Jonathan M Fishbein, MD
Pharmacovigilance Must Grow Up
Pharmacovigilance needs to catch up to the information age, deploy new capabilities and utilize technology that will improve the safety of all therapeutic products.
Founder and President, Veracuity LLC. Dr. Fishbein formerly served as Senior Vice President for Safety and Commercialization at PRA Health Sciences.
​
Full BIO | LinkedIn
Mary Tobin, PhD
Missed Opportunities and Proposed Solutions
The efforts to include patients in clinical research (whether called patient engagement, patient centricity, patient empowerment) is a laudable goal, one which should positively impact drug safety and patient satisfaction.
Conceptual thinker and developer. Entrepreneurial mindset and organization builder. Identify core issues and design solutions. Multi-discipline researcher and integrator. No-nonsense advisor. Mediator and Writer.
As Special Advisor to the President/Chief Executive Office at the Alliance for Clinical Research Excellence and Safety (ACRES), assist this global non-profit organization, based in Cambridge, Massachusetts, to build a comprehensive, sustainable and interoperable global system for clinical research. Bringing together clinical research stakeholders worldwide that will enhance safety, data quality and integrity to improve the health and lives of people everywhere. As Managing Director of IMPACT LLC, bring professional services to Life Sciences industry clients and U.S. federal government’s HHS Operating Divisions, including FDA.
​
Stephen Mott
At last, identifying the causes of ADRs at the point of consultation
Decision support system for clinicians to identify adverse drug events, and rank causal relationship probability and identify alternate drug or therapeutic class choices. The aim is to reduce the burden of ADRs on health systems.
Stephen’s background is in the life science industry and medical information. A graduate in Human Biology and Anatomy, Stephen was responsible for developing the electronic Medicines Compendium
for the Association of the British Pharmaceutical Industry, and for producing medicines information content for NHS Choices website. Steve founded Keep Me Informed Ltd which keeps patients up to date about the conditions and medicines they are interested in. Steve is also a founder of The Pharma Knowledge Group (PKG) in the UK that partners the US company DrugLogic, and has developed a powerful probability engine that enables clinicians to identify likely causes of ADRs.
​
Danny Lieberman
Fast data and compliance automation for clinical trials
I am founder and CEO of flaskdata.io - fast signal acquisition and automated detection and response for clinical trials.
I am a solid-state physicist by training, serious amateur musician and entrepreneur heavily involved in medical device security and use of AI for assuring patient compliance to clinical protocols in clinical trials.
I'm proud to be working with some very smart people, all smarter than me.
Contact me at any time on LI if you have ideas for new ventures or partnerships.
​
Veronika Valdova
Avoidable Patient Harm and Resulting Liability
Quantifying the cost of patient harm remains a challenge. Reduced visibility of Adverse Drug Events makes it difficult for physicians to adjust their prescribing practices, which extends occurrence of preventable error related injuries, with associated liability risk.
The tech and science person on the Veracuity team, with experience in a variety of roles from case processing to compiling safety reports and analyses. Author of courses and training programs.
​
Manuel Prado
Leveraging unstructured medical records for Pharmacovigilance
Instead of asking doctors to take an extra step in the interest of PV, we need to be able to leverage the data they are already creating. EMR data is great for maximizing physician reimbursement, but if you really want to understand all the details about a patient, you have to access and leverage the unstructured part of the medical record.
Manuel Prado, Founder and CEO of RealHealthData.
Spending many of his formative years in Lima, Peru, Manuel Prado chose Southern Methodist University where he could both study and run cross country.
While injuries brought an early retirement to the latter he excelled in the classroom and graduated in under 3.5 years. Upon graduation, he worked in investment banking for several years before moving to the San Francisco Bay area. When presented with an opportunity to take a year’s sabbatical to travel the globe, Prado took it, meeting his now-wife in Thailand before returning to his California home.
Inspired by his cultural journey, Prado soon founded the first of his two companies, VIVA Transcription Corporation, which developed patent-pending technology that brought the company national brand presence in the field of medical transcription, serving over 7,000 physicians across all 50 states and employing more than 400 people globally.
In 2014, Manuel Prado began to transition away from the daily management of VIVA and founded RealHealthData, which provides real-world healthcare insights derived from medical transcription documents. With virtually real-time data coming from over 150,000 physicians across the country from every possible specialty, RealHealthData boasts a client list which includes many of the largest pharmaceutical companies in the world.
Outside a career spent in real-world medical data, Manuel enjoys competitive swimming and spending time with his wife and two children.
Peter Cook
Innovation: Sex, Pharmaceuticals and Rock and Roll
I'm offering an innovation masterclass with some parallel insights from the field of music. At the same time I'll relate these to the pharma industry based on my experience of scale up of products from Human Insulin to the first treatments for Herpes and HIV / AIDS. The session will be both informative and enjoyable.
Peter Cook leads Human Dynamics, offering Business and Organisation Development. He also delivers keynotes around the world that blend business intelligence with parallel lessons from music via The Academy of Rock.
Author of and contributor to eleven books on business leadership. His three passions are science, business and music, having led innovation teams for 18 years to develop life-saving drugs including the first treatments for HIV / AIDS, Herpes and the development of Human Insulin. 18 years in academia and 18 + years running his businesses. All his life since the age of four playing music.
Matthew D Whalen, PhD
Independent Investigation for Biomedical R&D Product Safety Crises
Based on the current state of biomedical R&D's pain and pressure points for all stakeholders confronting unexpected serious safety incidents, there is a collaborative effort to encourage and implement a global Independent Investigation process and mechanism.
Dr. Whalen is the founding Chief Operating Officer (COO) of the neutral non-profit Alliance for Clinical Research Excellence and Safety (ACRES). n the course of his career, Whalen has worked in and with Government, Industry, Academia, Non-Profit,
and Multi-Lateral organizations related to biomedical clinical research and strategic and organizational change. He is a social entrepreneur investing time and expertise in organizations and programs that are socially-responsible. He has also served on Boards and leadership committees of organizations including professional societies and journal editorial Boards.
Whalen’s University faculty experience includes Business and Public Policy, Honors, and Arts and Humanities at the University of Maryland, College Park and Temple University, Philadelphia, PA.
Jane Ginn & Katie Kusjanovic
Using Cyber Threat Analysis for Pharmacovigilance
Establishing Priority Intelligence Requirements to drive threat hunting activity. We will focus on these three objectives: 1) Intellectual Property theft, 2) Supply-chain weaknesses, 3) Customer database privacy.
Jane Ginn Cyber Threat Intelligence Network (CTIN). Ms. Ginn has over 30 years of international business experience in engineering consulting, information technology, and cyber security threat intelligence. She serves as Secretary of the OASIS
Cyber Threat Intelligence - Technical Committee (CTI TC) on STIX/TAXII standards development. She is also an adviser to the European Network Information & Security Agency (ENISA) Threat Landscape Stakeholders' Group. She also serves on the Board of Directors of the Cyber Resilience Institute (CRI), the primary sponsor of the Sports-ISAO.
​
Katie Kusjanovic
EclecticIQ
Network and information security analyst, threat Intel parfaits and SIEM engineering and optimization.
​
Robert Durham
Turbocharge Your Pharmacovigilance Data Collection & Analysis with Accreditation & HIE
What is a Medication Error?
A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing, order communication, product labeling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use."
National Coordinating Council for Medication Error Reporting and Prevention
A Founding Member of NCCMERP. The Joint Commission requires tracking of medication management measures as well as patient-safety measures for medication incidents as part of acute care facility accreditation processes.
We have worked with over 250 acute care facilities in the US for 20 years providing accreditation tracking software used to comply with The Joint Commission Standards. A subset of this experience has focused on support for medication errors tracking. The collection of accreditation specific errors, defined as a pharmacovigilance cohort, combined with Health Information exchange (HIE) interoperability provides a path for both managing costs and laying a foundation for the future of pharmacovigilance reform.
Sreeram Penna
The Role of Social Media in Pharmacovigilance
Social media contain wealth of information about individuals including their wealth. Social media mining for pharmacovigilance is an emerging concept with potential to generate vast amount of data.
Founding Chief Medical officer of Veracuity LLC, a biopharmaceutical safety informatics, data and analytics company.Dr. Sreeram Penna has more than 15 years of experience as a clinician and researcher. He worked
in orthopaedic surgery and his research interests include big data, machine learning and artificial intelligence concepts in health care. He has experience in generating real-world evidence using social media data to be used in health care research. He would like to bring this experience in pharmacovigilance.