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Work Background
Co-Founder
Avalor TherapeuticsCo-Founder
Jan. 2024Washington DC-Baltimore AreaCo-Founder of Avalor Therapeutics, a biotech start-up developing breakthrough precision medicine for chronic inflammation. Avalor is initially focused on disease modification in osteoarthritis.
Co-Founder, Chairman of the Board
Paulex BioCo-Founder, Chairman of the Board
Jan. 2024Washington DC-Baltimore AreaCo-founder and Chairman of the Board of Paulex Bio, a clinical-stage biotech company working towards a world without diabetes. Paulex is developing preventative and regenerative therapies for Type-1 and Type-2 Diabetes.
Founder, CEO
Tolerance BioFounder, CEO
Jan. 2024Washington DC - BaltimoreFounder and CEO of Tolerance Bio, a biotech start-up focused on improving healthspan by restoring and preserving the function of the thymus, a key regulator of immune tolerance.
Chief Scientific Officer, Provention Bio - a Sanofi Company
SanofiChief Scientific Officer, Provention Bio - a Sanofi Company
Apr. 2023 - Jan. 2024Boston, Massachusetts, United States · RemoteAfter the acquisition, I help transition and advance the Provention Bio pipeline in Sanofi, focusing on Tzield (PROTECT completion and regulatory activities, intellectual property development, life cycle).
Board Director
VAXDYN SLBoard Director
Jan. 2020Seville, SpainVaxdyn is a biotechnology company located in Seville, Spain, developing a vaccine platform for antibiotic-resistant bacteria, such as Klebsiella, Acinetobacter and Pseudomonas. Our goal is to decrease the impact on public health of infections caused by drug-resistant pathogens
Co-Founder, Chief Scientific Officer
Provention Bio (acquired by Sanofi in 2023)Co-Founder, Chief Scientific Officer
Oct. 2016 - Apr. 2023Red Bank, NJ, USACo-Founder, Chief Scientific Officer, former Board Director (2018-2019), former Chairman of the Scientific Advisory Board (2017). Provention Bio was acquired by Sanofi in April 2023. Provention was a clinical-stage biopharmaceutical company dedicated to sourcing, developing and commercializing novel therapeutics and cutting edge solutions to intercept and prevent immune-mediated disease. Our founding mission was to reduce the high-morbidity/mortality and escalating costs of autoimmune and inflammatory diseases, such as type 1 diabetes, celiac disease, Crohn’s disease, ulcerative colitis, lupus and emerging viruses. Our pioneering approach was to “predict” and “pre-empt” immune-mediated disease – to identify at-risk patients and intervene before the targeted disease begins, re-appears or progresses. At Provention, I had the privilege of leading scientific aspects of our programs, with focus on the advancement of teplizumab/TZIELD®, and responsibility for our celiac (PRV-015, anti-IL-15), lupus/gene therapy (PRV-3279, CD32B/CD79B bi-specific) and coxsackie vaccine (PRV-101) programs. I functionally managed Translational Medicine, Biomarkers, Intellectual Property and Pharmacokinetic teams, and supported Business Development, Investor Relations, Corporate Communications and Commercial.
Co-Founder, Partner
Gluten Detect (Glutenostics LLC)Co-Founder, Partner
Jun. 2016Los Angeleshttps://glutendetect.us/ Glutenostics commercializes rapid detection assays (GlutenDetect Stool and Gluten Detect Urine) and lab-based assays (iVYCHECK lateral flow test, iVYDAL ELISA) to help people avoiding gluten to be more compliant with their diets.
Co-Founder, CEO, Chief Medical Officer
Celimmune (acquired by Amgen in 2017)Co-Founder, CEO, Chief Medical Officer
Feb. 2015 - Oct. 2018Bethesda, MDCo-founded Celimmune, an immunotherapy company focused on gastrointestinal autoimmunity. CEO and Chief Medical Officer from Feb 2015 to November 2017, when Amgen acquired Celimmune following completion of Phase 2 clinical trials of AMG 714 (anti-IL-15 mAb) in celiac and refractory celiac disease Type II (pre-EATL/intestinal T cell lymphoma).
Adjunct Research Associate Professor of Medicine
Jefferson Medical College, Dept. of GastroenterologyAdjunct Research Associate Professor of Medicine
Jun. 2011 - Dec. 2020Dpt. of Gastroenterology, Jefferson Medical College, Thomas Jefferson UniversityProvided advice on innovative clinical trials in celiac disease.
Vice President & Head, Immunology Translational Medicine
Janssen/J&JVice President & Head, Immunology Translational Medicine
Sep. 2010 - Jan. 2015Springhouse, PAFounded the Immunology Translational Medicine team at Centocor, later Janssen. Responsible for translational strategies and early clinical development of biologic and small molecule therapies for immune-mediated diseases (Phase 0 to proof-of-concept) at Johnson & Johnson.
Founder, President
PharmImmuneFounder, President
Jul. 2010Potomac, MDCompany ideation and consultancy firm.
Vice President & Chief Medical Officer
Alba TherapeuticsVice President & Chief Medical Officer
Sep. 2007 - Sep. 2010Baltimore, MDHead of Clinical Development. Early and Late Development including Regulatory. Celiac Disease, Crohn's Disease. Led clinical aspects of the out-licensing of larazotide acetate to Cephalon/TEVA.
Director, Clinical Development, Inflammation & Respiratory
MedImmune/AZDirector, Clinical Development, Inflammation & Respiratory
Sep. 2006 - Sep. 2007Gaithersburg, MDInflammation therapeutic area, focus in Asthma, serving as development leader for the anti-IL-9 and anti-IL5R programs (clinical lead for Phase 1 FIH study for benralizumab, FASENRA) as well as earlier stage programs. Contributed to biomarker efforts in mucosal vaccines (FluMist), life-cycle management and corporate and business development activities.
Director, Clinical Discovery, Immunology & Oncology
Bristol-Myers SquibbDirector, Clinical Discovery, Immunology & Oncology
Sep. 2004 - Aug. 2006Princeton, NJEarly development of immune modulators in Immunology and Oncology. Phase I-IIa, biomarkers, POC, clinical pharmacology. Focus on costimulation (abatacept/ORENCIA sBLA, belatacept/NULOJIX biomarker patents, immune monitoring of ipilimumab/YERVOY responses, in-licensing discussions for nivolumab/OPDIVO with Ono) and chemokine receptors (development team co-leader for a small molecule inhibitor of CCR2).
Research Fellow, Lab. of Clinical Investigation, Lab. of Molecular Immunology, NIAID
National Institutes of Health (NIH)Research Fellow, Lab. of Clinical Investigation, Lab. of Molecular Immunology, NIAID
Jan. 2002 - Aug. 2004Bethesda, MDPostdoctoral Research Fellow at the Laboratory of Clinical Investigation (Head: Dr. Warren Strober), reorganized in 2004 as Laboratory of Molecular Immunology (Head: Dr. Phil Murphy), at the National Institutes of Allergy and Infectious Diseases, National Institutes of Health (LCI-LMI/NIAID/NIH), Bethesda, MD, Feb 2002- Sept 2004. Study of the role of dendritic cells (DC) in the pathogenesis of Inflammatory Bowel Disease (IBD), psoriasis and other autoimmune diseases, under the supervision of Dr. Brian Kelsall, Head of the Immunobiology Section. Development of novel immuno-modulatory therapeutics, pre-clinical validation, immunological monitoring of phase I and IIa clinical trials.
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