Profile
About Zane Arp
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.
- Co-founded the company alongside Yuvraj Shinde (CEO) and Parth Gigoo (CPO).
Career highlights
- Directed a 70-person division at FDA's CDRH with a $15M annual budget.
- Delivered 40 regulatory science tools that improved medical-device quality and review efficiency.
- Secured and influenced $9M+ in external funding through partnerships with NIH, NSF, academia, and the Gates Foundation.
- Co-founded an FDA satellite research facility with the Department of Veterans Affairs, roughly doubling operational capacity without increasing internal costs.
- Selected to the FDA Regulatory Science Impact Council, shaping priorities across CDRH, CDER, and CBER.
- Guided rapid-response regulatory decisions on high-priority medical-device policy during COVID-19.
- Certified across IND, 510(k), PMA, De Novo, combination-product, and in-vitro-diagnostic review processes.
Experience
May 2025 – Present
Head of Strategic Business Development
Avo Photonics · Philadelphia, PA
Partner to the President on corporate growth strategy, external engagement, and market expansion across sectors including medical device. Led government affairs and advocacy efforts, and directed quality and compliance initiatives aligned with ISO 13485 and AS 9100.
Mar 2025 – Present
Founder & Principal Consultant
Advanced Regulatory Professional Services Consultancy · Pennsylvania
Boutique executive advisory firm specialising in regulatory strategy, combination-product navigation, and innovation acceleration for MedTech and pharmaceutical clients, from startups to publicly traded companies. Supports M&A due diligence and technology evaluation for investors and acquirers.
2022 – Oct 2024
Co-Founder & Co-Director, FDA–VA Joint Venture Program
U.S. Food & Drug Administration · Seattle, WA
Conceived and operationalised a new FDA satellite facility in partnership with the VA's Operating Room of 2050 initiative — a first-of-its-kind public-private model developing regulatory science tools for real-world evidence and precision medicine in medical devices.
2018 – Oct 2024
Director, Division of Biomedical Physics
U.S. FDA, Center for Devices and Radiological Health · Silver Spring, MD
Senior executive leader of a 70-person division with full accountability for strategy, operations, regulatory science, talent, and a $15M annual budget — one of the few FDA leaders to hold concurrent advisory roles across multiple NIH and NSF initiatives.
2019 – Oct 2024
Board Member, Industry
PATHS-UP, NSF Engineering Research Center · College Station, TX
Provided strategic guidance on point-of-care and precision-medicine solutions targeting cardiovascular and diabetes outcomes in underrepresented populations.
2015 – 2018
Director, U.S. Lead Imaging Technologies · Co-Director, GSK–UIUC Center for Molecular Optical Imaging
GlaxoSmithKline · King of Prussia, PA
Led a matrixed team from senior executives to bench scientists, developing molecular imaging techniques as biomarkers to advance clinical and pre-clinical drug development, with primary focus on ophthalmology and dermatology.
2006 – 2015
Manager, U.S. Lead of Imaging Technologies · Investigator · Senior Scientist
GlaxoSmithKline · King of Prussia, PA
Progressive R&D roles across process analytical investigations for three product-development sites and most of North American contract manufacturing.
2002 – 2005
Research Scientist · Post-Doctoral Assistant
Wyle Laboratories · Los Alamos National Laboratory · Texas A&M University
Developed sensors and instrumentation for NASA bioreactors to detect small analytes, and spectroscopic detection techniques including ERE CARS for airborne bacterial spore detection.
Education
- Ph.D., Chemistry — Texas A&M University (1996–2001)
- B.S., Chemistry — Angelo State University
Quick facts
Role
Chief Regulatory Officer & Co-Founder
Company
Bonn-Weiss Group Private Limited
Based in
Greater Philadelphia, USA
Experience
20+ years regulatory & R&D
Former
Director, FDA CDRH · GlaxoSmithKline
Co-founders
Yuvraj Shinde, Parth Gigoo
Areas of expertise
Regulatory strategy (IND, 510(k), PMA, De Novo, combination products, in-vitro diagnostics) · precision and personalised medicine · digital health and interoperability · biophotonics, imaging and biomarker development · translational R&D and public-private partnerships · board advisory, M&A due diligence and investor engagement. Therapeutic areas include dermatology, ophthalmology, cardiology, and neurology.
Note: Zane Arp's FDA tenure is part of his individual professional history. It does not constitute an FDA endorsement of, or regulatory clearance for, Bonn-Weiss Group or its products. See our legal notice for the company's current regulatory status.
For media inquiries, interview requests, or speaking opportunities, see the Bonn-Weiss Group press page or email zane@bwg.life.
