“CROs need to be faster, smarter and more re­spon­sive to ac­com­mo­date”

Dr Su­jay Singh

BioSpectrum (India) - - BIO CONTENT - « Dr Su­jay Singh CEO, IMGENEX In­dia Pvt Ltd.

CEO, IMGENEX In­dia Pvt Ltd.

IMGENEX In­dia Pvt. Ltd., a Bhubaneswar based biotech­nol­ogy com­pany has re­ceived sev­eral grants from Depart­ment of Biotech­nol­ogy to de­velop drugs for os­teo­poro­sis us­ing nan­otech­nol­ogy based drug de­liv­ery. Its biosim­i­lar trastuzumab will be ready for pre­clin­i­cal study at the end of 2017. Other biosim­i­lars in the pipe­line in­cludes hu­mira, avastin, em­brel and stel­lara. In an in­ter­ac­tion with BioSpec­trum In­dia Dr Su­jay Singh, CEO, IMGENEX In­dia Pvt Ltd. shared his views about the is­sues be­fore the CROs and how to im­prove sit­u­a­tions.

Ex­cerpts of the interview

What are the ma­jor is­sues be­fore the in­dus­try?

The FDA stated that clin­i­cal stud­ies con­ducted in as­so­ci­a­tion with a drug or med­i­cal de­vice must fol­low Good Clin­i­cal Prac­tice (GCP) guide­lines and is re­viewed by an in­de­pen­dent eth­i­cal com­mit­tee (IEC) to re­duce the un­eth­i­cal prac­tice and poor qual­ity. In­dia’s clin­i­cal trial in­dus­try faced se­ri­ous le­gal chal­lenges and dis­rup­tion of all clin­i­cal trial ac­tiv­i­ties due to 2011 lit­i­ga­tion chal­leng­ing the reg­u­la­tory frame­work and pa­tient safety guide­lines. The re­sult was the im­ple­men­ta­tion of re­stric­tive three­tier clin­i­cal trial ap­pli­ca­tion process, which con­sid­er­ably de­layed ap­proval time­lines and In­dia be­came less com­pet­i­tive in com­par­i­son to other emerg­ing mar­kets for con­duct­ing clin­i­cal tri­als.

Do you feel the clin­i­cal re­search space in In­dia will get boost?

Con­sid­er­ing the ad­van­tages of a large and di­verse ge­netic pool of a treat­ment-naive pop­u­la­tion com­bined with cost savings and in­creas­ing difficulty in sourc­ing pa­tients for clin­i­cal tri­als in devel­oped coun­tries, In­dia stands aside as a prime choice for clin­i­cal tri­als. Apart from that with high­est dis­ease bur­den (cancer in­ci­dence of one mil­lion pa­tients and a preva­lent pop­u­la­tion of 2.5 mil­lion), In­dia specif­i­cally of­fers a tremen­dous op­por­tu­nity in con­tribut­ing data for on­col­ogy tri­als. To sup­port this, on­col­o­gists are in­creas­ingly us­ing ge­nomic test­ing to gen­er­ate qual­ity ge­nomics data and iden­tify pa­tients based on their ge­nomic pro­files.,In­dia has the high­est num­ber of FDA-ap­proved man­u­fac­tur­ing plants out­side the US. With in­creas­ing fo­cus on con­strain­ing health­care costs in the US, In­dia’s low-cost man­u­fac­tur­ing ca­pa­bil­i­ties com­bined with high qual­ity stan­dards are ad­van­ta­geous.In­dia also has proven ca­pa­bil­i­ties in mmed­i­cal skills, IT ca­pac­ity, and a large pool of sci­en­tific man­power with 200 years of shared le­gacy with the US in med­i­cal ed­u­ca­tion and med­i­cal prac­tice.

And can In­dia bounce back as clin­i­cal re­search hub in the com­ing years?

In re­cent years, there was a de­cline in the num­ber of clin­i­cal tri­als, which was as­so­ci­ated with an in­crease in re­ported clin­i­cal re­search mishaps, neg­a­tive me­dia cov­er­age, ac­tivist protests, stag­na­tion of the reg­u­la­tory process and de­par­ture of spon­sors and col­lab­o­ra­tors. In 2014, CDSCO has taken cog­nizance of pa­tient safety and re­im­burse­ment in case of mishaps and made fresh guide­lines and pro­to­cols for pa­tient con­sent, is­sued a di­rec­tive that clin­i­cal tri­als could only be car­ried out at ac­cred­ited cen­ters with strin­gent qual­ity checks by ethics com­mit­tees, and lim­it­ing the num­ber of con­cur­rent tri­als by a Prin­ci­pal In­ves­ti­ga­tor. In 2016, CDSCO has also is­sued GCP in­spec­tion check­list to help spon­sors and sites. In a way, CDSCO has taken ini­tia­tive to en­sure bet­ter qual­ity tri­als and cleaner data en­sur­ing pa­tient safety. The evolv­ing process pos­i­tively sup­ports clin­i­cal re­search in In­dia. With 12-13% year-on-year growth, the In­dian pharma in­dus­try is rapidly achiev­ing a dis­tinc­tive po­si­tion in the global pharma space with CROs and clin­i­cal tri­als.

What are you sug­ges­tions to im­prove the sit­u­a­tions of the clin­i­cal re­search space in the coun­try?

CROs need to be faster, smarter and more re­spon­sive to ac­com­mo­date the needs, com­bi­na­tion reg­i­mens, de­liv­ery sys­tem and com­pan­ion di­ag­nos­tics. Apart from managing com­plex­ity, they should uti­lize cre­ative study de­sign tool such as adap­tive de­sign, which means the abil­ity to gather and vi­su­al­ize data faster which is es­sen­tial to make smarter de­ci­sion. They should fo­cus on cost con­tain­ment and short­en­ing de­vel­op­ment time­lines with­out com­pro­mis­ing qual­ity data gen­er­a­tion, while guide­lines on sub­ject pro­tec­tion, doc­u­men­ta­tion and au­dit prac­tices need to be strictly en­forced.

Newspapers in English

Newspapers from India

© PressReader. All rights reserved.