BIOLOGICS

For the question pertaining to clinical trials, the U.S. Clinical Trials infobase can be found here:
http://www.clinicaltrials.gov/

1. (4 pts) On the main webpage of each of these corporate entities, typically from a link labeled “About Us” or something similar, you will be able to access a listing of key personnel, categorized in at least two groups: “Management Team”, and “Scientific Advisory Board”; and in many cases also including “Founders”, and for publicly held companies, “Board of Directors”. Some of the listed individuals are likely to appear in more than one of these groups.
Identify two individuals, from two different groups among those listed above (e.g., one from Scientific Advisory Board, one from Management Team), and briefly summarize (a) their name and formal education (what degrees do they hold, and from where did they earn them?), (b) key career highlights, and (c) their current position(s). Firmly resist the urge to copy all the information over from the website (my time for grading/evaluation is limited); condense to the shortest possible summary that captures the key aspects.

If you are assigned a large publicly held company (such as Amgen or GlaxoSmithKline or Eisai), or a larger privately held company (such as Biogen), your answers above may be somewhat differentand even among these, there will be differences depending on whether the company is publicly held or private. If you need guidance on this, contact me. In some cases, the development of an entity created at a smaller company is being co-sponsored (and perhaps partly carried out) by a larger company, and in most such instances, I have supplied the names of both entities, with the originator being listed first. This question will be easier to address for the smaller/inventing company than for the large sponsor, so in general, you will want to be working via the website of the former as a starting point (see also Question 2 below).

2. (3 pts) A medicinal substance in clinical studies, or perhaps already approved, was assigned for you to investigate along with the corporate entity. (a) What disorder or disorders are being targeted for treatment with this medicinal substance? (b) For each disorder you listed in 2a (there may only be one), in what phase of clinical development is this therapy? Note that this list may include “NDA filed” or “approved” indications. Information concerning your assigned substance will in most cases be found at the companys website, under links that typically say R&D or Pipeline or Technology or Portfolio. But, you may have to search for other sources for this information. Also — important — note that the same agent may be in multiple clinical trials at that represent different phases (list accordingly).

3. (3 pts) Many of the websites should have a capsule summary of the known or hypothesized mechanism of action associated with the assigned medicinal substance. In other cases, you will need to find information elsewhere (but in all such cases that this should not take much timeif it seems to be, please contact me, we may need to replace your assigned agent). Summarize this mechanistic information as briefly as reasonably possible (no more than 4-6 sentences, even 1-2 good sentences may suffice), and be sure to include information about the molecular nature of your assigned medicinal (i.e., “what is it?”). A few of the assigned agents are cells, so in that case, your answer will be rather different.

4. (2 pts) Using the U.S. clinical trials infobase (link given above), find two locations at which a clinical trial for the assigned medicinal substance is being conducted, or is being planned, or has been completed. You may even stumble on a Louisiana study site. (I note, however, that there are no listings for Louisiana entities on the PhRMA report from which I drew (referenced on your class slideset).) In a few instances, you may not find a U.S. clinical trial listing, but you may find a listing in a European or other international listing. If you can’t find something quickly, please contact me–do not waste any time searching. Sometimes, a search via Google or an alternative search engine, including the name or alternative names (typically given on the assignment list), and adding “clinical trial”, may unearth the needed information in such cases. Again, please do not spend excessive time on such a search, that would not be consistent with the purposes of this assignment.

5. (2 pts) Most of the companies will provide a link to “pipeline” information, or alternatively, a “technology” listing, or a summary of scientific directions or strategies being pursued. Very briefly describe the scope and nature of the company’s pipeline or scientific strategies. Unless the list of pipeline entities is very short (< 4 items), you should not provide a list, but rather, just an overview (capsule summary) of the portfolio. If you are assigned a project from a large company, simply list areas of heavy corporate emphasis.