• W Robert Simons is a seasoned, hands-on market access specialist and econometrician with leadership skills and business acumen and well-documented ability to think strategically and execute.• Applied to Health Technology Assessments (HTA) globally, he successfully achieved broad public listings at favorable and sustainable prices for close to twenty drugs in Australia, Canada, Asia (i.e., South Korea and Taiwan), Latin and South America and across Europe.• He’s also built, trained and mentored multiple Health Economic and Outcomes Research (HEOR) teams in the U.S., U.K., Germany, Paris, Canada, Taiwan, South Korea, Brazil, Mexico and Australia. In the last few years, these teams submitted HTA dossiers for two drugs, one in metastatic breast cancer and one in epilepsy. Eleven of the twelve submissions were approved.• With business acumen, he built a successful global consultancy with an Australian subsidiary that was also a preferred analyst and service provider for the Australia Department of Health and Aging with an eighty percent approval rate.• Within industry as global Market Access/ HTA lead, he integrated health economics and outcomes research, and more specifically, regional Market Access needs into clinical development and regulatory strategies for registration submissions.• As a new initiative -seeking to have quality of life added to label- he worked with regulatory and clinical development and regulatory authorities (i.e., FDA, EMA and Australia TGA) for quality of life endpoints to be included in label.Built, inspired and motivated effective Outcomes Research and Regional HTA Teams in all but one continent.
Global Health Technology Assessments (Hta), A Division Of Gheor
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PrincipalGlobal Health Technology Assessments (Hta), A Division Of Gheor Oct 2000 - PresentEconrob862@Gmail.ComSpecializing in Market Access, Health Technology Assessments, Evidence Based Value Messages and Pricing in all markets, achieve goals through strategic alliances and smart analytics.Prepare HTA submissions for Australia, Asia, Canada, Latin America and across EuropeUse long documented history of expertise in all data sources, including Patient-Reported Outcomes, longitudinal data such as electronic medical records (e.g., GE, IMS-Germany, France, UK and US), Pharm-Metrix, HCUP and Australia General Practitioner Research Project and clinical trials.Craft all sections of HTA submissionsMeasuring and replicating outcomes that make sense with clinical trials and clinical practice.
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PresidentGlobal Health Economics & Outcomes Research Pty Ltd Sep 2002 - PresentSydney AustraliaKey accomplishments• Successfully initiated, developed and incorporated Australian subsidiary• Became a preferred analyst for the Department of Health & Aging• Prepared submissions (All Sections) for the Pharmaceutical Benefits Advisory Board (PBAC) with an 80% approval using both longitudinal and clinical trial data• Designed and conducted quantitative research establishing heart rate as a new recognized marker for all-cause mortality, replicating its quantification within 1/1,000th in three continentso A Few Submissions Including the One and Only Rejected One• Fotemustine (Muphoran) Melanoma -Approved.• http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-treprostinil-nov05• http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-docetaxel-mar06• http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-insulinglargine-mar06• http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-ivabradine-nov07• http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-ramipril-mar07• http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-clopidogrel-mar08
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PresidentGlobal Health Economics & Outcomes Research Oct 2000 - PresentKey accomplishments• Successfully initiated, developed and nurtured a global corporation designing and conducting health economic analyses in support of brand messages and registration and pricing• Employ, train and direct up to eight FTEs• Designed, managed and conducted in excess of 100 health economic studies, principally quantitative using every imaginable data source and advancing health economic science• Designed, developed and published a Diabetes Risk Equation replicated its quantification within 1/100th trice in the U.K., Germany and the U.S.Canadian Regulatory Submissions• 15 Submissions: Available Upon RequestEuropean Regulatory Submissions• Numerous
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Director, Health Technology AssessmentEisai Feb 2011 - Nov 2013Key Accomplishments• Developed newly created Global Health Technology Assessment (GHTA) / Market Access Group integrating HTA/Pricing and Reimbursement with Clinical Development and Global Regulatory Affairs to serve Regional Market Access requirements and needs • Lead Global/ Regional Teams for the strategic planning and actual preparation of HTA Dossiers with internal capabilities, including analyses of clinical trials in SAS, construction of Cost-Effectiveness Models in EXCEL/ SAS and Dossier preparation.• Defined Global/ Regional roles and responsibilities • Developed a Global Affordable Pricing Model and price corridors for markets• Responsible for all statistical analysis Plans for Quality of Life and Health Economic and Outcomes Research clinical trial data• Establish and implement appropriate quality control procedures for all HTA /HEOR analyses• Trained Regions on HTA Models, as needed, and QoL data• Effectively communicated GHTA mission, goals and strategic plans to Senior Management in Japan as well as Regions• Collaborate with Clinical Development and Global Regulatory Affairs aligning clinical/ regulatory objectives with regional commercial requirements• Meet regularly as needed with regional HTA Agencies in Asia, Australia, Canada and Europe as pre-submission meetings for advice, following submissions and price negotiations.• Contribute and present to FDA at EOP2 meetings arguments for the suitability and inclusion of QoL in label• Contribute and present at joint Scientific/ HTA meetings• 15 posters/ oral presentations at professional meetings -
Vice PresidentMillenium Biostatistics 1999 - 2000Bound Brook NjKey accomplishments• Designed and conducted the economic evaluation for eight products in Canada• Successfully completed twenty submissions for provincial formulary acceptance• Fast tracked the review process for three submission• Gain formulary approval to date for three product in schizophrenia, asthma, and oncology• Coordinated and conducted a multinational European longitudinal data analysis in hypertension
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Director Of Health EconomicsSanofi Aug 1995 - Nov 1999Built an HEOR staff in NYC and Gentilly, developed, marketed internally and completed HEOR launch strategy within the Sanofi-BMS joint venture -
Asst Director , Health EconomicsBayer Pharmaceuticals May 1993 - Aug 1995West Haven, ConnecticutDevelop and completed HEOR strategies for the launch of Adalat CC. -
Director, EconomicsCenter For Health Economics Jun 1990 - Jan 1993Lead, developed and nurtured a HEOR team, specializing in econometrics
Robert Simons Skills
Robert Simons Education Details
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Fordham University3.75
Frequently Asked Questions about Robert Simons
What company does Robert Simons work for?
Robert Simons works for Global Health Technology Assessments (Hta), A Division Of Gheor
What is Robert Simons's role at the current company?
Robert Simons's current role is Global HTA, Inc. & GHEOR, Inc..
What schools did Robert Simons attend?
Robert Simons attended Kent State University, Kent State University, Fordham University.
What are some of Robert Simons's interests?
Robert Simons has interest in My 7 Year Old Son, Ryan, My 9 Year Old Son.
What skills is Robert Simons known for?
Robert Simons has skills like Health Economics, Outcomes Research, Economics, Market Access, Oncology, Pharmaceutical Industry, Diabetes, Sas, Global Marketing, Clinical Trials, Hta, Statistics.
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