MORE THA AN A BOOM

CUBAN BIOTECH­NOL­OGY

On Cuba - - COVER | PORTADA - Amil­car Pérez Riverol

THE CUBAN BIOTECH­NO­LOG­I­CAL IN­DUS­TRY HAS EX­PE­RI­ENCED A SIG­NIF­I­CANT RISE SINCE ITS BOOM, PRO­MOTED IN THE 1980S WITH THE INAU­GU­RA­TION OF HA­VANA’S CEN­TER FOR BI­O­LOG­I­CAL RE­SEARCH (CIB) AND THE CEN­TER FOR GE­NETIC EN­GI­NEER­ING AND BIOTECH­NOL­OGY (CIGB). THE CRE­ATION OF BOTH IN­STI­TU­TIONS IS CLOSELY LINKED TO THE IDEAS OF CUBAN FOR­MER PRES­I­DENT FIDEL CAS­TRO, WHO IN 1960 PRE­DICTED THAT: “THE FU­TURE OF OUR NA­TION NEC­ES­SAR­ILY HAS TO BE A FU­TURE OF MEN OF SCI­ENCE….”

Fol­low­ing this vi­sion, and with the help of for­eign spe­cial­ists like U.S. Pro­fes­sor Ran­dolph Lee Clark, Cuba pri­or­i­tized a sig­nif­i­cant in­vest­ment in the de­vel­op­ment of its biotech­no­log­i­cal in­dus­try. Just in the pe­riod from 1990 to 1996, the coun­try in­vested around a bil­lion dol­lars which re­sulted in the emer­gence of the so- called Sci­en­tific Hub West of Ha­vana, a clus­ter of sci­en­tific cen­ters that, in 2003, al­ready had 52 in­sti­tu­tions. The cre­ation of the Hub sig­nif­i­cantly mod­i­fied the panorama of the ex­port sale of biotech­no­log­i­cal prod­ucts on the is­land which went from 100 mil­lion dol­lars a year dur­ing the 1990s to close to 300 mil­lion dol­lars in 2005.2 It also en­abled Cuba to pro­duce ap­prox­i­mately 60% of the ba­sic ta­ble of medicines used in the coun­try.

All these fac­tors have made it pos­si­ble for Cuba to cur­rently share – with In­dia and Brazil – one of the best biotech­no­log­i­cal in­dus­tries of de­vel­op­ing coun­tries.

Two strate­gies char­ac­ter­ize the ex­pe­ri­ence of Cuban biotech­nol­ogy. They are the full in­te­gra­tion and co­op­er­a­tion be­tween the cen­ters of the Sci­en­tific Hub, and these with other na­tional in­sti­tu­tions – Min­istry of Pub­lic Health, of Agri­cul­ture and of Higher Ed­u­ca­tion – and the closed cy­cle

fo­cus. The lat­ter en­sures the co­or­di­na­tion of the in­sti­tu­tions that par­tic­i­pate in each one of the com­plex stages for ob­tain­ing and li­cens­ing a biotech­no­log­i­cal prod­uct. The Quimi Hib vac­cine against Hae­mophilus inf luen­zae type B, the first in the world pro­duced based on syn­thetic anti­gens, and ob­tained based on the col­lab­o­ra­tion of four of the Hub’s in­sti­tu­tions and the Univer­sity of Ha­vana, is an ex­am­ple that con­firms the suc­cess of these strate­gies. A third el­e­ment that makes the Cuban biotech­no­log­i­cal ex­pe­ri­ence spe­cial is the fact of pri­or­i­tiz­ing the na­tional mar­ket and, there­fore, the re­search projects di­rected at of­fer­ing so­lu­tions for the prin­ci­pal pub­lic health and food prob­lems af­fect­ing the coun­try.

The in­crease of the Cuban biotech­no­log­i­cal prod­ucts port­fo­lio and of ex­ports trans­formed biotech­nol­ogy into one of the strate­gic sec­tors of the econ­omy. This fac­tor – among oth­ers – mo­ti­vated the cre­ation, in De­cem­ber 2012, of the BioCubaFarma Busi­ness group, which in­te­grated the work of 38 in­sti­tu­tions of the Sci­en­tific Hub West of Ha­vana and of the for­mer QUIMEFA Busi­ness Group. Ac­cord­ing to its deputy di­rec­tor, Doctor Ed­uardo Martínez Díaz, BioCubaFarma is co­or­di­nat­ing to­day the work of 31 en­ter­prises and 62 pro­duc­tive in­stal­la­tions. The group has a hu­man cap­i­tal of 22,000 work­ers; its in­stal­la­tions cur­rently pro­duce 569 generic medicines out of the 857 in the ba­sic ta­ble of the coun­try’s medicines. The en­ter­prise is work­ing with more

than 450 prod­ucts cor­re­spond­ing to R&D pro­grams, has 900 san­i­tary reg­istries in more than 50 coun­tries and has been given more than 1,800 patents abroad.

In a re­cent speech, the pres­i­dent of the Group, Car­los Gu­tiér­rez Calzado, an­nounced that, just in 2015, BioCubaFarma saved the coun­try some 1.94 bil­lion dol­lars in terms of im­port sub­sti­tu­tions in the health area. This sig­nif­i­cant con­tri­bu­tion is added to the one also an­nounced in 2014 by Gu­tiér­rez Calzado when he re­ported that BioCubaFarma was aim­ing to con­trib­ute to the na­tional econ­omy close to 5.076 mil­lion dol­lars from the ex­port of biotech­no­log­i­cal prod­ucts.

With these in­di­ca­tors, the biotech­no­log­i­cal in­dus­try has po­si­tioned it­self as a pri­or­ity sec­tor in the Port­fo­lio of Op­por­tu­ni­ties for For­eign In­vest­ment (FI) in Cuba. Cuban biotech­nol­ogy is part of the in­dus­trial sec­tor, third in FI lev­els (10%) in 2014. Ac­cord­ing to that re­port, in Cuba there are now nine projects of the biotech­no­log­i­cal in­dus­try with op­por­tu­ni­ties for for­eign in­vest­ment, eight of them lo­cated in Sec­tor A, Zone A-3 of the Mariel Spe­cial De­vel­op­ment Zone. These projects in­clude the con­struc­tion of plants for the pro­duc­tion of mon­o­clonal an­ti­bod­ies for ther­a­peu­tic use against can­cer, hemod­eriva­tives and bio­ma­te­ri­als.

MORE THAN THREE DECADES OF EF­FORT AND IN­VEST­MENTS HAVE SWELLED THE PORT­FO­LIO OF CUBAN BIOTECH­NO­LOG­I­CAL PROD­UCTS WITH MEDICINES OF HIGH IN­TER­EST ON A NA­TIONAL AS WELL AS IN­TER­NA­TIONAL LEVEL

More than three decades of ef­fort and in­vest­ments have swelled the port­fo­lio of Cuban biotech­no­log­i­cal prod­ucts with medicines of high in­ter­est on a na­tional as well as in­ter­na­tional level. An ex­am­ple of this is the Ci­mavax vac­cine used for the treat­ment of lung can­cer, the first of its type, and the Ni­mo­tuzumab mon­o­clonal an­ti­body, reg­is­tered for the ther­apy in head, neck, brain, esoph­a­gus and re­cently pan­cre­atic can­cer. Both prod­ucts, ob­tained in the Cen­ter for Molec­u­lar Im­munol­ogy (CIM), have been li­censed for clin­i­cal tri­als in the United States, thanks to the sign­ing of agree­ments with New York’s Roswell Park Can­cer In­sti­tute.

He­ber­prot-P, a lead­ing prod­uct of Cuban biotech­nol­ogy used for the ther­apy of di­a­betic foot ul­cers, de­serves a men­tion apart. Ac­cord­ing to re­cent data, more than 55,000 Cuban pa­tients have been treated with He­ber­prot-P, avoid­ing close to 12,000 am­pu­ta­tions. This value rep­re­sents a more than 75% re­duc­tion in the cases of am­pu­ta­tion pre­viewed be­fore the prod­uct’s ex­is­tence. More­over, He­ber­prot-P has ben­e­fited close to 240,000 pa­tients in more than 20 coun­tries of Latin Amer­ica, Asia, Africa and Europe.

Cuban and U.S. spe­cial­ists agree in af­firm­ing that the use of He­ber­prot-P would rep­re­sent a sig­nif­i­cant con­tri­bu­tion to the

U.S. health sys­tem. Ac­cord­ing to a re­port pub­lished by The Huff­in­g­ton Post, which uses data from the Amer­i­can Di­a­betes As­so­ci­a­tion, more than 29.1 mil­lion peo­ple in the United States (9.3% of the pop­u­la­tion) suf­fer from di­a­betes. Of them, be­tween 70,000 and 80,000 suf­fer am­pu­ta­tions each year fun­da­men­tally due to the ap­pear­ance of di­a­betic foot ul­cers – the statistics also in­di­cate that half of them die five years af­ter the am­pu­ta­tion. The United States spends 250 bil­lion dol­lars a year in treat­ments re­lated to di­a­betes, plus what pa­tients and the Fed­eral Pro­grams spend. The Amer­i­can Di­a­betes As­so­ci­a­tion af­firms that one out of every five dol­lars used in the health pro­grams are de­voted to the treat­ment of di­a­betes.

De­spite these data and the new panorama in Cuba-U.S. re­la­tions, pro­moted by pres­i­dents Raúl Cas­tro and Barack Obama, He­ber­prot-P can­not be used by U.S. pa­tients. The bans that per­sist re­lated to the block­ade and ex­e­cuted by OFAC, pre­vent its mar­ket­ing in U.S. ter­ri­tory. How­ever, Cuban author­i­ties re­cently re­ported that the medicine ob­tained a li­cense for its clin­i­cal as­sess­ment, a light at the en­trance of the U.S. health sys­tem and to the ben­e­fit of thou­sands of U.S. pa­tients af­fected by di­a­betic foot ul­cer.

In or­der to con­serve and ex­pand the achieve­ments of the Cuban biotech­no­log­i­cal in­dus­try, the BioCubaFarma Busi­ness Group, its ad­min­is­tra­tive lead­ers and sci­en­tists must see to the ex­ter­nal and in­ter­nal fac­tors that the re­sults of the sec­tor have been drag­ging from the past. The most sig­nif­i­cant of the ex­ter­nal fac­tors is un­doubt­edly the U.S. com­mer­cial and fi­nan­cial block­ade that hin­ders (or bans) the pur­chase of reagents, equip­ment, de­vices and the ac­cess of Cuban biotech­no­log­i­cal prod­ucts to the U.S. mar­ket. The in­ter­nal fac­tors in­clude the marked ag­ing of the hu­man cap­i­tal – fun­da­men­tally sci­en­tific – as­so­ci­ated to the high lev­els of em­i­gra­tion of young re­searchers, in­suf­fi­cient wages, the ex­ces­sive politi­ciza­tion in the ad­min­is­tra­tive lead­er­ship, the lim­ited num­ber of ba­sic stud­ies that lead to ob­tain­ing prod­ucts of a new type, of high added value, the low lev­els of ac­cess to the In­ter­net and of in­ter­na­tional sci­en­tific ex­change of many of its pro­fes­sion­als and, fi­nally, the scarce im­pact on other spheres like agri­cul­ture and food pro­duc­tion.

Cuban biotech­nol­ogy has sur­passed the boom stage to be­come a struc­tured sec­tor and in con­stant de­vel­op­ment in the sys­tem of na­tional sci­en­tific in­sti­tu­tions.

Its suc­cess demon­strates – per­haps as no other on the is­land – that the com­bi­na­tion of a cor­rect vi­sion, the ra­tio­nal de­sign, sys­tem­atic in­vest­ment and, above all, the pres­ence of an ex­cel­lent hu­man cap­i­tal guar­an­tee a dy­namic in­dus­try with a high im­pact on the coun­try’s so­cial, eco­nomic and de­vel­op­ment as­pi­ra­tions.

cien­tí­fico in­ter­na­cional de mu­chos de sus pro­fe­sion­ales y, fi­nal­mente, el es­caso im­pacto en otras es­feras como la agri­cul­tura, y la al­i­mentación.

La biotecnología cubana ha su­per­ado la etapa del boom para con­ver­tirse en un sec­tor es­truc­turado y en con­stante de­sar­rollo den­tro del sis­tema de in­sti­tu­ciones cien­tí­fi­cas na­cionales.

Su éx­ito de­mues­tra – quizás como ningún otro en la Isla– que la con­ju­gación de una visión ac­er­tada, el dis­eño racional, la in­ver­sión sis­temática y, so­bre todo, la pres­en­cia de un ex­ce­lente cap­i­tal hu­mano, garan­ti­zan una in­dus­tria dinámica y con el­e­vado im­pacto en las as­pira­ciones so­ciales, económi­cas y de de­sar­rollo del país.

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