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THERAPEUTIC EXPERTISE

Oncology & Hematology Clinical Development Expertise

Oncology & Hematology Clinical Development Expertise

Oncology & Hematology Clinical Development Expertise

Scientific understanding applied to complex clinical programs across disease settings, therapeutic modalities, biomarker strategies, and the development continuum.

Scientific understanding applied to complex clinical programs across disease settings, therapeutic modalities, biomarker strategies, and the development continuum.

Scientific understanding applied to complex clinical programs across disease settings, therapeutic modalities, biomarker strategies, and the development continuum.

HEMATOLOGIC MALIGNANCIES

HEMATOLOGIC MALIGNANCIES

SOLID TUMORS

SOLID TUMORS

PHASE II–IV

PHASE II–IV

Explore Capabilities
Let’s Talk
THERAPEUTIC EXPERTISE

Oncology & Hematology Clinical Development Expertise

Scientific understanding applied to complex clinical programs across disease settings, therapeutic modalities, biomarker strategies, and the development continuum.

HEMATOLOGIC MALIGNANCIES

SOLID TUMORS

PHASE II–IV

Explore Capabilities
Let’s Talk
THE SCIENTIFIC POSTURE

We turn scientific questions into accountable execution.

We turn scientific questions into accountable execution.

We turn scientific questions into accountable execution.

We turn scientific questions into accountable execution.

We translate the question into evidence requirements, operating choices, and accountable decisions — without collapsing distinct disciplines into a generic service list.

We translate the question into evidence requirements, operating choices, and accountable decisions — without collapsing distinct disciplines into a generic service list.

We translate the question into evidence requirements, operating choices, and accountable decisions — without collapsing distinct disciplines into a generic service list.

OPERATING METHOD

OPERATING METHOD

01

01

DEFINE THE QUESTION

DEFINE THE QUESTION

Disease context, modality, endpoints, and evidence needs.

Disease context, modality, endpoints, and evidence needs.

02

02

MAP THE IMPLICATIONS

MAP THE IMPLICATIONS

Phase, design, biomarkers, operations, and standards.

Phase, design, biomarkers, operations, and standards.

03

03

PRESERVE THE DECISION

PRESERVE THE DECISION

Inputs, rationale, approval points, and handoff remain visible.

Inputs, rationale, approval points, and handoff remain visible.

FIG. 01  /  DISEASE AREAS

Depth across hematologic malignancies and solid tumors.

Depth across hematologic malignancies and solid tumors.

Depth across hematologic malignancies and solid tumors.

Depth across hematologic malignancies and solid tumors.

The disease setting changes the scientific question, the assessment framework, and the operating plan.

The disease setting changes the scientific question, the assessment framework, and the operating plan.

The disease setting changes the scientific question, the assessment framework, and the operating plan.

DISEASE AREAS

DISEASE AREAS

HEMATOLOGIC MALIGNANCIES

HEMATOLOGIC MALIGNANCIES

—

—

—

Leukemia

Leukemia

Leukemia

—

—

—

Lymphoma

Lymphoma

Lymphoma

—

—

—

Multiple Myeloma

Multiple Myeloma

Multiple Myeloma

—

—

—

Myelodysplastic Syndromes (MDS)

Myelodysplastic Syndromes (MDS)

Myelodysplastic Syndromes (MDS)

—

—

—

Myeloproliferative Neoplasms (MPN)

Myeloproliferative Neoplasms (MPN)

Myeloproliferative Neoplasms (MPN)

SOLID TUMORS

SOLID TUMORS

—

—

—

Lung Cancer

Lung Cancer

Lung Cancer

—

—

—

Breast Cancer

Breast Cancer

Breast Cancer

—

—

—

Colorectal Cancer

Colorectal Cancer

Colorectal Cancer

—

—

—

Prostate Cancer

Prostate Cancer

Prostate Cancer

—

—

—

Ovarian Cancer

Ovarian Cancer

Ovarian Cancer

—

—

—

Pancreatic Cancer

Pancreatic Cancer

Pancreatic Cancer

—

—

—

Melanoma

Melanoma

Melanoma

—

—

—

CNS Tumors / Glioblastoma

CNS Tumors / Glioblastoma

CNS Tumors / Glioblastoma

—

—

—

Testicular Cancer

Testicular Cancer

Testicular Cancer

Microscope and slides

OPERATING IMPLICATION

OPERATING IMPLICATION

Disease context informs endpoints, assessment, monitoring, and evidence review.

Disease context informs endpoints, assessment, monitoring, and evidence review.

DISCUSS AN ONCOLOGY OR HEMATOLOGY PROGRAM

DISCUSS AN ONCOLOGY OR HEMATOLOGY PROGRAM

→

→

FIG. 02  /  DEVELOPMENT CONTINUUM

We plan each phase around the decision it must support.

We plan each phase around the decision it must support.

We plan each phase around the decision it must support.

We plan each phase around the decision it must support.

Phase-specific planning connects scientific intent to operating evidence and approval points.

Phase-specific planning connects scientific intent to operating evidence and approval points.

Phase-specific planning connects scientific intent to operating evidence and approval points.

DEVELOPMENT CONTINUUM

DEVELOPMENT CONTINUUM

PHASE II

PHASE II

Proof-of-Concept

Proof-of-Concept

Clinical signal evaluation in defined populations.

Clinical signal evaluation in defined populations.

Clinical signal evaluation in defined populations.

PROOF GATE

PROOF GATE

Gate: endpoint and analysis alignment.

Gate: endpoint and analysis alignment.

PHASE IIB

PHASE IIB

Expansion

Expansion

Cohort expansion and biomarker-informed strategies.

Cohort expansion and biomarker-informed strategies.

Cohort expansion and biomarker-informed strategies.

PROOF GATE

PROOF GATE

Gate: selection logic and evidence threshold.

Gate: selection logic and evidence threshold.

PHASE III

PHASE III

Registrational

Registrational

Pivotal, regulatory-focused study design and execution.

Pivotal, regulatory-focused study design and execution.

Pivotal, regulatory-focused study design and execution.

PROOF GATE

PROOF GATE

Gate: traceable decisions and controlled handoffs.

Gate: traceable decisions and controlled handoffs.

PHASE IV

PHASE IV

Post-Approval

Post-Approval

Post-approval evidence, safety surveillance, and label commitments.

Post-approval evidence, safety surveillance, and label commitments.

Post-approval evidence, safety surveillance, and label commitments.

PROOF GATE

PROOF GATE

Gate: commitment scope and reporting cadence.

Gate: commitment scope and reporting cadence.

FIG. 03  /  MODALITIES & BIOMARKERS

From modality to measurable response.

From modality to measurable response.

From modality to measurable response.

From modality to measurable response.

Modality and biomarker strategy alter selection, sampling, endpoints, data flow, and the decisions that follow.

Modality and biomarker strategy alter selection, sampling, endpoints, data flow, and the decisions that follow.

Modality and biomarker strategy alter selection, sampling, endpoints, data flow, and the decisions that follow.

MODALITIES & BIOMARKERS

MODALITIES & BIOMARKERS

MODALITY

MODALITY

Mechanism and therapeutic construct

Mechanism and therapeutic construct

BIOMARKER STRATEGY

BIOMARKER STRATEGY

Selection, sampling, and assay

Selection, sampling, and assay

MEASURABLE RESPONSE

MEASURABLE RESPONSE

Endpoints, data flow, and evidence

Endpoints, data flow, and evidence

THERAPEUTIC MODALITIES

THERAPEUTIC MODALITIES

—

—

Targeted Therapies

Targeted Therapies

—

—

Antibody-Based Therapies

Antibody-Based Therapies

—

—

Antibody-Drug Conjugates (ADCs)

Antibody-Drug Conjugates (ADCs)

—

—

Bispecific Antibodies

Bispecific Antibodies

—

—

Immune Checkpoint Inhibitors

Immune Checkpoint Inhibitors

—

—

Cellular Therapies

Cellular Therapies

—

—

RNA-Based Therapeutics

RNA-Based Therapeutics

BIOMARKER STRATEGIES

BIOMARKER STRATEGIES

—

—

Population Selection

Population Selection

—

—

Predictive Biomarkers

Predictive Biomarkers

—

—

Response & Resistance Monitoring

Response & Resistance Monitoring

—

—

Pharmacodynamic Evaluation

Pharmacodynamic Evaluation

BIOMARKER TECHNOLOGIES

BIOMARKER TECHNOLOGIES

—

—

—

NGS

NGS

NGS

—

—

—

IHC

IHC

IHC

—

—

—

PCR

PCR

PCR

—

—

—

Flow Cytometry

Flow Cytometry

Flow Cytometry

—

—

—

FISH / ISH

FISH / ISH

FISH / ISH

—

—

—

RNA Sequencing

RNA Sequencing

RNA Sequencing

—

—

—

ctDNA

ctDNA

ctDNA

—

—

—

Proteomics

Proteomics

Proteomics

—

—

—

Imaging Biomarkers

Imaging Biomarkers

Imaging Biomarkers

—

—

—

MRD

MRD

MRD

FIG. 04  /  COMPLEX TRIAL DESIGN

Choose the design by the question it must answer.

Choose the design by the question it must answer.

Choose the design by the question it must answer.

Choose the design by the question it must answer.

Design choices carry operational consequences. This ledger keeps the question and implication together.

Design choices carry operational consequences. This ledger keeps the question and implication together.

Design choices carry operational consequences. This ledger keeps the question and implication together.

DESIGN LEDGER

DESIGN LEDGER

DESIGN

DESIGN

APPROPRIATE QUESTION

APPROPRIATE QUESTION

OPERATING IMPLICATION

OPERATING IMPLICATION

Adaptive Designs

Adaptive Designs

Adaptive Designs

Can prespecified evidence modify the study?

Can prespecified evidence modify the study?

Can prespecified evidence modify the study?

Decision rules, analysis, supply, and operations must remain aligned.

Decision rules, analysis, supply, and operations must remain aligned.

Decision rules, analysis, supply, and operations must remain aligned.

Basket Trials

Basket Trials

Basket Trials

Can one biomarker inform several tumor types?

Can one biomarker inform several tumor types?

Can one biomarker inform several tumor types?

Common logic must coexist with disease-specific evidence checks.

Common logic must coexist with disease-specific evidence checks.

Common logic must coexist with disease-specific evidence checks.

Umbrella Trials

Umbrella Trials

Umbrella Trials

Can several therapies be evaluated within one disease?

Can several therapies be evaluated within one disease?

Can several therapies be evaluated within one disease?

Stratification and treatment assignment must remain traceable.

Stratification and treatment assignment must remain traceable.

Stratification and treatment assignment must remain traceable.

Platform Studies

Platform Studies

Platform Studies

Can therapies enter or leave one continuing infrastructure?

Can therapies enter or leave one continuing infrastructure?

Can therapies enter or leave one continuing infrastructure?

Governance, versioning, and longitudinal controls become central.

Governance, versioning, and longitudinal controls become central.

Governance, versioning, and longitudinal controls become central.

Master Protocols

Master Protocols

Master Protocols

Can several hypotheses share a controlled protocol core?

Can several hypotheses share a controlled protocol core?

Can several hypotheses share a controlled protocol core?

Common elements and substudy boundaries require explicit ownership.

Common elements and substudy boundaries require explicit ownership.

Common elements and substudy boundaries require explicit ownership.

Randomized Controlled Designs

Randomized Controlled Designs

Randomized Controlled Designs

Does the comparator reflect the current standard of care?

Does the comparator reflect the current standard of care?

Does the comparator reflect the current standard of care?

Randomization, blinding, and endpoint adjudication must stay operationally intact.

Randomization, blinding, and endpoint adjudication must stay operationally intact.

Randomization, blinding, and endpoint adjudication must stay operationally intact.

Seamless Phase II/III

Seamless Phase II/III

Seamless Phase II/III

When is the expansion-to-registration transition supportable?

When is the expansion-to-registration transition supportable?

When is the expansion-to-registration transition supportable?

Transition criteria, evidence gates, and operational readiness must align.

Transition criteria, evidence gates, and operational readiness must align.

Transition criteria, evidence gates, and operational readiness must align.

FIG. 05  /  ASSESSMENT FRAMEWORKS

Frameworks that define clinical success.

Frameworks that define clinical success.

Frameworks that define clinical success.

Frameworks that define clinical success.

Applicability depends on the indication, protocol, endpoints, and approved competency scope.

Applicability depends on the indication, protocol, endpoints, and approved competency scope.

Applicability depends on the indication, protocol, endpoints, and approved competency scope.

ASSESSMENT FRAMEWORKS

ASSESSMENT FRAMEWORKS

TUMOR RESPONSE

TUMOR RESPONSE

—

—

RECIST 1.1

RECIST 1.1

—

—

iRECIST

iRECIST

HEMATOLOGIC DISEASE

HEMATOLOGIC DISEASE

—

—

Lugano

Lugano

—

—

IMWG

IMWG

—

—

ELN

ELN

CNS ONCOLOGY

CNS ONCOLOGY

—

—

RANO

RANO

ADDITIONAL ASSESSMENTS

ADDITIONAL ASSESSMENTS

—

—

PK / PD Assessments

PK / PD Assessments

—

—

Safety Endpoints

Safety Endpoints

—

—

Biomarker Endpoints

Biomarker Endpoints

—

—

Imaging Assessments

Imaging Assessments

FROM EXPERTISE TO EXECUTION

Six service capabilities.

Six service capabilities.

Six service capabilities.

Six service capabilities.

Scientific depth moves through the same accountable system — from operating plan to public record and financial line.

Scientific depth moves through the same accountable system — from operating plan to public record and financial line.

Scientific depth moves through the same accountable system — from operating plan to public record and financial line.

CAPABILITIES CATALOG

CAPABILITIES CATALOG

Explore All Capabilities
FAQ

Frequently asked questions.

Frequently asked questions.

Frequently asked questions.

Frequently asked questions.

The answers define timing, inputs, ownership, and the limits of the engagement.

The answers define timing, inputs, ownership, and the limits of the engagement.

The answers define timing, inputs, ownership, and the limits of the engagement.

Bring the scientific question. We’ll map it to execution.

Bring the scientific question. We’ll map it to execution.

Bring the scientific question. We’ll map it to execution.

Bring the scientific question. We’ll map it to execution.

Start with the disease context, the constraint, or the decision that needs a defensible path forward.

Start with the disease context, the constraint, or the decision that needs a defensible path forward.

Start with the disease context, the constraint, or the decision that needs a defensible path forward.

Let’s Talk→  24 HOUR RESPONSE
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