Lever­ag­ing clin­i­cal re­search ex­ports

Enterprise - - Tdap -

Clin­i­cal Re­search, also known as Clin­i­cal In­ves­ti­ga­tion, is the busi­ness of test­ing new drugs or com­pounds in hu­man sub­jects for dis­cov­er­ing po­ten­tial ben­e­fi­cial ef­fects and de­ter­min­ing safety and ef­fi­cacy. This ac­tiv­ity is now be­ing in­creas­ingly out­sourced by the multi­na­tional phar­ma­ceu­ti­cal in­dus­try. It was es­ti­mated to be a $6 bil­lion mar­ket in 2002 and had reached around $10 bil­lion by the end of 2005. The sec­tor is now es­ti­mated to have reached a vol­ume of $60 bil­lion and the Asian and East­ern Euro­pean Con­tract Re­search Or­ga­ni­za­tions (CROs) are said to have played an im­por­tant role in this re­gard.

Pak­istan is the 6th most pop­u­lous coun­try in the world with a pop­u­la­tion of 180 mil­lion. Ac­cord­ing to WHO es­ti­mates, the coun­try has nearly 10 mil­lion pa­tients. By the end of 2009, the to­tal num­ber of reg­is­tered doc­tors was 139,555, den­tists 9,822 and reg­is­tered nurses 69,313. Ac­cord­ing to avail­able fig­ures, the pop­u­la­tion–to-doc­tor ra­tio is 1183:1, which means there is one doc­tor for1, 183 per­sons. The pop­u­la­tion-to-den­tist ra­tio is 16,914:1 and the pa­tient per bed ra­tio is 1592:1. Health­care units in the pub­lic sec­tor are: hos­pi­tals - 968; dis­pen­saries - 4813; ba­sic health units - 5,345 and ru­ral health cen­tres - 572.

There are eight CROs cur­rently work­ing in Pak­istan, of which six are in Karachi such as Met­rics Re­search, which is also the coun­try’s first CRO (es­tab­lished in 2003,), IRD, Clin­i­sion, Verum Ven­ture, Medco Group, Uni­ver­sal labs, Medessense in La­hore and Mile­stone Bios­tud­ies Cen­tre in Islamabad. Many of these CROs are in­volved in in­ter­na­tional clin­i­cal tri­als in ther­a­peu­tic care such as on­col­ogy, hema­tol­ogy, os­teo­poro­sis, in­fec­tious dis­eases, car­dio­vas­cu­lar dis­eases, oph­thal­mol­ogy and di­a­betes.

Clin­i­sion has 1100 health­care pro­fes­sion­als and Met­rics has 400 such pro­fes­sion­als, who are mainly doc­tors, univer­sity stu­dents and some in­ter­na­tional stu­dents, GSK, Eli Lilly, Pfizer and Sanofi Aven­tis have also trained a large num­ber of per­son­nel.

With a large num­ber of English-speak­ing physi­cians, a large net­work of med­i­cal cen­tres cou­pled with the low value of the Pak ru­pee, Pak­istan should be an at­trac­tive venue for Con­tract Re­search. The role of the Trade De­vel­op­ment Au­thor­ity of Pak­istan (TDAP) is cru­cial in this re­gard. As the TDAP’s man­date is to en­hance ex­port of goods and ser­vices from Pak­istan, Clin­i­cal Re­search Ser­vices can of­fer a great po­ten­tial in gen­er­at­ing ex­port rev­enue for the coun­try.

Re­al­iz­ing this po­ten­tial, the TDAP, in col­lab­o­ra­tion with the Min­istry of Health and the Jin­nah Post­grad­u­ate Med­i­cal Cen­tre (JPMC), aims to in­vite com­pa­nies that con­duct clin­i­cal tri­als to come to Pak­istan and es­tab­lish their cen­tres in the coun­try. These three gov­ern­ment or­ga­ni­za­tions have al­ready planned to at­tract more in­ter­na­tional out­sourced clin­i­cal tri­als from over­seas.

To fur­ther ex­pand the ac­tiv­ity area, there is a need to de­velop part­ner­ships with in­ter­na­tional CROs and other out­sourc­ing providers. Some of the ma­jor CROs in the world are in­ter­ested in work­ing in Pak­istan but they need en­cour­age­ment from the reg­u­la­tors in Pak­istan. They are also con­cerned about data re­li­a­bil­ity and man­age­ment, doc­u­men­ta­tion and in­tel­lec­tual prop­erty rights. There should be a plat­form that can look at these is­sues holis­ti­cally and also acts as co­or­di­na­tion plat­form. TDAP in­tends to pro­vide such a plat­form.

In a num­ber of sem­i­nars or­ga­nized in this re­gard, the TDAP Chief Ex­ec­u­tive, Tariq Puri, has fo­cused on the un­der­stand­ing of Clin­i­cal Trial Man­age­ment and what Pak­istan can of­fer to the for­eign CROs, iden­ti­fy­ing the gaps in the sys­tem and find­ing ways and means to make the en­vi­ron­ment more vi­able for for­eign in­sti­tu­tions to in­vest in clin­i­cal re­search in Pak­istan.

TDAP is com­mit­ted to rec­og­niz­ing and en­cour­ag­ing the need for de­vel­op­ing clin­i­cal trial man­age­ment in Pak­istan, since CROs also of­fer op­por­tu­ni­ties to en­hance the coun­try’s health­care fa­cil­i­ties when they con­duct clin­i­cal re­search and man­age data as per in­ter­na­tional stan­dards which would lead to qual­ity train­ing of health­care providers and man­age­ment of re­search in the coun­try. Fo­cus on this area is re­quired to pro­mote and cre­ate aware­ness about the op­por­tu­ni­ties in a $60 bil­lion global mar­ket.

TDAP has as­sured the stake­hold­ers that it will take ev­ery pos­si­ble mea­sure to pro­vide sup­port both to the gov­ern­ment in­sti­tu­tions and the phar­ma­ceu­ti­cal com­pa­nies to jointly ben­e­fit and pro­mote Pak­istan’s po­ten­tial in the field to lever­age ex­ports in the ser­vices sec­tor

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