[three_fourth]
[h2]Course Overview[/h2]
Therapeutics for cancer are entering a new era, where precision approaches promise to revolutionize the way in this disease is treated. This comprehensive course reviews current and emerging drugs, immunotherapies, their application to specific cancer types, how to conduct clinical trials for oncologic therapies, and the drug development process for drug candidates leading to their approval. The US Food & and Drug Administration (FDA) regulatory considerations for Oncology drugs, registration endpoints, and accelerated and breakthrough approval mechanisms are also covered.
Note: Due to precautions and restrictions in place to slow the spread of COVID-19, PERI has made the decision to offer this course as a virtual training program instead of an in-person course this spring.
[h3]Benefits of Attendance[/h3]
[icon_list type=”triangle”]
- Understand cancer and different treatments including emerging immunotherapies
- Learn clinical endpoints needed for review and regulatory approval
- Be able to discuss leading cancer types such as lung, breast, prostate, and others
- Find out about clinical protocol designs and imaging techniques
- Network with colleagues and experts in the oncology arena
[/icon_list]
[h3]Download the final agenda for the virtual training program for PERI’s summer oncology course.[/h3]
[space height=”5″]
[tabs]
[tab title=”Objectives”]
[icon_list type=”triangle”]
- Discuss the scope, nature and epidemiology of top human cancers with an emphasis on principles of case management of common malignancies
- Describe specific applications of commonly used cancer treatments
- Evaluate the design and conduct of oncology Phase I, II, and III clinical trials
- Apply FDA requirements for oncology clinical trials and drug development programs to facilitate/expedite drug development
[/icon_list]
[/tab]
[tab title=”Key Topics”]
[icon_list type=”triangle”]
- Overview of Oncology Drug Development, Including Dosing Selection and Clinical Trial Design
- Leading Cancer Types (New Cases/Deaths Per Year)
- Emerging Drugs, Vaccines, other Immunotherapies
- Overview of US Regulatory Pathways and Outcomes
- Pediatric Development Initiatives and Regulations for Pediatric Cancer Treatments
[/icon_list]
[/tab]
[tab title=”Who Should Attend”]
[icon_list type=”triangle”]
- Clinical Team members
- Project Clinicians
- Clinical research associates or CRO staff
- Regulatory affairs professionals
- Product managers
- Statisticians, data managers, medical writers
- Marketing research staff
- Pharmaceutical Physicians
- Anyone working in oncologic drug development or professionals moving to this area
[/icon_list]
[/tab]
[tab title=”Continuing Education”]
Continuing Education Credit
Pharmaceutical Education & Research Institute, Inc. (PERI) is pleased to make continuing education credit available to you for attendance at this program. To receive credit, you must attend the entire program and submit the Continuing Education Application form directly to a PERI on-site coordinator. Additional $35 fee applies for students who are applying for continuing education credit.
ACPE Statement:
Pharmaceutical Education & Research Institute, Inc. (PERI) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Activity Number is 0708-0000-20-004-L01-P. 1.35 continuing education units (CEUs) are available for this program. Initial Release Date: 06/22/2020. This is a knowledge-based CPE Activity.
[clear]
[clear]
ACCME Statement:
PERI, Inc. is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. PERI, Inc. designates this live activity for a maximum of 13.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
[clear]
[clear]
[/tab]
[/tabs]
[clear]
[h3]PERI Faculty List[/h3]
Shaily Arora, PharmD
Associate Director for Safety (Acting), Office of Oncologic Diseases
Center for Drug Evaluation & Research
US Food and Drug Administration
Marijo Bilusic, MD, PhD
Director, Hematology Oncology Fellowship Program
National Cancer Institute
National Institutes of Health
Florence Houn, MD, MPH, FACP
VP, Global Regulatory Science
Bristol Myers Squibb
Malini Iyengar, PhD
Head of Clinical Pharmacology
TEVA Pharmaceuticals
Chul Kim, MD
Associate Professor
Thorasic Oncology
MedStar Georgetown University Hospital
Pashna Munshi, MD
Associate Clinical Director
Stem Cell Transplant and Cellular Immunotherapy Program
MedStar Georgetown University Hospital
Lanre Okusanya, PharmD, MS
Clinical Pharmacology Team Leader, Office of Clinical Pharmacology
Center for Drug Evaluation & Research
US Food and Drug Administration
Melanie Royce, MD, PhD
Physician/Medical Officer, Office of Oncologic Diseases
Center for Drug Evaluation & Research
US Food and Drug Administration
May Tun Saung, MD
Medical Officer, Office of Oncologic Diseases
Center for Drug Evaluation & Research
US Food and Drug Administration
Sonia Singh, MD
Pediatric Oncologist, Office of Oncologic Diseases
Center for Drug Evaluation & Research
US Food and Drug Administration
Julius Strauss, MD
Assistant Research Physician, Laboratory of Tumor Immunology and Biology
National Cancer Institute
National Institutes of Health
Simon Williams, PhD
Pharmacologist, Office of Oncologic Diseases
Center for Drug Evaluation & Research
US Food and Drug Administration
[h3]Commercial Support[/h3]
In-kind financial support (faculty’s time) has been provided by the following companies:
– Bristol Myers Squibb
– TEVA Pharmaceuticals
[/three_fourth]
[one_fourth_last]
[h3]Event Details[/h3]
Date: June 22 – 24, 2020
Location: Virtual Training
Course Price: $1795
This course has concluded.
[h3]Request a Proposal[/h3]
Interested in bringing this course to your company? Request a proposal and a PERI team member will be in touch about hosting this course as a Corporate Education program.
[button_medium color=”orange” url=”/corporate-education/request-a-proposal/”] Request Proposal[/button_medium]
[h4]Course Information[/h4]
Lauren Kirk
Course Manager
571-490-8409
[button_small color=”slate” url=”mailto:lkirk@peri.org”]Email Question[/button_small]
[space height=”20″]
[h4]Our Students[/h4]
[sliders]
[slider]
[dropcap1]1[/dropcap1] “I have a better understanding of disease states and treatment options to draw from when planning clinical trials.”
[/slider]
[slider]
[dropcap2]2[/dropcap2] “I have a better appreciation of the bleakness of certain cancers for patient outcomes and the urgent need for development of effective treatments.”
[/slider]
[slider]
[dropcap1]3[/dropcap1] “I will now try to focus clinical terms on designing studies that are more focused on specific patient populations.”
[/slider]
[/sliders]
[/one_fourth_last]
[space height=”1″]