Welcome to Functional TransGenomics

Our passion is to find solutions for unmet health issues. Established diverse portfolio in translational medicine from an innovation to market under global regulatory requirements with precision using functional genomics to system and signaling cascades in stem cell differentiation and development related to pathology (disease), targeted molecule, drug for biomarker selection, or discovery. Thus, our regulatory medical written reports reflect quality deliveries, after a careful data and gap analysis.

Translational Science in Clinical Medicine: Fast-tracked translational research development in key health areas by conducting pre-clinical studies and by collaborating with medical teams to maintain quality deliverables. Achieved cost reduction, improved success rates by customized biosensor/biomarkers. Guided the planning and implementation of all operational aspects of Translational Medicine clinical trials from study concept to reporting in accordance with timelines, budget, operational and quality standards for all aspects of the management, clinical execution in multiple therapeutic areas.

Regulatory and Medical Affairs: Author, editor, regulatory documents on clinical research, protocols, publications, patents, grants. Clinical study reports (CSRs), Informed consent forms (ICF), Target Product Profile (TPP), labeling, Common Technical Document (CTD), Investor Brochures (IB), Post Market Surveillance, Risk Analysis and Management, Compliance, Quality, Design, GCP, Biologics, GMP. US FDA: IDE, PMA, 510 k & IND, BLA, NDA EU EMA: CTA, MAA, IMPD, EU MDR 2017/745, Clinical Evaluation Plan & Report (CEP/CER), EU IVDR 2017/746, Performance Evaluation Plan & Report (PEP & PER) 

Ethics, Global Strategy for Medical Devices, Global Strategy for Pharmaceuticals (P), Medical Device Definition and Lifecycle (M), Pharmaceutical Definitions and Lifecycle (MP), Role of the Regulatory Professional, Project Management for the Regulatory Professionals (PM), Risk Management (M), PMS (M), CAPA and Recalls (M), Due Diligence Product Development (MP), GCP (MP), Understanding of the Clinical Applications (MP), Effective Regulatory Communications (MP), Writing with Good Writing Practice and Statistical Applications (MP), Medical Writing for Biologics and Pharmaceuticals (CTD, NDA, MAA, BLA), Medical Writing, Investigational Applications(IND, IDE, Canadian CYA, Canadian ITA, European CTA, European IMPD), Medical Writing for Medical Devices (PMA, 510k), Global Regulatory Affairs &Intelligence, European Regulatory Affairs & Strategy, US Regulatory Affairs & Strategy. Authored, reviewer for regulatory documents, reports on clinical research and trial design, protocols, publications, articles, abstracts, and scientific posters with a matching scientific approach from sequencing, large datasets, integration of information, and statistics.

Business Development with Strategic Alliance & Key Opinion Leader (KOL) Engagements: Ensured product selectiveness for a biomarker developer client by communicating with research, product development, and marketing teams, assisting in industry testing, and presenting product innovation strategies to stakeholders. Stayed vigilant in life science market and follow the trend closely to analyze the primary acquisition goals, mergers, partnerships. Evaluated the market and positioned the product value to gain easy integration and acceptance for sale. Built-up teams and reached out to KOLs to provide logistics and deliverables.  

Established a strong and diverse portfolio for clinical applications using single cell mechanisms and signaling cascades. Bridged between the clinical development and operations under regulatory requirements for product development. Fostered academic and industrial collaborations by implementing true translational medicine from an idea to the market with precision.Savvy in cutting edge technology development, adaptation and implementation. 

* Strategic Translational Medicine with Combined Products 

* In vitro Diagnostic Technologies

* Medical Device Development 

* Biologics Development

* Drug Development

* Medical and Regulatory Affairs

* Alliance Management and KOL Programs

 Single cells (immune, microbiome, stem cells, viral, bacterial, fungi), Cellular differentiation and programing, Development, Genetics, Genomics, Chromosome Walking, In Vivo, Immunology, Inflammation, Genomics, Microbiome, Physiology, Biomarkers-Biosensors, Nanotechnology, Gene and Cellular Therapy (Adeno Associated Virus (AAV), LentiViral (LTV), lipid, naked plasmid), Laser, Optics, comparative development, physiology, signaling cascades, GPCR, single/stem cell, Metabolism, Endothelial Cell Activation, Vaccines, companion diagnostics (CDx), pharmacogenetics/ pharmacogenomics (PGx), bioinformatics. Neurodegenerative: Alzheimer’s Disease; Blood Brain Barrier (BBB), Rare Diseases: Hemophilia B, Cystic Fibrosis, CFTR, Oncology, Hematology, Tumor, Blood Cancers, Cardiovascular (CVD), Thrombosis, Trauma, Stroke, Dementia, Cancer Coagulopathies, Human Vein Tissue engineering (Lentiviral), Anti-Coagulant Therapy, Diabetes, Industrial Microbiology, Biotechnology, Infection, GI Microbiome, Host-Pathogen, Sepsis, Anti-Fungal Treatment, Comorbidities, regulatory affairs, strategy, medical affairs, US FDA, EU, ISO, ICH.