Eiko Shimizu
Life Science Summit Executive Committee ? SecretariatStaffJapan Association of Bioindustries Executives (JABEX) ?Secretariat Staff
Introduction
The Seventh Life Science Summit, which attracted approxi-mately 420 attendees, was held on June 4, 2007, at theTokyo Prince Hotel (see Photo #1). The Diet Members’Promotion Alliance for Life Sciences (Mr. Koji Omi,Chairman), the Cabinet Office’s Council for Science andTechnology Policy (Dr. Tasuku Honjo, Member), andJABEX (Mr. Katsuhiro Utada, Chairman) formed the LifeScience Summit Executive Committee that organized theevent.
The Life Science Summit is an event attended by frontlineexperts from academic, industrial, and government sectorswho specialize in the fields of life science and biotechnolo-gy ? two important fields of innovation. These specialistsgather to participate in discussions and make recommenda-tions and announcements that are geared toward identifyingspecific challenges and determining subsequent solutionsand reforms. The importance of the summit increases witheach passing year, and the resulting declarations have led tothe establishment of new government policies. This year’s Life Science Summit featured lively panel dis-cussions centered around two themes: 1) clinical researchsystem reform and 2) realizing innovation in the promisinglife science industry ? the role of bioventures and applica-tion in society. At the end, the summit approved of a decla-ration to seek fundamental changes in clinical research sys-tems and facilitate the development of venture businesses,underscoring a new resolve to pursue reforms.

(1) Greetings from the Summit Organizers
Mr. Fumio Kishida (Photo #2), Director-General of the DietMembers’ Promotion Alliance for Life Sciences, opened thesummit as the host. He was followed by Mr. SadakazuTanigaki (Photo #3), Acting Chairman of the same Alliancewho stated his belief that the Life Science Summit hasplayed a vital role. He also explained that there had beensignificant developments concerning the issue of clinical tri-als that was discussed at the previous summit, and that hewas very happy to see concrete results are beginning toappear. He concluded by expressing his hope that the day's discussions would give clear direction to the future develop-ment of life sciences in Japan.
The next speaker was JABEX Chairman Mr. KatsuhiroUtada (Photo #4), who explained that life science andbiotechnology offer dreams and hope to the human race andthe promise of a solution to the world’s food, environmental,and energy problems in addition to better health. In conclu-sion, he expressed his great hope that the day’s discussionswould eventually lead to the creation of new life scienceindustries and promotion of growth therein.

(2) Keynote Report by Diet Members’ Promotion Alliancefor Life Sciences Secretary Mr. Hiroyuki Hosoda
Mr. Hosoda, Secretary of the Alliance (Photo #5) reportedthat the Diet Members’ Promotion Alliance for Life Scienceshad last August set up an internal ad hoc committee on clini-cal trial reforms (chaired by Mr. Hosoda). He stated that,based on discussions that this committee held with relevantparties and on feedback from the Cabinet Office’s Councilfor Science and Technology Policy and JABEX, the Allianceadopted three resolutions: 1) stimulate clinical researchactivities, including clinical trials, 2) expedite approvalprocesses for new pharmaceuticals and other medical prod-ucts, and 3) engage in high-level policy dialogues. As aresult of these resolutions, the number of evaluatorsemployed by the Pharmaceuticals and Medical DevicesAgency doubled and high-level talks regarding new pharma-ceuticals between public and private sectors were held,Hosoda reported.

(3) Panel Discussion #1: Clinical research system reforms
The first panel discussion began with panelists identifyingchallenges and proposing solutions to those challenges, afterwhich they engaged in debate. Following this, panelists andattendees alike participated in a panel discussion that wasmoderated by Dr. Hiroo Imura, Senior Fellow of the JapanScience and Technology Agency’s Center for Research andDevelopment Strategy.
In addition to Dr. Imura, the panel was comprised of sixother panelists (Photo #6): Dr. Tasuku Honjo (Member,Cabinet Office’s Council for Science and TechnologyPolicy), Mr. Yukihide Hayashi (deputy Minister, MEXT),Dr. Yasuhiro Fujiwara (Laboratory Director, NationalCancer Center Hospital), Mr. Tetsuo Tsuji (AdministrativeVice Minister, Ministry of Health, Labour and Welfare), Dr.Hatsuo Aoki (Chairman, Japan PharmaceuticalManufacturers Association (JPMA)), and Dr. MotoyukiFujii (Member, House of Councilors).
Dr. Imura opened the panel discussion by stating, “Whileour nation’s fundamental research strength is on the rise, thefact that we are behind in clinical research is a serious prob-lem, and numerous impediments exist. What are the rootcauses? Resources, human or otherwise? Today’s panelistswill point out challenges that require immediate attention.Then we will discuss how reforms can be rapidly imple-mented, and what policies and legislation is required.”Panelists pointed out the following
1) The importance of training human resources that willhandle clinical research activities, particularly medicaldoctors
2) University education of human resources and strengthen-ing/improvement of clinical research infrastructure
3) Establishment of a system for protecting trial subjects andprovision of support staff
4) National consensus is required for clinical research insur-ance benefits
5) A large-scale increase in the national clinical researchbudget
6) Continue to strive to realize the type of society indicatedin Innovation 25
Next, the panelists discussed the importance of 1) concen-trating resources (staff, facilities, funds) in specific locationscharacterized by scientific, clinical research programs leadby medical doctors, 2) cooperation with government min-istries and agencies, 3) improved benefits for clinicalresearchers, and 4) differentiation of hospital functions andother means that enable hospitals to concentrate on clinicalresearch.
Additionally, the panelists explained that development ofpharmaceuticals and medical devices should be consideredfrom the perspective of national security, and that new lawswere necessary to enable the worry-free promotion of clini-cal research and to protect clinical trial subjects. They alsostated that clinical infrastructure should be developed andinvestments made in research, and that clinical researchreform efforts should be led by policiticans.
During the panel discussion that involved everyone in addi-tion to the panelists, summit attendees pointed out problemsand provided recommendations to which the panelistsresponded.
Attendees pointed out the following
1) In Japan, specialists are dispersed in each individual fieldof medical treatment, which means that it is difficult topromote clinical trials based on upgrading the existinginstitutions.
→Each and every site should be focused for review andfollow-up at each stage.
2) Venture businesses play a vital role in the drug discoveryindustry. Innovation should be recognized and reflectedin pharmaceutical pricing. Pharmaceutical prices shouldbe varied according to values.
3) In Japan, clinical trials above P-II level are impossible.Hospitals that can handle everything up to P-I in a rapidmanner should be built. Drug approval processes shouldbe expedited.
→Expedite the approval process for revo-lutionary new drugs.
4) Clinical training is mandatory.
→Proceed with the devel-opment of an environment that enables clinical research.
Dr. Imura summed up the discussion by first stating thatefforts must be taken to enhance medical technology devel-oped in Japan. For this purpose, establish a controlling bodyso that government agencies can cooperate and concentrateheavily on making it happen. In order to accelerate clinicalresearch efforts, it is necessary to develop laws/regulations,staff and research centers, create a new system that enablestreatment of both with/without health insurance, provide forthe protection of clinical trial subjects, and increase researchfunding. If Japan is able to realize high-quality clinicalresearch that can be performed quickly and at comparativelylow cost, then it will be able to compete internationally.Reforms should be pursued as early as possible.

(4) Panel Discussion #2: Realizing innovation in thepromising life science industry ? The role of bioventuresand application in society

The second panel discussion was moderated by Mr. MitsuruMiyata (Director of Nikkei BP’s Bio Center), and featuredseven other panelists (Photo #7): Mr. Tetsuhiro Hosono(Director-General, METI Manufacturing Industries Bureau),Dr. Yutaka Mizushima (Chairman, Bio-Venture AssociationOriginated from Universities), Dr. Ryuichi Morishita(Director, AnGes MG), Dr. Mujo Kim (President, PharmaFoods International), Dr. Takaharu Tanaka (Advisor forProduction & Research, Suntory, Ltd.), Mr. YasuchikaHasegawa (President and CEO, Takeda PharmaceuticalCo.), and Dr. Yoshihiro Ohtaki, (President, BiofrontierPartners).
Mr. Miyata opened the panel discussion by stating,“Bioventures in the U.S. and other countries have reached aturning point and are now on their ways to becoming prof-itable. At the same time, Japanese bioventures have distin-guished themselves from their U.S. and European counter-parts. Today’s discussion will center on how to facilitateJapanese bioventure growth and whether or not bioventuresare important to Japanese society.”
Panelists pointed out the following
1) In Japan, venture capital investment is extremely weak.Investment environments should be improved to enablethe development of bioventures into industries.
2) University ventures involved in innovative activities arefaced with problems related to funding and humanresources.
3) Aid should be provided to venture businesses to promotedevelopment of orphan drugs, and drug prices should beset high enough as to create incentives.
4) New medicine and food concepts must be developed withthe original technologies unique to Japan. For this pur-pose, universities should actively invest in bioventuresand vice versa.
5) While opportunities exist for venture businesses to enterthe field of functional food products that combine medi-cine and food, the current approval process takes years.
6) The investment risks associated with drugdiscovery/development are extremely high even for majorcorporations. Therefore, companies should select promis-ing venture businesses and invest in them instead. Japanmust foster a climate that facilitates venture growth.
7) Up until now, venture capital investments have had virtu-ally no effect on the creation of venture businesses, whichposes a crisis. A public-private association should be setup to implement venture support measures.
Next, the panelists mentioned the significance of the factthat the topic of venture business development was one ofthe main themes of this year’s summit. They also agreed thatall parties involved should make a concerted effort to ensurethat life science ventures become a mainstay of Japanesesociety, and that alliances with major corporations ? andmechanisms for facilitating those alliances ? are necessaryfor venture development. In Japan, there is virtually no cli-mate that encourages investment in venture companies.Larger companies aware the significance of finding seedsand targets of venture businesses. Bioventures that haveachieved some degree of maturity after ten years of opera-tion are finding themselves in crisis mode due to a lack offunding.
During the panel discussion that involved both attendees andpanelists, it was pointed out that venture incubation capabili-ty was vital and that national-level organizations should alsopossess such capability; in other words, the national govern-ment should focus its efforts on early-stage development.The group also discussed the necessity of bioventures shift-ing their focus from quantity to quality, and the importanceof IPOs as a means of procuring funding. Meetings andstudy sessions that involve both venture companies and mar-ket representatives are necessary in order to give appropriateevaluations. Participants stated that the summit should beused to recommend specific government policies. It was avery lively panel discussion.
“If no changes are made, Japan runs the risk of losing indus-tries that protect the health and happiness of the population.Support of venture businesses is necessary to finding a solu-tion to this crisis. We must develop mechanisms for carryingout clear national strategies and public intentions in order tosolidly establish Japanese bioindustries,” concluded Mr.Miyata.

(5) Greeting from Mr. Koji Omi, Minister of Finance andChairman of the Diet Members’ Promotion Alliance forLife Sciences
Chairman Mr. Omi (Photo #8) stated that clinical trial dis-cussions held at last year’s Life Science Summit helped pro-mote the development of a national screening system. Hesaid he hopes to contribute to developing a system in Japanthat reflects the expectation of everyone. He also mentionedthat, as Minister of Finance, he had made it clear that he wasopposed to science and technology budget cuts.

(6) Summit declaration that underscores reform resolveadopted
A summit declaration based on the results of the two paneldiscussions was approved by all summit participants as indi-cated by the applause of all present. The declaration includ-ed policy recommendations pertaining to future reforms.Specifically, the declaration calls for
1) The national government’s proactive and strategic promo-tion of clinical research
2) Official support and development of core bases
3) University education and evaluation system reformsgeared toward development of human resources
4) Bioventure development and application in society
5) Creation of a bioventure support framework
6) Easy procurement of bioventure funding and acceleratedapplication in society
7) Solid implementation of promotional strategies in the lifescience field
8) Ongoing policy recommendations from the Life ScienceSummit
Finally, Dr. Tasuku Honjo (Photo #9) of the CabinetOffice’s Council for Science and Technology Policy closedthe summit with this statement: “Under the Third Scienceand Technology Basic Plan, life sciences are designated asstrategic priorities and an emphasis has been placed on thepromotion of clinical research. The wheels have begun toturn at this year’s summit.” Dr. Honjo also stated, “We needto provide support to life science fields, which are coveredin Innovation 25, and extend these efforts to fields includingthe environment, energy, food.”

(7) Social networking party for attendees from academic,industrial, and government circles
After the summit ended, JABEX and 10 other bio-relatedgroups held a social networking event entitled “JapaneseBio-innovation.”
JABEX Chairman Mr. Katsuhiro Utada welcomed attendeesto the event
“After listening to the summit discussions, I feel that every-one’s understanding of the problems we face has deepened.We must develop life sciences and biotechnology in order tomaintain and promote the health of our national population.I believe that life sciences should be included in a ‘large-boned policy.’
”Mr. Sadakazu Tanigaki, Acting Chairman of the DietMembers’ Promotion Alliance for Life Sciences:“The discussions were dynamic and the Diet Members’Promotion Alliance for Life Sciences will make effortstoward the realization of the points specified in the summitdeclaration. The role of life sciences in such fields as food,the environment, and energy are becoming increasinglyimportant.”
After a congratulatory speech by Prime Minister Mr. ShinzoAbe, who did not attend, was presented, Senior ViceMinister of Economy, Trade and Industry Mr. HiromichiWatanabe gave his own honorary speech
“Life sciences lead to technological innovation. The scale ofthe nation’s bioindustries has reached 1.8 trillion yen. Weplan to seek tax and framework reforms that are gearedtoward the promotion of venture businesses.”
Environment Minister Mr. Masatoshi Wakabayashi
“Bioindustries and life sciences should be considered asmeans of securing the environment, food supply, and ener-gy. There is a growing interest in life sciences as a solutionto such global challenges as climate change and maintainingbiodiversity.”
Mr. Hiroyuki Hosoda, Secretary of the Diet Member’sPromotion Alliance for Life Sciences expressed his hope forthe continued success and development of the Life ScienceSummit.
Dr. Tasuku Honjo led the official toast by wishing for thesuccess of the Life Science Summit and solutions to globalproblems and allergies to genetically-modified crops andfoods.
During the remainder of the party, summit panelists, Dietmembers, industry and academic representatives, andbureaucrats enjoyed creating new friendships and exchang-ing information. It was an event that was attended by high-ranking representatives from all sectors.