** Deadline for applications for this workshop was January 30, 2019 **
Location
This workshop was held at SAS Hall on the campus of NC State University, Raleigh, NC.
Description
The purpose of the workshop was to bring together experts in industry, academia, and regulatory affairs to discuss current advances and future goals in the field of precision medicine. In alignment with SAMSI’s year-long Program on Statistical, Mathematical, and Computational Methods for Precision Medicine (PMED), the speakers ranged in topics from hospital care and workflow, pharmaceutical development, observational and real-world evidence, and regulatory developments.
The conference featured world-leading presenters from industry, regulatory, and academia. Speakers covered a range of healthcare industries including hospitals, home care, insurance, Big Pharma, CROs, biotech, and mobile health.
The workshop featured two round-table discussions:
1. Lessons and Challenges in Observational Health Data: A round-table debate on the work generated by the Observed Medical Outcomes Partnership (OMOP) and the Observational Health Data Sciences and Informatics program (OHDSI). The panel was led by Rosa Gini (Agenzia regionale di sanità della Toscana, Florence, Italy), Miguel Hernan (Harvard), David Madigan (Columbia University), and Marc Suchard (UCLA).
2. Regulatory Advancements in the FDA: A panel discussion about recent developments in the FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER). The panel was led by Telba Irony (FDA CBER).
The workshop featured a presentation speed-session for researchers to introduce their work.
Confirmed speakers for this event were:
- Demissie Alemayehu (Columbia University)
- David Banks (SAMSI Director and Duke University)
- Jason Burke (UNC Healthcare)
- Glen Wright Colopy (Current Health and Oxford University)
- Rachael DiSantostefano (Johnson & Johnson)
- Lauren Drinkard (Lumeris)
- Jessilyn Dunn (Duke University)
- Madalina Fiterau (University of Massachusetts – Amherst)
- Jeff Fuller (UNC Health)
- Rosa Gini (Agenzia regionale di sanità della Toscana, Florence, Italy)
- Sophie Guo (Deep6 AI)
- Boris Hayete (GNS Healthcare)
- Miguel Hernan (Harvard T.H. Chan School of Public Health)
- Martin Ho (FDA CBER)
- Telba Irony (FDA CBER)
- Alistair Johnson (MIT)
- Warren Kibbe (Duke University)
- Rebecca Krouse (Rho)
- Lisa LaVange (University of North Carolina at Chapel Hill)
- Ilya Lipkovich (Senior Research Advisor at Eli Lilly, Real World Analytics)
- David Madigan (Statistics Department, Columbia University)
- Carol Mansfield (RTI Health Solutions)
- Christopher McCann (Current Health)
- Jeff Painter (JiveCast)
- West Paul (WakeMed)
- Paolo Piraino (Bayer AG)
- Russell Reeve (Senior Director of Advisory Analytics, IQVIA)
- Estelle Russek-Cohen (FDA CBER)
- John Scott (FDA CBER)
- Xiling Shen (Duke University)
- Marc Suchard (Departments of Biomathematics and of Human Genetics, David Geffen School of Medicine, UCLA)
- Benjamin Villard (Oxford and University of Nagoya)
- Brian K. Walsh (Liberty University)
- Herb Weisberg (Causalytics, LLC)
- Richard Zink (Senior Director of Data Management and Statistics, TARGET PharmaSolutions)
Schedule and Supporting Media
Printed Schedule
Speaker Titles/Abstracts
Poster Titles
Thursday, March 14, 2019
Auditorium Room 2203, SAS Hall, N.C. State University, Raleigh, N.C.
Description | Speaker | Slides |
---|---|---|
Introduction and Opening Remarks | David Banks, SAMSI/Duke University | |
Session 1: Advances in Biopharmaceuticals | Sophie Guo, Deep6 AI | |
Boris Hayete, GNS Healthcare | ||
Jessilyn Dunn, Duke University | ||
Xiling Shen, Duke University | ||
Herb Weisberg, Causalytics, LLC | ||
Session 1: Advances in Biopharmaceuticals (continued) | Lauren Drinkard, Lumeris | |
Jeff Painter, JiveCast | ||
Warren Kibbe, Duke University | ||
Discussion | ||
Plenary Panel: Lessons and Challenges in Observational Health Data | Panelists | |
Moderator: Demissie Alemayheu, Columbia University | ||
Rosa Gini, Agenzia Regionale di Sanità della Toscana | ||
Miguel Hernan, Harvard University | ||
David Madigan, Columbia University | ||
Marc Suchard, UCLA | ||
Session 2: Personalization in Hospital Care | Madalina Fiterau, UMass Amherst | |
Alistair Johnson, MIT | ||
Jeffery Fuller, UNC Health | ||
Benjamin Villard, Oxford and University of Nagoya | ||
Session 3: Medical Device Analytics | Brian K. Walsh, Liberty University | |
Christoper McCann, Current Health | ||
Paolo Piraino, Bayer AG | ||
Rebecca Krouse, Rho | ||
Session 4: Advances in Pharmaceuticals | Derek Lawrence, Rho Inc. | |
Heather Kopetskie, Rho Inc. | ||
Dukka KC, NC A&T State University | ||
Session 5: Early Career Researcher/Poster Presentation Speed Session | Bill Tian, Duke University | |
Mercedeh Ghadessi, Bayer Pharmaceuticals | ||
Hai-Yan Yu, Penn State University | ||
Jessie Sutphin, RTI | ||
Sara Mohammad Taheri, Northeastern University | ||
Xinyi Li, SAMSI | ||
Stan Young, CG Stat | ||
Hoa Le, PAREXEL Int’l/UNC-Charlotte | ||
Poster Session and Social |
Friday, March 15, 2019
Auditorium Room 2203, SAS Hall, N.C. State University, Raleigh, N.C.
Description | Speaker | Slides |
---|---|---|
Session 6: Advances in Industry | Russell Reeve, IQVIA | |
Richard Zink, TARGET PharmaSolutions | ||
Ilya Lipkovich, Eli Lilly | ||
Session 7: Advances in Industry | Glen Wright Colopy, Current Health and Oxford University | |
Jason Burke, UNC Healthcare | ||
West Paul, WakeMed | ||
Session 8: Patient Preference Studies: Advancements in Industry | Rachael DiSantostefano, Johnson & Johnson | |
Carol Mansfield, RTI | ||
Plenary Panel: Regulatory Advancements in the FDA | Panelists | |
Moderator: Lisa Lavange, University of North Carolina at Chapel Hill | ||
Telba Irony, FDA CBER | ||
Estelle Russek-Cohen, FDA CBER | ||
John Scott, FDA CBER | ||
Martin Ho, FDA CBER | ||
Closing Remarks |
Questions: email [email protected]