Publications and Presentations

• Manuscripts
• Poster Presentations
• Podium Presentations
• BBCIC Research Reports

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Manuscripts

General / Real-World Evidence

• Barriers and facilitators to conduct high-quality, large-scale safety and comparative effectiveness research: The Biologics and Biosimilars Collective Intelligence Consortium experience
  Catherine M. Lockhart, Cara L. McDermott, Thomas Felix, Nancy D. Lin, Mark J. Cziraky, Aaron B. Mendelsohn, Jeffrey S. Brown
  Pharmacoepidemiol Drug Saf. 2019;1-3. [First published: 11 August 2019]

• Harnessing the Biologics and Biosimilars Collective Intelligence Consortium to evaluate patterns of care
  Cheryl N. McMahill-Walraven, Daniel J. Kent, Catherine A. Panozzo, Pamala A. Pawloski, Kevin Haynes, James Marshall, Jeffrey Brown, Bernadette Eichelberger, Catherine M. Lockhart
  J Manag Care Spec Pharm. [Published online August 9, 2019]

Data and Methods

• Mapping from the International Classification of Diseases (ICD) 9th to 10th Revision for Research in Biologics and Biosimilars Using Administrative Healthcare Data
  Mengdong He, Adrian J. Santiago Ortiz, James Marshall, Aaron B. Mendelsohn, Jeffrey R. Curtis, Charles E. Barr, Catherine M. Lockhart, Seoyoung C. Kim
  Pharmacoepidemiol Drug Saf. 2019. [Epub ahead of print.]
• Capture of Biologic and Biosimilar Dispensings in a Consortium of U.S.-Based Claims Databases: Utilization of National Drug Codes and Healthcare Common Procedure Coding System Modifiers in Medical Claims
  Jie Zhang, Kevin Haynes, Aaron B. Mendelsohn, James Marshall, Charles E. Barr, Cara McDermott, Jeffrey Brown, Annemarie Kline, James Kenney, Katelyn J. King, Cynthia Holmes, Kai Yeung, John Barron, Huifeng Yun, Catherine M. Lockhart
  Pharmacoepidemiol Drug Saf. 2019. [Epub ahead of print.]
• Methodologic considerations for noninterventional studies of switching from reference biologic to biosimilars
  Rishi J. Desai  Seoyoung C. Kim  Jeffrey R. Curtis  Jaclyn L.F. Bosco  Bernadette Eichelberger  Charles E. Barr  Catherine M. Lockhart  Brian D. Bradbury  Jerry Clewell  Hillel P. Cohen  Joshua J. Gagne on behalf of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) Switching Workgroup.
  Pharmacoepidemiol Drug Saf. 2019;1-13 [First published 12 July 2019. Published online August 2019]

Utilization 

• Patient Characteristics and Utilization Patterns of Short-Acting Recombinant Granulocyte Colony-Stimulating Factor (G-CSF) Biosimilars Compared to Their Reference Product. 
  Aaron B. Mendelsohn, James Marshall, Cara L. McDermott, Pamala A. Pawloski, Jeffrey S. Brown, Catherine M. Lockhart.
  Drugs – Real World Outcomes. Online First. doi:10.1007/s40801-021-00228-9. 

• Utilization Patterns and Characteristics of Users of Biologic Anti-Inflammatory Agents in a Large, US Commercially Insured Population
  Aaron B. Mendelsohn, Young Hee Nam, James Marshall, Cara L. McDermott, Bharati Kochar, Michael D. Kappelman, Jeffrey S. Brown, Catherine M. Lockhart
  Pharmacology Research & Perspectives. 2021;9.e00708.

Descriptive Analyses

• BBCIC Research Network Analysis of First-Cycle Prophylactic G-CSF Use in Patients Treated with High Neutropenia Risk Chemotherapy
  Pamala A. Pawloski, Cara L. McDermott, James H. Marshall, Vanita Pindolia, Catherine M. Lockhart, Catherine A. Panozzo, Jeffrey S. Brown, Bernadette Eichelberger.
  J Natl Compr Canc Netw. In Press. [Published online August 16, 2021] 

• Incidence of Serious Infections and Design of Utilization and Safety Studies for Biologic and Biosimilar Surveillance
  Jie Zhang, Gayathri Sridhar, Charles E. Barr, Bernadette Eichelberger, Catherine M. Lockhart, James Marshall, Jerry Clewell, Neil A. Accortt, Jeffrey R Curtis, Cynthia Holmes, Cheryl N. McMahill-Walraven, Jeffrey Brown, Kevin Haynes
  J Manag Care Spec Pharm. 2020; 417-490 [Published online April 26, 2020]
• Descriptive Analysis of Long- and Intermediate-Acting Insulin and Key Safety Outcomes in Adults with Type 2 Diabetes Mellitus
  Daniel J. Kent, Cheryl N. McMahill-Walraven, Catherine A. Panozzo, Pamala A. Pawloski, Kevin Haynes, James Marshall, Jeffrey Brown, Bernadette Eichelberger, Catherine M. Lockhart
  J Manag Care Spec Pharm. [Published online August 16, 2019] 

Poster Presentations

Anti-Inflammatory

• Poster presentation at ICPE 2018:
  Incidence Rate of Serious Infections in Patients Receiving Biologic Anti-Inflammatory Agents for Treatment of Rheumatologic, Dermatologic, and Gastrointestinal Conditions
  Jie Zhang, PhD, Gayathri Sridhar, PhD, Charles E. Barr, PhD, Bernadette Eichelberger, PharmD, James Marshall, MPH, BBCIC Anti-inflammatory Research Team, Kevin Haynes, PharmD, MSCE
  2018 August 22-26, Prague, Czech Republic

Data & Methods

• Poster presentation at ICPE 2021: 
  Characterization of real-world data sources to support observational studies of biologics, including biosimilars in oncology.  
  Ryan M. Seals, Catherine M. Lockhart, Nancy Lin, John D. Seeger. 
  2022 August 23-26, Virtual 
• Poster presentation at AMCP 2021 [Bronze medal winner]: 
  Characterization of real-world data sources to support observational studies of biologics, including biosimilars in oncology. 
  Ryan M. Seals, Catherine M. Lockhart, Nancy Lin, John D. Seeger. 
  2021 April 12-16, Virtual 
• Poster presentation at 35th ICPE Meeting, 2019:
  Methodologic considerations for data source selection and study design of non-interventional studies comparing the safety and effectiveness of biosimilars and reference biologics: insulin glargine products as a case example
  Nancy D Lin*, Jaclyn LF Bosco, Cynthia H Holmes, Catherine M Lockhart and John D Seeger
  2019 August 26-29, Philadelphia, PA

Diabetes

• Poster presentation at ICPE 2022:
  Utilization, user characteristics, and adverse outcomes of insulin glargine originators and follow-on drug in patients with diabetes in the US
  Ashish Rai, Young Hee Nam, Aaron B. Mendelsohn, James Marshall, Cara L. McDermott, Sengwee Toh, Catherine M. Lockhart
  2022 August 24-28, Copenhagen, Denmark
• Poster presentation at AMCP Nexus 2018:
  Descriptive analysis of the use of long- and intermediate-acting insulin, and key safety outcomes in adults with diabetes mellitus
  Cheryl McMahill-Walraven, MSW, PhD,  Daniel Kent, PharmD, CDE,  Cathy Panozzo , MPH, PhD,  Pamala A. Pawloski, PharmD, Kevin Haynes, PharmD,  Catherine M. Lockhart, PharmD PhD, James Marshall, Jeffrey Brown, PhD, Bernadette Eichelberger, PharmD, and the BBCIC Insulin Research team
  2018 October 22-25, Orlando, FL  

G-CSF

• Poster presentation at 2022 San Antonio Breast Cancer Symposium:
  A Population-based Analysis of Prophylactic G-CSF Biosimilar and Originator Administration over time among Patients Diagnosed with Breast Cancer
  Pamala A. Pawloski, Cara L. McDermott, Gabriella Vazquez Benitez, Terese DeFor, Aaron Mendelsohn, James Marshall, Erick Moyneur, Catherine M. Lockhart, on behalf of the G-CSF Comparative Effectiveness Research Team
  2022 December 6-10, San Antonio, TX
• Poster presentation at 2022 ACCP Global Conference on Clinical Pharmacy:
  Changes in G-CSF Biosimilar and Originator Use over Time  
  Pamala A. Pawloski, Cara L. McDermott, Gabriella Vazquez Benitez, Terese DeFor, Aaron Mendelsohn, James Marshall, Erick Moyneur, Jaclyn Bosco, Maria Bottorff, Djeneba Audrey Djibo, Elizabeth Engelhardt, Aziza Jamal-Allial, Annemarie Kline, Edward Li, Sam Li, Nancy Lin, Ali McBride, Cheryl McMahill-Walraven, Gary Yee, Catherine M. Lockhart
  2022 October 15-18, San Francisco, CA
• Poster presentation at ASCO Quality Care Symposium 2022:
  An Exploratory Comparative Effectiveness Analysis of Febrile Neutropenia Incidence among Patients with Cancer Receiving Granulocyte Colony Stimulating Factors  
  Pamala A. Pawloski, Catherine M. Lockhart, Gabriella Vazquez Benitez, Terese DeFor, Aaron Mendelsohn, James Marshall, Érick Moyneur, Cara L. McDermott, on behalf of the G-CSF Comparative Effectiveness Research Team
  2022 September 30-October 1, Chicago, IL
• Poster presentation at ISPOR 2022:
  Challenges to Identification of Cancer Chemotherapy Regimens and Patient Cohorts in Administrative Claims
  Catherine M. Lockhart, Cara L. McDermott, Gabriela Vazquez Benitez, Terese DeFor, Aaron B. Mendelsohn, James Marshall, Ali McBride, Érick Moyneur, Pamala A. Pawloski, and the BBCIC G-CSF Comparative Effectiveness Research Team
  2022 May 15-18, National Harbor, MD

ICD-9 to ICD-10 Mapping

• Poster presentation at ISPOR 2019:
  ICD-9 to ICD-10 mapping for database research in biologics and biosimilars
  Mengdong He, MHS; Adrian J. Santiago Ortiz, BS; James Marshall, MPH; Aaron B. Mendelsohn, PhD, MPH; Jeffrey R. Curtis, MD, MPH;
  Charles E. Barr, MD, MPH; Catherine M. Lockhart, PharmD, PhD; Seoyoung C. Kim, MD, ScD, MSCE
  2019 May 18-22, New Orleans, LA
• Poster presentation at AMCP Nexus 2018:
  ICD-9 to ICD-10 Mapping for Database Research in Originator Biologics and Biosimilars
  Mengdong He, MHS; Adrian J. Santiago Ortiz, BS; Aaron B. Mendelsohn, PhD, MPH; Charles E. Barr, MD, MPH; Catherine M. Lockhart, PharmD, PhD; James Marshall, MPH; Seoyoung C. Kim, MD, ScD, MSCE 
  2018 October 22-25, Orlando, FL 

Literature Reviews

• Poster presentation at AMCP Nexus 2021: 
  A scoping review of real-world evidence and outcomes for trastuzumab in breast cancer.  
  Rupesh Panchal, Theodoros Giannouchos, Ainhoa Gomez-Lumbreras, Priyanka Ghule, Catherine M. Lockhart, Diana Brixner. 
  2021 October 18-21, Denver, CO 
• Poster presentation at AMCP Nexus 2021: 
  A scoping review of real-world evidence and outcomes for bevacizumab in age-related macular degeneration.
  Ainhoa Gomez-Lumbreras, Priyanka Ghule, Rupesh M. Panchal, Theodoros Giannouchos, Catherine Lockhart, Diana Brixner 
  2021 October 18-21, Denver, CO 

NDC/J-Code Workgroup

• Poster presentation at 35th ICPE Meeting, 2019:
  Capture of Biologic and Biosimilar Dispensings in a Consortium of U.S.-Based Claims Databases -Utilization of National Drug Codes and HCPCS Modifiers in Medical Claims
  Jie Zhang, Kevin Haynes, Aaron B. Mendelsohn, James Marshall, Charlie Barr*, Cara McDermott, Annemarie Kline, James Kenney*, Katelyn J. King, Cynthia Holmes, HuifengYun, Kai Yeung, John Barron, Jeffrey Brown, Cate Lockhart
  2019 August 26-29, Philadelphia, PA
• Poster presentation at the AMCP 2019 Annual Meeting:
  Capture of Biologic and Biosimilar Dispensings in a Consortium of U.S.-Based Claims Databases – Utilization of National Drug Codes and HCPCS Modifiers in Medical Claims
  Jie Zhang, Kevin Haynes, Aaron B. Mendelsohn, James Marshall, Charlie Barr*, Cara McDermott, Annemarie Kline, James Kenney*, Katelyn J. King, Cynthia Holmes, Huifeng Yun, Kai Yeung, John Barron, Jeffrey Brown, Cate Lockhart
  2019 March 25-28, San Diego, CA

Oncology

• Poster presentation at AMCP Nexus 2020:
  Global Evaluation of Real-World Studies on Biosimilar Usage in Oncology
  Shyra G. Bias, PharmD Candidate 2021, Nkiruka Emezienna, MS, PharmD Candidate 2021, Catherine M. Lockhart, PhD, Jamila Jorden, PharmD, Paula J. Eichenbrenner, MBA, CAE 
  2020 October 20-22, Virtual

• Presented at NCCN 2020: Updated Analysis of G-CSF Monitoring Query
  Longitudinal evaluation of characteristics, treatment patterns, and general outcomes among patients using granulocyte colony stimulating factors: a study by the Biologics and Biosimilars Collective Intelligence Consortium
  Catherine M. Lockhart, Cara L. McDermott, James Marshall, Aaron B. Mendelsohn, Pamala A. Pawloski, Jeffrey Brown
  2020 February 29, Virtual

• Presented at ICPE 2020 All Access:
  Variation in evaluations of granulocyte colony stimulating factor use: a scoping review of observational studies
  Cara L. McDermott, Pamala Pawloski, Prasad Gawade, Cynthia Holmes, Edward Li, Aaron Mendelsohn, Gary C. Yee, Catherine M. Lockhart
  2020 September 16-17, Virtual

• Presented at AMCP Nexus 2019:
  Longitudinal evaluation of characteristics, treatment patterns, and general outcomes among patients using granulocyte colony stimulating factors: a study by the Biologics and Biosimilars Collective Intelligence Consortium
  Catherine M. Lockhart, Cara L. McDermott, James Marshall, Aaron B. Mendelsohn, Pamala A. Pawloski, Jeffrey Brown
  2019 October 29-November 1, National Harbor, MD

Real-World Outcomes

• Poster presentation at HCSRN 2018:
  A Research Network for Biosimilars:  Creation and Activities of the BBCIC
  Pamala A. Pawloski, PharmD, Kevin Haynes, PharmD, Dan Kent, PharmD, CDE, Cheryl Walraven, MSW, PhD, Catherine Panozzo, MPH, PhD, Vanita Pindolia, PharmD, Jeffrey Brown, PhD, Catherine M. Lockhart, PhD, Charles E. Barr, PhD, Bernadette Eichelberger, PharmD
  2018 April 11-13, Minneapolis, MN

• Poster presentation at the HCSRN Annual Meeting 2019:
  Perspectives from a Coordinating Center: Lessons learned from the Biologics and Biosimilars Collective Intelligence Consortium
  Sarah Malek , Katelyn J. King, Catherine M. Lockhart, Aaron B. Mendelsohn, Jeffrey Brown, Harvard Medical School and Harvard Pilgrim Health Care Institute; Biologics & Biosimilars Collective Intelligence Consortium, Academy of Managed Care Pharmacy
  2019 April 8-10, Portland, OR

• Poster presentation at AMCP Nexus 2018 (Gold Medal Winner):
  Development and Management of a Distributed Research Network for Evaluating Real-World Outcomes for Originator Biologics and Biosimilars
  Aaron B. Mendelsohn, Charles E. Barr, Jeffrey Brown, Mark Cziraky, Katelyn King, Nancy Lin, Catherine M. Lockhart, Pamala A. Pawloski, Bernadette Eichelberger
  2018 October 22-25, Orlando, FL
• Poster presentation at AMCP Nexus 2018:
  Evaluating Biologics and their Biosimilars Using a Distributed Research Network to Demonstrate Real-World Outcomes
  Pamala A. Pawloski, PharmD, Kevin Haynes PharmD, Daniel Kent PharmD, Cheryl N. McMahill-Walraven MSW PhD, Catherine A. Panozzo MPH PhD, Vanita Pindolia PharmD, Catherine M. Lockhart PharmD, PhD, Jeffrey Brown PhD, Aaron Mendelsohn PhD MPH, Charles E. Barr MD, Bernadette Eichelberger PharmD
  2018 October 22-25, Orlando, FL
• Poster presentation at AMCP Nexus 2018:
  Differentiation of adults with type 1 versus type 2 diabetes in administrative claims analysis: experience from the Biologics and Biosimilars Collective Intelligence Consortium
  Cheryl McMahill-Walraven, MSW, PhD, Daniel Kent, PharmD, CDE, James Marshall, Catherine M. Lockhart, PharmD, PhD, and the BBCIC Insulin Research team
  2018 October 22-25, Orlando, FL 

Utilization

• Poster presentation at AMCP Nexus 2022:
  Patient characteristics and utilization for bevacizumab in ophthalmology and oncology in a distributed research network  
  Jenice Ko, Aaron Mendelsohn, Kimberly Daniels, Ainhoa Gomez-Lumbreras, James Marshall, Cara McDermott, Pamala Pawloski, Gary Yee, Catherine Lockhart
  2022 October 11-14, National Harbor, MD
• Poster presentation at ASCO Quality Care Symposium 2022:
  Utilization, user characteristics, and adverse outcomes of bevacizumab products in oncology in a distributed research network  
  Jenice Ko, Aaron Mendelsohn, Kimberly Daniels, Ainhoa Gomez-Lumbreras, James Marshall, Cara McDermott, Pamala Pawloski, Gary Yee, Catherine Lockhart
  2022 September 30-October 1, Chicago, IL
• Poster presentation at AMCP Nexus 2021 [Platinum Award Winner]: 
  Utilization and patient characteristics for the trastuzumab originator and biosimlars and other HER2 inhibitors in the United States.  
  Young Hee Nam, Aaron B. Mendelsohn, James Marshall, Nancy D. Lin, Jeffrey S. Brown, Cara L. McDermott, Pamala A. Pawloski, Catherine M. Lockhart. (Selected oral abstract presented by CM Lockhart) 
  2021 October 18-21, Denver, CO 
• Poster presentation at ASCO Quality Care 2021: 
  Utilization and patient characteristics for the trastuzumab originator and biosimlars and other HER2 inhibitors in the United States.  
  Young Hee Nam, Aaron B. Mendelsohn, James Marshall, Nancy D. Lin, Jeffrey S. Brown, Cara L. McDermott, Pamala A. Pawloski, Catherine M. Lockhart. 
  2021 September 24-25, Boston, MA 
• Poster presentation at AMCP 2021:
  Utilization patterns and characteristics of patients treated with the originator and follow-on insulin glargine in the United States.  
  Young Hee Nam, Aaron B. Mendelsohn, James Marshall, Cara L. McDermott, Jeffrey S. Brown, Catherine M. Lockhart. 
  2021 April 12-16, Virtual 

Podium Presentations

Biosimilars & Real-World Evidence

• Oral presentation at AMCP Nexus 2021: 
  New Mabs on the block: a rocking research update on biosimilar uptake and benefit design strategies in the United States.
  Tasmina Hydery (Xcenda), Jennifer Snow (Xcenda), and Catherine M. Lockhart (BBCIC). 
  2021 October 18-21, Denver, CO. 

• Oral presentation at AMCP Nexus 2019:
  Biosimilars in the United States: Barriers, Solutions, Real-World Evidence, and the Experience of One Health System
  Gillian Woollett, MA, DPhil, Cate Lockhart, MS, PharmD, PhD, and Molly Leber, PharmD, BCPS, FASHP.
  2019 October 29-November 1, National Harbor, MD

• Oral presentation at CBI Annual Biosimilars Summit:
  Real-World Evidence and Post-Marketing Surveillance to Support Treatment and Coverage Decisions
  Cate Lockhart, MS, PharmD, PhD
  2019 January 22-23, Alexandria, VA

• Oral presentation at AMCP Nexus 2018:
  The State of U.S. Biosimilar Utilization and Post-Marketing Surveillance Initiatives to Support Treatment and Coverage Decisions
  Catherine M. Lockhart, MS, PharmD, PhD, Biologics and BiosimilarsCollective Intelligence Consortium.
  2018 October 22-25, Orlando, FL

• Oral presentation at AMCP Nexus 2017:
  The Application of Real-World Evidence to Biosimilars
  Pamala A. Pawloski, Pharm.D., FCCP and Cheryl N. McMahill-Walraven, PhD.
  2017 October 16-19, Grapevine, TX
• Oral Presentation at ICPE 2018:
  Methodologic Considerations for Non-Interventional Studies Evaluating Outcomes of Originator-to-Biosimilar Switching
  Jaclyn L. F. Bosco, PhD, MPH
  2018 August 22-26, Prague, Czech Republic
• Oral Presentation at DIA 2018:
  Payers, Industry and Academia Collaborating on Post-Marketing Surveillance
  Charles E. Barr, MD, MPH
  2018 June 24-28, Boston, MA

• Oral presentation at ISPOR 2018:
  Biosimilars, Utilization, and Post-Marketing Surveillance in the United States
  Michael  D.  Blum,  MD,  MPH, Mark Cziraky, PharmD, CLS, Cate Lockhart, PharmD, PhD
  2018 May 19-23, Baltimore, MD

ICD-9 to ICD-10 Mapping

• Oral presentation at ICPE 2019:
  ICD-9 to ICD-10 Mapping for Research in Biologics and Biosimilars Using Administrative Healthcare Data
  Mengdong He  MHS, Adrian J. Santiago Ortiz BS, James Marshall, MPH, Aaron B. Mendelsohn, PhD, MPH; Jeffrey R. Curtis, MD, MPH; Charles E. Barr, PhD, Catherine M. Lockhart, PharmD, PhD and Seoyoung C. Kim, MD, ScD, MSCE
  2019 February 2

BBCIC Research Reports

We will list BBCIC research reports not submitted to peer-reviewed journals here.