Advanced Biosimilar & Advanced Therapy Statistics

Navigating the complex statistical landscape of biosimilar development and advanced therapy medicinal products requires specialized expertise.

As a dedicated biosimilar and advanced therapy consultant, I help pharmaceutical companies, biotechnology firms, and research institutions tackle the unique statistical challenges of these cutting-edge treatments.

Whether you’re developing biosimilar products, conducting cell therapy trials, or analyzing gene therapy efficacy, my expertise ensures your statistical approach meets regulatory standards and scientific rigor.

Comprehensive Biosimilar & Advanced Therapy Services

Transform your complex biologic data into regulatory-compliant insights.

My specialized statistical services address the unique challenges of biosimilar development and advanced therapy medicinal products (ATMPs).

Study Design & Protocol Development

Design robust trials that meet regulatory expectations for biosimilar and advanced therapy products.

  • Develop biosimilar equivalence studies with appropriate margin selection
  • Design cell therapy and gene therapy clinical trials with proper controls
  • Plan potency assays and comparability studies for regulatory submission
  • Create adaptive trial designs for CAR-T therapy and immunotherapy development
  • Establish endpoints and sample size calculations for regenerative medicine studies
  • Design combination therapy trials with complex interaction modeling

Specialized Regulatory Statistics

Navigate the unique regulatory landscape of biosimilars and ATMPs.

  • Conduct biosimilar biostatistics analyses meeting FDA and EMA guidelines
  • Perform three-way comparability studies for biosimilar products
  • Analyze immunogenicity data with appropriate statistical methods
  • Execute pharmacokinetic and pharmacodynamic equivalence assessments
  • Handle complex biosimilar development statistical challenges
  • Prepare regulatory-compliant statistical analysis plans and reports

Advanced Therapy Data Analysis

Specialized statistical approaches for cutting-edge therapies.

  • Analyze cell therapy efficacy with time-to-event and longitudinal methods
  • Conduct gene therapy statistics including vector biodistribution analysis
  • Perform stem cell therapy outcome assessments with mixed-effects modeling
  • Analyze tissue engineering studies with complex nested data structures
  • Execute CAR-T therapy response analyses with immune monitoring integration
  • Handle combination therapy interactions and dose-response relationships

Manufacturing & Quality Statistics

Ensure product quality through robust statistical process control.

  • Develop statistical process control for biologics manufacturing
  • Conduct potency assays validation with appropriate statistical methods
  • Perform comparability studies for manufacturing changes
  • Analyze batch-to-batch variability in biosimilar production
  • Design acceptance criteria for advanced therapy manufacturing
  • Execute stability studies for temperature-sensitive biologics

Immunogenicity & Safety Analysis

Specialized approaches for complex safety profiles of biologics.

  • Analyze anti-drug antibody (ADA) development patterns
  • Conduct immunogenicity risk assessment for biosimilar products
  • Perform safety signal detection in advanced therapy populations
  • Analyze cytokine release syndrome in CAR-T therapy trials
  • Execute immune monitoring studies with high-dimensional data
  • Handle adverse event analysis in rare disease populations

Regulatory Submission Support

Comprehensive support for regulatory interactions and submissions.

  • Prepare statistical sections for IND and BLA submissions
  • Develop responses to FDA and EMA statistical questions
  • Create statistical analysis plans meeting ICH guidelines
  • Prepare briefing documents for regulatory meetings
  • Support advisory committee presentations with statistical summaries
  • Provide post-market surveillance statistical analysis
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Why Work With Me For Your Biosimilar & Advanced Therapy Needs?

Working with a biosimilar and advanced therapy expert benefits you in multiple ways.

Time Efficiency

Focus on drug development while I handle complex statistical requirements.

Regulatory Compliance

Ensure your statistical approach meets FDA, EMA, and ICH standards for biosimilars and ATMPs.

Specialized Knowledge

Access expertise in the unique statistical challenges of biologics, cell therapy, and gene therapy development.

Confident Decision-Making

Make informed development decisions backed by robust statistical analysis tailored to your specific therapy type.

The Biosimilar & Advanced Therapy Process

My consulting process is designed for regulatory success and scientific rigor.

Discovery & Requirements

We discuss your specific biosimilar or advanced therapy development needs, regulatory pathway, and statistical challenges. I assess your data structure, study objectives, and timeline requirements.

Protocol Development & Statistical Planning

Together, we develop comprehensive statistical analysis plans that align with regulatory expectations. I create detailed study designs, power calculations, and analysis strategies specific to your therapy type.

Data Analysis & Implementation

I execute sophisticated statistical analyses using validated methods appropriate for your biosimilar or advanced therapy. I handle complex issues like immunogenicity assessment, potency assay validation, and manufacturing comparability.

Regulatory Documentation & Support

I deliver comprehensive statistical reports, regulatory submission documents, and publication-ready analyses. I provide ongoing support for regulatory interactions and post-market requirements.

For urgent questions, my on-demand consultation service offers quick, cost-saving solutions.

Book Express Consultation

Case Studies

I worked on large medical datasets to answer causal questions related to epidemiological determinants of disease through complex exposures. Challenges included selection bias, confounding, and missing data. I successfully developed a strategy that gave researchers confidence in their results.
I’ve worked with R&D scientists who were simultaneously running multiple experiments to answer important questions about their cutting-edge products that would have a direct impact on various stakeholders. My role was to help in designing and analyzing the experiments, balancing the conceptual purity of the Design of Experiments theory (DoE) with pragmatic concerns relating to costs and timeline. Most of this work is sealed behind a Non-Disclosure Agreement (NDA) which prevents me from elaborating more.

Don’t Just Take My Word For It…

The positive experiences of my happy collaborators showcased through their glowing testimonials, serve as powerful proof of trustworthiness and the impact of the results I deliver. These testimonials offer real-life examples of how I’ve helped research projects succeed. Here are some of their thoughts:

5/5

"He has a deep understanding of statistics, yet is able to skillfully explain complex concepts to people with little-to-no background in statistics both in French and English."

Elsa Brunet-Ratnasginham

Post-doc, UCSF

5/5

"I had never before worked with a biostatistician who speaks the same language as me! [...] Personally, our collaboration has allowed me to reconcile with statistics."

Manon Nayrac

Post-doc, CRCHUM

5/5

"I highly recommend Justin and his team for your data processing needs in order to have a more robust statistical model than the tests we are accustomed to conducting as biologists!"

Gérémy Sannier

Ph.D candidate, CRCHUM

5/5

"Thanks to him, statistics appeared to me as solutions rather than obstacles."

Mathieu Dubé

Research Associate, CRCHUM

Read Full Collaborator Testimonials
Justin Belair - Causal Inference Expert

My Statistics and Causal Inference Expertise

As a university-level statistics lecturer with a substantial LinkedIn following, scientists from all over the world come to me for my unique combination of academic excellence and practical experience in statistics and causal inference.

I’ve applied causal inference methods in varied settings in both academia and industry: in biomedical sciences such as nephrology, immunology, neuroscience, virology, occupational therapy, epidemiology, dermatology, psychiatry, and oncology; in natural sciences such as agronomy, ecology, and zoology; and social sciences such as communication, and psychology. The list keeps on growing!

I am currently writing an advanced textbook that I hope will give a young generation of academic and industry researches the tools needed to grapple with the complexities of causal inference, and maybe even develop a passion for the subject!

Need help with biosimilar or advanced therapy statistics? From protocol development to regulatory submissions, I offer specialized expertise in the unique statistical challenges of these complex therapies.

Let's Talk

Tools and Technologies

Advanced Statistical Software

Using R, SAS, and Python with specialized packages for biosimilar equivalence testing, survival analysis, and longitudinal modeling specific to advanced therapies.

Regulatory-Compliant Systems

I work with validated statistical environments that meet 21 CFR Part 11 requirements for pharmaceutical development and regulatory submissions.

Specialized Bioinformatics Tools

For gene therapy and cell therapy applications, I utilize specialized software for genomic data analysis, flow cytometry data processing, and immune monitoring assessments.

Client Industries Served

My statistical consulting expertise extends beyond specific industries, serving clients in fields ranging from R&D in biotechnology and pharmaceuticals to researchers and Principal Investigators (PI) in academia.