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.
Pharma industry leaders share their expertise on Pharma Forum Dialogues, the blog launched by New York Pharma Forum in 2014. Here are the top 3 most-read blog posts of 2014.
Drug companies face two regulatory reviews when adopting new trade names for their drug products in the United States, at the United States Food and Drug Administration (“FDA”) and the United States Trademark Office (“USTO”). Both of these agencies review trade names to reduce or eliminate any confusion that the name might cause. However, because the agencies are trying to protect different classes of people from confusion, their review standards and procedures often differ. FDA is trying to prevent healthcare professionals from giving the wrong medicine to a patient, while the USTO is trying to prevent companies from adopting names that confuse consumers regarding the source of the labeled goods.
Corruption and Bribery Concerns Affecting Japanese Pharmaceutical Companies Operating in the United States
Recent criminal enforcement actions against Japanese companies and executives have made very clear that no company or employee is safe from charges of bribery and corruption. Japanese pharmaceutical companies that operate in the United States must be aware of anti-corruption laws in both the United States and Japan. These laws can be used to prosecute misconduct occurring in Japan, the United States, and even other countries—highlighting the need for companies to ensure that they have robust compliance policies and programs in place around the globe.