The very best approach for problem solving - every possible problem!
DRUG DEVELOPMENT DECONSTRUCTOR MANIFESTO: : “Tell me how you read and I'll tell you who you are.” ― Martin Heidegger
Friday, November 30, 2012
The optimal solid form
From an advertisement:
Selection of the optimal solid form is a critical decision in the development
lifecycle. It is also an effective means to overcome development challenges and
accelerate the development and commercialization of small-molecule drug
candidates.
The optimal solid form such as crystal-form, salt or cocrystal
can:
- Enhance the solubility and bioavailability relative to a crystalline form of the parent molecule
- Reduce pharmacokinetic variations (dose-to-dose, inter-subject and inter-species)
- Improve the stability of the API and drug product
- Increase the robustness of the manufacturing process of the API and drug product, and
- Accelerate development and commercialization
Which solid form is more suitable for your product?
My post No.... 1000!!!
March 9, 2012 I have
published my first post on this blog... Today, November 30, I am
publishing post No 1000! In general I am very glad to have this blog:
- I have a lot of open public information collected and summarized just in one place.
- Sometimes I obtain very useful and constructive comments from readers.
- I have an additional structurization of my professional life.
I plan to continue this
work – it is fun and life is developed in extremely exciting way:
drug development issues, politics, philosophy, modern science and
world economy never were so interesting! Just go forward,
Pelichanics!
Thursday, November 29, 2012
Big Pharma and academia. Symbiosis or love? I think both...
I have
postulated here that academia in general is
patronized by Big Pharma which slows down the efforts of academia in the
development of new medicinal products. Big Pharma as an enterprise has to be
interested in making profits in the first hand – development of novel drugs
is not so useful due to it undermines IP value of existed products. Here we have a very nice example of
typical symbiotic relationship between Big Pharma (in this particular example GSK)
and academia:
The 2006 report described a trial that compared three diabetes drugs and
concluded that Avandia, the company’s new drug, performed best.
What only careful readers of the article would have gleaned is the
extent of the financial connections between the drugmaker and the research. The
trial had been funded by GlaxoSmithKline, and each of the 11 authors had
received money from the company. Four were employees and held company stock.
The other seven were academic experts who had received grants or consultant
fees from the firm.
Whether these ties altered the report on Avandia may be impossible for
readers to know. But while sorting through the data from more than 4,000 patients,
the investigators missed hints of a danger that, when fully realized four years
later, would lead to Avandia’s virtual disappearance from the United States:
“If you looked closely at the data that was out there, you could see
warning signs,” said Steven E. Nissen, a Cleveland Clinic cardiologist who
issued one of the earliest warnings about the drug. “But they were overlooked.”
A Food and Drug Administration scientist later estimated that the drug
had been associated with 83,000 heart attacks and deaths.
Arguably the most prestigious medical journal in the world, the New
England Journal of Medicine regularly features articles over which
pharmaceutical companies and their employees can exert significant influence.
Over a year-long period ending in August, NEJM published 73 articles on
original studies of new drugs, encompassing drugs approved by the FDA since
2000 and experimental drugs, according to a review by The Washington Post.
Of those articles, 60 were funded by a pharmaceutical company, 50 were
co-written by drug company employees and 37 had a lead author, typically an
academic, who had previously accepted outside compensation from the sponsoring
drug company in the form of consultant pay, grants or speaker fees.
Are you
surprised? It is absolutely obvious that the academia is not independent
anymore. It was bought entered in symbiosis with Big Pharma and we have
win-win-lose situation: Big Pharma and academia are winners and sick population
is a loser. It looks like Big Pharma and academia mutually fit each other, they
perfectly match each other. So romantic relationship! And I guess that one day
they have to die together…
Wednesday, November 28, 2012
Post-modernistic biceps
The largest biceps in the world! For what purpose? Who cares? Welcome to post modern...
Another magic cure against cancer. Post No 28. Immunotherapy
And again
amazing theory – immunotherapy of cancer. The video from 2002. They promised a
lot (as usual). Nothing happened so far. Small problems here and there and
there are no any panacea on the market! Whom to blame?
Tuesday, November 27, 2012
Healthy dose of russian propaganda
Russia was ruined by the Cold War. But Russia is superpower again? So fast...
Another magic cure against cancer. Post No 27.
A novel
(actually from 2002) amazing theory. I think we are very close to get a really
working and harmless medicine against cancer. According to the author of the
theory the only problem is commercialization and authorities (as usual! J)
Novartis: the novel and simple approach
We know
that R&D process of Big Pharma is not efficient but
there is a need to launch novel products on the market to increase or even just
maintain profits. What to do? You probably will say that R&D process should
be improved somehow… Well, there is an alternative: just press the authorities and government!
It looks like this approach looks more reliable according to Novartis:
This
approach is not innovative but can be very effective one! We will see: Big
Pharma is really big and has the power to press…
Monday, November 26, 2012
Sunday, November 25, 2012
Saturday, November 24, 2012
The essence of small business
From here:
Это классическая схема "малого бизнеса на понтах":
Третья фаза как раз и предполагает продажу дерьма за цену понтового супера.
Это классическая схема "малого бизнеса на понтах":
- Нарабатываем репутацию
- Конвертируем ее в понты
- Конвертируем понты в прибыль
Третья фаза как раз и предполагает продажу дерьма за цену понтового супера.
Health spending falls: is it unexpected?
Economic crisis has come
to politcorrect Europe. Now it is obvious and absolutely clear. There
is no any possibility to hide it anymore:
Health
spending per capita fell 0.6% across the region, declining from an
average annual growth rate of 4.6% between 2000 and 2009 as
government austerity measures began to bite, according to a new joint
report produced by the Organisation for Economic Cooperation and
Development (OECD) and the European Commission.
The
declines among individual EU nations were much greater. Health
spending in Ireland, which had been growing by an average of 6.5% a
year between 2000 and 2009, fell 7.9% in 2010, while for Estonia,
where annual growth had been over 7% in the previous 10 years, the
drop was 7.3%. And estimates for Greece put 2010's decline at 6.7%,
compared to annual growth of 5.7% during 2000-2009
Health
spending as a share of Gross Domestic Product (GDP) was highest in
the Netherlands (12%) in 2010, followed by France and Germany, both
on 11.6%. The share of GDP allocated to health was 9.0% across all EU
countries, down from 9.2% in 2009.
Pharmaceutical
expenditure accounted for 19% of all health spending on average in EU
member states in 2010, reaching more than 190 billion euros overall
and making it the third biggest spending component after inpatient
and outpatient care, the study notes. However, it also finds wide
variations in drug spending per capita throughout the region.
The
biggest spender on medicines per capita was Ireland, at 528 euros,
which is 50% above the EU-wide average of 349 euros. Other countries
with relatively high pharmaceutical expenditures are Germany, which
spent 492 euros per capita in 2010, Belgium on 479 euros and France
at 468 euros.
At
the other end of the scale, Romania spent only 164 euros per capita,
and other countries which spent less than 70% of the EU average for
the year included Denmark, Estonia, Latvia and Poland.
Pharmaceutical
spending accounted for 1.6% of GDP on average across EU member
states, ranging from below 1% in nations such as Denmark, Luxembourg
and Norway to more than 2% in Bulgaria, Hungary, the Slovak Republic
and Serbia.
Looking
at the effects of the economic crisis on pharmaceutical expenditures,
the report notes that while such spending had risen by an average
3.2% each year across the EU during 2000-9, in 2010 this growth came
to a halt. In Ireland, which had seen annual spending increases of
more than 8% during the previous 10 years, growth slowed to under 2%,
while several other countries severely affected by the economic
crisis cut their drugs spending drastically during the year -
Iceland's spending fell 6.3%, Lithuania's 4.6% and Portugal's 3.3%.
The
reduction or slowdown in health spending in nearly all EU countries
may have a long-term impact on health care outcomes, the report
warns.
And
whom to blame? What is wrong with the liberal democracy? We cannot
blame communists or the cold war or dictatorships or whatever! What
is the origin of the crisis? This question is forbidden... So far!
Friday, November 23, 2012
FRS does not own any gold
New portion of anti-FRS propaganda
Anotherpropaganda-video is here:http://viktorkaushan.livejournal.com/1988693.html
Quote of the day. Einstein (but I am not so sure)
То, чего вы больше всего боитесь, является вашим самым большим ресурсом.
Thursday, November 22, 2012
Buchi's "encapsulator"
A strange name "encapsulator". Why not "dropper", "dropmaker", "micronisator" etc?
Pfizer and ethics. Just one example.
I have
already written regarding ethical aspects of Big Pharma. And
now we have extremely childish example of ethical problems of Pfizer.
Pfizer Inc. (PFE) destroyed documents about the
development of its Celebrex and Bextra arthritis drugs while denying the
existence of electronic databases containing millions of files about the
medicines, lawyers for some of the company’s investors said in court filings.
“Defendants destroyed documents in bad faith and
compounded their initial misconduct by making false statements about the
existence of centralized databases,” Jay Eisenhofer, a New York-based attorney
serving as lead counsel in the investors’ securities-fraud suit, said in the
filing.
Last month, Pfizer officials agreed to pay $164
million to settle claims by a separate group of investors that the drugmaker
distorted the results of a study about Celebrex’s safety profile.
Pfizer officials said today they are asking the judge
in New York to throw out investors’ claims over statements about the drugs and
called the sanctions request over the company’s document handling “baseless.”
The
reaction just to destroy documents looks so childish and stupid that I do not
have any further questions regarding good or bad faiths of Pfizer actions.
Another magic cure against cancer. Post No 25
Ablynx N.V. (Euronext:ABLX) and Algeta ASA
(OSE:ALGETA) partnered to evaluate a targeted thorium conjugate (TTC) of
Algeta's thorium-227, an alpha-particle emitting radionuclide, and Ablynx's
Nanobodies against an undisclosed tumor target. Under the one-year research
deal, Ablynx will provide Nanobodies against the target and Algeta will provide
access to chelation and conjugation technologies, as well as thorium-227. Both
companies are also providing resources but are not disclosing details.
It is
definitively the sexiest magic bullet I’ve seen ever! In this attempt just in
ONE vial will be combined the following “hot” things:
1. Targeted approach
2. Thorium-227 radionuclide
3. Nanoparticles
Once again: 3 approaches just in one
vial! Targeting, radiology and nanotechnology! No one investor should resist
putting his own money to such exiting product! I would just recommend spicing
the final medicine with some amount of Viagra… Just for fun… Just to make the medicine sexier!
Wednesday, November 21, 2012
AD and mAbs: from gamblers point of view
Prepping for an ambitious late-stage
program to test its experimental Alzheimer's therapy, TauRx says it has banked
a $31.5 million tranche from Malaysia's Genting Management, part of a $112
million commitment for the biotech upstart. TauRx says the rest of the money
should arrive before the end of the year.
The cash will buy Genting--a company with
widespread investments in Asia--20% of TauRx along with a board seat. And the
biotech says that it has now raised an impressive $300 million in the 10 years
since the company was founded.
"This investment by GMS affirms
Genting's confidence in TauRx and will be directed to the conduct of our
pivotal global Phase 3 clinical trials in mild to moderate Alzheimer's disease
with LMTX, TauRx's tau aggregation inhibitor," said Professor Claude
Wischik, the U.K. scientist and executive chairman and co-founder of TauRx. The
drug is the first such "TAI" to reach late-stage clinical trials, and
investigators clearly believe that they can do what several Big Pharmas have
failed to accomplish with amyloid beta drugs.
Well, it is
well known that mAb are not helpful for treatment of AD. Why somebody will
spend $112 million for that? I think this is pure gambling. In a casino if you
bet on a number you have your bet as a downside and 1/34 chance to get 32 times
your bet. With AD upside is let’s say $5 billion. Downside - $112 million so if
the drug will be successful the company will win 44.6 times the bet. Not bad!
What is the chance to win? Without massaging FDA, EMA and other authorities? I
think the chance is not more than statistical deviation…
Tuesday, November 20, 2012
Drug shortage: why?
98.9%
of US oncologists polled for a recent survey say they have experienced
shortages of cancer drugs in the last year, and that as a result of the
shortages, cancer has progressed in more than 60% of their patients.
Over 70% of patients have experienced more severe side effects as a
result of the shortages, add the oncologists, responding to a survey conducted
by the Community Oncology Alliance (COA). Almost half of the physicians also
reported that they were seeing more than one patient per day affected by a drug
shortage, and 58.2% say the shortage of cancer drugs is increasing.
In addition, over 80% of the patients and more than 90% of the practices
affected by a cancer drug shortage experienced a more severe financial burden,
says the COA.
I do not
understand the situation: the logic should be following:
Cancer medicine
is expensive and makes huge profit for Big Pharma
→
Every medicine vial sold
gives a profit to Big Pharma
→
But the
phenomenon of shortage does exist which means that something in our scheme is
missing… What is missing? So far I do not know but I am convinced that somebody
has to get benefits (political if not direct financial and economic ones) from
this situation and I guess it should be Big Pharma. In which way? It will be
clear very soon…
Monday, November 19, 2012
Genes: Another level complexity.
Genes
have a memory... Well, the whole paradigm “one gene – one
disease” is simply materialistically simplified B.S. I like the
nature – it is extremely complicated and hidden from scientific
arrogance. An additional level of complexity is evolved and the most
important question is not answered: “who controls the activity of
our genes?” Just to be more puzzled: see here.
Sunday, November 18, 2012
Nanorobots – engineering impossible.
About size
and complexity of a simplest bacteria. Interesting
lecture about social biology in connection to nanorobots.
Saturday, November 17, 2012
Slow release? No, thank you!
One of the most important
argument for development of new drug delivery systems is possibility
to provide controlled or just simply slow release of an API. It is
almost accepted that controlled release is “always” preferable.
But
something went wrong with a controlled-release formulation of
pregabalin, a GABA receptor agonist.
Next time we have just to
be more careful regarding slow release: slow or controlled release is
not better per automatic!
Cloud Atlas. Intriguing trailer...
... but the movie is absolutely BS - 100% bull shit. Bueeehhh....
Masterpiece of the day: Dialog of a wise philosopher (Sekatski) with one absolutely stupid journalist
Really stupid journalist. Who is he? Who cares? Who will remember his childish notions?
Friday, November 16, 2012
Another magic cure against cancer. Post No 24.
From here:
ImmunGene
and Caliber Biotherapeutics are launching Valor Biotherapeutics as a
joint venture. The upstart plans to use technology developed at UCLA
to create new cancer therapies that marry antibodies to interferon,
with licenses to three mAb-IFN fusion product candidates now in
preclinical development. Singhvi, who will lead Valor, is the
managing director of Caliber.
Well, the approach to
combine mAbs with IFN is in accordance with the modern paradigm,
however there
are even sexier approaches in terms of investment attraction. In
any way we have to wish the authors of the idea good luck in hope
that the approach will be helpful in our understanding of what works
against cancer and what doesn't.
Thursday, November 15, 2012
Diabetes in US. Fresh numbers.
Diabetes
market is awesome huge. It should be as huge as weapon, narcotics or
prostitution markets. Probably is larger than these markets combined. I just do
not have numbers for these markets to make a correct comparison but diabetes
market is extremely huge. I have written already about this issue here
and here
(and also here,
here
and here).
And here
are some fresh numbers:
US biopharmaceutical research companies are
currently developing a total of 221 new medicines for the treatment of diabetes
and related conditions, according to new industry data.
They include 32 new treatments for type 1
diabetes, 130 for type 2, 14 for unspecified diabetes and 64 for
diabetes-related conditions, says PhRMA, which describes this pipeline as
"an exciting new chapter in the ongoing quest to better treat this
debilitating disease."
Since 1990, six new classes of diabetes
type 2 medicines have been approved by the FDA. The products which are
currently in development include: - a once-daily medicine that selectively
inhibits the protein associated with glucose metabolism; - a medicine designed
to inhibit an enzyme linked to diabetic neuropathy; and - a medicine used to
treat type 2 diabetes that may allow for once-weekly dosing.
25.8 million people in the US - nearly 8.3%
of the population - have diabetes, says PhRMA. An estimated 18.8 million of
these people have been diagnosed, but seven million are not aware that they
have the disease, and another 79 million have pre-diabetes.
And as many as one in three US adults could
face the disease by 2050 if current trends continue, according to the US
Centers for Disease Control and Prevention (CDC). The prevalence is expected to
rise sharply for a variety of reasons, including an ageing population more
likely to develop type 2 diabetes, increases in minority groups at high risk
for the disease, and longer lifespans among diabetes patients.
If untreated, the condition can lead to
severe health problems and complications, such as heart disease, stroke, vision
loss and amputation, notes PhRMA, which also points out that average medical
expenditures among people with diagnosed diabetes are 2.3 times higher than
such spending for people who do not have the disease.
The industry group also discusses the
significant economic consequences of diabetes, which in 2007 totalled $174
billion in the US. $116 billion of this was accounted for by direct medical
costs, while indirect costs (including disability, work loss and premature
mortality) came to $58 billion. If the additional costs of undiagnosed diabetes
($18 billion), pre-diabetes ($25 billion) and gestational diabetes ($623
million) are factored in, the total annual cost of diabetes in the US amounts
to $218 billion, it says.
However, improved adherence to diabetes
medications can lead to better health outcomes and reduced costs, PhRMA notes.
Recent research suggests that patients with diabetes who do not consistently
take their medicines as prescription are 2.5 times more likely to be
hospitalised than those who follow their prescribed treatment regimens more
than 80% of the time.
Also, a recent study in the journal Health
Affairs projected that improved adherence to diabetes medications could result
in more than 1 million fewer emergency room visits and close to 620,000 less
hospitalisations annually, giving total potential savings of some $8.3 billion
a year.
Wednesday, November 14, 2012
Who are these people?
If reality does not exist - let them beat their heads by the wall - with all energy! It will not damage their minds - the wall does not exist according to their mistaken interpretation of quantum mechanics!
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