China’s recent regulatory reforms, including fast-track approval and a local-study waiver for qualifying products, have opened the door to launch the innovative new biopharmaceutical products to the emerging market seamlessly. As China has already become a priority destination for global multi-regional clinical trials, biopharma companies eyeing up China should keep up with these changes and consolidate their commercial and regulatory strategies to in the early drug development stage.

US and China have offered the enormous opportunities for pharmaceutical companies to develop new products and expand the market of approved products.  Global pharmaceutical companies are expanding their investment of new drug development in China. More China-based emerging biotech companies are applying INDs and conducting clinical trials in US. The US-China alliance will bring great values to patients and create mutual benefits to both sides' pharma industries.

The National Institutes of Health (NIH) has technology transfer offices that have established themselves as open for business – as go-to places for companies to partner with thought-leaders, license innovations that overcome technology gaps, and benefit go-to-market strategies. Translational and clinical inventions across 27 Institutes and Centers cover an extensive range of disease and disorders - many representing strong market sectors. We develop drugs, devices, diagnostics, and digital health solutions. Kite Pharma, founded around NIH therapeutic assets, conducted clinical trials with NIH before being acquired for US$11B. Somnology, developing a sleep apnea wearable device, is achieving first-in-human validation via a clinical collaboration.

This talk will give an understanding of different FSP models and how they can evolve within organizations.  It will give this view from the perspective of the supplier and also of the client and make some key recommendation to think about when considering a FSP.

Overview of the Clinical Trial Solutions at Tempus which support precision patient identification and recruitment for oncology clinical trials through the TIME Trial program, a rapid activation Just-in-Time network of research-experienced clinical trial sites

Watch a live demonstration of protocol design utilizing real-world data on the TriNetX platform for a phase III cardiovascular randomized controlled trial, and a subsequent label expansion.

There are many advantages to conduct clinical trials in China including large patient populations, a large network of hospitals, skilled clinical trial professionals, and improved regulatory environment. However, several challenges remain, such as language and cultural differences, imbalanced quality among cities and hospitals, and the uncontrolled use of traditional Chinese medicine. Quality control is the key. This presentation will discuss the solutions to conduct high quality clinical trials in China.

Since China became a member of ICH in 2017,  China's drug development began with generic drug development followed by innovation imitation, and now is entering a leapfrog stage of new drug innovation.  Foreign drugs are encouraged to be registered in China, and China research sites are also actively participating in global multi-center trials. In the future, clinical research will drive to develop a collaboration model for global synchronization and integration.

Effectively conducting post marketing heightened safety surveillance is always a challenge for pharmaceutical companies, especially for those with medicinal products marketed internationally.  Familiar with post marketing safety regulations and/or requirements in various major countries and regions will make such a challenge less stressful.  The presentation will share worldwide experiences in conducting post marketing (PM) heightened safety surveillance activities, including US PM safety requirement (PMR) and commitment (PMC), EU PASS in related to post authority measures (PAMs), Japan PM active safety surveillance program.  It will also discuss the perspective from both regulatory and industry regarding the post marketing active safety surveillance and the drug intensive safety monitoring.

Founded in 2006, Highthinkmed is the fastest growing clinical CRO in China with over 800 full time employees, providing one-stop clinical services including clinical operation, medical affairs, data management, biostatistics, pharmacovigilance, regulatory affairs etc. Highthinkmed owes its own eCTD system meeting requirements of FDA, EMA and NMPA with a professional team providing eCTD submission services. Highthinkmed welcomes all partners across the world for international collaboration.

Different endpoints derived from wearables can require very different wearable sensors.  Unfortunately, qualifying and integrating different wearables often from different vendors can be time-consuming and uncertain.  Learn how Shimmer Research is addressing this challenge by introducing a series of wearables that are all part of its highly flexible Verisense platform.

Cmed Technology CTO, Dr. Tim Corbett-Clark shares his views on the current landscape within clinical trials, discussing the challenges that point and unified solutions bring. He also examines how to best optimize clinical trial data workflows by bringing the tech to data, removing the silos, and eliminating the barriers to getting holistic data for total control and visibility from phase one to four.