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Design Portfolio

Overview

Since 2020, we have seen a marked increase in both the adoption and sophistication of adaptive trial designs. Innovations are present across therapeutic areas and throughout the development cycle from early dose finding to late-stage confirmatory studies.
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Design
  • Platform Trials
  • Combination Therapy
  • Adaptive Sequential Bayesian
  • External Controls
  • Population Enrichment
  • Sample Size Re-Estimation
  • Group Sequential
  • Seamless Phase 2/3
  • Adaptive Dose-Finding
  • Cohort Expansion
  • Bayesian Basket
  • Single and Dual Agent Dose Escalation

Recent Innovative Design Projects

Bayesian Dynamic Borrowing Design

Phase 2 - Dermatitis

Adaptive Population enrichment design

Phase 3 - Oncology

Dual endpoints (one continuous, one binary)

Phase 3 - Inflammation

Single arm open label extention; Historical control borrowing plan

Phase 2 - Nephrology

Bayesian SCA + Multiple Endpoints

Phase 3 - Allergy

Biomarker Predictive Model (Sensitivity/Specific study)

Phase 2 - BC Assay

Seamless p2/3 design

Phase 2/3 - Rare Pulmonary

Dose Escalation - TITE BOIN design

Phase 1 - Oncology

Using Early endpoint as surrogate for primary EP

Phase 2/3 - Lupus

Dose Escalation - BLRM design

Phase 1 - Oncology

Design using RWD simulations

Phase 3 - CV

Dose Escalation - BOIN & Dose Expansion

Phase 1/2 - Oncology

Meet the teams contributing to the CDI

Whether for Rx new medicines, medical devices or over the counter (OTC) products, we share your ambition to bring new products to market quickly, efficiently and safely - with the utmost scientific rigor and to the maximum benefit of patients.

Our team members help you craft a bespoke development plan for your asset, optimizing your regulatory, clinical, and market access pathways, by identifying appropriate strategies and using data to support the decision-making process at every stage, from concept to commercialization.
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Who We Are

Our team of highly qualified MDs and PhDs includes expertise in regulatory, clinical, statistics, pharmacometrics, data science, and commercialization.  Our people are widely published, internationally prominent thought leaders who collaborate with an extensive network of health professionals from industry, academic institutions, and government bodies.

Our team of highly qualified MDs and PhDs includes expertise in regulatory, clinical, statistics, pharmacometrics, data science, and commercialization. Our people are widely published, internationally prominent thought leaders who collaborate with an extensive network of health professionals from industry, academic institutions, and government bodies.

 

Featured CDI Contributors

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Anna-Karin Alm

VP and Managing Director, SDS MedteQ
Mike_Fosslerx220

Michael Fossler

Vice President, Therapeutics Development Team
Yannis_Jemiai-4

Yannis Jemiai

Chief Scientific Officer
Albert Kim

Albert Kim

Chief Medical Officer
Maria_lundberg

Maria Lundberg

VP and Managing Director, SDS Life Science
JamesMatcham

James Matcham

Vice President, Therapeutics Development Team
D. Elizabeth McNeil

Elizabeth McNeil

Vice President, Therapeutics Development Team
Natasha Muhleman

Natasha Muhlemann

Vice President, Therapeutics Development Team
Krishna Padmanabhan

Krishna Padmanabhan

Senior Research Principal, Therapeutics Development Team
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Peter Russell

Senior Vice President, Therapeutics Development Team
Anna_Torner

Anna Törner

Founder and Business Developer, SDS Life Science
PantelisVlachos

Pantelis Vlachos

Vice President, Customer Success
Kyle_Wathenx220

Kyle Wathen

Vice President, Scientific Strategy & Innovation

CDI Members from Software Leadership

Yannis_Jemiai-4

Yannis Jemiai

Chief Scientific Officer
Kyle_Wathenx220

Kyle Wathen

Vice President, Scientific Strategy & Innovation
PantelisVlachos

Pantelis Vlachos

Vice President, Customer Success
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SDS Partners

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