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Toshiyuki Asaki, Ph.D. (Team leader, Pain 1G, Pain & Neurology Dept,

1. Bringing Japanese University and Corporate Research to AAU. Information Meeting on Danish, European and Japanese Funding Sources for Collaboration and Exchange Nov 27, 2012. Toshiyuki Asaki, Ph.D. (Team leader, Pain 1G, Pain & Neurology Dept, Medicinal Research Lab, Shionogi & Co., Ltd.).

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Toshiyuki Asaki, Ph.D. (Team leader, Pain 1G, Pain & Neurology Dept,

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  1. 1 Bringing Japanese University and Corporate Research to AAU Information Meeting on Danish, European and Japanese Funding Sources for Collaboration and Exchange Nov 27, 2012 Toshiyuki Asaki, Ph.D. (Team leader, Pain 1G, Pain & Neurology Dept, Medicinal Research Lab, Shionogi & Co., Ltd.)

  2. Agenda • My case; research stay in Aalborg Univ • Shionogi • R&D of new medicines • Aalborg Univ, state of the art pain research • Our academia-industry collaboration activities • Message to bring more researches from Japan

  3. Shionogi & Co., Ltd. 3 • Business activities; R&D, Manufacturing, and sales of medicines • Office; Japan (HQ), US, UK & China • Established; 1878 (history of 134 years) • Sales in 2011; \267,275 million (about €2,500 million), 9th in Japan • Therapeutic Areas; Pain, Infectious diseases, Metabolic syndrome and others (Alzheimer, AD/HD, Cancer, Allergy…) Europe US Asia

  4. Issue 1: Huge Cost in Clinical Development €500 million (Only in Japan), €1,500 million (Global) Issue 2: Low Success Rate especially in Ph II 40% 70% 80% ~100% (Total 20%) x x x Poor data correlation between animals and patients Research & Development of new medicines 4 Basic research (~5 years) Clinical development (~10 years) Phase 1 (Healthy person) Phase 2 (Patient) Phase 3 (Patient) Animal study Approval Getting more and more risky and expensive year by year

  5. Issue 1: Huge Cost in Clinical Development €500 million (Only in Japan), €1,500 million (Global) Issue 2: Low Success Rate especially in Ph II 40% 70% 80% ~100% (Total 20%) x x x Poor data correlation between animals and patients Research & Development of new medicines 5 Basic research (~5 years) Clinical development (~10 years) Phase 1 (Healthy person) Phase 2 (Patient) Phase 3 (Patient) Animal study Approval • Check Efficacy • Select indication • Re-confirm Efficacy & Safety • (Larger scale than Ph2) • Check Safety • Find candidate • Efficacy & Safety Getting more and more risky and expensive year by year

  6. Solution?: Human experimental pain research 6 Clinical development Ph 1 (Healthy) Ph 2 (Patient) Ph 3 (Patient) Animal study Approval Large Gap

  7. Ph1.5 (Healthy+Stimuli) “Surrogate models of actual patients” Solution?: Human experimental pain research 7 Clinical development Ph 1 (Healthy) Ph 2 (Patient) Ph 3 (Patient) Animal study Approval • Much Shorter Period& Lower Cost than Ph2 • Early Estimation of Efficacy in Actual Patients • Feedback to Animal Studies We can expect.. • Saving cost and time (early decision) • Better understanding the diseases

  8. Aalborg Univ, State of the art human pain research 8 Center for Sensory-Motor Interaction (SMI), Aalborg Univ. (Prof. Lars Arendt-Nielsen) • Leading laboratory of translational pain researches in the world • Abundant know-how • Unique devices • Established system for human experimental researches • Easy access to patients • Strong network of key researchers • Consulting contract with Lars • My research stay from June 2012 for a year • Study the know-how • Feedback to our animal studies • Adopt Ph1.5 trial in our development • Further collaboration in the future

  9. Agenda • My case; research stay in Aalborg Univ • Our academia-industry collaboration activities, • Memorandum for collaboration in R&D • Shionogi Science Program (SSP) • “SONG for you !” campaign • 3. Message to bring more researches from Japan

  10. Memorandum for collaboration in R&D • Signed with five Danish universities on Aug 31, 2012 • Aalborg University • Aarhus University • Technical University of Denmark • University of Copenhagen • University of Southern Denmark • Main agreements • 1. Establish a cooperative research relationship whereby Shionogi matches the seeds of research organizations in Danish universities with its drug-discovery technology and needs for drug discovery, and carry out joint research on items that match. • 2. Promote personnel exchange with research organizations in universities in Denmark as Shionogi aim to develop international human resources.

  11. Shionogi Science Program, SSP

  12. Shionogi Science Program, SSP • Purposes; Matching needs and seeds, Support young researchers, Cultivate Shionogi researchers • Recruiting areas; • Novel target molecules, analytical methods and research models to treat pancreatic islet dysfunction related to type 2 diabetes, chronic kidney diseases, HIV, emerging and re-emerging infectious diseases, cancer immunotherapy, psoriasis, atopic dermatitis, allergy immunotherapy, AD/HD, or sleep disorder, or for neuro-protective/regenerative drugs, Ideas for novel next generation biologics, or technology of drug formulation • Target countries; Australia, Belgium, Denmark, Luxembourg, Netherlands, UK • Research period; maximum 5 years (lead to further collaboration) • Research budget; maximum \1,5 million (app €150,000) / year • Selected/Applied numbers in past programs • FINDS2007-2011 (Japanese SSP): 19/837 • SSP2011 in UK: 2/106 • SSP2012 • 94 applications (14 from Denmark) • Completed the 1st selection

  13. Conceptual phase Support music therapy for dementia in EU through AAU Conceptual phase Support music therapy for cancer pain in JP & US Europe AAU “SONG for you !”; Supporting music Corporate slogan: “SONG for you !” ShiONoGi JP US Famous music TV show in Japan brought by Shionogi for 48 years

  14. Message on the basis of my experience • To bring more researchers from Japanese companies and universities… • Focus on uniqueness of research technology or system (ex. It’s quite hard to conduct the human experimental pain studies in other countries in terms of ethics, social system, know-how or devices.) • Match seeds in Danish universities with needs in Japanese companies through events like competition (ex. SSP2012) • Promotion through Japanese researchers who studied in Denmark (ex. Making a list of the Japanese researchers) Denmark has a lot of excellent laboratories and good points to live (except winter weather..). I believe Danish potential which can attract more Japanese researchers by appropriate appeal.

  15. 15 Thank you ! Toshiyuki Asaki, PhD ta@hst.aau.dk toshiyuki.asaki@shionogi.co.jp

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