Chief Regulatory Officer & Co-Founder · Bonn-Weiss Group

Zane Arp, Ph.D.

A former FDA division director with more than twenty years across the FDA and GlaxoSmithKline, guiding BWG toward certification.

Zane Arp
About

Few executives have shaped regulatory policy from inside a regulator and then led R&D strategy in global pharma. Zane Arp has done both. Over a career spanning the U.S. Food & Drug Administration and GlaxoSmithKline, he built a dual fluency: the regulatory credibility of a former FDA division director and the commercial instincts of a pharma R&D leader.

At FDA he directed a 70-person division within the Center for Devices and Radiological Health (CDRH), managed a $15M annual budget, co-founded a first-of-its-kind FDA–VA research facility, and helped shape regulatory frameworks still in use today. At GlaxoSmithKline he drove imaging-biomarker innovation that delivered a 10x return on investment and cut clinical-trial costs by more than 12x in a single programme.

He is based in the Greater Philadelphia area, and alongside his role at Bonn-Weiss Group serves as Head of Strategic Business Development at Avo Photonics and as founder of his own regulatory advisory consultancy.

Role at Bonn-Weiss Group
  • Leads regulatory strategy and quality systems as Chief Regulatory Officer, guiding the company toward certification.
  • Heads business development, building commercial partnerships and market access.
  • Directed a 70-person division at FDA’s CDRH with a $15M annual budget.
  • Co-founded the company alongside Yuvraj Shinde (CEO) and Parth Gigoo (CPO).
Quick facts
Role
CRO & Co-Founder
Company
Bonn-Weiss Group Pvt Ltd
Focus
Regulatory strategy, quality, business development
Prior
FDA CDRH division director; GSK R&D
Based in
Greater Philadelphia, USA
Co-founders
Yuvraj Shinde, Parth Gigoo