RegulatoryScience Community

We are excited to serve as Chair and Vice Chair of the AAPS Regulatory Science Community and look forward to building a meaningful community together.

Regulatory science is not confined to any single discipline - it connects every stage of pharmaceutical development, from discovery and manufacturing through clinical development, approval and post-approval. We see the Regulatory Science Community playing a deliberate connector role - engaging across communities, identifying shared regulatory science priorities, and creating programming that bridges rigorous science with practical regulatory decision-making.

Our first priority is building those connections. We will be working with chairs and leadership across all AAPS communities to collaborate where regulatory science intersects with their work.

We look forward to the AAPS community chairs orientation call next week and will share details on our first Regulatory Sciences Community meeting and programming priorities as plans develop. In the meantime, we welcome your ideas, your input, and your involvement - this community is strongest when it reflects the full breadth of perspectives our members bring.

If you work at the interface of science and regulation in any discipline or at any stage of development, we want to hear from you - we are actively looking for volunteers to help lead, contribute, and shape what this community becomes.

@Allison Radwick Chair, AAPS Regulatory Science Community and Regulatory Response Subcommittee

@HaiAn Zheng Vice Chair, AAPS Regulatory Science Community 

Thank you, Allison. Coming from a bioanalytical/gene therapy background, my regulatory interest is in guidances and expectations around companion diagnostics and immunogenicity screening for patient trial enrollment, in both the EU and US. Look forward to learning more broadly about regulatory matters.

Regards,

Tom Klem

Sr Director, CGT & Biologics, Pharmaron

We are excited to serve as Chair and Vice Chair of the AAPS Regulatory Science Community and look forward to building a meaningful community together.

Regulatory science is not confined to any single discipline - it connects every stage of pharmaceutical development, from discovery and manufacturing through clinical development, approval and post-approval. We see the Regulatory Science Community playing a deliberate connector role - engaging across communities, identifying shared regulatory science priorities, and creating programming that bridges rigorous science with practical regulatory decision-making.

Our first priority is building those connections. We will be working with chairs and leadership across all AAPS communities to collaborate where regulatory science intersects with their work.

We look forward to the AAPS community chairs orientation call next week and will share details on our first Regulatory Sciences Community meeting and programming priorities as plans develop. In the meantime, we welcome your ideas, your input, and your involvement - this community is strongest when it reflects the full breadth of perspectives our members bring.

If you work at the interface of science and regulation in any discipline or at any stage of development, we want to hear from you - we are actively looking for volunteers to help lead, contribute, and shape what this community becomes.

@Allison Radwick Chair, AAPS Regulatory Science Community and Regulatory Response Subcommittee

@HaiAn Zheng Vice Chair, AAPS Regulatory Science Community 

We are excited to serve as Chair and Vice Chair of the AAPS Regulatory Science Community and look forward to building a meaningful community together.

Regulatory science is not confined to any single discipline - it connects every stage of pharmaceutical development, from discovery and manufacturing through clinical development, approval and post-approval. We see the Regulatory Science Community playing a deliberate connector role - engaging across communities, identifying shared regulatory science priorities, and creating programming that bridges rigorous science with practical regulatory decision-making.

Our first priority is building those connections. We will be working with chairs and leadership across all AAPS communities to collaborate where regulatory science intersects with their work.

We look forward to the AAPS community chairs orientation call next week and will share details on our first Regulatory Sciences Community meeting and programming priorities as plans develop. In the meantime, we welcome your ideas, your input, and your involvement - this community is strongest when it reflects the full breadth of perspectives our members bring.

If you work at the interface of science and regulation in any discipline or at any stage of development, we want to hear from you - we are actively looking for volunteers to help lead, contribute, and shape what this community becomes.

@Allison Radwick Chair, AAPS Regulatory Science Community and Regulatory Response Subcommittee

@HaiAn Zheng Vice Chair, AAPS Regulatory Science Community