• A comprehensive, three-day, advanced-level review course of the what specifically, a pharmaceutical or diagnostic/laboratory testing company’s medical & marketing functions’ executives and other executives should know in order to optimally develop and commercialize their anti-cancer drugs or molecular diagnostic tests
  • An ideal "immersion" preceptorship for experienced pharmaceutical or diagnostic company executives who are relatively new to oncology/hematology
  • This Master Class is also an excellent comprehensive review for experienced pharmaceutical executives
  • Taught by the true experts in oncology/hematology: experts in academic medical oncology/hematology, and also by the leaders in the essential ancillary areas of oncology/hematology professions such as reimbursement, pathways, clinical trial design, etc.

Dara L. Aisner, MD, PhD
Assistant Professor
Department of Pathology
Co-Director of the Colorado Molecular Correlates Laboratory
University of Colorado School of Medicine
University of Colorado Cancer Center
Denver, CO

Joseph S. Bailes, MD
Medical Oncologist
Texas Oncology, PA (TOPA)
Frisco, TX
Previous key positions affiliated with the American Society of Clinical Oncology, including President, Interim CEO, and Chair of the US Government Relations Council

Ethan Basch, MD, MSc
Professor, Heath Policy and Management
Director, Cancer Outcomes Research Program
Lineberger Cancer Center
Associate Professor, Hematology and Oncology
University of North Carolina
Chapel Hill, NC

Paul A. Bunn, Jr., MD
Distinguished Professor
Division of Medical Oncology
University of Colorado Denver
James Dudley Chair in Lung Cancer Research, Denver, CO
Past President of the American Society of Clinical Oncology,
Past Executive Director of the International Association for the Study of Lung Cancer

Suzanne Dahlberg, PhD
Senior Research Scientist
Biostatistics and Computational Biology
Harvard Medical School
Dana-Farber Cancer Institute
Boston, MA

Marianne J. Davies, DNP, MSN, RN, APRN, CNS-BC, ACNP-BC, AOCNP
Assistant Professor of Nursing
Division of Acute Care/Health Systems
Thoracic Oncology Program
Yale School of Nursing
Yale Cancer Center
New Haven, CT

John Fox, MD, MHA
Senior Medical Director
Priority Health
Grand Rapids, MI

Edward S. Kim, MD
Chair of Solid Tumor Oncology
Investigational Therapeutics
Levine Cancer Institute of the
Carolina's Heath Care System
Charlotte, NC

Jim Koeller, MS
Professor
University of Texas at Austin
College of Pharmacy
Pharmacotherapy Division
Adjoint Professor
University of Texas Health Science Center at San Antonio
School of Medicine
Pharmacotherapy Education & Research Center
San Antonio, TX

Rogerio C. Lilenbaum, MD
Professor of Medicine
Yale School of Medicine
Chief Medical Officer
Smilow Cancer Center
West Haven, CT

Stephen G. Madison
President and CEO
Oncology Learning Center, Inc., and the
BioMedical Learning Institute
Plano, TX

Jeffrey F. Patton, MD
Chief Executive Officer
Tennessee Oncology
Nashville, TN

Blase Polite, MD
Assistant Professor of Medicine
University of Chicago Medicine
Center for Clinical Cancer Genetics and Global Health
Chicago, IL

Suresh Ramalingam, MD
Professor of Hematology/Oncology
Deputy Director
Winship Cancer Institute
Director, Lung Cancer Program
Winship Cancer Institute
Assistant Dean for Cancer Research
Co-Leader, Discovery & Developmental Therapeutics Program
Emory University
Atlanta, GA

Scott Ramsey, MD, PhD
Full Member,
Cancer Prevention Research Program,
Fred Hutchinson Cancer Research Center
Director,
Hutchinson Institute for Cancer Outcomes Research (HICOR)
Seattle, WA

Mary Redman, PhD
Assistant Member, Cancer Prevention
Fred Hutchison Cancer Research Center
Seattle, WA
Statistician,
Southwestern Oncology Group (SWOG)

David Stewart, MD, FRCPC
Chief and Head,
Division of Medical Oncology
University of Ottawa
Ottawa Hospital
Ottawa, ON
CANADA

Guneet Walia, PhD
Sr. Director, Research and Medical Affairs
Bonnie J. Addario Lung Cancer Foundation
San Carlos, CA

H. Jack West, MD
Medical Director, Thoracic Oncology Program
Swedish Cancer Institute
President and CEO
Global Resource for Advancing Cancer Education
Seattle, WA

 
130
130
Class is sold out. We are accepting wait list registrations only. We expect a small number of last-minute cancellations so do not be hesitant to put yourself on the wait list.

Day 1 - October 19, 2016
11:00AM
CHECK-IN FOR PRE-REGISTRANTS
Seating is limited for optimal faculty/audience interaction. Registration will close at 90 participants. Reaching 90 is expected to occur. A waiting list will be developed, if necessary.
12:00PM
INTRODUCTION, OBJECTIVES & CME/CE PRE-TEST
Steve Madison

  • The 90 participants will be able to engage the faculty throughout the entire three-day program via the use of their "smart devices:" -- any Wi-Fi enabled devices: (iPads, Tablets, iPhones, Androids, Laptops, etc.) connected to our internal Master Class private network for asking queued-up questions of the faculty at any time. Questions will be addressed during the numerous Q&A/Panel Discussions.

12:20PM
CLINICAL TRIALS for CANCER THERAPIES: How and Why Are Cancer Clinical Trials So Different from Other Therapeutic Areas?
Paul Bunn
  • How are cancer drug trials evolving?
  • Why does the FDA accept Phase 2 Trials for oncology/hematology registration?
  • What are some of the most important differences from other therapeutic areas, e.g., using companion diagnostics and Master Protocols for oncology/hematology? And more.....
12:40PM
Q & A
12:50PM
EFFICACY ENDPOINTS: The Significance of the Current and Evolving Clinical Endpoints for Evaluating Cancer Clinical Data Trials
Mary Redman
  • What do most oncologists/hematologists need to better understand about today’s cancer trial endpoints?
  • A review of the clinical endpoints that are very specific to oncology/hematology, e.g., waterfall plots, spider plots, scatter diagrams, etc.
  • What new endpoints are being embraced by the FDA for oncology/hematology?
1:10PM
PATIENT REPORTED OUTCOMES AS A CANCER TRIAL ENDPOINT
Ethan Basch
  • Interest is burgeoning to integrate systematic collection of symptoms from patients during routine cancer clinical care.
  • Patient-reported outcomes (PROs) are reflections of how patients feel and function and are measured via questionnaires.
  • Multiple studies have been conducted that tested whether it is feasible to integrate PROs into routine cancer care (it is), and whether outcomes are improved as a result (they are).
1:30PM
Q & A AND PANEL DISCUSSION
2:00PM
FDA APPROVALS IN THE NEW ERA OF MOLECULAR ONCOLOGY
Suzanne Dahlberg
  • How is FDA changing its evaluation and expectations based on larger results in smaller populations?
  • Which randomized phase III trial designs may or may not be feasible in the future?
  • What is the current state of and future of companion diagnostics and patient enriched populations for FDA approvals?
2:35PM
Q & A AND PANEL DISCUSSION
2:45PM
BREAK
3:00PM
DRUG DEVELOPMENT AND TRIAL OVERSIGHT: Is there a better way?
David Stewart
  • What are the biology-defined subgroups for targeted therapies?
  • Hyper-protection of patients?
  • Well-meaning but excessive regulation?
  • Bigger differences observed in smaller trials?
  • CROs and the incentive to generate extra work
  • Is there a better model?
3:25PM
Q & A AND PANEL DISCUSSION
3:40PM
MOLECULAR AND NEXT GENERATION SEQUENCING (NGS) DIAGNOSTICS: Their increasing applications in regulatory clinical trials & in routine practice
Dara Aisner
  • Broad patient populations versus biomarker-limited subsets...big or limited molecular subsets?
  • Partner/companion diagnostics for a smaller sub group for FDA approval?
  • Are or will liquid biopsies with Next Generation Sequencing (NGS) testing replacing interventional tests?
  • What are the practical implications of knowing by NGS testing that a specific tumor specimen may respond to a targeted therapy outside of approved FDA labeling?
  • How should pharmaceutical companies incorporate companion or other diagnostics into clinical development?
  • Clinical value of NGS testing...
4:05PM
Q & A AND PANEL DISCUSSION
4:20PM
COST and VALUE: WHAT IS A FAIR PRICE FOR EFFECTIVE CANCER THERAPY?
Scott Ramsey
  • How is value defined for anti-cancer therapy?
  • What role do value assessments play in the US vs. other developed countries?
  • How do payers determine value?
  • How do payer policies regarding cost and value impact practicing oncologists?
  • What are the new and evolving models for enhancing value and/or reducing cost?
4:45PM
Q & A AND PANEL DISCUSSION
5:00PM
DAY ONE SESSIONS COMPLETED
6:30PM
RECEPTION for NETWORKING (Pre-dinner Refreshments) Directly outside of the Meeting Room Foyer "A rare opportunity for you to get to know you who you need to know --- Where industry & cancer HCPs can connect"
7:30PM
FORMAL DINNER in the North America Room "Another rare opportunity to meet and network with the oncologists and other KOL faculty; Exempt from the Sunshine Law Reporting."
8:00PM
ADJOURN
To register now click here or call 214-269-2014.
Day 2 - October 20, 2016
7:00AM
BUFFET BREAKFAST
8:00AM
INSIDE AN "ACADEMIC" CANCER HOSPITAL AND THE PRACTICE CHANGING ENVIRONMENT
Rogerio Lilenbaum
  • Bodies of Influence that impact patient care to help with the who and supply the people
  • The focus is on those individuals who directly interact with patients, pharmaceutical companies and other stakeholders. Also, this includes following a patient through each type of Practice Setting.
  • What happens inside an academic hospital or cancer center like Yale so that the pharmaceutical companies know how to be of benefit to the oncologists/hematologists and other HCPs within these institutions?
  • Knowing how these cancer centers and academic hospitals function can only help drug company executives add value
  • "Follow the patient"
  • Where, if at all, can pharma participate and add value? E.g., in Grand Rounds or Tumor Boards, etc.?
  • Admissions/Case manager
  • P&T committees and purchasing decisions
8:20AM
Q&A
8:30AM
WHAT MAKES SOMEONE AN ACADEMIC THOUGHT LEADER or KEY OPINION LEADER?
Paul Bunn
  • Academic Thought Leaders? KOLs? The same as Medical Experts? Are these names interchangeable? How do the experts (KOLs) feel about these labels?
  • Dr. Paul Bunn, one of the most widely known and most respected "academic thought leaders" will share his perspectives on the definition of what is a "KOL" and how they benefit HCPs for the ultimate goal of improved patient care?
  • What are the mutual beneficial relationships between KOLs and pharmaceutical companies for advancing patient care?
  • Relationships between KOLs and community oncologists/hematologists: "Curbsides" versus clinical trial enrollment
  • What makes a "KOL?" Are the KOLs well published? Are they committee members or chairs of major professional organizations such as the American Society of Clinical Oncology or the American Society of Hematology? Cooperative Groups? What else?
  • Are KOLs defined by their scientific and clinical research advances? Etc.?
  • Are there differences in KOLs regarding Regional and National influence?
  • Do international (ex-USA) KOLs impact patient care in the USA?
8:50AM
INTERACTIVE PANEL DISCUSSION: HOW CAN INVOLVEMENT WITH ACADEMIC THOUGHT LEADERS HELP IMPROVE CANCER PATIENT CARE? Planning and conducting clinical trials, Post-FDA approval?
Moderator: Steve Madison
Panelists: Paul Bunn, Suresh Ramalingam, Edward Kim, Jeff Patton, Jim Koeller
  • This will be a highly interactive panel discussion. Steve will help solicit questions from the pharmaceutical industry audience to the several KOLs on the panel, including Drs. Paul Bunn, Suresh Ramalingam, Rogerio Lilenbaum and Jeff Patton.
  • The audience is encouraged to make this a highly interactive dialogue with the KOL faculty by asking as many questions as possible. Audience questions can be asked at any time either by using their iPads for queued-up questions or a floor microphone.
  • Some key questions that will be addressed include:
    • How do KOLs help facilitate the dissemination of optimal research, nationally and regionally?
    • How do KOLs help with other aspects of the cancer business that ultimately affect patient care?
    • Why does "everyone" want access to KOLs?
    • What are some of the best ways to access KOLs?
    • What are some of the "does and don’ts" when working with KOLs, according to the KOLs?
    • Do local hematologists/oncologists often adopt the therapy regimens of their nearby KOLs
  • Communications & access: The difference between knowing who they are & which KOLs will respond to your email or phone call
9:30AM
THE EVOLVING ROLES OF PROFESSIONAL CANCER ORGANIZATIONS, SOCIETIES, and MEETINGS: How They Help Provide Optimal Patient Care: Now and in the Future?
Suresh Ramalingam
  • The focus is on "the changing way oncologists/hematologists and other Cancer HCPs are obtaining information"
  • What is the purpose & mission of the major professional organizations and how they help improve patient care?
  • Examples of key professional organizations: American Society of Clinical Oncology, American Society of Hematology, and numerous others such as Community Oncology Alliance (COA) Lymphoma & Leukemia, Myeloma Foundation, State Cancer Societies, US Oncology/Texas Oncology, Guidelines Organizations, Advocacy Groups and their different missions, and specialty patient education organizations such as GRACE, etc.)
  • History of evolution of NCI COOP groups and their relevance today? Some believe that COOP remain hugely important versus those that believe they are dinosaurs that are not nimble enough....Who uses COOP groups? Why are they important to the pharmaceutical industry?
  • Are there financial incentives for community/academic oncologists/hematologists to avoid COOP Groups for alternatives?
  • Annual Private CME meetings, e.g., the 9th Annual Personalized Lung Cancer Symposium...are live meetings the forums of the past, only to be replaced by Webinars and Webcasts?
  • Numerous Annual Industry/Investigator Meetings such as the 16th Targeted Therapies for Lung Cancer Symposium
9:50AM
Q&A
10:00AM
BREAK
10:20AM
INSIDE A "LARGE COMMUNITY-BASED PRIVATE PRACTICE" — How will Private Practices survive in the long term? What is the future of community-based oncology/hematology?
Jeff Patton
  • As with the cancer centers/academic hospitals, the intent here is to teach the drug company audience what happens inside a large practice so that they can understand where they as drug company executives may be able to add value.
  • Is anyone entering community practice outside of fellowship?
  • What is the future of community practice?
  • What is the future of small cancer hospitals? How will rural areas be best served?
  • "Follow the patient" -- Who are the stakeholders who directly interact with patients?
    • Physicians, NPs, Nurses, PA’s, Pharmacists
    • Case manager, Office Manager, Billing & Reimbursement Management
  • EMR (Electronic Medical Records)
  • Pathways and group purchasing decisions
10:40AM
Q & A
11:00AM
EXPANDING OPPORTUNITIES FOR EARLY DRUG DEVELOPMENT: Engaging Community Hospitals and Regional Oncology/Hematology Practices in Specialized Hospital Networks
Edward Kim
  • The vital role of regional hospital networks
  • Benefits to patients: easier access to investigational therapies
  • How these are helping define the future of cancer care: where innovations in research and treatment are brought closer to home for patients
  • Providing access to the leading oncologists/hematologists and other cancer HCPs regardless of geography
11:20AM
THE CRITICAL ROLES OF PHARMACEUTICAL SERVICES IN CANCER HOSPITALS AND PRIVATE PRACTICE CANCER CLINICS
Jim Koeller
  • The impact of Pathways on pricing (the company, VIA, is a pathway provider)
  • Formularies
  • Patient Co-Pays & PAPs (Patient Assistant Programs)
  • Specialty pharmacies: help or hindrance? Perspectives from the hospital pharmacy customer
11:40AM
Q&A AND PANEL DISCUSSION
NOON
BUFFET LUNCH ("Lunch with the Professors")
1:00PM
REIMBURSEMENT Part 1: What Every Cancer Healthcare Professional Should Know Today, and What the Future will Bring as We are Moving Away from Fee for Service to Value and Quality?
Joe Bailes
  • Government: Medicaid, Medicare Parts A, B, D, Donut Hole, etc.
  • The traditional pricing model: paid by Traditional Wholesalers --- Wholesale Acquisition Cost (WAC), Average Sales Price (ASP), ASP + 6 % billing Medicare; Net to the Practice; Charge Backs
  • Shifting site of care (from private practice, into hospitals, Oncology Medical Homes, etc.)
  • Understanding and embracing the changes to value and quality
1:20PM
Q&A
1:30PM
REIMBURSEMENT Part 2: For Cancer Drug Therapy from the Large Community Practice Perspective
Jeff Patton
  • Practice Management: understand how a private practice operates as a small business; staffing; revenues, un-reimbursed services, claim adjudications)
    • Large & Small Group Practices
    • US Oncology
    • Practice Economics
  • Shifting site of care (private practice, in hospital, Oncology Medical Home, etc.)
  • Health Economics and Outcomes Research (HEOR) (Flat Iron Health = Health Care Analytics)..this is what payers look at to make decisions
  • 340B Hospitals
  • Oncology Drug Reimbursement (coding, appeals process, etc.)...different perspectives from speaker #1 above
  • Challenges to reimbursement denial decisions/ prior authorizations denied...from the prescriber’s perspective
  • The increasing role of the patient in shared decision making
  • Accountable Care organizations
1:50PM
Q & A AND PANEL DISCUSSION on REIMBURSEMENT
Bailes and Patton
2:10PM
ENGAGING ADVOCACY GROUPS EARLIER IN THE CLINICAL DEVELOPMENT PROCESS: What would be the impact on the clinical development program of an early collaborative, team effort for a clinical trials program that included R&D, Medical Affairs, Marketing/Strategic Product Planning, all working with Advocacy Groups?
Guneet Walia
  • Current Patient Advocacy Group Goals
  • Support
    • Education
    • Research
    • Screening
    • Awareness/funding
    • The future is now: "Understanding and embracing the role of early advocacy group interaction in clinical planning"
2:30PM
Q & A
2:40PM
HOW THE NON-FDA REGULATORY FRAMEWORK AFFECTS CANCER CARE
Blase Polite
  • Changing landscape of what is positive: e.g., the rise of patient-facilitated research, a more liberal FDA, the usage of Biomarkers to more precisely identify patient populations
  • Patient facilitated research online groups Like "Me" help facilitate the clinical trials enrollment
  • The ascent of Consortiums Pathways versus the historical legacy of COOP groups (e.g., Consortiums are the Triple Negative Breast Cancer Group and others for each malignancy, etc.) Are Consortiums replacing COOP groups? Should they? Pros and cons? What is likely or inevitable?
  • Sunshine Law: Is it achieving the desired effect or has it gone too far?
    • its impact on Pharmaceutical company traditional activities with HCPs (what cannot be done anymore?)
    • How is this affecting participation in Ad Boards? Marketing Research? Speakers Bureaus?
  • Affordable Care Act: Impact on Cancer Care; How is this affecting communications between academic thought leaders and commercial interests, e.g., The barriers to research and regulatory burdens to clinical research and drug development
3:00PM
Q & A
3:10PM
BREAK
3:30PM
FROM DATA PRESENTATIONS TO LASTING PRACTICE CHANGES: What Factors Change Prescribers’ Perspectives Based Upon New Data?
H. Jack West
  • The variability in oncologist adoption: from "art of medicine" to Level 1 evidence
  • Which factors are most and least influential in changing practice?
  • Why does quality of evidence vary in different clinical settings?
  • What endpoints matter most?
  • What are the variables that increase the probability of physicians adopting new evidence to change practice?
3:50PM
Q & A
4:00PM
EXTERNAL MARKET FORCES AFFECTING PATTERNS IN PATIENT CARE: PATHWAYS, GUIDELINES, QOPI
Jim Koeller
  • What/who is defining and shaping "best practices"?
    • Guidelines (e.g., American Society of Clinical Oncology, National Comprehensive Cancer Network, Pathology testing Guidelines, disease-specific organizations)
    • QOPI and the need for metrics
    • National and Regional KOLs?
    • Value-based payment systems
    • Network/practice-based practice guidelines
    • Up-To-Date subscriptions?
  • Maximal efficacy vs. cost-benefit? How much does drug cost influence guidelines?
  • P&T Committees – availability of agents
  • How much do changing value-based payments and incentives for practicing oncologists truly change practice?
  • Limited trial enrollment: are trials valuable to practicing non-academic oncologists?
    • Benefits to patients
    • Time considerations
    • Losing patients to outside institutions
    • Access to novel therapies
    • Sufficient support to run trials?
  • Pharmaceutical Industry Sources
    • Websites
    • Advertising in Journals & elsewhere (reminders, clinical trials enrollment, other objectives)
    • How do HCPs react to direct to patient advertisements? How effective are these advertisements? Does it matter where they are placed? What about direct to consumer ads?
    • Advisory Boards
    • Promotional Emails
4:20PM
Q & A
4:30PM
THE RISE OF THE PATIENT IN SHAPING CANCER RESEARCH AND TREATMENT
Marianne Davies
  • Informed Patients
    • What is an e-patient?
    • How is internet use changing for US population in accessing health care
    • Who do they listen to?
    • How do you involve patients in what has become known as Patient Centered care?
    • How does the Nurse or Advanced Nurse Practitioner Help?
  • Self-Directed Sources of Information: How are patients obtaining information this, and is it a good thing?
    • Dr. Google
    • ASCO’s Cancer.Net
    • Advocacy groups
    • Video-based content
    • Patient blogs
    • Patient vs. HCP-directed cancer info: Is there a line between them?
    • Online patient communities
    • Molecularly and clinically defined subgroups
  • Direct-To-Consumer/Patient Advertising
    • Is it valuable for patients?
    • Is it valuable for companies?
    • Does it undermine physicians?
4:50PM
Q & A
5:00PM
DAY TWO SESSIONS COMPLETED
5:00PM
Private Shuttle Buses for participants departing to the HYATT REGENCY (in Terminal C) either a 10-minute bus ride or 15-minute walk from the GRAND HYATT (Terminal D)
6:00PM
Private Shuttle Buses for participants departing the HYATT REGENCY (in Terminal C) returning to the GRAND HYATT (in Terminal D)
6:30PM
RECEPTION for NETWORKING (Pre-dinner Refreshments) Directly outside of the Meeting Room Foyer "A rare opportunity for you to get to know you who you need to know --- Where industry & cancer HCPs can connect"
7:30PM
FORMAL DINNER in the North America Room "Another rare opportunity to meet and network with the oncologists and other KOL faculty; Exempt from the Sunshine Law Reporting."
8:00PM
ADJOURN
To register now click here or call 214-269-2014.
Day 3 - October 21, 2016
7:00AM
BUFFET BREAKFAST
8:00AM
DRUG DEVELOPMENT & PHARMACEUTICAL COMPANY COMMUNICATIONS WITH CLINICAL INVESTIGATORS "2.0": The Next Decade & What Needs to Change?
H. Jack West
  • How can pharmaceutical professionals provide valuable information to oncologists today?
  • How can currently enrolling trials become publicized to facilitate rapid enrollment?
  • What practices are on the decline and should be diminished or cut?
  • What are changing factors that will change the ability to reach oncologists in the coming years?
  • What are key factors to motivate KOLs?
  • What are key factors to help motivate community oncologists?
  • What do pharma companies need to know to cultivate or maintain strong relationships with KOLs? With practicing community oncologists?
8:25AM
Q&A
8:40AM
REIMBURSEMENT For Cancer Drug Therapy: from the Insurance Company Perspective
John Fox
  • The functions and responsibilities of medical oncologists/hematologists within the insurance industry
  • The pre-authorization process
  • Denials and appeals for approval?
  • Decisions for off-label usage requests, especially with NGS testing
  • Pricing to Group Purchasing Organizations (GPOs), Contracting and Discounts
  • Differences by Practice Setting/Insurance Coverage/etc.
  • Managed Care Organizations (formularies, PBM (Pharmacy Benefit Managers), etc.)
  • Oncology Drug Reimbursement (coding, appeals process, etc.)
  • Challenges to reimbursement denial decisions / prior authorizations denied
9:10AM
Q&A
9:30AM
THE CRITICAL IMPORTANCE OF DEVELOPING THE FRAMEWORK OF FDA LABELLING AT THE INITIAL STAGES OF CLINICAL DEVELOPMENT OF AN ANTI-CANCER THERAPY: How important and beneficial is it that clinical and marketing work together at the earliest/initial stages of the drugs’ entire clinical development to prepare the proposed package inserts? A Role-Play "DEBATE"
  • Pembrolizumab (Edward Kim)
  • versus
  • Nivolumab (Jim Koeller)

Rationale: Different pharmaceutical companies utilize different approaches for the development of their new anti-cancer drugs. In this learning exercise we will use a "debate" for role playing to explore the non-confidential aspects of the real-life situations of two nearly identical, recently-FDA approved, immune-oncology therapies for NSCLC, which in their drug development strategies, plans and clinical studies, pursued the same initial NSCLC indications: pembrolizumab (Merck) and nivolumab (Bristol-Myers Squibb [BMS]). Merck chose to develop pembrolizumab with a companion diagnostic to identify an enriched population of NSCLC Patients with high PD-L1 expression. BMS chose not to use a companion diagnostic and to seek FDA approval for nivolumab for a broad, unselected population.

Dr. Ed Kim and Jim Koeller will "debate" each other, each by speculating and presenting why they believe that Merck and Bristol-Myers Squibb chose completely different development strategies from the outset of their drug development. They will each "role play" as the heads of their respective drug development teams, and comment on the value or lack thereof, and the real-world consequences of the two very different decisions as evidenced in the marketplace today in the US between Clinical and Marketing groups at each of the two companies.

The primary objective of this "debate" or role-play exercise is to help everyone better understand how Clinical AND Marketing collaborative regarding the preparation of the package insert, may or may not lead to a better road map for their respective overall clinical development programs, and ultimately better serving the unmet medical needs of the NSCLC patients receiving PD-1 checkpoint inhibition therapy. Two additional objectives of this role-play debate are: 1) to understand the basic elements of the FDA-approved package insert of an anti-cancer drug, and 2) understand more about the increasing usage of companion diagnostics in the FDA approval process for anti-cancer drugs. This should be especially helpful for executives who are new to oncology/hematology.

After their debate, the floor will be open for a completely wide-open 30-minute Q&A and discussion among the two debaters, plus Drs. West and Fox as additional panelists, and the industry executives in the audience. No doubt, there will be audience questions queued up on everyone’s iPads or iPhones, or other smart devices waiting to be answered. Jim Koeller and Dr. Kim may also ask questions of the audience and the two other panelists, Drs., West and Fox, regarding how (not why---due to protecting confidentiality) each of the two drug companies might have worked internally as a team and to what extent, or not at all, to develop their totally different strategies (e.g., Clinical and Marketing) to jointly decide the desired end-result FDA package inserts from the outset of the drug development planning. NO CONFIDENTIAL information is to be discussed. This role-play debate is simply a way to stimulate a very engaging discussion about making drug development decisions that ultimately impact cancer patients. It will shed light on how Clinical and Marketing may have or may not have worked together optimally, in each situation.

Dr. Ed Kim will "role play" with his 15-minute presentation, acting to represent the marketing and clinical departments at Merck with the anti-PD1 checkpoint inhibitor, pembrolizumab. He will not contact Merck nor use any confidential information or data from Merck. He will prepare his presentation intended for an obvious group discussion with the audience and the expert faculty interacting and answering questions of the audience: Drs. Kim, West, Fox and Jim Koeller. Jim Koeller will "role play" with his 15-minute presentation acting to represent the marketing and medical departments at Bristol-Myers Squibb (BMS) with the anti-PD1 checkpoint inhibitor, nivolumab. He will not contact BMS nor use any confidential information or data from BMS.

10:00AM
BREAK
10:30AM
"PUTTING IT ALL TOGETHER" A Quasi-Panel Discussion Interacting with The Audience summarizing the "conclusions" to help the participants of this Master Class apply what they have learned these past 3 days; how can and/or should pharmaceutical companies make themselves more valuable to oncologists/hematologists & other HCPs, resulting in the ultimate objective of being able to apply this new knowledge to improve cancer patient care.
Jack West and Ed Kim
  • Drs. West and Kim will offer frank perspectives in the form of a group SWOT (strengths/weaknesses/opportunities/threats) analysis together with the audience, for pharma company interactions and relationship building with oncologists that synthesizes key points from sessions over the past several days
  • Listing the top changes and interventions to pursue to overcome challenges in practice change and help strengthen messages to, and cultivate relationships with, target audience of cancer care professionals
11:15AM
FINAL AUDIENCE Q & A..."Open-Microphone" Session for all questions
11:45AM
POST TEST for CME/CE Credit
Steve Madison
NOON
ADJOURN

Master Class Objective top

The overall objective of this live, 3-day cancer business master class, and the archived Internet webinars as enduring materials for one year, is to provide training much needed advanced-level training regarding the business aspects of cancer care to the executives within cancer pharmaceutical companies and diagnostic/laboratory companies. In addition, these training initiatives are designed to help Health Care Professionals (HCPs) who provide patient care, to better understand the business aspects of cancer care, and also, better understand how pharmaceutical companies and diagnostic companies can be of optimal assistance to the oncologists, hematologists, pathologists, fellows, nurses pharmacists and other HCPs involved in delivering care to cancer patients.

What makes this course so unique is that it is a CME/CE-accredited or certified course that utilizes academic and cancer leaders in ancillary areas as the course faculty. We have accredited this course for CME/CE because many, if not the majority of the executives within pharmaceutical and diagnostic/laboratory companies, are physicians, nurses, pharmacists and other HCPs. The "business of cancer" is a broad term, but as it is defined and addressed in this specific course, it provides a forum for bringing the pharmaceutical and laboratory/diagnostic industries and all levels of anti-cancer HCPs together where the HCPs providing patient care explain their needs and identify where industry has or has not meet them; and where industry may have fallen short of needs and expectations this course will enable industry and clinicians to better understand each other which will only help everyone involved ultimately result in better patient care.

Professionals in health care sciences within pharmaceutical and diagnostic/laboratory companies to engage. Therefore, we have designed this 3-day Master Class to focus on the needs that are based upon medical and scientific research that both the clinical and marketing executives must thoroughly understand in order to be of benefit in the chain of communication from drug discovery through commercialization through to the bedside and patient care. And to help ensure no potential for bias, we intentionally made this CME.CE so that no commercial interests could be a part of the faculty. In this Master Class the oncologists, hematologists, nurses, pharmacists and other HCP faculty members will teach the HCP executives of the pharmaceutical and diagnostic/laboratory industry what they as their cancer industry customers need and want.

The comprehensive agenda describes in great detail the content of this Master Class. In addition, the expert academic and leading ancillary expert faculty members and their biographies are described.

The educational format or learning design of this Master Class is one that is intentionally highly interactive. From the beginning through the final panel discussion, all presentations, session and panels are structured so that the audience can ask questions of the expert faculty. And vice-versa, the faculty will be asking questions of the audience throughout the entire program.

To receive CME/CE credit, the learners attending the September 10th symposium have up to one week following the symposium to complete the required symposium survey (on line), and to successfully answer the knowledge test questions found on BioMedical Learning Institute (BMLI) Website. All of the PowerPoint® slides, recorded audio and PowerPoint presentations will be available for download and "24/7" access approximately 6 to 8 weeks following the symposium.

Bring your own "Smart Devices" to interact with the faculty
Please bring your iPhones, iPads, tablets, Androids, Laptop Computers, etc., to the October 19-21, 2016 Strategic Cancer Business Master Class. If you forget, we will have extras for you to use in Dallas. This will enable you and the other symposium participants to use your personal "smart devices" during the symposium to ask any questions of the faculty throughout the symposium from your seats in the audience, and also, to enable you and others in the audience to answer the numerous clinical care treatment questions of each faculty member during their presentations.

Educational Need

The business of cancer is very different from all other therapeutic areas for many reasons that are described in the following paragraphs. Moreover, today there are hundreds of pharmaceutical companies and diagnostic/ laboratory companies who are engaged in the cancer business. As an interesting anecdote, in 1983 when the developer of this Master Class began his career in oncology/hematology there were only three companies in the USA that were considered as cancer companies: Bristol-Myers, Mead Johnson and Adria. The business of cancer has led to some incredible scientific breakthroughs and clinical advances. Cancer patient care has definitely improved. But ironically, since 33 years ago the concept of training has not changed. From at least 1983 and until today essentially no executives other than the sales forces of cancer companies receive any formal training.

Several years ago we recognized that most pharmaceutical companies invest a considerable amount of money and resources to train their sales representatives. However, essentially no pharmaceutical company or diagnostic/laboratory testing company trains the other executives within their organization: in their headquarters any various support functions around the US.

Whether you are a manager or director, or in some cases even a Vice President (depending upon the size of your company) in marketing or medical affairs, or in project management, or in a clinical or drug development function, or in any of a number of different support functions for anti-cancer drug or testing development ranging from marketing research to patient advocacy or even legal or regulatory affairs, you don’t get training. And in the rare cases that you might receive any training whatsoever, it is either minimal, or "on the job" but hardly ever is it formal training that prepare you to perform your job functions optimally. Nowhere other than oncology and hematology is this educational need for training greater. The amount of information and ongoing knowledge required by any executive in a cancer position within a pharmaceutical or diagnostic trading company as quite significant and much greater than in any other therapeutic area. This is for many reasons including the fact that developments and breakthroughs occur in oncology and hematology with many multiples greater than in any other therapeutic area.

Therefore, we strongly believe that regular training of all the executives within pharmaceutical and diagnostic laboratory companies engaged in the business of oncology and hematology is a critical need, in order for any company to provide their customers: the academic and private-practice/community oncologists, hematologists, nurses, pharmacists and other Health Care Professionals (HCPs), with the knowledge and information that they definitely need in order to provide optimal care for their cancer patients. Ultimately, that’s what this is all about: the patient, and better patient care. But a missing link in the chain of communications to oncology/hematology HCPs regarding new drugs, new drug developments and other supportive information, is the adequate training of the various levels of professional executives within pharmaceutical companies and diagnostic/laboratory companies engaged in the business of cancer.

When we conducted the first course or Master Class on this topic several years ago, we learned that indeed there was a significant an unmet educational need that this course filled. We kept the course to a relatively small size (about 90) to facilitate optimal interaction between the thought leader (KOL) faculty and the executives participating as the audience or "students" of the course. The participant reviews and their evaluation forms were strongly positive, and since our initial course several years ago we have been routinely asked to repeat this Strategic Cancer Business Master Class and a few other tumor-specific master Classes, which we will do soon.

And finally, as an example of some Practice Gaps underlying the unmet medical as well as educational needs for this Master Class we cite from a recent Anthem Blue Cross Blue Shield of Missouri study, # 29014:

  1. Up to 1 in 3 people treated with chemotherapy do not receive a treatment plan that is consistent with current medical evidence and best practices. Wu 2012, Bilimoria 2009, Spencer 2008, Neuss 2013, Malin 2006
  2. Costs of new cancer therapies are growing by 25 percent annually. Express Scripts, Drug Trend Report 2013, page 25.
  3. As many as 180 medical journals publish new studies on cancer monthly and quarterly, making it difficult for oncologists and hematologists to stay up-to-date.
  4. Cancer drugs – unlike other therapies – are purchased directly by practices and hospitals from manufacturers or distributers. Health insurers generally reimburse practices a set percentage above the cost of the drug.
  5. "This program (#29014) – while sharing best practices and evidence-based medicine – also helps to support oncologists and hematologists who require large staffs to treat these complex patients and provides the practice with enhanced reimbursement to offset the lower fees they receive when prescribing less expensive drugs," said Wayne Meyer, M.D., Medical Director of Anthem Blue Cross and Blue Shield in Missouri.
  6. All fully-insured and self-insured members, Medicare Advantage members and national account members who live in states where the program has been implemented are part of this program.
  7. Providers will continue to be reimbursed for visits and cancer drugs according to the terms of the member’s health plan regardless of whether a treatment is on pathway, however, only pathway regimens are eligible for enhanced reimbursement.
  8. "Chemotherapy makes up 25 percent of the costs to treat health plan members who have cancer, and this percentage is growing faster than any other part of care," said Dr. Meyer. "It’s clear that our approach to cancer therapy is the answer in making a positive impact on quality and in slowing the rate of these increases to keep premiums as affordable as possible."

Target Audience top

The target audience for this CME/CE educational activity is primarily the oncologists, hematologists, pathologists, scientists, pharmacists, nurses, Nurse Practitioners, Physician assistants, dieticians and other physicians and Health Care Professionals (HCPs) who have chosen their careers to work within pharmaceutical, biotech and diagnostic/laboratory companies, and ancillary companies such as medical advertising and communications companies. In addition, all HCPs, including oncologists, hematologists, physicians nurse, pharmacists and other HCPs, in either private practice or academia, who are interested in this CME/CE activity are invited to attend. And finally, anyone else who may not be a HCP, but rather are important and integral members of the chain of professionals involved in the delivery of care to cancer patients are also invited. These include consultants, specialty pharmacies and other corollary personnel involved in the business of cancer. The inclusion of everyone from various backgrounds, especially in a limited group of 90 participants, will only help to facilitate an important interactive dialogue during this three-day program.

Learning Objectives

Physicians

  1. Compare and contrast how clinical trials used for FDA registration of oncology/hematology drugs differ from trials for drugs in other therapeutic areas.
  2. Understand the differences between the efficacy endpoints used to interpret and assess efficacy of anti-cancer drug clinical trials versus drugs from other therapeutic areas.
  3. Explain the influence of molecular diagnostic testing on the FDA drug approval process for anti-cancer drug therapy.
  4. Assess the differences in the cost effectiveness and value of new and emerging anti-cancer therapy versus established anti-cancer therapy in order to optimize cost of therapy for new anti-cancer drug regimens.
  5. Evaluate the therapeutic strategy options to best utilize academic/KOL thought leader input and assistance for developing treatment strategies that provide optimal patient outcomes.
  6. Understand the evolving roles of the various professional cancer organizations, societies and meetings and how to best utilize them to help with overall cancer patient management.
  7. Describe the various decision-making processes and decision-making personnel within each of the different clinical institutions that provide cancer care (cancer center, cancer hospital or private practice) in order to determine the optimal overall therapeutic management for each cancer patient.
  8. Understand the distinctly different roles of the payer decision makers (academic thought leaders, insurance companies, private practice clinic managers, government, etc.) in the reimbursement decisions for determining anti-cancer therapy for specific patients with malignancy.
  9. Explain the impact on therapy decision making of the various non-FDA organization, bodies and reimbursement infrastructure (consortiums, pathways, COOP groups, and even the Affordable Care Act and Sunshine laws) has on ultimate therapy selection for patients with cancer.
  10. Discuss how the emerging data from clinical trials (official NCCN and ASCO Guidelines, KOLs, QOPI, Phase II/III data, P&T Committees, pharmacists, data and information from social media, CME educational activities, and pharmaceutical company promotional information) impacts the prescribing habits of oncologists and hematologists.
  11. Integrate the role of cancer patient involvement and the entire process of cancer patient-centered care, especially utilizing patient advocacy groups and self-directed consumer sources of information, especially involving cancer nurses and Advanced Nurse Practitioners, into the development of overall anti-cancer therapy.
  12. Improve and expand the role of research-based pharmaceutical companies at all levels of their potential involvement in patient management decision making as key stakeholders in order to optimize cancer patient outcomes.
  13. Compare and contrast the different approaches to developing the FDA-approved labelling (package insert) for FDA approved new therapies, especially similar anti-cancer drugs where patient pre-selection and/or personalized medicine is an option for ultimate usage of the therapy by oncologists, hematologists, pharmacists and other HCPs.
  14. Formulate strategies whereby research-based pharmaceutical companies can improve their roles in assisting oncologists/hematologists, pharmacists, nurses and other HCPs in providing optimal care for cancer patients.

Pharmacist

  1. Define how clinical trials used for FDA registration of oncology/hematology drugs differ from trials for drugs in other therapeutic areas.
  2. Recall the differences between the efficacy endpoints used to interpret and assess efficacy of anti-cancer drug clinical trials versus drugs from other therapeutic areas.
  3. Review the influence of molecular diagnostic testing on the FDA drug approval process for anti-cancer drug therapy.
  4. List the differences in the cost effectiveness and value of new and emerging anti-cancer therapy versus established anti-cancer therapy in order to optimize cost of therapy for new anti-cancer drug regimens.
  5. Recognize the therapeutic strategy options to best utilize academic/KOL thought leader input and assistance for developing treatment strategies that provide optimal patient outcomes.
  6. Recall the evolving roles of the various professional cancer organizations, societies and meetings and how to best utilize them to help with overall cancer patient management.
  7. Identify the various decision-making processes and decision-making personnel within each of the different clinical institutions that provide cancer care (cancer center, cancer hospital or private practice) in order to determine the optimal overall therapeutic management for each cancer patient.
  8. Review the distinctly different roles of the payer decision makers (academic thought leaders, insurance companies, private practice clinic managers, government, etc.) in the reimbursement decisions for determining anti-cancer therapy for specific patients with malignancy.
  9. Recognize the impact on therapy decision making of the various non-FDA organization, bodies and reimbursement infrastructure (consortiums, pathways, COOP groups, and even the Affordable Care Act and Sunshine laws) has on ultimate therapy selection for patients with cancer.
  10. Define how the emerging data from clinical trials (official NCCN and ASCO Guidelines, KOLs, QOPI, Phase II/III data, P&T Committees, pharmacists, data and information from social media, CME educational activities, and pharmaceutical company promotional information) impacts the prescribing habits of oncologists and hematologists.
  11. Review the role of cancer patient involvement and the entire process of cancer patient-centered care, especially utilizing patient advocacy groups and self-directed consumer sources of information, especially involving cancer nurses and Advanced Nurse Practitioners, into the development of overall anti-cancer therapy.
  12. Recall the role of research-based pharmaceutical companies at all levels of their potential involvement in patient management decision making as key stakeholders in order to optimize cancer patient outcomes.
  13. Identify the different approaches to developing the FDA-approved labelling (package insert) for FDA approved new therapies, especially similar anti-cancer drugs where patient pre-selection and/or personalized medicine is an option for ultimate usage of the therapy by oncologists, hematologists, pharmacists and other HCPs.
  14. List strategies whereby research-based pharmaceutical companies can improve their roles in assisting oncologists/hematologists, pharmacists, nurses and other HCPs in providing optimal care for cancer patients.

Nurses and Advanced Nurse Practitioners

  1. Define how clinical trials used for FDA registration of oncology/hematology drugs differ from trials for drugs in other therapeutic areas.
  2. Recall the differences between the efficacy endpoints used to interpret and assess efficacy of anti-cancer drug clinical trials versus drugs from other therapeutic areas.
  3. Review the influence of molecular diagnostic testing on the FDA drug approval process for anti-cancer drug therapy. 4. List the differences in the cost effectiveness and value of new and emerging anti-cancer therapy versus established anti-cancer therapy in order to optimize cost of therapy for new anti-cancer drug regimens.
  4. Recognize the therapeutic strategy options to best utilize academic/KOL thought leader input and assistance for developing treatment strategies that provide optimal patient outcomes.
  5. Recall the evolving roles of the various professional cancer organizations, societies and meetings and how to best utilize them to help with overall cancer patient management.
  6. Identify the various decision-making processes and decision-making personnel within each of the different clinical institutions that provide cancer care (cancer center, cancer hospital or private practice) in order to determine the optimal overall therapeutic management for each cancer patient.
  7. Review the distinctly different roles of the payer decision makers (academic thought leaders, insurance companies, private practice clinic managers, government, etc.) in the reimbursement decisions for determining anti-cancer therapy for specific patients with malignancy.
  8. Recognize the impact on therapy decision making of the various non-FDA organization, bodies and reimbursement infrastructure (consortiums, pathways, COOP groups, and even the Affordable Care Act and Sunshine laws) has on ultimate therapy selection for patients with cancer.
  9. Define how the emerging data from clinical trials (official NCCN and ASCO Guidelines, KOLs, QOPI, Phase II/III data, P&T Committees, pharmacists, data and information from social media, CME educational activities, and pharmaceutical company promotional information) impacts the prescribing habits of oncologists and hematologists.
  10. Review the role of cancer patient involvement and the entire process of cancer patient-centered care, especially utilizing patient advocacy groups and self-directed consumer sources of information, especially involving cancer nurses and Advanced Nurse Practitioners, into the development of overall anti-cancer therapy.
  11. Recall the role of research-based pharmaceutical companies at all levels of their potential involvement in patient management decision making as key stakeholders in order to optimize cancer patient outcomes.
  12. Identify the different approaches to developing the FDA-approved labelling (package insert) for FDA approved new therapies, especially similar anti-cancer drugs where patient pre-selection and/or personalized medicine is an option for ultimate usage of the therapy by oncologists, hematologists, pharmacists and other HCPs.
  13. List strategies whereby research-based pharmaceutical companies can improve their roles in assisting oncologists/hematologists, pharmacists, nurses and other HCPs in providing optimal care for cancer patients.

CME & CE Credit top

This symposium provides 17 hours of CME credit to physicians, 17 hours of CNE credit to nurses, 17 hours of CPE credit to pharmacists, and a Certificate of Attendance for fellows and other HCPs for receiving 17 hours of credit from their professional organizations and accrediting societies.

Accreditation Statements top

Physicians

The BioMedical Learning Institute is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The BioMedical Learning Institute designates this live activity for a maximum of 17 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Pharmacists

The BioMedical Learning Institute is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

UAN: 0838-0000-16-003-L01-P
Credits: 17 hours (1.7 ceus)
Type of Activity: Knowledge

To receive CE contact hour credit, attendance at the entire activity and the successful completion of the post‐test and evaluation form is required.

Nurses

The BioMedical Learning Institute is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.

The BioMedical Learning Institute designates this educational activity for 17 contact hours.

Accreditation by the American Nurses Credentialing Center's Commission on Accreditation refers to recognition of educational activities and does not imply approval or endorsement of any product.

To receive CE contact hour credit, attendance at the entire activity and the successful completion of the post‐test and evaluation form is required.

Other

Physician Assistants: AAPA accepts certificates of attendance for educational activities certified for Category 1 credit from AOACCME, Prescribed credit from AAFP, and AMA PRA Category 1 Credit™ from organizations accredited by ACCME or a recognized state medical society. Physician Assistants may receive a maximum of 17 hours of Category 1 credit for attending this symposium.

Fellows will receive a certificate of attendance that they can submit to their accrediting organizations for continuing education credit.

Location

Airline Transportation (Important Information) top

For the convenience of all attendees of the 2016 Strategic Cancer Business Course we have selected the Grand Hyatt Hotel inside Terminal D of the Dallas/Ft. Worth International Airport.

Please note: As is the situation in many cities in the United States, there is another airport servicing the Dallas area: Dallas Love Field. And this airport, Dallas Love Field, is located approximately 30 miles away from Dallas Fort Worth international airport, where the 2016 Strategic Cancer Business Class will be conducted. Depending upon traffic this will be between 30-and 90-minute taxi drive between these two airports and about a $70 taxi fare. Also, please note that Southwest Airlines DOES NOT service Dallas Ft. Worth International Airport. So should you choose to fly Southwest Airlines please be aware if these issues. It is highly advisable that participants flying to Dallas using airline that flying sent to Dallas Fort Worth international Airport (DFW) so that when you arrive you need not leave the terminal, because the Grand Hyatt Hotel, where the 20-16 Strategic Cancer Business Master Class will be held, is inside the airport. Almost all airlines except Southwest, service DFW International Airport.

Hotels top

Please note: Both of the Hyatt hotels located inside the DFW International airport are completely sold out, including the GRAD HYATT where the Master Class is being held in Terminal D of the DFW Airport. There are a limited number of seats available (approximately 10) in the Master Class, so anyone wishing to attend the Master Class needs to reserve a sleeping room at any of the numerous hotels located very nearby the DFW airport. Most are a 10-minute FREE shuttle bus away located just outside the airport. Please see Hotels.com or any other discount hotel Website and search for hotels near the Dallas Ft. Worth International Airport. Hotels include a 4-start Sheraton, Marriott, Westin and many others.

Please Note: There are two Hyatt hotels inside the Dallas-Ft. Worth (DFW) International Airport. One is the GRAND HYATT DFW (Terminal D) and the other is the HYATT REGENCY DFW (Terminal C). The Master Class and all related activities will be conducted inside the GRAND HYATT DFW (Terminal D).

Because of an unexpectedly very large number of registrations for the October 19-21 Strategic Cancer Business Master Class, the initial block of 90 sleeping rooms has sold out. The classroom seating capacity is 120 persons. The good news is that we have been able to secure an additional block of sleeping rooms to accommodate the ongoing registrations for this Master Class. On the first two nights, Tuesday 10/18/16 & Wednesday 10/19/16, these extra sleeping rooms are at the GRAND HYATT DFW (inside Terminal D of the DFW airport) at the discounted rate of $299.

Unfortunately, the 20 extra sleeping rooms we have recently secured for the final night of the Master Class, Thursday October 20, are only available at the other Hyatt hotel located inside the Dallas – Fort Worth (DFW) International airport. That other hotel is the HYATT REGENCY (inside Terminal C of the DFW airport) whereas, the Master Class and the first two nights of hotel rooms are in the GRAND HYATT inside Terminal D of the DFW airport. Therefore, using these additional available sleeping rooms will require a brief transfer from the GRAND HYATT to the HYATT REGENCY on the final night, Thursday October20th. These two Hyatt hotels are separated by only a 10-minute walk or a 5-minute shuttle bus ride. Arrangements have been made for or a private shuttle bus to transfer to 20 people affected by this need to change hotels in order to make this transfer as convenient as possible. This transfer will occur at the 5:15PM on Thursday October 20th, the second day of the Master Class. To further help with this transfer the sleeping room rate for the final night has been lowered to compensate for this very slight inconvenience. The rate will be $99.50 paid for by The Oncology Learning Center and ONLY $99.50 plus taxes for the 20 guests affected by this transfer. Thus, anyone registering now fort the Master Class will only pay $99.50 for their 3rd sleeping room night which will be at the HYATT REGENCY versus the $299 at the GRAND HYATT DFW hotel.

We apologize for the need to transfer the 20 additional participants at this Master Class and hope that the arrangement to help move people between both hotels plus the savings of $200 will compensate for the slight inconvenience.

The procedure for registering for this Master Class and to reserve your hotel sleeping rooms need to do the following two steps:

#1 – Using the following "passkey" link https://resweb.passkey.com/Resweb.do?mode=welcome_gi_new&groupID=63969556 please make a sleeping room reservation at the GRAND HYATT DFW (inside Terminal D of the airport) for the first two nights: 10/18 & 10/19 at the rate of $299 per night.

#2 – Please make your sleeping room reservation for the final night, Thursday 10/20, at the HYATT REGENCY (inside Terminal C of the airport) at the rate of $99.50 per night using the following "passkey" link Click here to reserve your room

In other words, you will have two separate reservations, one for each hotel. If you have any questions, please contact Jackie Welch of the Oncology Learning Center at 214-269-2014. Ifd she is unable to take your call immediately, she will get back to you in less than 24 hours.

Networking top

One benefit in addition to the knowledge gained from attending this three-day Master Class is that you will have what is becoming a rare opportunity to network with many of the key oncology/hematology opinion leaders (KOLs) and key ancillary cancer experts, as well as with your colleagues from other oncology/hematology pharmaceutical, biotech, and diagnostic/laboratory companies.

The Sunshine Law requiring the public reporting of almost any interactions with physicians has become a major barrier to meeting or networking with the KOLs that you need to or in some cases "must know" know in oncology/hematology. Because this three-day 2016 Strategic Cancer Business Master Class is a CME event, you can meet with the KOLs without the need for Sunshine Reporting. The reason is that CME meals are exempt from Sunshine Reporting as long as they are buffet meals. Thus, our two evening dinner/receptions will be light buffet dinners. Our two breakfasts and one lunch will be also be full buffet meals. The lunch on Thursday will be a "Lunch with the Professors" where each KOL is assigned to a separate table and each of the 90 participants is provided the opportunity to sit at the table of their choice with the KOL of their choice on Thursday on a first-come basis.

These buffet meals will afford you five opportunities for networking with the "faculty of the day" as well as with the other, approximately 90 executives in the pharmaceutical, biotech and diagnostic/laboratory companies involved with cancer therapy participating in this Master Class.

We encourage you go take advantage of these networking opportunities. To help maximize them for everyone, we have intentionally selected the Grand Hyatt DFW Hotel inside the Dallas Ft. Worth Airport, so that nobody will likely leave the property for meals. Dinners and meals are "on the house" in a very cozy, comfortable venue within the hotel. It is logistically arranged for ideal networking opportunities.

Privacy Policy

Our privacy policy is that any information provided by any participant will not be sold or distributed outside of the Oncology Learning Center, Inc. Information you provide will be used only to contact you for our other Oncology Learning Center Master Classes or other training courses. You may opt out of our mailing list at any time by contacting us at registration@OncologyLearningCenter.com or call 214-269-2014 and leave a detailed message.

  • Oncology/hematology strategic decision maker executives within the pharmaceutical and molecular diagnostic testing industries
  • Cancer medical and marketing executives: R&D, clinical development, medical affairs, MSLs (Medical Scientific Liaisons), clinical and strategic project management, business and strategic development management, and executives in marketing research, strategic product planning and sales
  • KOL management/liaisons and development executives
  • Experienced pharmaceutical industry executives new to oncology/hematology needing to quickly "get up to speed"
  • Medical communications and advertising agency executives, especially account executives and writers
  • Consultants to the pharmaceutical & diagnostic industries: for R&D, clinical and marketing
  • Clinical Research Company executives (CROs)
  • Private-practice community oncologists/hematologists and related HealthCare Professionals
  • No other cancer training course like this 2016 Strategic Cancer Business Master Class exists. The Oncology Learning Center teaches this course every four years.
  • There is an ever increasing number of competitive anti-cancer products and molecular diagnostic tests on the market today or soon to become FDA approved. Can you afford not to be the most competitive within your industry?
  • Experienced oncology/hematology pharmaceutical industry executives will benefit greatly from this course because of the growing amount of new information about the cancer business and insights from the cancer experts, but for those who are new or relatively new to cancer this is a "must-attend" course.
  • Obtain invaluable information and perspectives from the world’s top academic cancer KOLs and experts in ancillary areas such as insurance, reimbursement, drug development, and other areas of support to drug development and oncology/hematology pharmaceutical and diagnostic testing companies
  • In most companies, only the sales representatives receive formal cancer training of any kind. In addition, your customers, the practicing oncologists, hematologists and other cancer HCPs are required to take 30 hours of oncology/hematology CME or CE training annually. Therefore, how do cancer executives like yourself receive this essential training? How do you keep current? How do retain your competitive advantage, especially with the KOLs?
  • Rare opportunity to meet and network with oncology/hematology KOLs, practice leaders and colleagues of other companies
  • Learn exactly what the academic and private practice oncologists/hematologists want and need from the pharmaceutical and laboratory testing company executives; and learn via a "live & in person" program if they believe they are receiving it and how industry can be of more value to them and to their cancer patients. Meet with the faculty personally at the various meal functions, receptions and breaks.
  • Interact live by asking questions and participating in audience/faculty Q&A and panel discussions throughout the course
  • Learn how to maximize your drug development program or your diagnostic tests and testing panels
  • Learn how to enhance the effectiveness of you commercial marketing programs for the cancer medical and research community
  • Private practice medical oncologists/hematologists and related cancer HCPs will benefit from this three-day update by the academic experts and by networking with the pharmaceutical/diagnostic industry executives
  • What new data and information and support do oncologists/hematologists want from pharmaceutical companies before they will change their patient treatment habits?
  • Clinical trials and drug development: Why and how are trials for cancer drugs so different from other areas?
  • Strategies for expanding opportunities for optimal early drug development and improved patient access to investigational cancer therapies in rural areas using innovative regional cancer networks
  • Reimbursement from several perspectives, including the current fee-for-service system and moving towards value-based reimbursement and pricing
  • What is the importance, impact and future of practice guidelines and pathways?
  • KOLs: Who they are, and why they are important to everyone in the "cancer world" for optimal patient care
  • New and evolving clinical endpoints for anti-cancer drugs, including the latest, "patient reported outcomes," as well as an in-depth understanding of hazard ratios, waterfall plots, spider diagrams and other modern-day efficacy metrics, beyond the traditional survival curves and response rates...and taught by the SWOG statistician
  • Importance of including the input and decisions from marketing & business development at the early stages of drug development, along with executives from clinical development, medical affairs and R&D
  • Understand the FDA approval process in today’s modern era of molecular oncology/hematology and companion diagnostics
  • The practical and investigational roles of Next Generation Sequencing (NGS) & other molecular testing for enriched cancer target patient populations
  • Evaluating the cost & value of new oncology/hematology drugs: How to determine a fair price for therapy?
  • The many cancer organizations & professional societies: their evolution and importance to drug development
  • Understand the inside operations of a cancer hospital and also a large community clinical practice
  • How does the non-FDA regulatory framework affect cancer care, e.g., the Sunshine Law and CME and non-CME programs?
  • What are the best ways to engage with Advocacy Groups? And which groups?
  • The importance of developing the best FDA labeling, and how to do this?
© 2018 Oncology Learning Center, Inc.