Website www.pharmaevolution.com has been eliminated. If the reader needs a copy of the post, please post a request and a copy of the posts can be sent.
Will Pharma's Global Customers Redefine Maslow’s Hierarchy of Needs? January 27, 2014
- Pharma companies will have to figure out how to reach the world's masses, rather than small patient populations, if they are to succeed in the long term.
- On average, the industry's success rate of development and commercialization, for both small molecule and biotech drugs, will not change much from its current level. “Eroom’s Law” still limits pharma's destiny.
- High drug pricing soon will be frowned upon and discouraged by PBMs (pharmacy benefit managers) and hospitals.
- Instead of becoming “process-centric,” pharma will stay “regulation-centric.” Process-centricity, if adopted, would allow companies to exceed regulatory requirements, which could also avoid many issues that have created public relations and financial headaches. Current regulatory guidelines and requirements discourage change. Since changing an existing process requires approval, it is still perceived to be a long and expensive step, and something to be avoided.
- Industry will hedge in adopting many of the internal changes (manufacturing methods, technology, and supply-chain improvements) that could improve profitability and move from the current quality by analysis/aggravation to a quality by design approach. Again, this is due to regulatory constraints. Short patent lives for the ethical (brand) drugs will impede innovation in manufacturing technologies. At the same time, most generics manufacturers have been in business too short a time for their managers to grasp the value of better technologies and methods.
- Since current or higher level of profits can be achieved with the current inefficient practices, industry leadership does not see any value in improving its product development, business, and technology practices. External forces will drive change.
- With not much forthcoming from the industry to improve its manufacturing and business practices, regulatory bodies will enact regulations that will force the industry to adopt better practices. This tug of war will continue, unless the industry takes the lead.
- Continuous formulation processes could be a reality in the next five years for new drugs.
- Continuous API manufacturing is possible, but it will require a different economic and manufacturing model.
Can Emerging Pharma's Leadership Move On to the Next Stage?
December 18, 2013
This past summer, when news of regulatory noncompliance troubles in the region reached a high point, I asked Indian pharma CEOs in a post on this site whether they had lost their chance to innovate.
- The need to compete on quality
- Overdependence on founders, whose judgment may not be enough to sustain the company during years of rapid growth
- the purpose and character of the use, including whether such use is of a commercial nature or is for nonprofit, educational purposes
- the nature of the copyrighted work
- the amount and substantiality of the portion used in relation to the copyrighted work as a whole
- the effect of the use upon the potential market for or value of the copyrighted work