Asia is a grow­ing mar­ket for drug dis­cov­ery

BioSpectrum (Asia) - - Bio Contents - Siva Ra­mamoor­thy

eph­i­cacy life­science An­a­lyt­ics Pvt. ltd., a clin­i­cal re­search or­gan­i­sa­tion fo­cus­ing on bio­statis­tics and sta­tis­ti­cal pro­gram­ming ser­vices in the clin­i­cal do­main, re­cently won an award at the ‘big Data, An­a­lyt­ics & In­sights Sum­mit’ in the ‘ex­cel­lence in In­dus­try Ap­pli­ca­tion Award (Pharma & health­care)’ cat­e­gory. Dur­ing his in­ter­ac­tion with bio Spec­trum, head of op­er­a­tions – In­dia, Siva ra­mamoor­thy, elab­o­rates on eph­i­cacy’s busi­ness plans and other de­tails:

Apart from the US, how big is In­dia and APAC mar­ket for Eph­i­cacy?

Eph­i­cacy has built its pres­ence over the last seven years and has catered to the needs of sev­eral multi­na­tional and In­dian cus­tomers. We have con­sis­tently in­creased our promi­nence in in­dus­try-wide con­fer­ences by presenting pa­pers, posters etc. both in In­dia and in the US.

Asia as a mar­ket for drug dis­cov­ery is grow­ing sig­nif­i­cantly in ge­ogra­phies such as China, Ja­pan, Korea. We are ex­cited about these mar­kets and are en­gag­ing with prospec­tive cus­tomers. In­dian clin­i­cal in­dus­try is poised for a

big­ger growth hav­ing be­ing the sec­ond most pre­ferred coun­try af­ter China for clin­i­cal trial con­duct and ser­vices. The fi­nan­cial growth of clin­i­cal tri­als in In­dia has in­creased from Rs50 to Rs5,000 crores dur­ing the last decade. And Eph­i­cacy is ex­cited about this growth and would look at this as an op­por­tu­nity for cre­at­ing more jobs and tak­ing up chal­leng­ing projects.

Recog­ni­tion too has come to us as part of Eph­i­cacy’s jour­ney. Our pa­pers and posters at con­fer­ences have won us ac­co­lades both in In­dia and in the US. We have also been recog­nised re­cently by be­ing awarded the ‘Big Data & An­a­lyt­ics Award’ for ex­cel­lence in in­dus­try ap­pli­ca­tion – Pharma and Health­care.

What are the key trends and fac­tors driv­ing your busi­ness in In­dia and the US?

Phar­ma­ceu­ti­cal or­gan­i­sa­tions de­pend on block­buster drugs. And they team up with sev­eral ser­vice com­pa­nies to achieve this goal. Be­ing in the pharma do­main, Eph­i­cacy be­lieves in the motto ‘bring­ing smiles’smiles on a pained lot. By join­ing hands with phar­ma­ceu­ti­cal or­gan­i­sa­tions, biotech­nol­ogy re­search firms, clin­i­cal re­search or­gan­i­sa­tions we strive to achieve this motto.

The found­ing team, com­pris­ing Ganesh Gopal – en­tre­pre­neur and an ex­pert in statis­tics do­main along with Pratap Ma­lik – thought leader, strate­gist and en­tre­pre­neur, sowed the seeds of this or­gan­i­sa­tion. I am head­ing the In­dia op­er­a­tions. I have worked with var­i­ous firms and pro­vided ex­per­tise in groom­ing start-ups. This team, cou­pled with tech­ni­cal and op­er­a­tion ex­perts in the clin­i­cal do­main, is lay­ing the bricks of growth at Eph­i­cacy based on a strong foun­da­tion of val­ues.

Over the years, phar­ma­ceu­ti­cal de­vel­op­ment and ser­vice pro­vi­sion have been grow­ing sig­nif­i­cantly in In­dia thanks to eco­nomic lib­er­al­i­sa­tion. Though the fruits of eco­nomic lib­er­al­i­sa­tion reached our sec­tor over a pe­riod of time, it has been rel­a­tively suc­cess­ful in cre­at­ing job op­por­tu­ni­ties and has given birth to sev­eral busi­ness ver­ti­cals. Ta­lent pool in the re­gion has sig­nif­i­cantly in­creased, giv­ing op­por­tu­nity for sev­eral multi­na­tional play­ers to set up of­fices here. Cost-ef­fec­tive work­ing mod­els have cre­ated a win-win sit­u­a­tion for all play­ers in the do­main.

At Eph­i­cacy, highly qual­i­fied pro­fes­sion­als, pro­fes­sion­als with in­ter­na­tional pedigree and work ex­po­sure are form­ing part of the in­tel­lec­tual bank of the in­dus­try and are guid­ing our growth to the next level.

We have the ISO 9001 cer­ti­fi­ca­tion for qual­ity man­age­ment and ISO 27001 cer­ti­fi­ca­tion for in­for­ma­tion se­cu­rity man­age­ment. With im­mense fo­cus on com­pli­ance to reg­u­la­tory and statu­tory needs of the in­dus­try, we have added sev­eral suc­cess sto­ries to our cap and are con­tin­u­ing to grow with steady fo­cus on timely and qual­ity ser­vice to our cus­tomers.

Apart from ser­vices in the ar­eas of bio­statis­tics and pro­gram­ming, we have part­nered with a US-based tech­nol­ogy start-up firm work­ing on launch­ing prod­ucts, which could add value to cur­rent work­ing mod­els of bio­statis­tics and sta­tis­ti­cal pro­gram­ming. We are an ex­tended arm of their prod­uct de­vel­op­ment, qual­ity test­ing and in­ter­face de­sign teams.

Eph­i­cacy is strength­en­ing its base in In­dia and has of­fices in Chen­nai and Ben­galuru. What is your over­all strat­egy in the Asia-Pa­cific (APAC) re­gion in gen­eral and In­dia in par­tic­u­lar?

We be­lieve in or­ganic growth; by this, we mean a ro­bust, qual­ity-ori­ented growth in the niche area of bio­statis­tics and sta­tis­ti­cal pro­gram­ming, en­sur­ing long-term part­ner­ship with our cus­tomers. We have been cater­ing to the needs of or­gan­i­sa­tions based out of the US and EU re­gions. Though FDA ap­proved drugs have found ac­cept­abil­ity in sev­eral coun­tries, the reg­u­la­tory frame­work varies coun­try-wise. Eph­i­cacy hand­picks in­di­vid­u­als who have global reg­u­la­tory ex­po­sure, knowl­edge and skill.

We’ve seen growth in Hy­der­abad in the past year. We also have cus­tomer-fac­ing of­fices at New York and New Jer­sey. We see In­dia as a ma­jor play­ground in the APAC re­gion and the op­por­tu­ni­ties here are yet to be tapped. Over the last few months, we’ve seen sig­nif­i­cant trac­tion of cus­tomer re­quests in the Delhi-NCR and Mum­bai re­gions.

We have been ser­vic­ing stud­ies/projects con­ducted in the APAC re­gion in col­lab­o­ra­tion with other clin­i­cal re­search or­gan­i­sa­tions. We have been re­ceiv­ing ser­vice re­quests di­rectly from po­ten­tial cus­tomers based out of this re­gion and are in sev­eral phases of dis­cus­sion. Hope­fully, we should be di­rectly serv­ing APAC cus­tomers in the com­ing years.

Can you elab­o­rate on some ma­jor dif­fer­ences be­tween the clin­i­cal trial in­dus­try in the US and the APAC?

US, wield­ing high fi­nan­cial power and avail­abil­ity

of skilled and trained pro­fes­sion­als, has been in the driver’s seat, fol­lowed by coun­tries in EU.

The global clin­i­cal tri­als mar­ket has been es­ti­mated to reach USD14.2 bil­lion in 2016 and is pro­jected to reach around USD22 bil­lion by the year 2021, grow­ing at a com­pound an­nual growth rate of 7.5 per cent dur­ing the fore­cast pe­riod 2016 to 2021.

Cost for clin­i­cal labour is con­sid­er­ably low. For ex­am­ple, if the over­all clin­i­cal cost is 1 unit, then in In­dia it would be as low as 0.11 units. In­dia stands fourth in clin­i­cal cost-max­imi­sa­tion af­ter Rus­sia, Ar­gentina and China. Cur­rently, top multi­na­tional pharma/biotech com­pa­nies like Pfizer, Glaxo Smith Kline, No­var­tis, As­tra Zeneca, Eli Lilly and oth­ers are con­duct­ing clin­i­cal tri­als in In­dia. Amongst In­dian pharma/biotech com­pa­nies, Dr. Reddy’s, Pi­ra­mal Health­care and Ci­pla are also con­duct­ing ma­jor tri­als.

The num­ber of con­tract re­search or­gan­i­sa­tions (CROs) in the coun­try is also grow­ing; Quin­tiles, Parexel, ICON, Clin­i­gene In­ter­na­tional, INC re­search, to name a few. Global CROs are re­duc­ing their pres­ence in de­vel­oped economies and are ex­pand­ing in emerg­ing economies like In­dia to achieve greater over­all prof­itabil­ity.

In the fore­casted global mar­ket, the de­vel­oped coun­tries will likely ac­count for about 66.8 per cent by 2020, down from 76 per cent at present; whereas the emerg­ing coun­tries com­bined to­gether will likely ac­count for 25.2 per cent, up from 15.7 per cent at present.

Most com­pa­nies are out­sourc­ing the clin­i­cal tri­als of their newly de­vel­oped drugs to var­i­ous con­tract re­search or­gan­i­sa­tions as this could save them the has­sles of reg­u­la­tory is­sues and pa­tient re­cruit­ment bur­den from the re­search and de­vel­op­ment phase. Clin­i­cal tri­als al­low the drug to be tested for safety by dif­fer­ent eth­nic pop­u­la­tions. Due to the higher med­i­cal needs and in­creas­ing dis­ease preva­lence, de­vel­op­ing coun­tries are be­com­ing a hub for clin­i­cal trial ex­e­cu­tion.

US and Canada have the high­est mar­ket share in the clin­i­cal tri­als mar­ket, fol­lowed by Europe where Ger­many leads the mar­ket fol­lowed by Poland and Western Europe. Asia is one of the fastest grow­ing mar­kets. In­dia, China, Sin­ga­pore and South Korea are the ma­jor play­ers.

The In­dian gov­ern­ment’s ini­tia­tives and vi­sion for bring­ing in more in­vest­ment in this space has been yield­ing re­sults with many top CROs hav­ing made In­dia their ma­jor base.

What is your busi­ness plan for 2017?

Eph­i­cacy looks 2017 as a year of ‘five’ with fo­cus on five ma­jor ac­tiv­i­ties, viz, ge­o­graph­i­cal ex­pan­sion in new re­gions of In­dia to tap the best ta­lent ev­ery­where; grow cus­tomer base sig­nif­i­cantly, es­pe­cially emerg­ing biotech com­pa­nies; lever­age our strength in statis­tics and anal­y­sis and help cus­tomers in other busi­ness; groom high per­form­ing ta­lent and win a rep­u­ta­tion as a great place to work; grow tech­ni­cal in­fra­struc­ture, in­clud­ing a data cen­tre. Also, cus­tomers in the pharma space re­quire on-premise data cen­tres due to data se­cu­rity needs. We shall look into that as­pect.

How will the life sci­ence sec­tor per­form in 2017?

The life sci­ence sec­tor in 2017 will con­tinue adding value to the eco­nomic growth only next to IT sec­tor. Orig­i­na­tion of sev­eral in­no­va­tive tech­nolo­gies con­verg­ing with health­care and ap­pli­ca­tion of these in the sec­tor will con­tinue hav­ing an im­pact on the field. Along with these, come the chal­lenges of op­er­at­ing per­for­mance in a reg­u­lated and risky en­vi­ron­ment, sup­ply chain man­age­ment, chang­ing po­lit­i­cal land­scapes such as Brexit, cost and pric­ing pres­sures, changes in reg­u­la­tions, adop­tion of tech­no­log­i­cal ad­vances and most im­por­tantly, the qual­ity of the prod­uct.

Achiev­ing op­er­a­tional ex­cel­lence across the or­gan­i­sa­tions post-merg­ers/ac­qui­si­tions, within their or­gan­i­sa­tions and with sev­eral ser­vice providers would be an in­ter­est­ing as­pect since it’s im­por­tant to re­alise the com­plete value of syn­er­gies.

Em­ploy­ment op­por­tu­ni­ties will see an up­ward growth. Life sci­ence com­pa­nies will have to work to­wards find­ing a fine bal­ance be­tween or­gan­i­sa­tional ef­fi­ciency and in­no­va­tion.

An­a­lyt­ics will play a ma­jor role in the com­ing year, with ex­per­i­men­ta­tion on pa­tient-cen­tric mod­els; analysing pop­u­la­tion be­hav­iour us­ing so­cial me­dia; analysing the data from elec­tronic sys­tems. Dif­fer­ent busi­ness mod­els to ac­com­mo­date risk-based mon­i­tor­ing will come into vogue to meet the re­quire­ments of the ever-chang­ing tech­no­log­i­cal and re­search land­scape.

How im­por­tant are an­a­lyt­ics and sta­tis­ti­cal meth­ods for the phar­ma­ceu­ti­cal sec­tor?

Phar­ma­ceu­ti­cal com­pa­nies are sub­ject to a variety

of laws and reg­u­la­tions re­gard­ing patent­ing, test­ing and mar­ket­ing of drugs. It takes an av­er­age of 12 years (eight years re­main from the 20 years’ patent granted) and over USD350 mil­lion to get a new drug from the lab­o­ra­tory onto the phar­macy shelf. Once a com­pany de­vel­ops a drug, it un­der­goes around three and a half years of lab­o­ra­tory test­ing, be­fore an ap­pli­ca­tion is made to a reg­u­la­tory body such as FDA to be­gin test­ing the drug in hu­mans. Only one in 1,000 of the com­pounds that en­ter lab­o­ra­tory test­ing will ever make it to hu­man test­ing.

Cur­rent chal­lenges in the pharma in­dus­try in­clude short­en­ing time to ap­proval; iden­ti­fy­ing mean­ing­ful end points and cri­te­ria for treat­ment ef­fec­tive­ness; han­dling er­ro­neous data; deal­ing with global reg­u­la­tory en­vi­ron­ments. All of these have im­pli­ca­tions as to how statis­tics has evolved and con­tin­ues to evolve in the drug in­dus­try.

Statis­ti­cians play sig­nif­i­cant role in de­sign­ing and analysing the ex­per­i­ments (here, ex­per­i­ments mean clin­i­cal tri­als), thus en­sur­ing the clin­i­cal study ob­jec­tives are met, thereby re­duc­ing the like­li­hood of any re­peat ex­per­i­men­ta­tion and hence re­duc­ing cost, time and any im­plied eth­i­cal con­sid­er­a­tions.

Please ex­plain the im­por­tance of statis­tics while com­pil­ing clin­i­cal tri­als data.

Sta­tis­ti­cal meth­ods pro­vide for­mal ac­count­ing for sources of vari­abil­ity in pa­tient re­sponses to treat­ment. The use of statis­tics allows the clin­i­cal re­searcher to form rea­son­able and ac­cu­rate in­fer­ences from col­lected in­for­ma­tion and to make sound de­ci­sions in the pres­ence of un­cer­tainty. Mastery of sta­tis­ti­cal con­cepts can pre­vent nu­mer­ous er­rors and bi­ases in med­i­cal re­search, de­fine and quan­tify the ob­jec­tive, to use ap­pro­pri­ate study de­signs and proper meth­ods of anal­y­sis.

The jour­ney of any drug has two im­por­tant goals – to prove its safety and ef­fi­cacy. Hav­ing been through the jour­ney, the drug would have en­tered the last phases of the trial and with huge data in place, mak­ing sense out of this data is a daunt­ing task.

Data pre­sen­ta­tion (ta­bles, graphs) and ap­pro­pri­ate in­ter­pre­ta­tion of re­sults play a key role in analysing the clin­i­cal trial data, thus form­ing an in­te­gral part of a clin­i­cal study re­port. Statis­ti­cians and sta­tis­ti­cal pro­gram­mers’ role here in en­sur­ing the right in­ter­pre­ta­tion to be part of the fi­nal doc­u­ment is a cru­cial ac­tiv­ity which de­cides the fate of the drug.

Please elab­o­rate on the sta­tis­ti­cal sup­port

ser­vices that Eph­i­cacy of­fers.

Data an­a­lyt­ics play a key role in en­abling the drug dis­cov­ery to drug ap­proval by reg­u­la­tory bod­ies. Eph­i­cacy works with pharma com­pa­nies and en­ables their struc­tured data into knowl­edge. As such we work in three ar­eas:

• Statis­tics - Our statis­ti­cians en­able pharma com­pa­nies in de­sign­ing drug tri­als. Dur­ing tri­als, they also as­sist the pharma com­pa­nies de­cide what suc­cess would look like.

• Stats pro­gram­mers - pro­gramme to struc­ture the

data gen­er­ated dur­ing trial.

• Data stan­dard­i­s­a­tion - pharma in­dus­try ac­cepted stan­dards for clin­i­cal trial data which are recog­nised by global reg­u­la­tory au­thor­i­ties.

Eph­i­cacy pro­vides bio­statis­tics and sta­tis­ti­cal pro­gram­ming ser­vices to its clients in the en­tire clin­i­cal de­vel­op­ment cy­cle - pro­to­col de­vel­op­ment, study de­sign, sta­tis­ti­cal anal­y­sis, and reg­u­la­tory sub­mis­sion.

Our ser­vices in­clude:

• Sta­tis­ti­cal In­put to Pro­to­col/Study De­sign De­vel­op­ment

• Sam­ple Size Es­ti­ma­tion

• Ran­domi­sa­tion Sched­ule

• Re­view of CRF and Data Man­age­ment Plan

• Sta­tis­ti­cal Anal­y­sis Plan (SAP) and Mock-up Shells

• Anal­y­sis of Safety, Ef­fi­cacy Data for CSR and Reg­u­la­tory sub­mis­sions

• SAS Pro­gram­ming - SDTM/Adam Datasets and Ta­bles, List­ings, Fig­ures

• De­sign and De­ploy­ment of Sys­tem-level SAS Macros

• PK/PD Anal­y­sis

• In­te­grated Safety and Ef­fi­cacy Anal­y­sis (ISS/ISE)

• Anal­y­sis for BA/BE Stud­ies, Meta-Anal­y­sis

• CDISC stan­dards Im­ple­men­ta­tion Ser­vice

• Sup­port Safety Mon­i­tor­ing, In­terim and Ex­ploratory

Anal­y­sis, Manuscripts and Ab­stracts

• Pa­tient Pro­files/Safety Nar­ra­tive

• Sta­tis­ti­cal Re­port Writ­ing

In­dia’s clin­i­cal tri­als in­dus­try has been through a try­ing phase for the past few years. In your opin­ion, what could be the ma­jor rea­sons?

In­dia’s de­ci­sion to be­come TRIPS com­pli­ant in 2005 and the amend­ment to sched­ule Y of the ‘Drug and Cos­met­ics Rules’ had an im­pact on the clin­i­cal trial in­dus­try. This is com­mon across in­dus­tries; ini­tial hic­cups, try­ing phases fol­lowed by a sus­tained

growth curve is the pat­tern seen in busi­ness. This is true to our in­dus­try too, since our reg­u­la­tory and le­gal thoughts had to be re-looked into both at the in­tel­lec­tual and bu­reau­cratic lev­els. This led to a slow start. Marred by few reg­u­la­tory findings such as FDA au­dits on In­dian com­pa­nies, we have re­cov­ered ex­tremely well and have shown the world that com­pli­ance and con­fi­den­tial­ity with re­spect to data in­tegrity is of high-im­por­tance and we ad­here to it.

To­day, global phar­ma­ceu­ti­cal com­pa­nies, clin­i­cal re­search or­gan­i­sa­tions are look­ing at the sub-con­ti­nent as source of ta­lent and man-power. With the growth of com­pa­nies like Eph­i­cacy, the prospect of growth is high in coun­tries such as In­dia. In­dia boasts of re­source ad­van­tages in the fol­low­ing ar­eas:


• Spe­cial­ists in dif­fer­ent ther­a­peu­tic ar­eas

• English trained pro­fes­sion­als

• Treat­ment pro­to­cols in-line with the West.

• ICH/GCP com­pli­ance

Pa­tient pop­u­la­tion

• Large di­verse gene pool

• Dis­ease seg­ment

Clin­i­cal re­search in­fra­struc­ture

• Over 250+ med­i­cal col­leges

• Hos­pi­tals, di­ag­nos­tic labs

• Skilled com­puter-savvy work­force

IT Sup­port

• In­dia is known for its IT brains, IT sup­port is an­other fac­tor of im­por­tance.

In your opin­ion, which are the ma­jor coun­tries in the world that lead in con­duct­ing clin­i­cal tri­als and why?

Un­doubt­edly, the United States is the leader in this space, fol­lowed by Canada and EU coun­tries which have ex­cel­lent R&D spend­ing and rel­e­vant in­fra­struc­ture. It ought to be clear then that when the Western multi­na­tional cor­po­ra­tions are shift­ing the clin­i­cal part of drug de­vel­op­ment to coun­tries like In­dia, it is not for al­tru­is­tic rea­sons, nor is it for their in­abil­ity to re­cover their costs in­curred in R&D in the western coun­tries, but be­cause they have been pre­sented by the WTO Patent Regime an op­por­tu­nity to max­i­mize their prof­its by us­ing the easy avail­abil­ity of pa­tients from de­vel­op­ing coun­tries.

Ac­cord­ing to Phar­ma­ceu­ti­cal Re­search and Man­u­fac­tur­ers of Amer­ica (PHRMA), R&D ex­pen­di­ture of US pharma com­pa­nies has been grow­ing mod­er­ately since the year 2000 and cur­rently amounts to around USD58.8 bil­lion. R&D spend­ing by In­dian pharma in­dus­try has in­creased from around USD426 mil­lion in 2005 to 1013 mil­lion in 2012.

What are the emerg­ing trends in bio­science/medtech/drug dis­cov­ery/tech­nol­ogy fields?

Tech­no­log­i­cal trends such as wear­ables and elec­tronic health man­age­ment sys­tems are on an up­swing. Re­duced source date ver­i­fi­ca­tion prac­tices us­ing risk-based method­olo­gies would con­tinue to play a ma­jor role in rev­o­lu­tion­is­ing the sec­tor.

Real-world ev­i­dence-based stud­ies in con­cur­rence with ran­domised con­trol tri­als would gain promi­nence. Adap­tive de­signs would con­tinue to be of in­ter­est in the bio-sta­tis­ti­cal fra­ter­nity. Stan­dard­i­s­a­tion would also en­ter the list of trends to be looked into with re­spect to the clin­i­cal do­main. Sim­u­la­tions and mod­el­ing would be an­other area of fo­cus that could im­pact the clin­i­cal in­dus­try in the long run.

What are the new tech­nolo­gies and trends that the com­pany is fo­cus­ing on?

Eph­i­cacy, known for its eth­i­cal and com­pli­ant busi­ness model, would fo­cus on con­tin­u­ing the com­pli­ance lev­els. Data se­cu­rity and sub­ject data in­tegrity be­ing im­por­tant, our in-house data cen­tre would un­dergo trans­for­ma­tion by em­brac­ing cut­ting-edge tech­nolo­gies/so­lu­tions.

Fo­cus on learn­ing and de­vel­op­ment to sus­tain the com­pe­tency level of our em­ploy­ees to have an edge in the com­pe­ti­tion will be one of the pri­mary goals. Met­rics­driven and flex­i­ble project man­age­ment model im­ple­men­ta­tion would be an­other area of in­ter­est.

En­gag­ing with cus­tomers and de­liv­er­ing value to the world through in­no­va­tive method­olo­gies would be of in­ter­est too. Ap­pli­ca­tion of new trends and method­olo­gies in bio­statis­tics and sta­tis­ti­cal pro­gram­ming in­clud­ing us­ing R, WPS soft­wares is on the anvil.

Sun Pharma to ac­quire No­var­tis’s can­cer drug Odomzo for $175m

Sun Phar­ma­ceu­ti­cal In­dus­tries Ltd is plan­ning to ac­quire No­var­tis AG branded can­cer drug Odomzo for $175 mil­lion. Un­der the agree­ment, Sun Pharma will get global mar­ket­ing rights for the prod­uct and No­var­tis will re­ceive cer­tain ad­di­tional mile­stone pay­ments.

Odomzo is used for the treat­ment of ad­vanced basal cell car­ci­noma (BCC) that re­curs for pa­tients who are not can­di­dates for surgery or ra­di­a­tion ther­apy. This drug has mar­ket­ing ap­proval in over 30 coun­tries glob­ally, in­clud­ing the US, Europe and Aus­tralia and ap­proved by the US Food and Drug Ad­min­is­tra­tion in July 2015. The deal is ex­pected to be fi­nalised af­ter getting clear­ance from the US an­titrust agency.

Kirti Ganorkar, Global Head - Busi­ness De­vel­op­ment Sun Pharma said, “Odomzo gives us an op­por­tu­nity to mean­ing­fully ex­pand our al­ready estab­lished branded der­ma­tol­ogy busi­ness and sup­port our ex­pan­sion into branded on­col­ogy with a launched brand. We see mean­ing­ful global po­ten­tial for Odomzo by lev­er­ag­ing Sun Pharma’s ex­ist­ing der­ma­tol­ogy and on­col­ogy in­fra­struc­ture to pro­vide an in­no­va­tive prod­uct to BCC pa­tients world­wide.”

Ac­cord­ing to Jes­per Jensen, Head - Bi­o­log­ics and Der­ma­tol­ogy, Sun Pharma, “We look for­ward to col­lab­o­rat­ing with the med­i­cal com­mu­nity to bring this novel ther­apy to the mar­ket to pa­tients suf­fer­ing from lo­cally ad­vanced basal cell car­ci­noma. Odomzo com­ple­ments and en­hances our ex­ist­ing der­ma­tol­ogy fran­chise. This ac­qui­si­tion has the po­ten­tial to lever­age and ex­pand the re­la­tion­ships that our Le­vu­lan sales team have with the der­ma­tol­o­gists that treat com­mon pre-can­cer­ous skin con­di­tions.”

Sym­cel, Colzyx part­ner to test 25 novel, col­la­gen VI de­rived anti-mi­cro­bial pep­tides with calScreener

Sym­cel, the com­pany be­hind the cell-based as­say tool for real-time cel­lu­lar bioen­er­getic mea­sure­ments, calScreener, has part­nered with Colzyx to test 25 dif­fer­ent new col­la­gen VI de­rived an­timi­cro­bial pep­tides analysing their ca­pa­bil­ity to kill bac­te­rial growth. These newly dis­cov­ered, first-in-kind pep­tides each have the ca­pa­bil­ity to kill bac­te­ria in dif­fer­ent ways. The tech­nol­ogy will be used flex­i­bly to test each pep­tide in­de­pen­dently or in com­bi­na­tion with oth­ers.

Test­ing the col­la­gen VI de­rived pep­tides with Sym­cel’s calScreener, with the calori­met­ric mea­sure­ment of heat gen­er­ated by meto­bolism, pro­vides rapid gen­er­a­tion of unique in­for­ma­tion that can’t be ac­quired through other ex­per­i­men­tal meth­ods.

The novel calScreener tech­nol­ogy pro­vides con­tin­u­ous ki­netic data for bac­te­rial growth and in­hi­bi­tion - mak­ing it a valu­able tool for eval­u­at­ing novel an­tibac­te­rial com­pounds. These newly cre­ated pep­tides are of a type that has never been tested in this field of R&D be­fore.

Eskil Söder­lind, CEO, Colzyx said, “We are de­lighted to have part­nered with Sym­cel in what is an in­dus­try first in R&D on mul­ti­ple counts. Their in­no­va­tive calScreener tech­nol­ogy is set to fur­ther test and val­i­date the ef­fec­tive­ness of our novel col­la­gen VI pep­tides which, for the first time in re­search his­tory, are be­ing put to use to com­bat mi­cro­bial in­fec­tion by de­stroy­ing bac­te­ria”.

Chris­ter Wallin, CEO, Sym­cel com­mented: “We are very pleased to be work­ing with Colzyx and very much look for­ward to putting our tech­nol­ogy to use in mea­sur­ing and eval­u­at­ing the im­pact that their pep­tides have in killing bac­te­rial growth. CalScreener was se­lected be­cause of its abil­ity to de­liver unique data in real-time for these truly ground­break­ing tests - the re­sults of which

will be of high sci­en­tific and health­care in­ter­est.”

“Our pep­tides have the po­ten­tial to pro­vide a new and unique form of an­tibi­otics for treat­ing in­fec­tions in the fu­ture. Our highly nat­u­ral so­lu­tion - util­is­ing the bod­ies own built in de­fence mech­a­nism and de­vel­op­ing that into a form of a phar­ma­ceu­ti­cal drug for tar­get­ing mi­cro­bial in­fec­tion - has great health­care po­ten­tial,” said Söder­lind.

wat­son-Mar­low Fluid Tech­nol­ogy Group ac­quires Aflex Hose Ltd

Wat­son-Mar­low Fluid Tech­nol­ogy Group strength­ens its prod­uct port­fo­lio through the ac­qui­si­tion of Aflex Hose Lim­ited. Wat­son-Mar­low Fluid Tech­nol­ogy Group, the world leader in niche peri­staltic pumps and as­so­ci­ated fluid path tech­nolo­gies, has ac­quired Aflex Hose Lim­ited and its sub­sidiary Aflex Hose USA LLC through its par­ent com­pany Spi­rax-Sarco En­gi­neer­ing plc, for £61.4 mil­lion.

Aflex, based in Hal­i­fax, Eng­land and with a sales/assem­bly op­er­a­tion in Penn­syl­va­nia, USA, spe­cialises in the de­sign and man­u­fac­ture of PTFE lined flex­i­ble hose for the phar­ma­ceu­ti­cal, food and chem­i­cal process in­dus­tries.

Aflex is highly syn­er­gis­tic with, and a nat­u­ral ex­ten­sion to, the WMFTG fluid path prod­uct port­fo­lio and fur­ther strength­ens WMFTG’s al­ready strong global pres­ence in the biotech­nol­ogy, phar­ma­ceu­ti­cal, in­dus­trial/chem­i­cal and food & bev­er­age sec­tors. Aflex utilises patented, mar­ket-lead­ing tech­nol­ogy to pro­duce PTFE lined flex­i­ble hose, which out­per­forms other PTFE and stan­dard hose-types within the most de­mand­ing ap­pli­ca­tions, en­sur­ing the high­est lev­els of chem­i­cal re­sis­tance, su­pe­rior flex­i­bil­ity and steril­ity.

Aflex joins a fluid path prod­uct range com­pris­ing Wat­son-Mar­low Pumps, Wat­son-Mar­low Tub­ing, Flex­i­con Filling Sys­tems, BioPure sin­gle-use tub­ing con­nec­tor sys­tems, Asepco asep­tic valves, FlowS­mart seals and gas­kets, Alitea OEM Pumps, Ma­soSine Process Pumps

and Bre­del Hose Pumps.

Jay Whalen, Pres­i­dent, Wat­son-Mar­low Fluid Tech­nol­ogy Group said: “The strate­gic ac­qui­si­tion of Aflex fur­ther broad­ens our fluid path prod­uct range and strength­ens Wat­son-Mar­low’s po­si­tion in across all our ma­jor mar­ket sec­tors. For ex­am­ple, in the bio­phar­ma­ceu­ti­cal sec­tor we now have a com­plete and com­pre­hen­sive prod­uct range to en­able cus­tomers to source the world’s lead­ing, most tech­ni­cally ad­vanced prod­ucts from a sin­gle trusted part­ner. Our range cov­ers all as­pects of tech­nol­ogy re­quired for fluid trans­fer from source to de­liv­ery point. This is an­other ex­cit­ing mile­stone for Wat­sonMar­low and we are look­ing for­ward to ac­cel­er­at­ing our growth with our broad­ened prod­uct port­fo­lio cou­pled to our process ex­per­tise. e are pleased that Rod An­der­son, founder, will con­tinue in a tech­ni­cal ad­vi­sor ca­pac­ity and that se­nior man­age­ment will re­main.”

Jeremy Hud­son, Man­ag­ing Di­rec­tor, Aflex said, “I am very ex­cited to be part of the Wat­son-Mar­low Fluid Tech­nol­ogy Group and look to drive sales fur­ther with the ex­pan­sive WMFTG sales net­work.”

New chikun­gunya vac­cine brings in hope!

Bring­ing in a much-needed re­lief to mil­lions of peo­ple suf­fer­ing from chikun­gunya ev­ery year, re­searchers from The Univer­sity of Texas Med­i­cal Branch at Galve­ston have re­vealed that they have de­vel­oped the first vac­cine for chikun­gunya fever that pro­duces a strong im­mune de­fence and com­pletely pro­tects mice and non­hu­man pri­mates from dis­ease when ex­posed to the chikun­gunya virus.

The vac­cine is made from an in­sect-spe­cific virus that doesn’t have any ef­fect on peo­ple, mak­ing the vac­cine safe and ef­fec­tive. The findings were pub­lished in jour­nal of Na­ture Medicine. Chikun­gunya is a mos­quito-borne virus that causes a dis­ease char­ac­terised by fever and se­vere joint pain, of­ten in hands and feet, and may in­clude headache, mus­cle pain, joint swelling, or rash. Some pa­tients will feel bet­ter within a week but many de­velop longer-term joint pain that can last up to years. Death is rare but can oc­cur.

Se­nior au­thor and re­searcher Scott Weaver from the Univer­sity of Texas Med­i­cal Branch at Galve­ston, said,

“This vac­cine of­fers ef­fi­cient, safe and af­ford­able pro­tec­tion against chikun­gunya and builds the foun­da­tion for us­ing viruses that only in­fect in­sects to de­velop vac­cines against other in­sect-borne dis­eases.”

Re­searchers used the Ei­lat virus as a vac­cine plat­form since it only in­fects in­sects and has no im­pact on peo­ple. The UTMB re­searchers used the virus clone to de­sign a hy­brid virus-based vac­cine con­tain­ing chikun­gunya struc­tural pro­teins. The Ei­lat/Chikun­gunya vac­cine was found to be struc­turally iden­ti­cal to nat­u­ral chikun­gunya virus. The dif­fer­ence is that al­though the hy­brid virus repli­cates very well in mos­quito cells, it can­not repli­cate in mam­mals.

Within four days of a sin­gle dose, the Ei­lat/Chikun­gunya can­di­date vac­cine in­duced neu­tral­is­ing an­ti­bod­ies that lasted for more than 290 days. The an­ti­bod­ies pro­vided com­plete pro­tec­tion against chikun­gunya in two dif­fer­ent mouse mod­els. In non­hu­man pri­mates, Ei­lat/ Chikun­gunya elicited rapid and ro­bust im­mu­nity - there was nei­ther ev­i­dence of the virus in the blood nor signs of ill­ness such as fever af­ter chikun­gunya virus in­fec­tion.

Other au­thors in­clude UTMB’s Jesse Eras­mus, Al­bert Au­guste, Huanle Luo, Shan­nan Rossi, Karla Fen­ton, Grace Leal and Tian Wang; Ja­son Kael­ber and Wah Chiu from Bay­lor Col­lege of Medicine; Dal Kim and Ilya Frolov from the Univer­sity of Alabama at Birm­ing­ham and Fa­rooq Nasar from the United States Army Med­i­cal Re­search In­sti­tute of In­fec­tious Dis­eases.

lonza to buy Cap­sugel for $5.5bn

Swiss pharma giant Lonza group an­nounced that they have inked an agree­ment un­der which Lonza will ac­quire Cap­sugel from KKR for USD 5.5 bil­lion in cash, in­clud­ing re­fi­nanc­ing of ex­ist­ing Cap­sugel debt of ap­prox­i­mately USD 2 bil­lion, through a trans­ac­tion that has been ap­proved by the Boards of Di­rec­tors of both Lonza and Cap­sugel. The trans­ac­tion will be fi­nanced with a com­bi­na­tion of debt and eq­uity fi­nanc­ing.

The deal will help Lonza to ac­cel­er­ate growth and de­liver value along the health­care con­tin­uum by com­ple­ment­ing its ex­ist­ing of­fer­ings and by open­ing up new mar­ket op­por­tu­ni­ties in the pharma and con­sumer health­care and nutrition in­dus­tries. The ac­qui­si­tion of Cap­sugel will add a trusted brand to Lonza with a large breadth of tech­nolo­gies and will ex­pand the mar­ket reach of its con­tract de­vel­op­ment and man­u­fac­tur­ing or­gan­i­sa­tion (CDMO) and prod­ucts busi­nesses. It will also sup­port Lonza’s strate­gic am­bi­tion of getting closer to the pa­tient

and end con­sumer.

With ap­prox­i­mately 3,600 em­ploy­ees and 13 fa­cil­i­ties on three con­ti­nents, Cap­sugel has a cus­tomer-cen­tric, en­tre­pre­neur­ial and col­lab­o­ra­tive cul­ture that closely aligns with Lonza’s cor­po­rate cul­ture. Both com­pa­nies fo­cus on qual­ity, op­er­a­tional ex­cel­lence and de­liv­er­ing on prom­ises.

“The ac­qui­si­tion of Cap­sugel meets Lonza’s strate­gic and fi­nan­cial goals. It ac­cel­er­ates our health­care con­tin­uum strat­egy by giv­ing us broader ex­po­sure to the fast-grow­ing pharma and con­sumer health­care mar­kets,” Richard Ridinger Chief Ex­ec­u­tive Lonza said in a state­ment.

The com­bined busi­ness will be well po­si­tioned to ben­e­fit from the dy­nam­ics in these in­dus­tries and to an­tic­i­pate and ad­dress tech­nol­ogy trends in or­der to sup­port the evolv­ing needs of its cus­tomers. It will pro­vide ad­di­tional value by of­fer­ing an in­te­grated port­fo­lio of in­dus­trylead­ing tech­nolo­gies, from ac­tive phar­ma­ceu­ti­cal in­gre­di­ents (APIs) through ex­cip­i­ents to dosage forms and de­liv­ery tech­nolo­gies.

The deal will strengthen Lonza’s po­si­tion in con­sumer health­care and nutrition as Lonza be­comes a fully in­te­grated and in­no­va­tive ser­vice provider of ac­tive in­gre­di­ents, oral dosage forms, de­vel­op­ment ser­vices and de­liv­ery tech­nolo­gies. As a re­sult, Lonza will be well po­si­tioned to meet the in­creas­ing need for op­ti­mised con­sumer health and nutrition through a wide of­fer­ing of next-gen­er­a­tion dosage forms. The com­bined busi­ness will also be able to lever­age its bioavail­abil­ity tech­nol­ogy to cre­ate a new di­etary in­gre­di­ent-ready of­fer­ing, as well as cap­i­talise on its for­mu­la­tion ex­per­tise to de­velop new in­gre­di­ents and to mar­ket new com­bi­na­tion prod­ucts.

Guido Driesen, Pres­i­dent and Chief Ex­ec­u­tive Of­fi­cer,

Cap­sugel, said, “This trans­ac­tion brings to­gether two lead­ing com­pa­nies that share a com­mon vi­sion - to de­liver real value to cus­tomers by ac­cel­er­at­ing their abil­ity to de­velop and com­mer­cialise in­no­va­tive phar­ma­ceu­ti­cal and health­care prod­ucts. The com­bi­na­tion of our com­ple­men­tary tech­nol­ogy plat­forms will put us in a strong po­si­tion to ben­e­fit from evolv­ing trends in the pharma and con­sumer health­care mar­kets.”

He added, “Both com­pa­nies en­joy a strong qual­ity and reg­u­la­tory track record, and we be­lieve that the com­bi­na­tion en­ables us to pro­vide the most com­plete set of tai­lored and in­te­grated so­lu­tions for our cus­tomers. We look for­ward to bring­ing to­gether our talented teams to de­liver sci­ence- and en­gi­neer­ing-based so­lu­tions to cus­tomers for the ben­e­fit of the pa­tients and con­sumers who use their prod­ucts. I am per­son­ally com­mit­ted to mak­ing this in­te­gra­tion a suc­cess.”

Trump prom­ises to bring down drug prices

In a re­cent in­ter­view with a lead­ing mag­a­zine, US Pres­i­dent-elect Don­ald Trump said that he would bring down drug prices and re­duce the cost of pre­scrip­tion drugs. Trump pre­vi­ously had also sug­gested that he was open to al­low­ing im­por­ta­tion of cheaper medicines from over­seas.

In a cover story for Time mag­a­zine, which named him its Per­son of the Year, Trump said: “I don’t like what has hap­pened with drug prices.” This might bring re­lief to many con­sumers who have been con­stantly af­fected with rising drug prices.

Re­cently a Reuters re­port stated that, top ex­ec­u­tives from large US drug­mak­ers dis­cussed for the first time pos­si­ble changes for the in­dus­try un­der Pres­i­den­t­elect Don­ald Trump, and is­sues that have dam­aged the rep­u­ta­tion of their in­dus­try.

Brent Saun­ders, Chief Ex­ec­u­tive, Al­ler­gan Inc said, “Though pharma com­pa­nies are now breath­ing a sigh of re­lief, Trump could be more crit­i­cal of drug­mak­ers and their price in­creases than the in­dus­try ex­pects.” Saun­ders pre­dicted that Trump could be a “more vi­cious tweeter” against the drug in­dus­try than his for­mer Demo­cratic ri­val Hil­lary Clin­ton had been dur­ing the cam­paign.

Clin­ton’s tweets com­mit­ting to a crack­down on ex­or­bi­tant drug price in­creases weighed heav­ily on phar­ma­ceu­ti­cal shares since her first tweet in Septem­ber 2015. Pharma shares jumped in the days af­ter Trump’s elec­tion as Clin­ton’s pro­posed price con­trols fell off the ta­ble.

Saun­ders said Amer­i­cans are rightly an­gry about price in­creases, and the in­dus­try needs to po­lice it­self or face gov­ern­ment reper­cus­sions.

“I worry that the phar­ma­ceu­ti­cal in­dus­try has a very false sense of se­cu­rity be­cause of the Trump ad­min­is­tra­tion and a Repub­li­can-con­trolled Congress,” Saun­ders said.

Re­gen­eron Phar­ma­ceu­ti­cals CEO Len Sch­leifer, speak­ing on a panel at the Forbes con­fer­ence, said the in­dus­try will be seen in a bad light as long as it main­tains the com­mon prac­tice of tak­ing twice yearly, of­ten dou­bledigit, price in­creases on widely-used medicines.

“We as an in­dus­try have used price in­creases to fill gaps in in­no­va­tion,” he said. “You can’t say ‘I set the price based on the value of the drug’ and then have these egre­gious price in­creases,” Sch­leifer said, adding that the value of a drug to so­ci­ety does not in­crease each year.

Ian Read CEO Pfizer Inc took ex­cep­tion to Sch­leifer’s char­ac­ter­i­sa­tion of the price hikes, ar­gu­ing the cost of pre­scrip­tion drugs as a per­cent­age of over­all health­care spend­ing had not changed in two decades. In an over­hauled US health­care plan un­der Trump, Read said he would like to see fi­nan­cial risk shift from in­sur­ers to providers, such as hos­pi­tals, with an em­pha­sis on pre­ven­tion and well­ness.

“Give them the tools and the free­dom and the in­cen­tive to man­age that risk,” Read said. Sep­a­rately, Merck & Co CEO Ken Fra­zier said he thought one of Trump’s pro­posed health­care re­form poli­cies - al­low­ing the im­port of cheaper drugs from other coun­tries - will not work. The US pays more than any other coun­try for medicines, and cur­rent US law for­bids im­por­ta­tion of drugs from other coun­tries that charge far less.

“I don’t think it’s go­ing to be made pos­si­ble,” said Fra­zier, dur­ing an in­ter­view on CNBC af­ter an ap­pear­ance

at the con­fer­ence. “Ev­ery time we’ve tried to do that no FDA com­mis­sioner has ever been will­ing to cer­tify the safety of those drugs.”

Strides Sha­sun ac­quires Per­rigo’s us FDA ap­proved API fa­cil­ity in In­dia

Ben­galuru-based phar­ma­ceu­ti­cal com­pany Strides Sha­sun Lim­ited have signed an agree­ments to ac­quire the en­tire share­hold­ing in Ma­ha­rash­tra based Per­rigo API In­dia for INR 1000mil­lion. Per­rigo API In­dia got ac­cess to two US FDA AOI fa­cil­i­ties hav­ing a com­bi­na­tion of API’s for cap­tive consumption and com­mod­ity APIs. Post-merger with Sha­sun Phar­ma­ceu­ti­cal Lim­ited in 2014, the Com­pany has sig­nif­i­cantly scaled up its API prac­tice through up­grade of in­fra­struc­ture and qual­ity stan­dards with a fo­cus on build­ing a port­fo­lio of back­ward in­te­grated small mol­e­cules and cater­ing to high en­try bar­rier mar­kets of Ja­pan and South Korea.

Un­der the terms of agree­ment, Strides Sha­sun will ac­quire 100 per cent of the is­sued cap­i­tal of Per­rigo API In­dia. Also, Per­rigo par­ent or af­fil­i­ates will con­tinue to source few prod­ucts from the fa­cil­ity un­der a long-term sup­ply agree­ment.

Per­rigo API In­dia’s fa­cil­ity brings into the fold a US FDA ap­proved API fa­cil­ity lo­cated at Am­ber­nath, Ma­ha­rash­tra, to be used for cap­tive consumption and will aug­ment the Com­pany’s re­sources to han­dle high ve­loc­ity of new prod­uct de­vel­op­ment and com­mer­cial launches in the for­mu­la­tions port­fo­lio. The fa­cil­ity with a po­ten­tial ca­pac­ity of 600 tons per year had zero 483s dur­ing its last US FDA in­spec­tion.

Com­ment­ing on the de­vel­op­ment, Shashank Sinha, Group CEO of Strides Sha­sun stated “With this ac­qui­si­tion, we bring into our fold a man­u­fac­tur­ing fa­cil­ity de­signed to han­dle mul­ti­pur­pose small batch pro­duc­tions and ac­cel­er­ates our time to mar­ket. This au­gurs well for the Strides’ stated strat­egy of build­ing a back­ward in­te­grated port­fo­lio of niche and small vol­ume prod­ucts for the reg­u­lated mar­kets.”

Ja­pan’s Takeda to in­vest €40 mil­lion in Ir­ish fa­cil­ity

Ja­panese drug giant Takeda is plan­ning to in­vest nearly €40 mil­lion in a new fa­cil­ity in Dublin in a move that will lead to the cre­ation of 40 jobs. The com­pany first in­vested in the coun­try about 20 years ago, in 1997 and is now plan­ning to build a pro­duc­tion fa­cil­ity, ded­i­cated to man­u­fac­ture its on­col­ogy prod­uct NINLARO (TM) for global mar­kets from Dublin. The move is set to fur­ther ex­pand Takeda’s Ir­ish foot­print.

Takeda is the largest phar­ma­ceu­ti­cal com­pany in Ja­pan em­ploy­ing more than 400 peo­ple at its three sites in Dublin. Plant Di­rec­tor at Takeda Ire­land Grange Cas­tle, Paul Keogh said in a state­ment that the ad­di­tional in­vest­ment in Ire­land “demon­strates the con­fi­dence and com­mit­ment” Takeda has in its Ir­ish op­er­a­tion.

Keogh said, “We are de­lighted that Takeda has cho­sen

Ire­land for this in­vest­ment and proud that we have been en­trusted with the re­spon­si­bil­ity to pro­duce and de­liver this very im­por­tant treat­ment for can­cer pa­tients world­wide. We have a great team here in Ire­land and are com­mit­ted to con­tin­u­ing to put pa­tients first through the timely man­u­fac­ture and sup­ply of high qual­ity prod­ucts from our site.”

Wel­com­ing the in­vest­ment, Mitchell O’Con­nor, Min­is­ter for Jobs, En­ter­prise and In­no­va­tion said, “The pharma in­dus­try makes a huge con­tri­bu­tion to the Ir­ish econ­omy in terms of jobs and ex­ports, and is one of the fastest grow­ing sec­tors. Takeda’s de­ci­sion to man­u­fac­ture their new can­cer treat­ment in Ire­land is a great win and vote of con­fi­dence in Ire­land and it builds on our on­go­ing ex­pan­sion of the sec­tor here. I’m de­lighted that this in­vest­ment will bring a fur­ther 40 jobs to the com-

pany’s ex­ist­ing Clon­dalkin fa­cil­ity.”

Mar­tin Shana­han CEO IDA Ire­land com­mented on the in­vest­ment and said, “Ire­land is glob­ally recog­nised as a cen­tre of ex­cel­lence in life sciences due to the coun­try’s reg­u­la­tory track record and ta­lent avail­abil­ity.”

Korea’s pharma work­force up by 27 per cent

With the South Korean pharma in­dus­try ex­pand­ing, the size of the lo­cal pharma work­force grew by 27 per cent com­pared to four years ago re­ported the Korean Her­ald. Ac­cord­ing to the Korea Phar­ma­ceu­ti­cal Man­u­fac­tur­ers As­so­ci­a­tion, a to­tal of 94,500 peo­ple were em­ployed at some 842 phar­ma­ceu­ti­cal com­pa­nies as of 2015, a sharp in­crease from 2011, when 74,000 peo­ple were em­ployed at 822 com­pa­nies.

The as­so­ci­a­tion pointed out that though the num­ber of phar­ma­ceu­ti­cal com­pa­nies rose just 2 per cent dur­ing the four-year pe­riod, the num­ber of peo­ple em­ployed in the field rose 27 per cent. KPMA said in a state­ment that, “De­spite deep­en­ing un­em­ploy­ment, Korea’s phar­ma­ceu­ti­cal in­dus­try ap­pears to be ac­tively con­tribut­ing to con­tin­ued job cre­ation.”

The big­gest growth came from the drug man­u­fac­tur­ing and re­search and de­vel­op­ment are­nas. The num­ber of man­u­fac­tur­ing per­son­nel rose 34 per cent from 23,500 in 2011 to 31,700 in 2015. The num­ber of R&D per­son­nel grew 26 per cent from 8,800 to 11,000 dur­ing the four-year time frame.

Mean­while, the change in the size of the phar­ma­ceu­ti­cal sales and mar­ket­ing work­force was smaller but still sig­nif­i­cant - grow­ing from 24,500 peo­ple in 2011 to 25,700 peo­ple in 2015, ac­cord­ing to the as­so­ci­a­tion.

On the whole, man­u­fac­tur­ing per­son­nel took up the big­gest share of the phar­ma­ceu­ti­cal work­force in 2015 at 33.5 per cent, fol­lowed by sales and mar­ket­ing at 27.24 per cent, ad­min­is­tra­tive roles at 20.23 per cent, R&D at 11.7 per cent and oth­ers at 7.33 per cent.

APAC pharma mar­ket to see mod­est growth in 2017

Ac­cord­ing to BMI Re­search, Sin­ga­pore’s phar­ma­ceu­ti­cal mar­ket will see a mod­est growth of around 6 per cent in 2017. The firm also said that the whole APAC re­gion will see a rise of 5 per cent. The firm said that the Asia Pa­cific phar­ma­ceu­ti­cal mar­ket will see mod­est growth in 2017, as on­go­ing trends such as the roll out of uni­ver­sal health­care and ad­vances by pri­vate health­care providers is seen to con­tinue.

The firm fur­ther elab­o­rated that two themes will de­fine 2017 in APAC, one of which is the demise of Trans-Pa­cific Part­ner­ship. “The TPP had the po­ten­tial to re­shape the op­er­at­ing en­vi­ron­ment for multi­na­tional drug­mak­ers. This in­cludes strength­en­ing the in­tel­lec­tual prop­erty regime with patent ad­just­ments to a more trans­par­ent pro­cure­ment process,” the firm noted.

It added, “No­tably, the im­pact of the TPP would have ex­tended beyond the seven APAC sig­na­to­ries’ mar­kets, as lead­ers from coun­tries such as In­done­sia, Thai­land and South Korea had ex­pressed their in­ter­est in even­tu­ally par­tic­i­pat­ing in the trade deal.”

BMI also cited that in 2017, cost con­tain­ment in the APAC re­gion will be­come more acute as gov­ern­ments seek to con­tain rising health­care spend­ing amid a more un­cer­tain eco­nomic out­look. “While the broader trend

of con­trol­ling costs has been an on­go­ing theme within the re­gion, we ex­pect 2017 to mark a key in­flec­tion point as gov­ern­ments adopt ad­di­tional mea­sures to fur­ther re­duce spend­ing. No­tably, 2017 will see a more tar­geted ap­proach be­ing adopted, as au­thor­i­ties seek to mit­i­gate the fi­nan­cial pres­sures stem­ming from the use of high value phar­ma­ceu­ti­cals,” BMI said.

Asia to re­place europe as the sec­ond­largest health­care mar­ket by 2025

Re­search firm Frost & Sul­li­van said that Asia is all set to re­place Europe as the sec­ond-largest health­care mar­ket in the world by 2025. The new anal­y­sis, “Vi­sion 2025 - Fu­ture of Health­care,” which is part of Frost & Sul­li­van’s Ad­vanced Med­i­cal Tech­nolo­gies Growth Part­ner­ship Ser­vice pro­gram, sees the global health­care in­dus­try grow­ing at a com­pound an­nual growth rate (CAGR) of 5.6 per cent to reach rev­enue of $2.69 tril­lion by 2025.

The re­port states that though North Amer­ica is the largest health­care mar­ket in the world to­day, it may only re­tain this lead un­til 2028. With growth in health­care ex­pen­di­ture as a per­cent of GDP set to be higher than North Amer­ica and Europe, Asia is poised to take the lead. The an­a­lyst firm also pre­dicts that by 2025, Latin Amer­ica is set also fore­cast to over­take Ja­pan to be­come

the fourth-largest health­care mar­ket glob­ally.

Mean­while, ag­ing pop­u­la­tions world­wide are chal­leng­ing and will con­tinue to chal­lenge ex­ist­ing health­care sys­tems fi­nan­cially and re­quire im­proved health­care out­comes. Frost & Sul­li­van ex­pects this to cause a shift to­wards value-based care and re­quire na­tional poli­cies to change dra­mat­i­cally. The rise of con­sumeri­sa­tion as well will lead to pa­tient-cen­tric health­care.

“With an ag­ing pop­u­la­tion and in­creas­ing chronic dis­ease preva­lence, the fo­cus on pre­ven­tion and mon­i­tor­ing will be en­forced. This is re­flected in rising shares of health­care ex­pen­di­ture for pre­ven­tion, mon­i­tor­ing, and di­ag­no­sis, while the share for treat­ment will de­cline,” noted Sid­dharth Shah, Frost & Sul­li­van Trans­for­ma­tional Health Re­search An­a­lyst.

“Emerg­ing tech­no­log­i­cal ad­vances to help al­le­vi­ate the sit­u­a­tion will en­able sev­eral new bil­lion-dol­lar op­por­tu­ni­ties to arise in all sec­tors. The com­bined ef­fect of trans­for­ma­tional shifts and new op­por­tu­ni­ties will fa­cil­i­tate the emer­gence of new busi­ness mod­els in the in­dus­try,” Shah said.

ul­tra­sound de­vices mar­ket to reach $10,476mn glob­ally by 2022

A new re­port pub­lished by Al­lied Mar­ket Re­search, ti­tled, “Ul­tra­sound De­vices Mar­ket - Global Op­por­tu­nity Anal­y­sis and In­dus­try Fore­cast, 2014 - 2022”, projects that the global ul­tra­sound mar­ket would reach $10,476 mil­lion by 2022. Di­ag­nos­tic ul­tra­sound sys­tem would con­tinue to be the high­est rev­enue-gen­er­at­ing seg­ment through­out the fore­cast pe­riod. Europe ac­counted for al­most one-third of the mar­ket share in 2015, and is ex­pected to dom­i­nate the over­all mar­ket dur­ing the study pe­riod.

The ma­jor fac­tors boost­ing the mar­ket growth in­clude tech­no­log­i­cal ad­vance­ments (such as ad­vent of 3D and 4D ul­tra­sound that pro­vides de­tailed in­for­ma­tion about a known ab­nor­mal­ity from dif­fer­ent an­gles), rising in­ci­dence of chronic dis­eases, and in­creas­ing geri­atric pop­u­la­tion world­wide.

The rising num­ber of ap­pli­ca­tion ar­eas of ul­tra­sound cou­pled with in­creas­ing adop­tion of ul­tra­sound sys­tems in ob­stet­rics and gy­nae­col­ogy field, is set to boost the growth of the ul­tra­sound mar­ket world­wide. Cost ef­fec­tive­ness, safety, high ac­ces­si­bil­ity, and clin­i­cal value in pre­lim­i­nary di­ag­no­sis are strength­en­ing the tech­nolo­gies value propo­si­tion in tech­no­log­i­cal ad­vance­ments in the ul­tra­sound mar­ket. In ad­di­tion, in­crease in num­ber of di­ag­nos­tic imag­ing pro­ce­dures, and rising aware­ness for early di­ag­no­sis of clin­i­cal dis­or­ders are an­tic­i­pated to fur­ther drive the de­mand for ul­tra­sound de­vices. How­ever, dearth of skilled and ex­pe­ri­enced sono­g­ra­phers and tech­no­log­i­cal lim­i­ta­tions of ul­tra­sound sys­tems are some of the fac­tors re­strict­ing the mar­ket growth.

The ra­di­ol­ogy/gen­eral imag­ing seg­ment ac­counted for the ma­jor share of 30 per cent of the over­all ul­tra­sound mar­ket in 2015. This is pri­mar­ily due to the wide adop­tion of ul­tra­sound de­vices in the di­ag­no­sis of rising num­ber of ab­dom­i­nal dis­eases. Urol­ogy has emerged as the fastest grow­ing seg­ment, reg­is­ter­ing a CAGR of 11.3 per cent dur­ing the fore­cast pe­riod, due to the grow­ing in­ci­dences of uri­nary tract in­fec­tions cou­pled with the rapidly ag­ing pa­tient pop­u­la­tion.

Di­ag­nos­tic ul­tra­sound de­vices such as 2D ul­tra­sound, 3D & 4D ul­tra­sound, and Dop­pler de­vices have given rise to new ap­pli­ca­tions (such as biop­sies and im­ageguid­ing in­ter­ven­tions) across dif­fer­ent clin­i­cal spe­cial­ties.

The grow­ing de­mand for both ul­tra-por­ta­ble and por­ta­ble di­ag­nos­tic ul­tra­sound sys­tems in di­ag­nos­tic and im­age guid­ance area at points-of-care have fur­ther boosted the mar­ket growth.

The ad­vent of porta­bil­ity in ul­tra­sound has built a strong path for the in­creased de­mand of these de­vices for point-of-care ap­pli­ca­tions such as emer­gency medicine, anaes­the­si­ol­ogy, mus­cu­loskele­tal, and crit­i­cal care medicine. The trol­ley/cart-based ul­tra­sound de­vices seg­ment ac­counted for the ma­jor mar­ket share of the to­tal ul­tra­sound mar­ket in 2015, whereas, the com­pact/ hand­held ul­tra­sound de­vices seg­ment is ex­pected to grow at a higher CAGR dur­ing the fore­cast pe­riod.

Ge­o­graph­i­cally, the Euro­pean re­gion ac­counted for the ma­jor­ity share in the over­all ul­tra­sound mar­ket in 2015, and is ex­pected to main­tain this lead through­out the

fore­cast pe­riod. The growth in the ul­tra­sound mar­ket is at­trib­uted to the in­creased adop­tion of ul­tra­sound for di­ag­no­sis, in­creased pro­ce­dure vol­umes re­sult­ing from rapidly ag­ing pop­u­la­tion, and in­creased preva­lence of chronic dis­eases.

How­ever, reg­u­la­tory frame­work con­cerns and dearth of ex­pe­ri­enced and skilled sono­g­ra­phers in var­i­ous coun­tries in Europe are ex­pected to ham­per the mar­ket growth. In ad­di­tion, the grow­ing mo­men­tum of HIFU in Euro­pean coun­tries for the treat­ment of prostate can­cer is fur­ther set to drive the ul­tra­sound mar­ket.

Asia-Pa­cific is pro­jected to be the fastest grow­ing re­gion through­out the anal­y­sis pe­riod. This is mainly due to the im­prov­ing health­care in­fra­struc­ture and health­care ex­pen­di­tures in the emerg­ing mar­kets (such as In­dia and China) to over­come the un­met med­i­cal needs in these coun­tries. Tech­no­log­i­cal ad­vance­ments for cost-ef­fec­tive de­vices in these na­tions of­fers a lu­cra­tive op­por­tu­nity for the growth of the ul­tra­sound de­vices mar­ket.

Key Findings:

• In the year 2015, 2D imag­ing sys­tems was the lead­ing seg­ment, ac­count­ing for al­most half of the over­all mar­ket rev­enue, and is pro­jected to grow at a CAGR of 3.3 per cent dur­ing the fore­cast pe­riod.

• HIFU seg­ment is ex­pected to grow at a re­mark­able CAGR of 22.5 per cent, ow­ing to the non-in­va­sive na­ture and high ac­cu­racy of tech­nol­ogy for the treat­ment of prostate can­cer.

• Asia-Pa­cific ac­counted for about one-third share of

the global ul­tra­sound mar­ket in 2015.

• The ob­stet­rics/gy­nae­col­ogy seg­ment is pro­jected to sur­pass the ul­tra­sound mar­ket for ra­di­ol­ogy/gen­eral imag­ing dur­ing the fore­cast pe­riod.

• China and Ja­pan are the ma­jor share­hold­ers in the Asia-Pa­cific re­gion, jointly ac­count­ing for about twothirds share of the re­gions ul­tra­sound mar­ket.

The key play­ers in the ul­tra­sound mar­ket are highly fo­cused on ex­pand­ing their busi­ness op­er­a­tions in the fast-grow­ing emerg­ing coun­tries and new prod­uct launches as a pre­ferred strat­egy. The com­pa­nies pro­filed in this re­port in­clude Ana­logic Cor­po­ra­tion, Esaote SPA, Fu­ji­film Cor­po­ra­tion, Gen­eral Elec­tric Com­pany, Hi­tachi, Ltd., Konin­kli­jke Philips N.V., Min­dray Med­i­cal In­ter­na­tional Lim­ited, Sam­sung Medi­son Co. Ltd, Siemens AG, and Toshiba Cor­po­ra­tion.

Agi­lent Tech­nolo­gies col­lab­o­rates with Tran­scrip­tic for in­no­va­tive bi­ol­ogy so­lu­tions

In or­der to foster in­no­va­tion and to de­velop novel syn­thetic bi­ol­ogy so­lu­tions, Agi­lent Tech­nolo­gies have re­cently col­lab­o­rated with Tran­scrip­tic. Tran­scrip­tic’s au­to­mated dis­cov­ery bi­ol­ogy en­ables scal­able life sci­ence re­search through a con­ve­nient and sim­ple web in­ter­face. This plat­form can be used by bi­ol­o­gists to con­trol their sci­ence and gen­er­ate data re­motely via the cloud.

This col­lab­o­ra­tion will add mul­ti­ple Agi­lent Ge­nomics prod­uct lines for mu­ta­ge­n­e­sis and cloning to the pro­to­col li­brary within the Tran­scrip­tic ro­botic Cloud lab­o­ra­tory like QuikChange Light­ning which will ac­cel­er­ate the gen­er­a­tion of mul­ti­ple mu­tants for large pro­tein func­tion projects and pro­vid­ing cut­ting-edge Agi­lent biore­agents in a ro­botic lab­o­ra­tory set­ting al­low­ing a global cus­tomer base to au­to­mate and op­ti­mise work­flows for rapid and ef­fi­cient re­search dis­cov­er­ies.

Her­man Ver­relst, Vice Pres­i­dent and Gen­eral Man­ager of Ge­nomics So­lu­tions Divi­sion and Clin­i­cal Ap­pli­ca­tions Divi­sion, Agi­lent said, “We’re ex­cited to com­bine our genome en­gi­neer­ing tools with au­to­mated ex­per­i­men­ta­tion. Tran­scrip­tic’s ser­vices are val­i­dated, scal­able, and ac­ces­si­ble from any­where in the world, which will en­hance the mar­ket for our in­dus­try-lead­ing reagents.”

Yvonne Lin­ney, Chief Op­er­at­ing Of­fi­cer, Tran­scrip­tic said, “By bring­ing these prod­ucts to Tran­scrip­tic, we will make it ex­tremely easy for cus­tomers to scale up their re­search, us­ing many mu­tants to pro­duce very large datasets for ex­plor­ing pro­tein func­tion.”

He­mocue launches world’s first re­al­time anaemia mon­i­tor­ing sys­tem

Hemo Cue, the global leader in point-of-care di­ag­nos­tics, launched Hemo Cue Health Tren­der Ane­mia, the new-age anaemia screen­ing and mon­i­tor­ing sys­tem at an event held on Novem­ber 30, 2016 at Em­bassy of Swe­den, New Delhi. The event was graced by im­por­tant stake­hold­ers in­clud­ing pol­icy mak­ers, gov­ern­ment of­fi­cials, bu­reau­crats, health ad­min­is­tra­tors, pub­lic health ex­perts, doc­tors.

Anaemia presents a for­mi­da­ble pub­lic health chal­lenge,

af­fect­ing nearly half of all In­dian women, a fourth of all men, 79 per cent of chil­dren aged 6-59 months and caus­ing 20 per cent ma­ter­nal deaths.

Speak­ing at the event, Dr. Ajay Khera, Deputy Com­mis­sioner, Min­istry of Health and Fam­ily Wel­fare, em­pha­sised the need of tech­no­log­i­cal in­ter­ven­tions to sup­port and strengthen gov­ern­ment ef­forts to erad­i­cate anaemia. Dr Khera pointed out, “Anaemia has be­come a bur­geon­ing health con­cern not just in In­dia but across the world. The Gov­ern­ment of In­dia ac­knowl­edges the ur­gency of the sit­u­a­tion and is com­mit­ted to battle out the epi­demic.”

He added, “While we are do­ing our best, we face for­mi­da­ble chal­lenge, es­pe­cially vis-à-vis quick and re­li­able di­ag­no­sis of anaemia. Tech­nol­ogy-based in­ter­ven­tions can de­liver fast re­sults in terms of speedy and ac­cu­rate screen­ing as well as data col­la­tion.

Early and ac­cu­rate di­ag­no­sis can play a key role in im­prov­ing treat­ment out­comes in anaemia. Em­ploy­ing de­tec­tion meth­ods that are fast, ac­cu­rate and re­li­able prom­ises to be a sig­nif­i­cant step for­ward in meet­ing the chal­lenge anaemia poses. More­over, man­ual col­la­tion of data as­so­ci­ated with these meth­ods takes months and is er­ror-prone, which in turn means that anaemia man­age­ment poli­cies of­ten have to be based on ei­ther in­suf­fi­cient or un­re­li­able data.

Bjorn Christ, Pres­i­dent - He­mocue AB said, “To di­ag­nose anaemia and make early cru­cial de­ci­sions re­lated to man­ag­ing anaemia in pa­tients and to mon­i­tor re­sponse to ther­apy, haemoglobin mea­sure­ment re­mains the prime fo­cus. And that is where He­mocue can make a dif­fer­ence with its tech­nol­ogy-en­abled prod­ucts. We have been able to achieve great re­sults in other coun­tries as well. Con­tin­u­ing with our mis­sion of im­prov­ing lives through in­no­va­tion, we have de­vel­oped He­mocue. Health Tren­der, an in­no­va­tive sys­tem that en­sures op­ti­mal us­age of re­sources to se­cure max­i­mum out­come of health­care pro­gramme.”

“He­mocue Health Tren­der Ane­mia is an in­no­va­tive de­vice that when in­te­grated with com­mu­nity health pro­grammes, es­pe­cially in ru­ral ar­eas, can help ad­dress the is­sues of de­layed and in­cor­rect di­ag­no­sis. We strongly be­lieve that the real-time data that it helps gen­er­ate and an­a­lyse can be in­stru­men­tal for de­ci­sion mak­ers to cre­ate poli­cies around anaemia man­age­ment,” said Deepak Sharma, Re­gional Sales Di­rec­tor Asia Pa­cific, He­mocue. Num­bers re­veal that the phys­i­cal and cog­ni­tive losses due to iron de­fi­ciency have a sig­nif­i­cant ef­fect on the Gross Do­mes­tic Prod­uct - in some de­vel­op­ing coun­tries up to as much as 4 per cent.

The Gov­ern­ment of In­dia is re­lent­lessly in­volved in car­ry­ing out pro­grammes to fight anaemia. Many of the pro­grammes are ex­e­cuted by vil­lage clin­ics, health­care cen­tres and NGOs in ru­ral ar­eas un­der harsh con­di­tions with lim­ited ac­cess to elec­tric­ity, pure wa­ter com­bined with a poor in­fra­struc­ture.

Un­der these con­di­tions, it be­comes vir­tu­ally im­pos­si­ble to col­lect data, to re­view, act or eval­u­ate the pro­grammes in a timely and ef­fec­tive way; some­thing that has been re­quested for a long time but never ad­e­quately solved.

He­mocue Health Tren­der Ane­mia is a Cloud-based so­lu­tion can help over­come these chal­lenges as it of­fers im­me­di­ate in­sight us­ing real-time data cap­tured from the He­mocue Hb201+ anal­yser in the field. A stream of data over time can help pol­i­cy­mak­ers ma­noeu­ver the di­rec­tion of pro­grammes and also fa­cil­i­tate con­sis­tent mon­i­tor­ing of haemoglobin lev­els in the tar­get groups.

Siva Ra­mamoor­thy

Head of In­dia Op­er­a­tions, Eph­i­cacy Life­science An­a­lyt­ics Pvt. Ltd.

Head of In­dia Op­er­a­tions, Eph­i­cacy Life­science An­a­lyt­ics Pvt. Ltd.

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