Saturday, March 29, 2014 7:30am - 6:00pm

New York Head & Neck Institute Head & Neck Endocrine Symposium: Molecular Diagnostics: A New Era in the Management of Thyroid Nodules A CME Conference designated for 8.75 AMA PRA Category 1 Credits™

Lenox Hill Hospital, Einhorn Auditorium 130 E. 77th Street, New York, NY 10075

Dear Colleagues: On behalf of the New York Head & Neck Institute, part of North Shore-LIJ Health System, we enthusiastically invite you to attend our first Head & Neck Endocrine symposium on “Molecular Diagnostics for the Management of Thyroid Nodules: A New Era.” This CME event will occur on Saturday, March 29th, 2014 at Lenox Hill Hospital in New York. The detection of thyroid nodules and well-differentiated thyroid cancer has increased at an alarming rate. Nearly 30% of FNABs for thyroid nodules result in an “indeterminate” diagnosis and create a diagnostic and treatment dilemma for patients and clinicians. Some patients will repeat a biopsy without benefit. Approximately 75% of patients undergoing a diagnostic lobectomy for indeterminate nodules are unnecessarily subjected to the risk of surgical complications and life-long thyroid hormone replacement for benign disease; others are subPeter D. Costantino, jected to completion thyroidectomy when the first operation could have been MD, FACS their last. Molecular diagnostics will have a major impact on treatment planning for thyroid nodules that elude a definitive diagnosis via traditional cytology, eliminating nearly 50% of diagnostic thyroidectomies and completions. The predictive value, reliability, and cost of these tests have generated much excitement, confusion and debate. This event is intended to provide state-of-the art knowledge and practical expertise from a multidisciplinary panel of experts in this rapidly evolving field. The New York Head & Neck Institute and its faculty are honored to host three keynote speakers. • Yuri Nikiforov, MD
University of Pittsburgh, Pennsylvania • Bryan McIver, MD Moffitt Cancer Center, Tampa Florida • James A. Fagin, MD Memorial Sloan Kettering Cancer Center, New York Daniel B. Kuriloff, MD, FACS

I hope that you can spend the day with us in New York to attend this important update on state-of-the-art management of thyroid nodules and the role of molecular genomic testing. Sincerely,

Peter D. Costantino, MD, FACS

Daniel B. Kuriloff, M.D, FACS

Executive Director, New York Head & Neck Institute

Director, Center for Thyroid & Parathyroid Surgery New York Head & Neck Institute, Lenox Hill Hospital

Senior Vice-President, Otolaryngology and Head & Neck Surgery Service Line, North Shore-LIJ Health System 2

Course Director Daniel B. Kuriloff, MD, FACS Director, Center for Thyroid & Parathyroid Surgery New York Head & Neck Institute Lenox Hill Hospital

Guest Faculty James A. Fagin, MD

Yuri Nikiforov, MD

Bryan McIver, MD

Elana Opher, MD

Chief, Endocrine Services Memorial Sloan-Kettering Cancer Center

Vice Chair; Department of Pathology Division Director, Molecular & Genomic Pathology University of Pittsburgh

Program Leader in Endocrine Malignancy, Moffitt Cancer Center

Chief, Cytopathology Service Lenox Hill Hospital

Edward Merker, MD

Madeline Vazquez, MD

Director, Division of Endocrine Pathology & Integrated Diagnostics Chief, Cytopathology, CBLPath

Interim Director of Endocrinology, Lenox Hill Hospital

New York Head & Neck Institute Faculty Sanford Dubner, MD

Section Director, Head & Neck Long Island Jewish Medical Center Clinical Assistant Professor, Hofstra North Shore-LIJ School of Medicine

Gady Har-El, MD

Dennis Harry Kraus, MD

Director, Center for Head & Neck Oncology, New York Head & Neck Institute and North Shore-LIJ Cancer Institute Co-Director, Center for Thyroid & Parathyroid, New York Head & Neck Institute

Director, Head & Neck Surgical Oncology, New York Head & Neck Institute Associate Director, Brooklyn, Otolaryngology – Head & Neck Surgery Service Line

Daniel B. Kuriloff, MD

David Henry Hiltzik, MD

Jessica Wong Lim, MD

Director, Division of Otolaryngology – Head & Neck Surgery Staten Island University Hospital Assistant Clinical Professor in the Department of Otolaryngology – Head & Neck Surgery at Columbia College of Physicians

Director, Center for Thyroid & Parathyroid Surgery, New York Head & Neck Institute Lenox Hill Hospital Site Director, Otolaryngology Residency Program, Lenox Hill Hospital

Benjamin Eli Saltman, MD

Assistant Professor, Hofstra North Shore-LIJ School of Medicine

Arnold Komisar, MD Medical Director, Lenox Hill Hospital

Conference Planning Committee Daniel Kuriloff, MD FACS

Gerren Faustini

David Zeman

Conference Coordinated By Sumon Saha Practice Secretarial Associate, New York Head & Neck Institute 3

New York Head & Neck Institute Head & Neck Endocrine Symposium: Molecular Diagnostics: A New Era in the Management of Thyroid Nodules Program of the Day | Saturday, March 29, 2014 • 7:30am - 6:00pm

7:30 am Registration and Continental Breakfast 8:00 am Welcome and Opening Remarks Daniel B. Kuriloff, MD 8:05 am Detection & Over-Detection of Thyroid Nodules: A New Epidemic Jessica Wong Lim, MD 8:25 am Evidenced-based Ultrasonographic Characteristics of Thyroid Nodules Predictive of Malignancy & Patient Risk Factors to Triage for USGFNAB Versus Observation Daniel B. Kuriloff, MD 8:50 am Difficulties in the Cytologic Interpretation of Thyroid Nodules and Limitations of the current Bethesda Classification System: Predicting the “pre-test” Risk of Cancer in Indeterminate & Suspicious Thyroid Nodules (Bethesda Categories III-V) Elana Opher, MD 9:15 am Role of Immunohistochemistry & Somatic Mutations in the Cytologic Diagnosis of Thyroid Nodules: Minimizing indeterminate Cytologic Interpretations & Challenges with Thyroiditis Madeline Vazquez, MD 9:40 am Coffee Break 10:00 am An Overview of the Genetics and Biology of Thyroid Cancer & Update on the TCGA (The Cancer Genome Atlas) NCI Studies of Whole Exome & Transcriptome Sequencing of 500 Papillary Thyroid Carcinomas James A. Fagin, MD

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10:30 am Understanding Molecular Genetics for Targeted Therapies in Advanced and Recurrent Radio-iodine Refractory Thyroid Cancer James A. Fagin, MD 11:00 am Targeted Next-Generation DNA Sequencing Panel, “ThyroSeq” based on Multiple Known & New Markers for the Diagnosis and Treatment of Patients with Thyroid Cancer Yuri Nikiforov, MD 11:30 am The Utility of Genomic Molecular Testing in FNA Samples in Predicting Thyroid Cancer, Tumor Biology, Cancer Recurrence and Its Potential Role in Individualized Treatment Planning. Can we rely on the BRAF V600E Mutation? Yuri Nikiforov, MD 12:00 pm Lunch Break 12:45 pm Comprehensive Review: Clinical Utility of the AFIRMA® Gene Expression Classifier in Managing the Indeterminate Thyroid Nodule (Bethesda Categories III & IV) Bryan McIver, MD 1:15 pm Imprecision and Inter-Observer Variability in the Cytologic Classification of Thyroid Nodules: The Pre-test Probability of Malignancy with its Potential Impact on the Real-World Negative Predictive Value of the AFIRMA® Gene Expression Classifier. Are we still testing the test? Bryan McIver, MD 1:45 pm Comparison of Commercially Available Molecular Genomic Testing of Thyroid Nodules & their Real-World Utility Yuri Nikiforov, MD

For information visit online nynhi.org or call (516) 465-3CME (3263)

New York Head & Neck Institute Head & Neck Endocrine Symposium: Molecular Diagnostics: A New Era in the Management of Thyroid Nodules Program of the Day | Saturday, March 29, 2014 • 7:30am - 6:00pm

2:05 pm Understanding Positive & Negative Predictive Values, Accuracy & Test Validation as it Applies to Commercially Available Molecular Tests Bryan McIver, MD 2:25 pm Current NCCN/ATA Practice Guidelines for Molecular Diagnostic Testing of Thyroid Nodules: Practical Considerations, Insurance Participation, Patient Incurred Costs & Problems with Exclusive use of “Texas Cytology Partners”: Decision Making for the Endocrinologist Edward Merker, MD 2:45 pm Pearls and Pitfalls in Office Based Ultrasound Guided Fine Needle Aspiration Biopsy: Deciding when to do the AFIRMA® GEC Up Front Versus Standard Cytology, Immunohistochemistry & Gene Mutation Panels Daniel B. Kuriloff, MD 3:10 pm Coffee Break 3:25 pm Is the Use of Molecular Diagnostics a Cost Effective Approach for the Evaluation of Thyroid Nodules in General? Arnold Komisar, MD 3:45 pm AFIRMA® “Suspicious” Nodules and Surgical Decision Making Sanford Dubner, MD

4:05 pm Controversies in Elective and Therapeutic Management of Lymph Node Metastases in Well-Differentiated Thyroid Carcinoma Dennis Harry Kraus, MD 4:25 pm Case Presentations & Panel Discussion 1: Challenging Cytologic Interpretations & How Immunohistochemistry and Molecular Diagnostics Saved the Day Gady Har-El, MD (Moderator), David Hiltzik, MD, Madeline Vazquez, MD, and Elana Opher, MD 5:00 pm Case Presentations & Panel Discussion 2: A Rational Approach to Patient Management Using Molecular Diagnostics. Routine “Regional Cytology” with Immunohistochemistry may be more Cost Effective with Reflex to Molecular Diagnostics if Indeterminate/Suspicious Cytology (Bethesda Categories III & IV) Bryan McIver, MD (Moderator), Yuri Nikiforov, MD, Edward Merker, MD, Benjamin Eli Saltman, MD and Madeline Vazquez, MD 5:35 pm The Future of Molecular Diagnostics: Next Generation Sequencing & Micro RNA Expression Profiles, Audience Participation for Questions and Answers Yuri Nikiforov, MD (Moderator), Bryan McIver, MD and James A. Fagin, MD 6:00 pm Adjourn

Symposium Sponsor: Platinum Level - CBLPath

For information visit online nynhi.org or call (516) 465-3CME (3263)

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Statement of Need: Positive patient outcomes rely on clinicians’ awareness of available diagnostic tools, treatment options and the optimal use of current technology. As new technologies evolve it is imperative to keep physicians updated. Knowledge gaps exist regarding a lack of awareness of newly introduced diagnostic criteria to triage thyroid nodules for biopsy, use of state-of-the-art molecular genomic testing of FNA specimens for indeterminate cytology, and the utility and differences between available gene expression classifiers, gene mutation panels, and evolving next generation gene sequencing technologies. Program Objectives: All North Shore-LIJ Health System CME activities are intended to improve patient care, safety and outcomes. At the conclusion of this symposium, participants should be able to: ■ DISCUSS the role of ultrasonographic triage of thyroid nodules for FNA versus observation based on current guidelines. ■ DISCUSS the differences between rule-in and rule-out tests for benignity & malignancy based on negative and positive predictive values. ■ SUMMARIZE the indications and limitations of the Afirma® Gene Expression Classifier for indeterminate thyroid nodules (Bethesda Categories III/IV). ■ DESCRIBE the limitations of gene mutation panels for indeterminate & suspicious thyroid nodules and their potential role in selecting the extent of thyroidectomy and lymph node dissection for tailored treatment planning and follow-up strategies. ■ DISCUSS the differences between analytically validated and clinically validated tests based on regional variations in pretest population malignancy risks. ■ SUMMARIZE and compare the cost-effectiveness of various diagnostic approaches incorporating molecular genomic testing for the initial evaluation of thyroid nodules. ■ DISCUSS research and the clinical utility of a thyroid cancer next-generation gene sequencing panel called “ThyroSeq” currently being offered by the MGP laboratory at the University of Pittsburgh Medical Center that will impact clinical management and create new standards of care in the future. Target Audience: Physicians and allied health professionals involved in the care of patients with thyroid nodules and thyroid cancer. Internists, Endocrinologists, Physician Assistants, Nurse Practitioners, Pathologists, Cytopathologists, Ultrasonographers, Radiologists and Nuclear Medicine physicians are all intended participants. CME Accreditation: North Shore-LIJ Health System is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Credit Designation: North Shore-LIJ Health System designates this live activity for a maximum of 8.75 AMA PRA Category 1 credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity. Verification of Attendance Will be available to provide all professionals attending the conference via the CME tracker database. Location: Lenox Hill Hospital, Einhorn Auditorium, 130 E. 77th Street, New York, NY 10075. Registration Fee: $225 for all attending MD’s $125 for all Allied Healthcare personnel $65 for all residents, fellows and medical students Faculty Disclosure Policy: North Shore-LIJ Health System adheres to the ACCME’s New Standards for Commercial Support. Any individuals in a position to control the content of a CME activity, including faculty, planners and managers are required to disclose all financial relationships with commercial interests. All identified potential conflicts of interest are thoroughly vetted by North Shore-LIJ for fair balance and scientific objectivity and to ensure appropriateness of patient care recommendations. Cancellation Policy: All cancellations must be confirmed in writing to the Office of Continuing Medical Education by Friday, March 21, 2014. An administrative fee of $25 will be retained. No refunds after this date, or for “no shows”. Americans with Disabilities Act: This conference is in compliance with provisions of the Americans with Disabilities Act (ADA) and is accessible for individuals with special needs. If you would like to attend this conference and require any special needs or accommodations, please contact the Office of CME at (516) 465-3263. 6

New York Head & Neck Institute Head & Neck Endocrine Symposium: Molecular Diagnostics: A New Era in the Management of Thyroid Nodules Program of the Day | Saturday, March 29, 2014 • 7:30am - 6:00pm

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For information visit online or call (516) 465-3CME (3263).

Saturday, March 29, 2014 • 7:30am - 6:00pm

Head & Neck Symposium: Molecular Diagnostics: A New Era in the Management of Thyroid Nodules

New York Head & Neck Institute Lenox Hill Hospital Einhorn Auditorium 130 E. 77th Street New York NY 10075

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