Focused Experience

Name: Faber Daeufer & Itrato
Price range: $

Getting ready for a phase 2 or 3 clinical trial

Overview

We have provided counsel to hundreds of companies about to conduct multi-country, late-stage clinical studies.

Based on your trial protocol, site selection criteria, and the capabilities of the CRO of your choice, we’ll identify key issues, then tailor a contracting strategy that:

Protects control of intellectual property
Preserves access to data
Ensures regulatory compliance
Fairly allocates risk

Industry Knowledge

Developing an understanding

We are advisors who understand the unique challenges drug development companies face, and specifically the need to balance speed with attention to the details that could derail your project.

At Faber, we develop a deep understanding of our pharmaceutical and medical device company clients and their specific clinical studies, and we utilize that knowledge through our client teams of lawyers and contract specialists who:

have years of in-house and other experience at pharmaceutical and medical device companies

work with each client on an ongoing basis, thereby enabling the team to provide focused services to meet the specific needs of each client

We have a comprehensive understanding of industry practices, both within geographical regions, and categories of sites - from large academic institutions to smaller private clinics.

We take into account the indication under investigation, targeted patient population, sites and country mix, and our client’s needs and expectations in order to:

develop contracting models and document templates tailored for the particular participants, study, and country mix
help our client's structure its relationships with vendors, consultants and contractors so as to manage risk, and build in counterparty accountability mechanisms
bring in, when needed, the expertise of local legal counsel who we have existing relationships with due to previous collaborations in the countries involved in the study

We are better able to negotiate on behalf of our clients by utilizing:

our comprehensive understanding of industry practices, both within geographical regions and within categories of sites (from large academic institutions to smaller private clinics)
our extensive experience working with centralized International Review Boards (IRBs), country and regional ethics committees, scientific advisory boards, Key Opinion Leaders (KOLs), and in consulting relationships
our profound understanding of both the legal issues and the practical concerns involved in starting up a late phase clinical study, including Good Clinical Practices (GCP) concerns, Information Consent Form (ICF) issues, data sharing and privacy issues, protection of confidential information, and intellectual property rights

A focus on what matters

Standard CRO agreements often include numerous generic provisions that can bog down negotiations. By contrast, we’ll design clinical trial agreements (CTAs) that are streamlined, laser-focused and complete in order to expedite negotiations and help you enroll your trial sooner.

Our approach, which is modeled on the practices of major pharmaceutical companies, is unique among law firms.

If you are conducting your products clinical trial(s) in collaboration with a strategic partner such as Big Pharma, that strategic partner has likely imposed obligations on you designed to protect intellectual property rights, preserve confidentiality and data privacy, ensure compliance, and address liability. Typically, you will be required to pass these obligations along to your clinical trial vendors and sites. Our licensing lawyers have extensive in-house experience operationalizing these complex license and collaboration agreements with strategic partners in the context of clinical trials.

A deeper understanding

We can help you understand your obligations, and how to incorporate these kinds of requirements effectively into your services and clinical site agreements in order to help you meet aggressive timelines and manage your legal costs.

Recent clinical projects

Partners In Health

Clinical Trial

CRO and Site Agreements for Phase 4 Clinical Study of Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World

2020

See Study

Portola Pharmaceuticals, Inc.

Clinical Trial

CRO and Site Agreements for a Phase 3 Clinical Study of Betrixaban with over 180 Sites in 34 Countries

2016

See Study

Puma Biotechnology, Inc.

Clinical Trial

CRO and Site Agreements for an Open-Label, Phase 2 Study with 30 Sites in 9 Countries exploring the efficiency of Neratinib on Patients with Solid Tumors with Somatic Human Epidermal Growth Factor Receptor (EGFR, HER2, HER3) Mutations Or EGFR Gene Amplification

2022

See Study

BeiGene, Ltd.

Clinical Trial

CRO and Site Agreements for a BGB-3111-302 Phase 3 Global Trial with 60 Sites in 12 Countries

2016

Press Release

Deciphera Pharmaceuticals, LLC

Clinical Trial Agreements

Clinical Trial Agreements Contracting support for clinical trials 2036-01-004, 2618-01-001, 2618-03-002 Intrigue, 3014-01-001, 2036-01-003 & 2618-03-001 Invictus

Website

Blueprint Medicines Corporation

Clinical Trial Agreements

Contracting support for clinical trials BLU-285-1303, BLU-285-2203 and BLU-285-2202

Website

Sirtex Technology Pty Ltd

Clinical Trial

CRO and Site Agreements for a pivotal device study with 15 US sites to evaluate the safety and effectiveness of SIRT using SIR-Spheres Y-90 resin microspheres as first-line treatment for local control of HCC (Barcelona clinic liver cancer (BCLC) stage A, BCLC stage B1 and BCLC stage B2)

2021

See Study

IDEAYA Biosciences, Inc.

Clinical Trial

CRO and Site Agreements for a Phase I Study to evaluate the safety, pharmacokinetics, and pharmacodynamics of escalating doses of IDE397 (MAT2A inhibitor) in patients with advanced solid tumors

2021

See Study

Instylla, Inc.

Clinical Trial

CRO and Site Agreements for a randomized multi-center, parallel-group study to evaluate the safety and effectiveness of the Instylla Hydrogel Embolic System (HES) compared with standard of care transcatheter arterial embolization (TAE)/transcatheter arterial chemoembolization (cTACE)

2021

See Study

HUTCHMED Limited

Clinical Trial

Contracting support for a global, multicenter, randomized, placebo-controlled Phase 3 Trial to compare the efficacy and safety of Fruquintinib plus best supportive care to placebo plus best supportive care in patients with refractory metastatic colorectal cancer (FRESCO-2)

2020

Press Release