Christina Fam Faragalla, MS, PMP

23 Years of Clinical Research Development and Management Experience. Trial, asset and Portfolio Management. Extensive Experience in Clinical Endpoint Development, Biomarker Strategy, Psychometry Assessments, Translational Medicine Extensive engagement in Rare Disease landscape including case control, natural history, adaptive design and synthetic arm concepts; Rare and Ultra Rare Disease Class experience including but not limited to Cystic Fibrosis, Mitochondrial Disorders, Lysosomal Storage Diseases, Rare Cancers. Experience with Gene and Cell Therapies and SiRNA, RNA and other intensive Therapeutic Platforms Lifecycle Stages: POC to Early and Late phase drug development, IND enabling, FIH, thru end of Phase 2 Meeting Fast Track and NDA experience to registries (vertex) and post marketing trials. Extensive Neurology and Psychiatry Endpoint and Biomarker strategy experience including validated Scale use and adaptation to EPro, Remote and Decentralized Rater Vendor Selection management and oversight. Risk Assessment and Management. Strategic Assessment and Project Management of the entire landscape from endpoint selection and negotiation w regulatory agencies through protocol development. Nexgen Biomarker Experience includes New or Companion Diagnostic biomarker strategy, genomics, including WES and single gene or TSO; pathology including Pathological AI application development and endpoints.

Expert at navigating in a variety of settings: Small intense biotech startups, Large cross functional Biopharma teams, and managing for Corporate Governance across the array.

TA Experience Includes: 

Oncology: Solid Tumors (basket studies and stratification into indications of interest); Bladder, Lung, RCC, Prostate, Liver Primary and Mets, Ovarian, GBM, etc;  Liquid Tumors, Lymphomas including: Cutaneous T-Cell Lymphoma, AML, MDS

CNS: Schizophrenia, Vasospasm following Sub-arachnoid Hemorrhage, Multiple Sclerosis, TRD,  Alzheimer's Disease, Vascular Dementia, Epilepsy, Major Depression, Subtype Atypical Depression, General Anxiety Disorder, Panic Disorder, Orphan drugs, PMDD, Bipolar Disorder, Autism Spectrum Disorders, etc. Anesthesia, Stroke, Pain, MDD & TRD: Depressive Disorders, Anxiety Disorders, Alzheimer’s, Epilepsy, Stroke; Acute and Rehabilitation,  Pain Management. Post Herpetic Neuralgia, 

Cardiometabolic: Hyperlipidemia, Obesity, Diabetes, Chronic Stable Angina

Infectious Disease/Respiratory:  Vaccine, Hepatitis-C, Asthma, and Exercised-Induced Bronchospasm (EIB); Ant-infectives, COPD, 

Women's Health: Contraceptives: Implantable; Drug Eluting and Not, Oral Contraceptives, Long Acting Injectable; PMDD; Fertility; Gyn. Cancers   

GI: Short Bowel Syndrome, IBD, Chrohn's, Celiac Disease, Hernia Repair (Mesh tissue implant),    

Orphan and Rare Disease: : Dermatomyositis, Cystic Fibrosis, Rare Cancers,  Mitochondial and Lysosomal Disorders; Gene, Cell and RNA therapies; Many more not listed     

Urology, Nephrology, Anti Infective, Dermatology  Ophthalmology, Anesthesia, Post Herpetic Neuralgia, COPD, 

• Support implementation of Study and Site enrollment strategy and plans to support JNJ to complete enrollment of Esketamine trials to secure a breakthrough designation and Urigen to complete enrollment in their pivotal trial for their lead asset.
• Managed a cross functional team to achieve successful and timely IND submissions at Protagenic, Elucida and at least three other biotechs.