In biotech the answer to a question isn't always as complicated as a double helix. On the Motley Fool Rule Breakers discussion boards, a common question is: What resources can investors use to research biopharma and pharmaceutical manufacturers?
Of the websites that save me time when I'm digging for answers about biotech stocks and pipeline drugs, some provide a healthy dose of analysis with their reporting, and others are sites that are lists of resources. All should help any biotech investors, no matter their level of experience.
Where to start
It's not possible to know if a drug candidate stands a chance of getting marketing approval until you know what the requirements for approval are. Therefore, any research into a potential new drug should start with similar compounds that are already approved to treat the particular disease.
The quickest way to get a general overview of approved drugs: Go to this Food and Drug Administration website index, type a drug's brand name or active ingredient into the search box, and then read its label. A drug's label will include data and information about most (but not all) of a compound's key clinical trials, and that should offer a start for investors looking to compare the effectiveness and safety results of compounds.
If a drug is approved in the European Union before it's up for review at the FDA, you can look up the drug on the site of the EU's equivalent to the FDA. The European Medicines Agency has a detailed scientific review of the compounds it has approved and sometimes provides a much different perspective on a drug than the FDA does.
Once you know the names and characteristics of the pivotal studies for a drug from the label, the drugmaker's corporate website, or filings with the Securities and Exchange Commission, you can use WebMD's (Nasdaq: WBMD) Medscape or another database to find journal articles with more detailed data on a study or compound. Medscape and journals like The New England Journal of Medicine or Nature Biotechnology are not free options for most investors, but usually a local library will have free access to these resources, and universities do, too -- if you're a student or know someone who is.
If you want the details and study completion dates of an ongoing clinical trial, then looking at the drugmaker's website and checking ClinicalTrials.gov is the best way to go. For instance, for details of Vertex Pharmaceuticals' (Nasdaq: VRTX) ongoing telaprevir Prove 3 study, just do a search for "prove 3" and it will be the first study that pops up.
More FDA resources
Knowing some details about past FDA-approved drugs for a particular disease can guide investors on the effectiveness and safety expectations that drugs in development must meet to be approved for the market. But approval standards change (or devolve, depending on your perspective) at the FDA all the time.
By far, the best way to get unvarnished insight into the mind-set of FDA reviewers and their thoughts on a class of drugs or a particular disease is to read transcripts from the advisory panel hearing and the briefing documents the agency releases for these hearings.
Here are recent advisory committee documents and information. Older transcripts and documents from the FDA's Center for Drug Evaluation and Research are also sorted by advisory committee.
Investors wanting to bet on the outcome of a future FDA advisory panel meeting -- such as the hearing set for Feb. 27 on Theravance's (Nasdaq: THRX) lead antibiotic drug -- can refer to a calendar of all the advisory panels.
The guidance documents that the agency releases are another good source for information on official FDA opinions about a particular regulatory area.
Neither the advisory panel or guidance documents are riveting bedside reading, but they are essential for any biotech investors who want a feel for how different FDA divisions approach drug approval decisions.
News and analysis
Once biotech investors know what sort of information they should look for when evaluating a drug's profile, where can they go for investment ideas?
One of my favorite sites, Signals Magazine, provides comprehensive overviews on many facets of the industry. A good source of more company-specific biotech opinion can be found from TheStreet.com's Adam Feuerstein. His "Biotech-Stock Mailbag" is one of my favorite weekend reads, and even when we disagree, as with the near-term approval chances for Genentech's (NYSE: DNA) Avastin to treat breast cancer, he usually provides a reasonable rationale.
Many excellent blogs focus on different areas of biotech land. When he's not contributing to The Motley Fool, Stephen Albainy-Jenei roasts up opinions on the legal aspects of the pharma and biotech space at Patent Baristas, Pharmalot sometimes gets the scoop on interesting biotech news or interviews, and Derek Lowe's "In the Pipeline" feature offers a less investor-focused but interesting perspective on drug development from an insider's point of view.
These websites don't make up a complete list of the most useful biotech Web resources, and I'd be remiss if I didn't point out the excellent analysis done by the Fool's biotech baron, Charly Travers, for our Rule Breakers newsletter service. There have been hits and misses along the way, like our disappointing experience with Panacos Pharmaceuticals (Nasdaq: PANC). But other picks from him, like Myriad Genetics (Nasdaq: MYGN) and BioMarin (Nasdaq: BMRN), are up 108% and 106%, respectively, since Charly first recommended them to newsletter subscribers.
More Foolish biotech resources:
