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[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.
[h3]Benefits of Attendance[/h3]
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- Understand cancer and different treatments including emerging immunotherapies
- Learn clinical endpoints needed for review and regulatory approval
- Learn about operations and presentations, important for Advisory Committees
- Be able to discuss various cancer types such as lung, breast, colon, and others
- Find out about clinical protocol designs and imaging techniques
- Network with colleagues and experts in the oncology arena
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[h3]Download the final agenda for PERI’s comprehensive oncology course.[/h3]
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- Discuss the scope, nature and epidemiology of many 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
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[tab title=”Key Topics”]
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- Overview of Oncology Drug Development, Including Dosing Selection and Clinical Trial Design
- Cancer Types: Prostate, Lung, Breast,
Gynecologic, Brain and CNS, Colorectal, Melanoma, Renal Cell, Pancreatic - Emerging Drugs, Vaccines, other Immunotherapies
- Overview of US Regulatory Pathways and Outcomes
- Pediatric Development Initiatives and Regulations for Pediatric Cancer Treatments
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[tab title=”Who Should Attend”]
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- 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
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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 0708-0000-19-007-L01-P. 1.65 continuing education units (CEUs) are available for this program. Initial Release Date: 10/23/19. This is an application-based CPE Activity.
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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 16.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
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[h3]PERI Faculty List[/h3]
Shaily Arora, PharmD
Clinical Reviewer, Gynecologic Malignancies Team
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
VP, Global Regulatory Science
Celgene Corporation
Malini Iyengar, PhD
Head of Clinical Pharmacology
Adaptimmune
Sekwon Jang, MD
Director, Melanoma and Cutaneous Oncology Therapeutics and Research
Inova Schar Cancer Institute
Shakun Malik, MD
Head, Thoracic Cancer Therapeutics
National Cancer Institute
National Institutes of Health
Lanre Okusanya, PharmD, MS
Clinical Pharmacologist, Office of Clinical Pharmacology
Center for Drug Evaluation & Research
US Food and Drug Administration
Lorraine Pelosof, MD, PhD
Medical Officer, Gastrointestinal Oncology Team
Center for Drug Evaluation & Research
US Food and Drug Administration
Sonia Singh, MD
Pediatric Oncologist
Center for Drug Evaluation & Research
US Food and Drug Administration
Julius Strauss, MD
Staff Clinician, Laboratory of Tumor Immunology and Biology
National Cancer Institute
National Institutes of Health
Deepa Subramanian, MD, MSc
Director, Oncology Research & Development
AstraZeneca Plc
Suparna Wedam, MD
Medical Oncologist
Center for Drug Evaluation & Research
US Food and Drug Administration
Benjamin Weinberg, MD
Gastrointestinal Medical Oncologist
Lombardi Comprehensive Cancer Center
MedStar Georgetown University Hospital
[h3]Commercial Support[/h3]
In-kind financial support (faculty’s time) has been provided by the following companies:
– AstraZeneca Plc
– Celgene Corporation
– TEVA Pharmaceuticals
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[h3]Event Details[/h3]
Date: October 23-25, 2019
Location: MicroTek Washington
1110 Vermont Avenue NW, #700
Washington, DC 20005
Course Price: $1895
This course has concluded. Please visit the Professional Development Calendar for upcoming programs.
[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]
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[h4]Our Students[/h4]
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[dropcap1]1[/dropcap1] “I have a better understanding of disease states and treatment options to draw from when planning clinical trials.”
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[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.”
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[dropcap1]3[/dropcap1] “I will now try to focus clinical terms on designing studies that are more focused on specific patient populations.”
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