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ClinGen Somatic Cancer and VICC Virtual Molecular Tumor Board Case Series
Monday, October 18, 2022
3:00 - 4:00pm ET
www.acmgeducation.net
Course Description
Dr. Michael Pishvaian from Johns Hopkins University presents “Not all BRCA mutations respond to platinums the same”. Variants in the BRCA1 and BRCA2 genes have been widely associated with sensitivity to platinum therapies in many cancer types, including pancreatic cancer as seen in this case presentation. As genomic testing has become more accessible and corresponding clinical research has evolved, we have learned more about how variants within BRCA1 and BRCA2 correspond to sensitivity to platinum therapy. Not all BRCA variants confer the same therapeutic response. Register to participate in this exciting session to learn more.
Target Audience
All medical and healthcare professionals and researchers interested in understanding cancer genomic testing and somatic and germline variant interpretation methods. This series is presented as a collaboration between ClinGen Somatic, VICC, and ACMG consortia.
Agenda
Presentation followed by live Q&A.
Learning Objectives
At the conclusion of this session, participants should be able to:
- Describe the genomic testing methods used to detect genomic variants in this case.
- List the resources used to interpret the variant(s) observed.
- Explain the features of the BRCA1/2 variants that confer sensitivity to platinum therapy.
Moderator:
Gordana Raca, MD, PhD, FACMG (moderator)
Children’s Hospital of Los Angeles
Director, Clinical Cytogenomics Laboratory, Center for Personalized Medicine (CPM)
Associate Professor of Clinical Pathology, Keck School of Medicine of USC
Presenter(s):
Michael Pishvaian, MD, PhD
Director of Gastrointestinal, Developmental Therapeutics, and Clinical Research Programs; Associate Professor of Oncology, Johns Hopkins University
Dr. Pishvaian is a gastrointestinal cancer specialist with expertise in targeted therapies for patients with advanced colorectal and pancreatic tumors. He received a Ph.D. in tumor biology and completed medical school at Georgetown University, where he also completed an internship and residency in internal medicine and a fellowship in hematology and oncology. His research has focused on detecting novel biomarkers for therapeutic prediction and the development of new therapies for gastrointestinal cancers – specifically studying DNA damage response and repair (DDR) and resistance to PARP inhibitors in pancreatic cancers. The results of Dr. Pishvaian’s research has aided in the understanding of best practices in patient testing strategies for pancreatic cancers.
Jonathan Brody, PhD
Research Professor
Vice Chair of Research Dept. of Surgery
Cell, Developmental and Cancer Biology
Associate Director for the Brenden-Colson Center for Pancreatic Care
Oregon Health & Science University
Dr. Jonathan Brody is the Vice Chair of Research for the Dept. of Surgery and is the Associate Director of Translational Research of the Brenden-Colson Pancreatic Center for Patient Care. He was a member and co-leader of the GI Cancer Program at the Sidney Kimmel Cancer Center (Thomas Jefferson University 2006-2020). Dr. Brody received his Ph.D. from The Johns Hopkins University School of Medicine, and his thesis specialized in studying the molecular aspects of cancer and cancer genetics. He patented, with Dr. Scott Kern, novel buffers for DNA identification (DNA electrophoresis buffer), that have changed the format of this molecular biology technique used to detect DNA. He was elected Chair of the Cancer Research Program (PRCRP), Department of Defense council and serves on many international study sections, including currently being the Chair of the Tumor Biology and Genomics study section for the American Cancer Society and a permanent member of the Cancer Prevention Study Section NCI study section panel. He has published over 135 peer review publications in many top tier scientific and cancer journals. Additionally, he was an American Cancer Society Research Scholar, is NIH (NCI, R01) funded, and won the American Association of Cancer Research, Pancreatic Cancer Career Development Award in 2010.
Financial Disclosures
Disclosure Statement
It is the policy of the American College of Medical Genetics and Genomics to plan and implement all of its educational activities in accordance with the ACCME Essentials and Areas and ACCME® Policies to ensure balance, independence, objectivity and scientific rigor. In accordance with the ACCME® Standards for Commercial Support, everyone (speakers, moderators, committee members and staff) who is in a position to control the content of an educational activity certified for AMA PRA Category 1 Credit™ is required to disclose all financial relationships with any commercial interests (see definition below) within the past 12 months that creates a real or apparent conflict of interest. Disclosure must include financial relationships of the individual and those of their spouse/partner. Individuals who do not disclose will be disqualified from participating in a CME activity.
This disclosure pertains to relationships with ACCME-defined commercial interests whose products or services may be related to the subject matter of the presentation topic. Any real or apparent conflicts of interest related to the content of the presentations must be managed prior to the educational activity. ACMG will identify, review and resolve all conflicts of interests prior to an educational activity being delivered to learners.
NOTE:
ACMG will follow the ACCME’s expectation that no employees or owners of commercial interests will be involved as planners/faculty/presenters of a CME accredited activity.
The ACCME definition of a commercial interest is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.
The ACCME does not consider providers of clinical service directly to patients to be commercial interests - unless the provider of clinical service is owned, or controlled by, an ACCME-defined commercial interest.
Diagnostic laboratories are not considered commercial interests unless they are owned by or have a sister organization which is a commercial interest.
Planning Committee and ACMG Staff*
The following have nothing to disclose.
Beth Pitel, MS, CG(ASCP)
Manuela Benary, PhD
Gordana Raca, MD, PhD, FACMG
Jason Saliba, PhD
Alex Wagner, PhD
*Maximilian Muenke, MD, FACMG
*Jane Radford, MHA, CHCP
The following reported disclosures and none are relevant to the content of this session. All of the relevant financial relationships listed for these individuals have been mitigated.
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Faculty
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Company Name
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Role
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Michael Pishvaian, MD, PhD
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Merck, Astra Zeneca, Novartis, Pfizer, Seattle Genetics, Arcus Bio, GSK, Perthera.
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Advisory Board, Advisory Board, Consulting, Consulting, Institutional Funding, Institutional Funding, Institutional Funding, Stock
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Jonathan Brody, PhD
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Perthera, COSE BIO, Faster Better Media, LLC.
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Advisory Board, Sponsored Research Agreement, Co-owner
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Educational Credit
Accreditation Statement
The American College of Medical Genetics and Genomics is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
Designation Statement
The American College of Medical Genetics and Genomics designates this live activity for a maximum of 1 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Claiming your Educational Credits
Complete the activity and carefully complete the evaluation form. Deadline to claim educational credits is within 30 days from the date of the webinar. ACMG will not accept any credit request for live meetings after that period.
CME Policies and Procedures
It is the policy of the American College of Medical Genetics and Genomics to plan and implement all of its educational activities in accordance with the ACCME® Policies to ensure balance, independence, objectivity and scientific rigor. In accordance with the ACCME® Standards for Integrity and Independence in Accredited Continuing Education, everyone (speakers, moderators, platform presenters, presenting authors, committee members, and staff) who is in a position to control the content of an educational activity certified for AMA PRA Category 1 Credit™ is required to disclose all financial relationships with any commercial interests (see definition below) within the past 24 months that creates a real or apparent conflict of interest.
Individuals with potential for influence or control of CME content include:
- planners, planning committee members, staff
- submitters and first authors
- presenters, teachers
- educational activity directors
- educational partners
- others who participate, e.g., facilitators and moderators
This disclosure pertains to relationships with ACCME-defined Ineligible companies. (Definition of ineligible company: Those whose primary business is producing, marketing, selling, reselling, or distributing healthcare products used by or on patients.) Financial relationships are relevant if the following three conditions are met for the individual who will control content of the education:
- Financial relationship, in any amount, exists between the person in control of content and an ineligible company.
- The financial relationship existed during the past 24 months.
- The content of the education is related to the products of an ineligible company with whom the person has a financial relationship.
ACMG’s POLICY AND PROCEDURE FOR IDENTIFYING AND RESOLVING
CONFLICTS OF INTEREST FOR CME EDUCATIONAL ACTIVITIES
The ACCME® Standards for Integrity and Independence in Accredited Continuing Education describe five standards: (1) Ensure Content is Valid, (2) Prevent Commercial Bias and Marketing in Accredited Continuing Education, (3) Identify, Mitigate, and Disclose Relevant Financial Relationships, (4) Manage Commercial Support Appropriately, (5) Manage Ancillary Activities Offered in Conjunction with Accredited Continuing Education.
The Standards are designed to:
- Ensure that accredited continuing education serves the needs of patients and the public.
- Present learners with only accurate, balanced, scientifically justified recommendations.
- Assure healthcare professionals and teams that they can trust accredited continuing education to help them deliver safe, effective, cost-effective, compassionate care that is based on best practice and evidence.
- Create a clear, unbridgeable separation between accredited continuing education and marketing and sales.
The purpose of this policy is twofold: [1] Prevent Commercial Bias and Marketing in Accredited Continuing Education as required in Standard 2, and [2] Identify, Mitigate, and Disclose Relevant Financial Relationships required in Standard 3.
Regardless of role, disclosure forms for speakers, moderators, all presenting authors, program committee and staff participating in a CME activity will be collected and reviewed.
Content Validation and Fair Balance
1. ACMG follows the ACCME policy on Content Validation for CME activities, which requires:
a) All recommendations involving clinical medicine must be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients.
b) All scientific research referred to, reported or used in CME in support or justification of patient care recommendations must conform to the generally accepted standards of experimental design, data collection and analysis.
2. Activities that fall outside the definition of CME/CE; “Educational activities that serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships that a physician uses to provide services for patients, the public, or the profession” (source: ACCME and AMA) will not be certified for credit. CME activities that promote recommendations, treatment, or manners of practicing medicine or pharmacy that are not within the definition of CME/CE or, are known to have risks or dangers that outweigh the benefits or, are known to be ineffective in the treatment of patients.
3. Presentations and CME/CE activity materials must give a balanced view of therapeutic options; use of generic names will contribute to this impartiality. If the CME/CE educational materials or content includes trade names, where available, trade names from several companies must be used.
HIPAA Compliance by Faculty
The American College of Medical Genetics and Genomics ("ACMG") supports medical information privacy. While the ACMG is not a "covered entity" under the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") and its implementing regulations (the "HIPAA Privacy Rules") and, therefore, is not required to meet the standards set forth in the HIPAA Privacy Rules, ACMG takes reasonable steps to attempt to ensure that any presentation of individually-identifiable health information at ACMG-sponsored events has been properly authorized.
Each presenter must acknowledge and sign the Verification of HIPAA Authorization Form prior to the presentation.
Disclaimer
ACMG educational programs are designed primarily as an educational tool for healthcare providers who wish to increase their understanding of the application of genomic technologies to patient care. The ACMG does not endorse or recommend the use of this educational program to make patient diagnoses, particular by individuals not trained in medical genetics. Adherence to the information provided in these programs does not necessarily ensure a successful diagnostic outcome. The program should not be considered inclusive of all proper procedures and or exclusive of other procedures and that are reasonably directed at obtaining the same results. In determining the propriety of any specific procedure or, a healthcare provider should apply his or her own professional judgment to the specific clinical circumstances presented by the individual patient or specimen.
Questions regarding CE credit should be directed to education@acmg.net