About the BBCIC BBCIC Program Director Opening


The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) was established in 2015 to address anticipated needs for post-marketed evidence generation for novel biologics, their corresponding biosimilars and other related products. 

The BBCIC is a non-profit, scientific public service initiative that will monitor biosimilars and corresponding novel biologics for effectiveness and safety – to provide the reassurance that patients and physicians want.  The BBCIC:

Managed care and integrated delivery organizations have devoted significant resources to develop an infrastructure that makes possible active surveillance of biosimilars and novel in distributed research networks (DRNs). The BBCIC marshals these resources for the important public health benefit inherit in monitoring biosimilar safety and effectiveness, using ongoing sequential analyses to compare biosimilars to their innovator product.

BBCIC Mission

The BBCIC mission is to provide a range of research services that support the following value propositions:

  1. Address important questions about the use, impact, safety, and clinical effectiveness of biologics and biosimilars on human health.
  2. Increase the rigor and credibility of real world evidence
  3. Provide access to a large population for epidemiologic studies and health services research
  4. Improve the efficiency and cost-effectiveness of post-marketed observational studies
  5. Develop standard approaches to common data needs and address gaps in tools and methods.
Addressing a Public Health Need

Prior to the founding of the BBCIC there was no proactive and systematic post-approval evidence generation system in the US for purposes of monitoring biologics and biosimilars, which is an important public health need. The BBCIC meets this need with its science-driven fully transparent approach which leverages existing distributed research network resources. The BBCIC is the neutral convener to provide investigators, biopharmaceutical companies, managed care organizations (MCOs), integrated delivery networks (IDNs), pharmacy benefit managers (PBMs), physicians and patient advocates with an organized process to characterize patient populations and generate evidence for biologics and biosimilars in a manner that promotes robust and relevant scientific research and exchange and with the goal of making meaningful contributions to the scientific record.

BBCIC Range of Research

The BBCIC will conduct a range of analyses from population characterization, epidemiologic studies, and active observational sequential analysis of biologics/biosimilars using a distributed network of healthcare organizations.
Specific observational research activities may include, but are not limited to:

BBCIC Transparency of Its Science-Driven Approach

The BBCIC focus is its transparent science-driven research.  The BBCIC scope does not include advocacy or political functions, including taking a position or commenting on legislative or regulatory proposals.  The AMCP BBCIC is committed to transparency in all aspects of its research and operations.

The BBCIC requires all BBCIC Research Reports to be communicated promptly in an appropriate scientific forum.  The Research Team will register all BBCIC Research Protocols in ClinicalTrials.gov prior to initiating the study.  Methodological and other projects will be registered at HSRProj

BBCIC 2016-2017 Research Plan

Specific Research Plans and Protocols are posted at www.clinicaltrials.gov once they are written and approved by the BBCIC Science Committee and Planning Board.  The 2016-2017 Research plan covers:

Descriptive Analysis Studies.  A precursor to actual observational research studies, these protocols establish indicators  to be measured by characterizing patient populations, identifying exposures and outcomes, as well as patterns of use  and clinical risk factors that may influence patient response.

Four descriptive analysis protocols are being completed in q2-q3 2017. Examples of specific indicators to be examined in the protocols include:

In 2017 We Are Convening:

BBCIC Participating Organizations

With thanks to the founding participants of the BBCIC:

AbbVie Aetna Amgen AMCP Anthem-Healthcore Apobiologix Boehringer Ingelheim Pharmaceuticals Inc Express Scripts Inc. Harvard Pilgrim Health Care HealthPartners Henry Ford Health System Kaiser Permanente Washington Health Research Institute Merck Momenta Pharmaceuticals Inc. Optum Pfizer Sandoz Sanofi and the Hematology Oncology Pharmacy Association

Contact the BBCIC

Bernadette Eichelberger, PharmD
Program Director, Biologics and Biosimilars Collective Intelligence Consortium (BBCIC)
675 North Washington Street, Suite 220, Alexandria, VA 22314
beichelberger@bbcic.org
703-683-8416

News and Events
BBCIC is seeking a Program Director (PD) with extensive clinical experience including knowledge of observational research methods.

Below are links describing the science behind data consortiums, and why the BBCIC is engaging data consortium, managed care specialty drug experts, researchers and industry in the BBCIC.


Press Events

Presentations and Background Papers

Webinars

Papers

BBCIC Governance

The BBCIC is a participant driven consortium governed by a Board of Managing Directors, a Planning Board and a Science Committee.



Board of Managing Directors
The BBCIC Board of Managing Directors is responsible for oversight of the AMCP BBCIC and consists of the following positions:

Planning Board
The Planning Board is responsible for the BBCIC charter, operational policies & procedures and research plans. The Planning Board also oversees public communications regarding AMCP BBCIC activities and findings. Click Here to view the members of the Planning Board.


Science Committee
The Science Committee is responsible for the development and conduct of the overall research plan and publication plans. The Science Committee consists of scientific experts from the participating organizations. Click Here to view the members of the Science Committee.


Research Teams
The Research Teams reflect the various BBCIC Participants and include data, clinical, epidemiology, statistics and HEOR expertise. The BBCIC Science Committee appoints additional subject matter experts where the expertise is not available from our Participant organizations. Research Teams write formal Research Protocols to be approved by the Science Committee and work with the Coordinating Center to execute the completion and publication of the protocol results. Click Here to view the members of the Research Teams.


BBCIC Leadership
Bernadette Eichelberger, PharmD
Program Director, Biologics and Biosimilars Collective Intelligence Consortium (BBCIC)
675 North Washington Street, Suite 220, Alexandria, VA 22314
beichelberger@bbcic.org
703-683-8416


BBCIC Charter
The BBCIC Charter was approved by the BBCIC Board of Managing Directors on October 23, 2015. The BBCIC Charter details the principles and policies governing all BBCIC research projects.
Click Here to access the BBCIC Charter PDF.


BBCIC Antitrust Policy
The BBCIC follows strict antitrust guidelines. BBCIC policy is to comply fully and strictly with all federal and state antitrust laws.
Click Here to access the BBCIC Charter PDF.

Thank You for Your Participation

The leadership of AMCP would like to thank the following:



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