Kevin Leach

Senior Vice President Scientific and Regulatory Affairs @Avance Clinical

Lexington, MA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Aug 2023 — Present

Senior Vice President Scientific and Regulatory Affairs @Avance Clinical

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Boston, MA, US

EDUCATION

1989 — 1993

University of Richmond

BS, Biology

1993 — 1999

Virginia Commonwealth University School of Medicine

Doctor of Philosophy (Ph.D.), Biochemistry

2001 — 2004

Massachusetts Institute of Technology

Post Doctoral Fellow, Biological Engineering

SKILLS

Protein ChemistryAdmeClinical TrialsManagement of Outside Laboratories Both Domestic and InternationalToxicologyIndSmall MoleculesLife SciencesBiochemistryImmunologyAssay DevelopmentClinical DevelopmentGlpNon-ClinicalBiomarker DiscoveryToxicology, Adme, PharmacologyMedical AffairsPreparation of Regulatory SubmissionsMolecular BiologyBiotechnologyCROIn VitroDrug MetabolismClinical ResearchClinical PharmacologyPharmaceutical IndustryCRO ManagementLaboratoryDrug DevelopmentBiopharmaceuticalsTranslational ResearchTarget IdentificationDmpkOrphan DrugsDrug DiscoveryU.s. Food and Drug Administration (Fda)PharmacologyCell CultureRegulatory SubmissionsIn Vivo

ABOUT KEVIN LEACH

Highly motivated nonclinical and translational scientist with over 19 years of experience in the pharmaceutical industry working in discovery and development settings for both large and small organizations.I have hands on experience and led teams in areas of DMPK, Toxicology, Pharmacology, Bioanalysis, Biomarkers and Clinical Pharmacology. I have worked on and led projects with several different molecular modalities including, small molecules, antibodies, peptides, therapeutic proteins, anti-sense oligonucleotides and RNAi. Over the last 10 years I have been part of the executive and leadership teams of the organizations where I worked, have led large and small teams. I have experience both managing projects with internal and external resources. I have also been the scientific lead of several in-licensing and out-licensing efforts with successful outcomes in either direction.My management style is collaborative and is based on clear and frequent communication between myself, the team and other stakeholders.Current - VP Non-clinical and Translational Research - Enveric BioEnveric is developing next generation psychedelics for difficult to treat psychiatric diseases such as GAD, Depression and AddictionPast - SVP Non-clinical and Translational Research and Portfolio Management - QuralisQuralis is using both small molecule and anti-sense oligonucleotide approaches to treat ALS and FTDPast - VP Non-clinical and Translational Research - Spring Bank PharmaceuticalsSpring Bank was using small molecule nucleotide hybrid molecules to stimulate the immune system to treat infectious diseases (HBV) and to treat patients with cancer Past-Sr. Director of Nonclinical and Translational Research - TravereTravere focuses on treatments for rare diseases. They have ongoing clinical programs and several approved drugs. I started as a director of Pharmacology,there and later I headed the Research and Development organization. While I was there we brought 2 molecules through to Phase 3. 1 of those compounds, Sparsentan is continuing towards approval in the kidney disorders, FSGS and IGaN.Past-Pre Clinical Scientist-Shire Pharmaceuticals (Takeda)Shire was mainly focused on rare diseases but also had several specialty franchises. I achieved my board certification in Toxicology there and I led scientific efforts for the HAE and ADHD programs.Past-ADME/DMPK Scientist - MerckI worked in the DMPK department at the Merck Boston site. We worked on oncology and CNS programs there. I also started a investigative toxicology effort while I was at Merck.

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Kevin Leach — Senior Vice President Scientific and Regulatory Affairs at Avance Clinical in Lexington, MA, US | Unifers