Pharmacies represent an enormous growth market for diagnostics. According to the Department of Health and Human Services, there are 13 billion pharmacy visits in the United States each year. In contrast, there are 470 million physicians visits. Cambridge Healthtech Institute’s Inaugural Leveraging Pharmacies for Rapid Diagnostics conference aims to bring together both diagnostic test manufacturers and pharmacy services professionals to outline partnership potential as well as provide education on the services available in this emerging area. Representatives from pharmacy will discuss the retailization of healthcare as well as the capabilities of pharmacies and the feasibility of integrating diagnostics into the workflow. Diagnostics professionals will address testing capabilities as well as the types of tools that make sense in a pharmacy setting. Finally, the two sides will come together to showcase the development and implementation of a sustainable program.
The Future of Point-of-Care Diagnostics in Pharmacies
WEDNESDAY, AUGUST 19
7:15 am Registration
8:25 Chairperson’s Opening Remarks
Gyorgy Abel, M.D., Ph.D., Lahey Hospital & Medical Center
8:30 KEYNOTE PRESENTATION: Coming to a Lab Near You: Global Review of POCT
Gyorgy Abel, M.D., Ph.D., Director, Molecular Diagnostics, Immunology & Clinical Chemistry, Laboratory Medicine, Lahey Hospital & Medical Center
Clinical demand, convenience, and technological advancements have contributed to the increasing popularity of point-of-care testing (POCT) world-wide. Yet there are considerable differences in the utilization of POCT depending on the different medical needs, health care delivery and reimbursement systems in various countries. The presentation reviews these differences, the key drivers, challenges, trends, and the attitudes toward POCT by geographic/economic region.
9:00 Use of a Point-of-Care Laboratory to Successfully Manage Ebola Patients
James C. Ritchie, Ph.D., Medical Director & Professor, Pathology & Laboratory Medicine, Emory University
Our hospital has successfully treated 4 Ebola patients. These patients were entirely managed using laboratory values generated by a point-of-care testing laboratory located within the treatment unit. We will discuss the instrumentation used, the staff preparation, and the teamwork needed to make this approach viable. We will also briefly discuss the results for the common chemistry analytes on these patients throughout their treatment course. Finally we will discuss the shipping of specimens and decontamination of equipment and the laboratory after the patients depart.
9:30 Ambulatory Point-of-Care Testing for Ebola, Lassa, Fever and Trace Infections
Mustapha S. Fofana, Ph.D., Associate Professor, Mechanical, Biomedical and Manufacturing Engineering, Worcester Polytechnic Institute
The Ambulatory Point-of-Care Testing (POCT) vehicles are designed for rapid verification of people suspected of Ebola, Lassa, Fever and Trace (ELFT) infections. We will discuss the basic mechanics for POCT, explain engineering innovations of the POCT vehicles, outline new approach of POCT for ELFT infections, discuss safety topics related to renewable standards for evaluating and treating ELFT patients.
10:00 Improving Patient Care through Decentralizing Molecular Diagnostic Tests for Infectious Diseases
John Clarkson, Ph.D., Chief Executive, Atlas Genetics Ltd
Diagnostic test accuracy and turn-around time are vital characteristics in the fight against infectious diseases. Decentralizing diagnostic tests to the doctors’ office, specialist clinics or hospital ER can improve response time and increase test coverage of the population. In this presentation, attendees will gain an understanding of recent developments in decentralized diagnostics and what aspects of the system specification will drive clinical uptake.
10:15 Manufacturing Innovation for POC Devices
Erol Harvey, Ph.D., CEO, miniFAB
Microfluidics has matured to a point where production volumes reach into the millions per annum, and products are achieving market success. This journey to maturity has included many lessons, such as understanding the division of function between consumable and re-usable components. Dr Harvey’s presentation will discuss key design and manufacturing principles that, when considered, optimize the chances of commercial success.
10:55 Chairperson’s Opening Remarks
Donald G. Klepser, Ph.D., MBA, Associate Professor, Pharmacy Practice, University of Nebraska Medical Center
11:00 Point-of-Care Diagnostics: Business Case and Patient Perceptions
Donald G. Klepser, Ph.D., MBA, Associate Professor, Pharmacy Practice, University of Nebraska Medical Center
This program will discuss research studies examining patient acceptance of and willingness to pay for pharmacy based point-of-care tests.
11:30 Point-of-Care Diagnostics: Regulatory Perspective
Allison M. Dering-Anderson, BA, Pharm.D., RP, FAAIM, Clinical Assistant Professor, Pharmacy, University of Nebraska College of Pharmacy
This program will focus on the regulatory and statutory issues that may be encountered by pharmacies conducting Point-of-Care Tests or planning to conduct Point-of-Care Tests. It will also be useful to test manufacturers and developers who are looking to enter the community pharmacy market.
RETAIL PHARMACY CASE STUDY:
12:00 pm Reimbursement of Point-of-Care Testing in a Retail Health Clinic Setting
Daniel R. Kerls, MBA, OTR/L, Director, Ambulatory Operations, CVS MinuteClinic
This presentation will focus on how point of care labs influence overall reimbursement in a retail health setting and provide an overview of current challenges and opportunities, as well as considerations of supplies and control testing.
12:30 Enjoy Lunch on Your Own
1:25 Refreshment Break in the Exhibit Hall with Poster Viewing
1:50 Chairperson’s Opening Remarks
Allison M. Dering-Anderson, BA, Pharm.D., RP, FAAIM, Clinical Assistant Professor, Pharmacy, University of Nebraska College of Pharmacy
2:00 Community Pharmacies: The Face of Neighborhood Healthcare
Alex J. Adams, Pharm.D., IOM, Vice President, Pharmacy Programs, National Association of Chain Drug Stores (NACDS)
Community pharmacists are among the most accessible and trusted healthcare professionals; 95% of all Americans live within 5 miles of a pharmacies. Increasingly the public is turning to pharmacies for expanded services such as immunizations and point-of-care tests. This session will describe the community pharmacy landscape and opportunities to bring tests truly to the point-of-care.
2:30 Utilizing Pharmacists in Point-of-Care Testing: Scope of Practice Opportunities and Barriers
Krystalyn K. Weaver, Pharm.D., RPh, Director, Policy and State Relations, National Alliance of State Pharmacy Associations
This session will provide information on pharmacists’ education and training as it relates to point-of-care testing. An overview will be provided on how state laws and regulations that define pharmacist scope of practice create opportunities and barriers for the implementation of point-of-care testing programs in community pharmacies.
KEY INFORMANT INTERVIEWS:
3:00 Key Informant Interviews: Preliminary Results and Next Steps
Kenneth C. Hohmeier, Pharm.D., Assistant Professor, Clinical Pharmacy; Director, Community Affairs, College of Pharmacy, University of Tennessee
This session will present preliminary results from key informant interviews of diagnostic test manufacturers and pharmacy leaders. Manufacturers will have an opportunity to ask questions about the pharmacy market and pharmacy representatives will provide insight into the needs of the pharmacy market. The session will also include an opportunity for the audience to inform future interviews.
4:00 Refreshment Break in the Exhibit Hall with Poster Viewing
4:45 FEATURED TECHNOLOGY: Demonstrating Point-of-Care Diagnosis of Infectious Diseases with a Smartphone Dongle
Tiffany Guo, Department of Biomedical Engineering, Columbia University
We have developed a smartphone accessory, or dongle, that can perform a full laboratory-quality immunoassay. This low-cost dongle replicates all mechanical, optical, and electronic functions of lab-based enzyme-linked immunosorbent assay (ELISA) without requiring any stored energy; all necessary power is drawn from a smartphone. The dongle performed a triplexed immunoassay not currently available in a single test format: HIV antibody, treponemal-specific antibody for syphilis, and non-treponemal antibody for active syphilis infection. Testing in the field can exhibit markedly different performance from tests run in a laboratory owing to variations in clinical specimens, local environmental conditions, and variations in how the tests are run by individual users, and we sought to evaluate our diagnostic under real-life conditions. After a short 30 minute training, Rwandan health care workers used the dongle to test whole blood obtained via fingerprick from 96 patients enrolling into care at prevention of mother-to-child-transmission clinics or voluntary counselling and testing centers. In a blinded experiment, health care workers obtained diagnostic results with sensitivity of 92-100% and specificity of 79-92%. Importantly, patient preference for the dongle was 97% compared to lab-based tests, with most pointing to the convenience of obtaining quick results with a single fingerprick. Utilizing increasingly accessible consumer electronics allowed us to reduce device cost while increasing usability. This device demonstrates the potential to expand certain lab-based diagnostics to almost any population with access to smartphones.
5:00 FEATURED TECHNOLOGY: Diagnosis of Infection Utilizing Accellix CD64
Tobias Volker, Ph.D., Senior Vice President, Commercial Operations, LeukoDxDifferentiating patients who are infected or not in the intensive care unit can be very difficult. Present diagnostic tests remain inadequate. CD64 is constitutively expressed on the cell surface of PMNs and monocytes, but at low levels during the absence of infection. Upon invasion of a pathogen into the circulation, at a very early step of the immune host response, the expression level of CD64 on neutrophils increases dramatically. CD64 has a high specificity as its expression is not significantly elevated in malignancy of myeloid cells, any drug therapy (other than cytokines), clinical conditions with localized tissue damage, pregnancy and auto-immune disorders. The purpose of this study was to evaluate the Accellix CD64 instrument which provides results in 20 minutes in ICU patients with and without infections.<br /><br />Methods: The Accellix CD64 cartridge has all pre-analytical & analytical processing performed in the cartridge without further user intervention. This has been enabled by the development of a onetime use cartridge which includes onboard reagents and control material as well as an integrated flow cell. Infected (ICUi) and non-infected ICU patients (ICU Control-ICUc) and normal volunteers (C) had CD64 levels measured by the Accellix CD64 instrument. Measurements were calculated as 'CD64 index', i.e. the ratio between the fluorescence of the PMN population and the fluorescence of control beads. ICU infection, ICU control and normal control patients’ results can be seen in Figure 1.<br /><br />Results: Sixty patients were studied (ICUi- 17, ICUc-13 and C-30). CD64 Index levels were higher (mean ± SEM) in ICU infection patients then ICU control and normal control patients (2.49 ± 0.42 vs. 1.30 ± 0.32 vs. 0.56 ± 0.02, p = 0.03). <br /><br />Conclusion: CD64 Index levels are higher in infected than non-infected ICU patients. Accellix CD64 is a promising instrument to differentiate infected from non-infected ICU patients in a timely manner.
5:15 The Shifting Landscape of Diagnostic Testing
Harry Glorikian, Senior Executive/Board Director/Healthcare Consultant
Diagnostic technology is continually evolving to meet changing models of care. This talk will discuss the trends driving the shift of where testing is performed. We will also discuss existing and emerging technologies in relation to diagnostics. We will discuss CLIA-waived tests and rapid tests that don’t require extensive processing but also other emerging trends that affect patient care and management. Finally, potential clinical and business opportunities for this market will be addressed.
5:45 What Tests Are Currently Available and Do They Fit into a Community Pharmacy Practice
Michael E. Klepser, Pharm.D., FCCP, Professor, Pharmacy Practice, Ferris State University College of Pharmacy
The emerging market to use of CLIA-waived POC tests in community pharmacies will be discussed. Existing and developing care models will be explored. A review of test characteristics that would be attractive for pharmacy use will be provided. Opportunities and barriers for implementation of CLIA-waived POC test integrated care models will be explored.
6:15 Close of Day
6:00 Dinner Short Course Registration
THURSDAY, AUGUST 20
7:30– 8:25 am Problem-Solving Breakout Discussions with Continental Breakfast
These interactive discussion groups are open to all attendees, speakers, sponsors, & exhibitors. Participants choose a specific breakout discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion.
Expanding the Role of Community Pharmacists in Diagnostic Testing
Moderator: Casey L. Kozlowski, R.Ph., MBA, Director, Diagnostic Testing Product Development, Pharmacy Transformation, Walgreens Boots Alliance
- What role do pharmacists currently play in the diagnostic testing space?
- With some states granting pharmacists provider status, how do you see this role evolving?
- How will companion diagnostics and pharmacogenomics play a role?
Combining Pharmacists’ Knowledge and Accessibility with Rapid Diagnostic Testing to Improve Public Health
Moderator: Krystalyn K. Weaver, Pharm.D., RPh, Director, Policy and State Relations, National Alliance of State Pharmacy Associations
- How can pharmacists in the community setting be used to administer rapid diagnostic tests and provide appropriate treatment based on the results?
- What barriers exist to such a program?
- How does state-to-state variability in pharmacist scope of practice laws affect the implementation of such a program?
8:25 Chairperson’s Opening Remarks
Michael E. Klepser, Pharma.D., FCCP, Professor, Pharmacy Practice, Ferris State University College of Pharmacy
8:30 PANEL DISCUSSION:
Moderator: Michael E. Klepser, Pharm.D., FCCP, Professor, Pharmacy Practice, Ferris State University College of Pharmacy
Panelists: Casey Kozlowski, Director, Diagnostic Testing, Walgreens
Jesse McCullough, Pharm.D., Clinical Services Manager, Rite Aid Pharmacy
Daniel R. Kerls, MBA, OTR/L, Director, Ambulatory Operations, CVS MinuteClinic
- Using technology to advance clinical services
- Developing an untapped market
- Generating data to support new programs
- Challenges faced by pharmacy
- Challenges faced by diagnostic manufacturers
9:30 What's Holding Back Point-of-Care Diagnostics?
Jerry Lee, CEO, True Diagnostics, Inc.
The potential of the POCT Market rests not only on its ability to provide a quick response for providers and patients but also its capacity to deliver more specific results, simpler procedures and improve healthcare economics. True Diagnostics is advancing these competitive advantages to enable opportunities for the POCT Market.
9:45 Sponsored Presentation (Opportunity Available)
10:00 Coffee Break in the Exhibit Hall with Poster Viewing
RETAIL PHARMACY CASE STUDIES:
10:50 Point-of-Care Testing in a Retail Health Clinic Setting
Alexander Sbordone, J.D., Operations Manager, MinuteClinic, CVS Caremark Corporation
As retail health clinics continue to grow, more patients are using this model for the convenience that it offers. Practitioners in this setting are relying on point-of-care lab testing to assist in the diagnosis and treatment of both acute and chronic disease. This presentation will review the testing utilized at CVS Minute Clinic as well as the laboratory challenges and opportunities found in this setting.
11:20 Shifting the Paradigm: Bringing Lab Services to the Corner Drugstore
Casey L. Kozlowski, R.Ph., MBA, Director, Diagnostic Testing Product Development, Pharmacy Transformation, Walgreens Boots Alliance
Using Theranos’ innovative technology and Walgreens’ nationwide footprint, the two companies have partnered to bring diagnostic testing closer to the patient, and possibly change the way patients think about their pharmacy, pharmacists, and lab testing.
11:50 Late Breaking Presentation
12:20 pm Sponsored Presentation (Opportunity Available)
12:50 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:20 Session Break
2:00 PANEL DISCUSSION: Clinical Informatics Needed to Ensure Implementation of Your Test
Moderator: Julie Lynch, Ph.D., MBA, RN, Principal Investigator, Veterans Health Administration
Panelists: Terah B. Collins, Genomics Strategist, Cerner Corporation
Valentina I. Petkov, M.D., MPH, Health Scientist/Program Officer, Surveillance Research Pro-gram, Division of Cancer Control and Population Sciences National Cancer Institute
Danielle Chun, MPH, Genomics Informaticist, VINCI Services, VA
Scott Kulich, M.D., Ph.D., Associate Professor, Pathology, Division of Pathology and Division of Neuropathology, VA Pittsburgh Healthcare System (VAPHS)
- How do you meet informatics requirements for your test
- Linking test results to pharmacy and EHR
- Guidelines for HIPAA compliance of your test with requirements
- How do you ensure utilization of test?
3:30 Chairperson’s Remarks
Ali Tinazli, Ph.D., Vice President, Head, Business Development & Sales, SonyDADC Biosciences
3:35 CLOSING KEYNOTE: Commercializing Personalized Medicine: It’s All About the Value Proposition
Daryl Pritchard, Ph.D., Vice President, Science Policy, Personalized Medicine Coalition
A key barrier to the commercialization of personalized medicine products involves an unclear value proposition. Many factors are involved in value assessments, but determining what are the most important value drivers depends on who you are asking.
4:05 Close of Conference