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 - 9:10AMTop Down View:
Use Case Trends, Opportunities and Challenges of Smart Pills
9:10AM - 9:50AMUnderstanding the Regulatory Guidelines and Protocols in the Development and Approval of “Digital Pills” for Patient Use
9:50AM - 10:00AMBREAK
10:00AM - 11:00AM CASE STUDY:
What are Smart Pills Doing in the Market Today
11:00AM - 11:35PMTwo Parts Make a Whole: Quality Assurance Considerations in the Era of Smart Pills and Other Drug Device Combination Products
11:35PM - 12:10PMThe Physician Perspective
Understanding the Need and Appropriate Use of Digital Pills for Multi-Generational Patients
12:10PM - 1:10PMNETWORKING LUNCH
1:10PM - 1:45PMThe Ethical Considerations and Risks of Smart Pills
Speaker: Robert Klitzman, Professor, Psychiatry (in Sociomedical Sciences) at the Columbia University Medical Center
1:45PM - 2:45PMEmerging Applications Panel:
What’s Coming Next in the Use of Ingestible Sensors
2:45PM - 2:55PMBREAK
2:55PM - 3:55PMTHE TECH PANEL
Making Sense on What “Technically" Goes into Smart Pills
3:55PM - 4:30PMGastric Resident Bio-electronics
Speaker: Yong Lin Kong, Assistant Professor, Department of Mechanical Engineering at the University of Utah
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.

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.

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 11 Oct 2019
Standard Fee
After 11 Oct 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.

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