ICAN Biomarkers Council

The ICAN Biomarkers Council and Molecular Tumor Board

The ICAN Biomarkers Council was founded in 2011 as an extension of ICAN’s pioneering vision on the implementation of personalized medical care for individuals living with metastatic cancer.  During its formative years, molecular profiling of patient tumors was not yet a mainstream approach, mostly limited to major cancer centers and physicians familiar with cellular signaling processes.  In support of ICAN’s personalized patient efforts, the ICAN Biomarkers Council established and curated databases of molecular lesions associated with different cancer types, along with outcomes that associated with therapeutic treatment strategies, including the limited number of targeted therapies that were available at the time.  As the new paradigm of personalized medicine has become mainstream, most oncology teams now embrace molecular profiling and incorporate this into patient care strategies as predictive indicators.  Commercial and in-house molecular profiling reports now often include algorithmic suggestions on therapeutic benefits associated with specific biomarkers. 

The thought leaders and cutting-edge scientists from leading academic and industry groups on the Biomarkers Council excel in molecular and cellular diagnostics.  As scientific leaders in platform development, members provide ICAN with critical insights into current clinical applications of available molecular and cellular assays, as well as a vision of how the field is evolving and where it is heading.  Biomarker Council scientists have deep expertise across a broad spectrum of areas vital to cancer patient care including, but not limited to, personalized (precision) medicine, cancer biology, translational research, nucleic acids, next-generation sequencing, proteomics, transcriptomics, epigenetics, immunology, immune cell studies, signal transduction and systems biology, oncogene addiction, circulating tumor cells and free nucleic acids, exosomes, drug and targeted therapy development, companion diagnostics, metabolomics, glycomics and glycoproteomics, lipidomics, microbiomics, virology, pathology, radiology, and artificial intelligence.  In addition, the members also help ICAN develop relationships with the translational medicine, medical affairs, and clinical operations divisions in pharmaceutical and biotech companies, as well as make introductions to leaders in molecular profiling laboratories, academic medical centers, comprehensive cancer centers, cancer biologists, and molecular biologists involved in next-generation sequencing and novel platforms for use in tissue and liquid biopsies.

Biomarker Council leaders have been involved in important advocacy efforts for ICAN cancer patients.  These efforts include the adoption and implementation of whole genome sequencing (WGS) for late stage cancer patients—an effort that would open up the possibility of identifying therapeutic choices for those who have exhausted their options based on the limitations of current molecular diagnostics tests.

In the decade since our founding, the ICAN Biomarkers Council has grown into a global, world class molecular tumor advisory board under the auspices of our all-virtual Robert W. Reimer Biomarkers Center.  As of year-end 2020, membership included thought leaders and scientists from cutting edge academic and industry groups who generously offer their time and expertise while reviewing de-identified patient cases.  The Biomarkers Council provided ICAN with a deep understanding and critical analysis of molecular profiling platforms as well as an ongoing awareness of innovative and impactful targeted therapy and diagnostic programs.  Serving ICAN as the equivalent of a molecular tumor review board, the Biomarkers Council worked to apply its expertise across oncology, signal transduction, systems biology, tumor immunology, diagnostics, and other areas that are fundamental to understanding the mechanisms that drive individual tumor growth.  The Biomarkers Council continued throughout 2020 to expand--adding experts in new, innovative areas that enable us to broaden our expertise and impact cancer patient care.  We remain forward-looking, always seeking to bridge state of the art research with patient care, while simultaneously actively advocating for the implementation of powerful testing platforms such as whole genome/transcriptome sequencing that promise to improve patient outcomes.

1) Emphasis on Solid Tumor and Rare Molecular Subtype Cases:  As a result of the ongoing paradigm shift towards personalized cancer patient care, physicians and patients are increasingly familiar with, and reliant upon, molecular profiling to guide individualized therapeutic strategies.  As such, the Biomarkers Council is more focused on the most challenging of individual cases.  These include cases that are confounding in their presentation, cases that have progressed despite best treatment efforts, and cases which might benefit from the impact of more comprehensive molecular profiling tests such as WGS.  Throughout 2020, the Biomarkers Council strongly supported the Exon 20 Group at ICAN’s dedicated efforts to drive innovative programs that focus on underserved rare molecular subtypes, including EGFR and HER2 exon 20 insertion mutations.

The year 2020 saw an emphasis on Non Small Cell Lung Cancer (NSCLC)--EGFR-mutated cases and other NSCLC rare molecular subtypes—in addition to microsatellite stable colon cancer cases, glioblastoma cases, and rare cancer cases from the gynecologic area.  The majority of the solid tumor cases that came in for review had inadequate (or delayed) molecular profiling either on diagnosis or on diagnosis of metastasis. 

2) ICAN Biomarkers Council Membership and Leadership:  In addition to their molecular profiling expertise, many of the accomplished scientists and clinicians on the Biomarkers Council have impressive experience in biomarker discovery and application, early drug development, clinical development, translational medicine studies, medical affairs, clinical operations, and clinical trial design.

The ICAN Biomarkers Council is led by Founding Chairman, Scott M. Kahn, PhD, a pioneer in basic personalized medicine research and “oncogene addiction,” and a former two-decade Member of the Herbert Irving Comprehensive Cancer Center, Columbia University. Serving as Vice Chairmen are Eric J. Thompson, PhD, who helped establish molecular profiling norms in panel composition and data reporting as the founder of the evidence-based medicine group at Caris-MPI (now Caris Life Sciences), and Roger D. Klein, MD, JD, a leading authority on public policies related to the implementation of precision medicine and the current Chair of the Association for Molecular Pathology’s (AMP’s) Solid Tumors Division. 

Current members of the ICAN Biomarkers Council include:

Scott M. Kahn, PhD


Eric J. Thompson, PhD

Vice Chairman; Director, Molecular Profiling

Roger D. Klein, MD, JD

Vice Chairman, Senior Advisor, Molecular Pathology, Legal Issues

Viktor Adalsteinsson, PhD

Senior Advisor, Sequencing and Circulating Tumor Cells

Carl Barrett, PhD

Senior Advisor, Oncology

Shelly Blam, PhD

Senior Advisor, Cancer Biology

Chirantan Bose, PhD

Senior Advisor, Tumor Profiling

Neil Butters, PhD

Director, Biomarkers Literature Collation

Anton Buzdin, PhD

Senior Advisor, Genomics and Cellular Networks

Olli Carpen, MD, PhD

Senior Advisor, Pathology and Diagnostics

Berwyn Clarke, PhD

Senior Scientific Advisor, Genomics and Biomarkers

Barbara Clendenen, BSc, MSc

Senior Advisor, Institutional Review Board Issues

Margery Connelly, PhD, MBA

Senior Advisor, Biochemical Biomarkers

Dmitry N. Derkach MD, PhD

Senior Advisor, Genomic Screening

Charles DiComo, PhD

Senior Advisor, Prostate Cancer

Fernando Ferrer, MBA

International Pharmaceutical Outreach and Special Advisor,
ICAN-Latin America Patient Engagement Issues

Maria Fe Paz, MD

Senior Advisor, Molecular Diagnostics

Jessica Geahlen, PhD

Senior Advisor, Genomics and Gastrointestinal Cancer Issues

Laura Housman, MPH, MBA

Senior Advisor, Regulatory Issues

Jason (Gang) Jin, PhD

Senior Scientific Advisor, Genomics and Biomarkers

Minji Jo, PhD

Senior Advisor, Patient Advocacy

Ronald Jubin, PhD

Senior Scientific Advisor, Immunology and Cancer Virology

Boaz Kurtis, MD

Senior Advisor, Cancer Diagnostics

Zhongwu Lai, PhD

Senior Advisor, Targeted Therapies and Biomarkers

Han Liang, PhD

Senior Advisor, Personalized Medicine

Raja Luthra, PhD

Senior Advisor, Molecular Diagnostics

Kamala Kalyani Maddali, DVM, PhD

Senior Advisor, Molecular Diagnostics

Nupur Mehrotra, MBBS, PGD

Senior Advisor, Drug Development

Joshua Miller, PhD

Senior Advisor, Lung Cancer

LaVerne Mooney, DrPH

Senior Advisor, Epidemiology and Publications

Sethu Narayanan, PhD

Senior Advisor, Rare Malignancies

Stephen Naylor, PhD

Senior Advisor, Personalized Medicine

Takashi Niwa, MD

Senior Advisor, Lung Cancer, Japan

Oscar Puig, PhD

Senior Scientific Advisor, Translational Clinical Research 

Richa Rajwanshi, MD

Senior Advisor, Patient Safety

Vivek Rajwanshi, PhD

Senior Advisor, Medicinal Chemistry

David Richardson, BSE, PSM

Senior Advisor, Molecular profiling

Mathias Schulz, MD, MBA

Senior Advisor, Hematology

David Shames, PhD

Senior Advisor, Novel Therapeutics

Yu Shi, PhD

Senior Advisor, Tumor Microenvironment

Eve Shinbrot, PhD

Senior Advisor, Molecular Diagnostics

Linda Strause, PhD

Director, Biotechnology

Mike Thompson, MD, PhD

Senior Advisor, Rare Malignancies

Chip Van Sant, PhD

Senior Advisor, Predictive Biomarkers

Nic Waddell, PhD

Senior Advisor, Precision Analytics

Lei Wang, PhD

Senior Advisor, ImmunoOncology

Hans Winkler, PhD

Senior Advisor, Oncology Biomarkers

Shannon Winski, PhD

Senior Advisor, Translational Medicine

3) ICAN Participation at Conferences and Symposia: Biomarkers Council members are called upon to make presentations and serve as delegates on behalf of ICAN at major conferences and symposia.  The Biomarkers Council strives to maintain awareness of new developments that could impact ICAN’s Personalized Medicine Cancer Case Navigation Programs.  Oncology conferences are where major announcements are made that can herald a new standard of care, and in 2020 we leveraged our resources to ensure we are always up to date on cutting edge science in cancer care.

4) Public Policy and Advocacy: ICAN professional staff, ICAN board members, and selected members of the Biomarkers Council serve as legislative and public policy advocates, and in any given year, the organization can be dealing with dozens of state legislatures, Congress, federal and state regulators, and all others to protect patient access to the most effective therapies.  In 2020, we worked with patients, families, physicians, and researchers to prepare them to advocate on behalf of patient access issues. We partnered in numerous coalitions with our fellow scientists and clinicians, research advocates, patient advocates, and industry partners. 

ICAN has earned the reputation of being a top public policy organization, helping fend off attempts at the state legislative level that would restrict patient access to personalized medicine, and working, since 2012, on a campaign that has involved 49 states to secure prescriber communication on biosimilars. 

The Biomarkers Council represented ICAN on public policy and patient and public education issues including, but not limited to, access to oral chemotherapy drugs and biosimilars, personalized medicine and molecular diagnostic testing costs, coverage, and reimbursement, often providing expert testimony which supplemented ICAN patient and care partner testimony to various health committees of state legislatures.  On issues of mutual interest, Biomarkers Council members represented ICAN in a variety of capacities with outside entities.  This empowered Council members to impact not just one patient, but all patients who are affected by legislation and executive rule making.  The organization’s impact in this regard can help patients both locally and globally depending upon the issues at hand.

ICAN’s ongoing legislative initiatives around the country seek to protect patient rights, the physician-patient relationship, ensure patient safety, and provide access to cutting-edge treatments.  If legislation seeking to restrict patient-physician shared decision-making ultimately prevails, then the preclinical and clinical pipelines will suffer because patients will not have robust access either to profiling and sequencing or to novel therapeutics. 

State legislators are becoming increasingly taken with the concept of “step therapy” or “fail first therapy” in which patients are forced to “fail first” on one or more drugs before they are permitted to take the drugs that their doctors originally prescribed—often newer drugs with much better outcomes.  If patients are held hostage to decades-old systemic chemotherapy combinations—with 11 or 22 percent response rates—before they can access a targeted therapy, they may be too debilitated to agree to tissue profiling of a metastatic site when they really need to know if they have a new actionable gene alteration or actionable protein expression.  The patient and healthcare provider education work we are doing at the state and federal levels by urging unfettered patient access to novel therapeutics directly supports the treatment centers, clinics, and labs that are on the forefront of medicine.

ICAN has also played a very active role in advocating for patient protections as states across the country begin to regulate biosimilars.  ICAN was integrally involved in advocating for biologics and biosimilars prescriber communication which involves requiring that pharmacists who dispense biosimilars or interchangeable biological products inform the doctor and the patient that a substitution for a name-brand biologic has been made.  ICAN has been a key participant in the efforts--at the national leadership level along with several other patient organizations--that by year-end 2019, had led to patient protections passing in 49 states. 

5) Outcome Metrics: ICAN’s CEO and members of the ICAN Strategic Planning Committee, supported by the Biomarkers Council, continued to consider the issue of patient-reported outcomes (PROs) as well as measuring time to progression, progression free survival, quality of life, and overall survival in the context of ICAN patient cases and cancer cases in general.

6) Assisting ICAN’s In-Kind Support: Where appropriate, Biomarkers Council members assisted in obtaining professional memberships, complimentary subscriptions, or complimentary/reduced price registration at important symposia and conferences.  This eases the financial burden on ICAN and serves to augment ICAN's Personalized Medicine Cancer Case Navigation Programs by enhancing the organization's information resources and professional outreach.

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