Consultant / Founder Bellemina Therapeutics LLC                               

                                                                         July 2020 - Present                                                                            

Providing regulatory and preclinical strategy expertise from discovery to first-in-human, write-up of regulatory documents, teams/projects/CROs/KOLs management, personnel supervision, company representation to FDA and MHRA meetings, protocols design, data interpretation, set-up of program Gantt chart.

AAV and HSV gene therapy, cDNA and Zinc-Fingers, Small Molecule, Device

Adults and Pediatrics

Numerous regulatory submissions and indications

Multiple routes of administration (see CLIENTS page)

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                                              Advisor, Stanford Medicine                                                        

                                                                     Sep 2020 - Present                                                                                  

Advising academic teams on regulatory and preclinical strategies to first-in-human and building value for angel investors funding with streamlining research spending.

Small Molecules and Biologics, Metabolic, Oncology​

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                                                  Angel Investor, LSA group                                                      

                                                                      Sep 2021 - Jan 2026                                                                              

Due diligence and investments.

Small Molecules, Biologics, Devices

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                                           Vice President, Preclinical Development                                     

                                                     June 2018 - July 2020, SwanBio Therapeutics Inc                                           

Head of toxicology group with direct reports. Set-up and implemented preclinical strategy, represented to company to FDA pre-IND meeting, wrote pre-IND preclinical sections and investigational brochure, pediatrics first-in-human dose justification (inclusive of volume and endotoxin levels) and orphan drug designation. Studies design and data interpretation: NHPs safety studies, proof of concept studies in mice, drug product-device compatibility (infusion pump), drug product potency assay qualification, bioanalytical assays qualifications (capsid and transgene biodistribution, antibodies), biomarker assay qualification for target engagement and NHPs pre-screening for pre-existing antibodies to capsid. Management of CROs and KOLs.

AAV9 Gene Therapy, Pediatrics

Adrenoleukodystrophy, CNS intrathecal delivery-pump infusion, pre-IND​​

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                                          Vice President, Preclinical Development                                      

                                                April 2017 - May 2018, Adverum Biotechnologies Inc                                         

Head of toxicology, pharmacology and bioanalytical groups with direct reports. Set up/implemented/oversight of proof-of-concept studies in mice and NHPs as well NHP safety studies. Protocols design, data interpretation, CROs management, drug products potency assays qualifications, bioanalytical assays qualifications (capsid and transgene biodistribution, antibodies), biomarker assays qualifications for target engagement and NHPs pre-screening for pre-existing antibodies to capsid. Wrote regulatory documents (pre-INDs, INDs, IBs, orphan drug designations), justified first-in-human dose (inclusive of volume and endotoxin level) as well as administration routes (intravitreal, intrapleural).

AAV Gene Therapy, Adults, Pediatrics

Wet Age-Related Macular Degeneration, AAV2/6 cDNA, pre-IND meeting, IND 2018

Alpha-1 Antitrypsin Deficiency, AAV10 cDNA, pre-IND meeting, IND 2017

Blue Cone Monochromacy, Friedreich Ataxia, Hereditary Angioedema, AAV10 cDNA, POC 

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                                         Senior Director, Preclinical Development                                      

                                               April 2016 - March 2017, Audentes Therapeutics Inc                                           

Head of toxicology, pharmacology and bioanalytical groups with direct reports. Set up/implemented/oversight of proof-of-concept studies in mice and NHP safety studies. Protocols design, data interpretation, CROs management, drug products potency assays qualifications, bioanalytical assays qualifications (capsid and transgene biodistribution, antibodies), biomarker assays qualifications for target engagement and NHPs pre-screening for pre-existing antibodies to capsid. Wrote regulatory documents (pre-INDs, pre-CTAs, INDs, IBs, orphan drug designations), first-in-human doses justifications and endotoxin levels for pediatrics (inclusive of intravenous route and volume), represented the company at pre-IND meetings with FDA and pre-CTA meetings with MHRA.

AAV Gene Therapy, Pediatrics

X-Linked Myotubular Myopathy, AAV8 cDNA, pre-IND and pre-CTA, IND 2017 

Crigler-Najjar Syndrome, AAV8 cDNA, pre-IND and pre-CTA, IND 2016 ​

Catecholaminergic Polymorphic Ventricular Tachycardia, AAV8 cDNA, POC 

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                                          Senior Director, Preclinical Development                                     

                                                         March 2015 - April 2016, Retrotope Inc                                                       

Head of toxicology, pharmacology, bioanalytical, CMC, Regulatory and QA functions with one report. Set up/implemented/oversight of program strategy, proof-of-concept and safety studies in mice and dogs (genotoxicity, general tox-acute and chronic, safety pharmacology, DMPK/ADME, drug-drug interactions, CYP induction/inhibition, QT/QTc studies, Biomarkers, Metabolites). CROs management, protocols design, data interpretation, performed WinNonlin/NONEM PK modeling and set-up the program Gantt chart. Oversight of CMC manufacturing, drug product specifications, formulation and packaging, drug product stability design and assays validations (drug product, metabolites, target engagement, biodistribution), as well as QA assessments. Wrote regulatory documents (pre-IND, IND-inclusive of preclinical, clinical Phase I and PK sections, CMC, IB, orphan drug designation, clinical manual) and justified first-in-human pediatrics dose inclusive of formulation, impurities, leachable and extractables as well as route of administration (intravenous). Coordinated regulatory efforts for pre-IND meeting and IND submission with FDA. Represented the company at pre-IND meeting with FDA.

Small Molecule, Pediatrics

Friedreich Ataxia, Deuterated Linoleic acid, pre-IND, IND 2015

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                                          Senior Director, Preclinical Development                                     

                                                         March 2011 - Oct 2012, Viropharma Inc                                                       

Head of toxicology, pharmacology and bioanalytical groups with direct reports. Set up/implemented/oversight of preclinical strategies, proof-of-concept and safety studies in mice/dogs/NHPs (genotoxicity, general tox-acute and chronic, safety pharmacology, DMPK/ADME, drug-drug interactions, CYP induction/inhibition, QT/QTc studies, biomarkers, metabolites, reproductive toxicity studies). CROs management, protocols design, data interpretation, bioanalytical assays validations and analyses, performed WinNonlin/NONEM PK modeling, simulations and population PK analyses. Wrote pre-IND/pre-NDA/IND/NDA/BLAs preclinical and clinical PK sections, investigational brochures, orphan drug designations, first-in-human doses justification (adults and pediatrics, routes-oral, IV, formulation, impurities, endotoxin, leachable and extractables). Represented the company at regulatory meetings with FDA.

Small Molecules, Biologics

Adults, Pediatrics

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Friedreich Ataxia, Indole-3 propionic acid, POC

Adrenal Insufficiency, Plenadren (Hydrocortisone), pre-NDA meeting, NDA 2012

GI infections, Nontoxigenic Clostridium Difficile, BLA 2012

Antibody Mediated Kidney Rejection and Delayed Graft Function, human C-1 esterase inhibitor, pre-IND, IND 2012

Hereditary Angioedema, Cinryze (human C-1 esterase inhibitor), BLA 2012

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                              Project Director - Director of Preclinical Development                         

                                                                        Feb 1997 - March 2011                                                                       

       Bayer Biotechnologies, GSK Biologicals of North America, Poniard Pharmaceuticals, Conjuchem      

Head of toxicology, pharmacology and bioanalytical groups. with direct reports. Set up/implemented/oversight of preclinical strategies, proof-of-concept and safety studies in mice/rabbits/dogs/NHPs (genotoxicity, general tox-acute and chronic, safety pharmacology, DMPK/ADME, drug-drug interactions, CYP induction/inhibition, QT/QTc studies, biomarkers, metabolites, reproductive toxicity studies). CROs management, protocols design, data interpretation, bioanalytical assays validations and analyses. Performed WinNonlin/NONEM PK modeling, population PK analyses and PK profiles for different routes of administration: Oral-IV cross-over, subcutaneous, intravenous, intraperitoneal, intramuscular. Wrote regulatory documents (pre-INDs/pre-NDA/ INDs/CTAs/NDA preclinical and clinical PK sections, IB), first-in-human dose justification inclusive of formulation, route, impurities, leachable and extractables. Represented the company at regulatory meetings with FDA and MHRA.

Small Molecules, Biologics, Vaccines, Oligonucleotides gene therapy, Conjugated drugs

Adults

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Small Cell Lung Cancer, Picoplatin (platinum-based chemotherapeutic), NDA 2010

Non-Hematological Malignancies, Picoplatin, IND 2007

Protollin-adjuvated Anti-Plague Vaccine (NIH funded), IND 2006

Protollin-adjuvated Anti-Plague Vaccine (NIH funded), POC, 2006

HIV, Interleukin-2 analogue, pre-IND, wrote IND preclinical sections, IND 2002

Melanoma Renal Cell Carcinoma, Interleukin-2 analogue, pre-IND, CTA and IND 2001​

Multiple Sclerosis, Interleukin-4 analog, pre-IND meeting, CTA and IND 2001

Anti-thrombosis, Argatroban analog, pre-IND meeting, IND 2000

Pain Management, Dynorphin analog, pre-IND meeting, IND 2000