“We re­main very op­ti­mistic about the fu­ture of clin­i­cal tri­als in In­dia”

BioSpectrum (India) - - COVER STORY - - Dr John Moller CEO, Novotech, a Syd­ney-based full-ser­vice con­tract re­search or­gan­i­sa­tion (CRO), hav­ing op­er­a­tions in In­dia, with a fo­cus on clin­i­cal mon­i­tor­ing

The In­dian CRO mar­ket has un­doubt­edly con­tracted over the last few years fol­low­ing the ef­fec­tive shut­down of clin­i­cal trial ac­tiv­ity af­ter the 2012 Supreme Court pe­ti­tion by the NGO Swasthya Ad­hikar Manch.

Since then the In­dian govern­ment has worked hard to re­struc­ture clin­i­cal trial over­sight and gov­er­nance, and as we know there were some chal­lenges im­ple­ment­ing a num­ber of the new rules. No­table ex­am­ples were is­sues around video con­sent­ing and pa­tient com­pen­sa­tion.

Many of these chal­lenges have now been re­solved, but the re­al­ity is that spon­sors have been much slower to re-enter the In­dian mar­ket than ex­pected.

If we look at data from clin­i­cal­tri­als.gov, there were 101 “In­dus­try Funded” tri­als started in

2012, but only 27 recorded in 2016. Novotech’s key cus­tomer group is small to mid­sized bio­phar­ma­ceu­ti­cal com­pa­nies, and they have fallen from 44% of trial ac­tiv­ity in 2012 to 15% in 2016. This shift is un­der­stand­able as the larger phar­ma­ceu­ti­cal com­pa­nies of­ten have ex­pe­ri­ence in In­dia and es­tab­lished JV re­la­tion­ships, while smaller bio­phar­ma­ceu­ti­cal com­pa­nies, with a smaller port­fo­lio of com­pounds will be more risk averse un­til they are very cer­tain that the en­vi­ron­ment has im­proved.

As clin­i­cal trial ac­tiv­ity, has de­clined, many CROs have re­de­ployed their very tal­ented staff into ar­eas such global or re­gional pro­ject man­age­ment, bio­met­rics, phar­ma­covig­i­lance, riskbased mon­i­tor­ing and ad­min­is­tra­tive sup­port, and so the con­trac­tion of the in­dus­try won’t re­flect the de­cline in clin­i­cal trial ac­tiv­ity. In­deed, Novotech’s In­dian work­force has in­creased by around six-fold since 2012. While set­ting up any busi­ness in Asia has it’s com­plex­i­ties with a range of reg­u­la­tions, and bu­reau­cratic in­sti­tu­tions need­ing to be nav­i­gated, we have found In­dia to be a rel­a­tively busi­ness­friendly en­vi­ron­ment,, with no­table im­prove­ments over the last three years.

We re­main very op­ti­mistic about the fu­ture of clin­i­cal tri­als in In­dia, and the key macro fac­tors that will in­flu­ence the mar­ket are: i) huge treat­ment naïve pop­u­la­tion, with In­dia ex­pected to sur­pass China as the most pop­u­lous county in the world in com­ing decades ii) highly ed­u­cated tech­ni­cal staff iii) A well-es­tab­lished phar­ma­ceu­ti­cal man­u­fac­tur­ing sec­tor en­sur­ing spon­sors con­tinue to in­vest in in­fra­struc­ture and tal­ent iv) An at­trac­tive cost base.

We are cur­rently start­ing a cou­ple of clin­i­cal tri­als in In­dia for smaller bio­pharma clients and we are very ex­cited by the progress. Reg­u­la­tory time­lines have been faster than ex­pected, and ev­ery­one is very en­gaged in­clud­ing sites, in­ves­ti­ga­tors, ethics com­mit­tees, and

Sub­ject Ex­pert Com­mit­tees. Novotech is in­vest­ing ad­di­tional re­sources in over­see­ing our In­dian clin­i­cal tri­als be­cause we are very keen to an­tic­i­pate and min­imise any is­sues, so that we can pro­mote In­dia as the clin­i­cal trial des­ti­na­tion it de­serves to be.

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