On My Mind Contemporaneously August to September 2018

Contemporaneously
August to September
2018
Ajaz S. Hussain, Ph.D.
2 October 2018

Contemporaneously August to September 2018
View Post Monday October 1st, 2018
Traveling to build global solutions to facilitate
pharmaceutical professional development. Taking a Big
Idea forward and making it an evidence-based
approach for building and maintaining an effective
pharmaceutical quality management system, which is
an ecological system with some engineered parts. Off
the social-media for next month or so. If you happen to
visit this page scroll down to review some insights that I
recorded contemporaneously at this site. Will reconnect
from Africa. For more information on educations
programs in Kilimanjaro, Tanzania, visit the following
pages on the internet: Kilimanjaro-Purdue MS Degree
Biotechnology and Innovation: Regulatory and Quality
Compliance Springer, Mitchell, Lauren Terruso, Mary
Speer, Zita Ekeocha, Stephen Byrn, and Kari Clase.
"Administering A US Based MS Degree in Kilimanjaro,
Africa–A Global Benchmarking in Regulatory Science."
In ASEE 2016 Annual Conference Proceedings. 2016.
https://peer.asee.org/administering-a-u-s-based-m-s-
degree-in-kilimanjaro-africa-a-global-benchmarking-in-
regulatory-science.pdf
https://polytechnic.purdue.edu/research/research-
grants/merck-scholarships-kilimanjaro-purdue-ms-
degree-biotechnology-and
View Post Monday October 1st, 2018
Before I log-out and say "Bye now" and "Take care";
some parting thoughts and the rendition of Kun Faya
Kun by the Berklee College, Boston, USA. At the end of
2015, Prof. Kegan’s “Big Idea” appealed to me, in 2016 I
“believed it to be true.” Since 2016 I sought evidence to
“know why it might be true.” To do so, I looked inwards,
within an individual and within our global
pharmaceutical quality system. contemporaneously
recorded my insights and shared it on social media.
Now it is time to share this evidence in a formal format
(more on this later). Our species is living longer in
response to Einstein’s challenge that we will never solve
the problems tomorrow with the same order of
consciousness we are using to create the problems of
today! Some of us are living longer to find, in Gandhi’s
words, "a way out of hell!". My take on Prof. Kegan’s “Big
Idea” – those of us who are experienced professionals
must now work to support the development of all
people...there is no more important work to do!
https://www.linkedin.com/pulse/six-blind-men-
regulatory-science-bobs-big-idea-way-hussain-ph-d-/
The literal translation of Kun Faya Kun is “Be,and it is”. It
is one or another reminder that all our wisdom
traditions from Hindu, Jewish, Budhist, Christian, Islamic
and others are seeking the same - Truth. Scientific
method is also for seeking- Truth. The problem is how
we think - that this is a either or (XOr) problem. It is a
problem of human development vs economic growth.
The solution is AND. Induction AND Deduction.
INTERNAL and EXTERNAL Validation. AND is integration;
it is key to Systems Thinking. See blog for song lyrics
and translation.
https://blog.chandrahasa.com/archives/2992/amp

View Post Sunday September 30th,
2018
Taking leave now for a month or so. So please note - no
response is not evidence of "no-responsibility". Will plan
to reconnect from Kilimanjaro,Tenzania. Continuing my
search for a door to open; to continual professional
development. Leveraging an insight from down a
memory lane - Empowerment is necessary but not
sufficient. Wisdom is in actions when we CARE. From
what was reported in "media", in 2007, of my testimony
to the US Senate: Ajaz Hussain, who oversees biological
drugs for Novartis AG's generics unit Sandoz, said
science shows follow-on biologics can treat the same
conditions as their more expensive counterparts. "FDA
already has the expertise" to review them, he told the
panel. "What you need to do is to empower them to act."
Lawmakers weigh path to generic biologic drugs |
Article [AMP] | Reuters
http://mobile.reuters.com/article/amp/idUSN084228552
0070308 BARLAS, S., 2006. Opening the door to follow-
on proteins?. Biotechnology Healthcare, 3(5), p.47.
109 Reactions 6 Comments
2018
Take time to unwrap present to See Good inside & to
align Care, Power and Wisdom: Research, Knowledge &
Wisdom.

2018
Present is a gift we wrap in anticipation to see what is
good inside.
2018
Current Good Practice is to Do and See Good in the
Present.
2018
It is hard to remain at higher Order of Consciousness
(Doing and Seeing Good).
2018
Looking Good to Being Good to Doing Good to Seeing
Good: Orders of Consciousness.
2018
Care is Research, Knowledge is Power and Wisdom is
Practice.
View Post Saturday September 29th,
2018
Pictures
2018
Visit to ANVISA June 2018.

2018
Team members exchanged stories and got to know
each other. They even danced together in one exercise.
Reviewers, inspectors and compliance officers all went
through the same training. FDA's PAT Team: Shall We
Dance?
https://www.pharmamanufacturing.com/articles/2005/2
16 Team leader Ajaz Hussain faced many of the same
challenges -- silos and tight budgets, for instance, and
lack of a quality systems approach -- that corporate
manufacturing visionaries face. But, if barriers in
industry are calcified, imagine them within a
government agency. Getting reviewers, investigators,
and compliance officers, and other staff within the
Agency's different divisions together was only the first
step. Then, they all had to be sold on a radically new
vision for compliance. When FDA's original PAT team
was assembled in 2002, members were drawn from
FDA's review, inspection and compliance sectors. Some
had been with the Agency for years, others came from
industry. Some knew each other, others didn't. The
team hired a consultant to help break the ice. Team
members exchanged stories and got to know each
other. They even danced together in one exercise.
Reviewers, inspectors and compliance officers all went
through the same training. At one batch manufacturing
course, they even made product as a team.
2018
We have another universe that really is the one that
counts, but we are afraid to share it. Down a memory
lane. Historical transcripts 16 November 2001 FDA
Science Board Norman Winskill: The second scenario is
"don't tell." Under this, we want the information so
much, we use it but we don't register it and we don't
openly talk about it. So we have one set of
methodologies that are in the files, and these are used
for regulatory approval, and we conform to the specs,
we conform to the dossiers. But in addition to that, and
in addition, not instead of, we use all these model
techniques in parallel, and really we operate in two
parallel universes. We have a regulatory universe with
old-fashioned conventional technologies. We have
another universe that really is the one that counts, but
we are afraid to share it.
2018
Historical meeting 16 November 2001. Archived now -
link to archive site provided below. Food and Drug
Administration Science Board November 16, 2001
Slides Emerging Science Issues: Pharmaceutical
Manufacturing

2018
A vision in 2004 - now a mature committee E55. Process
Analytical Technology and ASTM Committee E55. D.
Christopher Watts, Ph.D. Ali M. Afnan, Ph.D. and Ajaz S.
Hussain, Ph.D. Collaboration with ASTM provides the
pharmaceutical industry with opportunities to: • Learn
from other industrial sectors, such as petrochemicals,
where the use of process analyzers, statistical
principles, and risk management have been in practice
for a number of years (and not “reinvent the wheel”). •
Focus our efforts on “process” and bring a much-needed
(pharmaceutical) engineering dimension. • Work toward
international consensus. • Involve all stakeholders and
multidisciplinary expertise (FDA does not have the
resources to do this).
2018
ASTM International’s committee on manufacturing
pharmaceutical and biopharmaceutical products (E55)
developed the new standard (E3177), which covers both
the sample from which data is taken and the sample
that is taken for reference. “This standard describes for
the first time the considerations around sampling using
process analytical technology, which most new
pharmaceutical products rely on during development
and manufacturing,” says ASTM International member
Martin Warman, director, Martin Warman Consultancy
Ltd. “The measurements taken directly on products or
on material removed for laboratory analysis will support
control and quality.”
2018
There’s something mysterious coming up from the
frozen ground in Antarctica, and it could break physics
as we know it. [Also see the previous post].

2018
Having excluded Sandard Model explanations at >5σ
confidence, these authors have argued that the Sub-EeV
Earthemergent Cosmic Rays phenomenon, if confirmed,
can support a discovery-level claim of “beyond the
Standard Model” (BSM) physics. Fox, D.B., Sigurdsson,
S., Shandera, S., Mészáros, P., Murase, K., Mostafá, M.
and Coutu, S., 2018. The ANITA Anomalous Events as
Signatures of a Beyond Standard Model Particle, and
Supporting Observations from IceCube. arXiv preprint
arXiv:1809.09615.
2018
PDSA and PDCA Dr. Deming emphasized the PDSA
Cycle, not the PDCA Cycle, with a third step emphasis on
Study (S), not Check (C). Dr. Deming found that the
focus on Check is more about the implementation of a
change, with success or failure. His focus was on
predicting the results of an improvement effort,
studying the actual results, and comparing them to
possibly revise the theory. He stressed that the need to
develop new knowledge, from learning, is always guided
by a theory. By comparison, the Check phase of the
PDCA cycle focuses on the success or failure of a Plan,
followed by needed corrections to the Plan in the event
of failure. Click here to find an excellent article by Ron
Moen and Cliff Norman, offer a deeper explanation of
the difference between the PDSA and PDCA Cycles.

2018
The Encube Team in Goa India after a learning
experience of an FDA inspection. As a mentor and
advisor my feedback- Good Practice. Make next
experience a common routine.
2018
International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use
(ICH).
2018
Just Roll With It? Make sure your horse is placed in front
of your cart. Design of Experience and Design of
Experiments. Which is the horse? DoE can also mean
_________? Fill in the blank.
2018
System Analysis.

2018
Gauge R&R - going beyond calibration.
2018
The Order of Consciousness is eroding and is at the
Procrustean level in many places and slipping lower to
loose control of Impulses can happen quickly. Be
careful.
2018
Generic Data Life Cycles Don't Work in the Laboratory!
Generic models are good in that they provide a simple
basis for understanding a data life cycle, but may be too
simplistic to apply to all situations, especially in a GXP
regulated laboratory. An analytical data life cycle must
be tailored for each situation.

2018
With violated expectation a negative association
between rumination and activation was found in the
posterior cingulate cortex, which is responsible for
change detection in the environment and subsequent
behavioral modification. Rumination – as a stable
tendency to focus repetitively on feelings related to
distress – represents a transdiagnostic risk factor.
2018
Assurance, in and of itself, is a Critical Quality
Attributes. QMS effectiveness comparability plus patient
education necessary. Effective healthcare professional–
patient dialogue is key in transferring confidence to the
patient, and has been shown to reduce nocebo effects
in patients when switching from an originator to a
biosimilar.
2018
Current evidence is insufficient to confirm a biosimilar
nocebo effect, although higher discontinuation rates in
infliximab biosimilar open-label studies support this
theory. Further studies are needed to evaluate the
existence of a biosimilar nocebo effect.
2018
Virtual Reality as medicine.
2018
Informing patients about the nocebo effect might be an
innovative and feasible intervention to reduce the
burden of side effects and strengthen patients’
perceived control over adverse symptoms.

2018
How to stop shoveling sand against the tide?
2018
Therapeutic Equivalence by definition is an Expectation!
So are Placebo and Nocebo effects. Assurance is the
bridge that is being stretched to its limits by the
increasing inequality.
2018
Suitability and Capability: Processes, PQS and
Professionals.
2018
Mind, Matter & Mojo.

2018
With a 2020 vision...
2018
On the road to process understanding in 2004.
2018
Integrated Review and Inspection: Perfector +
Conservator?
2018
A 2004 mental model of pharmaceutical Process
Understanding. How should it be modified in 2018?

2018
What are the main issues and challenges today in
Quality by Design? My 2014 talk at MFDS Korea.
2018
Hi Hans Lennernäs - congratulations on the publication
of your recent paper on absorption from
nanosuspension. Jejunal absorption of aprepitant from
nanosuspensions: role of particle size, prandial state
and mucus layer
https://www.sciencedirect.com/science/article/abs/pii/S
0939641118307604
View Post Friday September 28th, 2018
Arikayce is the first drug to be approved under the
Limited Population Pathway for Antibacterial and
Antifungal Drugs, or LPAD pathway, established by
Congress under the 21st Century Cures Act to advance
development and approval of antibacterial and
antifungal drugs to treat serious or life-threatening
infections in a limited population of patients with unmet
need. Approval under the LPAD pathway may be
supported by a streamlined clinical development
program. These programs may involve smaller, shorter
or fewer clinical trials. As required for drugs approved
under the LPAD pathway, labeling for Arikayce includes
certain statements to convey that the drug has been
shown to be safe and effective only for use in a limited
population.
With a continuous line, because we incorporate sensors
and we monitor how it's doing in real time, all those
issues go away. We're always aware of the quality of the
product as the line runs. So that's been a big advantage.

Price war - Mylan set its list price just $800 per month
below Teva’s $5,800 and then served up discounts.
European Medicines Agency has piled onto China’s
Zhejiang Huahai, finding its manufacturing out of
compliance for the valsartan API that has been recalled
globally after being found to contain a suspected
carcinogen.
Whistleblower alleges API production fraud at Fosun
Pharma.
In a world where everyone is afraid of looking stupid, a
lot of basic improvements and ideas get missed for fear
of embarrassment. So be intellectually secure in
yourself - raise your hand without fear and ask a "dumb
question" to become smarter.

On an evolutionary scale "academic attainment"
capabity seems to be eroding. It is generally accepted
that "nurturing" is more significant than genetics in
educational attainment. Yet it is possible to measure
influence of genetic variations on scholastic
achievements. About 74 significant loci associated with
earning a higher degree identified. In another study,
using data from Iceland that include a substantial
fraction of the population , it is shown that individuals
with high academic scores tend to have fewer children,
mainly because they have children later in life.
Consequently, the average score has been decreasing
over time in the population. The rate of decrease is
small per generation but marked on an evolutionary
timescale. Another important observation is that the
association between the score and fertility remains
highly significant after adjusting for the educational
attainment of the individuals. Selection against variants
in the genome associated with educational attainment |
PNAS http://www.pnas.org/content/114/5/E727.full
Both high and low percentages of carbohydrate diets
were associated with increased mortality, with minimal
risk observed at 50–55% carbohydrate intake. Low
carbohydrate dietary patterns favouring animal-derived
protein and fat sources, from sources such as lamb,
beef, pork, and chicken, were associated with higher
mortality, whereas those that favoured plant-derived
protein and fat intake, from sources such as vegetables,
nuts, peanut butter, and whole-grain breads, were
associated with lower mortality, suggesting that the
source of food notably modifies the association
between carbohydrate intake and mortality.
Log-out and change your password.

The internet has become a surveillance economy in an
experience economy. A growing range of everyday
things — from Barbie dolls to medical devices —
connect to the internet and transmit information about
our movements, our behavior, our preferences, and
even our health. A dominant web business model today
is to amass as much data on individuals as possible and
then use it or sell it — to target or persuade, reward or
penalize.
Remember, everything is right until it’s wrong. You’ll
know when it’s wrong. Ernest Hemingway, The Garden
of Eden
A strong tsunami triggered by a magnitude 7.5
earthquake has hit a coastal Indonesian city, officials
say. Waves of up to 2m (6.6ft) high swept through Palu
on Sulawesi island, not long after authorities had lifted a
tsunami warning. Video on social media shows people
screaming and fleeing in panic and a mosque amongst
the buildings damaged.
https://www.bbc.com/news/world-asia-45683630
Specifically, nudging people to think about what they
could do in a situation, rather than what they should do,
can create a mindset that yields non-binary possibilities
for problem solving.

There are several key messages; there is a high
prevalence of ordinary unethicality in society, and
despite its enormous effect on our life, it is being
neglected because the legal system focuses too much
on smoking guns and gross violations of the law. Policy
makers need to recognize that “good” people want to
behave in a way which allows them to feel good about
themselves without paying too big of a price for their
compliance.
First, start within. Second, on the outside.
The FDA has discussed continuous manufacturing with
the European Medicines Agency and the Japanese
Pharmaceuticals and Medical Devices Agency. All three
agencies have given presentations at continuous
manufacturing workshops. The three agencies
recognize the potential benefits of continuous
manufacturing and support its adoption.
Overhaul of New Drug Approval Process Moves
Forward at US FDA.

Sum of first n odd numbers is n-squared. Triangular
squared. Visualize irrationality.
Design of Experiences with Design of Experiments!
Arrangement of derangement is a system and order in
chaos.
The th subfactorial (also called the derangement
number; Goulden and Jackson 1983, p. 48; Graham et al.
2003, p. 1050) is the number of permutations of objects
in which no object appears in its natural place (i.e.,
"derangements").
fac·to·ri·al fakˈtôrēəl/ noun MATHEMATICS 1. The
product of an integer and all the integers below it; e.g.,
factorial four ( 4! ) is equal to 24. adjective
MATHEMATICS 1. Relating to a factor or factorial. "a
factorial design"
The Science of Language. Let's not forget the basics-
Grammar, Logic and Rhetoric: Knowledge,
Understanding and Wisdom. This basic message should
have been more clear in Pinker's nine voluminous books
he discusses in the article linked below. Hidden in plain
sight and kept it that way.

When you change the way you perceive a thing, the
thing you see changes. This picture (from a post on
LinkedIn) - is intially perceived as upside down plates;
changes to normally placed plates. We can see both
sides and train ourselves to see both sides
"alternatingly".
What permutation and combination of 3rd and 2nd
Order of Consciousness achieve peace?
3! + !3 + !3 = 10 From "3 Batches" to a Factorial System
for "Process Validation". Sensemaking and systems
thinking.

View Post Thursday September 27th,
2018
More evidence that paracetamol use in infancy may
have an adverse effect on respiratory health for
children with particular genetic profiles and could be a
possible cause of asthma. A previous meta-analysis
noted that the association during early pregnancy
exposure was highly variable between studies and
exposure during infancy appears to be moderately
confounded by respiratory tract infections. There is
insufficient evidence to warrant changing guidelines on
early life paracetamol exposure at this time.
https://scholar.google.com/scholar?
hl=en&as_sdt=0%2C21&q=paracetamol+and+asthma&
oq=paracetamol+and+as#d=gs_qabs&p=&u=%23p%3D
TUHY5n7uWHkJ
2018
Give these words new urgency.
2018
Dramatic is emotional.
2018
You don’t tell your opponent what to think or what’s best.
You help them discover for themselves what feels right
and best and most advantageous to them. Their
ultimate decision is based on self-interest. That’s
emotional. I want this. This is good for me and my side.
There’s a detailed and systematic way to go about
building vision the right way.
2018
Tribal to Procrustean to Loss of Impulse Control.

2018
The Japanese space agency has released stunning new
pictures taken by a rover standing on top an asteroid.
The images, sent down from the surface of the asteroid
Ryugu, show the rock in amazing and eerie detail. They
were sent back over a distance of around 180 million
miles.
https://www.independent.co.uk/news/science/japanese-
space-agency-asteroid-jaxa-latest-pictures-images-
a8557571.html
View Post Wednesday September 26th,
2018
A negative and lasting impact on users’ ability to think,
remember, pay attention, and regulate emotion
Frontiers | Smartphones and Cognition: A Review of
Research Exploring the Links between Mobile
Technology Habits and Cognitive Functioning |
Psychology
https://www.frontiersin.org/articles/10.3389/fpsyg.2017.
00605/full

2018
Only 1 out of 159 medical students correctly performed
all 11 elements in a BP check challenge with simulated
patients, and the average number of steps performed
properly was an abysmal 4.1.
2018
An estimated 80,000 Americans died of flu and its
complications last winter—the disease's highest death
toll in at least four decades.
2018
Destined to fulfill that unavoidable duty? I don't buy it.
Oppenheimer’s words are often remembered as an
illustrative synthesis of the vital process of a scientist
who devoted his talent to developing the deadliest
weapon ever invented by humans, and then embarked
on a pacifist crusade that would last until the end of his
days. A superficial interpretation would speak of
remorse and the search for redemption. But the truth is
that in more than two decades working for nuclear
peace, the physicist never once said that he regretted
building the bomb or recommending its use against
Japan. How is Oppenheimer’s metamorphosis to be
understood? Was there really one?

2018
Proof of concept- mosquito genocide. What next?
2018
Do Not Prosecute (DNP) order.
2018
As we envision our future, don’t think money, money,
money to maximize profit. Think relate, relate, relate to
maximize community.
2018
Here are five reasons to keep doing those small things
you do that make the world a better place.

2018
A Zone of Influence A quantum atmosphere, Wilczek
explained, is a thin zone of influence around a material.
According to quantum mechanics, a vacuum isn’t
completely empty; rather, it’s filled with quantum
fluctuations.
2018
quantum atmosphere.
2018
They simply said yes at a party when someone offered
them pills.
2018
Canny (and uncanny) politicians have learned how to
milk the politics of fear by comparing the present to the
past.
2018
A team from the Institute of Stem Cell Biology and
Regenerative Medicine in India has sequenced a protein
crystal from the gut of Diploptera punctata (Pacific
Beetle Cockroach), the only known cockroach to give
birth to live young. To feed its offspring, the roach also
produces a milk-like substance with protein crystals
which have three timesthe energy of buffalo milk.

2018
Worrisome.
2018
Years from now, we will look back in horror at the
counterproductive ways we addressed the obesity
epidemic and the barbaric ways we treated fat people—
long after we knew there was a better path.
View Post Tuesday September 25th,
2018
“Medicine shortages have become an increasing
problem in Australia, as the current voluntary scheme
for reporting shortages has proven ineffective,” TGA
said,
2018
How well we navigate the next downturn will depend on
how we are with each other. Laws and the system can
take you so far. It all depends on whether we view those
issues we face as common problems and we remain
calm and work ourselves through that, or we become
emotional and fight with each other.”

2018
Americans now owe nearly 5% more than they did at
the onset of the Great Recession. Additionally, there's
more to the story than just the numbers.
2018
Post-World War II, it was the U.S. that led global trade
and infrastructure build-out—the Marshall Plan in
Europe, the Interstate Highway System domestically.
Both projects required massive amounts of
commodities and raw materials, and employed
hundreds of thousands of people.
2018
Backlash? Or Right on? Celebrity or not, you're in
Australia," one said. "The caste system does not exist
here. So please don't think you're high up. The way you
handled this - attention seeking?"
2018
$56,603 for an air ambulance flight.

2018
The Centers for Disease Control and Prevention
reported unprecedented year-after-year rises in rates
of sexually transmitted infections in the United States.
2018
Gaslighting is a tactic in which a person or entity, in
order to gain more power, makes a victim question their
reality. It works much better than you may think.

2018
Instead of changing to fit other people’s ideas of normal,
children who are wired a bit differently should be
encouraged to find their place in the world where they
feel they fit.
2018
Globaloney!
2018
Licenced Pharmacists need FDA Guidance on Sanitary
Conditions! This is driving me to explore the relationship
between Yugas and Human Consciousness. When does
Kali Yugh end? FDA says it will “will help compounding
facilities to identify insanitary conditions so that they
can implement appropriate corrective actions and will
assist states in identifying insanitary conditions during
their inspections.”
2018
Dogmas and DNA. Let us not forget epigenetics. DNA
sequence information has become increasingly easier
and less expensive to obtain, but interpretation remains
a challenge.

2018
Dropping Donuts is too nutty.
2018
Research from the University of Texas at Austin found
that glyphosate, a chemical found in Roundup, one of
the most widely used weed killers, causes bees to lose
the beneficial bacteria in their guts. This leaves them
more susceptible to infection and death from harmful
bacteria. Glyphosate perturbs the gut microbiota of
honey bees | PNAS
http://www.pnas.org/content/early/2018/09/18/1803880
115/tab-figures-data
2018
Camp David 75 years old. It is nestled in the bounds of
Catoctin Mountain Park, but you wouldn’t know it if you
visited. The private presidential getaway turned 75 last
year, and it’s been a retreat for presidents.
2018
In Orwell’s world of 1984 Oceania, there is no longer a
sense of due process, free inquiry, rules of evidence
and cross examination, much less a presumption of
innocence until proven guilty. Instead, regimented
ideology — the supremacy of state power to control all
aspects of one’s life to enforce a fossilized idea of
mandated quality — warps everything from the use of
language to private life.

2018
It’s a wonder her arm didn’t fall off. From December
2002 to January 2010, more than 335,130 prescriptions
for painkillers were issued under the name of Dr.
Katherine Hoover at the West Virginia clinic where she
worked — a rate of about 130 per day, assuming she
worked seven days a week.
2018
The RSA Student Design Awards is a global curriculum
and competition for emerging designers that’s been
running since 1924. The Awards include over £30,000 in
cash prizes and paid placements. Winners also receive
practical support from the RSA and their partners, and
join a global community of alumni that includes Apple
Design Chief Jonathan Ive, digital public services
mastermind Ben Terrett and Forbes ’30 Under 30’ social
entrepreneurs Elena Dieckmann and Ryan Robinson.
2018
A “living nature” fabric, an inclusive kitchen hob guard
that enables people with disabilities to cook with
confidence, and an animation that champions truth in
an era of fake news are among the innovations
announced today as winners of the 2018 RSA Student
Design Awards.

2018
Student Design Awards: Looking for Emerging Designer.
Interested?
2018
Compare the high rate of error in pharmaceutical
labeling to the low "certified six sigma" error rate of the
Dabbawalas of Mumbai, most are illiterate. Shame on
our "Good Practices". Soon humans will not have a job
in pharmaceutical operations. Robots with artificial
intelligence will reduce the errors to give us assurance.
2018
Woodcock on the stress on generic companies ("a silent
crisis that's very bad"), drug shortages (the "root cause
is the marketplace and economics") and even
marijuana ("we are totally agnostic about cannabis").
2018
Pill ghost strikes again. Novartis’ traditional pill
manufacturing will shoulder the brunt of a cost-cutting
effort announced today as it looks to a future in biologic
drugs and higher margins.

2018
Digital biomarkers.
2018
Interchangeability – switching or substitution?
2018
Fake News is Deadly.
View Post Monday September 24th,
2018
Wobbly Earth . The changes in terrestrial water storage
(TWS) and global cryosphere together explain nearly
the entire amplitude (83 ± 23%) and mean directional
shift (within 5.9° ± 7.6°) of the observed motion.
Climate-driven polar motion: 2003–2015 | Science
Advances
http://advances.sciencemag.org/content/2/4/e1501693.
full
2018
Hydrophobic surface - clover pattern. Hydrophilic
surface - Sun flower pattern.

2018
To be is to be perceived- Berkeley. Was Berkeley,
CALIFORNIA named after George Berkeley?
View Post Sunday September 23rd,
2018
This is Big Bad Pharma or a problem with the licencing
system?
2018
the AWAKE experiment
2018
pa·tient ˈpāSHənt/ adjective 1.able to accept or tolerate
delays, problems, or suffering without becoming
annoyed or anxious. "be patient, your time will come"
synonyms:forbearing, uncomplaining, tolerant,
resigned, stoical; More noun 1.a person receiving or
registered to receive medical treatment. synonyms:sick
person, case; More 2. LINGUISTICS the semantic role of
a noun phrase denoting something that is affected or
acted upon by the action of a verb.
2018
The division of labour between humans, machines and
algorithms is shifting fast.

2018
In an odd turn of events, the FDA found that a
company’s pharmaceutical testing area was
overlapping with beer brewing. They we not happy with
this arrangement.
2018
See you at: In Vitro and In Silico BE Assessments:
Opportunities, Strengths and Challenges Moderator:
Ajaz Hussain, Ph.D., President, National Institute for
Pharmaceutical Technology and Education (NIPTE)
2018
A sketch of a common scene at pharmaceutical facilities
in India on day 1 of GMP Inspections by auditors from
Europe or the USA. Planting of a sapling, a source of
additional knowledge that should grow to become a tree
of life.
2018
Push to improve knowledge acquisition, transfer and
utility.

View Post Saturday September 22nd,
2018
Monetary penalties are nice way to make a violation
"cost of doing business". Can the sector ever achieve
credibility? The FDA draft guidance comes as a recent
BMJ paper found that 49% of clinical trials on the EU
register have not reported results, while a US study
from 2015 found about 20% of industry trials did not
report results when required to do so, while about 50%
of NIH-sponsored research went unreported. Science’s
In the Pipeline has more color on that data.
2018
For biotechnology products, advancing the
manufacturing technology behind upstream and
downstream processes has the potential to reduce
product shortages and variability, allow for production
flexibility, simplify scale-up procedures, improve
product quality, reduce facility footprints, increase
productivity, and reduce production costs.
2018
In Parkinson's the neural network underlying the
placebo effect have been largely confirmed and
accepted, what remains to be established is how, when,
and where the expectation of reward (mediated by the
ventral striatum) interacts with the primary motor
system (mediated by the dorsal striatum) to induce
clinical improvement in motor symptoms.
View Post Friday September 21st, 2018
Check out the redacted Form 483, link in the article.

After examining several GSK-made internal safety
reports obtained through an ongoing lawsuit alleging
that Pandemrix caused the sleep disorder, the medical
journal found a large discrepancy in adverse event
rates dated years back between Pandemrix and two
other GSK pandemic vaccines. Pandemrix have not
been available for several years now.
“What do you mean, ‘I’m sorry’?” he remembers
responding. Lee explained that there had been
problems with the injected drug, and that other patients
had come in with the same symptoms. A retina
specialist next door gave Cosby aspirin in the hope that
it might increase blood flow to the back of his eye. It
didn’t.
2018
Collaboration across institutes can train students in
open, team science.

2018
When you change your perception......
2018
Controlling and focusing our mind.
2018
Failuer to plan is planning to fail.
2018
How to Rescue a pH Sensitive Protein FREE open access
webinar — Invite your colleagues! September 20th @
12:30 p.m. EDT
2018
This study evaluates the expansion potential of stirred-
tank bioreactors for immunotherapy manufacture and
compares that to current state-of-the-art static and
wave-agitated cultures

2018
A kinetic modelling approach involving passive
permeation and efflux transport mechanism allowed
the estimation of the passive diffusional component and
the Michaelis-menten parameters. The estimated Km
value demonstrated that at clinical luminal
concentrations the efflux process is not saturated and
then it could be inhibited by other drugs, excipients or
food components leading to the already reported
clinical drug-drug and drug-food interations.
2018
Expectancy-induced analgesia and placebo effects in
general have emerged as useful models to assess
individual endogenous pain modulatory systems.
Different systems and mechanisms trigger placebo
effects that highly impact pain processing, clinical
outcomes, and sense of well-being.
2018
Comparative presentation of frequencies for side
effects with and without drug intake including
statements on the causal relation significantly improves
understanding.
2018
Biologics versus biosimilars: The switch may induce
nocebo effects?

2018
The very relationship of race to drug development is
fraught with controversy. Race is primarily seen as a
social concept, rather than as a product of measurable
biological traits. Yet there’s growing evidence that,
whether for environmental or genetic reasons, drugs
may have different effects on different populations.
2018
With smart cancer diagnostics, one-stop-shop diabetes
kits and AI systems to improve ambulance pick-ups for
patients with chest pain, AstraZeneca (AZN.L) aims to
move from simply supplying drugs to become a broad
healthcare provider in China.
2018
New Cats in a Box. Reality that depend on perspective
or that quantum theory does not apply to complex
things such as people. Reimagining of Schrödinger’s cat
breaks quantum mechanics — and stumps physicists.
https://www.nature.com/articles/d41586-018-06749-8?
utm_source=briefing-
dy&utm_medium=email&utm_campaign=briefing&utm_
content=20180919

2018
Digital dementia. Outsourcing our smartness to our
smartphone.
2018
In 2012 every 19 minutes a person died ...... what about
in 2018?
2018
“There are periods in human and cultural evolution
when humanity passes through such fundamental
transformations that our reality shifts and new patterns
of thought are required to make sense of the unfolding
human drama . . . The profound transformation we are
now witnessing has been emerging on a global scale
over millennia and has matured to a tipping point and
rate of acceleration that has radically altered and will
continue to alter our human condition in every aspect.
We must, therefore, expand our perspective and call
forth unprecedented narrative powers to name,
diagnose, and articulate this shift.” Gangadean, 2006, p.
382 Link to this article (pdf):

2018
"That which Below corresponds to that which is Above,
and that which is Above, corresponds to that which is
Below, to accomplish the miracles of the One Thing”.
These words were translated by Sir Isaac Newton from
the Emerald Tablet—a Hermetic text attributed to
Hermes Trismegistus Source: Dobbs, B. J. T.: Newton's
commentary on the emerald tablet of Hermes
Trismegistus: its scientific and theological significance
In I. Merkel & A. G. Debus (Eds.), Hermeticism and the
Renaissance. Cranberry, NJ: Folger Books ((1988). Also
see:
2018
Four Quartets held together by the singular soothing
voice of Guinness. The central theme tying together the
four poems---“Burnt Norton,” “East Coker,” “The Dry
Salvages,” and “Little Gidding”---is time: as eternity, as
emptiness, as a wasteland of words and gestures
without meaning or purpose.
2018
Quality by Design can only be Dil Se! Deception is
common in nature and humans are no exception.
Modern societies have created institutions to control
cheating, but many situations remain where only
intrinsic honesty keeps people from cheating and
violating rules. Weak institutions and cultural legacies
that generate rule violations not only have direct
adverse economic consequences but might also impair
individual intrinsic honesty that is crucial for the smooth
functioning of society. Nature volume 531, pages 496–
499 (24 March 2016). “The results are consistent with
theories of the cultural coevolution of institutions and
values, and show that weak institutions and cultural
legacies that generate rule violations not only have
direct adverse economic consequences but might also
impair individual intrinsic honesty that is crucial for the
smooth functioning of society.” Source for pdf:
http://eprints.nottingham.ac.uk/32492/1/Gaechter-
Schulz%20_NottinghamEprints.pdf Mainstream
interpretation - http://www.versiondaily.com/study-
corrupt-societies-create-dishonest-citizens/

2018
Employees of a large, international bank behave, on
average, honestly in a control condition. However, when
their professional identity as bank employees are
rendered salient (i.e., noticeable or important), a
significant proportion of them become dishonest (
Nature volume 516, pages 86–89 (04 December 2014)).
That is bankers are not inherently dishonest; rather, the
banking culture leads them to act dishonestly.
2018
A highly recommended article: The Market for
"Lemons": Quality Uncertainty and the Market
Mechanism (link to pdf below). George A. Akerlof wrote
this 13 page-paper for which he was awarded the Nobel
Prize in Economics during his first year as assistant
professor at Berkeley, in 1966-67!
https://www.sas.upenn.edu/~hfang/teaching/socialinsur
ance/readings/fudan_hsbc/Akerlof70(2.1).pdf
https://www.nobelprize.org/prizes/economics/2001/ake
rlof/article/

2018
People say money doesn't buy happiness. Except,
according to a 2010 study from Princeton University, it
sort of does — up to about $75,000 a year. The lower a
person's annual income falls below that benchmark, the
unhappier he or she feels. But no matter how much
more than $75,000 people make, they don't report any
greater degree of happiness. What have we learned in
the past 8 years? A large analysis published in the
journal Nature Human Behavior used data from the
Gallup World Poll, a survey of more than 1.7 million
people from 164 countries, to put a price on optimal
emotional well-being: between $60,000 and $75,000 a
year. However, there is substantial variation across
world regions, with satiation occurring later in wealthier
regions. We also find that in certain parts of the world,
incomes beyond satiation are associated with lower life
evaluations.
2018
Cheating by Desing was and will always be lucrative!
Are you sure you want to be a practitioner of Quality by
Desing? As for what happened to Clark Stanley after it
was found that his whole empire was based on a lie? He
was fined $20 (that's about $429 in today's dollars) for
violating the food and drug act and for "misbranding"
his product by "falsely and fraudulently represent[ing] it
as a remedy for all pain." Stanley did not dispute the
charges. Stanley's Snake Oil didn't contain any snake oil
at all. The Pure Food and Drug Act of 1906 sought to
clamp down on the sale of patent medicines and it was
that legislation that led to Stanley's undoing. After
seizing a shipment of Stanley's Snake Oil in 1917,
federal investigators found that it primarily contained
mineral oil, a fatty oil believed to be beef fat, red
pepper, and turpentine. That's right — Stanley's
signature product did not contain a drop of actual snake
oil, and hundreds of consumers discovered they had
been had.
https://www.thevintagenews.com/2017/02/03/in-the-
late-19th-century-clark-stanley-patented-snake-oil-and-
advertised-it-as-a-painkiller/

2018
A History Of 'Snake Oil Salesmen': How did a legitimate
medicine become a symbol of fraud? The origins of
snake oil as a derogatory phrase trace back to the latter
half of the 19th century, which saw a dramatic rise in
the popularity of "patent medicines." Often sold on the
back pages of newspapers, these tonics promised to
cure a wide variety of ailments including chronic pain,
headaches, "female complaints" and kidney trouble. In
time, all of these false "cures" began to be referred to
as snake oil.
2018
Can you believe this? In June 2018 the “fiduciary rule,"
which required advisors who offer investment advice on
retirement savings accounts to put their clients'
interests before their own, was vacated. Now What?
Now that the rule has been vacated, investors will need
to be vigilant about determining whether their advisor is
acting as a fiduciary — that is, working in their best
interest. "The rule was meant to reassure customers
that their advisors were acting in their best interest
when helping them make decisions about their IRAs,
401(k)s or retirement plan rollovers," says Kathleen
Stewart, Senior Director and Family Wealth Strategist at
BNY Mellon Wealth Management. "People want to work
with someone that they trust, and they generally expect
their financial advisor to be working in their best
interest. When they discover that's not the case, it can
be eye-opening."

2018
Optimism, anxiety, extraversion, neuroticism—
successfully differentiated placebo responders from
non-responders in the cohort of chronic pain patients
who participated in this study. In this study, placebo pill
response was driven primarily by a combination of a
greater openness to experience, increased emotional
awareness, decreased distraction about pain and
discomfort, augmented capabilities in describing inner
experiences, and higher sensitivity to non-painful
situations. These results reveal that placebo response
can be predicted from an ability to recognize subtle
cues in the body regarding emotional and physical well-
being, to remain attentive to these cues and emotions
by not ignoring or suppressing them, and to choose to
accept these states as opposed to becoming worried or
burdened by them. Nature Communications volume 9,
Article number: 3397 (2018)
https://www.nature.com/articles/s41467-018-05859-1
2018
We see only what we want to see is true for individuals
not for a system. This example illustrates the need for
system improvement.
2018
Yesterday I was clever, so I wanted to change the world.
Today I am wise, so I am changing myself.” Rumi

2018
Younger and older me perusing the same goal for
decades- wise or foolish? If you want to live a happy life,
tie it to a goal, not to people or things. Albert Einstein
Look deep into nature, and then you will understand
everything better. Albert Einstein
2018
This reminds me of Einstein - Imagination is more
important than knowledge. For knowledge is limited to
all we now know and understand, while imagination
embraces the entire world, and all there ever will be to
know and understand. Contextual/expectation-driven
(relative relief-related) analgesia was blocked by
naloxone. In contrast, pain reappraisal through mental
imagery was intact despite opioid receptor blockade,
suggesting opioid independence. These results support
mental imagery as a powerful, clinically relevant
strategy for regulating pain as it does not rely on a
functioning opioidergic system.
2018
Emotional component of sickness behavior is, at least
partly, shaped by top-down expectations. Helping
patients having a realistic expectation of symptoms
during treatment of an illness may thus reduce
aggravated emotional responses, and ultimately
improve patients’ quality of life and treatment
compliance.

2018
There is more to Nocebo than just how information is
shared (framing). Positive framing reduced side effects
short-term, but not at follow-up. Expectations did not
differ between negative and positive framing. Nocebo
effects appeared to generalize to other unmentioned
symptoms over a 24-hr period.
2018
On dogmas - for half a century, a high level of total
cholesterol (TC) or low-density-lipoprotein cholesterol
(LDL-C) has been considered to be the major cause of
atherosclerosis and cardiovascular disease (CVD), and
statin treatment has been widely promoted for
cardiovascular prevention. However, ...... search for
falsifications of the cholesterol hypothesis confirms that
it is unable to satisfy any of the Bradford Hill criteria for
causality.

Compliance or Adherence? How to Approach cGMP
Regulations In The 21st Century. The words we use
influence the way we think, organize information, make
decisions, and behave. Consider two commonly used
words in our vocabulary: compliance and adherence. In
pharmaceutical operations, compliance is used to
describe the behavior of following written instructions
or operational routines (SOPs). In healthcare, the noun
adherence describes the behavior of following written
instructions for taking medications (prescriptions). In
the cGMP context, would you consider compliance and
adherence to be synonymous? This article was part of
the CPhI 2016 Annual Report, which was released
during the CPhI Worldwide event in Barcelona (October
4-6, 2016).
Meaning makes the pursuit of happiness possible. The
picture is a photograph of a print hanging on a wall. It is
a local scene in Frederick, MD.
The Shift to Real World Demonstration of Effectiveness
What has markedly changed in recent years is the
demand for certainty on how that clinical data
translates into the real world setting and what impact a
new product promises under such conditions. Formulary
decision-making is increasingly influenced by actual
real-world effectiveness considerations that go beyond
RCT efficacy claims. A useful paper that you may wish to
download and review: Setting up for Success: TOWARDS
THE NEW FRONTIER IN US OUTCOMES-BASED
CONTRACTING. It is a "commercial" paper (and I have
no association with its provider). https://analytica-
laser.com/2999-2/?
utm_source=New%20York&utm_medium=medium&utm
_campaign=SBNASPnews1&utm_content=NASPNEWS1
The picture is to remind us of the growing importance of
quality assurance in the context of real-world evidence.

Question: What is the effect of an invitation to a single
prostate-specific antigen (PSA) screening on prostate
cancer detection and median 10-year prostate cancer
mortality?

Question: What is the effect of a healthy low-fat (HLF)
diet vs a healthy low-carbohydrate (HLC) diet on weight
change at 12 months and are these effects related to
genotype pattern or insulin secretion?
Compounded drugs were said to pose unique risks.
They were not FDA approved, neither do compounded
drugs undergo pre-market review for safety,
effectiveness or quality. Also, if a compounder
distributed drugs to several states, it can be difficult to
gather information about possible adverse events
associated with those drugs, link them to the
compounder, and undertake coordinated action to
address potentially serious public health problems.
“These risks were illustrated by the 2012 nationwide
fungal meningitis outbreak. This tragic outbreak led to
more than 750 cases of illness and the deaths of 64
individuals,” said the FDA. “They had used a
compounded drug for injection that was supposed to be
sterile but had become contaminated before
distribution to patients and providers.”

The introduction of fractal geometry for the quantitative
analysis and description of the geometric complexity of
natural systems has been a major paradigm shift in the
last decades. Now a days, modern neurosciences admit
the prevalence of fractal properties such as self-
similarity in the brain at various levels of observation,
from the microscale to the macroscale, in molecular,
anatomic, functional, and pathological perspectives.
Fractal geometry is a mathematical model that offers a
universal language for the quantitative description of
neurons and glial cells as well as the brain as a whole,
with its complex three-dimensional structure, in all its
physiopathological spectrums.
Chaos Theory of Careers with particular reference to
the concepts of “attraction” and “attractors”. Attractors
are defined in terms of characteristic trajectories,
feedback mechanisms, end states, ordered
boundedness, reality visions and equilibrium and
fluctuation. It is contended that ultimately the context of
human experience is an open system and that career
development difficulties arise when closed systems
thinking is used in an open systems reality.

Unlike a machine, which is a closed system, a family is
open-ended, and its survival depends upon its ability to
weather periods of extreme turbulence and chaos en
route to calmer oases. The job of the family therapist is
to identify the strange attractors that promote
transformation. Using . . . vignettes and . . . metaphors,
[this book] demonstrates how readers can apply the
science of chaos theory to the art of engendering family
change. (PsycINFO Database Record (c) 2016 APA, all
rights reserved)
Functional brain imaging now shows that conscious
cognition is distinctively associated with wide spread of
cortical activity, notably toward frontoparietal and
medial temporal regions. Unconscious comparison
conditions tend to activate only local regions, such as
visual projection areas. Frontoparietal hypometabolism
is also implicated in unconscious states, including deep
sleep, coma, vegetative states, epilepticloss of
consciousness, and general anesthesia.
This article examines some of the most regarded brain-
based, metastable consciousness models, the
Operational Architectonics Theory of Brain-Mind, Global
Workspace Theory, Information Integration Theory, and
the Dynamic Core Hypothesis. Through an overview and
critique of these models, the authors illustrate their
insights and deficits, and discuss why the Default Space
Theory is the most comprehensive theory of
consciousness.

According to this hypothesis, a stimulus is consciously
perceived for as long as it is recoded to fit an ongoing
stream composed of all other perceived stimuli. The
authors suggest that this' updating'process is governed
by at least three factors (1) context,(2) stimulus saliency
and (3) observer's goal. Finally, this framework forces
us to reconsider the typical distinction between
conscious and unconscious information processing.
Integrated information theory: from consciousness to its
physical substrate Giulio Tononi, Melanie
Boly[…]Christof Koch Nature Reviews Neuroscience. 17:
450–461 (2016) Abstract In this Opinion article, we
discuss how integrated information theory accounts for
several aspects of the relationship between
consciousness and the brain. Integrated information
theory starts from the essential properties of
phenomenal experience, from which it derives the
requirements for the physical substrate of
consciousness. It argues that the physical substrate of
consciousness must be a maximum of intrinsic cause–
effect power and provides a means to determine, in
principle, the quality and quantity of experience. The
theory leads to some counterintuitive predictions and
can be used to develop new tools for assessing
consciousness in non-communicative patients.
insurance (n.) 1550s, "engagement to marry," a variant
of ensurance "an assurance, pledge, guarantee," from
Old French enseurance "assurance," from ensurer,
from en- "make" (see en- (1)) + sur "safe, secure,
undoubted" (see sure (adj.)). Commercial sense of
"security against loss or death in exchange for
payment" is from 1650s. Assurance was the older word
for this specific sense (late 16c.). Compare insure.
A 12oz glass of orange juice has about 10 teaspoons of
sugar, the same amount as a can of full-calorie soda.
Stop juicing children.

Teaching is the one profession that creates all other
professions. -Unknown. The state of teaching says it all.
safety (n.) is the condition of being protected from or
unlikely to cause damage; also denoting something
designed to prevent injury or damage. When do design
for "sustainability and safety" beyond the "shelf-life" or
intended use? Why are we then surprised?
The lowest state-rate of obesity is 22.6 percent in
Colorado and the highest is 38.1 percent in West
Virginia.
Running out of reproductive capacity and extinction of
this population is looming.

On a variety of human tendencies that get in the way of
innovation and how might design thinking’s tools and
clear process steps help teams break free of them.
More than 90 organizations, predominantly patient
groups, criticized CVS Caremark's decision last month
to incorporate value-based drug pricing analyses in
some of its coverage choices. Quality Adjusted Life-style
Years QALY! CVS seeks to exclude certain drugs that
carry list prices which come in above a threshold of
$100,000 per QALY — a measure that attempts to
define a drug's value.
Apolipoprotein A-IV (ApoA-IV)!

The American Pharmacists Association (APhA) requests
several changes to the guidance, including calling on
FDA to develop a framework to standardize its
approach to granting an indication that is broader or
narrower than the population studied. APhA says that
FDA should test out the recommendations it makes in
the guidance on the inclusion and prominence of the
Limitations of Use section. “Because prominent
placement of Limitations of Use in the labeling may
infer a greater risk, APhA recommends FDA test
whether the labeling is confusing or misleading to
health care practitioners,” APhA writes. Additionally,
APhA says it believes FDA increase its surveillance of
products with expanded or narrowed indications and
pay close attention to adverse events that occur in
populations that were not studied and whether certain
populations are being excluded from labeling more
frequently than others.
The FDA’s latest testing of products shows an additional
unexpected impurity in three lots of Torrent
Pharmaceuticals’ recalled valsartan drug products. This
second impurity, N-Nitrosodiethylamine (NDEA) is a
known animal and suspected human carcinogen. These
Torrent products were included in the company’s recall
on August 23, 2018.
Update on US FDA’s efforts to utilize lessons learned
from the Quality Metrics Feedback and Site Visit
programs to revise its draft guidance. On June 29, 2018,
FDA announced the availability of the Quality Metrics
Feedback Program, which includes a pilot program, and
the Quality Metrics Site Visit Program. FDA views quality
metrics as a tool for helping to predict drug quality
problems, mitigate the risk of drug shortages and
inform risk-based inspection scheduling of drug
manufacturing facilities Resources 1. Quality Metrics
Site Visit Program for Center for Drug Evaluation and
Research and Center for Biologics Evaluation and
Research Staff; Information Available to Industry;
Extension of the Proposal Period, 83 Fed. Reg. 41080
(Aug. 17, 2018). 2. Quality Metrics Site Visit Program for
Center for Drug Evaluation and Research and Center for
Biologics Evaluation and Research Staff; Information
Available to Industry Quality Metrics Site Visit Program),
83 Fed. Reg. 30751 (June 29, 2018); Modernizing
Pharmaceutical Quality Systems; Studying Quality
Metrics and Quality Culture; Quality Metrics Feedback
Program (Quality Metrics Feedback Program), 83 Fed.
Reg. 30748 (June 29, 2018). 3. Quality Metrics for Drug
Manufacturing (updated July 16, 2018). 4. Request for
Quality Metrics; Notice of Draft Guidance Availability
and Public Meeting; Request for Comments, 80 Fed.
Reg. 44973 (July 28, 2015); FDA Draft Guidance for
Industry, Request for Quality Metrics (2015 Quality
Metrics Guidance) (July 2015)

A brain chip can now pilot a swarm of drones — or even
advanced fighter jets.
No amount of pontificating will change what we already
know. The [American] education system needs to be
completely revamped – from the first grade to the Ph.D.
2018
China-based active pharmaceutical ingredient (API) and
intermediate manufacturer Jiangsu Yew Pharmaceutical
Co. has refused an inspection by Hungarian officials.
The refusal of the inspection on 20 June means the
company, which manufactures intermediates for the
active substance temozolomide, will not win approval
for a Certificate of suitability (CEP). This is just one in a
series of Asia-based companies refusing
inspections.Last month, the US FDA added four Chinese,
one Indian and one South Korea-based drug
manufacturers to its import alert list for refusing
inspections.
2018
Babylon already has several contracts with the NHS, the
UK's national health service, and its AI medical service
is embedded in Samsung phones in the US.

2018
Babylon's app has been downloaded over a million
times and it allows people in UK, Ireland, and Rwanda to
ask a chatbot a series of questions about their condition
without having to visit a GP. The medical chatbot
provides feedback on the patient's symptoms and
recommends a paid-for video call with a human doctor
when the occasion calls. In the UK, one-off calls with a
doctor start at £25, while calls with a specialist cost
more. Alternatively, Babylon users can pay £5 a month
for a subscription to the service. In Rwanda, where
Babylon has 450,000 users, people pay 50p for a
consultation.
2018
The FDA has awarded $250K per year for up to two
years to Simulations Plus (SLP +0.2%) to help fund the
integration of drug product quality attributes into the
GastroPlus TCAT model.
2018
How to create a Pharmaceutical Manufacturing
Renaissance? Actively confront critical assumptions
about pharmaceutical manufacturing. Manufacturing
quality counts. We need alignment and prioritization of
research, education and policy efforts. To realize right-
first-time development and manufacturing of generic
drugs in the U.S. we must work to identify and
aggressively address vulnerabilities in the U.S. drug
supply. In doing so, pharmaceutical manufacturing in
the U.S. will become a contributing factor in reducing
drug costs. After all, the most expensive drug is the one
that doesn’t work because of poor quality.
2018
Looking to make “disruptive” changes to U.S. drug
pricing to bring down costs for patients?

2018
Evidence from behavioural psychophysics, structural
mechanics and neuronal modelling, shows that tools
are treated by the nervous system as sensory
extensions of the body rather than as simple distal links
between the hand and the environment.
2018
A direct connection between the cellular process that
eliminates damaged mitochondria — called mitophagy
— and inflammation.
2018
A previously unknown electron-transfer pathway now
reveals an energy-generation system used by bacteria
in the human gut.

2018
Teaching science to machines: AI-based ‘speed-readers’
are useful because the scientific literature is so vast. By
one estimate, new papers are published worldwide at a
rate of 1 million each year — that’s one every 30
seconds. It is practically impossible for researchers to
keep up, even in their own narrow disciplines. So, some
seek to computationally tame the flood.
2018
Group peer-teaching exercises could help to improve
the peer-review process for all researchers, even the
experienced ones.
2018
Stimulate awareness of thought processes
(metacognition), a useful faculty when it comes to
dealing with uncertainty and unpredictability in research
results.
2018
South Africa’s science system is set for its biggest
shake-up in 20 years, amid proposed legislation
changes that aim to make research efforts better serve
citizens and address problems such as poverty and
unemployment.
2018
India has set an ambitious goal to send people to space
by 2022. The mission and its short timeline —
announced by Prime Minister Narendra Modi on 15
August — surprised many, including the head of the
country’s space agency.

2018
Trust in pharma in the US has seen the biggest drop yet
in the five years since they started tracking it. Be the
lab, not the sales force: focus on messaging around
R&D, innovation and hard science versus profits, sales
and marketing to avoid the “pricing outrage cycle”. Treat
the whole person: the Edelman data shows that people
generally have positive feelings towards the future of
health technology – and holistic wellness and disease
management solutions matter as well as new
treatments. Localize and humanize: tailor your
communications to meet local standards and
expectations. One size does not fit all. Don't be a
Procrustean.
2018
Insecurity is neither a flaw nor a drive. It is a byproduct
of a workplace culture in which individualism is
rampant, relationships are instrumental, and bias goes
unquestioned. To accept and overcome insecurity, we
rather need to stop caring too much about each other
and start to care more for each other, and for the place
we work in.
2018
Generic labels may negatively affect adherence to
treatment even if patients report ex ante positive
evaluations of the quality of generics drugs.
2018
A crystallization model with enhanced prediction
capability.

2018
How easy it is to be "in over our heads"! Complexity and
uncertainty we confront today requires us to increase
our orders of conciousness at all levels- fractals. As
above so below. This contaminant started way back in
2012, so why did it take six years to come to light?" she
asked. "Public safety is our number-one priority and so
I'm not making light of this at all."
2018
Regulators took rapid action, but exposed patients still
require long term monitoring.

2018
Nirmal explained- new FDA guidance on elemental
impurities in medicines required a reformulation of
nitrofurantoin, so Nostrum pulled the product out of the
market while it implemented the necessary changes.
The generic drug business has become so bogged down
in inefficiencies at the Food and Drug Administration,
increased industry fees and regulations that his
business has lost money in eight of the 11 years it’s
been in operation.As a result, he needs to raise prices
when he can. Chaos!
2018
Nitrofurantoin's use has increased exponentially since
recent guidelines repositioned it as first-line therapy for
uncomplicated lower urinary tract infection (UTI).

2018
How does nitrofurantoin comare to placebo? Benefit
27/35 in the nitrofurantoin group and 19/35 in the
placebo.
2018
Nitrofurantoin pills now costs $2,393, up from ~$475.
CEO Nirmal Mulye is not only unabashed with the
aggressive hike, he is downright proud. In an interview
with the Financial Times, he said that he had "a moral
requirement" to make money and to "sell the drug for
the highest price," adding "this is a capitalist economy
and if you can't make money you can't stay in business."
means soft. Nirmal compared his decision
to increase the price to an art dealer that sells “a
painting for half a billion* dollars” and said he was in
“this business to make money”.
2018
Wong, 54, has worked at the neonatal intensive care
unit at the hospital in Palo Alto, California, for 32 years.
Seeing the name Seminatore on a young doctor's ID
badge caused her nursing senses to tingle......rest of the
story brings a smile.....

2018
#DoItForPeace join in.
2018
Nine in a row.
2018
After a long, slow fall, the blood-testing company is
officially dissolving. This is the final act in Theranos'
dramatic downfall. Founded in 2003 by then teenage
Stanford dropout Elizabeth Holmes, Theranos grew into
a $9 billion firm based on its promise of a blood test
requiring only a finger prick.

2018
Placebo- generic or brand? Remember the song by
Huey Lewis? Oh I want a new placebo, one that won't
make me sick One that won't make me crash my car Or
make me feel feet, feet, feet thick I want a new placebo,
one that won't hurt my head One that won't make my
mouth too dry Or make my eyes too red ....
2018
Baby rat soup.
2018
Last year was the world's saddest in more than a
decade. More people reported feeling stressed,
worried, anxious and in physical pain in 2017 than in any
previous year, according to Gallup's annual Global
Emotions Report.

2018
U.S. universities have sponsored endangered scholars
and recently created a consortium that offers a broader
academic community to refugee scholars threatened by
war and authoritarian governments.
2018
Sinkhole in Frederick, MD!
2018
Real world challenges- conspiracy theories have gained
a cult following and are posing risk driving deep
divisions in the society.
2018
Can you believe this? A growing number of Russian
publications have been putting forth an absurd new
theory—that a NASA astronaut deliberately caused the
leak on board the station in order to force the
evacuation of a sick crew member.

2018
After an earlier flirtation with up the coast toward
Virginia, the southern turn brings Georgia into the path
of the storm.
2018
I am who I am.
2018
One survey of 3,659 students in Belgium suggests that
32% of Ph.D. students are at risk of having or
developing a psychiatric disorder such as depression.
2018
“A pill would be way better for patients."
2018
In the name of enhancing transparency in agency
decisions and compliance actions, FDA is publishing
updated information on how it selects and schedules
pharmaceutical plant inspections around the world and
the process for disclosing the findings of those
oversight actions. The increasingly global nature of the
biopharmaceutical supply chain has prompted FDA to
revise its inspection process and to seek harmonization
in standards for United States and foreign regulatory
oversight to further ensure the safety and quality of
medicines in the US and around the world.
Harmonization without considering professional
development is like treating symptoms. Well most drugs
do the same so why not.

2018
The second law of thermodynamics gives life its
meaning. The law states that entropy, i.e. decay, will
continuously increase. "People often get stuck in
thinking about individual problems," Prentiss said.
Whether or not England's ideas turn out to be exactly
right, she said, "thinking more broadly is where many
scientific breakthroughs are made."
2018
The reality is that most people are not set up to take
advantage of development opportunities. Many
organizations view learning as something extra,
something to fit in on top of the regular work. But to
create a culture that encourages employee growth,
managers need to make learning an expectation — not
an option.
2018
Pharmaceutical Professionals can learn a lot from
Kabaddi. Player of one side try to tag the player(s) of
opposite team, while saying Kabaddi Kabaddi and
keeping his/her breath alive and then gets back to
his/her own side once he/she tags. While the defending
team which is being tagged will try to take down the
player who is saying Kabaddi Kabaddi until his breath
runs out.
2018
New campaign with a new tagline ‘Bachpan ka khel hai,
baccho ka nai’ (loosely translated as kabaddi has been
played as a childhood sport; however, it is no child’s
play).

2018
Global Kabaddi League (GKL) started its online
registration of the worldwide kabaddi players on
September 11.
2018
Practices that have a potential to pose a risk of
contamination to products that are intended to be
sterile continue until a routine inspection by FDA. Then
recalls occur. What is the difference between before
and after FDA inspections? A game of Kabbaddi we play
at work. Enjoy Kabaddi after work.
2018
Asian researchers put the AI takeover in just 30 years,
while their North American counterparts see that
happening inabout 74 years. Full automation of labor is
expected in under 125 years.
2018
When relationships are struggling there’s no way to take
care of the next level of thinking. When students are
dealing with social drama, they have a lot less mental
space for academics. Secure a learning space.

2018
Each time you check your smart phone you tap into a
global brain. And when you finally put down the phone,
you shake your head: So much going on. In fact, the
tightening weave in the global network means that
never has there been an era in human history in which
so many people learn together.
2018
The ability to talk to each other across specialization is
something philosophers greatly prize, and rightly so. It
is what gives meaning to many of the activities they
engage in, from presenting their ideas at weekly
meetings to convening in workshops and conferences.
This is why many of the most prestigious philosophy
journals are open to submissions from any quarter
rather than being restricted to a particular subfield.

2018
Philosophy plays an essential role for society because
scientific knowledge is inherently incomplete.
2018
Pharma companies spent more on legal and
consultancy services than companies in any other
industry. "Internal validation" is a better approach.
2018
With the coming of the period of decline, the winds of
knowledge stopped blowing.
2018
Emphasize the importance of relationships to learning.

2018
Flu risk doubling as season progresses.
2018
Procrustean physicians. In too many cases, addiction
still starts with a prescriber's pen.
2018
The U.S. Food and Drug Administration has issued
warnings to two additional companies selling the
controversial supplement kratom, signaling that the
agency’s crackdown on the substance continues to face
challenges nearly one year later.
2018
Florence is unprecedented.

2018
Spread pricing is a practice that’s most common with
generic drugs, which make up almost 90 percent of all
prescriptions dispensed in the U.S. Generic pills often
cost pennies on the dollar compared with brand-name
versions, and promoting them has been the focus of
U.S. efforts to keep drug costs under control—especially
in insurance programs like Medicaid that provide care
to millions of lower-income people.
2018
“Fall forward. Sometimes, it’s the best way to figure out
where you’re going. Never be discouraged, never hold
back, give everything you got, and when you fall
throughout life remember this: fall forward.”
2018
The World is Made of Events, not Things. The Order of
Time. Allen Lane, Penguin. 2018.

2018
In my beginning is my end. T. S. Eliot.
2018
Procrustean order of conciousness.
2018
Have you considered the consequence for your
approved, or in development, biosimilar products when
a competing product achieves the designation of
“interchangeable”? The reference product
manufacturing process is claimed to be “Six Sigma”?

2018
Pharmaceutical Professional Development is to go
beyond traditional education & training to be self-
authored in what we know and how we know it. Be self-
transforming in filling gaps between what we know and
what we can implement. Feel the need, and know the
ways, to leverage our collective experiential learning.
Understand the context for our abstract nouns;
increasing Order of Consciousness. The current
regulatory system is founded on the assumption of
adequate education, training, and experience (e.g., 21
CFR 211.25), yet there are no consensus standards to
assess education, training and PD competencies of
regulators and of industry professionals (blind-spot).
#professionaldevelopment
2018
Are you a pharmaceutical scientist interested in a
unique professional development, continuing education,
and collaboration opportunity? The National Institute for
Pharmaceutical Technology & Education (NIPTE) invites
you to attend our course on Solid Oral Delivery Systems.
Developed and taught by globally recognized leaders in
pharmaceutical drug product development, renowned
professors from top US Universities and guest lecturers
from FDA, this course is the first in our 4-part Certificate
Series.
2018
The fundamental problem of communication is to
reproduce at one point in the universe a message
created at another point. The problem is made more
difficult by the fact that there is always noise that
distorts this message—0s get flipped into 1s, b’s sound
like d’s, and smoke signals get, well, blown away. So the
receiver of any message has to have a strategy to deal
with this noise. That turns out to be entirely possible in
many situations.

2018
Remember when humility was an American virtue? Our
leaders have lost this idea.
2018
Hurricane Florence will lash the Carolinas and Virginia
late Thursday as an intense hurricane with life-
threatening storm surge, destructive winds and
potentially catastrophic inland rainfall flooding as one of
the strongest strikes on record for this part of the East
Coast.
2018
The only question left open after you finish reading
1984 is How do we avoid getting there? But with Brave
New World, it’s much, much more difficult. Everybody is
satisfied and happy and pleased with everything that
happens. There are no rebellions, no revolutions, there
is no secret police, there is just free sex and rock and
roll and drugs and whatever. And nonetheless you have
this very uneasy feeling that something is wrong here,
and it’s very difficult to put your finger on what’s wrong
with a society in which you’ve hacked people in such a
way that they’re satisfied all the time. …
2018
A decade later, core questions still stand: was such a
high level of confidence ever warranted? Why weren’t
economists able to predict or stave off the crash? How
had they steered the world from prosperity into
austerity?

2018
On 10 September, the US Court of Appeals for the
Federal Circuit awarded the pivotal intellectual property
to the Broad Institute of MIT and Harvard in Cambridge,
Massachusetts, upholding a previous decision by the US
Patent and Trademark Office. The decision spells defeat
for a team of inventors at the University of California,
Berkeley (UC), led by molecular biologist Jennifer
Doudna.
2018
The US FDA and industry have been working to
establish an electronic drug tracking system. The
process for establishing the rules and infrastructure for
the track-and-trace system envisioned in the Drug
Supply Chain Security Act, part of the Drug Quality and
Security Act of 2013 is proving to be complex and
challenging for all parties. Why? Understand the "Big
Picture". When you change the way you look at a
problem, the problem changes and you gain insights.

2018
I plan to be more active at this YouTube site in a few
months. Use this link to subscribe:
2018
I have been posting recorded presentations on YouTube
but have been passive and not promoted it. Consider
subscribing to this channel. I plan to be more active at
this site in a few months. Use this link:
https://www.youtube.com/channel/UCRkXTgz4kZ7WQdY
O1uf9RyQ
2018
Wow this 2001 presentation is now "commercialized"
via a internet Bot with a creepy AI voice over.

2018
Culture of Pharmaceutical Quality @ Patheon Seminar
on 31 July 2014 in Bridgewater, NJ.
2018
First training session in Bangalore, India (2014).
Connecting the dots between culture of quality, quality
management system and GXP.
2018
11 September 2001, the day that chaged the world;
ironically it was also the day FDA CDER held its 1st
workshop on PAT-QbD, which had to be cancelled after
keynote addresses for obvious reason.
2018
We have inherited from our forefathers the keen
longing for unified, all-embracing knowledge. The very
name given to the highest institutions of learning
reminds us, that from antiquity to and throughout many
centuries the universal aspect has been the only one to
be given full credit. But the spread, both in and width
and depth, of the multifarious branches of knowledge by
during the last hundred odd years has confronted us
with a queer dilemma. We feel clearly that we are only
now beginning to acquire reliable material for welding
together the sum total of all that is known into a whole;
but, on the other hand, it has become next to impossible
for a single mind fully to command more than a small
specialized portion of it. I can see no other escape from
this dilemma (lest our true aim be lost forever) than that
some of us should venture to embark on a synthesis of
facts and theories, albeit with second-hand and
incomplete knowledge of some of them -and at the risk
of making fools of ourselves. So much for my apology.

2018
Adult Transformation Process & Epistemology Humans
are makers of meaning; some adults transform to
higher order of consciousness some do not.
Transformation requires changing the way we make-
meaning. It can occur when we are able to step back
and reflect on something that is an “object”. Reflection
on what is “subject” (e.g., our-selves) is not possible for
many and difficult for some. As we begin to see
increasingly complex elements as “objects” our
viewpoint broadens and we are able to reflect on more
complex “objects” which used to be “subjects”. The
Subject – to Object transformation occurs when we can
change the way we behave, the way we feel, what we
know, and the way we know it.
2018
If we consider the cat in the trunk akin to
pharmaceutical quality; what does "you were going 108
miles per hour!" remind you of in the CGMP context?
Who are, and should be, the regulators in this gibe? The
following witticism, which I read on an internet website,
is a light hearted way to summarize the post linked
below. Heisenberg and Schrödinger get pulled over for
speeding. The cop asks Heisenberg "Do you know how
fast you were going?" Heisenberg replies, "No, but we
know exactly where we are!" The officer looks at him
confused and says "you were going 108 miles per hour!"
Heisenberg throws his arms up and cries, "Great! Now
we're lost!" The officer looks over the car and asks
Schrödinger if the two men have anything in the trunk.
"A cat," Schrödinger replies. The cop opens the trunk
and yells "Hey! This cat is dead." Schrödinger angrily
replies, "Well he is now."

2018
Some (regulatory) defaults can accumulate silently,
because there is no clearance mechanism and become
cognitive biases; and eventually can contribute to
toppling of our knowledge pyramid!
2018
2018 has been an amazing journey within and a big step
forward to a vision 2020. I can see more clearly now.
2018
Nearly twice as many people in the trial who knowingly
received placebo pills reported experiencing adequate
symptom relief, compared with the people who received
no treatment. Not only that but the men and women
taking the placebo also doubled their rates of
improvement to a point that was about equal to the
effects of two IBS medications that were commonly
used at the time.
2018
How Did These Drugs Get Approved? How is it possible
that medications with such weak efficacy data were
approved by the FDA? The answer lies in an
understanding of the approval criteria used by the FDA.
The FDA requires two adequately conducted clinical
trials showing a significant difference between drug and
placebo. But there is a loophole: There is no limit to the
number of trials that can be conducted in search of
these two significant trials. Trials showing negative
results simply do not count.

2018
Now you can buy Zeebo – "Honest Placebo Pills
Designed to Help You Create a Safe Experience on Your
Path to Well-being!"
2018
Market for placebo!
2018
Maryland prepares for a major hurricane to hit the
Southeast coast later this week.

2018
No evidence for "special cause", a "common cause"
challenge. How does one address "common cause " -
improve the system- as above so below.
2018
Convolutional neural networks can be used to automate
the extraction of features of the built environment from
satellite images for studying health indicators.
Understanding the association between specific
features of the built environment and obesity
prevalence can lead to structural changes that could
encourage physical activity and decreases in obesity
prevalence.

On My Mind Contemporaneously August to September 2018

On My Mind Contemporaneously August to September 2018

Recommended

Recommended

More Related Content

Similar to On My Mind Contemporaneously August to September 2018

Similar to On My Mind Contemporaneously August to September 2018 (8)

More from Ajaz Hussain

More from Ajaz Hussain (20)

Recently uploaded

Recently uploaded (20)

On My Mind Contemporaneously August to September 2018