About AdverseEvents

Adverse Events is a California-based healthcare informatics company that improves patient safety and reduces systemic healthcare costs through the comprehensive analysis of post-marketing drug side effect data.

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Brian M. Overstreet, President

As co-founder and President of AdverseEvents, Brian oversees the company’s growth strategy. Prior to AdverseEvents, Brian was a co-founder of Sagient Research Systems Inc. He served as the company's president and CEO from 1999 to 2009 and as the chairman of the board from 2010 until the company's acquisition in May 2012 by Informa plc. Sagient Research Systems is a publisher of specialized research and data. They develop, produce, and sell proprietary research products to global enterprises, including pharmaceutical companies, investment banks, mutual and hedge funds, academic institutions, and government agencies.

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Jim Davis, Executive Vice President

Jim brings over 12 years of experience in commercial strategy, global sales management and execution, business development, and product development. He has over 9 years of specific domain expertise in biopharma market research, intelligence, and data. Prior to joining AEI, Jim served as the Global Head of Sales for the BioPharm Solutions Suite at Infinata, Inc. (A part of The Mergermarket Group, a Financial Times Group company and a division of Pearson, Plc.).

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Robert Kyle, Chief Product Officer

As co-founder and Chief Product Officer of AdverseEvents, Inc., Bob Kyle is in charge of defining and driving the company’s product strategy and managing the product life cycle, from conception through launch. Bob’s product vision drives and inspires the company to continually innovate and rapidly adapt products to the changing needs of the marketplace. Executing consistently and effectively on product refinements and new releases ensures that AdverseEvent’s growth strategy is intertwined with that of its clients.

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Keith Hoffman, Ph.D. - V.P. Scientific Affairs

Keith has 17 years of science, business, and intellectual property development experience in the biotechnology, pharmaceutical, and consumer goods industries. Prior to AEI, he was the CBO of Antigen Discovery, COO of ChemoTherapeutics, COO of LALO Tactical, COO of Thuris Corporation, and Head of Scientific Affairs at Ancile Pharmaceuticals. Keith has a PhD in Neuropharmacology from the laboratory of Gary Lynch and an undergraduate degree in biology, both from UC Irvine.

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Sharon Miller - V.P. Marketing

Sharon has deep experience in creating, marketing, and running consumer-facing companies. She has held senior marketing and operational positions at Kaplan (A Washington Post Company), NBC and The News Corporation. Prior to those she held senior positions within several marketing communications firms and has been the recipient of numerous product, marketing and public relations industry awards.

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Medicaid Managed Care Proposed Rule

The Centers for Medicare and Medicaid Services (CMS) issued a proposed rule in May aimed at improving the quality and performance of Medicaid managed care organizations (MCOs).

It seeks to “modernize the Medicaid managed care regulations to reflect changes in the usage of managed care delivery systems.” Simply, the goal is to align with existing commercial, Marketplace, and Medicare Advantage regulations in order to improve the quality of care. CMS must look for ways to use available data to help Medicaid MCOs drive significant improvements in patient care and lower overall costs. Incorporating analysis of data that can help reduce of preventable events affecting outcomes and costs, including analysis of adverse drug events, as part of CMS’ overall quality strategy is one way to modernize and affect positive change.

Our Response

We submitted a letter providing comments on the proposed rule, including recommended changes to strengthen the Medicaid drug benefit within managed care programs. To view our comment letter on the proposed rule, click the link below.

Download Policy Letter

Want to Get Involved?

If you agree it’s time to take action to improve patient safety and lower healthcare costs, let your voice be heard! There are two ways you can get involved:

1. Write to your elected officials in Congress (download a template email letter here), urging them to ask CMS to make evaluation of adverse drug event data a requirement for drug coverage decisions made by Medicaid and Medicare prescription drug plans. You can search, and find contact information, for your Senators/Representatives here.

2. Submit your own comment on the proposed rule by clicking here.

Learn more about our policy activities

Blog Post: It Is Time For A Change
Blog Post: When Opportunity Knocks, Open the Door

For more information contact Ian Race

William Bunney, M.D., University of California at Irvine

Dr. Bunney is the Distinguished Professor of Psychiatry and Human Behavior and the Della Martin Chair of Psychiatry at UCI. His major research interests involve clinical psychobiological studies of manic-depressive illness, and schizophrenia. These include behavioral studies, studies of the efficacy and mode of action of pharmacological agents, brain imaging, genetic studies utilizing and investigations of brain circuitry abnormalities which may be related to the major psychoses.

Murali Doraiswamy, M.D., Duke Institute for Brain Sciences

Dr. Doraiswamy is a professor in Psychiatry and Medicine at Duke University Medical Center and a leading expert in psychopharmacology, drug safety and clinical trials. He has coauthored more than 200 scientific articles and served as an advisor to the WHO, FDA, NIH, pharmaceutical companies and leading advocacy groups.

Greg Fiore, M.D., SSI Strategy

Dr. Fiore is president of SSI Strategy, which provided pharmaceutical management and pharmacovigilance consulting. Prior to SSI, Dr. Fiore was the Chief Medical Officer of The Medicines Company, a global pharmaceutical company focused on advancing the treatment of critical care patients. Dr. Fiore also held senior positions at Merck, Abbott Laboratories, and McKinsey Consulting.

Robert Harrington, M.D., Stanford University

Dr. Harrington is the new Chair of the Department of Medicine at Stanford University School of Medicine, effective July 2012. Prior to joining Stanford, Dr. Harrington was the director of the Duke Clinical Research institute, the largest academic clinical research organization in the world with a faculty of over 200 and a professional staff of over 1,100 that represents every major therapeutic area in medicine. Dr. Harrington’s research interests include evaluating antithrombotic therapies to treat acute ischemic heart disease and to minimize the acute complications of percutaneous coronary procedures, studying the mechanism of disease of the acute coronary syndromes, understanding the issues of risk stratification in the care of patients with acute ischemic coronary syndromes, trying to better understand and improve upon the methodology of clinical trials.

Nicholas Tatonetti, Ph.D., Columbia University

Dr. Nicholas Tatonetti trained in mathematics and molecular biology at Arizona State University before receiving his PhD in biomedical informatics in 2012 from Stanford University. His dissertation was focused on the development of novel statistical and computational methods for observational data mining. He applied these methods to drug safety surveillance where he discovered and validated new drug effects and interactions. In September 2012, Dr. Tatonetti joined the faculty as an Assistant Professor in the Departments of Biomedical Informatics, Systems Biology, and Medicine. Shortly after, he became Director for the Clinical Informatics Shared Resource (CISR) at the Herbert Irving Comprehensive Cancer Center. His lab at Columbia is focused on expanding upon his previous work in detecting, explaining, and validating drug effects and drug interactions from large-scale observational data.

Widely published in both clinical and bioinformatics, Dr. Tatonetti is passionate about the integration of hospital data (stored in the electronic health records) and high-dimensional biological data (captured using next-generation sequencing, high-throughput screening, and other "omics" technologies). His lab develops the algorithms, techniques, and methods for analyzing enormous and diverse data by designing rigorous computational and mathematical approaches that address the fundamental challenges of observational analysis -- bias and confounding. Foremost, they integrate medical observations with systems and chemical biology models to, not only, explain clinical effects, but also further our understanding basic biology and human disease. Dr. Tatonetti has been featured by the New York Times, Genome Web, and Science Careers. His work has been picked up by the mainstream and scientific media and generated hundreds of news articles.

A new era of drug safety: Using adverse events big data to improve outcomes and decrease healthcare costs
Adverse drug event data is available: Why isn’t it being used?
CardioBreak: Obesity Drug Safety, HF Device Flop, $$ for Heart Docs
Three Years Later, Jury’s Still Out on Growing Category of Anti-Obesity Drugs
A Cost Measurement Pharma Can Live With (CROs/CMOs, Too)
Startup AdverseEvents makes side effects a factor in the cost of a drug
Adverse Event Data Promotes Population-Based Health Analyses
AdverseEvents: New generation of hep C meds bests older therapies in side-effect reports
AdverseEvents: Analysis of side-effect reports turns up troubling safety signals for Novartis, Eisai drugs
Weighing Adverse Events to Get at a Drug's Real Costs
AdverseEvents Sets New Standard For Drug Decision Making With Launch Of RxCost™
A Drug Safety Call To Arms - Why now is the time to update the FAERS system
A Drug Safety Call To Arms
Will 2015 really be the year of healthcare technology?
New Eliquis (Apixaban) Alert: Unexpected Side Effect
Adverse Events Reviews: FDA Needs to Boost 'Accuracy and Efficiency'

Regulatory Recon: Bayer Loses Major Battle Over Cancer Drug
Post-marketing data analysis of pharmaceuticals discovers side effects not previously known
We publish, you pick: FiercePharma's 10 best-read stories of 2014
Contrave: Where Does New Obesity Drug Fit in Armamentarium?
Drug side effects study published, debunks previously accepted limitation in the use of FEARS data for monitoring drug safety
The top 10 best-selling multiple sclerosis drugs of 2013: Betaseron/Betaferon
The top 10 best-selling multiple sclerosis drugs of 2013: Tecfidera
Drug Safety Report Details 49,000 Undisclosed Side Effect Reports
OpenFDA: What’s good, what’s bad and what needs to be fixed right now
FDA opens up datasets on drug adverse events to developers, researchers
OpenFDA – the Good, the Bad, and the Ugly
OpenFDA – the Good, the Bad, and the Ugly
How Questcor’s Disclosure on Acthar Side Effects is Game Changing
Acthar's Future Could Be An Adverse Event For Mallinckrodt
New adverse-events reporting service speeds results to payers
Which Are the Safest (and Least Safe) MS Drugs on the Market?
Is this Biogen's Biggest Risk?
Biogen MS blockbuster Tecfidera earns high marks for safety
New report finds Bydureon safest of new class of diabetes drugs
Overstreet, Winner in Startup Tax Battle, Gets $2M for AdverseEvents
FDA makes adverse drug event data public, but this health IT startup makes it useful
The FDA Opens Its Vast Files on Drug Side Effects to the Public
New versus Old: Post-Approval Side Effects from Blood Thinners
Eliquis earns best safety score in its class in analysis of FDA adverse event reports
Analysis of FDA side-effect reports flags Sanofi, Celgene meds
Addiction Treatment With a Dark Side
Development of a drug safety ePlatform for physicians, pharmacists,
and consumers based on post-marketing adverseevents

From big data to bedside decision-making: the case for AdverseEvents
Oseltamivir and Neuropsychiatric Adverse Effects
Side effects of prescription drugs can be reported and studied on Web sites
In an EHR era, adverse event reporting takes on a new look
Advair boomed amid health risks
Potency Of Statins Linked To Muscle Side Effects
Q&A with Brian Overstreet, CEO of AdverseEvents
Seeking Hard Data on Adverse Effects of Drugs
Adding Rigor to the Adverse Event Reporting Process
At Your Fingertips, For A Price
A Closer Look at the FDA Adverse Event Reporting System
Video - Is Your Prescription Making You Sick?
Searching for Side Effects
Turbocharge Your EHR With Additional Data Sources
Bristol-Myers Warning Ignored on Steroid Shots Tied to Deaths
Making Sense of Safety Data
FDA AERS Provides Surprising Look at Statin Class Side Effects
Companies React to Facebook's Open Walls
FDA Behind The Curve In Monitoring Safety of Approved Drugs
A New Way To Find Side Effect Info
Start-Up With AERS Filter Eyes Bisphosphonate Events
Drug Maker's Ploy to Delay Generics: Add a Line to Pill
Healdsburg Company Makes Drug Data Accessible
Did A Scrappy Little Startup Just Embarrass the FDA?
Websites Mine Clumsy U.S. Health Data to Rate Medical Products
AdverseEvents Seeks to Keep Track of Drug Side Effects the Way the FDA Never Could
Pharmacy Times - AdverseEvents Launch
Fast Company - AdverseEvents: Why Big Pharma Is Scared Of This Startup
Audio Podcast - New Program May Make Reporting Drug Side Effects More Efficient
Audio Podcast - FDA User-Unfriendly Adverse Event Reporting System
IT Vendor Takes on The FDA Adverse-Events Database
Startup Targets Big Pharma, Consumers with Side Effect Data