Guiding Drug Development

Oncology drug development presents extraordinary challenges. It requires significant scientific expertise, financial resources and dedication. Preclinical and clinical studies take years to complete and, even if successful, may not meet the standards for regulatory approval or pricing and reimbursement. With stakes this high, it’s no surprise that so many companies looking to develop and market treatments for cancer—and other life-threatening diseases—seek the advice of Ropes & Gray.

We guide organizations of all sizes through every phase of oncology drug development, from early-stage research to regulatory approval and market entry to post-approval compliance and evaluation of safety and efficacy issues. We also conduct regulatory due diligence for financial investors considering oncology-related opportunities.

Our team includes lawyers who have worked at the FDA and international regulatory authorities, as in-house counsel at life sciences companies, and as key policy advisors in the U.S. Congress, giving us a broad, cross-border perspective on the entire oncology drug development and approval process.

Through our multidisciplinary approach, we advise on matters such as:

• Clinical trial design, including the use of adaptive approaches that can potentially reduce the number of patients and the time frame necessary to support product approval, multiregional clinical trials that gather data across geographic locations, and decentralized clinical trials
• Use of real-world evidence—based on data obtained from sources such as electronic health records, medical claims and wearable technology—to support regulatory submissions, coverage and reimbursement determinations, and product marketing
• Expanded access or compassionate use programs, including the development of company policies, review of specific requests and communications with regulatory authorities
• Clinical trial recruitment efforts and transparency initiatives, including clinical trial websites, social media outreach efforts and plain-language summaries of clinical trial results
• Strategies for securing regulatory incentives and benefits—such as accelerated or conditional approval, breakthrough or Fast Track designation, and orphan designation—that can expedite drug development or spur innovation
• Development and regulatory approval of companion diagnostic (CDx) laboratory tests to help guide appropriate oncology drug selection
• Appeals of adverse regulatory decisions on product applications or discrete issues that arise during the product development process
• Promotional matters in various geographic regions, including legally compliant strategies for sharing scientific data on existing or novel therapies
• Pre-and post-approval regulatory inspections and internal investigations of compliance issues relating to clinical studies, drug manufacturing, product promotion and other aspects of regulatory compliance
• Post-approval compliance matters such as manufacturing quality, adverse event reporting and product recalls
• Market access strategies, including supportive evidence required to demonstrate treatment value
• Representation of companies before regulatory authorities and policymakers, as well as legal proceedings concerning lawfulness of decision-making
  
   

Shortening the Path to Oncology Drug Introduction

Life sciences regulatory and compliance partner Kellie Combs describes how Ropes & Gray guides life sciences companies through the opportunities and challenges they face when bringing new oncology products to market.