Steve Quessy has more than 30 years experience in the Pharmaceutical Industry across multiple therapeutic areas and in a broad range of functions including: clinical research, medical affairs, regulatory affairs, pharmaceutical development, QA and manufacturing.  He has held positions of responsibility and leadership at 3M Healthcare Australasia, 3M Pharmaceuticals in St Paul, Minnesota, Burroughs-Wellcome, Glaxo-Wellcome and GlaxoSmithKline. From 1991 through 2006 Steve was active in multiple clinical development projects targeting a diverse range of pain and musculoskeletal indications, including:

 

·         acute post-operative pain and chronic painful conditions such as osteoarthritis, rheumatoid arthritis, back pain, fibromyalgia syndrome, diabetic neuropathy and other types of neuropathic pain

·         clinical development programs in osteoporosis and osteoarthritis disease modifying agents

New drug development programs encompassed a wide range of mechanisms of action including:

·         NSAID/COX2 inhibitors and other prostanoid targets, Na channel blockers, glycine/NMDA antagonist, adenosine agonist, TRPV1 antagonist, monoamine reuptake inhibitors, cannabinoid CB2 agonist, p38 inhibitor

Accountability for clinical content of briefing documents, responses to FDA/EMEA issues and clinical interactions with FDA across many analgesic developments at various stages, including pre-IND meetings, IND filings, end-of-phase II meetings and special protocol assessments

·         Due diligence review of in-licensing opportunities and numerous detailed technical evaluations

 

Since forming qd consulting LLC in 2006, Steve has served in consulting capacity to assist a number of small and medium sized companies address development or submission issues and to provide independent technical review/feasibility assessment of candidates or in/out-licensing opportunities. Consulting activities have included:

 

·         Develop candidate profiles and Phase II/III clinical development strategies

·         Critical review of protocols and advice on protocol design options

·         Critical review and assistance in interpretation of study results

·         Critical review of and assistance in developing MAA and NDA core technical document content (Modules 2 and 5, ISS and ISE)

·         Anticipating and preparing responses to address submission issues from FDA, EMEA or Health Canada

·         Development of clinical sections of US package inserts and European SmPCs

·         Clinical sections of Risk Management Plans, including abuse liability

·         Development of pediatric waiver or deferral requests

·         Technical review and conduct due diligence review of in-licensing opportunities

 

Scientific writing experience includes writing or substantive drafting of clinical sections of NDA/MAA core technical Modules 2 and 5 for efficacy or safety in the areas of neuropathic pain, diabetes and epilepsy; draft labeling; updates of clinical sections of Investigator Brochures; safety in special population groups for biologicals in the areas of diabetes and coagulation; peer reviewed publications of research articles, topical reviews and book chapters.