Thursday, June 23, 2005

HIV/AIDS Vaccine Information

Found this article about a change in India's generic HIV/AIDS drugs due to WTO requirements.

VAX 3(3), March 2005

IAVI Report

India changes law regarding generic medicines

India’s parliament recently passed legislation that amends the country’s 35-year-old patent law regarding the manufacture of patented medicines by generic companies, in order to allow the country to join the World Trade Organization. Indian companies will now have to pay a licensing fee to the patent holders to continue producing the currently available copied drugs, known as generics. The new law also limits the ability of generic manufacturers to copy patented drugs in the future.

Since Indian companies are a major supplier of discounted antiretroviral (ARV) drugs, many fear that the law could prevent newer and better medicines from reaching the majority of people with HIV. Companies like Cipla and Ranbaxy supply affordable ARVs to millions of people in several countries. This new policy could mean that newer generics, if available, will come with much higher prices.

“It is unclear how these drugs will be made available in the future. It could hamper access to medicines because India has played such a huge role in providing drugs throughout the developing world,” says Rachel Cohen, a US advocacy liaison at Doctors Without Borders. Cohen credits the actions of activist groups for influencing the Indian parliament from passing further limitations on the production of generic medicines.

Wednesday, June 22, 2005

A little research on the side.....

Recently I have been acting as research assistant for my husband. He is in the process of writing a book about why cities are segregated. Anyway, I started thinking about the meaning of the term "Exurb". I guess I should since I used it as the title and part of the url for this blog. I recall reading Edge City by Joel Garreau back in the early 1990s just because I wanted to read it. My undergraduate study was in urban planning and this book had not yet become part of the required reading - if it is not, then it should be! But that is just my opinion. If I recall correctly, Garreau mentioned the term exurb. I am intrigued to observe how suburbs, in addition to urban areas, will evolve over the next 10 years.

Another reason I have been contemplating exurbs must be my experience in Paris several weeks ago when we went to La Defense. This place is at the end of one of the major rail lines. As you are riding up the escalator to the plaza, the entire scene is just so surreal. Once you reach the top, you can not help but notice the extremely odd shaped arch - actually it is an office building with monumental stairs leading up to it. Concrete is everywhere - like a suburban wasteland. On the other side of La Defense is an interesting cemetary that does not look like a cemetary. At first glance it resembles some sort of maze or large scale park, which is what cemetaries were originally. It is closed in by a highway and highrises and you can look down into it. Another strange feature of the area is a pedestrian bridge that goes to nowhere. This bridge is surrounded by cement spaces that are just there. No thought behind why these spaces exist.
Honestly, surreal is the only word to describe this place.

Pimp My Ride?

Secret Confession - I totally love this show! I am not one who would ever do this to my own car. Actually I take extreme care of my car and do not put any decals or stickers it although I did put several on my Lexus (such as my NASA and Mac/Apple stickers). Well, I guess I could put a white Mac/Apple sticker on the Volvo. Gotta think about that one.

Now back to the show..... The guys at West Coast Customs are extremely talented. There is an "art" to their work. The guys appear to love what they do. That is one of the secrets in life - love what you do and do it well!

Can't wait to see the new season!


Pimp My Ride

Monday, June 20, 2005

Paris.....



There we are! From left to right: Eli, David, me and my mom.

Sunday, June 19, 2005

Krakow Square



Eiffel Tower



La Defense


La Defense.....again



Friday, June 17, 2005

My S_60

Just thought I would post a photo of my S_60 (courtesey of the VolvoUSA.com website) I must admit I am extremely impressed with how safety and styling come together in this car. Safety is of the utmost importance.

I am also considering buying a roof mounted bike rack. I already have one but I would need to install a hitch. One problem with that is if a Volvo dealer does the installation, then the price would be high. The other problem is if I get another type of hitch installed, it could really screw up the clearance and I really do not want that. So I guess I will ponder this situation.....

On the topic of bikes....I purchased a Specialized Hardrock last fall.

Listening:: Metric_Dead Disco

Thursday, June 16, 2005

Which Housewife Are You?

Just took the new Desperate Housewives "Which Housewife Are You?" quiz. This time I was Gabrielle - which is funny to me as I am not attracted to younger gardener guys. The last time I took that quiz, I was Edie. I really do not think I am any of the Desperate Housewives but I do love the show because of it's dark humor and the fact it is well written.

So silly! Sometimes I love trivial and shallow things - sometimes.

Shopping and well, more shopping

This is a blast from the past - 2 years to be exact. Thought I would post my MFA thesis statement. I should have a link to my multimedia thesis project in the near future. Enjoy!

Watching television is the most popular activity in America. Shopping
is second, yet in terms of public activity, it ranks first. Most shopping occurs in malls and big-box,suburban shopping centers. The mall replicates and replaces downtown as the physical and social focus of civic life. Malls embody urban characteristics yet they exist within a suburban context. These spaces react to the suburbs while embracing the idealized memory of Main Street. This condition blurs the notion of urban and suburban space. Thus, it creates an in-between, or liminal, condition. Liminal spaces slip between public and private and define a new, entirely different spatial experience. This thesis explores the aspect of control within this liminal condition and questions the assumptions we make when we shop in suburban malls.

The thesis begins with how one is controlled within a mall. Because the essence of a mall is control, how does this experience effect the physical environment of mall space? Malls are very calculated and scientific systems characterized by parallels to television. In this new medium, social and public activities seemingly thrive. But by controlling what one can say, do or see (no skate boarders or homeless people) the mall removes baggage common to the "real" downtown. Though shoppers feel safe and secure in this environment, they have ceded many liberties to participate in this new collective.

Shopping is interpreted as an activity where the consumer has the freedom to choose. Yet in a mall space consumers actually forgo freedoms so they may participate in the collective act of shopping. Designers fabricate physical and mental landscapes scientifically calculated to simultaneously increase sales and experience a false sense of freedom. This paradox is graphically explored in this thesis as control.

Mapping is an excellent way to understand this "control" space. Understanding
the underlying structure of a mall evokes the intent of the mall designers. Maps create wonderful interfaces for humans to see and react to the environment. This project maps both the physical and the experiential aspects of the mall by recalling the literal and conceptual notions of liminal space. Within each piece, the user has the freedom to make decisions (as one does when shopping in the mall), yet one must follow the structure dictated by the piece. Especially in the digital interface, the concept of the mall is experienced in a larger context (like television). Because consumers experience a barrage of images and information while shopping inside the mall, the interactive medium solicits the user to experience similar shifts of perception of time and space. The clicking between screens and sections mimics the clicking of the remote control: a monotonous and mind numbing experience. Shopping in a mall space is akin to experiencing television in the third dimension. Here, in the liminal fog of what is real and not-real, controlled and free, is the essence of my thesis.

***COPYRIGHT 2003*** BY THE AUTHOR

Tuesday, June 14, 2005

US Open

Tis the season for the US Open. I am looking forward to this Major. I must admit I do enjoy the Major tournaments of the PGA. Next up - in July - is the British Open. The British Open is second only to Augusta - but that is just my opinion.

Good luck to Fred Couples. I hope he plays well this week.

Thursday, June 09, 2005

Intelligence News....

More intelligence news.....

***Thanks to InstaPundit for the heads up on this story***

Of course, I am skeptical of this story.....

Business Intelligence

STATIC ANALYSIS

HIV/AIDS Vaccine Industry

Rating the Five Forces of the HIV/AIDS Vaccine Industry (5 = strong, 1 = weak)

1. Threat of New Entrants - 3

a. Barriers to Entry

· High front-end capital investment costs in research and development (R&D).

· Difficulty in raising private funds for capital investment due to risky and expensive scientific uncertainties, especially in the area of understanding the virus (Ainsworth and Batson, 2001).

b. Experience Effects

· Five companies dominate the landscape with 93% of the market share:

Aventis Pasteur, GlaxoSmithKline (GSK), Wyeth, Merck and Chiron (Kalorama, 2004). These corporations have the infrastructure and consortia in place thus creating other cost advantages over new entrants.

· HAART (highly active anti-retroviral therapy) has been successful in decreasing HIV/AIDS mortality rates yet HIV/AIDS cases are still on the rise (Savopoulos, 2004). The opportunity for new vaccines for other facets of the disease are always in demand.

· Although the dominant companies have compounds and vaccines in several stages of the pipeline process, success is not guaranteed. The pipeline process may take from 15 – 20 years from the R&D phase until the approval phase (HIV R&D, 2001). Recently a new strain of HIV, known as HIV 2, made headlines on February 12, 2005 (MSNBC, 2005). This new strain is resistant to all HIV/AIDS vaccine and medications. The vaccines at various points in the pipeline may become obsolete. These companies will have to take previous data and create a new strategy allowing for this new strain of the virus. During this time, new companies have the opportunity to enter into the market.

· Shift from technological based acquisitions toward production based acquisitions thus allowing an opening with in the market for companies with production capabilities (Van Arnum, 2003).

c. Distribution Access

· The company securing the patent on the HIV/AIDS vaccine should not have difficulty in distribution in the United States. The FDA approval process may be delayed at times therefore delaying distribution into the market place.

· The problem lies within getting access in other countries where the governmental regulations and cultural differences have the potential to create a barrier for entry into those foreign markets (Kalorama, 2004).

d. Government

· Changes in government regulation has created an increase in research costs from the late 1990s that have quadrupled from $80 million to $100 million dollars up to $350 million dollars per each product. This increase results from the increase in the requirements of necessary data for approval by federal standards (Navarro, 1997).

e. Product Differentiation

· Product differentiation does not pose any barrier to entry at this time. HIV/AIDS is a life threatening disease that has no proven cure at this time. Marketing is not needed for this type of vaccine.

2. Bargaining Power of Suppliers – 4

a. Concentration

· No substitute available for capital equipment (or laboratory equipment) as the technology is extremely sophisticated and specialized. In order to conduct R&D in-house, the companies must purchase this equipment from these suppliers at the price they dictate in addition to having the capability to utilize the technology.

· The top four companies have in-house R&D capabilities. Smaller companies working on HIV/AIDS vaccines do not have the capacity and must rely on smaller academic institutions and companies to provide “bioprocess development and manufacturing” (IAVI, 2005).

· High costs result from clinical trials. The average cost for a single trial begins around $30 million (Ainsworth and Batson, 2001). Patient pools must be rather large, up to 10,000 patients, as to yield proper results in the testing. Since 2000, the number of candidates in trials has doubled.

b. Organization

· Protection of intellectual property factors prominently as the top manufacturers produce the viruses, processes and chemicals in-house. Outsourcing is not an option for these top manufacturers as they are seeking patents for their product (Feliza, 2003). Higher margins and higher pricing are possible as a result.

· According to organizations such as the IAVI (International AIDS Vaccine Initiative), if a company receives funding for R&D, then they must set the price of the vaccine to be affordable in developing nations (http://www.iavi.org).

c. Government

· Shift in demands since 9|11 results in the focus to meet needs for critical vaccines to save lives (Wechsler, 2002). This shift affects FDA policy development, which affects the emphasis of federal government funding for R&D. The development of HIV/AIDS vaccine falls under this category.

· Patent suppliers and FDA approval costs have increased significantly. After the Vioxx case (recently taken off the market), the FDA recently requested more funding for the post-approval monitoring process.

3. Bargaining Power of Buyers – 1

a. Differentiation

· Guaranteed market for these vaccines creating a “seller’s market”.

b. Importance

· Buyers will purchase the vaccines based on need, not on price.

c. Importance of Quality

· Buyers will pay the price dictated by manufacturers if the vaccine is effective and of high quality.

· The focus will be on issues of quality along with manufacturer liability.

· Patent protection protects intellectual property thus allowing the manufacturer to dictate price of vaccine in most cases. So far only certain processes and chemicals have been patented, not a vaccine. Once a manufacturer obtains this patent that particular manufacturer will dictate the price. But as previously stated, manufacturer may be obligated to set the price of vaccine at an affordable price.

4. Threat of Substitute Products or Services - 4

a. Relative Price/Performance Trade-Off

· Currently the only options available for the prevention of HIV/AIDS are condom use and abstinence. Condoms are not 100% effective in the prevention of HIV/AIDS (IAVI, 2005).

· Although five companies dominate the current landscape, many more are vying for a position in the pipeline (Scrips, 2002). The first company to secure the patent for the vaccine will dominate the market.

· The arrival of the HIV 2 virus changes the dynamics of the landscape and creates uncertainty for products and services.

b. Switching Costs / Profitability

· The Bush Administration is pushing for a generic version of an HIV/AIDS vaccine to be made available for victims in underdeveloped nations such as Africa. Generics will affect the company that holds the patent. Intellectual property becomes an issue (Pharmaceutical Today, 2005).

5. Rivalry Among Existing Competitors -3

a. Market Growth

· The market is expected to increase 9 – 11% compounding annually (Scrips 2002).

· At this time, only five companies dominate the market. The market can sustain future growth as none of the companies has produced a successful HIV/AIDS vaccine, either therapeutic or prophylactic.

Company Market Share

Aventis Pasteur 30%

GlaxoSmithKline 18%

Wyeth 17%

Merck 17%

Chiron 11%

(Chart: Kalorama 2004)

Chiron is the newest company to become a major contender in the landscape. As recently as 1999, the top four companies dominated.

b. Barriers to Exit/Switching Costs

· Low barriers due to high entry capital costs. The top five companies have diversified product lines that create low barriers.

c. Diversity

· The trend shows an influx of companies moving toward the HIV/AIDS vaccine industry. Available opportunities are abundant in this area of vaccine research. Many unknown companies have an opportunity break into the vaccine pipeline.

Conclusion: The HIV/AIDS vaccine industry is undergoing a major shift in the landscape. Although the costs for entry into the market are high and uncertainty surrounds the scientific research and understanding of the virus, the market is poised for growth. There is a great need for development of both therapeutic and prophylactic HIV/AIDS vaccines yet the pipeline process may take a decade or more. The primary forces affecting this industry include the emergence of companies vying for the creation of an effective vaccine, government and private funding, application for patents and the issue of intellectual property rights in addition to the recent discovery of the newest strain of the virus, HIV 2.

COPYRIGHT 2005 : NOT TO BE USED WITHOUT THE PERMISSION OF THE AUTHOR.