The Werner Group - What We Do

Regulatory, legislative and policy analysis and strategy development – Analyze specific issues relating to the biotech and pharmaceutical industry, patients, physicians, and other medical research stakeholders including FDA drug/device review and approval processes; NIH policies; reimbursement and CMS policies; intellectual property; and bioethics. Help organizations identify, understand and anticipate developments on key issues, and create appropriate strategies to accomplish goals.

Legislative advice – Identify state and federal legislative threats and opportunities. Analyze legislative proposals and provide strategic advice, direction, and support.

Bioethics advice – Identify and analyze bioethics challenges facing clients and develop necessary strategies. Help organizations develop policies and procedures to address bioethics issues.

Risk management – Provide analysis of public policy trends and provide strategic advice that accounts for public responses to company activities. Strategize on how to proactively take steps to minimize negative reaction and/or to generate maximum support from appropriate decision makers and public and private groups. Help lead and shape company thinking about the social consequences of proposed development of and uses of technology, and develop a company framework to address these issues. Help companies participate in appropriate and productive public dialogue about the risks and benefits of the company’s technology and business strategy.

Alliance building – Identify key individuals, organizations and groups and build relationships between your firm and those groups to achieve company goals. Work with the company to forge relationships with groups that could be hostile to try to neutralize, or at a minimum, understand and productively react to this opposition.

Maximize relationship with BIO – Identify opportunities to strategically participate in BIO and take full advantage of a company’s membership in the organization. Help the company access key BIO staff and resources as well as participate in activities including: government relations; regulatory analysis and action; and business development.