DIA
Drug Information Association Logo

5th DIA Cardiac Safety Workshop in Japan

Oct 23 2014 9:00AM - Oct 24 2014 5:00PM | KFC Hall 1-6-1 Yokoami Sumida-ku Tokyo 130-0015 Japan

« Back to Listing

Overview 

The current cardiac safety paradigm based on S7B and E14 has largely eliminated new drugs with torsadogenic potential entering the market. However, since the paradigm cannot necessarily provide enough precise information to predict proarrhythmic effects of new compounds, pharmaceutical companies may have inappropriately discontinued the development of efficacious drugs solely due to their QT–interval prolonging property. At a FDA/CSRC/HESIsponsored Think Tank Meeting held at FDA Headquarters on July 23, 2013, a new cardiac safety paradigm was proposed. It involves the Comprehensive In Vitro Proarrhythmia Assay (multiple ionic current measurement, in silico proarrhythmia prediction model, and usage of human ventricular myocytes) and careful Phase 1 ECG assessment.

Can TQT studies be completely removed from the paradigm? What should an intensive ECG study be? How will the IQ-CRSC prospective study influence the new paradigm? Will the current S7B and E14 guidelines be revised or will new guidelines be drafted?

This is a challenging time. The 5th Cardiac Safety Workshop in Japan - Moving Towards Integrated Cardiovascular Risk Assessment Models - will deal with the above and other topics.

Who Should Attend 

  • Drug development and clinical research managers and associates
  • Pharmacovigilance, drug safety and drug surveillance personnel
  • Pharmaceutical physicians and medical directors
  • Safety pharmacology and non-clinical scientists
  • Clinical pharmacology scientists
  • Regulatory affairs officers
  • Biostatisticians
  • Data managers
  • Outsourcing and marketing managers
  • Decision makers in cardiac drug safety, including toxicology, pharmacology and compliance

Hotel & Travel 

Attendees should make airline and hotel reservations as early as possible. Dai-ichi Hotel Ryogoku is a convenient accomodation adjacent to the venue. To reserve, please contact the Dai-ichi Hotel Ryogoku below.
Address: 1-6-1 Yokoami, Sumida-ku, Tokyo 130-0015, Japan
Telephone: +81-(0)3-5611-5211 / Fax: +81-(0)3-5611-5212
email: daiichi-hotel@dh-ryogoku.com
URL: http://www.dh-ryogoku.com/english/index.html

Contact Information 

Please contact the DIA Japan office in Tokyo for further information.

Tel: +81-3-5575-2130
Fax: +81-3-3583-1200
DIAJapan@diajapan.org
www.diajapan.org

Program Committee 

Previous Next

Agenda  

Day 1 Thursday, Oct 23, 2014

  • 9:00AM - 9:20AM (Tokyo Standard Time)

    Welcome and Opening Remarks

    Speaker(s):

    • Ko Sekiguchi, MBA
      Representative Director
      DIA Japan, Japan
    • The Mission of the 5th DIA Cardiac Safety Workshop in Japan
      Hiroyuki Fukase
      CPC Clinical Trial Hospital, Medipolis Medical Research Institute, Japan
    • Overview and Raising Issues
      Atsushi Sugiyama, MD, PhD
      Professor and Chairman, Dept of Pharmacology
      Toho University School of Medicine, Japan
  • 9:20AM - 12:30PM (Tokyo Standard Time)

    Session 1-1: Integrated Cardiac Safety - Regulatory Update


    Session Chair(s):

    • Krishna Prasad, MD, FRCP
      Manager, CV-Diabetes Unit/Consultant Cardiologist
      Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
    • Kaori Shinagawa
      Senior Scientist for Clinical Medicine
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    Speaker(s):

    • Comprehensive in vitro Proarrhythmia Assay
      Norman Stockbridge, MD, PhD
      Director, Division of Cardiovascular and Renal Products, OND, CDER
      FDA, United States
    • Current Status and Future Perspectives on ICH S7B including CiPA (tentative)
      John E. Koerner, PhD
      Sr. Pharmacologist, OND, CDER
      FDA, United States
    • The IQ-CSRC Prospective Clinical Study: Can 'Early QT Assessment' Replace the TQT Study?
      Börje C. Darpö, MD, PhD
      Global Medical Director
      iCardiac Technologies, Sweden
    • Current Status and Future Perspectives on ICH E14 (tentative)
      Kana Watanabe
      Reviewer, Office of New Drug IV
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Alternatives to TQT - Early Clinical QT or Proarrhythmia? Do we know?
      Krishna Prasad, MD, FRCP
      Manager, CV-Diabetes Unit/Consultant Cardiologist
      Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
    • Exploring Alternative Cardiac Safety Paradigms: A Regulatory Perspective
      Colette Strnadova, PhD
      Senior Scientific Advisor
      Health Canada, Canada
    • Panel Discussion
      All Session Speakers, Japan
    • Koki Nakamura, MD, PhD
      Senior Director, Global Medical Affairs-Japan, Takeda Development Center Japan
      Takeda Pharmaceutical Company Limited, Japan
    • Atsushi Sugiyama, MD, PhD
      Professor and Chairman, Dept of Pharmacology
      Toho University School of Medicine, Japan
  • 12:30PM - 2:00PM (Tokyo Standard Time)

    Lunch Break
  • 2:00PM - 5:55PM (Tokyo Standard Time)

    Session 1-2: Integrated Cardiac Safety - Scientific Update


    Session Chair(s):

    • Boaz Mendzelevski, MD
      Vice President of Cardiology
      BioClinica, Inc., United Kingdom
    • Atsushi Sugiyama, MD, PhD
      Professor and Chairman, Dept of Pharmacology
      Toho University School of Medicine, Japan

    Speaker(s):

    • The Current Trends and Issues on Integrated Cardiac Safety
      Atsushi Sugiyama, MD, PhD
      Professor and Chairman, Dept of Pharmacology
      Toho University School of Medicine, Japan
    • Impacts of CiPA on Cost-benefit Performance in a Drug Development
      Kentaro Ando, PhD
      Dept of Pharmacology
      Toho University School of Medicine, Japan
    • In vitro Assay: iPS-cell Derived Cardiomyocytes (tentative)
      Yasunari Kanda
      Division of Pharmacology
      National Institute of Health Sciences, Japan
    • Potential Applications of Heart Simulation to the Safety Pharmacology Study in the Future
      Takashi Ashihara, MD, PhD
      Associate Professor, Dept of Cardiovascular Medicine
      Shiga University of Medical Sciences, Japan
    • In Silico Cardiac Safety Assessment of Drug Effects on Multiple Ionic Currents Using the Heart Simulator
      Jun-ichi Okada, PhD
      Graduate School of Frontier Sciences
      The University of Tokyo, Japan
    • The Thorough QT/QTc Studies - Current Status in Japan
      Yuji Kumagai, MD, PhD
      Director, Clinical Trial Center
      Kitasato University East Hospital, Japan
    • The Utility of Phase 1 QT Data to Replace the Thorough QT Study
      Hiroyuki Fukase
      CPC Clinical Trial Hospital, Medipolis Medical Research Institute, Japan
    • Genetic and Clinical Characteristics of Infants, Children and Adolescents with Long QT Syndrome in Japan
      Masao Yoshinaga, MD, PhD
      Chief Director, Dept of Pediatrics
      National Hospital Organization Kagoshima Medical Center, Japan
    • Panel Discussion
      All Session Speakers, Japan

Day 2 Friday, Oct 24, 2014

  • 9:00AM - 10:20AM (Tokyo Standard Time)

    Session 2: Blood Pressure Changes Associated With New Drug Development - Regulatory and Scientific Updates


    Session Chair(s):

    • Kentaro Ando, PhD
      Dept of Pharmacology
      Toho University School of Medicine, Japan
    • No-image Yuji Kumagai, MD, PhD
      Director, Clinical Trial Center
      Kitasato University East Hospital, Japan

    Speaker(s):

    • Off-Target Drug-induced Blood Pressure Changes: A Case Study
      Rajnikanth Madabushi, PhD
      Team Leader, Division of Clinical Pharmacology I, OCP, OTS, CDER
      FDA, United States
    • Non-clinical Assessment of Blood Pressure Changes: Challenges, New Technologies and Translation to Human
      Andrea Greiter-Wilke, DVM, PhD
      Head, Safety Pharmacology
      F. Hoffmann-La Roche AG, Switzerland
    • Off Target Blood Pressure Changes and Evaluation in Drug Development
      Boaz Mendzelevski, MD
      Vice President of Cardiology
      BioClinica, Inc., United Kingdom
    • Panel Discussion
      All Session Speakers, Japan
  • 10:50AM - 11:30AM (Tokyo Standard Time)

    Session 3: Abstract Session


    Session Chair(s):

    • Hiroyuki Fukase
      CPC Clinical Trial Hospital, Medipolis Medical Research Institute, Japan
    • No-image Yuji Kumagai, MD, PhD
      Director, Clinical Trial Center
      Kitasato University East Hospital, Japan

    Speaker(s):

    • Quantitative T Wave Morphology Analysis as an Adjunct to QT Assessment of New Drugs
      Robert Kleiman
      Chief Medical Officer and Vice President, Global Cardiology
      ERT, United States
    • Investigating the Ethnic Differences between the Effects of Moxifloxacin on Cardiac Conduction in Japanese and Caucasians
      Jorg Taubel, MD, FFPM
      Chief Executive Officer
      Richmond Pharmacology Limited, United Kingdom
  • 11:30AM - 1:00PM (Tokyo Standard Time)

    Lunch Break
  • 1:00PM - 2:40PM (Tokyo Standard Time)

    Session 4: Cardio-Oncology - Regulatory and Scientific Updates


    Session Chair(s):

    • Zhe Jin, MD, PhD
      Safety Physician, Manager, Japan Safety & Surveillance Div, R&D
      Janssen Pharmaceutical K.K., Japan
    • Boaz Mendzelevski, MD
      Vice President of Cardiology
      BioClinica, Inc., United Kingdom

    Speaker(s):

    • Evaluation of Effects of Drug on QT/QTc Interval in Oncology Drug Development in Japan
      Misaki Naota, DVM
      Reviewer, Office of New Drug V
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Why is Cardio-oncology Important for the Regulators?
      Krishna Prasad, MD, FRCP
      Manager, CV-Diabetes Unit/Consultant Cardiologist
      Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
    • Detection of Heart Failure and Myocardial Toxicity
      Yuichi Ando, MD, PhD
      Professor, Dept of Clinical Oncology and Chemotherapy
      Nagoya University Hospital, Japan
    • Impact on 'Alternative' QT Studies in New Oncology Drug Development
      Boaz Mendzelevski, MD
      Vice President of Cardiology
      BioClinica, Inc., United Kingdom
    • Panel Discussion
      All Session Speakers, Japan
  • 3:10PM - 4:30PM (Tokyo Standard Time)

    Session 5: Cardio-Metabolic - Regulatory and Scientific Updates


    Session Chair(s):

    • Koki Nakamura, MD, PhD
      Senior Director, Global Medical Affairs-Japan, Takeda Development Center Japan
      Takeda Pharmaceutical Company Limited, Japan
    • Colette Strnadova, PhD
      Senior Scientific Advisor
      Health Canada, Canada

    Speaker(s):

    • The Cardiovascular Safety of Diabetes Drugs - The Alogliptin Experience
      Emiko Koumura
      Senior Director, Clinical Science, Japan Development Center
      Takeda Pharmaceutical Company Limited, Japan
    • Japan’s Participation in a Global Cardiovascular Outcome Study
      Masako Nakano, MD, PhD
      Medical Fellow
      Eli Lilly Japan K.K., Japan
    • The CSRC Diabetes CV Expert Perspective Paper - Overview and Recommendations
      Mary Jane Geiger
      Senior Director, Cardiovascular & Metabolism Therapeutics
      Regeneron Pharmaceuticals, Inc., United States
    • Panel Discussion
      All Session Speakers, Japan
  • 4:30PM - 4:40PM (Tokyo Standard Time)

    Closing Remarks

    Speaker(s):

    • Boaz Mendzelevski, MD
      Vice President of Cardiology
      BioClinica, Inc., United Kingdom

Exhibits  

The 5th DIA Cardiac Workshop in Japan offers interested companies the opportunity to exhibit with a tabletop display.

Fee:
2,300 x 1,400 mm booth space..........¥216,000*
NOTE: *fee includes 8% Japanese Consumption Tax

Booth Rental Fee includes (per 2,300mm x 1,400m booth space):

  • One (1) complimentary full-meeting registration*
  • Two (2) complimentary exhibit booth personnel registrations*
  • One (1) 1,800 x 450 mm table
  • Two (2) chairs
  • One (1) 5A electrical connection
  • Internet access

No pre-fitted shell-scheme or pipe-and-drape structure is provided.

Additional expenses associated with the exhibit, including special booths, drayage, lights, phone, carpeting, additional electrical connections, etc., will be the responsibility of the exhibitor. Additional Exhibit Booth Personnel will be allowed for ¥12,960 each (limit of 3 per booth space) - please use the Additional Exhibit Booth Personnel Registration Form under Useful Links to register additional staff.

* Special Offer (number of included full-meeting and booth personnel registrations) for this meeting only

Exhibit Show Dates: October 23-24, 2014

Useful Links:

  • BioClinica Inc.
  • CPC Clinical Trial Hospital, Medipolis Medical Research Institute
  • ERT Asia Group K.K.
  • Ina Research/Cardiocore
  • Quintiles Transnational Japan K K
  • Suzuken Co., Ltd.

Registration Fees 

Member

Charitable Nonprofit/Academia Member/Medicals
¥25000.00
Member Government
¥25000.00
Member Standard
¥64000.00

Non-Member

Charitable Nonprofit/Academia Nonmember/Medicals
¥25000.00
NonMember Government
¥25000.00
NonMember Standard
¥79000.00
Group Discounts

There are no group discounts for this event.

Online registration has been closed.  Onsite registration will be available at the meeting venue.

Join DIA now to qualify to save on future events and to receive all the benefits of membership.

Register Online
« Back to Listing Back To Top