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Drug Development: Regulatory & Clinical Strategies for Australia and China Program

September 29, 2026 3:30 PM - 6:00 PM (EDT)

Description

Drug Development: Regulatory & Clinical Strategies for Australia and China 

Tuesday, September 29, 2026 3:30 PM – 6:00 PM 

Sheraton Valley Forge Hotel in King of Prussia 

This is an exclusive, invite-only roundtable program for approximately 15 participants from emerging biotech companies. Designed for executive and functional leaders involved in early-stage development, the discussion will focus on the critical decisions that shape a product's path to global markets. 

Participants will gain a deeper understanding of how regulatory strategy, clinical trial design, and study location selection can influence development timelines, future market opportunities, and overall program success. Our speakers include senior development and regulatory experts from Thermo Fisher Scientific who have supported biotech companies navigating development pathways across Australia and China.

Following the roundtable, attendees are invited to join the Life Sciences Future Welcome Happy Hour from 5:00 PM to 6:00 PM, which will include drinks, appetizers, and networking with conference attendees, sponsors, investors, and industry leaders. The roundtable and reception are designed to complement one another, providing an opportunity to continue conversations and build new connections with the broader life sciences community. 

You do not need to be registered for the conference to attend. 

There is no fee or other obligation associated with attending, but seating is limited. This roundtable is intended to provide a valuable educational and networking opportunity for biotech leaders navigating the complexities of global development.


For emerging biotech companies, early development decisions can shape how and where a product advances. As development becomes more global, choices around regulatory strategy, clinical trial design, and study location can expand future opportunities across markets or create challenges that may be difficult and costly to address later.

This session will focus on the key strategic decisions that matter when building a development plan for global markets. We will examine how expectations differ across major regulatory authorities, including the FDA, EMA, PMDA/MHLW, NMPA, and TGA, and how these differences can influence development timelines, clinical trial design, and the use of global or multi-regional clinical data. The discussion will address practical questions that arise when planning development across multiple regions, including how clinical data generated in one region may support development in another. We will also examine how different early clinical pathways can shape execution. For example, Australia’s CTN and CTX pathways offer different approaches to regulatory review and clinical study start-up.

The goal is to give biotech leaders a framework for making early, informed decisions that support opportunities across global markets, minimize delays and unnecessary rework, and create a clear and coordinated development strategy.

Time

3:30 PM - 4:00 PM - Registration/Networking 4:00 PM - 5:00 PM - Presentation Discussion 5:00 PM - 6:00 PM - Cocktail Reception/Networking

Location

Sheraton Valley Forge Hotel

Parking is complimentary. Please ignore the QR code signs located in the parking lot. Enter the hotel through the main lobby. Follow the stairs up to the second floor. Make a left and enter the glass room on your right.

Contact Information

Life Sciences PA
Name: Lauren Boyle
Phone: (610) 947-6800-204
Email: lboyle@lifesciencespa.org
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