An Initial Public Offering (“IPO”) is a pinnacle event in a biotech company’s life cycle. An IPO can provide a company with the necessary capital to realize its business strategy and the means to acquire new assets or technologies.
Embarking on the IPO process, though, is not for the faint of heart. It is a stressful journey, that can be lengthy in nature with success highly dependent upon events (i.e., market conditions) and participants (i.e., investors and regulatory authorities) the company cannot directly control. Also, management’s once very private business world is now opened up for all to inspect, question and at times challenge. Thankfully, some of the stress and anxiety that is inherent in this process can be mitigated through proper planning.
Today, life sciences companies are facing numerous compliance challenges like never before, from increased regulation, push toward harmonization, security and privacy concerns, globalization, mergers and acquisitions. Just as emerging markets now represent an increasing percentage of life sciences industry revenues, the regulatory standards of those markets have become an additional worry for regulatory affairs compliance officers. Considering the reliance on technology and cloud-based solutions, those approaches present an additional challenge for complete and consistent compliance.
Mike Frazier | TERIS
The regulatory landscape for the medical device industry is becoming increasingly complex; and compliance has never been more important. The Department of Justice set a new record in 2014 in FCA litigation by recovering nearly $6 billion, with qui tam relator recoveries totaling nearly $3B. Healthcare fraud continues to be a substantial component of these recoveries. Additionally, FCPA and Anti-kickback statute investigations, HIPAA and Sunshine Act compliance, and international trade compliance all continue to be top concerns for medical device executives as they look to expand their offerings across the globe. A robust compliance program is necessary to adequately and quickly respond to the aforementioned, and other, potential threats. That’s easier said than done. Navigating compliance with the myriad of domestic and international regulations, while balancing the pressures to meet individual and company revenue goals, can be a real challenge for any organization. There are rarely black and white answers – only shades of gray.
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Regulation aims to serve as a brake to curb some of the market’s excesses, protect customers, and try to keep competition fair. In healthcare, the need for regulation has greater stakes since we are dealing with the physical well-being of patients. Given the amount of money flowing into healthcare, regulations also consider the financial well-being of patients, insurers, taxpayers and other payers.
Bret Bissey | MediTract
In today’s highly regulated healthcare environment, establishing an effective compliance program is essential for healthcare providers, pharmaceutical and medical device companies. Equally important to the organization’s compliance and ethics program is the leadership assigned to oversee it. When selecting potential candidate(s), it’s critical to outline the desired qualities and know how these fit into the compliance culture of your institution.