“Gov­ern­ments should make global set of spec­i­fi­ca­tions that can be fol­lowed”

BioSpectrum (Asia) - - Bio Content - Kalyani Sharma kalyani.sharma@mmac­tiv.com

Bio-Techne Cor­po­ra­tion is a lead­ing de­vel­oper and man­u­fac­turer of high qual­ity pu­ri­fied pro­teins––no­tably cy­tokines and growth fac­tors, an­ti­bod­ies, im­munoas­says, as well as bi­o­log­i­cally ac­tive small mol­e­cule com­pounds --which are sold to bio­med­i­cal re­searchers and clin­i­cal re­search lab­o­ra­to­ries; these op­er­a­tions con­sti­tute the core Biotech­nol­ogy Di­vi­sion, head­quar­tered in Min­neapo­lis, Min­nesota. Bio-Techne prod­ucts as­sist sci­en­tific in­ves­ti­ga­tions into bi­o­log­i­cal pro­cesses and the na­ture and progress of spe­cific dis­eases. They aid in drug dis­cov­ery ef­forts and pro­vide the means for ac­cu­rate clin­i­cal tests and di­ag­noses. With thou­sands of prod­ucts in its port­fo­lio, Bio-Techne gen­er­ated ap­prox­i­mately $563 mil­lion in net sales in fis­cal 2017 and has ap­prox­i­mately 1,800 em­ploy­ees world­wide. In an in­ter­ac­tion with BioSpec­trum Charles (Chuck) Kum­meth, President & CEO, Bio-Techne Cor­po­ra­tion shared his views on op­por­tu­ni­ties and chal­lenges be­fore the bio sup­pli­ers mar­ket. Ex­cerpts of the in­ter­view.

What are the trends in bio sup­pli­ers mar­ket with re­spect to life sciences and health­care in­dus­try?

The health­care in­dus­try, in par­tic­u­lar the phar­ma­ceu­ti­cal in­dus­try, is cer­tainly ex­pe­ri­enc­ing a cer­tain level of con­sol­i­da­tion. In­dia has ben­e­fit­ted with roughly 8% of the global mar­ket for gener­ics. It’s a very high per­cent­age of gener­ics com­pared to the real size of the mar­ket here in In­dia; so that is prob­a­bly go­ing to dic­tate the trend of what’s go­ing to hap­pen here in In­dia.

I think in life sciences the trend in In­dia is very sim­i­lar to the trend across Asia, which is dif­fer­ent in the US and in Eu­rope which is found in biosim­i­lars.

So the big trend in Asia is to get away from tra­di­tional biosim­i­lar de­vel­op­ment of large and small mol­e­cule and go af­ter gener­ics with the chem­i­cal based ver­sion of a drug.

I think it’s dif­fi­cult to un­der­stand the trends and how much regulation there will be, how de­tailed they need to be plus it should be cheaper and more eco­nom­i­cal which is why I think peo­ple come to In­dia for gener­ics at first place.

I think, the ma­jor trend will be biosim­i­lars re­lated and heav­ily dic­tated by still form­ing reg­u­la­tions that will be re­quired to be in a mar­ket with a biosim­i­lar drug.

We see a con­sol­i­da­tion of the var­i­ous sup­pli­ers in this in­dus­try in an at­tempt to pro­vide more com­plete work­flow so­lu­tions to cus­tomers. The idea is that on­estop-shop­ping would make it eas­ier for a cus­tomer to find most of their needs.

How do you see the op­por­tu­nity for bio sup­plier in the same do­main?

Biosim­i­lars are the next gen­er­a­tion. There are around 800 biotech com­pa­nies in In­dia and I am sure many are de­vel­op­ing biosim­i­lars. Rea­sons like less cost and less cap­i­tal makes it a very en­tre­pre­neur­ial like and that’s why China and Korea are also chas­ing In­dia. Ja­pan is more into re­gen­er­a­tive medicine and is re­ally not fo­cussed on biosim­i­lars but they are the lead­ers when it comes to stem cells and IPS cells.

The pharma world has gone from a pure chem­istry based ap­proach in find­ing new drugs to now adopt­ing many bi­o­log­i­cals as new drugs. In do­ing so there is greater in­ter­est in learn­ing more about the func­tion of each mol­e­cule, its re­cep­tors and me­chan­ics to block or en­hance the ac­tion through the use of a bi­o­log­i­cal. This has re-en­er­gized the life sci­ence in­dus­try.

A lot is go­ing to come down to tools and reagents and spec­i­fi­ca­tions of how to ac­tu­ally make a good prod­uct. This in turn is go­ing to come down to qual­ity in gen­eral and for our com­pany too since we are mostly a re­search tools com­pany, com­prised of reagents and in­stru­ments. For us it is re­ally about the qual­ity of the pieces that go into the work­flow that will cre­ate biosim­i­lars. What is GMP and PDMA? What will the reg­u­la­tions be? This is go­ing to be very very crit­i­cal and peo­ple are go­ing to stretch the truth and some peo­ple are go­ing to claim to be GMP cer­ti­fied even if they are not.

Our com­pany has al­ways been a very lead­ing

com­pany putting qual­ity first, with a very gold stan­dard brand like R&D Sys­tems, so, we are very care­ful about mak­ing GMP and qual­ity claims. Each of our pro­tein prod­ucts carry bioas­says claims that en­sure the bioac­tiv­ity of these prod­ucts. Very few in our in­dus­try do this. I think many of these qual­ity is­sues will ul­ti­mately de­ter­mine who will suc­ceed and who will not in the sup­ply chain of biosim­i­lars. We are hop­ing suc­cess be­cause we think our brand and qual­ity rep­u­ta­tion will pro­vide con­fi­dence to those who rely on our prod­ucts.

What are the op­por­tu­ni­ties that can be gen­er­ated in biosim­i­lar do­main?

The op­por­tu­nity for Bio-Techne Cor­po­ra­tion is hav­ing so many prod­ucts that lend them­selves to the de­vel­op­ment of biosim­i­lars. We are not re­ally in­volved with pharma on small and large mol­e­cules or do­ing re­search with the prod­ucts. I think in terms of biosim­i­lars we can do much more in the work­flow and get more share of that sup­ply chain. We en­gage in many cus­tom de­vel­op­ments of an­ti­bod­ies for com­pa­nies right now. We have about 40,000 prod­ucts. We man­u­fac­ture in house, in terms of an­ti­bod­ies, as­says and pro­teins and we’ve been do­ing this for over 40 years. No­body has more cloned pro­teins and re­lated reagents than we do. Such a large col­lec­tion of bi­o­log­i­cally ac­tive mol­e­cules can be very ap­peal­ing to any com­pany try­ing to de­velop the next suc­cess­ful biosim­i­lars.

We are very well known for high level of pu­rity and qual­ity of an­ti­bod­ies. We don’t ex­pect to be in the drug business but we do ex­pect to be li­cens­ing more and more of our in­tel­lec­tual prop­erty to com­pa­nies who want to de­velop new drugs. Pharma will do the clin­i­cal tri­als which will re­quire sig­nif­i­cant cap­i­tal to sup­port these ac­tiv­i­ties. But in the end they will make good re­turns on their in­vest­ment. Again, our com­pany hav­ing roughly $600 mil­lion in rev­enues, can be sat­is­fied with a growth of 10 per cent per year, but for a large phar­ma­ceu­ti­cal com­pany this can be too small.

We launch in the mar­ket al­most 1500 new prod­ucts each year among an­ti­bod­ies, pro­teins and im­munoas­says. Also, we are the world lead­ers in Lu­minex-based im­munoas­says. Through our 10 ac­qui­si­tions in the last four years we are par­tic­i­pat­ing more and more in our cus­tomers’ whole work­flow by hav­ing in­stru­ments, prod­ucts in ad­di­tion to reagents. We think this is one way to scale our com­pany and go be­yond just re­search be­cause many of these tech­nolo­gies that use our reagents can also be­come com­pan­ion di­ag­nos­tics for the pharma in­dus­try.

What are ma­jor chal­lenges be­fore in­dus­try and what are your sug­ges­tions to over­come these is­sues?

Some of the chal­lenges in the bio­sup­plier space is that the bar­rier to en­try is low and it’s easy to launch prod­ucts, have a low price struc­ture and with a web­site ev­ery­one can look rep­utable. How­ever the qual­ity in these prod­ucts can be ques­tion­able and cus­tomers are chal­lenged in know­ing whether the prod­uct they are buy­ing at a low price has max­i­mal bioac­tiv­ity or pu­rity. These is­sues can set back a long term ex­per­i­ment or con­found the in­ter­pre­ta­tion of ex­per­i­men­tal data.

Con­cern­ing rules and reg­u­la­tions, what’s go­ing to hap­pen in In­dia will be dif­fer­ent in Ja­pan and dif­fer­ent in China. We are look­ing for gov­ern­ments to make a global set of spec­i­fi­ca­tions that can be fol­lowed. Since its dif­fer­ent ev­ery­where, it’s chal­leng­ing.

SOME OF THE CHAL­LENGES IN THE BIO­SUP­PLIER SPACE IN­CLUDE THE BAR­RIER TO EN­TRY IS LOW, IT’S EASY TO LAUNCH PROD­UCTS,

WHICH HAVE A LOW PRICE STRUC­TURE AND WITH A WEB­SITE EV­ERY­ONE CAN LOOK REP­UTABLE. HOW­EVER THE QUAL­ITY OF THESE PROD­UCTS CAN BE QUES­TION­ABLE.

Charles (Chuck) Kum­meth President & CEO, Bio-Techne Cor­po­ra­tion

Charles (Chuck) Kum­meth President & CEO, Bio-Techne Cor­po­ra­tion

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