Pre-Conference Workshop Day

Tuesday | June 25, 2024

컨퍼런스 이전 워크샵 데이

会前研讨会日

ワークショップデー

8:00 am Coffee & Check-In

9:00 am Workshop A

Navigating Varying Regulatory Guidance to Inform ADC Clinical Studies & Meet Global Regulatory Requirements

Synopsis

The biggest roadblock in developing ADCs in Asia is not having enough regulatory guidance from other agencies. This is especially important when trying to run clinical trials in multiple countries while adhering to varying regulatory guidelines. This interactive session will give you a holistic overview of varying government regulations and how to follow them to confidently meet expectations from agencies.

Join this workshop to:

  • Understand how to jump over regulatory hurdles in the APAC region
  • Examine the differing regulatory requirements of the FDA, EMA, NMPA, and more
  • Assess the best way to gain IND approval to kickstart your clinical trials
  • Analyze regulatory expectations from a CMC aspect • Focus on regulatory harmonization across the globe

12:00 pm
Lunch Break & Networking

1:00 pm Workshop B

Navigating Strategic Collaborations to Make a Mark in the ADC World

  • Shanshan Xu Vice President - External Innovations, BioNTech
  • Mary Chaohong Hu Chief Executive Officer, Shanghai Miracogen
  • Paul Song Chief Scientific Officer, Genequantum Healthcare

Synopsis

Numerous high-profile collaborations in Asia have propelled the scope of innovation in the region. Thus, partnering with external companies has become a strategic decision to increase your footing in the field. This interactive session will answer key collaborations questions to help you navigate the partnership landscape and foster strong relationships especially with mega pharma.

Join this workshop to:

  • Understand how global partnerships can open up global rights for development and commercialization
  • Evaluate what makes a company a good partner- is it an ADC in the clinic? Novel propriety technology?
  • Determine the potential bigger pharma have and what value you can bring to the table
  • Navigate different cultures and ways of working to harbor stronger relationships
  • Enhance communication with mega pharma

4:00 pm End of Pre-Conference Workshop Day

*All presentations will be in English