Of the 18 new drug and biologics molecules approved in 2010, about half seemed to have been developed by small companies. The Center for Drug Evaluation and Research (CDER) just announced an upcoming forum on designing clinical trials. This session is specifically for small businesses who want to learn more about how to plan and execute trials so they will generate data that meets FDA‘s review standards.
The meeting will be held on April 21, 2011 from 9:00 a.m. to 4:45 p.m. at the FDA White Oak Campus in Silver Spring, MD, just outside Washington, D.C.
According to CDER, topics to be covered include:
– Clinical trial design – the phased approach and the staged approach
– FDA’s Bioresearch Monitoring (BIMO) Inspection Program
– Challenges to conducting clinical research in the 21st century
– Practical concerns of electronic source documentation
– Different types of pharmacokinetic studies conducted during drug development
– Importance of bioequivalence studies
– Strategic Quality for Clinical Trials
– FDA inspection process
There is no fee to register for this meeting, and there are limited seats available.
Register, and download the agenda and presentation slides here.
Baxam Law Group, LLC advises startups and small business clients in intellectual property, regulatory and commercial law.
Posted in Regulatory Law
Tagged big pharma, Biotechnology and Pharmaceuticals, Business, Center for Drug Evaluation and Research, Clinical trial, Drug development, FDA, Food & Drug Administration, new drug, new drugs, Pharmaceuticals, R&D, research and development, small pharma, supplements
Pfizer®, that pharmaceutical behemoth of the late 20th century, announced today it is buying the consumer products business of Ferrosan, a Danish supplement maker. The deal price was not disclosed, but according to Yahoo Finance, Ferrosan said its 2010 earnings were about $55 million. That is small pickings for a company of Pfizer’s size, but it is yet another trickle in the shifting tides of big pharma’s business focus.
Truly novel blockbuster drugs are few these days. One could speculate ad nauseum on the reasons for this, but one possible cause is that the companies who invest money in bringing drugs to market don’t want to risk big money on unproven chemical entities and metabolic pathways that might also be a challenge to cautious regulatory reviewers like those at the FDA. The results of this very conservative approach from the industry (and from the government)are drugs that for the most part improve upon or modify some known molecular structure or sequence that has shown some success in the past. It is good business investment for the drug companies, but not so much for the consumers who need “disease preventers” instead of palliative treatments, and for those who are already sick and need a new therapeutic approach instead of a variation of the tried and true.
There is a new wave coming, and in my opinion big cures will be coming from natural products and botanicals in the early part of this century, so this is a good move on Pfizer’s part. It’s good for consumers too, because big drug companies have the cash to do the studies that would support approval of natural products and botanical therapies, even by the most conservative of regulatory systems. Let’s hope we see more moves like this.
Read Pfizer’s press release.
Other new product prototypes to watch include Dendreon’s Provenge® immunotherapy treatment for advanced prostate cancer.
Posted in Regulatory Law
Tagged blockbuster drug, botanicals, consumer product, FDA, FTC, investor, natural, natural products, pharma investment, regulatory, supplements