1. Translational & Clinical Strategy
Bridging preclinical insights to human study design
Key Offerings:
- Translational assessment for clinical readiness
- Early-phase clinical development strategy
- Indication selection and biomarker strategy
- Clinical Endpoint definition aligned with mechanism of action and potency assay
Comprehensive evaluation of preclinical datasets—including in vitro systems and in vivo models—to identify gaps, de-risk programs, and define actionable next steps. Where required, Esco Aster can further the research gaps and/or produce the GLP Tox material connects clients with qualified partners to generate additional data from small animal, large animal, microbiome testing, and new approach methodologies.
Integrated scientific and clinical guidance from lead optimization through early clinical stages across modalities such as CAR-based immune cells (T, NK, dendritic), viral vectors, plasmid DNA, exosomes, and stem cell therapies, therapeutic products, nutrition.
Collaboration with a network of clinicians and scientific experts to identify optimal target indications (e.g., oncology, infectious diseases, regenerative medicine) and define biomarkers that demonstrate target engagement and therapeutic effect.
Translation of preclinical efficacy signals (e.g., cell viability, apoptosis markers, mutation suppression) into clinically meaningful endpoints such as tumor response, viral load reduction, safety, and immunogenicity whilst still aligned to potency assay.
This integrated approach ensures efficient progression from preclinical models to robust, human-ready clinical strategies.
2. Protocol Design & Clinical Planning
Designing scientifically robust and operationally feasible early-phase studies
Key Offerings:
- Clinical Protocol development and scientific review
- Patient population and eligibility criteria design
- Study design optimization for FIH and proof-of-concept trials
- CMC-informed clinical planning
Design of early-phase clinical protocols informed by deep CMC and manufacturing knowledge. For ATMPs, where product variability (e.g., donor-derived materials, cell viability, release specifications) directly impacts clinical outcomes, protocols are tailored to reflect real-world product characteristics.
Design of early-phase clinical protocols informed by deep CMC and manufacturing knowledge. For ATMPs, where product variability (e.g., donor-derived materials, cell viability, release specifications) directly impacts clinical outcomes, protocols are tailored to reflect real-world product characteristics.
Expertise in dose-escalation strategies, PK/PD bridging, and safety monitoring approaches tailored to advanced therapies. Integration with CTM manufacturing ensures timely availability of clinical-grade material for study execution.
Upstream and downstream process development—including media optimization, seed preparation, and scale-up—directly informs clinical study design and feasibility.
3. Medical Writing & Regulatory Strategy
Enabling efficient and aligned clinical entry pathways
Key Offerings:
- IND/CTA-enabling documentation
- Integrated CMC and regulatory support
- Regulatory strategy and agency engagement
Preparation of high-quality data packages, including process characterization, manufacturing controls, scale-up strategies, and CTM quality attributes required for regulatory submissions.
Alignment of manufacturing processes with regulatory expectations, including compliance with global standards (e.g., container-closure integrity, product characterization, and release specifications).
Experience in supporting ATMP-focused regulatory interactions, including preparation of briefing documents, response strategies, and alignment of clinical development plans with regulatory pathways to accelerate approvals.
4. Clinical Trial Enablement
Supporting transition from study design to study initiation
Key Offerings:
- Investigator and clinical network access
- Study setup and initiation support
- CRO and partner coordination
Leveraging partnerships with healthcare institutions, investigators, and biotech collaborators to support site identification, key opinion leaders, and clinical execution for advanced therapies.
End-to-end coordination of early-phase trial readiness, including CTM supply for Phase I/II studies, process transfer, and manufacturing scale-up.
Seamless integration as fractional talent representing sponsor as chief medical officer to liase with CROs and clinical partners, supported by internal consultancy and fractional expertise to ensure continuity from manufacturing through clinical operations.
Integrated Clinical Development Support
Esco Aster offers flexible engagement models—ranging from full end-to-end support to modular, fractional services—tailored to early-stage biotech companies seeking a streamlined path from manufacturing to first-in-human and early patient studies.
Summary
As a one-stop CRDMO partner, Esco Aster integrates process development, cGMP manufacturing, regulatory strategy, and clinical enablement to accelerate the translation of advanced therapies and nutrition food products into the clinic—enabling faster, more reliable delivery of innovative treatments to patients.