May 1, 2019

MDIC’s Clinical Diagnostics Cancer Genomic Somatic Reference Samples working group seeks public comments on the draft list of prioritized tumor suppressors.

The goal of the initiative is to develop reference samples that can be made available to the public to improve the accuracy, reliability and transparency of Next-Generation-Sequencing (NGS) based oncology tests. In addition, the samples will improve the efficiency and cost-effectiveness of accurate NGS-based test development and validation by establishing and organizing a collaborative community effort to develop needed reference samples.

Availability of reference samples will aid in efficient NGS test development and validation which will in turn streamline and possibly obviate steps in the regulatory process for diagnostic companies, provide transparency, and compress development timelines for targeted therapeutics developers.

The team was asked to create a prioritized list of tumor suppressor genes that would be covered in an ideal set of reference materials. To ensure that this list identifies the most useful targets to benefit the most patients today, they drew the targets from the work of objective third parties without vested commercial interests in any particular target. Sources should therefore:

  • Represent current standard medical practice
  • Originate from a public sector or independent non-profit organizations
  • Represent the collective opinion of a broad swathe of clinicians and / or laboratory scientists.

The sources used included: OncoKB (oncokb.org),National Comprehensive Cancer Network (NCCN), and ongoing oncology trials catalogued on clinicaltrials.gov

We prioritized genes with Levels 1 and 2 clinical evidence as defined in CDRH’s tiering system for NGS. Level 1 representing those genes that are associated with approved companion diagnostics and Level 2 representing mutation with evidence of clinical significance, such as by inclusion in guidelines. Level 3 Variants will be presented later. We also prioritized variants relevant to solid tumors. HemOnc variants are out of the current scope.

You can access the draft Tumor Suppressor Gene list and instructions here.

 The public comment period is open from May 1 – 30, 2019.
April 24, 2019

On April 2, 2019, MDIC’s External Evidence Methods (EEM) program hosted an Executive & Fellows meeting with about 70 subject matter experts from FDA, industry, and non-profit organizations to discuss the existing methods and identify gaps for the use of external data.

MDIC’s EEM program aims to establish a more predictable pathway for use of external evidence methods, such as new, innovative (Frequentist/Bayesian) methods and the cataloging of existing methods for evidence fusion from data external to a clinical trial. External trial data includes but is not limited to real-world data (RWD), real-world evidence (RWE), engineering modeling and simulation, and similar device clinical trial data to support regulatory medical device decisions and other stakeholder decisions.

The meeting started with updates about MDIC and the program, followed by morning sessions led by FDA representatives highlighting the utility of the Medical Device Development Tools (MDDT) program in promoting innovation in medical device development and regulatory science to help bridge the gap between the research of medical devices and the delivery of devices to patients. Attendees also heard about the progress made through NESTcc initiative towards sustainable generation and use of timely, reliable, and cost-effective RWE throughout the total product lifecycle, using RWD. NESTcc’s Data Network Director Robert Zusterzeel also outlined the efforts made by NESTcc Data Quality and Methods Subcommittees towards developing data quality and methodological standards, design processes for demonstrating conformance to the standards, and recommendations for their implementation.

The morning concluded with a demonstration of one of the novel industry-FDA collaborative projects aimed at transforming the medical device innovation ecosystem with InSilico clinical trials and hearing ase studies focused on leveraging external data to generate evidence. Attendees were also able to learn how FDA and industry collaborated on a mock IDE submission sponsored by MDIC to augment a clinical study with Virtual Patient models. All resources related to this mock submission can be found here.

In the afternoon, the SMEs were split into four breakout sessions, as shown below – each group with equal distribution of FDA and industry members – and addressed different buckets of external data.

  1. Historical Clinical study data (US/OUS); Led by Chris Mullin (NAMSA)
  2. Registry Data; Led by Yun-Ling Xu (FDA)
  3. Modelling and Simulation; Led by Tarek Haddad (Medtronic)
  4. Admin Data (EHR, Claims etc.); Led by Ted Lystig (Medtronic)

The groups discussed characterizing data type (data quality; access; relevance), cataloging existing statistical methods that can be utilized (Frequentist/Bayesian), describing limitations of existing methods/data type, identifying areas where new methods need to be developed, and identifying examples for the use of external data as evidence.

Please follow MDIC’s EEM webpage for the latest updates.

March 30, 2019

MDIC released a Request for Information (RFI) on March 30, 2019. We are requesting technical information about available and possible approaches for creating a set of human cell lines that include all–or subsets of– specific variants. The variants were drawn from a larger list developed by the MDIC SRS working group and include clinically actionable oncogene variants as defined by (1) those that are included in companion diagnostic labels or described in NCCN guidelines (Level 1) or(2) variants included in registrational trials (Level 2). Please note that MDIC SRS is also interested to incorporate variants in tumor suppressor genes into a possible set of future reference samples.

The RFI is available for download in MDIC’s Resource Library.

A webinar will be held on Thursday, April 4 at 4:00 pm ET for Q&A on the RFI. For more information click here.

March 26, 2019

MDIC will release a Request for Information (RFI) on March 30, 2019. We are requesting technical information about available and possible approaches for creating a set of human cell lines that include all–or subsets of– specific variants. The variants were drawn from a larger list developed by the MDIC SRS working group and include clinically actionable oncogene variants as defined by (1) those that are included in companion diagnostic labels or described in NCCN guidelines (Level 1) or(2) variants included in registrational trials (Level 2). Please note that MDIC SRS is also interested to incorporate variants in tumor suppressor genes into a possible set of future reference samples.

The RFI will be available for download, on March 30 at 5:00pm in MDIC’s Resource Library.

A webinar will be held on Thursday, April 4 at 4:00 pm ET for Q&A on the RFI. For more information click here.

March 11, 2019

On March 6, 2019, MDIC released a Landscape Analysis report compiling all the currently available somatic variant reference samples for next-generation sequencing-based tests. This report, researched and assembled by MDIC’s Somatic Reference Samples Landscape Analysis working group, is a catalog of known SRS products for NGS-based oncology tests compiled in one resource, according to the same criteria, with links to more detailed information on the products. The authors grouped the SRS products first by format of the sample: synthetic DNA, genomic DNA, cell-free DNA, human cell line, and FFPE Then, for each SRS in that format,  they provide a description, references, genes and variants, the reference sample type/format, validation methods, a note on whether it’s publicly available, and a URL or contact information for additional details and information. The authors have removed all references to marketing claims, so this is an excellent source of need-to-know information without promotional language.

The Landscape Analysis report can found on the Resource Library.

Attending the American Association of Cancer Research Annual Meeting?

There will be an educational session held on March 30, from 3:15 – 5:15 in Room 402 – Georgia World CC.

Session: EDPOL04 – Cancer Genomic Reference Samples: MDIC Somatic Reference Sample Collaborative Initiative

More details available at: https://www.abstractsonline.com/pp8/#!/6812/session/29

February 25, 2019

Dr. Marc Horner, MDIC’s Blood Damage Modeling Working Group Chair, will discuss the Blood Damage Modeling project updates and future directions at the BMES/FDA Frontiers in Medical Devices Conference: The Role of Digital Evidence to Support Personalized Patient Healthcare on March 19-21, 2019 at the College Park Marriott Hotel and Conference Center at the University of Maryland.

This conference will provide a forum for participants involved in the development and evaluation of medical devices to meet and share their expertise, establish collaborations, and discuss strategies to effectively utilize computational modeling to support patient care and improve final outcomes.

MDIC’s Blood Damage Modeling Working Group was established in 2014 to explore the opportunity for computational modeling as a regulatory science tool to augment safety evidence for medical devices. The focus area of the Working Group is the in-silico evaluation of mechanical blood damage, specifically hemolysis, and thrombosis. The Working Group is comprised of computational modelers and experimentalists from FDA, medical device manufacturers, and nonprofits. The group working in close collaboration to generate data, develop and/or evaluate computational models using experimental systems that can assess and predict blood damage under a variety of conditions and to provide measures of precision and multi-laboratory reproducibility. MDIC’s Data Science & Technology Program Director, Dr. Jithesh Veetil, will be available at the conference to discuss various initiatives and opportunity for collaborations.

 

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February 21, 2019

The Medical Device Innovation Consortium (MDIC) is pleased to announce the addition of Doug Fridsma to the Board of Directors. Doug joins the Board to provide leadership for carrying out the Consortium’s mission to promote patient access to safe and effective medical technologies.

Doug Fridsma, MD, PhD, FACP, FACMI, is the President and Chief Executive Officer of AMIA, a $6.2 million 501 c (3) membership society representing 5400 professional and student informaticians and their interests and activities in academe, industry, government, and nonprofit organizations. AMIA’s sphere of influence focuses on both research and practice within the five primary informatics domains—translational bioinformatics, clinical research, consumer, public health and clinical informatics.

Dr. Fridsma is well-known in the informatics and healthcare community as an expert in informatics, interoperability, standards, and health IT (including meaningful use). His understanding of the science and application of informatics and experience as a practitioner and policymaker give him a depth of knowledge well-suited to the critical challenge of transforming health and health care.

Prior to joining AMIA, Dr. Fridsma was the Chief Science Officer for the Office of the National Coordinator for Health Information Technology, responsible for the portfolio of technical resources needed to support the meaningful use program and health information technology interoperability.  He was engaged in key initiatives involving the Federal Health Architecture; the Patient-Centered Outcomes Research Trust Fund (PCOR-TF) and the Standards and Implementation Framework.

Dr. Fridsma’s professional experience also includes academic appointments at the Arizona State University/University of Arizona, Department of Biomedical Informatics; the University of Arizona Medical School; the University of Pittsburgh, Department of Medicine and Department of Biomedical Informatics; and Stanford University Medical Center (Fellow, National Library of Medicine). His clinical practice was with the Mayo Clinic, Scottsdale, Arizona. He is also a published author with 25+ refereed articles, and 80+ conference papers, posters, presentations, talks and panels.

Dr. Fridsma received a Bachelor’s in Biomedical Sciences from the University of Michigan, and a Medical Doctorate degree in Internal Medicine from the University of Michigan School of Medicine—Inteflex. His Doctorate is in Biomedical Informatics from the Stanford University School of Medicine.

January 15, 2019

The Health Economics & Patient Access (HEPA) initiative launched last summer and began evaluating projects and focusing on tools to increase predictability of payer scientific and evidentiary requirements. Under the leadership of Liz Spurgin (Vice President, HEPA) and Andrew Greenfield (Vice President and General Manager, Abiomed) a steering committee of industry and regulatory members was formed to identify challenges and priorities.

Steering group member companies include Abbott, Abiomed, B Braun, BD, Baxter, Boston Scientific, Cook, CVRx, Edwards, Insulet, Integra Lifesciences, J&J, Medtronic, and Stryker. CMS is represented by MDIC board member, Tamara Syrek-Jensen and FDA by Katie O’Callaghan and other CDRH leaders. As the steering group explores collaborative efforts with CMS and private payers, MDIC industry group partners, AdvaMed and MDMA, are also engaged to ensure that HEPA projects will complement, not duplicate, their existing efforts.

At the first in-person steering group meeting in December, topics included CMS coverage updates, the CDRH Innovation agenda, and complementary MDIC efforts in Science of Patient Input (SOPI) and NESTcc. One of the first activities for 2019 will be a member survey to further define “pain points” with both CMS and private payer coverage processes. In the interim, please reach out to Liz Spurgin with any questions or to learn more about the initiative.

 

 

 

 

January 15, 2019

In 2018, MDIC supported CDRH’s Voluntary Medical Device Manufacturing and Product Quality Pilot Program which simplifies regulatory requirements for medical device manufacturers who practice and demonstrate mature quality practices.  As we’ve seen this pilot gain momentum throughout the past year, CDRH, MDIC, and CMMI aim to scale the pilot into a full program in 2019. At the Case for Quality (CfQ) forum in November, we discussed the future of the program and discussed one of the biggest challenges with this pilot: the name. Voluntary Medical Device Manufacturing and Product Quality Pilot is a long title for a program. The reality is that no one ever remembers it, and it doesn’t truly capture what this innovative program is about, and what it could be in the future.  With the opportunity for growth, we’re delighted to announce that the CDRH Voluntary Medical Device Manufacturing and Product Quality Pilot Program will be changing its name to the Case for Quality Voluntary Improvement Program (CFQ VIP) in 2019.

The MDIC Case for Quality Steering Committee launched a new working group in January that will guide the development of this expanded program. In addition, this name change will allow us to present this highly innovative and quality-focused program to stakeholders across the medical device ecosystem. By renaming the program, we believe that we will be better able to share with the ecosystem how a shift from a compliance mindset to an emphasis on quality provides better outcomes for the industry and patients.

Our next Case for Quality Forum is February 25, 2019 in San Diego, CA. At this first Forum of 2019, we’ll discuss the updates on the Case for Quality Voluntary Improvement Program, including regulatory incentives for 510K manufacturers. Visit MDIC’s events web page to register for the forum. Also, if you missed our final MDICx webinar on the pilot in December, the slides and video are now available here.