ECD Life Sciences - Your Partner in Drug Development
ECD Life Sciences - Your Partner in Drug Development
ECD Life Sciences
Strategic Drug Development Consulting
Expertise
Our goal is to partner with you to overcome your drug development hurdles. We do this through strong strategic collaboration, deep understanding of your asset, prioritization, and practical solutions.
Extensive Experience
With 20+ years of strategy, operations, regulatory and leadership experience in early clinical development, the team at ECD Life Sciences has a track record of successfully building cross-functional clinical development teams; transitioning molecules from development candidate nomination into first-in-human trials; navigating the complex regulatory landscape (in the US, Europe, and Australia), and developing drugs through proof of concept.
Therapeutic Expertise
- Solid Tumors
- Leukemia
- Lymphoma
- Rheumatology
- Rare Diseases
Core Capabilities
- Strategy
- Operations
- Medical Writing
- Relationship Building (Key Opinion Leaders / Principal Investigators / Sites)
Services
WHAT WE DO: ECD Life Sciences provides strategic drug development and consulting services to pharmaceutical, biotechnology and healthcare companies. Specific services are listed below. Contact us if you require assistance with other aspects of drug development so we can determine how best to support your needs.
Program Strategy
- Target Product Profile (TPP) development
- Integrated Development Plans (IDPs)
- Asset Leadership
- Program Management
Clinical Sciences
- Protocol Development
- Investigator Brochure Development
- Data Review
- Clinical Summary Reports
- KOL and PI Engagement
Clinical Operations
- CRO Selection
- CRO Oversight
- Medical Monitoring
Regulatory Affairs
- Pre-IND Interactions
- IND Filings
- Project Optimus
- Fast Track Designation
- Orphan Drug Status
- Project Front-Runner
Clinical Pharmacology & Clinical Biomarkers
- Healthy Volunteer Study Support for First-In-Human Trials, Food Effect Studies, Bioequivalence Studies, and Drug-Drug Interaction Studies
- PK Sampling Advice
- Biomarker Strategy to Support Proof-of-Concept
- Data Interpretation
Pharmacovigilance
- Review and approve Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment
- Company assessment for seriousness, expectedness, and causality
- Authoring/reviewing company comment, follow-up questions and analysis of similar event
- Drug Safety Update Reports
Daniel Weiss, MD - Principal, ECD Life Sciences
Certified Principal Investigator (CPI) | Independent Drug Development Consultant | Transitioning Assets from the Bench to the Bedside
About Me
I am a drug development professional with >20 years of industry experience. I currently support pharmaceutical companies with drug development efforts as a fully integrated member of the team. Prior to my full-time consulting work, I was Head of Early Clinical Development at Schrödinger where I successfully established clinical sciences, regulatory sciences, clinical operations, GCP quality, pharmacovigilance, and data sciences. Under my leadership, the clinical team filed two successful INDs and CTAs in oncology indications. I successfully advanced the company’s first two global oncology trials and an ex-US healthy volunteer trial into the clinic. In addition, I supported the clinical launch of other oncology assets in the pipeline.
Key areas of expertise include establishing and leading clinical development teams (science, regulatory, operations and quality), setting scientific strategy for early clinical drug development (including first-in-human and proof-of-concept studies), developing target product profiles (TPPs), creating integrated development plans (IDPs/CDPs), successfully submitting investigational new drug applications (INDs), KOL interactions, CRO oversight and medical monitoring of clinical studies. In my most recent role, I successfully transformed a preclinical biotech into a clinical organization through infrastructure build, strategy implementation, and operational excellence.
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