applications, GELife Sciences, said: ''Asthe regulatory pathway for biosimilars in Eu-rope and USbecomes clearer, manufacturingof these products still remain challenging.There is a pressure in increasing the effi-ciency and there are market uncertainties,"he said.

Idiid Road, Bangalore - 560 06630-2841 8780

Publication Business Standard

Edition Bangalore

Date June 04, 2010, p.07

Biosimilars to he next growth area for BT finnsDE BASIS MOHAPATRABangalore. 3 June

Not withstanding the reg-ulatory hurdles forbiosimilar drugs, these

generic products in the biotech-nology space are the nextgrowth areas for biopharmacompanies in India. Biosimi-lars are copy cat products ofpatented biotechnology drugswith different process of de-velopment.

"Though peptides are driv-ing the growth of our com-panyas of now, biosimilars aredefinitely the next growth areafor our company in near fu-ture," KV Subramanium, pres-ident and CEO, Reliance LifeSciences, said. Reliance Life

The revenue loss to the pharma industry will be around $78billion due to a 'patent cliff' during 2009-14 period which willthrow up new opportunities for biotechnology companies inthe biosimilar space

Sciences, a subsidiary ofMukesh Ambani-led RelianceGroup, has already launchedfour biosirnilar drugs in the se-mi-regulated market.

"We will soon launch ourfifth biosimilar with another17 products being under de-velopment," he added. Biosim-ilars, otherwise the gereric ver-sion of patented biotechnolo-gy drugs, will have a marketsize of $70 billion by 2013. Thisspace is set to expand with anumber of biopharma prod-ucts going off-patent by 2014."

"The revenue loss to thepharma industty will be around$78 billion due to a 'patent cliff'during 2009-14 period whichwill throw up new opportu-nities for biotechnology com-

panies in the biosimilar space,"Neelima Khairatkar-Joshi, sen-ior vice-president of GlenmarkResearch Centre, said.

Glenmark, which has asound pipeline of new mole-cules, is also bullish on thebiosirnilar vertical, she added.Other companies like Bioconand Auregene are expandingtheir present portfolio in thissegment.

In a bid to enhance its bio-similar portfolio, Biocon, re-cently, bought back the 51 percent stake from its Cuban part-ner, CIMAB to boost biosimilarmanufacturing facility.The Ban-galore-based biopharma com-pany has insulin and mono-clonal antibodies' developmentprogramme in this segment.

Similarly, Aurigene Dis-covery Technologies Ltd, anindependent subsidiary of DrReddy's Laboratories, is alsobetting big on this segment.

"Biosimilars pose both chal-lenges and opportunities for In-dian companies. In terms ofchallenges, there is a lack ofregulatory clarity, market ac-cess issues and such others.However, keeping in view thecost arbitrage, talent pool in In-dia, the opportunities are morethan challenges," C S N Murthy,CEO of Aurigene, said.

Presently, the market sizeof biosimilars in India standsat Rs 750 crore and is aroundRs 4,500 crore in the emergingeconomies and semi-regulat-ed markets

Avesthagen Limited.Discoverer, 9th Floor, Unit 3, International Tech Park, White Field Road, Bangalore - 560066

Tel: +91-80-2841 1665 /2770 / 2308, Fax: +91-80-2841 8780

Publication The Times of India

Edition Bangalore

Date June 04, 2010, p.21

Lab-on-a-chip concept catching onBangalore: India in the last decade sawrapid developments in the field of digi-tal diagnostics, as low-cost medical im-agingequipments includingportable ECGmachines hit the market.The next 10years could see the country

making rapid strides in mo-lecular diagnostics, makingpathology lab tests more af-fordable and portable. Theresult could be that a preg-nancy test, which now costsanywhere between Rs 60-80in a lab could come down toRs4,or a malaria test couldbe made available at one-tenth of the current cost.

Significant research and developmentis happening in the field of molecular di-agnosticsand India is on the vergeof new-age diagnostics based on genetic and pro-tein markers. Several small and mediumdiagnostic companies, which have devel-oped indigenous test kits, are now in-vesting into marketing their products.

Bangalore-based Bhat Biotech, for in-stance, is planning to invest Rs 3 crore

this year to develop ~ BAN GAL 0 R E is fast catching up,and market its DNA- as another city-based and protein- • A : I based diagnosticbased test kits. Last company Bigtec isyear, it developedthe ....• wor:kingonmarket-country's first IndIa s B,ggest Biotech Show. ing its hand-held di-Chikungunya kit, which is a rapid test agnostic device that can diagnose afor the detection of antibodies to Chikun- pathogen in 10-12minutes. The devicewas

gunya virus. The company has developed a year agowith a grant of Rs 6recently developed a swine-flu crore from the New Millennium Indiankit. Technology Leadership Initiative

Molecular diagnostic kits (NMITLI)of the Council of Scientific andtyp.ically analyse key DNAor Industrial Research (CSffi).The productprotein as against the old tech- will hit the market in a year, said Chan-nique of mixing up some drasekhar Nair,Bigtec'sfounder director.reagents. "The results are "Weare in talks with a few funding com-amazing as the device, that in- panies and also have our own go-ta-mar-tegrates one or severallabora- ket strategy," he said. Bigtec's kit is use-

tory functions on a single chip, cari de- ful in testing a wide range of diseases in-tect up to 100cases," said Dr Shama Bhat, cluding malaria, dengue, hepatitis AandCMDof Bhat Biotech. The company has hepatitis C.entered into partnership with lIT, Born- New-agediagnostics track disease pro-bay and has set up a firm, Polymeric Sen- gression and drug response, and are de-sors. The new firm is working on biosen- signed to customize therapy in a differ-sor based diagnostic kits in several dis- entiated manner, as they are DNA andease areas, he said. protein-based. However,funding remains

The lab-on-a-chipconcept, integrating a major challenge for the companies tobiology,chemistry, electronics, optics,mi- translate lab results into a commercialcro fluids and software in a single chip, product, Bhat said.

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Publication DNA

Edition Bangalore

Date June 04, 2010, p.04

Shift in partnering trends brings R&D tie-ups to the foreENGAGE INDIAN

PARTNERSHIPSE VALUE CHAIN

BIG DRAW: About 700 delegates from 20 countries areparticipating in the event which will conclude on Friday

Partnerships in global biotechnologyindustry are moving away from out-sourcing research and developmentpartnering models as the latest trendin this sector.

This is what has emerged on thesecond day of the three-day Banga-lore India Bio 2010,which began onWednesday.

Experts speaking at a session onbiopartnering at the event said thischange in the trend was mainly dueto the ability of the partners to ad-dress serious issues like data securi-ty and perfection of intellectual prop-erties.

Earlier, outsourcing to India wasconfined only to functional areas.But now, companies in the West areplanning to engage Indian companieswith partnerships higher up the val-ue chain, they said.

"Jubiliant-Astra Zeneca collabora-tion project (JAZ) is a strategic re-search collaboration and a classic ex-

ample for externalisation of R&D.Pharma industry is moving awayfrom highly internalised R&Dto anetwork model. The serviceprovider's role of emerging marketslike India is changing to effective in-novation management partnershipsbased on relationships rather thantransactions," said Sri Mosur, CEOand president, global discovery anddevelopment, Jubiliant Biosys, whileciting the example of a successfulpartnership between Astra Zenecaand Jubiliant Biosys.

Jit Patel, director, strategic plan-ning, business and development, As-tra Zeneca R&D,US, said: "Biopart-nering helped our company to growfrom only two products with $ 2.5bil-lion R&Dspending in 1999to 10proQ-ucts with $4.4billion R&Dspendingin 2009.R&Dpartnerships facilitatespeed, control on cost and qualityand finally establish new deliverystandards."

Chairing the session, Robert LeeKilpatrick, partner, Technology Vi-

sion Group, US, said, "Local presenceand global reach-out are the two buzzwords in working out biopartner-ships between companies belongingto two different geographies and cul-tures. Conference networking, part-ner networking and experts network-ing are the important routes that willeventually facilitate global partner-ships in R&D."

Experts also highlighted the im-portance of international partner-ships for key drug discovery andR&D.

Neelima Khairatkar Joshi, seniorvice-president, biological research,Glenmark Research Centre, said:"Partnership is needed in all stagesof drug discovery and there is a lot ofpartnership available. Several part-nership models are being used suc-cessfully in India. In the globalbiotech industry; Indian pharmacompanies are on the way to berecognised. The strategy should beflexible and there are no short cuts inthis process of drug discovery."

D·r Scott J Grossman, vice-president, scientificdirector, BBRC,Bristol-Myers Squibb Company,

says: "Innovation in pharmaceutical research is aliveand well, which is one of the major factors to succeed.In the earlier days, companies were built with self-suf-

ficiency and partnershipswere built internally toovercome all adversity.The new-age concept is tobuild not only partners~ips

nally. It also needsatility and flexibility to

succeed in today's biotechindustry."Today's partnership isabout transactional, co-operative, shared and co-

creatEld products. BBRCpartnered with Biocon and hasabout 660 scientists. This partnership makes a tangibledifference in the industry: In a recent research con-ducted, it was found that the API delivery time in 2010just took one month. This is possible due to the com-bined efforts through partnerships."

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