How Biotech Companies Can Manage the Pre-IPO Process


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.
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Regulatory Compliance Challenges in a Global Economy


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.
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50 Shades of Medical Device Compliance


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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Pharma’s Regulation Shifts in the Past Decade


Changes in marketing, big recoveries reshape drug industry
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.
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Hiring the Right Compliance and Ethics Officer


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.
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FDA Social Media Guidelines in 2015: Engaging with Your Audience on Their Terms


Since the first Food and Drug Administration (FDA) hearings about Social Media in 2009, clarification on proper use and the overall comfort level surrounding the use of social channels for pharmaceutical marketing has been gradual. Now, half-way through the 2010s, marketers and the FDA are facing a new set of marketing technology challenges, driven by the explosion of mobile devices, along with an increasing reliance on responsive web design to proportion web experiences on-the-fly according to screen-size.
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