Experience

Hurley Consulting Associates Ltd.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director Preclinical Pharmacology - Retired

  • Aug 2004 - Jul 2017

  Scientist and writer working in an interdisciplinary consulting team environment; expertise includes nonclinical drug development with emphasis on cardiovascular safety pharmacology. The following are highlights of team experience gained at Hurley Consulting Associates: • Major projects concerned development of small molecule, radiolabeled, and biologic (i.e., recombinant peptide, monoclonal antibody) therapeutics for diverse indications: schizophrenia, pain, oncology, osteoporosis… Show more Scientist and writer working in an interdisciplinary consulting team environment; expertise includes nonclinical drug development with emphasis on cardiovascular safety pharmacology. The following are highlights of team experience gained at Hurley Consulting Associates: • Major projects concerned development of small molecule, radiolabeled, and biologic (i.e., recombinant peptide, monoclonal antibody) therapeutics for diverse indications: schizophrenia, pain, oncology, osteoporosis, hypertension, PTSD/anxiety, actinic keratosis, acne and sunburn.  Prepared nonclinical sections of full and abbreviated new drug application submissions: written and tabulated summaries for IND, NDA/CTD 2.4 and 2.6, and 505(b)(2) submissions.  Contributed to nonclinical and clinical pharmacology, safety, and pharmacokinetics sections of FDA meeting request, FDA briefing book, reviewer/rappateur question response, and target product profile/draft labeling.  Contributed to preparation of NDA/CTD clinical sections 2.5.3, 2.7.2, appendix tabulations, and ISS/ISE.  Assessed submission suitability of nonclinical study reports; performed document and data tabulation quality (QC) assessments.  Participated in clinical study concomitant medications coding. • Coached FDA Advisory Committee presenters; prepared slides. • Assessed nonclinical programs; implemented supplemental nonclinical safety, pharmacokinetics, and toxicology studies using contract laboratories • Abstracted literature to proprietary Access databases; created literature summaries and position/white papers. Show less



Schering-Plough Research Institute

• United States
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Associate Principal Scientist

  • Jun 1974 - Feb 2004

  Bench scientist and manager whose small molecule drug discovery experience included in vitro/ex vivo and in vivo model development, target validation, mechanistic studies, and low-throughput primary and secondary screening of small molecules. The most recent work characterized targeted and ancillary pharmacology at G protein-coupled receptors (e.g., histamine, adrenergic, tachykinin, prostaglandin) and other diverse targets (e.g., ligand-gated ion channels, phosphodiesterases, receptor tyrosine… Show more Bench scientist and manager whose small molecule drug discovery experience included in vitro/ex vivo and in vivo model development, target validation, mechanistic studies, and low-throughput primary and secondary screening of small molecules. The most recent work characterized targeted and ancillary pharmacology at G protein-coupled receptors (e.g., histamine, adrenergic, tachykinin, prostaglandin) and other diverse targets (e.g., ligand-gated ion channels, phosphodiesterases, receptor tyrosine kinases) in human and animal ex vivo tissue models of neuromuscular and immune-inflammatory pathophysiology for disease indications such as asthma, respiratory allergy, and nasal congestion. Additional responsibilities included: service on new drug target task forces and a licensing due diligence team; ensuring laboratory compliance with SOPs and state and federal regulations (documentation, safety, animal welfare, etc.); and coordinating the activities of legal, accounts payable, receiving, and laboratory personnel to initiate and maintain vendor relationships for human tissue procurement. Accomplishments at Schering-Plough included the following: • Coauthored 36 journal articles and 28 abstracts; presented at American Thoracic Society, FASEB, and Neuroscience Conferences. • Received two Schering-Plough President's Awards (Research) recognizing outstanding scientific and technical achievement: 1989, A Novel Approach to Treating Bronchial Asthma; and 1998, The Design, Synthesis and Characterization of Novel, Dual, NK1/NK2 Antagonists. Show less