Pre-Commercial Life Sciences Companies

• Clinical Trials: Our healthcare and food and drug lawyers work together to provide seamless advice on the complex web of challenges to pursuing clinical investigations of new drugs and biological products. We help clients comply with diverse applicable regulations and guidelines, including those relating to Good Clinical Practices and similar matters. Our advice on these issues is informed by deep knowledge of industry practices. We extend this experience to our clients through intimate benchmarking forums in which manufacturers at all stages of development gather to discuss issues related to clinical trials (ctlegal) and pharmacovigilance (pvlegal), helping member companies share best practices and address current industry challenges.
• Food, Drug, and Medical Device: We advise pre-commercial companies on the marketing of products, including novel therapies such as gene and cell therapies, regulated by the FDA, EMA, and other governmental authorities. We help pre-commercial companies devise their pre-market regulatory strategies, avoid obstacles in the pre-submission process, navigate the pathway to approval, and communicate appropriately with prescribers, patients, and other stakeholders. When necessary, we advocate for our clients in disputes with the approval authorities. We offer our clients insight into how regulators think, as many of our lawyers have held senior positions at the FDA and other governmental agencies.

Law Firm of the Year – FDA Law
U.S. News – Best Lawyers® “Best Law Firms” 2022

• cGMP/QSR Compliance: Unique among law firms, we have a team of lawyers and other professionals dedicated to helping companies assess their manufacturing operations and quality systems, and those of their contracted manufacturers, and on compliance with cGMP/QSR and analogous regulatory requirements. We put “boots on the ground” at manufacturing sites worldwide to help companies prepare for regulatory inspections, promptly respond to issues and enforcement activities, and coordinate action plans and communications with regulators, consumers, and the public.
• Healthcare Compliance: We assist pre-commercial life sciences companies in evaluating risk arising from compliance with laws related to interactions with potential referral sources in the U.S. and abroad and other fraud and abuse laws and regulations and assist them in protecting themselves by designing, implementing, reviewing, and assessing compliance programs tailored to their size, stage, and role in the life sciences industry.
• Pricing and Reimbursement: We help pre-commercial life sciences companies price their products to best manage the legal, policy, political, and public relations risks associated with product pricing. Our lawyers interface with all relevant enforcement agencies and work with clients and trade associations to guide government decision-makers as they develop reimbursement policies for existing and novel products and services.
• Market Access/Payer Contracting: Life sciences companies must begin to shape their managed care and customer contracting strategy well before product launch. Our team works with companies in the pre-market phase to develop effective strategies to ensure optimal coverage of their products and to create coverage, coding, and reimbursement policies for new products.
• Privacy and Cyberlaw: Sidley’s privacy team helps pre-commercial companies build and implement data compliance programs that protect their most valuable assets, consistent with HIPAA, HITECH, GINA, various state healthcare privacy and state marketing laws, and international data protection laws, including the GDPR. When issues do arise, we help companies respond to data breaches and manage the related regulatory and litigation fallout. We also advise on avoiding risks related to Big Data and AI applications in the life sciences space, including on data bias, de-identification, and monetization. We offer clients access to critical industry benchmarking data through dplegal, our peer network focusing on data privacy and cybersecurity matters.
• Intellectual Property: Intellectual property is mission-critical for pre-commercial manufacturers of drugs, biologics, and devices. Companies — particularly early-stage companies — require strategies that effectively leverage their patent and other IP rights while navigating the rights of others. Our intellectual property lawyers, including litigators with deep scientific and patent knowledge and first-rate trial lawyers, have successfully enforced patents on blockbuster biologic products and drugs, industry-changing medical devices, and revolutionary treatment methods. Likewise, we have successfully defended life sciences companies in high-profile, bet-the-company IP disputes. And importantly, we use our litigation-hardened experience to help companies resolve IP disputes, often before litigation even starts. Our teams begin working with pre-commercial companies well before litigation is contemplated, helping them to assess patents that may be enforced or challenged, and then preparing them so that when litigation starts, they hit the ground running.

“Impact Case of the Year" for Immunex Corp., et al., v. Sandoz Inc., et al.
Managing Intellectual Property Americas Awards 2020

• Product Liability: All life sciences companies must anticipate potential product liability suits once their products are on the market. The best defense to those future challenges is to anticipate and proactively build defenses into the development records. Our product liability lawyers regularly conduct pre-launch risk assessments to identify and mitigate challenges before they turn into litigation. We identify potential product liability vulnerabilities, originating in the company’s data, regulatory submissions, documents, or otherwise; analyze them in the context of potential wrongful death, personal injury, FTC, and state unfair and deceptive trade practice claims, and advise companies on how to prevent litigation before it occurs.
• Labor, Employment, and Immigration: We help emerging life sciences companies manage their relationships with employees, including hiring, retaining, and ending employment relationships; defending and avoiding employment disputes; drafting and training on employment policies; and protecting and handling trade secrets disputes. We assist in the design of compensation and benefit programs to help life sciences companies attract, retain, and incentivize employees.