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Immuno-oncology


Providing personalized treatment with innovation for the future

PPD, a leader in immuno-oncology innovation, has conducted nearly 90 immuno-oncology programs that include checkpoint inhibitors, immune modulators, monoclonal antibodies, cancer vaccines, adoptive cell therapy and cytokines. Partnerships and collaborations are expediting an increasing number of combination trials that provide insight into checkpoint modulators as the backbone of immuno-oncology combinations. PPD has experience with 33 immuno-oncology combination studies. We manage one of the largest global immuno-oncology programs in lung cancer. Our experience and understanding of this unique treatment area — across all of our services — allows us to provide an in-depth offering.

immuno-oncology


Immuno-oncology, one of the pillars of cancer treatment, is driving engagement worldwide among biotech, large pharma, universities/cancer centers and the financial investment community. Currently, more than 130 biotech and 20 pharma companies are developing immuno-oncology therapies, according to the March 2016 Tufts Center for the Study of Drug Development (CSDD) report. That activity, Tufts CSDD said, reflects — and is fueling — worldwide immuno-oncology product sales, with annual revenues expected to reach $25 billion to $40 billion by 2020, up from $2.5 billion in 2015.

 


PPD has established an immuno-oncology center of excellence. This group has instituted a formal educational program for all our study teams and sites.


 

PPD’s Immuno-oncology Center of Excellence (IOCOE) is the foundation of our program:

immuno-oncology
  • The IOCOE’s personnel, innovative tools and resources encompass strong experience with implementing adaptive design approaches in early phase studies
  • Collaboration with academia, disease-specific organizations, clients, regulatory agencies, key opinion leaders and other groups support IOCOE members in developing efficient adaptive platform trials
  • With the increasing importance of immuno-oncology to oncology drug development and the growing need for knowledgeable research staff, the IOCOE provides a platform for PPD hematology/oncology personnel to stay informed about industry activity:
    • Current and expected immunotherapy drug approvals, in addition to the clinical trials that support such approvals
    • Recent clinical data with new agents in solid tumors and hematological malignancies
    • Emerging classes of immunotherapy and combinations - checkpoint receptor agonists and antagonists, targeted therapy, chemotherapy and cancer vaccines - including knowledge of competing trials with different patient populations
    • Regulatory strategies and considerations that provide breakthrough designations, priority review and accelerated approvals, which are becoming more common in immuno-oncology drug development
    • Approaches for reducing development timelines while mitigating for potential changes in standard of care

 


PPD manages one of the largest global immuno-oncology programs.


 

The IOCOE delivers immuno-oncology specific training that includes:

    immuno-oncology
  • Management of immune-related adverse events
  • Training in modified response evaluation criteria in solid tumors (RECIST) or immune-related response assessments to ensure integrity of the endpoints and to avoid premature discontinuation of treatment
  • Understanding the use of biomarkers in immuno-oncology clinical trials
  • Regulatory insight in this complex area, including awareness of the changing drug development landscape and supportive information for upcoming approvals

PPD’s immuno-oncology experience encompasses 29 individual indications including:

  • Non-small cell lung cancer
  • Multiple solid tumors
  • Melanoma
  • Non-Hodgkin's lymphoma
  • Breast cancer
  • Colorectal cancer
  • Head and neck cancer
  • Prostate cancer
  • Multiple myeloma
  • Renal cell carcinoma

Immuno-oncology Experts

Jaikrishna Balkissoon

Jaikrishna (Jai) Balkissoon, M.D., F.A.C.S

Vice President,
Immuno-oncology
Global Product Development

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Binh Nguyen

Binh Nguyen, M.D., Ph.D.

Vice President, Oncology
Global Product Development

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Kent Buhler

Kent Buhler

Senior Director,
Hematology/Oncology
Global Project Management

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Austin Combest

Austin Combest, Pharm.D., BCOP

Senior Director, Clinical
Science and Information
Global Product Development

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Andy Kinley

Andy Kinley, Ph.D.

Director, Feasibility
Strategy, SIA
Hematology/Oncology
Global Project Management

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