LEADING IMMUNOGENICITY
SOLUTIONS
Consulting services to help you navigate the unique challenges with immunogenicity and novel therapies.
Are you looking to:
Develop an immunogenicity strategy?
Develop an assay to test for immunogenicity?
Know if your assay is accurate and sensitive enough?
Decide if your immunogenicity program will be acceptable to regulatory agencies?
Communicate immunogenicity results to regulatory agencies and investors?
Understand a high rate of immunogenicity?
I'm an industry-recognized leader in immunogenicity, and here to help you address all issues related to immunogenicity testing, analysis, and regulatory steps. I have been working to provide solutions for immunogenicity problems as a consultant since 2014. Prior to that I built and led Amgen’s Clinical Immunology Department for 15 years.
How Can I Help You?
Let's Work Together
I leverage decades of industry experience to deliver solutions for you and your team, no matter the challenge.
Develop immunogenicity and drug levels assays
Preparation for meetings with FDA and other regulatory agencies
Establish an immunogenicity assessment strategy
Participate in meetings with federal agencies
Interpret immunogenicity results
Review validation protocols
Troubleshoot immunogenicity and drug levels assays
Provide assessment of a company's immunogenicity results
Develop an immunogenicity communication strategy
Develop a testing program for biotechnology clients
Write and/or review reports
Interpret and critique assay results
Services Provided >
Biotech Companies
-Establishing an immunogenicity assessment strategy
-Developing an Immunogenicity Risk Assessment Plan
-Interpretation of immunogenicity results
-Developing immunogenicity and drug levels assays
-Assisting in working with CROs to implement testing plans
-Troubleshooting immunogenicity and drug levels assays
-Preparation for meetings with the FDA and International Regulatory Agencies
-Participation in meetings with Regulatory Agencies
Services Provided >
Investment Companies
-Evaluation of immunogenicity risk with programs
-Interpretation of immunogenicity results
-Interface with drug companies to better understand risks of further drug development
-Provide an assessment of a company’s immunogenicity results
Services Provided >
CROs
- Assist in developing a testing program for biotechnology clients
-Work with the clients to better understand the needs of the testing plan
-Interpret and critique assay results
-Assist in developing assays
-Review validation protocols
-Review testing results
-Write and/or Review reports
Clients
My clients include small to mid-cap biotechnology companies, investment companies, contract research organizations, and exploratory startup companies. Client confidentiality is a top priority, so I do not list individual client names.
Your insights were vital on this project. Look forward to working with you on another project in the future.
Thank you for your partnership. You have always offered sound advice which greatly enhanced the confidence in our development/regulatory strategy and decision-making abilities. I look forward to keeping in touch.
