Publications

Guest presenter at PBSS

Experiences learned from IND filings - small molecule CMC IND filing for FIH studies.

UBC Webinar: Biomanufacturing & Quality Control

xCellarate delivered a 2-hr webinar on the topic of Biomanufacturing & Quality Control, -Cell & Gene Therapy, recombinant proteins, MAb's, and vaccines. The October 2022 webinar was a component of the Regulatory Affairs Micro-credential Programme at UBC.

Blog: Remote Auditing

Lessons learned from a year and a half of rapid changes imposed on the industry by the pandemic.

Webinar with Redica Systems

Invited to speak about strategies and lessons learned in developing a QMS for small enterprises. Including challenges observed from COVID-19 pandemic impact.

Publication in PDA JPST

-Lessons from a Pandemic

COVID-19 impact on global pharmaceutical supply chain management

Co-authored with Jose Caraballo of Bayer Pharmaceuticals

Lessons from a Pandemic: Maintaining Compliant GxP Surveillance Programs and Stable Pharmaceutical SupplyA public health emergency was declared in January 2020 because of the confirmed cases of Coronavirus 2019-nCoV ([1][1]). This initiated a sequence of events that impacted social and economic systems that persists today. The supply chain was disrupted as borders and markets started to be closed and

Rise of Virtual/Remote work article in PDA Letter

Case studies including COVID-19 project execution

Unprecedented global phenomenon

Co-authored with Ali Ardakani of Novateur Ventures

QA Compliance & GPP's in Cannabis Industry

Keystone Laboratories conference series

Speaking engagement in partnership with QnR Associates

Final Agenda Preparing Your Cannabis Facility for Success.pdf

Foreign Manufacturing Sites

Challenges with foreign sites in NHP industry

Foreign Sites article -Contact Canada 2008.pdf

QA Agreements in Health Regulated Industries

Vital importance of good QA Agreements

rock solid QA agreements article.pdf

GEN Article

Contributing writer for numerous articles

Fenton Fong GEN Apr15-07.pdf

Genetic Engineering News articles published

1. “Artificial Tissues Target Range of Medical Conditions”, Vol.20, No. 1 Jan 2000.

2. “Challenges in Pharmacogenomics”, Vol.20, No.6 Mar 15, 2000.

3. “Animal Cloning Techniques and Technologies”, Vol.21, No.1, Jan 1, 2001.

4. “Rational Drug Design in the Post-Genomics Era”, Vol.21, No. 20, Nov 15, 2001.

5. “Contract Bio-Product Stability Testing Services”, Vol. 23, No. 6 Mar 15, 2003.

6. “Recombinant protein product production in animal species”, 2003.

7. Structure-based Drug Design, 2004

8. “Techniques in Viral Clearance Validation”, 2005.

9. Corporate Profile: “Progenitor Tackles Obstacles in Cell Therapy”, vol.25, No. 17, Oct 1 2005.

10. “Techniques for Characterizing Biologics”, Apr-May 2007 -see above for copy