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About Kammerman Consulting
Our regulatory and industry experiences make us unique in solving your regulatory, endpoint, statistical and trial design challenges. Because we understand the challenges facing both industry and regulators, we help you anticipate regulatory hurdles and guide you to successful regulatory submissions.
About our Founder, Lisa Kammerman:
For over 24 years, I worked as a biostatistician at the Center for Drugs and Evaluation Research at the US Food and Drug Administration (FDA) in roles that included Master Reviewer, Team Leader and Statistical Reviewer.
The first seven years were a career highlight. I supported the Division of Anti-viral drug products at the height of the AIDS and HIV epidemic when only 1 approved treatment (AZT) was on the market. Working together with industry, we pioneered new study designs and first in class treatments for HIV/AIDS and opportunistic infections with the aim to get new medicines to patients as quickly as possible. One of my projects was the prototype for the accelerated approval regulation. As FDA approved new products, placebo-controlled studies were no longer an option and new approaches were required. Thus began the onset of equivalence studies, now known as non-inferiority studies, for which I initiated the first working group.
While many may say working at the FDA qualifies them to be your consultant, here is what differentiates me.
Master Reviewer
CDER appointed me the prestigious role of Master Reviewer in recognition of my regulatory and statistical expertise, skills and contributions across numerous therapeutic areas and policy initiatives. Only a few reviewers achieved this status that required a rigorous application and review process.
Leader or co-leader of guidance document working groups
- • Non-inferiority studies
- • Rare diseases
- • Content and format of clinical studies section of labeling
Member of guidance document working groups
- • Patient-reported outcomes
- • Data monitoring committees
- • Adaptive designs
- • EOP2A
Member of FDA and CDER committees
- • Science and Prioritization Review Committee (CDER)
- • Institutional Review Board (FDA)
- • Risk-based monitoring and site selection
- • Regulatory science
Advisory committee presenter
- • Six presentations (Anti-viral, pulmonary, reproductive and urology, gastro-intestinal)
- • Supervised many more
Patient-reported outcomes leader
- • Formulated statistical policy
- • Led patient-reported outcomes program for the Office of Biostatistics
- • Consultant to statistical and medical reviewers
Team leader and statistical reviewer
- • Participated in hundreds of meetings with industry
- • Reviewed NDA and BLAs and supervised countless reviews
- • Reviewed countless study protocols and SPAs covering all stages of drug development
Labeling expert
- • Initiated and led the working group that wrote the guidance on the Content and Format of the Clinical Studies Section of Labeling
- • Consulted for numerous review divisions
From FDA, I went to industry where I held numerous roles at AstraZeneca. I used my statistical regulatory experience and addressed challenging regulatory questions, prepared teams for regulatory interactions, and reviewed and commented on regulatory submissions. I used my statistical expertise and knowledge of regulatory expectations to lead the development of a Missing Data Best Practices guideline and to write the Patient-reported Outcomes Guidance on the design and interpretation of studies that use PROs. I served as the global project statistician for AZ’s Alzheimer’s product.
In my last role I was Director, Information Sciences for Oncology and Immuno-oncology. My group provided scientific information to all late-stage development oncology and immuno-oncology project to enable quick and well-informed decisions.
Member of Statistical Innovations Group, Advanced Analytics Center
- • Developed missing data best practices document
- • Regulatory consults
- o Submissions to health regulatory agencies (HRA)
- • Commented and reviewed documents
- • Wrote or guided responses to HRA inquiries
- o Prepared teams for regulatory interactions and advisory committee meetings
- o Numerous consults on protocol development, endpoint selection, analysis plans, interpretation of results
- o Submissions to health regulatory agencies (HRA)
- • Leadership team member, biometrics, respiratory and inflammatory therapeutic areas
Statistical regulatory expert and PRO consultant, Oncology and Immuno-oncology
- • Leadership team member, biometrics, oncology and immuno-oncology therapeutic area
- • Developed AstraZeneca’s patient-reported outcome guideline on the design, analysis and interpretations of studies that use PRO data
- • Consultant to statistical and clinical teams on regulatory and PRO topics and challenges
Director, Information Sciences for Oncology and Immuno-oncology
- • Leadership team member, biometrics, oncology and immuno-oncology therapeutic area
- • Led group of 12
- • Supported information needs of clinical teams to make the best clinical development decisions
- • Drafted information strategy for all late-stage development R&D
• Anti-virals
• Special pathogens
• Pulmonary
• Anti-inflammatory
• Gastro-intestinal
• Reproductive
• Urology
• Oncology
• Immuno-oncology
• Diabetes