PHASE II
Proof-of-Concept
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.
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.
HEMATOLOGIC MALIGNANCIES
HEMATOLOGIC MALIGNANCIES
SOLID TUMORS
SOLID TUMORS
PHASE II–IV
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
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
01
01
DEFINE THE QUESTION
DEFINE THE QUESTION
Disease context, modality, endpoints, and evidence needs.
Disease context, modality, endpoints, and evidence needs.
02
02
02
02
MAP THE IMPLICATIONS
MAP THE IMPLICATIONS
Phase, design, biomarkers, operations, and standards.
Phase, design, biomarkers, operations, and standards.
03
03
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
—
—
Lymphoma
Lymphoma
—
—
Multiple Myeloma
Multiple Myeloma
—
—
Myelodysplastic Syndromes (MDS)
Myelodysplastic Syndromes (MDS)
—
—
Myeloproliferative Neoplasms (MPN)
Myeloproliferative Neoplasms (MPN)
SOLID TUMORS
SOLID TUMORS
—
—
Lung Cancer
Lung Cancer
—
—
Breast Cancer
Breast Cancer
—
—
Colorectal Cancer
Colorectal Cancer
—
—
Prostate Cancer
Prostate Cancer
—
—
Ovarian Cancer
Ovarian Cancer
—
—
Pancreatic Cancer
Pancreatic Cancer
—
—
Melanoma
Melanoma
—
—
CNS Tumors / Glioblastoma
CNS Tumors / Glioblastoma
—
—
Testicular Cancer
Testicular Cancer
OPERATING IMPLICATION
OPERATING IMPLICATION
Disease context informs endpoints, assessment, monitoring, and evidence review.
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
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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
Proof-of-Concept
PHASE IIB
Expansion
Expansion
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
Registrational
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
Post-Approval
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
—
—
IHC
IHC
—
—
PCR
PCR
—
—
Flow Cytometry
Flow Cytometry
—
—
FISH / ISH
FISH / ISH
—
—
RNA Sequencing
RNA Sequencing
—
—
ctDNA
ctDNA
—
—
Proteomics
Proteomics
—
—
Imaging Biomarkers
Imaging Biomarkers
—
—
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
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.
Basket Trials
Basket Trials
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.
Umbrella Trials
Umbrella Trials
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.
Platform Studies
Platform Studies
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.
Master Protocols
Master Protocols
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.
Randomized Controlled Designs
Randomized Controlled Designs
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.
Seamless Phase II/III
Seamless Phase II/III
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.
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
01
01
ALL THERAPEUTIC AREAS
ALL THERAPEUTIC AREAS
Clinical Research Finance
Clinical Research Finance
EXPLORE FINANCE
EXPLORE FINANCE
→
→
02
02
ALL THERAPEUTIC AREAS
ALL THERAPEUTIC AREAS
Regulatory Disclosure
Regulatory Disclosure
EXPLORE DISCLOSURE
EXPLORE DISCLOSURE
→
→
03
03
HEM/ONC
HEM/ONC
Trial Operations & Site Management
Trial Operations & Site Management
EXPLORE TRIAL OPERATIONS
EXPLORE TRIAL OPERATIONS
→
→
04
04
HEM/ONC
HEM/ONC
Patient Recruitment & Retention
Patient Recruitment & Retention
EXPLORE RECRUITMENT
EXPLORE RECRUITMENT
→
→
05
05
HEM/ONC
HEM/ONC
Study Start Up & Documentation
Study Start Up & Documentation
EXPLORE START UP
EXPLORE START UP
→
→
06
06
HEM/ONC
HEM/ONC
Data Management & Integrity
Data Management & Integrity
EXPLORE DATA MANAGEMENT
EXPLORE DATA MANAGEMENT
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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.
01
When should therapeutic strategy enter the operating plan?
02
What inputs are needed to begin?
03
How are biomarkers connected to execution?
04
What does KARAMATA own?
05
What remains with the client?
06
How are exceptions handled?
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.