Clinical Development Oncology

James Burke. Expert Consultation.

Clinical Development & Oncology Strategy for Experimental Treatments.
Work directly with James Burke to evaluate the clinical development strategy behind your experimental treatment.

Together, you'll discuss implementation, clinical considerations, and the path toward responsible patient access.
Book 60-MinuteBook 30-Minute
Designed for biotechs preparing experimental treatment submissions.
DISCLAIMER: Independent scientific guidance. Consultations do not influence the outcome of any independent review process.
Preparing for Your Consultation.
To make the most of your session, share any available background information in advance, including a brief description of the therapy, supporting evidence, development stage, and any specific scientific questions they would like to discuss.
Submit Information
Selected Credentials
200+
Scientific Publications.
20+
Years of Research.
3
Scientific Fellowships.
01 OVERVIEW

Why Book This Consultation.

Experimental treatment submissions require scientific decisions that often extend beyond published guidance.

Evaluating evidence quality, identifying potential risks, and strengthening submission strategy all benefit from expert review before important decisions are made.
This consultation gives treatment developers direct access to Matt Kaeberlein's scientific insight to evaluate their therapy, strengthen submission strategy, and move forward with greater confidence.

How the Consultation Works.

Hear directly from Matt Kaeberlein about the scientific approach behind this consultation and how it can strengthen your treatment development strategy.
‍
·

Strengthen Your Submission.

Receive expert feedback to improve the scientific foundation of your therapy before independent review.
·

Reduce Scientific Risk.

Identify potential weaknesses, evidence gaps, and strategic questions before they become costly delays.
·

Accelerate Decision Making.

Receive expert feedback to improve the scientific foundation of your therapy before independent review.
Designed for biotechs preparing
experimental treatment submissions.
Book Consultation
02 Details

Consultation Scope.

Every consultation with Matt Kaeberlein is tailored to the current stage, challenges, and objectives of your treatment.
The discussion may include one or more of the focus areas below, depending on your treatment's priorities.

Scientific Rationale.

Evaluate whether the scientific foundation of your therapy is ready for submission.

Evidence Review.

Assess supporting data, identify evidence gaps, and discuss opportunities to strengthen your submission..

Submission Strategy.

Receive expert feedback to improve the scientific foundation of your therapy before independent review.

Development Planning.

Review next steps based on your therapy's current stage and long-term objectives.

Clinical Translation.

Explore practical considerations for moving promising therapies toward patient access.

Open Scientific Discussion

Bring specific questions about your therapy, development program, or submission strategy.

Consultation Details:

Duration:
30 or 60 min
Format:
Remote (Google Meet)
Availability:
Mon-Fri, 09:00-12:00
Time Zone:
Pacific Time (UTC−8)

Best Suited For:

▪ Biotechnology companies

▪ Clinical-stage therapeutic developers

▪ Research organizations

▪ Sponsors preparing experimental treatment submissions

▪ Teams evaluating scientific evidence and development strategy

Expected Outcomes:

▪ Clear next steps for your treatment strategy

▪ Practical scientific recommendations

▪ Greater confidence in your submission approach

▪ Answers to your most important technical questions
EXPERT PROFILE

Clinical Leadership.

James Burke, MD, is a board-certified medical oncologist with more than three decades of experience in cancer care and clinical development.

His career combines direct patient care with executive leadership in biotechnology, providing practical insight into the development, evaluation, and implementation of innovative therapies.
Through this consultation, James works directly with treatment developers to discuss clinical development strategy, oncology programs, and the practical considerations involved in advancing therapies toward responsible patient care.

Professional Highlights.

Chief Medical Officer:
KaliVir Immunotherapeutics
‍
Clinical Leadership:
Chief Medical Officer and senior clinical development roles across multiple biotechnology companies
‍
Medical Oncology:
More than 30 years of oncology
and hematology experience
‍
Board Certified:
Medical Oncology
(American Board of Internal Medicine)
‍
Recognition & leadership:
Healthgrades — Healthgrades Honor Roll
‍
Education & training:
University of California (San Francisco) — Fellowship, Hematology and Medical Oncology, 2000 - 2003

University of California (San Diego) Medical Center — Residency, Internal Medicine, 1997 - 2000

Georgetown University School of Medicine — Class of 1997

Affiliations.

Learn More.

Explore James Burke's professional background and clinical experience.

U.S. News & World Report ↗

Convene Healthcare Specialists ↗

ScienceDirect ↗

Scopus Preview ↗

Montana ETRB ↗

Doximity ↗

LinkedIn ↗ .
Book Consultation
Expert guidance for critical scientific
and submission decisions.
03 Process

Consultation Process.

Every consultation follows a straightforward process designed to maximize the value of your time with Matt Kaeberlein.
From booking to preparation and the consultation itself and follow ups, each step is focused on providing practical scientific guidance tailored to your therapy.

01—

Schedule Your Consultation.

Select the consultation length that best fits your needs and choose an available time directly from Matt Kaeberlein's calendar.

02—

Share Your Background.

Before the meeting, provide any relevant materials, including information about your therapy, supporting evidence, development stage, and the scientific questions you'd like to discuss.

This allows the consultation to focus immediately on the topics most relevant to your team.

03—

Iterate with
Matt Kaeberlein.

Discuss your therapy directly with Matt, receive scientific feedback tailored to your treatment, explore strategic questions, and leave with practical recommendations for your next stage of development.
03 Process

Consultation Process.

Every consultation follows a straightforward process designed to maximize the value of your time with Matt Kaeberlein.
From booking to preparation and the consultation itself and follow ups, each step is focused on providing practical scientific guidance tailored to your therapy.

01—

Schedule Your Consultation.

Select the consultation length that best fits your needs and choose an available time directly from Matt Kaeberlein's calendar.

02—

Share Your Background.

Before the meeting, provide any relevant materials, including information about your therapy, supporting evidence, development stage, and the scientific questions you'd like to discuss.

03—

Iterate with Matt Kaeberlein.

Discuss your therapy directly with Matt, receive scientific feedback tailored to your treatment, explore strategic questions, and leave with practical recommendations for your next stage of development.
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