「日本発のシーズを迅速に実用化する為にアカデミアが果たすべき役割」早期臨床試験Collaboration with Academia -For early clinical development-ファイザー株式会社クリニカルリサーチ統括部オンコロジ一疾患領域部廣橋朋子
•  To propose a new collaboration model between academia and industry in drug development of academia discovered seeds. NOTE: The content of my presentation comes from my personal experiences
Anti-Tumor Drug Development Forum, 2012. Feb. 18th
Open innovation ヘンリー・チェスプロウ助教授（2003） Closed innovation Open innovation Revenue Long product life Differentiation with the competitor Internal research cost Anti-Tumor Drug Development Forum, 2012. Feb. 18th
For industry (esp. J-subsidiary of global com.) •   Less effort for collaboration with academia –  Because HQ already has the function or system/process –  But open innovation is not a process, but comes from “WILL” •   Lack of knowledge about basic science • Less experiences to evaluate academia discovered seeds For academia (not only Japan, but also US) •   Little know-how about marketing strategy, clinical development strategy, regulatory strategy For academia and industry (not only Japan, but also US) • Overly protective of their/our science Lack of relationship, reliance
* Academia includes venture company
Anti-Tumor Drug Development Forum, 2012. Feb. 18th

New Role New competency New way of thinking
Anti-Tumor Drug Development Forum, 2012. Feb. 18th
Anti-Tumor Drug Development Forum, 2012. Feb. 18th The timing of hand-over from academia to industry Preclinical本Phase l体Phase II Phase III After POC is established <Industry> Demerit: Lots of competitors Merit: High success rate of launching <Academia> Demerit: Need more resource and funds Merit: Develop based on the founder’s concept New role of academia and industry in drug development of academia discovered seed Academia lead Science Oriented Industry lead Global expand -Role of Academia – - Role of Industry - •Basic science •Innovation investigator initiated trial experiences and knowledge •Regulatory strategy •Marketing strategy
Anti-Tumor Drug Development Forum, 2012. Feb. 18th
Expectations of academia driven clinical development o Develop therapies for rare diseases Leader of clinical development for next generation therapies •New innovative technology •New therapeutic concept
Anti-Cancer Symposium Poster Nov 18, 2011
Anti-Tumor Drug Development Forum, 2012. Feb. 18th Assessment points for buy-up of academia discovered seeds by industry •  Overall research/clinical development plan • POC data is reliable • No additional study/research is required • Any advantage over the competitors • Intelled ● Market Reliability of POC data • Enrich the pipeline • Potential indication expansion • No critical obstacle to expand to other countries ulatory Strategy critical regulatorystissues
11

•  No critical issues of CMC • If there is, POC study should be repeated •  Scientific rationale of POC establishment •  Adequacy of comparator •  Adequacy of efficacy assessment method •RECIST or other appropriate criteria •  Quality of data • Data management concept/system is applied •  No critical GCP issues NOTE; These are not mandatory criteria. ed on these points, the company will evaluate the seeds
Anti-Cancer Symposium Poster Nov 18, 2011
12

Adapt to an industry-like approach of drug development plan •Research/clinical development plan •Market potential •Regulatory Strategy •  The seeds from industry and academia will be reviewed based on the same review points. •  This competency will lead to meaningful dialogue with industry and to successful partnership r Oncology
Anti-Cancer Symposium Poster Nov 18, 2011
Proposal of new competency for the company (Japan subsidiary) 1.Improve knowledge of basic science 2.Understand the company policy – Capability of understanding the quality of the underlying hypothesis/discovery/science •  Discussion between Japan subsidiary and academia sometimes works effectively and leads to successful collaboration ( for global company) – Avoid unnecessary approach
Anti-Cancer Symposium Poster Nov 18, 2011

Partnering with Pfizer Worldwide R&D Each company may have particular areas of interest for collaboration with an external partner. Approach to the appropriate partner is the fastest way. st/research and development.jsp

Anti-Cancer Symposium Poster Nov 18, 2011

Knowledge transfer •Mini-trial inspection or site visit –Regulatory strategy (CMC, GLP, GCP) •Mini-consultation –IP assessment •Mini-consortium –Lecture exchange •Development plan, market strategy •Routine interaction Establish reliance

Resource sharing
•  Human resource sharing – Academia-Industry •  Company employee can be a member of academia project – Academia-Academia •  Make up for deficient resources each other •  Partnering/Team research (Function sharing) – One company – multi sites of academia – Multi-company – multi sites of academia – Not much focus on who should do what, &#But!#What skills should be brought to the table? ” 18
•
New role of academia
–  Leader of basic science, translational research and early development –  Develop therapy for rare disease –  Leader of development for next generation therapies . New competency –  Academia: Adapt to an industry-like approach of drug development –  Industry: Capability of basic science and review of seeds •   New way of thinking – Knowledge transfer – Resource sharing Develop new model from seeds to the market Thank you for your attention！ご静聴ありがとうございました。
Anti-Cancer Symposium Poster Nov 18, 2011