Presented by:
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Smart Pills: Decoding the Science and Technology to Ensure Quality

The Smart Pills Series will feature three workshops, with Part I commencing in November 2019 in collaboration with the US Pharmacopeia (USP), a scientific organization focused on developing quality standards for medicines, dietary supplements and foods. The overall goal of the workshop series is to explore emerging technologies, applications and platforms around smart pills (i.e. medicines with sensors). This includes an exploration of the benefits and challenges with the use of “ingestible sensors” for monitoring, diagnosing and otherwise impacting the delivery of a drug’s therapeutic effect to patients.

The agenda will highlight the creative engineering behind developing sensors that can be embedded into medicine to exist within the human body while satisfying the intended use of the sensor (i.e. data collection and transfer). The workshop will feature sessions on the progress of current use cases, emerging applications and where further development and evaluation may be needed. In addition, IEEE and USP will hold roundtable sessions to explore technical and scientific considerations that will help ensure quality in smart pills. One of the possible outcomes from these sessions is a white paper to engage industry, practitioners and other stakeholders.

Date:
21-22 November 2019

Venue:
USP Meeting Center
12601 Twinbrook Parkway
Rockville, MD  20852-91790, USA

Who Should Attend?

YOU, if you are in any of the following areas:

  • Clinical Trials Design & Operations
  • Clinical/Medical Professional
  • Health Insurance Payment
  • Health Wearable Start-Up
  • Hospital/Health System – Innovation and Data Project Leads
  • Medical Device Manufacturers – product design or engineering
  • Medical Device Software – design or engineering
  • Micro-Electro-Mechanical Systems (MEMS) product design or engineering
  • Sensor Development
  • Communications Network Engineering
  • Blockchain/DLT Technologists: Blockchain/DLTs
  • Government/Regulatory
  • Research: Academia or Industry
  • Pharmaceutical manufacturers
  • Biologics and biopharmaceutical manufacturers
  • Quality assurance, quality control and regulatory affairs professionals
  • Other: Enthusiast not mentioned in this list

Workshop Agenda

Please note the agenda is currently in development. We encourage you to visit this site often for new speaker additions and potential session title and times changes.

Each session will feature up to 10 mins of audience Q&A – included in the total session time.

TimeSession Name
8:00AM - 8:30AMRegistration Check-in and Breakfast
8:30AM - 8:50AMWelcome and Introduction
8:50AM - 9:25AMTop Down View:
Use Case Trends, Opportunities and Challenges of Smart Pills: Promoting patient interests in medication adherence monitoring - towards fully patient centered care
Speaker: Harald Schmidt, Perelman School of Medicine, University of Pennsylvania
9:25AM - 10:00AMUnderstanding the Regulatory Guidelines and Protocols in the Development and Approval of “Digital Pills” for Patient Use
Speaker: Speaker: Michael Drues, President, Vascular Sciences
10:00AM - 10:15AMBREAK
10:15AM - 10:45AM Smart Pills: Five Ways That They Will Transform Healthcare
Speaker: Alfred Poor, Founding Editor, Health Tech Insider
10:45AM - 11:15PMTwo Parts Make a Whole: Quality Assurance Considerations in the Era of Smart Pills and Other Drug Device Combination Products
11:15AM - 11:45PMDigital Pills and Pharmacy
Speaker: Ravi Patel, University of Pittsburgh
11:45PM - 12:15PMThe Physician/Researcher Perspective: Understanding Patient Perspectives Surrounding Smart Pills, and Interpretation of Adherence Data
Speaker: Peter Chai, Brigham and Women’s Hospital/Harvard Medical School
12:15PM - 1:15PMNETWORKING LUNCH
1:15PM - 1:50PMThe Ethical Considerations and Risks of Smart Pills
Speaker: Robert Klitzman, Professor, Psychiatry (in Sociomedical Sciences) at the Columbia University Medical Center
1:50PM - 2:20PMGastric Resident Bio-electronics
Speaker: Yong Lin Kong, Assistant Professor, Department of Mechanical Engineering at the University of Utah
2:20PM - 2:30PMBREAK
2:30PM - 3:30PMEmerging Applications Panel:
What’s Coming Next in the Use of Ingestible Sensors
3:30PM - 4:30PMTHE TECH PANEL
Making Sense on What “Technically" Goes into Smart Pills
Panelist: Harry Travis, etectRx
4:30PM - 5:00PMClosing Remarks

Whitepaper Roadmap Session Preview and Sign-Up for Day 2
5:00PM - 5:45PMNETWORKING RECEPTION
TimeSession Name
8:00AM - 8:45AMRegistration Check-in and Breakfast
8:45AM - 9:00AMOPENING REMARKS
Introduction to Purpose and Scope of Whitepaper Working Group Outcomes for the Day
9:00AM - 11:30AMWhitepaper: Roadmap to Addressing Challenges Impeding Wider Adoption of “Smart Pills”

This is a collaborative “working group” type session for all attendees to contribute ideas and help lay the foundation for the development of an IEEE-USP collaborated whitepaper.
11:30AM - 12:00PMReport Back and Discussion
12:00PM - 12:15PMClosing Remarks – Next Steps
12:15PM - 1:00PMNETWORKING LUNCH

Speakers: Subject Matter Experts

We are currently accepting submissions for topics for presentation. Please write to m.palombini@ieee.org with your suggested ideas.

Peter Chai Headshot

Dr. Peter Chai

Dr. Peter R Chai is an Assistant Professor of Emergency Medicine at Brigham and Women’s Hospital/Harvard Medical School and affiliate research scholar at the Fenway Institute and the Massachusetts Institute of Technology. He is interested in the development of technologies to detect changes in human health with a focus in medication adherence for HIV prevention. He is the recipient of independent research grants from Gilead Sciences as well as the National Institute on Drug Abuse to investigate the use of real-time adherence monitoring using ingestible sensors to measure Pre-exposure Prophylaxis for HIV using once daily Emitricitabine/Tenofovir. His interest in ingestible electronics leads to collaborations at the Massachusetts Institute of Technology where he is an affiliate research scholar to develop next generation long term ingestible sensors and drug delivery packages surrounding HIV prevention and substance use disorder treatment. He additionally collaborates with the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School on and ethical implications and health law policy surrounding of electronic adherence monitoring.

Michael Drues

Dr. Michael Drues

Michael Drues, Ph.D., is President of Vascular Sciences, an education, training, & consulting company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including stimulating & innovative educational programing, creative regulatory strategy & completive regulatory intelligence, regulatory submission design, FDA presentation preparation & defense, brain-storming sessions, prototype design, product development, benchtop & animal testing, , clinical trial design, reimbursement, clinical acceptance, business development & technology assessment.

Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University in Ames, Iowa. He has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services (CMS) and other regulatory and governmental agencies around the world.

Dr. Drues is an internationally recognized expert and featured keynote speaker on cutting- edge medical technologies and regulatory affairs. He conducts seminars and short-courses for medical device, pharmaceutical and biotechnology companies, the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the US Centers for Medicare and Medicare Services (CMS) and other regulatory and governmental agencies around the world.

Finally, as an Adjunct Professor of Regulatory Science, Medicine, Biomedical Engineering & Biotechnology, Dr. Drues teaches graduate courses in Regulatory Affairs & Clinical Trials, Clinical Trial Design, Medical Device Regulatory Affairs & Product Development, Combination Products, Pathophysiology, Medical Technology & Biotechnology at several universities & medical schools on-ground & on-line.

Robert Klitzman

Dr. Robert Klitzman

Dr. Robert Klitzman is a Professor of Clinical Psychiatry in the College of Physicians and Surgeons and the Joseph Mailman School of Public Health and the Director of the Masters of Bioethics Program at Columbia University. He co-founded and for five years co-directed the Center for Bioethics, and for 10 years directed the Ethics and Policy Core of the HIV Center. He has conducted research and written about a variety of ethical issues in medicine and public health to promote public and professional education concerning these issues. He has written eight books, and authored or co-authored over 120 articles, drawing on qualitative as well as quantitative methodologies. His work has appeared in Journal of the American Medical Association, Science, and elsewhere, and also has written for the New York Times, Newsweek, The Nation, and other publications. He has received several awards for his work, including fellowships from the Guggenheim Foundation, the Russell Sage Foundation, the Aaron Diamond Foundation, the Robert Wood Johnson Foundation, the Rockefeller Foundation and the Commonwealth Fund. He is a gubernatorial appointee to the NY State Stem Cell Commission, and a member of the Research Ethics Advisory Panel of the US Department of Defense. He has been interviewed about these issues widely by the media, including the New York Times, The Wall Street Journal, the Washington Post, NPR, PBS, CNN, CBS, NBC, ABC, the BBC and others.

Yonhg Lin Kong

Yong Lin Kong

Yong Lin Kong is an Assistant Professor of the Department of Mechanical Engineering at the University of Utah (2018 – Present). He received his Ph.D. in mechanical engineering and materials science from Princeton University in 2016. He was a postdoctoral associate at the Massachusetts Institute of Technology (2016–2017) working with Professor Robert Langer. His research focuses on fabrication of biomedical devices and printing of nanomaterial-based functional devices. Yong Lin Kong is an inventor of 3D printed active electronic materials and devices, 3D printed multi-functional hybrid devices and structures, and gastric resident electronics. He is a recipient of the MIT Technology Review Innovators Under 35 Asia Award, SPIE DCS Rising Researchers and ORAU Ralph E. Powe Junior Faculty Enhancement Award, Materials Research Society Graduate Student Award, The Daniel & Florence Guggenheim Foundation Fellowship, Sayre Graduate Prize, and the HKUST Academic Achievement Medal.

Ravi Patel Headshot

Ravi Patel

Ravi Patel, PharmD is the Lead Innovation Advisor at the University of Pittsburgh School of Pharmacy where he helps lead the Innovation Lab. In this role, he work with students, faculty, and partners to find what’s new and useful in pharmacy practice and education. His work in technology includes review of technology to see how it make apply to pharmacy (ex. Google Home, Amazon Alexa) and implementations of different technologies through user-centered design (ex, MEDIvate for reconciled medication lists at hospital discharge). Looking at the challenges of understanding and motivating change in behavior is a vast problem and opportunity for healthcare which he is most passionate about through the lens of technology.

Alfred Poor Headshot

Alfred Poor

Alfred Poor is an independent technology industry analyst, freelance writer, and professional speaker based in Pennsylvania, specializing in wearable and display technologies. He brings to his work strong communication skills, a broad background covering a wide range of technologies, more than 30 years of experience with the technology markets, and the ability to make complex concepts accessible to non-technical people, especially business professionals. He holds a BA in Biology from Harvard College, and PhD from Union Graduate School.

Harald Schmidt Headshot

Harald Schmidt, PhD, MA

Harald Schmidt, PhD, MA, is an Assistant Professor at the Department of Medical Ethics and Health Policy, and a Research Associate at the Center for Health Incentives and Behavioral Economics, both at the Perelman School of Medicine, University of Pennsylvania. His research centers around personal responsibility for health, public health ethics and priority setting. His principal current research focus is on the ethics of novel medication adherence monitoring technologies. He is particularly interested in understanding on what grounds patients might be obliged to use such approaches, and how the potential for patient-centered care can be maximized. Ongoing empirical research in this area focusses on post-transplant patients, HIV-positive women who are pregnant or post-partum, and tuberculosis patients. The overall goal of his research is to combine robust conceptual and empirical work to contribute to more evidence-based, equitable and efficient health care policy and practice.

Before coming to Penn, Harald was a Commonwealth Fund Harkness Fellow in Health Care Policy and Practice at the Harvard School of Public Health, and for seven years served as Assistant Director of the U.K.’s Nuffield Council on Bioethics in London. He completed his Ph.D. in Public Policy at the London School of Economics and Political Science’s LSE Health, and previously studied Philosophy at the Universities of Bremen, Oxford and Münster.

Harry Travis Headshot

Harry J. Travis

Harry J. Travis is a senior healthcare executive with over 30 years’ experience in all aspects of pharmaceutical distribution channel management. This includes multibillion-dollar specialty and non-specialty pharmacy operations, health plan pharmacy benefit design and pharmaceutical wholesale operations. Currently, Mr. Travis is the President and CEO of etectRx, Inc. etectRx has developed an innovative digital pill system that incorporates a tiny ingestible sensor into a capsule, which transmits a signal to a wearable reader and then to a smartphone-based app and secure cloud- based server to reliably and safely indicate when a patient has taken their medicine.

Mr. Travis has held senior leadership positions with Baxter Healthcare, Cardinal Health, Accredo/Medco and Aetna where he served as the VP of Aetna’s Specialty and Home-Delivery Pharmacy Business. He is a nationally known speaker on the topic of the disruptive impact of digital technologies on the practice and business of pharmacy.

He holds a BS in Pharmacy from the University of Pittsburgh, School of Pharmacy and an MBA from The Darden School at the University of Virginia.

Venue

USP Meeting Center
12601 Twinbrook Parkway
Rockville, MD 20852-1790, USA
See transportation directions and parking options

What To Know Before You Go
If you need to secure hotel accommodations near the USP Meeting Center in Rockville, MD; then please visit the USP local hotel and special offer opportunities:  https://www.usp.org/help/hotel-information

Attendee Registration Fee Schedule

Registration fee includes the following:

  • One full day of learning, networking and contributing towards solutions
  • Breakfast, lunch, and reception
  • Discount credit of $50 towards a one-year membership in the IEEE-SA Global Wireless Platform Development Lab
  • Opportunity to contribute to the workshop’s industry outcomes report
Early Savings Fee
Before 8 Nov 2019
Standard Fee
After 8 Nov 2019
General Attendee$199$299
IEEE Member or USP Volunteer
An assigned 10% discount code will be provided to both groups which must be entered at the time of registration.
$179$269

This workshop is presented in collaboration with USP.

USP is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. Through our standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and food for billions of people worldwide. For more information about USP, visit www.usp.org.

Area partner:

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Inquiries:

For questions on current and future workshop programs, technical standards activities and/or the overall WAMIII initiative, please write to:

Maria Palombini
Director of Communities and Opportunities Development, Life Science Practice m.palombini@ieee.org.

If you would like to be notified of event and initiative developments, subscribe to the WAMIII interest list