December 6, 2017, New York – New York Pharma Forum’s 28th Annual General Assembly titled “Pharma’s Commitment to Global Health”, took place on December 1st at the New York Academy of Medicine in New York City, and featured six high level speakers from leading pharma companies, non-profits, a strategy consulting firm, and investment fund, discussing new global health ecosystem models where innovation, strategic funding, and alliances accelerate development of new medicines and global access while still creating growth and meeting business goals.
By: Nao Takada and Eric W. Dittman, Paul Hastings LLP
イノベーション法（Biologics Price Competition and Innovation Act: BPCIA）を制定した。 従来、申請者はFDAにその製品の安全性および有効性を実証する臨床データを提供し、販売承認の許可申請であるバイオロジック・ライセンス・アプリケーション（ Biologics License Application: BLA）を提出していた。 BPCIAの元の簡略化された経路では、簡略化されたBLA（「aBLA」）の申請者は、その製品が「バイオシミラー」または「交換可能 であることを示す情報を代わりに提出する。既に承認されている参照製品のスポンサー（Reference Product Sponsor: RPS）は、後続のバイオシミラー製品に対して特許保護の有無にかかわらず、最長12年の独占期間を得る。
By: Nao Takada and Eric W. Dittman, Paul Hastings LLP
In 2010, Congress enacted the Biologics Price Competition and Innovation Act (“BPCIA”) as an attempt to balance innovation and competition in the biopharmaceutical market. Traditionally, an applicant filed a Biologics License Application (“BLA”) providing the FDA with clinical data demonstrating the safety and efficacy of its product. Through the BPCIA abbreviated pathway, an abbreviated Biologics License Application (“aBLA”) applicant instead submits information demonstrating that its product is “biosimilar” or “interchangeable.” The sponsor of an approved reference product, called a “reference product sponsor” or “RPS,” receives up to 12 years of exclusivity against follow-on biosimilar products, regardless of patent protection.
Did you miss out on reading one of New York Pharma Forum's most popular posts in 2015? Here’s a chance to catch up on what your colleagues found most interesting.
December 11, 2015, New York – “We reinvent pharma every few years, we’re always reinventing pharma, but you don’t see the drastic changes on a daily basis. This is why it’s a great value to step back and realize that we do in fact live in a changing time with serious challenges to our current business model,” said Ed Saltzman, President and Founder, Defined Health, at the 26th Annual General Assembly of the New York Pharma Forum.
New York Pharma Forum will hold its annual General Assembly on December 4th on "The Reinvention of Pharma." This symposium, which is free to attend, will be held at the New York Athletic Club in New York City from 3-5:30 pm. The event's speakers include:
What do four startups in the pharmaceutical, financial services, online retail, and solar lighting industries have in common? A July New York Pharma Forum program explored the “Roots of Disruptive Innovation,” the common element that brought together four successful entrepreneurs in very different fields to discuss their innovative products’ origins.
A pharmaceutical patent lawsuit against the Food and Drug Administration (“FDA”) earlier this year has clarified when 3-year Hatch-Waxman data exclusivity will prevent the United States Food and Drug Administration (“FDA”) from approving an application filed under section 505(b)(2) of the Food Drug and Cosmetic Act (the “FD&C Act”). In the case, Veloxis Pharmaceuticals, Inc. v. FDA, a United States District Court held that reliance on an earlier approval was not necessary for three year data exclusivity to delay the later filed 505(b)(2) application. Exclusivity arose solely because the later application was for the same drug as the earlier approval and would be approved for the same conditions of use.
By: Jyoti Sharma, Content Marketing Specialist, Catalent Pharma Solutions
The results from a recent drug delivery landscape survey1 confirm the key challenges faced by formulation scientists and R&D managers. Safety, efficacy, bioavailability and solubility issues dominated as the most significant factors in developing drug formulations. As per BCS classification, ~70% of new chemical entities (NCE) are class II or IV, either poorly soluble in water, have low cell permeability or both. It takes tremendous effort and investment for pharmaceutical companies to come up with NCEs which potentially can be commercialized into blockbuster drugs. A drug delivery system that can overcome the solubility and bioavailability challenges can result in increased probability of a commercially successful drug.
It’s no secret that consumers are social beings, so why should patients be treated any differently? Research has found that the average American goes to the doctor three times during the course of a year, but spends 52 hours online searching for health information. It’s not just from a computer either; 52 percent of smartphone users have looked up health or medical information from their mobile devices1. Americans want answers fast and head straight to online news outlets, social media channels, blogs, Wikipedia, pharmaceutical company websites, and everything in between.
Yet a recent Forbes article observes, “Among the 50 largest [pharmaceutical] companies, half still do not use social media to engage consumers or patients,” and only 10 of these 50 have made use of Twitter, YouTube, and Facebook, the top three social media channels.2
Why have so few pharmaceutical companies broken through using social media? Clearly companies remain concerned about running afoul of FDA regulators, and for that reason have not yet fully embraced new channels. When the FDA released long-awaited guidelines about the communication of health information via social media, it took a fairly restrictive stance, requiring that companies communicate information about risks and benefits in any social media message.