Robert Panek Email & Phone Number

New York, United States

Dublin, IE

Raleigh, North Carolina, US

• Responsibilities and Accomplishments
• Senior medical writer on clinical study or regulatory project teams for early phase through phase 3 projects providing scientific/regulatory writing (CSRs, protocols, protocol amendments, ICFs, narratives) and.
• Plans and coordinates report writing activities with staff to ensure completion of high-quality writing projects
• Scientific and writing competencies in several therapeutic areas including, immune diseases, oncology, diabetes, and cardio-metabolic diseases (lipid disorders, atherosclerosis and hypertension).
• Provides project management support throughout the document life cycle, establishing relationships with authoring teams to ensure efficient delivery of high quality content.
• Represents the medical writing department on clinical study teams and at meetings regarding the writing project.

Morrisville, NC, US

• Responsibilities and Accomplishments
• Provided scientific/regulatory guidance and technical expertise in the writing, production and review of clinical/regulatory and scientific documents. Planned and coordinated report writing activities with staff to.
• Independently developed and produced medical writing deliverables for clinical and regulatory documents: CSRs, protocols, protocol amendments, medical writing plans, narratives, ICFs, and commercial publication.
• Provided project management support throughout the document life cycle, establishing relationships with authoring teams to ensure efficient delivery of high quality content.2018/2019: in addition to several manuscripts.

Publications writer responsible for preparing pharmaceutical commercialization publications (Phases 2/3, Phase 4/post-marketing, and health outcomes) for submission to medical/scientific journals and scientific conferences and congresses..

Ann Arbor, MI, US

Investigated links between inflammation and vascular injury. Elucidating mechanisms of endothelial function/dysfunction in the context of vascular injury and consequences of NF-kB activation downstream of GPCRs.

Marlborough, MA, US

• Vascular repair mechanisms
• Co-leader for drug eluting stent project development and implementation of plans and testing path for evaluation of drug combinations for prevention of in-stent restenosis
• Formulated strategy for identification and assessment of candidate drugs for local delivery approaches to treat vulnerable atheroma to prevent ACS
• Global patent review board member, providing review and recommendations on intellectual property.
• Provided due diligence on technical assessments for potential investment opportunities

• Developed scientific strategies and tactical plans for preclinical development of a novel peptide for topical treatment to accelerate dermal wound repair

New York, New York, US

• Lipid and Metabolic disorders, Atherosclerosis
• Led SPT project team. Spearheaded identification and optimization of SPT inhibitors and inhibition of sphingomyelin synthesis pathway as a novel drug target to treat dyslipidemia and atherosclerosis. Delivered a lead.
• Managed development and execution of project plans including, compound testing funnel, in vivo pharmacology (efficacy, PK, biomarkers) studies, organization and preparation of team meetings, reports and presentations
• Developed a novel high-throughput SPT enzymatic screening assay that reduced resources
• Developed SPT inhibitor biomarker strategy to establish proof-of-mechanism
• Contributed to identification and lead optimization of a PPAR β/α dual agonist for dyslipidemia. Delivered clinical candidate which advanced to phase I. Pharmacology representative on the PPAR β/α agonist development.

New York, New York, US

• Lipid modulation, Angiogenesis
• Project lead for Liver X receptor (LXR) agonist program (lipid modulation target). Managed compound testing path, designed and implemented in vivo pharmacology studies that led to identification of novel, non-sterol.
• Member of the dyslipidemia/atherosclerosis new target team. Provided scientific review, recommendation of new targets approved into the cardiovascular discovery portfolio
• Member, therapeutic angiogenesis collaboration with Genvec, Inc., for the development of adenoviral VEGF121 (CI-1023) to promote re-vascularization to treat CAD and PVD
• Established angiogenesis assays (ie., aortic ring outgrowth, matrigel tube formation) to screen for novel small molecules that directly promote vascularization
• Managed external wound healing academic contracts. Coordinated in vivo studies assessing effects of adenoviral VEGF121 on promoting wound repair

• Vascular injury, Restenosis, Hypertension
• Co-Leader of the restenosis project team of 10 scientists. Identified selective PDGFβ and FGF-1 receptor tyrosine kinase inhibitors of VSMC proliferatiion and migration. Demonstrated in vivo inhibition of lesion.
• Managed external restenosis proof-of-concept studies with Matrigen Inc. and Cook, Inc. Demonstrated anti-restenotic efficacy with PDGF / FGF dual receptor tyrosine kinase inhibitors formulated for coated stent delivery.
• Identified small molecule inhibitors of the PI-3 Kinase SH2 / PDGFβ receptor interaction. Awarded patent for use of PI-3 Kinase/ PDGFβ receptor inhibitors as anti-proliferatives for treating restenosis
• Core team member, endothelin receptor antagonist project for treating hypertension. Implemented and directed screening path (ETa and ETb receptor binding and in vitro vascular tissue contraction assays). Published.

• Hypertension, In vitro lab group leader
• Managed Angiotensin AT1 receptor antagonist project in vitro laboratory. Responsible for compound screening and characterization of AT1 and AT2 receptor pharmacology. Identified clinical candidate CI-996. First to.
• Pharmacology representative on the CI-996 development team responsible for in vivo efficacy studies to support IND. Completed pharmacology section for IND filing
• Directed the development of a high-renin primate model of hypertension utilized for definitive in vivo efficacy evaluation of novel non-peptide renin inhibitors and selection of clinical candidates
• Designed and executed mechanistic studies evaluating ACE inhibition on modulation of the tissue renin-angiotensin system and regulation of blood pressure to support IND / NDA filings for Quinapril

Bs, Biochemical Pharmacology

Ph.D., Pharmacology

Postdoctoral Fellowship, Pharmacology, Cell Biology