Cell & Gene Therapies

Cell and gene therapies represent a frontier in medical innovation, offering hope for advanced therapeutic solutions and cures to rare, orphan, and challenging diseases. However, the complexity of these personalized medicines requires equally sophisticated quality standards. At Compliance Architects®, we specialize in navigating this complexity and helping companies develop robust regulatory strategies to ensure long-term success.

Throughout the journey of bringing cell and gene therapies from development to market, collaboration with biologics manufacturing companies, supply chain stakeholders, regulators, and policymakers is essential. We facilitate this collaboration and assist in establishing appropriate standards to manage the complexity effectively. We help you ensure that phase-appropriate compliant systems are in place, ensuring your program remains aligned with current standards and principles while staying ahead of the curve. This approach avoids wasting resources and capital or generating excessive bureaucracy.

Diluks De Silva is a seasoned industry professional with over 20+ years of expertise in Cell and Gene Therapy (CGT), Radiopharmaceutical Therapy, Theranostics, Biopharmaceuticals, Commercial Operations, and Quality. Diluks led the first Novartis commercial CART-T (KYMRIAH) Quality Manufacturing organization, successfully expanding its reach across the US, EU, and APAC regions. His pioneering efforts and ability to foster cross-functional collaboration contributed to influencing and redefining the regulatory landscape supporting Cell and Gene Therapy commercialization. Most recently, he held the North American Country Quality role at Novartis, Advanced Accelerator Applications (AAA) Diluks oversaw quality operations for AAA site operations, Radio Pharmacy operations, and supply chain operations in North America. He is a seasoned executive who drives innovation and strategic leadership. 

Teresa Gorecki comes to Compliance Architects® from Johnson & Johnson, Janssen Pharmaceuticals, where she was most recently Vice President, Market Quality.  At Johnson & Johnson, Teresa was one of J&J’s top-quality professionals, known for her ability to manage inspections and remediate and improve deficient operations. Teresa had senior-level roles across all three sectors within Johnson & Johnson:  Pharmaceuticals, Consumer Products, and Medical Devices. She has extensive experience with biotechnology-derived and cell-based products, including monoclonal antibodies. She also has extensive experience in pharmaceutical dosage forms for both OTC and Rx products; biological (r-DNA, cell therapy, and monoclonal antibody) products; and a wide range of consumer products (class I and II medical devices, OTC drugs, cosmetics and consumer products) in the US and Puerto Rico. Broad experience across all GxPs to include GCP (ICHE6), GMP, QSR and Part 4 Combination Products. Over 25 years of experience handling FDA inspections (routine, special cause, and PAI) for cosmetic/consumer, pharmaceutical/biological products, and combination products. Over 5 years experience as Responsible Head/Authorized Official interacting directly with CBER for biological products.