CynosureToxConsulting

Work Experience

2023 Managing Member/Founder, CynosureToxConsulting, LLC, New Jersey
2022-2023 Senior Director, Toxicology (Gene Therapy), PTC Therapeutics, New Jersey
2020-2022 Director, Toxicology (Gene Therapy), PTC Therapeutics, New Jersey
2020 Distinguished Scientist - Toxicologist, Sanofi, New Jersey
2016-2020 Associate Director - Toxicology, Sanofi, New Jersey
2015-2016 Senior Manager - Toxicology (Non-Promotion Title Change], Sanofi, New Jersey
2013-2015 Lead Research Investigator - Toxicology, Sanofi, New Jersey
2005-2013 Principal Research Investigator - Toxicology, Sanofi, New Jersey
2001-2005 Principal Scientist - Toxicology, Schering-Plough Research Institute, New Jersey
1999-2001 Associate Principal Scientist - Toxicology, Schering-Plough Research Institute, New Jersey
1998-1999 Safety Pharmacology and Toxicology Study Director, Huntingdon Life Sciences, New Jersey
1997-1998 Toxicology Study Director, Huntingdon Life Sciences, New Jersey
1995-1996 Associate Professor, Department of Pharmacology and Toxicology, Virginia Commonwealth University (VCU), Richmond, Virginia
1992-1996 Faculty Member, Graduate Curriculum in Neural Sciences, VCU, Richmond, Virginia
1989-1994 Assistant Professor, Department of Pharmacology and Toxicology, VCU, Richmond, Virginia
1987-1989 Postdoctoral Fellow, NIDA Individual Research Grant (DA-05330), VCU, Richmond, Virginia
1985-1987 Postdoctoral Fellow, NIDA Institutional Training Grant, Department of Pharmacology and Toxicology, VCU, Richmond, Virginia
1984-1985 Predoctoral Fellow, Scottish Rite Schizophrenia Foundation, Department of Pharmacology and Toxicology, University of Texas Medical Branch (UTMB), Texas
1984-1985 Teaching Associate in Pharmacology, School of Allied Health, UTMB, Texas
1982-1984 Medical Technician, Department of Clinical Microbiology, UTMB, Texas
1980-1984 Graduate Assistant, Department of Pharmacology and Toxicology, UTMB, Texas
1980 Research Technician, Department of Pathology and Clinical Chemistry, Barnes Hospital, St. Louis, Missouri
1978-1980 Medical Technician, Department of Clinical Chemistry, Children's Hospital, St. Louis, Missouri

Project Team Toxicologist

AADC deficiency AAV gene therapy (eladocagene exuparvovec approved in EU July 2022) - 2020 – 2023
Angelman Syndrome AAV gene therapy - 2020 - 2023
SAR443312 - January 2019 – 2020 (Lentivirus LV - FVIII - XTEN (hemophilia A))
SAR443375 - January 2019 – 2020 (Lentivirus FIX (hemophilia B))
GZ/SAR402671 (venglustat) - September 2018 – 2020 (SRT (Substrate Reduction Therapy))
SAR439794 - January 2016 – 2019 (Adjuvanted Peanut food allergy))
Xyzal (levocetirizine) - March 2015 – 2016 (Rx - to - OCT switch; Mature Product activity (e.g. PLLR); 3 NDAs (2 OCT; 1 Rx [children]))
GZ389988 - January 2015 – 2020 (Knee Osteoarthritis)
SAR439483 - January 2014 – 2020 (AAV gene therapy)
LC80820 - January 2014 - 2016, 2019 – 2020 (AAV RNAi gene therapy)
LC80768 - January 2016 - December 2017 (Adjuvanted peanut allergy)
LC80888 - January 2015 - July 2018 (Extended-release microsphere formulation)
LC81092 - January 2014 - December 2015 (Hemophilia gene therapy)
LC80921 - January 2014 - December 2016 (Spinal muscular atrophy AAV gene therapy)
GZ404477 - January 2014 - December 2017 (Parkinson Disease gene therapy)
GZ402661 - January 2013 - December 2015 (Kynamro/mipomersen antisense oligonucleotide)
SAR260301 - January 2013 - December 2015 (Oncology program)
SAR256212 - January 2013 - December 2015 (IgG2 oncology program)
Tasidotin - January 2013 - December 2013 (Microtubule - inhibiting oncology program)
SAR103168 - May 2010 - December 2012 (Multikinase inhibitor oncology program)
SAR154782 - April 2009 - December 2012 (NAMPT (visfatin) inhibitor oncology program)
CrTh2 asthma program: SAR398171 - November 2007 - May 2009
Schering - Plough antiemesis program: 2000 - 2005
Schering - Plough CB2 - mediated immunology program: 2000 - 2005

Strategy Contributions and Regulatory Interactions

2008 SAR398171 (CrTh2; asthma) Program: FDA pre -IND meeting and Briefing Package; principal contributor/speaker and respondent for questions related to nonclinical toxicology program proposal with associated specific study design
2015 Project Xanadu / Xyzal Rx -to -OCT switch: FDA pre -IND meeting and Briefing Package; principal contributor for nonclinical pharmacodynamics and toxicology
2016 Project Xanadu / Xyzal Rx -to -OCT switch: FDA post -meeting NDA requirement for a complete DALA Assessment; principal DALA strategist for Project Team as well as direct contributor for nonclinical pharmacodynamics and toxicology, plus consultant for clinical DALA assessment component
2016 Project Xanadu / Xyzal Rx -to -OCT switch: NDAs filed (three total; 2 OTC plus 1 Rx)
2016 SAR439438 (LCA1; AAV -GUCY2D gene therapy) Program: FDA pre -IND meeting and Briefing Package; principal contributor/speaker and respondent for questions related to nonclinical toxicology program proposal with associated specific study design
2016 SAR439794 (GLA/Peanut food allergy) Program: FDA pre -IND meeting and Briefing Package; principal contributor/speaker and respondent for questions related to nonclinical toxicology program proposal with associated specific study design
2016 SAR439794 (GLA/Peanut food allergy) Program: FDA IND and Clinical Investigator Brochure; principal contributor for nonclinical toxicology
2017 Project Xanadu / Xyzal Rx -to -OCT switch: NDAs approved by FDA (three total): 2 OTC NDAs and 1 Rx NDA
2017 GZ389988 (TrkA; osteoarthritis) Program: FDA consultation; principal contributor to document as Project Team Member (Preclinical Safety) detailing proposed nonclinical toxicology study to address FDA -required IND -enabling study to assess potential local nerve toxicity following intra -articular administration
2018 SAR439794 (GLA/Peanut food allergy) Program: IND Amendment; principal contributor to document and Team strategy as Project Team Member (Preclinical Safety) reinitiating clinical trials following Sponsor -determined hold following potential adverse events observed in nonclinical pharmacodynamics study
2018 Dec 17th submission of SAR439438 (gene therapy) Program: FDA IND and Clinical Investigator Brochure; principal contributor for nonclinical toxicology
2019 Response to FDA IND questions: authored nonclinical responses; contributor to clinical responses
2019 FDA INTERACT (pre -Pre -IND) meeting: participant and speaker (response/query)
2020 EMA ITF (Innovation Task Force) meeting: contributor of nonclinical sections
2021 Angelman Syndrome AAV gene therapy Program: FDA pre -IND meeting and Briefing Package; principal contributor for questions related to nonclinical toxicology program proposal and specific GLP study design
2022 AADC deficiency AAV gene therapy program: EU Registration/EMA Oral Explanation meeting and Briefing Package; principal contributor and respondent for questions related to nonclinical toxicology program
2023 Angelman Syndrome AAV gene therapy program: SNSA (Simultaneous National Scientific Advice, Regulatory Meeting)

Life-cycle management of mature / marketed products: Annual Reports AND DSUR

2013-2014 SAR260301 (oncology)
2013-2015 Demerol
2013-2020 NicodermCQ
2014 SAR256212 (oncology)
2014 LeGoo
2014 2017 GZ404477 (AAV hAADC 2; gene therapy)
2015 Auvi Q
2015 Hiprex
2015 Trental (pentoxifylline)
2015-2020 Ambien IR
2015-2020 Ambien CR
2018-2020 Xyzal

Life-cycle management of mature / marketed products: PLLR Label revisions

2018 Levomethadone: BrArM -required revision / update of label
2018 PLLR (Pregnancy and Lactation Label Revision) for Xyzal