IEEE-SA and BHTY Workgroup: Roadmap for Digitalizing Clinical Trials

Main Article Content

Todd Eury (Moderator)
Walter De Brouwer
Basker Gummadi
John D. Halamka
Amar Das

Abstract

Session Description: Digitalization of Clinical Trials from End-to-End – The Right Time is Now to Jump in - there are many hype words thrown around in the healthcare sector in an effort to place the impetus on the need for change. – “disruptive,” “innovation,” “breakthrough” and more- Put aside the hype – the lukewarm approach to embracing digital technologies for clinical trials is over.


The fever pitch of emerging technology applications impacting clinical trials are providing solutions for trial sponsors to combat the mounting challenges of cost and delays in bringing medicine to the market. The time is right to jump in to digitalizing the process if you want to get ahead of the curve in efficiency and efficacy to enhance patient safety and accelerate drug development.


The reality is simple - cutting-edge technologies can revolutionize the clinical trials model not only by optimizing the processes but delivering more value for patients and all the critical stakeholders. This session will feature an interactive panel discussion addressing the following key points:


1. What is the roadmap for an end-to-end digitalized clinical trial? What are the limitations? What are the opportunities?


2. Debunking the myth that digitization is digitalization of clinical trials


3. Identifying all potential areas where technologies like Blockchain, Robotic Process Automation, IoT, and Artificial Intelligence can digitize Clinical Trials


4. Can digitalization meet all the expectations of all stakeholders – regulatory, patients, pharma and others?


5. The combination of AI and Machine learning for “data-driven” decision models -what are we looking to solve, what will it change?

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Article Details

Section
Track: Knowledge and Leadership
Author Biographies

Todd Eury (Moderator), Pharmacy Podcast Network, Founder

"The most intriguing and important aspect of business is quality networking. To me, the most fulfilling part of my career has been building meaningful relationships which drive change, create improvements, and enhance people's lives."

Todd Eury grew up in Southwestern Pennsylvania in the small community of Evans City, thirty miles north of downtown Pittsburgh. He graduated summa cum laude from Geneva College with a dual degree in Business Administration & Human Resources. Todd started his professional career in telecommunications with Sprint's Small Business Division and spent 8 years in the field of business development for WorldCom and AT&T until entering the pharmacy technology sector of healthcare in 2004.

Todd helped to build a small software systems design company with barely 10 total customers to the most recognized long-term care pharmacy management system in the pharmacy industry, SoftWriters developers of FrameworkLTC. Having an entrepreneurial spirit and desire to launch his own company in the privately owned pharmacy sector, Todd created the “Pharmacy Technology Resource” which started from a small popular blog about pharmacy operators leveraging technology better to gain efficiency and maximize profitability.

In 2009, Todd launched the pharmacy industry’s first podcast about the Business of Pharmacy dedicated to healthcare professionals called the ‘Pharmacy Podcast Show’.

In 2011, the Pharmacy Technology Resource merged with a pharmacy-buying group called PharmacyGPO. Todd formed a partnership with a pharmacy owner and business developer in Pittsburgh and used H. D. Smith as their wholesaler to create a unique offering and building business for their pharmacy members through digital marketing and call center services.  Todd’s partners voted to sell the company in 2014 to a physician dispensing organization and he then began to consult for pharmacy software developers on improving their business development strategies, networking, and digital marketing efforts. 

In the fall of 2014, several pharmacists joined Todd’s podcast publication and the Pharmacy Podcast Show was transformed into the Pharmacy Podcast Network. Today the audio-blog publication is the U.S. Healthcare System’s largest network of podcasts dedicated to the profession of pharmacy with 23 co-hosts developing content for 15 different podcasts segmented on different topics like healthcare law, technology, medical cannabis, senior care, and pharmacogenomics.  The Pharmacy Podcast Network has a collective listener base of about 67,000 and has personalized podcast publications for national associations like the American Society of Consultant Pharmacists and the National Association of Specialty Pharmacy.

In 2015, Todd was contracted by WellMedRx to help build a mobile application to assist doctors in identifying if their patient’s were eligible for a pharmacogenomics test to ensure the medications they were taking would work as medically intended.

The world of pharmacy software and healthcare tech consulting wasn’t consistent enough and Todd found a new career in the field of opioid addiction recovery in business development and strategic marketing with national leader New Season headquartered in Orlando Florida, he has been with New Season since June 2016.

Todd is married to his wife Nicole who’s a nurse at a maximum-security state prison system and is a proud father to four daughters and two fur-babies. They live in Fayette County Pennsylvania and are planning to buy their second home in Eastern Florida to eventually live as “snow-birds” as they don’t like the cold winters of the northeast. 

Walter De Brouwer, doc.ai, CEO and Founder

Walter A. De Brouwer Ph.D., is the founder and CEO of doc.ai, an AI company with a presence on the Blockchain that uses Machine Learning on Precision Medicine. The company started in August 2016 and together with DLA Piper closed a successful Initial Coin Offering in 2017 (Concurrent Offerings Under Rule 506(c) And Regulation S) to decentralize its AI and allow anyone to start training their own AI. The Palo-Alto based crypto company is using Deep Neural Networks on rare diseases that have a genetic root. His Wikipedia page is here. https://en.wikipedia.org/wiki/Walter_De_Brouwer
Walter is an entrepreneur and investor in tech and science. Together with Nicholas Negroponte (MIT), he founded Starlab SA, Europe's premier Deep Future research lab on wearable computing, Quantum computation, computational genomics and MPEG-21 (IP was sold to Philips). In 1993 he co-founded the European internet backbone company PING out of the European UNIX Users Group later EUnet International Ltd. which merged with Qwest Communications and went from NASDAQ to NYSE now Centurylink. In 1994 he had founded one of the pioneers of online job boards in Europe called Jobscape which merged into Stepstone ASA and completed an IPO in March 2000. In 2002 he took over the Brussels-based Patronale Capitalisation and made it into a Fintech Life insurer. In 2007 Nicholas Negroponte appointed De Brouwer to set up the EMEA branch of MIT's NGO One Laptop per Child (OLPC). De Brouwer negotiated with 14 Ministers of Finance and 9 Presidents in South and West Africa, and eventually, The Learning Center was transferred from Massachusetts Institute of Technology (MIT) in Boston to Kigali (Rwanda) Institute of Science and Technology (KIST). The XO was the first 802.11 mesh-driven device in Africa.

Walter moved to Silicon Valley in 2011 to found Scanadu one of the first mobile health company building people-centric and portable medical devices (FDA pending) using machine learning. He served as the CEO of the 60$m- funded company until April 2016. In 2016 he set up doc.ai in USA and Gen.life in China where he serves as Chief Scientific Officer. In 2017 he set up TokenSoft, a smart-contracts company in San Francisco and became the scientific advisor to Ubiome. In 2018 he became involved in Havven (Australia) the stable coin company and is setting up a new crypto-investment bank in Palo Alto, CA to play a role in the coming "Tokenization of Corporate America."

Walter earned a master's degree in Formal Linguistics (University of Ghent, Belgium) and a Ph.D. in Computational Semantics ("Bio-semiotics: The Biology of Language. The search for the atomic unit of meaning") from the Catholic University of Tilburg, the Netherlands. He started as an academic lecturer at the Jesuit University of Antwerp, Belgium (Machine Translation and Chomsky's TGG), but left in 1989 to become an entrepreneur.

Basker Gummadi, Bayer, Digital Innovation

Basker is lead in Digital Innovation at Bayer.  Basker’s role is to develop and execute a solid program and lay a foundation for innovation and digital in the U.S, and work with the Americas to leverage and/or contribute to global approaches. The purpose is to drive digital innovation to successfully implement projects together with Business Partnering, and IT Operations, while ensuring a strong link to divisions’ business strategies for timeliness and relevance.

As a volunteer lead with the IEEE-Standards Association, Basker is committed to developing a community outside of Bayer focused on bringing the pharma industry and university to identify business cases for Clinical Trials using Block Chain, Artificial Intelligence, Robotic Process Automation, and Big Data.
Prior to joining Bayer Basker held positions of increasing responsibility: Business Solution Manager, Hoffman-La-Roche, Assistant Director, Schering Plough and Senior Analyst, Bristol Myers Squibb.

Prior to joining Bayer Basker held positions of increasing responsibility: Business Solution Manager, Hoffman-La-Roche, Assistant Director, Schering Plough and Senior Analyst, Bristol Myers Squibb.

John D. Halamka, Beth Israel Deaconess System, Chairman, New England Healthcare Exchange Network (NEHEN), Co-Chair, HIT Standards Committee, Professor, Harvard Medical School

Dr. Halamka completed his undergraduate studies at Stanford University, where he received a degree in medical microbiology and a degree in public policy with a focus on technology issues. He entered medical school at the University of California, San Francisco and simultaneously pursued graduate work in bioengineering at the University of California, Berkeley focusing on technology issues in medicine. He completed his residency at Harbor–UCLA Medical Center in the Department of Emergency Medicine.

In his role at BIDMC, Dr. Halamka is responsible for all clinical, financial, administrative, and academic information technology, serving 3,000 doctors, 12,000 employees, and 1,000,000 patients. As chairman of NEHEN, Dr. Halamka oversees clinical and administrative data exchange among the payers, providers, and patients in Massachusetts.   As a Harvard professor, he has served the George W. Bush administration, the Obama administration, and national governments throughout the world planning their healthcare IT strategy.

Dr. Halamka has authored five books on technology-related issues, hundreds of articles and thousands of posts on the popular Geekdoctor blog. He runs Unity Farm in Sherborn, MA and serves as caretaker for 150 animals, 30 acres of agricultural production and a cidery/winery.

Amar Das, IBM Research, Director, Learning Health Systems

Amar Das joined IBM in 2016 as a Director in IBM's Healthcare and Life Sciences research organization.  Amar is advancing the healthcare research agenda at IBM by proposing, modeling, and executing clinical studies and clinical trials of IBM solutions within healthcare. The research focuses on new statistical, computational, and regulatory approaches to the assessment, deployment, and adoption of these solutions.  The overall goal is to develop a learning health system that engages providers, patients, researchers and other stakeholders in continually evaluating the effectiveness of interventions, improving health outcomes, and delivering high value care.

Prior to joining IBM Research, Amar was a faculty member at Stanford University Medical School and the Geisel School of Medicine at Dartmouth.  At Dartmouth, he also served as Director of Biomedical Informatics within the Department of Biomedical Data Science, which he cofounded, and Director of the Biomedical Informatics Core within the SYNERGY Clinical and Translational Science Institute.  He also initiated and led the Informatics Collaboratory at Dartmouth, which engaged end users and stakeholders in an agile process for designing and hardening research informatics software.  His labs at Dartmouth and Stanford have primarily pursued new computational methods for managing, mining and visualizing longitudinal clinical data.  His work also includes decision support systems, knowledge management, machine learning, natural language processing, blockchain and health services research.  Amar has applied his research to HIV drug resistance, immune tolerance, autism spectrum disorders, and breast cancer care.  He has trained and mentored dozens of undergraduate, graduate and medical students as part of his lab, and developed new coursework based on his informatics research.

Amar obtained a BA with Distinction in Anthropology and the Honors Program in Mathematical Methods in the Social Sciences at Northwestern University.  He received his MD and PhD in Biomedical Informatics from Stanford University.  He completed a research track residency in Psychiatry and a postdoctoral fellowship in Clinical Epidemiology at Columbia University/New York State Psychiatric Institute.   Amar has received a number of teaching and research awards during his career in academic medicine.  He also serves on numerous US and international grant review panels.