national r dpolicy: an industrlalperspective · 53. lung disease patients with negative dthr*t had:...

10
53. Lung disease patients with negative DTHR*T had: caseating granuloma (1), silicosis (3), tuber- culosis with pleural effusion (l ), intravascular angiogenic tumor (1), chronic bronchiectasis (5), chronic organizing interstitial pneumonitis (4), recurrent cyst (1), coccidioidomycosis (1), sar- coidosis (2),chronie obstructive pulmonary dis- ease (8), chronic asthma emphysema, and pneu- monitis (5), pneumonia (3). 54. E. R. Pisher er al.; Cancer 36, 1 (1975): 55. D. L. Page et al., J. Natl. Cancer Lnst, 61,1055 (978). 56. Patients with the following cancers reacted neg- atively (one of each); B-celllymphoma; extra- pulmonary carcinoid ; astrocytoma; glioma; glio- ma-astrocytoma; liposarcoma; leiomyosarcoma; sarcomatous chordoma;'localized, encapsulated papillary-, mixed papillary-, and medullary10w- grade thyroid carcinoma. In addition; four pa- tients with acute or chronic myelocytic leukemia and two with Hodgkin's disease in remission reacted negatively. 57. M. I. Bernhard, H. J. Wanebo, J. Helm, R. C. Pace, D. L. Kaiser, Cancer Res. 43, 1932(1983). 58. J. H. Kaplan,S. H. Lockwood,T. J. Cunning- ham, G. F.'Springer, E. E. Uzgiris, in Cell Electrophoresis in Cancer and Other Clinical Research, A.W; Preece and P. A. Light, Eds. (Elsevier, New York,-l98l), pp. 197-202. 59.B.'D. Jankovic andB.H. Waksman, Jc lmmu- nol, -89, 598(1962); E.J. Holborow and G. Loewi, Immunology 5, 278 (1962). 60. W. O. Weigle,]. ,M.Chilleri G.S:Habicht, Transplant. Rev. 8, 3 (l972);P.A. Bretscher.v. lmmunol. 131, 1103 (1983). 61. The two-sample comparisons 'of the statistical results on carcinoma patients _with those on patients with benign disease of the same organ are in most instances extremely significant sta- tistically, with Pcvalues of the order of several one-thousands. This also applies to both catego- ries of squamous-cell carcinoma. In the case of pooled pancreas and 'pancreas benign, - P is 0.0043; there are only five benign pancreas patients. However,jfall pancreas carcinoma is compared-with all pooled noncercincma, P is 0.,0000. The same pertains if breast .carcinoma StageI infiltrating is compared with all noncar- cinema, while for breast carcinoma Stages II and III P hO.OOOI when .compared with all noncarcinoma. A two-sample Student test of the hypothesis that the combined carcinoma and the combined noncarcinoma populations are. the same has a P of 0.0000 and yields the very large, extremely significant r-statistic of ::> 9.5. Addi- tional statistical information will be furnished on request to the author, as will be the: individual QM' ranges. 62. P. M. Brickell et al., Nature '(London) 306, 756 (1984). G. F. Springer et al., unpublished data. 64. J. C. Mottram, J. Pathol. Bacterial. 40, 407 (1935); P. C.Nowell, Science193, 23 (1976); D. Douer et al., Br, J. Haematol, 49,615(981); B. G. Nee1, W. S. Hayward, H. L. Robinson, J; Fang,S. M. Astrin, Cell 23, 323 (1981). 65; D. V. Fournier et ai.iCancer 45,2198 (1980); N. Hayabuchi, W. J. Russell, J.Murakami, ibid. 52,1098 (1983). 66. G. W. G. Bird,-J. wingham, M. J. Pippard, J. G. Hoult, V. Melikian,Br.J. Haematol, 33, 289 (1976); P.'M, Ness, G. Garratty, P. A. Morel, H. P. Perkins, Blood 54,30 (1978), 67. A F: R.Rahman andBv Mi Longenecker, J. lmmunol, 129, 2021 (15182); S. Metcalfe, R.J. Svvennsen, G. F. Springer, H. Tegtmeyer, J. lmmunol. Methods 62, pM8 (1983): 68.M. K. Robinson and Gi.F. Springer, Proc.Am. Assoc. Cancer Res., in press. 69. I thank.M. Dwass, NorthwesternUniversity,for the statistics. This work benefitted from the contributions of" my colleagues; their names appear in the reterences.J owe special gratitude to E. F. Scanlon, P. R. Desai, W. A; Fry, and H. Tegtmeyer.l thank M. J. Cline, E. R. De- Sombre, ,Po Heller, W. H. Kirsten, S. E. Krown, R. D. Owen, and 1. Rosenblum for criticism: I thank Evanston Hospital's physicians for con- tinued encouragement to study their patients.. I dedicate this article to Heather Margaret Spring- er, nee Blight, who lived from age 48 through 54 with metastases from bilateral breast carcinoma. Her courageous participation in investigation of unknown immunological territory and her pains- taking clinical observations remain. an enduring obligation. Support was provided by grants CA 19083and CA 22540 from the NationalInstitutes of Health and by the Julia S. Michels Investiga- torship. National R & DPolicy: An Industrlal Perspective Roland W. Schmitt the performance of basic .research and the training of research manpower. The' distraction is.especially .great if Washing- ton pays toomuch attentionto the.grow- ing number of calls for the governmentto take over the job of . selecting and . sup- porting. R &.D programs aimed at corn- mercial results. The Federal Role Industrial )olicy has become one of the hot. issues on our national agenda, with various advocates telling us how to beat the Japanese and solve the prob- lems of unemployment"infiation',and industrial stagnation ,The 1984 tial candidates are picking up these ideas and testing the Ill. Industrial policy has many cornpo- nents-c-fiscal; monetary; and regulatory, for example. It touches on many .areas, from international trade to retraining the work force. I can bring my expertise to only One corner of this 'many-sided sub- ject; research and developmentpolicy. To me, industrial policy means what the government Illust?otq shape our nation- alindustrial posture', and a clear under- standing of what governmentshould not do. There has been 00 lack of proposals. Bills put before Congress in recent years have called for such changes as the es- The author is senior vice presldent.cCorporate Researchand Development, General Electric Come parry, Schenectady, New York 12301. This article is adapted from his keynote speech at the National Conference on the Advancement of Researchc-San Antonio, Texas, 10 October 1983. 1206 tablishment of a National Technology Foundation,or a Cabinet-level Depart- ment of Trade and Industry; the selec- tionofa National Commission.on "Tech- nological'Innovation and Industrial Mod- ernization to tell us ','what educational, and industrial priorities of 1J hitedStatesoughttobe' ;,'lriesi- dentialProgram for the Advancement of Science-and Technology; and a .Co ll1mis- sionon High Technology and Employ- ment Potential. Another proposal would establish a government program to ,con* duct research and development on im- proved manufacturingtechniques;,'oth;. ers would exempt joint research:. and development efforts from the .antitrust laws. All these proposals to aid U.S. R& D sho:wa healthyandencQuraging'concern about the state of American industrial technology, but they may at the same time distract politicians and policy-mak- ers from the most important need,and the mostImportantstep that government can take to strengthen U.S. innovation. That task is toensufeand strengthen 'the health of our university system-e-m. both In the commerciaLR & Darea there are some things that. government must and can do, and other things it cannot and should not do. Government has a crucial role to play. in creating favorable conditions for commercial innovation, but not in actually producing those inno- vations. There are several reasons for this. First; successful innovation requires a close .and intimate coupling between the developers of a technology and the busi- nesses that will bring products based on that technology to market and are them- selves in touch with that market; This is essential.in a diversified company, and even more essential in a complex and diversified economy. The R&D people must .. comprehend .• the..strategies ,of the business as well as know what the mar- ket constraints are. and what the compe- tition 'is up to.. business people, ill turn, must understand the capabilities and limitations of the technology. They must .possess thetechnicalstrength to complete the development and believe strongly enough in the technology's po- tential to make the big investment need- ed to bring it to market. SCIENCE, VOL. 224

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Page 1: National R DPolicy: An IndustrlalPerspective · 53. Lung disease patients with negative DTHR*T had: caseatinggranuloma(1), silicosis (3), tuber culosis with pleural effusion (l ),

53. Lung disease patients with negative DTHR*Thad: caseating granuloma (1), silicosis (3), tuber­culosis with pleural effusion (l ), intravascularangiogenic tumor (1), chronic bronchiectasis (5),chronic organizing interstitial pneumonitis (4),recurrent cyst (1), coccidioidomycosis (1), sar­coidosis (2),chronie obstructive pulmonary dis­ease (8), chronic asthma emphysema, and pneu­monitis (5), pneumonia (3).

54. E. R. Pisher er al.; Cancer 36, 1 (1975):55. D. L. Page et al., J. Natl. Cancer Lnst, 61,1055

(978).56. Patients with the following cancers reacted neg­

atively (one of each); B-celllymphoma; extra­pulmonary carcinoid ; astrocytoma; glioma; glio­ma-astrocytoma; liposarcoma; leiomyosarcoma;sarcomatous chordoma; 'localized, encapsulatedpapillary-, mixed papillary-, and medullary 10w­grade thyroid carcinoma. In addition; four pa­tients with acute or chronic myelocytic leukemiaand two with Hodgkin's disease in remissionreacted negatively.

57. M. I. Bernhard, H. J. Wanebo, J. Helm, R. C.Pace, D. L. Kaiser, Cancer Res. 43, 1932(1983).

58. J. H. Kaplan,S. H. Lockwood,T. J. Cunning­ham, G. F.'Springer, E. E. Uzgiris, in CellElectrophoresis in Cancer and Other ClinicalResearch, A.W; Preece and P. A. Light, Eds.(Elsevier, New York,-l98l), pp. 197-202.

59.B.'D. Jankovic andB.H. Waksman, Jc lmmu­nol, -89, 598(1962); E.J. Holborow and G.Loewi, Immunology 5, 278 (1962).

60. W. O. Weigle,]. ,M.Chilleri G.S:Habicht,

Transplant. Rev. 8, 3 (l972);P.A. Bretscher.v.lmmunol. 131, 1103 (1983).

61. The two-sample comparisons 'of the statisticalresults on carcinoma patients _with those onpatients with benign disease of the same organare in most instances extremely significant sta­tistically, with Pcvaluesof the order of severalone-thousands. This also applies to both catego­ries of squamous-cell carcinoma. In the case ofpooled pancreas and 'pancreas benign, -P is0.0043; there are only five benign pancreaspatients. However,jfall pancreas carcinoma iscompared -with all pooled noncercincma, P is0.,0000. The same pertains if breast .carcinomaStageI infiltrating is compared with all noncar­cinema, while for breast carcinoma Stages IIand III P hO.OOOI when .compared with allnoncarcinoma. A two-sample Student test of thehypothesis that the combined carcinoma and thecombined noncarcinoma populations are. thesamehas a P of 0.0000 and yields the very large,extremely significant r-statistic of ::> 9.5. Addi­tional statistical information will be furnished onrequest to the author, as will be the: individualQM' ranges.

62. P. M. Brickell et al., Nature '(London) 306, 756(1984).

63~ G. F. Springer et al., unpublished data.64. J. C. Mottram, J. Pathol. Bacterial. 40, 407

(1935); P. C.Nowell, Science193, 23 (1976); D.Douer et al., Br, J. Haematol, 49,615(981); B.G. Nee1, W. S. Hayward, H. L. Robinson, J;Fang,S. M. Astrin, Cell 23, 323 (1981).

65; D. V. Fournier et ai.iCancer 45,2198 (1980); N.Hayabuchi, W. J. Russell, J.Murakami, ibid.52,1098 (1983).

66. G. W. G. Bird,-J. wingham, M. J. Pippard, J. G.Hoult, V. Melikian,Br.J. Haematol, 33, 289(1976); P.'M, Ness, G. Garratty, P. A. Morel, H.P. Perkins, Blood 54,30 (1978),

67. A F: R.Rahman andBv Mi Longenecker, J.lmmunol, 129, 2021 (15182); S. Metcalfe, R.J.Svvennsen, G. F. Springer, H. Tegtmeyer, J.lmmunol. Methods 62, pM8 (1983):

68.M. K. Robinson and Gi.F. Springer, Proc.Am.Assoc. Cancer Res., in press.

69. I thank.M. Dwass, Northwestern University, forthe statistics. This work benefitted from thecontributions of" my colleagues; their namesappear in the reterences.J owe special gratitudeto E. F. Scanlon, P. R. Desai, W. A; Fry, and H.Tegtmeyer.l thank M. J. Cline, E. R. De­Sombre, ,Po Heller, W. H. Kirsten, S. E. Krown,R. D. Owen, and 1. Rosenblum for criticism: Ithank Evanston Hospital's physicians for con­tinued encouragement to study their patients.. Idedicate this article to Heather Margaret Spring­er, nee Blight, who lived from age 48 through 54with metastases from bilateral breast carcinoma.Her courageous participation in investigation ofunknown immunological territory and her pains­taking clinical observations remain. an enduringobligation. Support was provided by grants CA19083and CA 22540 from the NationalInstitutesof Health and by the Julia S. Michels Investiga­torship.

National R & DPolicy:An IndustrlalPerspective

Roland W. Schmitt

the performance of basic .research andthe training of research manpower. The'distraction is.especially .great if Washing­ton pays toomuch attentionto the.grow­ing number of calls for the government totake over the job of .selecting and .sup­porting. R &.D programs aimed at corn­mercial results.

The Federal Role

Industrial )olicy has become one ofthe hot. issues on our national agenda,with various advocates telling us how tobeat the Japanese and solve the prob­lems of unemployment"infiation',andindustrial stagnation ,The 1984 pres~den*

tial candidates are picking up these ideasand testing theIll.

Industrial policy has many cornpo­nents-c-fiscal; monetary; and regulatory,for example. It touches on many .areas,from international trade to retraining thework force. I can bring my expertise toonly One corner of this 'many-sided sub­ject; research and developmentpolicy.To me, industrial policy means what thegovernment Illust?otq shape our nation­alindustrial posture', and a clear under­standing of what governmentshould notdo.

There has been 00 lack of proposals.Bills put before Congress in recent yearshave called for such changes as the es-

The author is senior vice presldent.cCorporateResearchand Development, General Electric Comeparry, Schenectady, New York 12301. This article isadapted from his keynote speech at the NationalConference on the Advancement of Researchc-SanAntonio, Texas, 10 October 1983.

1206

tablishment of a National TechnologyFoundation,or a Cabinet-level Depart­ment of Trade and Industry; the selec­tionofa National Commission. on "Tech­nological 'Innovation and Industrial Mod­ernization to tell us ','what the~c?n~mic,educational, and industrial priorities ofth~ 1JhitedStatesoughttobe' ;,'lriesi­dentialProgram for the Advancement ofScience-and Technology; and a .Coll1mis­sionon High Technology and Employ­ment Potential. Another proposal wouldestablish a government program to ,con*duct research and development on im­proved manufacturingtechniques;,'oth;.ers would exempt joint research:. anddevelopment efforts from the .antitrustlaws.

All these proposals to aid U.S. R& Dsho:wa healthyandencQuraging'concernabout the state of American industrialtechnology, but they may at the sametime distract politicians and policy-mak­ers from the most important need,and themost Important step thatgovernment cantake to strengthen U.S. innovation. Thattask is toensufeand strengthen 'thehealth of our university system-e-m. both

In the commerciaLR & Darea thereare some things that. government mustand can do, and other things it cannotand should not do. Government has acrucial role to play. in creating favorableconditions for commercial innovation,but not in actually producing those inno­vations. There are several reasons forthis.

First; successful innovation requires aclose .and intimate coupling between thedevelopersof a technology and the busi­nesses that will bring products based onthat technology to market and are them­selves in touch with that market; This isessential. in a diversified company, andeven more essential in a complex anddiversified economy. The R&D peoplemust ..comprehend .• the..strategies ,of thebusiness as well as know what the mar­ket constraints are. and what the compe­tition 'is up to .. Th~ business people, illturn, must understand the capabilitiesand limitations of the technology. Theymust .possess thetechnicalstrength tocomplete the development and believestrongly enough in the technology's po­tential to make the big investment need­ed to bring it to market.

SCIENCE, VOL. 224

--_._----~""---------

Page 2: National R DPolicy: An IndustrlalPerspective · 53. Lung disease patients with negative DTHR*T had: caseatinggranuloma(1), silicosis (3), tuber culosis with pleural effusion (l ),

Il7

Pressure for Pat~nt Reform ..

ees in small companies with initially lowturnovers (or profits). The budget pro-.posed in mid-March brings Britishpolicyin this area more in line with that in theUnited States, however,

On the other side of the coin has beena grtater wuungness to COIIibiBe public

· , Camb~idge,Engl~nd, British scieI1tis{s:;c'~~~~~d t~'at differe'nc'~'~c'~n~:~atentlaws between Europe and the United StatesgiyeU.S.companie~apotential'advant~ge' .ill',the,:commercialization:qf:bi?technology, ','Und~t .European'patent ,lawstas.cientific discovery' cann()~,,',be.patented,once:it','~as beenpublished intheiopen literature or eYen~:ferredto in public debate. In'\contrast~'llp~O·1:yearis allowed after~~~Ii~,~ti,?~f?r, a p~te~t:a,J):pHc~~~6n to

<be filedjnt~e United States. C.; i ·\'·T';iT; ·"1 believe that the greatest inhibitory influence on acl0seLworkil1g:{:)YrelationshiB·bet~een,academic, and ;iI1dllstrialscientists;and:,t~e,:\~reatest. , 'managemelltPro~lem for people like me, comes from this busi~ssofprior

-: .disclosure.Y'says Sydney Brenner, direst~rofthe.y.K Medical.Research. Council's Laboratory of MolecularBiology in Cambridge, E?glandC

Therehaslo?ssbeen'an awareness 0.rthis~isprepancy,particplar!y:amongpatent officers on ~oth sides of the Atl~ntic,but until no"" II? serious;:pressure,for,chang~" Large corporatibl1s,/ill'~articulat;o~ten'\\r~lc,()ifle:being':;:

:. able to scan the scientific literature forne",,(and ~npatented)ldeaswhileemploying patent attorneys to keep aclosewatch on the proposed publica­tions of their ownscientists. They tend to argue that they filldJittl"""rong

.• with the current system. Robin Nicholson,chiefscientific adviser!o theBritish Cablnei, claims that "no one brought-the ·'issue'to out",atte'ntlon'"when his office was preparing a recently published set ofrecommendationsfor changes in the British patentIaw, and expresses some doubt over

:whether change is really necessary.. ..... .: •..•Among smaller companies. however.fhesituation is seen differently; "in

this field, the .l-year grace period afterpublication gives the. Americans a·considerable competitive advantage" says Gerard Fairtlough, chief execu­'tive ofCelltech: "I feel that Europe should have the same system:"

Although admitting that biotechnology patents can frequently be success­. fully challenged by sufficiently motivated competitors, such companies also

argue that patent rights are seen as crucial assetsby potentialinvestors.Brenner also ,argue~ that it would ease the management problem in 'basic

.research laboratories such as his~aswenastaking,some'ofthe:pressure off:mdividualiscientists-c-by removing th.e"irnmediate' conflict-between theprofessional demands for fast publicatfonand the commercialdem~ndsof·

patent application. "Patents could-be the currency of the interaction:,'between r~s·e~chscientistsand,industry'~says .Brenner.. '~At Jhe,niomentcthey arejustaburden." . .. •.••

Change will not come easily. Friedrich-Karl Beier.rdirector-of the.Max­PhmckClnstitutefor Foreign and International Patent Law in Munich, andlong a campaigner-in favor of a 6-month grace period in Europet?bring it

•more in line with the United States,points out that this woulcnowrequirean internationallyagreed change in t~<EuropeanPatent Conv"ntion. "Todo this, it Will mean finding sufficient support within the whole Europeancommunity.vsays .Beier.· However,' he has already,convinced:lh'e'lnterna­.tional.Associationfor the Protection of Intellectual.Propertyto endorse the'ideal and suggeststhat there maY:bea,g~?~r~l:[}1:~v:~,~nthis dir:C~ion"withinthe next 2 or 3 years," ••....;..>... ..:" '..

· Some British go~ernment officials point out that a grace period wouldhelp avoid situations-such. as ·tha!:,,,,,hich'()~curred'with'~mo?oclonal

antibodies in the, mid~1970's-s-where.the .commercialpotential.of a discov­ery is only realized. after it has been»)~blished,',and,when it 'can no' longer,under the present system, be patentedj~theUnitedKingdom,~D.D,

as well as general, increase the pressurefor 'university scientists-and universi­ties in general-to look elsewhere forfinancial support.

A second factor until now has been thetax, structure, which has made it moredifficult to offer stock options to employ-

first commercial successes, criticism of'its deal with the MRC shifted from thepolitical to the industrial community.Both large and small companies com­plained at being locked out of access toMRC's research. "The academic excel­lence in places like the MRC should betreated as a :nationalresource and thegovernment should. be providingeven~

handed access to it, " says Chris Keight­ley, managing director of one of thenewest and most active small biotechnol­ogy companies on the British scene, 10(Bio) Ltd. in Cambridge.

The main product of Keightley's com­pany, set up in 1981 by Acorn Cornput­ers and recently recipient of a $1.2-mil­lion investment from Rothschild's BIL,is a technique for improving the sensitiv­ity of enzyme-based diagnostic tests. Itis based on the research of a scientistwhose work was not supported by theMRC, Colin Self of Cambridge Universi­ty's biochemistry department.

Given the growing pressure to encour­age similar initiatives, the MRC has re­cently renegotiated its licensing arrange­ments with Celltech. The company willretain first option to developments infields in which it has already started todevelop products. In other fields, how­fever, it will now have.1.0 become a com-

etitive Dlaaer, lor the MRC is setting upn industrial liaison office '.to distributeicenses more widelvmong companies

interested jnfurriing its research intoIcommercialprodlrcts.

The new arrangements have met withgeneral approval in both the industrialand academic worlds. Sydney Brenner,director of the MRC's laboratory inCambridge, says that at the beginning"there is no doubt that in terms of good­will, theMRC connection was a majorasset to Celltech.". Since then, however, the laboratory

has been receiving an increasing numberof direct approaches from industry. "Inthe past, we have had to tell them to goaway, since the first options on researchin the defined fields had to be offered toCelltech. Now we no longer have to doso,"

Brenner and other British scientistspoInt out that mel e 41C so" etal differ­ences between the United Kingdom andthe United States in the factorSatrectingthe growth of links between the academ­ic }5lOmedlcaI researcn community andthe private sector.

One is a greater reluctance on the partof. BrItIsh academiCS to get lO¥oIved inthe process of transferring research re­sults from the laboratory -a ..traditionw~:~.ich is admittedly changing -as cuts ingovernment suppOrt for (he UOIversities

13APRIL 1984

Page 3: National R DPolicy: An IndustrlalPerspective · 53. Lung disease patients with negative DTHR*T had: caseatinggranuloma(1), silicosis (3), tuber culosis with pleural effusion (l ),

perspective; the Department of Energy 'sprogram -expense for-just one .unproved,highly speculative 'energy technique,magnetically contained -fusion, Was $295million in 1982-alone.-,We face the sameproblem in several other crucial areas ofuniversity research. This is particularlytrue of engineering rcsearch-c-fundamen­tal research in such areas as softwareengineering, automation, machining sys­terns, materials engineering, .and corn­puter-aided engineering techniques.

The crucial distinction again .is -be­'~tween support of the underlying research~the job that the government should bedoing) and support of efforts aimed di­rectly at generating products (the job thegovernment should stay; away from).Some of the bills before Congress do notclearly make this distinction. Consider,for example, the calls for governmentsupport of R&D in manufacturing tech­nology. If a program for conducting theunderlying research at universities is tobe established, I will support it whole­heartedly. ,But when programs to pro­duce more efficient manufacturing tech­nologies iare proposed.vI worry thatsomeone has ignored the differencebe- .tween broadly relevant research and thejob of selecting specific technology tar­gets for new, products and" processes.And when anyone proposes conductingresearch utilization activities .to encour­age widespread adoption of these tech­nologies, then I have serious reserva­tions.

In the technology of controls, for ex­ample, fundamental theoretical advancesare needed to catchup with the speedand power of microelectronics. Suchwork should be strongly supported at

'universities. But the job of putting re­search to .work .inv.say, robots-or ma­chine tool controls for commercial mar­kets should, be addressed by privatecompanies.

Some may be concerned that with somuch emphasis .on support, of academicresearchin fast-rnovingareasvsuch asmicroelectronics,' and computerscience,the needs oLcore industries, .such asautomobiles, and steel, will be neglected.That is,not •• so; The',increases inefficicn­cy needed by these industries .will beprovided much more by some of thesefast-moving-areas. than .by advancesinthe ,core,technologies." These industries ,tooc are.dependent.on strong universityresearch in the fast-moving areas. More­oyer, these, industries suffer from a lackof investment in already available tech­nology. Giving them new technologywithout the corresponding investment touse that technology is hardly likely toimprove their plight.

15JUNE 1984

Immigration Policy

Another policy issue that strikes at theheart of our universities, yet is rarelydiscussed in the context of R&D poli­cy, is immigration-policy, --In 1982,," asmany foreign students received engi­neering Ph.Dv's in ouruniversities as didAmerican students. Some regard theseforeign students as a problem, and thereeven have been proposals to reduce theirnumbers. But the real problem is that notenough Americans "are entering doctoralprograms. The solution is to encouragemore of our students, through adequate­ly supported graduate fellowships, to goon to graduate studies. What is clearlynot a solution is to force foreign studentsto leave. They are'an important resourcefor our country. They account for adisproportionately, large portion of'.ourskilled manpower in the fast-moving.ar­eas of science and technology. They arenot taking jobs away from Americans.They are filling a void and advancingU.S. science and technology. Historical­ly the United States has benefited im­measurably- from "opening .our ,doors toimmigrant scientists and engineers. Ineed only mention such greats, as Stein­rnetz, Alexanderson, and Giaever , atGeneral Electric; Tesla; Zworykin,andIpatieff at other companies; .and Fermi,Debye,Mark, and many others at Arricr­ican universities.Yet current laws createobstacles for foreign scientists who seekemployment here. If weare truly con­cerned about enhancing U.S. industry'scapability to do R&D, we should easethe regulatory barriers to hiring foreign­born students, especially those trainedinthis country. Proposed amendments tothe Simpson-Mazzoli immigration billnow before Congress would do exactlythat. Unfortunately, for reasons .thathave nothing at all to do with science andtechnology, that bill is now stalled in theHouse. The critical.role that foreign sci­entists play, in the United States must beaddressed directly" rather, than, as.ianafterthought to a bill intended to dealwith the problem of illegal, and largelyunskilled, aliens.

Technology Leaks

A related national issue also directlyaffects the health of our universities: theproblem of leakage of technologyto theSoviet Union. In an attempt to stop thatleakage, the Department of Defense andthe Department of Commerce, proposedregulations that would prevent foreignnationals from taking part .: in advancedmicroelectronics research in universities

and industry. This isintendedasjustafirst step. In the long run the two depart'ments are proposing to imposethesamerestrictions on virtually all fast-movingareas of advanced technology consid­ered.to be militarily ·critical.

There is no question that we must do abetter job of preventing the Soviets fromacquiring our technology, but such regu­lations are .overkill. The Defense andCommerce Departments propose tochange the export control regulations inways that would sericusly -disrupt thenature of scientific discourse in U.S.universities and industrial R&D labora­tories, No doubt some technology doesleak to the-'Soviets· in ,the-course ·of ouropen scientific discourse. .But by-theAdministration's own account, this is' avery small part of the problem. It iscounterproductive to impose such majorrestrictions, onU.S;'science and technol­ogy for such a small part of the problem.Again, foreign -scientistsplay a criticalrole in most of our important areas ofscience' and technology. Deny them ac­cess to these areas of research and -wewill do far more to damage our techno­logical capabilities than .any of the pro­posals being made in the name of indus­trial policy will do to help.

Conclusion

National R&D policy today poses,both risks and opportunities. The excite­ment and attention tnat proposals forindustrial R&D policy have generatedthreaten to distract us from the federalgovernment's most important tasks.Weneed to go back to the basics: We need toremind ourselves of what it is that the,government can and,cannot do, and what \it is that industry can.and cannot do;

In summary, I want to suggest fourspecific guidelines for federalR& D pol­icy: (i) concentrate direct . support onacademically based: research, not. ongovernment-targeted industrial R&D;(ii) concentrate on sunrise science andtechnology, not on sunrise industries andproducts; (iii)concentrate on strengthen­ing the climate for privatelybasedinno­vation, .. .not .ongovernment-selected in­novation; (iv) concentrate on develop­ment '" for the' .government's own needs,not on development for market needs, Ibelieve that these simple guidelines­many of which we have followed withsuccess in the past,some of which wehave violated with pain-will go a longway toward greatly strengthening andrejuvenating the 'dynamic innovativepowers of our' American system of re­search and development.

1209

Page 4: National R DPolicy: An IndustrlalPerspective · 53. Lung disease patients with negative DTHR*T had: caseatinggranuloma(1), silicosis (3), tuber culosis with pleural effusion (l ),

Boom Time for British Biotechnology?Venture capital is now flowing into small companies and the government

is encouraging the commercialization of university research it funds

and gained with it a seat on the board ofthe company.

Like similar companies in the UnitedStates, Celltech has actively sought col­laboration with larger companies withbroader industrial interests or specialmarketing skills. A joint venture waslaunched last year with Britain's largestpharmacy chain, Boots, for example, todevelop the application of monoclonalantibodies to new diagnostic products.And a technology licensing agreementhas been signed with the Japanese com­pany Sankyo to develop tissue plasmino­gen activator and calcitonin.

Fairtlough says that Celltech, with acurrent research staff of about 120 scien­tists and technicians, does-not at presentshare the ambitions of companies suchas Genentech to grow into a major cor­poration. However, with a number ofclearly defined product lines, each in apotentially large market, "We could betalking about a turnover of hundreds ofmillions of dollars in a few years."

Celltech is already earning profitsfrom a reagent for the purification ofinterferon and has recently created aCulture Products Division Which, basedon techniques developed with direct gov­ernment funding, already claims to bethe world leader in the in vitro bulkproduction of monoclonal antibodies.

One reason for Celltech's early sue­,""ess is a unique-and in some quarters'highly controversial-agreement withBritain's Medical Research Council(MRC), unc\erwhich-the-<:ompiiriywasinitiallygiven first option on the rights toall results produced in the fields of genet­ic engineering and monoclonal antibod­ies in the council's laboratories. Theseinclude the prestigious Laboratory ofMolecular Biology in Cambridge.

This arrangement was approved by the'conservative government over the oppo­

ition of officials in the Treasury, whoelt it wrong that one company should beranted exclusive access to what wasonsidered public property. One factorn the decision, it is widely rumored, washe failure in the late 1970's to take out aatent on the technique for producingonoclonal antibodies, which was first

eveloped in the MRC's Cambridge lab­ratory. Giving Celltech exclusive rightso MRC's work might avoid such lapsesn the future.

When Celltech started to register its

SCIENCE, VOL. 224

ter A. Laing of Biotechnology Invest­ments Limited (BIL), a venture capitalfund set up by merchant bank N. M.Rothschild in 1981 and chaired by aprevious top government science advis­er, Lord Rothschild. ElL is said to be thelargest biotechnology-oriented venturecapital fund in the world. Partly due tothis recent flow of venture capital, Brit­ain now has more small biotechnologycompanies than any of its Europeancompetitors.

The government's willingness to letthe commercial and industrial communi­ties act as the seniorpartner in its effortsto boost biotechnology research and de­velopmenthas played a large.'art in both,

the establishment and subsequent opera­tion of Celltech. The company was setup in 1980 primarily at the initiative ofthe National Enterprise Board, a govern­ment body recently amalgamated intothe British Technology Group. Althoughinitially providing 44 percent of Cell­tech's start-up capital, with the four re­maining stakes of 14 percent each divid­ed between a group of financial andindustrial institutions, the governmentalways intended to hand over its share toprivate enterprise. It moved inthis direc­tion last year when Rothschilds' venturecapital company-previously criticizedfor not investing its funds in any Britishbiotechnology company-bought out aproportion of the government's ·stock

London. After a relatively slow start inthe late 1970's, Britian's biotechnologyindustry is beginning to pick up speed.Government officials. academics and in­dustrialists all claim that a recent reportfrom the U.S. Office of Technology As­sessment (O'TA) was excessively pessi­mistic in its claim that Britain lacks the"dynamism" to produce. serious com­petitors to American companies. Theyalso contest the OTA's conclusion thatBritain ranks second behind West Ger­many among European nations.

"I think that conclusion is completelywrong, particularly if you take the com­bination of the science and its applica­tions into account" says Gerard Fairt-

. .iough, chief executive of Britain's princi­••-pal biotechnology company, Celltech,

which is currently riding a crest of inves­tor enthusiasm.

British industry has benefited fromvarious formsof direct government sup­port for biotechnology. Many smallercompanies, for example, have madegood use of consultancy grants andotherspecial funds offered as part of a $24­million. biotechnology package launchedby the Department of Trade and Industryin November 1982. Other industrial ini­tiatives in fields such as fermentationtechnology have been successfully cata­lyzed by the Biotechnology Directorateof the Science and Engineering ResearchCouncil (SERC).

According to Robin Nicholson, chiefscientific adviser in PrimeMinister Mar­garet Thatcher's Cabinet Office, broaderpolitical changes must also share thecredit. "The policy of the governmentsince 1979 has been to free restrictionsand to remove barriers to enterprise,"says Nicholson. "The relatively healthystate ofhiotechnology in the U.K. seemspartly to reflect the success of thosepolicies...

He picks out, for example, efforts toencourage Britain's venture capital mar­ket-now considered the second largestin the world after the United States-through developments such as the Busi­ness Expansion Scheme,,,which allowsndividuals to write off against taxan

investment of up to $60,000 in a smallcompany.. nrovided the money is left infor up to 5years.

"The Business Expansion Schemewas the first real fiscal change in smallcompany funding for 50 years" says Pe-

136

Page 5: National R DPolicy: An IndustrlalPerspective · 53. Lung disease patients with negative DTHR*T had: caseatinggranuloma(1), silicosis (3), tuber culosis with pleural effusion (l ),

Summary. An analysis of how the government can and cannot use research anddevelopment policyto improve the nation's industrial posture suqqests four guidelinesfor federal R&D policy: (i) concentrate direct SUPPQrt on academically basedresearch, not on gQvernment-targeted industrial R&D; (ii) concentrate on sunrisescience and technology, not on sunrise industries and products; (iii) concentrate onstrengthening lhe climate for privately based innovation,notQngovernment-selectedinnovation: (iv) concentrate on development for the government's own needs, not ondevelopment for market needs.

Second, innovation works best ifthisclose coupling .is in place during .theentire innovation process. It should existwhen the R&D project is identified andshould continue through planning anddevelopment. .It must survive the inev­itable adjustments during development,caused.iby .shittingmarket constraintsarid technical 'Surprises. It must with­stand the decision points-i-when to goahead or when to quit.

Finally; .in a free-enterprise system,governments not only do notcreate themarkets for products but are.notoriouslyslow in reacting to shifts in the market­place. They lack the crucial entrepre­neurial spirit toperceive or acknowledgeopportunities early in theirdevelopment.

During the years 'of heavy governmentinvolvement in energy R & D,we usedto hear over and over again the expres­SIOns ,\'technology transfer." .and':com­mcrciahzation.v Those terms embodiedthe-notion.that .once· a technology-wasdeveloped by a government. contractoror a natIOnaIlaboratory,the technologycould.then sornepQW be transferred toth~etplace.and commercialized.

That did not happen for a simple rea­on. Technology" transfer is. nota sepa-

rate processoccurring downstream fromR. & D. The user and the performer oftargeted R &D need to have establisheda,dose relation before, there .is,anythingto transfer.

In energyR & D, there were .sornewho fell-into the trap of thinking that ifthey got a concept defined, the technolo­gy to 'work, .and .someone to produce .afavorableeconomic analysis, then corn­mercialization would follow. They forgotto find out whether the customers wouldbuy the product. The result was a misdi­

.rection ofeffort and money into technol­ogies that never had a chance of corn­mercial success.

Even in.agriculture.iwhere the UnitedStates, has a great history of innovation,underlying" research .on .• corn geneticswas performed·at university researchstations and largely supported by gov­ernment. '•. But private ,seed companiesconverted that researchinto hybrid cornproducts.

A dose relation between the User andthe performer ofR'& D cannot, in gener­al;· form when govemmentselects com>rnercial R &-Dtargets.'Instead, the g()V M

ernment ends up being a third party­one that .. knows a great deal less -aboutthe technology than the developer and agreat deal less about the market than theuser.

As an example,there are-proposalsthat the government fund R&D in man­ufacturing technology, in such applica-

15'JUN'E1984

tion areas as programmable automation,robotics, advanced sensors, and comput­er-aided design and manufacturing. Partof this funding is to support R&D workto be done by industry.

These are key technologies for thefuture .but, because .they are soimpor­tant.ia large and growing number ofcompanies are already addressing-them.General Electric is investing millions ofdollars in each of them. And, in eachone, we are faced withalarge number of

tough' competitors-i-foreign firms andU.S. firms, established firms and newventures, joint ventures and industry­university cooperative programs. In justone corner of computer-aided design; forexample, the field of solid modeling, weare competing against at .least a dozencapable firms-established giants,small­er rivals, and newer ventures.

It is simply not plausible for an admin­istrator' in .Washington-c-even with thehelp of a blue-ribbon advisory panel-i-topick the winning solid-modeling productbetter than the dozen firms slugging itout in the marketplace. And even 'ifgovernment could, pickthe winnerv thatis only the first step. The suppliers of thefunds, the performers of the R&D, andthe businessmen who deal with thecus­tomers have to tie them.selves together ina long-term relation, A'governmentfund­ing agency', cannot '. create that: kind ofrelationship.

There .isv however, one important ex­ception, It occurs when the governmentis. the customer, for .Innovation-c-as ..·· indefense R & D.Governmentshouldconcentrate its development efforts onthese needs of its own; Ifhistoryis artyguide, it will thereby also generate prod:ucts and technology that can be tappedfor commercial uses.

The government has clear needs in thearea ofsupercomputers for weapons re­search.cryptanalysisvweather forecast­ing,economic modeling, the design ofimproved airfoils and, projectiles, andmany other uses. By meeting its needs insupercomputers, the government willalso be sponsoring the development of aproduct that 'has' many valuablecivilianuses, such as' improved oil exploration,

better understanding of crack formationand propagation -in alloys, new tech­niques in computer-aided engineering,and the design of new materials based ontheoretical principle's. The supercom­puter is a prime example of a technologyin which the government should take thelead.

In very. large scale integrated circuits(VLSI) the government will also be amajor customer and thus has a major 'rolein. sponsoring development work. One

emerging opportunity is in the area ofinference chips-VLSI implementationsof intelligent electronic- systems thatwork in real timer basedon.custom chipsrather than 'computers. 'Thes'e inferencechips could be used in military systems,for example, to help the pilot of an F-18with an engine hit by shrapnel make thebest use of'.the 3:6 seconds he has inwhich to decide whether he can limphome or shouldbailout:

Inference chips will also have greatvalue in many.commercial uses, such asin creating three-dimensional. computer­aided' design' images in real time and inhelping smart robots plan their paths,Again, by meeting' its' own developmentneeds, the government may advancetechnology that can be used in cornmer­cial innovations. When the' governmentis 'not thecustomer, government selec­tion of.developments is unlikely-to pro­mote such innovation and economicgrowth.

Competitton: from Japan

At this point;' Lwould expect somepeople to be thinking about the Japa­nese. Did their' government bureaucracynot. pick the commercial technicalwin~ners and put moneybehind them? No, itdid not. At the heart of that question is amisunderstanding 'about the Japanesegovernment's Ministry of InternationalTradeandIndustry (MITI). The popularpicture depicts MITIas selecting targetindustries, picking out the technologicaldevelopments they need, establishing aconsortium of Japanese 'firms, and SUP""porting the commercial R & Dneeded

1207

Page 6: National R DPolicy: An IndustrlalPerspective · 53. Lung disease patients with negative DTHR*T had: caseatinggranuloma(1), silicosis (3), tuber culosis with pleural effusion (l ),

Boom Time for British Biotechnology?Venture capital is now flowing into small companies and the government

is encouraging the commercialization ofuniversity research it funds

and gained with it a seat on the board ofthe company.

Like similar companies in the UnitedStates, Celltech has actively sought col­laboration with larger companies withbroader industrial interests or specialmarketing skills. A joint venture waslaunched last year with Britain's largestpharmacy chain, Boots, for example, todevelop the application of monoclonalantibodies to new diagnostic products.And a technology licensing agreementhas been signed with the Japanese com­pany Sankyo to develop tissue plasmino­gen activator and calcitonin.

Fairtlough says that Celltech, with acurrent research staff of about 120 scien­tists and technicians, does not at presentshare the ambitions of companies suchas Genentech to grow into a major cor­poration. However, with- a number ofclearly defined product lines, each in apotentially large market, "We could betalking about a turnover of hundreds ofmillions of dollars in a few years."

Celltech is already earning profitsfrom a reagent for the purification ofinterferon and has recently created aCulture Products Division which, basedon techniques developed with direct gov­ernment funding, already claims to bethe world leader in the in vitro bulkproduction of monoclonal antibodies.

One reason for Celltech's early sue-less is a unique-and in some quarters

'highly controversial-s-agreement withBritain's Medical Research Council(MRC), under which the company wasinitially given first option on the rights toall results produced in the fields of genet­ic engineering and monoclonal, antibod­ies in the council's laboratories. Theseinclude the prestigious Laboratory ofMolecular Biology in Cambridge.

This arrangement was approved by theConservative government over the oppo­ition of officials in the Treasury, whoelt it wrong that one company should beranted exclusive access to what wasonsidered public property. One factorn the decision, it is widely rumored, washe failure in the late 19iO's to takeout aatent on the technique for producingonoclonal antibodies, which was firsteveloped in the MRC's Cambridge lab­ratory, Giving Celltech exclusive rightso MRC's work might avoid such lapsesn the future.

When Celltech started to register its

SCIENCE, VOL. 224

eel/tech chief says orA misjudged Britain.

the establishment and subsequent opera­tion of Celltech. The company was setup in 1980 primarily at the initiative ofthe National Enterprise Board, a govern­ment body recently amalgamated intothe British Technology Group. Althoughinitially providing 44 percent of Cell­tech's start-up capital, with the four re­maining stakes of 14 percent each divid­ed between a group of financial andindustrial institutions, the governmentalways intended to hand over its share toprivate enterprise. It moved in this direc­tion last year when Rothschilds' venturecapital company-previously criticizedfor not investing its funds in any Britishbiotechnology company-bought out aproportion of the government's stock

ter A. Laing of Biotechnology Invest­ments Limited (BIL), a venture capitalfund set up by merchant bank N. M.Rothschild in 1981 and chaired by aprevious top government science advis­er, Lord Rothschild. BIL is said to be thelargest biotechnology-oriented venturecapital fund in the world. Partly due tothis recentftow .of venture capital, Brit­ain now has more small biotechnologycompanies than any of its Europeancompetitors.

The government's willingness to letthe commercial and industrial communi­ties act as the senior partner in its effortsto boost biotechnology research and de­veloprnentbas played a large part in both

Gerard Falrtlaugh

London. After a relativelyslow startinthe late 19iO's, Britian's biotechnologyindustry is beginning to pick up speed.Government officials, academics and in­dustrialists all claim that a recent reportfrom the U.S. Office of Technology As­sessment (OTA) was excessively pessi­mistic in its claim that Britain lacks the"dynamism" to produce serious com­petitors to American companies. Theyalso contest the OTA'8 conclusion thatBritain ranks second behind West Ger­many among European nations,

"I think that conclusion is completelywrong, particularly if you take the com­binationof the science and its applica­tions into account" says Gerard Fairt­

.lough, chief executive of Britain's princi­pal biotechnology company, Celltech,waich is currentlyriding a crest of inves­lor enthusiasm.

British industry has benefited fromvarious forms of direct government sup­port for biotechnology. Many smallercompanies. for example. have madegood use of consultancy grantsand otherspecial funds offered as part of a $24­million biotechnology package launchedby the Department of Trade and Industryin November 1982. Other industrial ini­tiatives in fields such as fermentationtechnology have been successfully cata­lyzed by the Biotechnology Directorateof the Science and Engineering ResearchCouncil (SERC).

According to Robin Nicholson, chiefscientific adviser in Prime Minister Mar­garet Thatcher's Cabinet Office, broaderpolitical changes must also share thecredit. "The policy of the governmentsince 19i9 has been to free restrictionsand to remove barriers to enterprise,"says Nicholson. "The relatively healthystate of biotechnology in the U.K. seemspartly to reflect the success of thosepolicies."

He picks out, for example, efforts toencourage Britain's venture capital mar­ket-now considered the second largestin the world after the United States­through developments such as the Busi­ness Expansion Scheme.o;;;",which allows\ndividuals to write off agaJDst tax-aninvestment of up to $60,000 in a small,company. e!:2vided the money is left infor up to 5 years.

"The Business Expansion Schemewas the first real fiscal change in smallcompany funding for 50 years" says Pe-

136

Page 7: National R DPolicy: An IndustrlalPerspective · 53. Lung disease patients with negative DTHR*T had: caseatinggranuloma(1), silicosis (3), tuber culosis with pleural effusion (l ),

Boom Time for British Biotechnology?Venture capital is now flowing into small companies and the government

is encouraging the Commercialization .. of university research it funds

and gained with it a seat on the board ofthe company.

Like similar companies in the Uri'itedStatesv Celltech has actively sought col­laboration -with larger,;;ompanies, withbroader industrial interests or specialll1arketing skills,/\ joint venture' \\laslaunched last year ¥lith, Britain's largestpharmacy chain, Boots,; for ,exall1ple, todevelop the application of monoclonalaWibodies to new diagnostic. ,products.And, a technologyIicensingagreememhas been signed:,\¥ith th~Jap,anesecom­pany San~yo todevelop tissue plasmino­gen activator and calcitonin.

Fairtlough says that Celltech, with acurrent research staff ofabout J20 scien­tists and technicians, ,?qespo,t,at prese:_rits~are .the ambitions.of_:c?ll1P~nies, suchas Genentech to grow into .a major cor­poration., Howe"er, ,with 'a,:number ,ofclearly defined product 'lines,' each, in apotentially large market, "We could betalking about a turnover of hundreds ofmillions ofdollars in a few years."

Celltech is already earning profitsfrom. a reagent forfhe purification. ofinterferon and has recently created aCulture Products Division which, basedon techniques.developed with direct gov­e~Ilrnent funding, already claims to. bethe world leader in the in vitro bulkproduction of monoclonal antibodies.

One. reason for. Celltech's early sue­,)ss isa unique-i-and in some, quarters'highly controversial--:agreement . withBritain's Medical Re~earch Council(MRC), under which be. companY)"iWinitially given first option on the n:grts:;.'t<.lall results produced in the fields of g!',IW,t­icengineering :and mOllodol1al, ~?ti'bod-:iesin the council's .laboratories.. Theseinclude" the prestigious Laboratory ofMolecular Biology in Cambridge,

This arrangement was approved by the.conserv~tiv~.governrnentover the opp~­

ition of officials' in the Treasury, whoelt it wrong that one company should be .rantedexcltlsiye acc~ss to what wasonsidered public property. One factor

n the decision,it is widely rumored, washe failure in the late 1970's to take out aatent on the technique for producingonoclonal antibodies, .which. was firsteveloped in lhe MRC's Cambridge lab­ratory, Giving, Celltechexclusive rightso MRC's work might avoid such lapsesn the future.

When Celltech started to register its

SCIENCE, ·YQL. 224

Gerard' Fairtlough

Celltech chief says OTA misjudged Britain.

ter A.• Laing of Biotechnology Invest­ments Limited (BIL), a venture capitalfund set up by merchant. bank N. M,Rothschild in 1981 and chaired by .aprevious top government science advis­er, LordRothschild. BIL is said to bethelargest biotechnology-oriented "venturecapital fund in the world, Partly due tothis recent_ flow, of venture capital, Brit­ain now has more small.biotechnologycompanies than any 'of its Europeancompetitors.

The government's willingness to letthecommercial and industrialcommuni­ties act as the senior partner in its, effortsto boost.biotechnology research and de­velopment has played a large part in both

the establishment and subsequent opera­tion" of, Celltech. The company, was setup in 1980 primarily 'at the initiativeofthe National Enterprise Board, a govern­menrbodv recently. amalgamated .intothe British Technology Group. Althoughinitially providing 44 percent of Cell­tech's start-up capital, with the four re­maining stakes of 14 percent each divid­ed between' a group of financial andindustrial institutions, the goverpmentalways intended to hand over its share toprivate enterprise. It moved in this direc­tion last year when Roths,childs' veIit~recapital company-eprevicnsly criticizedfor not investing its funds in any Britishbiotechnology company-e-bought .out. aproportion of" the government's stock

London. After arelatively slow start inthe late 1970's, Britian's biotechnologyindustry isbeginning to pick up speed.Government ofljdals,acad~micsand in­dustrialists all clairn that a recent reportfrom the U,S, Office of Technology As"sessment to'l'A) was excessivelypessi­mistic in its claim that Britain lacks the"dynamism" to produce serious corn­petitors to American companies. Theyalso contest the OTA's conclusion thatBritainranks second behind West Ger­many_amongEuropean nations,

"I think that conclusion is completelywrong, particularly if you take the com­bination -of the science and itsapplica­tionsIntoaccount" says Gerard Fairt-

)\;~~orq;h,l chief executive of.Britain' sprinci­+jlPall,iotechnology .company ,Celltech,

'?"~chis;~~rrentlyriding a crest of inves­',{orenthusiasm.

British industry has benefited fromvarious forms ofdirect government sup­port for biotechnology, Many Smallercompanies,' for' example, have madegood use of consultancy grants and otherspecialfunds offered as part of a $24­million.biotechnology package launched1Jyt~.~Departmentof Trade and Industryin1)lilv"mber 1982. Other industrial ini­

:Ctia.ti\r~esiQ;fields, such as fermentation. -,' _i>:, '-'::/,1 :'" .. '.

fechl'l"lqgy have been successfully cata­lyzed by the Biotechnology Directorateof the Science and Engineering ResearchCouncil (SERC).

According to Robin Nicholson, chiefscientific adviser in Prime Minister Mar­garet Thatcher's Cabinet Office, broaderpolitical changes. must .also share thecredit. :,,"ThepolicY,of the governmentsince 1979 has been, to free restrictionsa[l~ toremove 'barriers to "enterprise,"says Nicholson. ' 'The relatively healthystate of biotechnology in the U.K seemspartly to reflect the success of thosepolicies."

He picks out l for example, efforts toencourage Britain's venture capital mar­ket-i-now considered the second largestin the world after the United States-

~thr. o.u,.g.h.. d.e.. v.• elopm.•.• e•.• nts .su..•ch .a.s the.BU.•s••. i-.ness., Expansion, Sl:heme,~which 'allowsindividuals to write off agaiosJ: tax.....aninvestment of up to $60,000 in a small

omnanz, provided the money is left in• for upto 5 years, .

"The Business ,Expansi()n, Schemewas the, first real fiscal change .in smallcompany, funding for 50 years" saysPc-

136

Page 8: National R DPolicy: An IndustrlalPerspective · 53. Lung disease patients with negative DTHR*T had: caseatinggranuloma(1), silicosis (3), tuber culosis with pleural effusion (l ),

Boom Time for British Biotechnology?Venture capital is now flowing into small companies and the government

is encouraging the commercialization of university research it fundsand gained with it a seat on the board ofthe company.

Like similar companies in the UnitedStates, Celltech has actively sought col­laboration with larger companies withbroader industrial interests or specialmarketing skills. A joint venture waslaunched last year with Britain's largestpharmacy chain, Boots, for example, todevelop the application of monoclonalantibodies to new diagnostic products.And a technology licensing agreementhas been signed with the Japanese com­pany Sankyo to develop tissue plasmino­gen activator and calcitonin.

Fairtlough says that Celltech, with acurrent research staff of about 120 scien­tists and technicians, does not at presentshare the ambitions of'cornpanies suchas Genentech to grow into a major cor­poration. However, with a number ofclearly defined product lines, each in apotentially large market, "We could betalking about a turnover of hundreds ofmillions of dollars in a few years,"

Celltech is already earning profitsfrom a reagent for the purification ofinterferon and has recently created aCulture Products Division Which, basedon techniques developed with direct gov­ernment funding, already claims to bethe world leader in the in vitro bulkproduction of monoclonal antibodies.

One reason for Celltech's early sue­less is a unique-and in some' quarters

'highly controversial-agreement withBritain's Medical Research Council(MRC), under which the company wasinitially given first option on the rights toall results produced in the fields of genet­ic engineering and monoclonal antibod­ies in the council's laboratories. Theseinclude the prestigious Laboratory ofMolecular Biology in Cambridge.

This arrangement was approved by theConservative government.over theoppo­

ition of officials in the Treasury, whoelt it wrong that one company should beranted exclusive access to what wasonsidered public property. One factorn the decision, it is widely rumored, washe failure in thelate 1970's to take out aatent on the technique for producingonoclonal antibodies, which was first

eveloped in the MRC's Cambridge lab­ratory. Giving Celltech exclusive rightso MRC's work might avoid such lapsesn the future.

When Celltech started to register its

SCIENCE, VOL. 224

ter A. Laing of Biotechnology Invest­ments Limited (BIL), a venture capitalfund set up by merchant bank- N. M.Rothschild in 1981 and chaired by aprevious top government science advis­er, Lord Rothschild. BIL is said to be thelargest biotechnology-oriented venturecapital fund in the world. Partly due tothis recent flow of venture capital, Brit­ain now has more small biotechnologycompanies than any of its Europeancompetitors.

The government's willingness to letthe commercial and industrial communi­ties act as the senior partner in its effortsto boost biotechnology research and de­velopment has played a large';:art in both,,

the establishment and subsequent opera'tion of Celltech. The company was setup in 1980 primarily at the initiative ofthe National Enterprise Board, a govern­ment body recently amalgamated intothe British Technology Group. Althoughinitially providing 44 percent of Cell­tech's start-up capital, with the four re­maining stakes of 14 percent each divid­ed between a group of financial andindustrial institutions, the governmentalways intended to hand over its share toprivate enterprise. It moved in this direc­tion last year when Rothschilds' venturecapital company-previously criticizedfor not investing its funds in any Britishbiotechnology company-bought out aproportion of the government's stock

London. After a relatively slow start inthe late 1970's, Britian's biotechnologyindustry is beginning to pick up speed.Government officials, academics and in­dustrialists all claim that a recent reportfrom the U.S. Office of Technology As­sessment (OTA) was excessively pessi­mistic in its claim that Britain lacks the"dynamism" to produce serious com­petitors to American companies. Theyalso contest the OTA's conclusion thatBritain ranks second behind West Ger­many among European nations.

"I think that conclusion is completelywrong, particularly if you take the com­bination of the science and its applica­tions into account" says Gerard Fairt-

. .Iough, chief executive of Britain's princi­,1~a1 biotechnology company, Celltech,1wID.ch is currently riding a crestof inves­ltor enthusiasm.

British industry has benefited fromvarious fOIlDS ofdirect government sup­port for biotechnology. Many smallercompanies, for example, have madegood use of consultancy grants and otherspecial funds offered as part of a $24­million biotechnology package launchedby the Department of Trade and Industryin November 1982. Other industrial ini­tiatives ~I! fields such as fermentationtechnology have been successfully cata­Iyzed by the Biotechnology Directorateof the Science and Engineering ResearchCouncil (SERC).

According to Robin Nicholson, chiefscientific adviser in Prime MinisterMar­garet Thatcher's Cabinet Office, broaderpolitical changes must also share thecredit. "The policy of the governmentsince 1979 has been to free restrictionsand to remove barriers to enterprise,"says Nicholson. "The relatively healthystate of biotechnology in the U.K. seemspartly to reflect the success of thosepolicies."

He picks out, for example, efforts toencourage Britain's venture capital mar­ket-now considered the second largestin the world after the United States-through developments such as the Busi­ness Expansion Scheme,.,which allowsndividuals to write off against tax.......an

investment of up to $60,000 in a smallcompany. provided the money is left in

ifor up to 5 y~ars.

"The Business Expansion Schemewas the first real fiscal change in smallcompany funding for50 years" says Pe-

136

Page 9: National R DPolicy: An IndustrlalPerspective · 53. Lung disease patients with negative DTHR*T had: caseatinggranuloma(1), silicosis (3), tuber culosis with pleural effusion (l ),

ees in 'small companieswith .initiallylowturnovers (or profits). The budget pro' ,posed in mid-Marchbrings British policyin thisarea morein line with that in theUnited States;' however;

On the other side.of the coin hasbeena grt'a1erwlIImgm%s to ClHnbifle public

as well as general; increase the pressurefor university' scientists-s-and universi­tiestin general-s-to Iook elsewhere forfinancial support.

A 'second factor until nowhas been thetax structure; which has made it moredifficult to offer stock options to employ-

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first commercial 'successes, criticism' ofits deal with the MRC shifted from thepolitical to the industrial community.Both large and smallcornpaniesicom­plained at beinglocked out of .access toMRC's research. "The academic excel­lence in places like the MRC should betreated: as a national. resource .'and .thegovetnm~ntshouldbeproviding.even'­

handed access to it," says Chris Keight­ley, .managing director of one of thenewest and most active small biotechnol­ogy companies on the British scene, 10(Bio) Ltd. in Cambridge.

The main product of Keightleys com­pany, set up in 1981 by Acorn Comput­ersand recently recipient of a $1.2-mil­lion investment from Rothschild's ElL,is a technique for improving the sensitiv­ity of enzyme-based diagnostic tests. Itis based on the research of a scientistwhose work was not supported by theMRC, Colin Self of Cambridge Universi­ty's biochemistry department.

Given the growing pressure to encour­age similar initiatives, the MRC has re­cently renegotiated its licensing arrange­ments with Celltech. The company willretain first option to developments infields in which it has already started todevelop products. In other fields, how­ver, it will now have to become a com­etitive Bidder, tor theMRC is setting up

Ian industrial liaison office .10 distributeicenses mor;e-wideIy;:>among companies

,. nterested in turning its research intoIcommercialproillicts.

The new arrangements have met withgeneral approval iil both the industrialand academic worlds. Sydney Brenner,director of the MRC's laboratory inCambridge, says that at the beginning"there is no doubt that in terms of good M

will, the MRC connection was a majorasset to Celltech."

Since then, however, the laboratoryhas been receiving an increasing numberof direct approaches from industry. "Inthe past, We have had to tell them to goaway, since the first options on researchin the defined fields had to be offered toCelltech. Now we no longer have to doso."

Brenner and 'other 'British scientistspOInt out that thele dIe sCgetai differ­encesbetween the United Kingdom andthe United States in the factors affectingthe growth of links between the academ­ic DlOmedlcaI research community andthe~e-secfor .

One is a greater reluctance on the partof British academiCS to get lnyolved inthe process of transferring research re­sults from the laboratory a ,.,traditionwhich is admittedly changing as cuts ingovernment support for the UnIversities

13 APRIL 1984

Page 10: National R DPolicy: An IndustrlalPerspective · 53. Lung disease patients with negative DTHR*T had: caseatinggranuloma(1), silicosis (3), tuber culosis with pleural effusion (l ),

Boom Time for British Biotechnology?Venture capital is now flowing into small companies and the government

is encouraging the commercialization of university research it fundsand gained with it a seat on the board ofthe company,

Like similar companies in the UnitedStates, Celltech has actively sought col­laboration with larger companies withbroader industrial interests or specialmarketing skills. A joint venture waslaunched last year with Britain's largestpharmacy chain, Boots, for example, todevelop the application of monoclonalantibodies to new diagnostic products.And a technology licensing agreementhas been signed with the Japanese com­pany Sankyo to develop tissue plasmino­gen activator and calcitonin.

Fairtlough says that Celltech, with aCurrent research staff of about 120 scien­tists and technicians, does not at presentshare the ambitions of companies suchas Genentech to grow into a major cor­poration. However, with. a .number ofclearly defined product lines, each in apotentially large market, "We could betalking about a turnover of hundreds ofmillions of dollars in a few years."

Celltech is already earning profitsfrom a reagent for the purification ofinterferon and has recently created aCulture Products Division Which, basedon techniques developed with direct gov­ernment funding, already claims to. bethe world leader in the in vitro bulkproduction of monoclonal antibodies.

One reason for Celltech's early sue­less is a unique-and in .some quarters

'highly controversial-agreement withBritain's Medical Research Council(MRC), under which the company wasinitially given first option on the rights toall results produced in the fields of genet­ic engineering and monoclonal antibod­ies in the council's laboratories. Theseinclude the prestigious Laboratory ofMolecular Biology in Cambridge.

This arrangement was approved by the:Conservative government over the oppo­

ition of officials in the Treasury, whoelt it wrong that one company should be'anted exclusive access to what was

onsidered public property. One factorn the decision, it is widely rumored, washe failure in the late 1970's to takeout aatent on the technique for producingonoclonal antibodies, which was first

eveloped in the MRC's Cambridge lab­"t~tory. Giving Celltech exclusive rightso MRC's work might avoid such lapsesn the future.

When Celltech. started to register its

;iff SCIENCE, VOL. 224

ter A. Laing of Biotechnology Invest­ments Limited (BILl, a venture capitalfund set up by merchant bank N. M.Rothschild in 1981 and chaired by aprevious top government science advis­er, Lord Rothschild. BIL is said to be thelargest biotechnology-oriented venturecapital fund in the world. Partly due tothis recent flow of venture capital, Brit­ain now has more small biotechnologycompanies than any of its Europeancompetitors.

The government's willingness to letthe commercial andindustrial communi­ties act as the seniorpartner in its effortsto boost biotechnology research and de­velopment has played a large part in both

the establishment and subsequent opera­tion of Celltech. The company was setup in 1980 primarily at the initiative ofthe National Enterprise Board, a govern­ment body recently amalgamated into

.the British Technology Group. Althoughinitially providing 44 percent of Cell­tech's start-up capital, with the four re­maining stakes of 14 percent each divid­ed between a group of financial andindustrial institutions, the governmentalways intended to hand over its share-toprivate enterprise. It moved inthis direc­tion last year when Rothschilds' venturecapital company-previously criticizedfor not investing its funds in any Britishbiotechnology company-s-bought put aproportion of the government's jstock

London. After a relatively slow start inthe late 1970's, Britian's biotechnologyindustry is beginning to pick up speed.Government officials, academics and in­dustrialists all claim that a recent reportfrom the U.S. Office of Technology As­sessment (OTA) was excessively pessi­mistic in its claim that Britain lacks the"dynamism" to produce serious com­petitors to American companies. Theyalso contest the OTA's conclusion thatBritain ranks second behind West Ger­many among European nations.

"I think that conclusion is completelywrong, particularly if you take the com­bination of the science and its applica­tions into account" says .Gerard Fairt­.Iough, chief executive of Britain's princi­..pal biotechnology company, Celltech,which is currently riding a crest of inves­tor enthusiasm.

British industry has benefited fromvarious' forms of direct government sup­port for biotechnology. Many smallercompanies, for example, have madegood use of consultancy grants and otherspecial funds offered as part of a $24­million biotechnology package launchedby the Department of Trade and Industryin November 1982. Other industrial ini­tiatives infields such as fermentationtechnology have been successfully cata­lyzed by the Biotechnology Directorateof the Science and Engineering ResearchCouncil (SERC).

According to Robin Nicholson, chiefscientific adviserin Prime Minister Mar­garet Thatcher's Cabinet Office, broaderpolitical changes must also share thecredit, "The policy of the governmentsince 1979 has been to free restrictionsand to remove barriers to enterprise."says Nicholson. "The relatively healthystate of biotechnology in the U,K. seemspartly to reflect the success of thosepolicies. "

He picks out, for example, efforts toencourage Britain's venture capital mar­ket-now considered the second largestin the world after the United States-through developments such as the Busi­ness Expansion Scheme''I;:;"which allows'individuals to- write off agamst taxaninvestment of uP to $60,000 in a small~ompany. provided the money is left infor up to 5 years.

"The Business Expansion Schemewas the first real fiscal change in smallcompany funding for 50 years" says Pe-

136