Dr. Michael Yao, PhD (US FDA EXPERT)

PhD – Shaper of Global Biopharmaceutical Policy, Rarely Makes Appearances, to Attend International Summit on Biotechnology and Regenerative Medicine.
We are immensely honored to announce that Dr. Michael Yao, PhD-a senior expert with exceptional
influence in global biopharmaceutical policy and a recipient of the U.S. FDA Lifetime Achievement
Award (2017)-willjoin our conference as a distinguished guest.
His career seamlessly integrates profound regulatory experience, academic insight, and business vision, particularly positioning him as a key driver in advancing biotechnology and regenerative medicine across China, the United States, and Eurasia.
Professional Perspective: In any country, if a biotech R&D institution has not obtained the requisite clinical trial approvals from the national regulatory authorities (including those for autologous cells), local regulatory agencies should strictly prohibit any form of human application.

Recipient of the FDA Lifetime Achievement Award (2017): This award honors individuals with over 15 years of service at the FDA who have made lasting contributions to regulatory science and public health, representing one of the agency’s highest internal honors.
Architect of Cell and Gene Therapy Policies: During his 15-year tenure as a Senior Medical Officer at the FDA, Dr. Yao directly led and participated in the design and approval processes for U.S. Congressional/FDA regulations concerning biopharmaceuticals, especially cell and gene therapies.
These regulations have set reference standards for global oversight in these fields.
Understanding the FDA’s Global Influence:
Scientific Rigor and Foresight: The FDA’s review process is often regarded as the global “gold standard,” and its approvals for innovative products like cell and gene therapies have a profound international impact.
Policy Spillover Effect: Many countries closely reference or even adopt FDA regulations and technical guidelines when formulating their own national regulatory frameworks, making understanding FDA developments essential for global biotech companies and national agencies.

Key Figure in U.S.-Europe Policy Coordination: Dr. Yao co-chaired the FDA-EU Biopharmaceutical Policy Harmonization Committee, dedicated to bridging regulatory differences across the Atlantic for advanced therapies and promoting standard unification.
A Strategic Bridge in U.S.-China Biotech:
He is not only deeply involved in U.S. FDA policy but also serves as an advisor to the Chief Executive of the Macau SAR and the Chinese Academy of Engineering (in immunology).
He is also a Guest Professor at top Chinese institutions like Tsinghua University and Peking Union Medical College.
This unique dual capacity makes him one of the highest-level experts currently promoting exchange and cooperation between the U.S. and China in cutting-edge fields like biotechnology and regenerative medicine.

While the European Medicines Agency (EMA) is widely recognized as another globally influential, stringent regulatory system, future competition and collaboration extend far beyond. Leveraging his unique global perspective, Dr. Yao will analyze:
Which countries/regions beyond the U.S. and EU are rapidly establishing internationally competitive regulatory standards?
What challenges and opportunities does global regulatory coordination face in disruptive technology fields like cell and gene therapy?
How should countries and companies strategize to navigate this ongoing global paradigm shift in regulations?

Theme: Regulatory Frontiers and Future Trends in Global Biotechnology and Regenerative Medicine
Time: November 9th, 4:00 PM – 5:00 PM Professional Session (Limited Seats) & November 11th
Expert Forum

Analysis of Globally Leading Countries: Interpret the advantages and regulatory landscapes of the U.S., China, Japan, Germany, and others in regenerative medicine.
Importance and Process of Standardized Clinical Trials: Explain how they ensure therapy safety and efficacy, and provide an in-depth analysis of the complete pathway from trial design to regulatory approval.
Frontier Country Dynamics: Reveal how many countries are at the technological forefront globally and their innovation models.
Future Trends: Foresee industry-shaping trends like allogeneic cell therapies and Al-driven R&D.

Seats are extremely limited. Secure your participation now!
Whether you are a decision-maker in a biotech company, a policy formulator in a national regulatory agency, or a frontline researcher, Dr. Michael Yao’s sharing will provide you with:
-Unparalleled Insights: Understand the design logic and future direction of top-tier global regulatory policies.
-Strategic Foresight: Grasp the strategic dynamics of cooperation and competition in biotechnology between the U.S., China, and globally.
-Practical Guidance: Gain valuable experience for navigating and breaking through in the complex global regulatory environment.
This is not just a speech; it is a high-level dialogue to clarify the future landscape of global biopharmaceuticals for you and your organization. Mastering decision-making is the most critical step towards professionalism!

We eagerly anticipate the in-depth sharing from Dr. Michael Yao, PhD and exploring the future of global biopharmaceutical policy together. Act immediately to ensure your seat!