** July 15th BioBreakfast. Leveraging early phase clinical research results for market success. Sponsored by Kendle Australia.

      Sponsor                                

As biotech executives and research institutes plan their development strategies they need to carefully plan their late phase clinical development and market entry strategies.

Click here for registration form

Our July BioBreakfast brings together a panel of CRO consultants and Industry practitioners to provide an overview of market entry and clinical strategic planning.

Kendle Australia's Director- Regulatory Development & Commercialisation Ms Judy Bingham and Acrux Pty Ltd Director Clinical Development, Dr Tina Soulis will examine the following:

Market entry strategy

Product Competitiveness

Which countries / which regulatory agencies?

Labelling, Target Product Profile

Interpreting early phase data and the design of Phase III program

Getting ready for phase III

Which countries?

Which sites?

    The role and timing of feasibility

     Role of Key Opinion Leaders

Timelines and budget

Product Availability

• •     Chemistry Manufacturing Control
  •     Manufacturers appointed
  •     Scalability of manufacturing
•     Preclinical studies

Registrations received after the RSVP date cannot be accepted.

Venue: Supper Room, Melbourne Town Hall

Registration - from 7.15 am. Networking 7.20 am - 7.55 am.

Presentation and Breakfast commences 8.00 am sharp.

BioBreakfast concludes 9.00am.

RSVP DEADLINE - By 10.00am, Wednesday July 9th . 2008.

NOTE: Speakers and topics may change without notice.

Due to the popularity of our BioBreakfasts, Network Members have priority.

Nicole Pitcher: Administration Coordinator, email: npitcher@biomelbourne.org, tel: 9650 8800