Author Archives: Clark Herman

The Sunshine Act: Cloudier Still?

By Clark Herman | Published: February 7, 2013
With the recent release of the Patient Protection Sunshine Act (PPSA), the Center for Medicare and Medicaid Services (CMS) has established reporting requirements to ensure that drug manufacturers properly disclose payments to physicians in areas of research, continuing medical education, etc. However a key uncertainty is the issue of state pre-emption. While state and local [...]
Posted in Legal, Manufacturing, Medical Education, Meetings, Regulatory, compliance | Tagged , , | 1 Comment

Trends in R&D: The Widening Gap between Success and Failure

By Clark Herman | Published: January 31, 2013
The Office of Health Economics (OHE) has released a new study examining drug development costs over the past 30 years. The study finds that out-of-pocket costs to bring a new medicine to market have increased over this period by 600%, success rates from proof of concept to registration have decreased at least twofold since the [...]
Posted in Emerging Markets, Europe, R&D, Strategy, Technology | Tagged | 1 Comment

The Strange Twists and Turns of 'Pay for Delay'

By Clark Herman | Published: January 30, 2013
In the arcane world of patent litigation, the term ‘pay for delay’ can be misleading, and as the Washington debate to restrict these deals unfolds, it is becoming apparent that a  ban on such settlements may serve to delay generics even further.  Is the fresh grass of reform really always greener than the well-seeded status [...]
Posted in IP, Legal, Market Access, Regulatory, Strategy | Tagged , | Leave a comment

It's Blind Leading the Blind on Companion Diagnostics

By Clark Herman | Published: January 25, 2013
A new report from the Tufts Center for Study of Drug Development (CSDD), confirms that companion diagnostics are an important factor for pharma companies to consider when seeking reimbursement of their drugs. But companies still have a ways to go in allaying the concerns of investors, regulators and payors alike, and fixing this will require [...]
Posted in FDA, Orphan Drugs, R&D, Regulatory, Strategy, Technology | Tagged | Leave a comment

Pharma's Promotional Spend: What's the Right Target?

By Clark Herman | Published: January 17, 2013
Global consultancy Cegedim has released its latest survey on how and where big Pharma puts its promotional dollar. Pharmaceutical Promotional Spend: Global Trends reports that spending in emerging markets significantly increased last year, while Europe and US declined slightly.  Although overall promotion spending remained flat worldwide at $90 billion, the US still accounts for the [...]
Posted in Advertising, Emerging Markets, Europe, Global, Marketing, Meetings, Sales, Strategy, Technology, social media | Tagged , , , , , | Leave a comment