Sec­tor built on world class per­for­mance

Irish Examiner - Supplement - - LIFE SCIENCES - Joe Der­mody

Ire­land’s phe­nom­e­nal suc­cess in at­tract­ing high level in­vest­ment owes a great deal to the con­sis­tently world class per­for­mance of Ir­ish-based com­pa­nies in good man­u­fac­tur­ing prac­tice (GMP).

The re­cent ‘Mol­e­cules Make A Dif­fer­ence’ re­port by the Ibec group BioPharmaChem Ire­land (BCPI) — a strat­egy doc­u­ment which was cre­ated for the Ir­ish bio­phar­ma­ceu­ti­cal in­dus­try — praises the “ex­traor­di­nar­ily good” record of Ire­land’s pharma sec­tor in terms of com­pli­ance with statu­tory and qual­ity reg­u­la­tions.

Au­dits con­ducted by the US Food and Drug Ad­min­is­tra­tion (FDA), Health Prod­ucts Reg­u­la­tory Au­thor­ity (HPRA) and con­sumer au­dits all con­sis­tently give high rat­ings to Ir­ish GMP per­for­mance.

The BCPI re­port fur­ther states: “Ire­land has a very well-ed­u­cated, hard­work­ing, flex­i­ble work­force with a ‘can-do’ at­ti­tude and a pride that of­ten re­sults in the Ir­ish op­er­a­tions ex­celling in a cor­po­rate en­vi­ron­ment. The work­force, to­gether with low tax­a­tion, fi­nan­cial in­cen­tives and grants, and ac­cess to prof­itable key mar­kets, makes Ire­land the num­ber one choice for do­ing busi­ness.”

The BCPI re­port was con­ducted in part­ner­ship with many lead­ing com­pa­nies in Ire­land’s thriv­ing bio­pharma in­dus­try, and in­cludes key in­puts from the IDA. The IDA notes that the last three years have seen a strong resur­gence in the Ir­ish life sciences sec­tor; it cites 2015 as a “ban­ner year” — with ma­jor projects an­nounced by com­pa­nies such as Alex­ion, Am­neal and Re­gen­eron. Since Jan­uary 2012, this wave of an­nounced in­vest­ments has to­talled more than $4bn (€3.5bn) in cap­i­tal com­mit­ted and over 3,000 new high value di­rect jobs with a large num­ber of ad­di­tional in­di­rect jobs in con­struc­tion as well as other ser­vices. A strik­ing fea­ture of this on­go­ing in­vest­ment has also been the strong re­gional dis­per­sal, with lo­ca­tions such as West­port, Galway, Lim­er­ick, Cashel,Water­ford and Athlone all ben­e­fit­ting.

In in­fec­tious dis­ease the Hep­ati­tis C drugs from Gilead and Ab­bvie have been huge suc­cesses and led to in­vest­ment in Ire­land.

In car­dio­vas­cu­lar dis­ease the PCSK9 an­ti­bod­ies have cap­tured the imag­i­na­tion of the mar­kets, while Re­gen­eron and Am­gen have in­vested in their sup­ply chains in Ire­land.

The last few years have been a golden age for on­col­ogy re­search and Ire­land has ben­e­fit­ted in the form of ma­jor in­vest­ments to pro­duce the new Pd1 an­ti­bod­ies Op­divo and Keytruda from BMS and MSD.

Ire­land is also see­ing con­tin­ued growth in drug ap­provals in the or­phan and ul­tra-or­phan spa­ces as ev­i­denced by ad­di­tional in­vest­ment from com­pa­nies such as Alex­ion and Biomarin.

BPCI di­rec­tor Matt Mo­ran states that we are cur­rently see­ing the evo­lu­tion of this sec­tor in Ire­land, with more di­ver­si­fi­ca­tion ev­i­dent than ever be­fore. He notes that many of the new in­vest­ments in this area have been within the bi­o­log­ics sec­tor with Alex­ion, Re­gen­eron, Mallinck­rodt and Bris­tol Myers Squibb all es­tab­lish­ing sig­nif­i­cant fa­cil­i­ties in Ire­land. Ire­land con­tin­ues to de­velop into an im­por­tant sup­ply chain hub for the en­tire bio­pharma sec­tor.

He notes that the case stud­ies in the BPCI re­port clearly il­lus­trate how this de­vel­op­ment has evolved.

The case stud­ies also demon­strate how the en­tire in­fra­struc­ture has de­vel­oped in par­al­lel to sup­port the con­tin­ued ex­pan­sion of the sec­tor in Ire­land.

Mr Mo­ran says: “I see Ire­land con­tin­u­ing to play an im­por­tant role as a cen­tre of man­u­fac­tur­ing, sup­ply and de­vel­op­ment for the en­tire pharma sec­tor — from small through medium to large molecule.”

One case study fea­tured in BPCI’s re­port is global health and nutri­tion group FMC In­ter­na­tional, which has 5,000 em­ploy­ees in 36 coun­tries world­wide, and a sig­nif­i­cant op­er­a­tion in Cork since the 1970s.

Bren­dan Keane, gen­eral man­ager, FMC In­ter­na­tional, Cork, said: “We are a ma­ture, largely ex­port­ing, busi­ness es­tab­lished in 1978 in Cork- con­sis­tently grow­ing with our global cus­tomers in Phar­ma­ceu­ti­cal and food ap­pli­ca­tions.

“While wage and salary re­straint have con­trib­uted to re­tain­ing our com­pet­i­tive edge, hav­ing good people fo­cused on op­er­at­ing ex­cel­lence and also con­tin­u­ing to in­vest in au­to­ma­tion and pro­duc­tiv­ity have been crit­i­cal.

“We had just ex­panded the pro­duc­tion ca­pac­ity com­ing into the re­ces­sion, and our fo­cus on safe op­er­a­tion, pro­duc­tiv­ity and value adding ac­tiv­ity has led to the very re­cent cre­ation of sig­nif­i­cant ad­di­tional em­ploy­ment in fi­nan­cial ser­vices and cus­tomer sup­port. Ac­cess to and re­ten­tion of good people and suc­cess­fully driv­ing unit costs lower has been and re­mains crit­i­cal to our suc­cess,” stated Mr Keane.

Martin Shana­han, IDA chief ex­ec­u­tive, notes that more than €10bn has been in­vested in this very sig­nif­i­cant sec­tor dur­ing the past decade.

“Ire­land re­mains an ex­tremely at­trac­tive lo­ca­tion for for­eign di­rect in­vest­ment,” he states in the BPCI re­port. “We have over many years been suc­cess­ful in at­tract­ing in­vest­ment in a broad range of sec­tors. 2015 was one of the most suc­cess­ful years to-date for For­eign Di­rect In­vest­ment. There are now 187,000 people em­ployed in the IDA Ire­land port­fo­lio of com­pa­nies and when one takes in­di­rect em­ploy­ment into ac­count ap­prox­i­mately one in five people in Ire­land are de­pen­dent on FDI for em­ploy­ment.

“A key con­trib­u­tor to this suc­cess has been man­u­fac­tur­ing — and in par­tic­u­lar the Life Sciences sec­tor (Med­i­cal Tech­nolo­gies and Bio­phar­ma­ceu­ti­cals).

“These com­pa­nies are clus­tered in mul­ti­ple lo­ca­tions around the coun­try with strong in­fras­truc­tural and aca­demic sup­ports.

“It is the largest ex­porter of prod­ucts by value with man­u­fac­tur­ing as a whole ac­count­ing for more than 20% of Ir­ish GDP.

“Ire­land is the home of bio­pharma man­u­fac­tur­ing with a strong and deep life sciences back­ground for both drug sub­stance and for drug prod­uct. Ire­land is cur­rently see­ing a steady stream of new in­ter­na­tional in­vest­ments par­tic­u­larly in bio­phar­ma­ceu­ti­cals. Nine of the top ten global bio­phar­ma­ceu­ti­cal com­pa­nies have an in­ter­na­tional base in Ire­land to­day. Over €10bn has been in­vested in the sec­tor in the last decade.”

Martin Shana­han, IDA chief ex­ec­u­tive, says life sciences firms are Ire­land’s largest ex­porters of prod­ucts by value with man­u­fac­tur­ing ac­count­ing for more than 20% of Ir­ish GDP.

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