Millennials and Gen Ys Mold the future of Life Sciences


Articles, conversations, and debates abound over the cohort of adults born between 1980 and 2000. Coined the Millennials and Generation Y, the eldest have reached their mid-30s and occupy technical and management positions. They are the successors to Generation X and Baby Boomer executives and corporate leaders. What are the implications for Life Sciences and the Pharmaceutical industries and what shifts have already taken place?
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Document Management: The Key to Mitigating Medical Device Risk


In today’s highly regulated and complex medical device world, document control and management are critical to an organization’s success. Creating, producing and archiving all of the materials related to a product, such as a design history file or spec sheet, can be a daunting task especially considering aggressive development cycles, disparate teams and stringent regulatory requirements.
 
These factors have placed tremendous pressure on the traditional document processes organizations use today and created several challenges companies need to address in order to reduce risk and increase compliance. Before beginning to tackle the issues at hand, it is critical that manufacturers understand the requirements they must comply with first.
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On the Road to Compliance, a CPA Firm is a Biotech Entrepreneur’s Best Friend


For many pharmaceutical and biotech startups, the ultimate goal is to go public or be acquired by a larger company in the industry. To get the best deal, you’ll need the most accurate and verifiable records possible.
 
Along the way, there are plenty of hurdles to be cleared, including fundraising benchmarks, research and development breakthroughs and a series of FDA approvals. With each step in this long journey, the dream inches closer to reality and, financially speaking, the organization becomes more valuable. But it can take years.
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Personal Jurisdiction In Hatch-Waxman Actions In View of Daimler


Prior to the Supreme Court’s decision in Daimler AG v. Bauman, 134 S. Ct. 746 (2014), concerns over personal jurisdiction in Hatch-Waxman actions were essentially non-existent. General jurisdiction commonly provided the basis to assert jurisdiction over generic drug companies (generics).  Resort to state long-arm statutes or specific jurisdiction was rare.  If jurisdiction were questionable in the chosen forum and dismissal was possible, a second, so-called protective suit would be filed by the patentee in a district where jurisdiction was certain, e.g., the generic’s state of incorporation.  This insured that a proper suit was filed within 45-days of the patentee’s receipt of a generic’s notice letter, a critical benefit to patentees as it prevented the FDA from approving the generic’s ANDA for 30 months.
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Successful Mergers and Acquisitions Begin with a Well-Laid Plan (and That Plan Includes the CCO)


The life sciences industries are running rampant with transactional activity. Reports of new ownership of products, portfolios, or companies by acquisition, merger, or planned merger or acquisition make headlines on almost a daily basis. From the outside looking in, M&A activity is becoming “business as usual.” As with other aspects of the daily grind, however, the inside perspective tells a far different story: these mergers and acquisitions are fraught with a number of surprises—not the least of which is “what devil is (or how many devils are) in the details.”
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Generic Launch at Risk: No Patent Damages for Pediatric Exclusivity Period


As demonstrated in the recently-decided AstraZeneca v. Apotex, No. 14-1224 (Fed. Cir. 2015), whether computing lost profits or a negotiated reasonable royalty, courts will not award damages for generic infringement of patents whose terms have been “extended” in the Orange Book for pediatric exclusivity.  This is an important point that can be overlooked by brand plaintiffs contemplating the potential revenue stream from a generic willing to launch at risk and offering the olive branch or a reasonable royalty.  If maximum royalties are the goal, the brand needs to include the exclusivity period in its overall calculations, or couch the post-expiration payments as something other than a patent royalty.
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