DATA AN­A­LYT­ICS PLAY KEY ROLE IN EN­ABLING DRUG DIS­COV­ERY TO AP­PROVAL

BioSpectrum (India) - - Bio Contents - Siva Ra­mamoor­thy Head of In­dia Op­er­a­tions, Eph­i­cacy Life­science An­a­lyt­ics Pvt. Ltd.

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 In­dia plans and other de­tails:

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

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

Phar­ma­ceu­ti­cal or­gan­i­sa­tions de­pend on block-buster 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 groom-

ing 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.

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.

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; ini-

tial 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:

In­ves­ti­ga­tors

• 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 Pat- ent 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.

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.

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. Met­rics-driven 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.

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

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