Your PDT

Unmatched Credentials

Your RRD Product Development Team (PDT) is structurally and functionally similar to that of a core team in an established biopharmaceutical company.

With an unmatched set of credentials, your team will tailor a strategy designed to optimize product value to a defined stage of development and then direct and control execution of that strategy towards optimizing outcomes. RRD defines a specific PDT for each program with the appropriate expertise and experience to meet the program’s requirements.

Meet Your Strategic, Scientific, and Medical Leads

The PDT includes RRD senior leadership, strategic, scientific, and medical leads, and program and functional area leaders:

  • Program strategy is developed and led by the RRD senior team with strategic, scientific, and medical input from both internal and external experts. In collaboration with our partner, RRD leadership is closely involved in the oversight, decision-making, and governance of each program.
  • Execution of the strategy is led by Program and Functional Area Leaders. This integrated team is responsible and accountable for implementation and management of the development program strategy, including oversight and management of CROs and other vendors.

Strategic, Scientific, and Medical Leads

Donna Ambrosino, MD

ClearPath Vaccines
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George DeMuth, MS

Biostatistics
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Masaki Doi, PhD

Business Development & Licensing
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Catharine Dorrier, MS

Clinical Trial Design and Analysis
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Patrick (Pat) Frenchick, PhD, MBA

Immunology and Biochemistry
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Jeffrey Gelb, MD

Immunology, GI, Rare Diseases
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William G. Kramer, PhD

Pharmacokinetics and Bioanalytics
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Ian Krane, PhD

Protein Expression and Molecular Biology
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Mark Leney, PhD

ClearPath Vaccines
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Bridget Martell, MD

Oncology, Pain, and Addiction
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Ralph Raymond, MS

Biostatistics
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Laura Redden, MD, PhD

Neuroscience and Immunology
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Eric Rowinsky, MD

Oncology
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Neil Sandler, MBA

Strategic Investments
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George Siber, MD

ClearPath Vaccines
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David West, PhD, MPH

Medical Devices
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Gary Wolfe, PhD, DABT

Toxicology
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Kathryn Zunich, MD

Allergy and Immunology
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Your PDT

The right team members will be engaged, only when needed, to provide Partners with a full development team at a small fraction of the cost of building their own infrastructure. These Program and Functional Area Leaders are responsible and accountable for implementation and management of the development program strategy, including any third party vendor support that may be required.

BioPharma
Partner
Development Advisory
Committee+
BioPharma
Partner
RRD
DAC MembersDAC Members
RRD
Ops Liaison
Senior Program
Leader+

Functional Area Leaders

Project
Management+
QA +
Clinical
Pharmacology +
Regulatory
CMC+
Regulatory
Affairs+
Medical
Writing+
Clinical
Operations+
Medical
Monitoring +
CMC/Analytics +
Data
Management +
Biostatistics +
Contracts+
Toxicology +
Development Advisory
Committee+
BioPharma
Partner
RRD
DAC MembersDAC Members
BioPharma
Partner
RRD
Ops Liaison
Senior Program
Leader+
Project
Management+
QA +
Clinical
Pharmacology +
Regulatory
CMC+
Regulatory
Affairs+
Medical
Writing+
Clinical
Operations+
Medical
Monitoring +
CMC/
Analytics +
Data
Management +
Biostatistics +
Contracts+
Toxicology +