Vladislav Gurin :: BioTech & Pharma consulting

Having dealt with the selection and evaluation of projects for R&D, the steps in the Innovation Chain and the importance of time compression management in the introduction of new products with particular emphasis on the managerial skills that are essential. Of the many skills required in Project Management the following are the key:

1. Team Selection and Management
2. Project Definition
3. Resource Allocation
4. Methodology: Planning and Controlling

Another possible way of looking at this is to imagine it as a complex of WHAT, WHEN, WHO and HOW questions to be answered:

• WHAT is to be delivered by the project?
• WHEN is it to be delivered?
• WHO is going to deliver?
• HOW is it going to be delivered?
• What CONSTRAINTS are there on the project?
• WHEN will they be placed?
• WHO will place the constraints?
• HOW will they be applied?
• What RESOURCES will be required?
• WHEN will they be required?
• WHO will supply the resources?
• HOW will they be supplied?
• WHAT will control the project?
• WHEN will control be applied?
• WHO will control the project?
• HOW will we know the project under CONTROL?

The aim in composing this article is to share with you simple, but critical, steps for keeping up an optimal quality of life throughout your lifetime, regardless of your current age and the genes that you inherited from the parents. In fact, if you begin to follow the suggestions, within days and weeks you will most likely experience the following, no matter how old you are:

1. An increase in your energy levels
2. An enhanced enjoyment of the life and daily activities
3. A noticeable upsurge in the sharpness of your mind
4. A stronger sex drive

Your pathway to optimal health and youthful vigor via nutrition may differ from someone else’s, depending on your individual preferences and the foods available to you:

• Improve the heart-healthiness of your diet. Both French fare and a Mediterranean diet offer distinct health benefits. Particularly, the latter diet with its high content of olive oil, fish, and red wine is heart healthy.
• Eat fish at least 4 times per week. An increased intake of essential omega-3 fats may reduce your risk of heart disease, memory loss, and other health problems. Good types of omega-3-rich fish include salmon, mackerel, sardines, and herring.Drink alcohol in moderation. One to two alcoholic drinks per day appear to be more beneficial than none, but don’t drink in excess of this amount.
• Eat at least three to five vegetables and two to three fruits a day. Choose colorful fresh or frozen produce, and eat whole fruits rather than drinking juices that lack fiber.
• Increase fiber-rich foods in your diet. Fiber lowers blood sugar levels and cholesterol. Good sources include berries, dried beans, prunes, whole wheat bread, brown rice, bran, fruit, vegetables, and nuts.
• Drink plenty of liquids. Try to drink at least four to six glasses of liquid each day, and eat foods with higher water content, like melons and vegetables.
• Spice up your foods. Onions, turmeric, black pepper, cinnamon, ginger, thyme, cumin, oregano, basil, sage, curry, and garlic all have positive effects on health.
• Eat more yogurt. The probiotic effect of yogurt with live cultures may improve your health by preventing illness andlimiting inflammation.
• Consider using select herbal or other remedies. A limited number of herbal preparations may be effective in treating specific problems, such as ginger for vertigo and alpha-lipoic acid for diabetic neuropathy and possibly memory loss.

Many years ago money changers and merchants used a hard black stone, such as jasper or basalt, to test the quality of gold or silver by comparing the streak left on the stone by one of these metals with that of an alloy…

Essentially, emotions play similar roles in the interactive workings of the mind and brain. Using emotions as touchstones, the brain assesses the value of incoming information in terms of needs—the stronger a need, the stronger the emotional response to something that can satisfy the need. No emotional response to a marketing message means it failed to arouse emotions strong enough for the brain to think it relates enough to its owner’s interests to send the message to the owner’s conscious mind. This is not theory. We now know from brain research that it takes emotional arousal for a person to connect anything to his or her personal interests.

Emotions energize behavior. They are not vaporous puffs in our minds, but material changes in our body states. Emotions are formed by changes in blood pressure, adrenalin flow, pulse, muscle tension, salivation, and other body systems. Feelings of love, surprise, anticipation, fear, anger, and rage are outcomes triggered by stimuli in body chemistry. Many changes are too subtle to be detected by the conscious mind, yet they influence moods, perceptions, thoughts, decisions, and behavior. They are called background emotions.

For example, when you have a “gut feeling” about something, the feeling literally did originate in your gut. Changes in body states signal what is important enough for the brain to bring to the conscious mind’s attention. Reason plays a much smaller role in decisions than we have long thought—even less so as we age because once we enter our 30s, we make increasing use of emotion-generated gut feelings or intuition. We put more trust in first impressions, which are emotionally generated and experienced as feelings. The more we trust our feelings, the more resistant we are to efforts of others to change them. In the New Customer Majority, if you don’t get it right the first time, you are less likely to get a second chance than with younger customers.

We become less rational and more intuitive as we age because the more experiences we have reasoned through, the fewer we need to reason through in the future. With a neuronal macro in place, a mental activity that once took many steps to work through to yield a perception or thought can now be accomplished virtually instantly when something activates that neuronal macro. A more common term for neuronal macro that marketers often use is hot button.

The material brain uses the language of emotions to communicate with the nonmaterial mind. An emotion is how a need feels, or how an action or event that satisfies or frustrates a need feels. Feelings are the conscious mind’s attempt to figure out and label what our emotions are trying to tell us.

Emotions guide us toward pleasure and away from pain by how they make us feel. People choose products for the emotional payoff they feel the product will provide—not for what they think the product will provide. Companies and customers usually operate in a dichotomy of features versus feelings, because

• most companies focus on features, while
• all customers focus on feelings.

Companies will generally find greater success in today’s more emotionally directed second-half markets by focusing less on product features and more on customers’ feelings. This is what the “the customer experience” that everybody is talking about calls for. However, why has the customer experience seemingly overnight become the “big” thing in marketing? Some say it is because products have become commoditized. I say it is because of the New Customer Majority, most of whose members are experiencing ebbing of materialistic influences and rising influence of experiential aspirations on their behavior.

Bioethics was preceded by medical ethics, which focused primarily on issues arising out of the physician–patient relationship. The ancient Hippocratic literature (which includes but is not limited to the Hippocratic Oath) enjoins physicians to use their knowledge and power to benefit the sick, to heal and not to harm, to preserve life, and to keep in the strictest confidence information that ought not to be spread about. These basic values remain an essential part of contemporary bioethics. However, after the Second World War it became clear that the old medical ethics was not sufficient to meet contemporary challenges.
Unprecedented medical advances, such as the use of penicillin and immunization against childhood diseases, have saved literally millions of lives. So have open heart surgery and cardiac catheterization, chronic hemodialysis, and organ donation. At the same time, many of the methods of modern medicine are very expensive, and thus out of the reach of many who might benefit from them. Medicine’s success thus led to a debate about how to pay for healthcare. In most industrialized countries, the provision of healthcare is viewed as the government’s responsibility, comparable to the obligation to provide public education. By contrast, in the U.S. many still regard payment for healthcare as an individual responsibility, or at least something that employers, not the state, should provide. Among those who agree that some kind of national health insurance is both fair and fiscally sound, a debate continues between egalitarians, who insist that no care should be provided unless it is available to all who need it, and those who favor a tiered health care system that allows some medical services to be distributed by the market.
Medicine’s success in the post-war years raised another issue: the value of preserving life. Respirators were originally invented for people who were expected to recover and be able to breathe on their own. Within a short period of time they began to be used on people in persistent vegetative states, forcing medical professionals to ask whether this was an appropriate use of technology. Should people who are permanently and irreversibly unconscious be kept alive indefinitely? A similar issue resulted from the development of neonatal intensive care units (NICUs), which have saved the lives of many premature babies who would have died in earlier decades. Many of these babies go on to have normal, healthy lives, but many face a lifetime of severe disabilities and serious health complications.
Thus, NICUs raise the question: Ought life to be preserved regardless of the nature or quality of that life? And if there are times when life should not be preserved, who should be authorized to make these decisions?
During the 1960s these questions began to be debated at academic conferences and in scholarly journals, giving birth to the field of bioethics.

In 1969 the Hastings Center in Garrison, NY, an independent, nonpartisan, and nonprofit bioethics research institute, was founded by Dan Callahan and Willard Gaylin to explore fundamental and emerging questions in health care, biotechnology, and the environment. Its journal, the Hastings Center Report, first appeared in June 1971. In July of that year the Kennedy Institute of Ethics at Georgetown University opened, with two research scholars: LeRoy Walters, who soon became its Director, and Warren Reich, who was the editor of the first edition of the Encyclopedia of Bioethics, published in 1978.
The term ‘bioethics’ was coined in the early 1970s by biologists who brought to the public’s attention two pressing issues: the need to maintain the planet’s ecology, on which all life depends, and the implications of advances in the life sciences toward manipulating human nature. In his book, Bioethics: Bridge to the Future, published in 1971, Van Rensselaer Potter focused on the growing human ability to change nature, including human nature, and the implications of this for our global future.
Although the term ‘bioethics’ has referred almost exclusively to problems in biomedicine, in recent years the field has returned to ‘the wider context provided by the life scientists of the early 1970s, including their environmental and public health concerns’.
While bioethics has been interdisciplinary since its inception, theology played a foundational role in its creation. It continues to have a profound influence today, as reflected in the careful analysis and defense of the rule of double effect by Daniel Sulmasy. Three theologians in particular were instrumental in the birth of bioethics: Joseph Fletcher, an Episcopal minister; Paul Ramsey, a Methodist minister; and Richard McCormick, a Jesuit moral theologian.
The theologians were soon joined by philosophers who rejected the emphasis in contemporary analytic ethics on meta-ethics, to the exclusion of normative ethics.
Events in the 1960s—opposition to the Vietnamese war, the civil rights movement, and other social movements it spawned, such as the women’s movement, the disability rights movement, and the gay and lesbian rights movement—played a role in the revitalization of normative ethics, and philosophical interest in applied ethics. Students began to demand that their courses were ‘relevant’, and professional philosophers also became interested in writing on the issues of the day.

A number of HIV attributes and its mode of infection conspire to render creation of an effective vaccine less than straightforward. These factors include:

• HIV displays extensive genetic variation, often even within a single individual. Such genetic variation is particularly prominent in the viral env gene whose product, gp160, is subsequently proteolytically processed, yielding gp120 and gp41.
• HIV infects and destroys T-helper lymphocytes, i.e. it directly attacks an essential component of the immune system itself.
• Although infected individuals display a wide spectrum of antiviral immunoresponses, these ultimately fail to kill the virus. A deeper understanding of what immunity elements are most effective in combating HIV infection is required.
• After initial virulence subsides, large quantity of cells harbour unexpressed proviral DNA.
  The immune system has no method of identifying such cells. An effective vaccine must thus induce the immune system to:
  (a) bring the viral infection under control before cellular infection occurs; or
  (b) destroy cells once they begin to produce viral particles and destroy the viral particles released.
• The infection may often be spread, not via transmission of free viral particles, but via direct transmission of infected cells harbouring the proviral DNA.

Arthur Kornberg, the Stanford University Nobel laureate, who first synthesised DNA in a laboratory and whose identification of the enzymes used by cells to reproduce DNA laid the basis for the biotechnology, died of respiratory disorder on Friday at Stanford Hospital at the age of 89.

Kornberg was the founder of the Stanford University School of Medicine’s biochemistry department, taking in a talented group of unique scientists who worked together for nearly 50 years.

Kornberg lived to see his son Roger win the 2006 Nobel Prize in Chemistry.

It is often hard to conceive how little was known about the mysterious DNA molecule when Kornberg began his research in the 1950s. Scientists were pretty sure that it was the repository of genetic information. In spite of that, DNA was a mystery.

During the second world war Kornberg was interested in enzymes, the bioproteins used by cells to carry out chemical reactions, especially the synthesis of substances used by cells.

After preliminary work isolating enzymes involved in vitamin manufacturing, Kornberg tackled the more difficult challenge of DNA and RNA, the messenger molecule used by cells in the conversion of genetic information contained in DNA into proteins.

Kornberg reasoned that cells would produce DNA by stringing together pre-made nucleotides - combinations of a base, a sugar molecule and a phosphate group.

While Kornberg was working on the project in 1953, James Watson and Francis Crick published the DNA structure, providing clues to direct his efforts. By the following year, Kornberg and his colleagues had isolated the enzymes used to produce the nucleotides used in RNA and DNA.

By 1957, Kornberg had discovered and purified the key molecule, named DNA-polymerase, and submitted two papers describing the work to the Journal of Biological Chemistry. Referees, however, objected to calling the material produced by the enzyme DNA.

Disgusted, Kornberg withdrew the papers, but they were published the following year when the journal appointed a new editor.

His work confirmed speculation by Watson and Crick that genetic information was encoded in opposite directions on the two strands of double-helical DNA.

Kornberg shared the Nobel Prize in Physiology/Medicine for the DNA synthesis in 1959.

In association with Financial Times

In the XXI century, we are much more enthusiastic about outlooks of nanotechnologies for our life and environment. Nanotechnology, when fused with biotechnology, creates nanobiotechnology and nanobiomedical technology; the products of which hardly resemble the parent biotechnology products. These new scientific disciplines, by overall opinion, can even change the face of our civilization in this century. The important point is that dealing with nanotechnologies, we faced new phenomenon: the transition of compounds to nanostate dramatically changes their characteristics such as electrical, magnetic, optical, mechanical, biological and etc. This really great phenomenon permits creation of novel functional materials with unique custom-made properties.
Development of completely new technologies and innovative nanomaterials and nanosystems with exceptional desirable functional properties lead to a new generation of products that will improve the quality of life and environment in the years to come. There are numerous new generation nanomaterial products of high quality including biocompatible biomaterials, antimicrobial biodevices, surgical tools, implants, decorative and optical devices, and, finally, nanocarriers and nanosystems.
One of the most important applications of the so-called nanomedicine/nanotherapy appeared to be the targeting of medicines or additives to the desired organs and tissues using special nanoparticles and nanocapsules of various nature to cure human diseases. Because of their unique features, nanosystems enhance the medicines’ performance by improving their solubility and bioavailability, increasing their in vivo stability, creation of high local concentrations of bioactives in target cells and cellular compartments in order to gain therapeutic efficiency.
Nanocarrier systems used for medicine targeting are mainly consisting of lipid molecules, surfactants, and certain polymers, such as dendrimers, which are specially designed to be drug carriers. Hybrid organic/inorganic materials have also become popular now. Carbon-based nanostructures (nanotubes, etc.) are used for implant construction and as nanosystems for drug targeting.

Several days ago one friend of mine came to me and asked several questions about the Viagra’s description. It was not spontaneous because all of us know there are many suppliers of such pharmaceuticals as Viagra, Cialis, Tramadol, Edex, Levitra. Unfortunately, many of them don’t have valid licenses or even speculate with counterfeits.
First of all, dear readers, make your purchases only from recognised and officially-approved firms that are selling you such drugs everyday.
Secondly, I’ve already collected the description information on all drugs that are very popular and spreading quickly online, like epidemia.

• DESCRIPTIONS

LEVITRA® (Schering)
(vardenafil HCl)
Tablets

LEVITRA® is an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, mono-hydrochloride.
Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. LEVITRA is formulated as orange, round, film-coated tablets with “BAYER” cross debossed on one side and “2.5″, “5″, “10″, and “20″ on the other side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, yellow ferric oxide, and red ferric oxide.

VIAGRA® (Pfizer)
(sildenafil citrate)
Tablets

VIAGRA®, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H -pyrazolo[4,3- d ]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate.
Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. VIAGRA (sildenafil citrate) is formulated as blue, film-coated rounded-diamond-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose, triacetin, and FD & C Blue #2 aluminum lake.

CIALIS® (Eli Lilly ICOS)
(tadalafil)
Tablets

CIALIS® (tadalafil), an oral treatment for erectile dysfunction, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22 H 19 N 3 O 4 representing a molecular weight of 389.41.
The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol.
CIALIS is available as film-coated, almond-shaped tablets for oral administration. Each tablet contains 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.

EDEX® (Schwarz)
(alprostadil for injection)
For Intracavernous Use Only
Sterile Powder and Diluent
(sterile 0.9% sodium chloride) in Cartridges
Rx Only

Edex® (alprostadil for injection) is a sterile, pyrogen-free powder containing alprostadil in an alfadex ((alpha)-cyclodextrin) inclusion complex. Alprostadil is an endogenous substance known as prostaglandin E 1 (PGE 1 ). Edex® is supplied in single-dose, dual-chamber cartridges.

Edex® is lyophilized in single-dose, dual-chamber cartridges intended for use with the reusable edex® injection device. One chamber of the cartridge contains alprostadil, alfadex and lactose as a sterile, pyrogen-free powder. The other chamber contains 1.075 mL of sterile 0.9% sodium chloride. The edex® cartridges are supplied in three strengths: 10 mcg cartridge (10.75 mcg alprostadil, 347.55 mcg (alpha)-cyclodextrin, 51.06 mg lactose); 20 mcg cartridge (21.5 mcg alprostadil, 695.2 mcg (alpha)-cyclodextrin, 51.06 mg lactose); 40 mcg cartridge (43.0 mcg alprostadil, 1,390.3 mcg (alpha)-cyclodextrin, 51.06 mg lactose). The edex® injection device is used to reconstitute the sterile powder in one chamber with the sterile 0.9% sodium chloride in the other chamber. After reconstitution, the edex® injection device is used to administer the intracavernous injection of alprostadil.

The chemical name for alprostadil is (1R,2R,3R)-3-Hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxocyclopentane heptanoic acid. The empirical formula is C 20 H 34 O 5 and the molecular weight is 354.49.
The (alpha)-cyclodextrin inclusion complex improves the water solubility of alprostadil. The empirical formula of (alpha)-cyclodextrin is C 36 H 60 O 30 and the molecular weight is 972.85.

Alprostadil alfadex is a white, odorless, hygroscopic powder. It is freely soluble in water and practically insoluble in ethanol, ethyl acetate and ether. After reconstitution, the active ingredient, alprostadil, immediately dissociates from the (alpha)-cyclodextrin inclusion complex. The reconstituted solution is clear and colorless and has a pH between 4.0 and 8.0. When the single-dose, dual-chamber cartridge containing either 10.75, 21.5 or 43.0 mcg of alprostadil is placed into the edex® injection device and reconstituted, the deliverable amount of alprostadil in each milliliter is 10, 20 or 40 micrograms, respectively.

Pfizer’s scientists recently published the information on the researches of Viagra’s interactions with various biologically active ingredients. Here you’ll find the recommendations on its usage.

Physicians should discuss with patients the contraindication of VIAGRA with regular and/or intermittent use of organic nitrates.

Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician.

Physicians should advise patients to stop use of all PDE5 inhibitors, including VIAGRA, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors. Physicians should also discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators, such as PDE5 inhibitors.

Physicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of VIAGRA. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.

Physicians should advise patients that simultaneous administration of VIAGRA doses above 25 mg and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, VIAGRA doses above 25 mg should not be taken within four hours of taking an alpha-blocker.

The use of VIAGRA offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered.