Services:
ECD Life Sciences provides strategic drug development 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.
For international sponsors, ECD Life Sciences also serves as your U.S. FDA Agent, from a lean standalone agent-of-record, to fully integrated regulatory document preparation and submission.
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
- eCTD Publishing and FDA ESG Submissions
- U.S. Agent Services for Foreign Sponsors
- Project Optimus / Project Front-Runner
- Fast Track Designation / Orphan Drug Status
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 events
- Drug Safety Update Reports
U.S. FDA Agent Services
Official U.S. Agent representation for foreign sponsors filing with the FDA - available on its own or combined with full regulatory and development support.
- U.S. Agent designation and IND countersignature (Form FDA 1571)
- Secure receipt, monitoring, and management of FDA correspondence
- eCTD publishing and Electronic Submission Gateway (ESG) filings.
- Standalone agent-of-record or fully integrated support
Learn more: U.S. FDA Agent Services
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 three successful INDs and CTAs in oncology indications. I successfully advanced the company’s first 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.
Through ECD Life Sciences, I also serve as U.S. FDA Agent for international sponsors. The same hands that built regulatory and clinical operations functions and filed INDs at
Schrödinger now manage FDA correspondence, countersign applications, and guide submissions for companies entering the U.S. market. When you engage ECDLS, you work
directly with me - not a junior account team - and the experience described above is what stands behind every engagement.
