Dr. Da Silva is a distinguished leader in Biotech and Cell & Gene Therapy, recognized for more than two decades of advancing regenerative medicine, GMP manufacturing, and regulatory strategy across corporate, academic, government, and clinical environments. As the Founder and President of Borgonha Consulting, LLC, he provides strategic guidance for early‑stage clinical development in cell, gene, and exosome therapies, supporting clients in cGMP facility readiness, regulatory submissions, quality systems, and operational optimization. His consulting practice spans biologics, HCT/Ps, exosomes, cosmetics, dietary supplements, and other highly regulated manufacturing sectors.

His expertise is grounded in extensive leadership roles overseeing Research and Development, Quality Assurance, Regulatory Affairs, and global cGMP/cGTP operations. He is proficient in current Good Practices (cGxPs), including FDA 21 CFRs, ICH, the Canadian Food & Drug Act, and Eudralex/EMA requirements for Phase I/II clinical trials and commercial HCT/Ps and biologics. Throughout his career, he has built, restructured, and led biotechnology organizations, serving as Chief Scientific Officer, Head of Quality Assurance, Director of Regulatory Affairs, Director of Stem Cell Manufacturing, and Senior Scientist across corporate, federal, and academic institutions.

As CSO, he orchestrated the establishment of a company’s full operational infrastructure—overseeing R&D, Facilities, Equipment, Production & Processes, Regulatory Affairs, Quality Management Systems, Marketing, and Sales. His leadership extended to talent recruitment, vendor qualification, and establishing key partnerships with institutions such as UPENN, USC CHLA, Charles River, Wuxi, and Eurofins.

Across multiple organizations, he designed, developed, and implemented robust Management Quality Systems for Phase I/II clinical trials and ISO 13485‑certified companies. He restructured QA departments to eliminate backlogs and reduce deviations, CAPAs, and OOS events by up to 75%. He led pre‑IND and IND regulatory interactions with the FDA and spearheaded the eCTD submission system with the FDA, Health Canada, and PMDA—including the submission of 12 Master Files within six months.

At a major tissue bank, his leadership increased monthly graft release value by 400% through optimized final release operations. As Facility Director, he secured FACT Accreditation for a premier academic manufacturing program. His federal experience includes serving as Quality Assurance Manager III at the NIH/NCI Surgery Branch, where he championed quality systems and regulatory compliance for Phase I/II clinical trials involving apheresis, cell therapies, and vector products under cGMP/cGTP/GLP/GCP.

He is well‑versed in U.S. and international regulations, including FDA 21 CFRs, ICH guidelines, AHCA, CLIA, the Canadian Food and Drug Act, Eudralex, Korean FDA standards, EMA guidelines, and INVIMA requirements. He has ensured compliance with FACT, AATB, ISO, WHO, and PIC/S standards and has led numerous internal, external, and third‑party audits, including FDA, AATB, MFDS (Korean FDA), and state inspections. His regulatory portfolio includes FDA Type II Master Files, eCTD submissions, IND preparation and pre‑IND meetings, quality agreements, vendor oversight, regulatory gap analyses, audit remediation, and 21 CFR Part 11 electronic systems compliance.

As a consultant, he has played a key role in securing client contracts for USP <71> sterility testing, laboratory design, and operational readiness. His guidance includes cGMP facility design, commissioning, and qualification; sterility testing systems and isolator technologies; equipment qualification; analytical method qualification and validation; process qualification and validation; label control and labeling; CMO/CDMO oversight; mock FDA inspections; and supply chain and product partnership development.

Dr. Da Silva also brings a strong business and commercial background, shaped by his family’s diverse enterprises in Venezuela—including pasta factories, bakeries, gas stations, auto parts stores, and export/import companies. This early exposure to operations, logistics, and customer engagement strengthened his commercial acumen. Later, in his industry roles, he collaborated closely with sales and marketing teams to identify competitive advantages, strengthen product positioning, and develop strategies centered on product quality attributes. His experience in real estate sales further enhanced his negotiation and client‑facing capabilities.

In addition to his scientific and regulatory career, Dr. Da Silva is the owner of a mango farm abroad, specializing in cultivating over 16 different species. He also oversees the production and sale of mangoes, tamarind, pineapple, papaya, guava, and Spondias purpurea. He also oversees the cultivation and sells of heliconias, wild roses, and anthuriums to various nurseries and floral distributors. This agricultural enterprise reflects his hands‑on experience in supply chain management, crop production, quality control, and direct‑to‑market sales—further demonstrating his operational versatility and business leadership.

Dr. Da Silva holds a PhD and MS in Pharmaceutical Sciences from Northeastern University, where his dissertation on myocardial salvage and immunoliposome‑based cardioprotection earned the Young Investigator Award at the International Conference of Nuclear Cardiology. He has authored peer‑reviewed publications in Circulation, JAMA, JACC, and Stem Cell Translational Medicine, and contributed book chapters on stem cell therapies and cardiovascular medicine. He also holds a BS from Baylor University and completed post‑baccalaureate business coursework at Sam Houston State University. He further expanded his expertise with a certificate in AI for Biotech and Pharma from MIT Sloan, specializing in the integration of machine learning to enhance data integrity and regulatory compliance. He is fluent in English, Portuguese, and Spanish, and holds certifications in ASQ Risk Management and Project Management.

Across every role, Dr. Da Silva’s career is defined by strategic leadership, regulatory depth, operational transformation, and scientific rigor. His ability to integrate GMP manufacturing, regulatory strategy, commercial insight, agricultural operations, and translational science positions him as a trusted expert for organizations navigating the complexities of advanced therapies and regulated product development.