Women Leaders

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When I think of women leaders I immediately think of Hillary Clinton, Condoleezza Rice, Madeleine Albright, Margaret Thatcher and Sonia Sotomayor. I think of these women not only because of their leadership qualities but first and foremost because they fought the odds by being a leader in a man’s world. However, it is not uncommon today to find women leaders in industries that were once lead by men such as, Mary Barra, newly appointed CEO of General Motors, Sheryl Sandberg – Facebook, Margaret C. Whitman – Hewlett Packard, Ursula M. Burns – Xerox, and Virginia M. Rometty – IBM to name a few. You can see a complete list of fortune 500 CEOs at http://goo.gl/n8SzKl . Who do you think of when thinking of women leaders? In your opinion, what makes them leaders?

In my opinion, a good leader, man or women inspires others to give 110 percent; in my opinion, a good leader is passionate, exudes positive energy, acts rather than reacts and is an excellent communicator. The common traits that allows the women I mentioned above to demonstrate good leadership skills are, their outstanding ability to multi-task, their collaborative approach their excellent communication skills, ability to “seek to find meaning and purpose” through their vision, and their excellent emotional intelligence. I thought of this article regarding a women’s ability to take advantage of Business School to “hone” in on leadership skills http://news.yahoo.com/women-business-… is worth taking a few minutes to read including the imbedded links.

Even with the strides women in leadership positions have made there are still stereotypes that powerful women have to deal with. There was an article in Forbes magazine that speaks about this topic http://goo.gl/H5gOrt

Male or female we all have had to deal with the terrible leader and boss. This is an article well worth reading so that you can head off a disaster waiting to happen and run like the win. http://goo.gl/TPP9VT . I know the long term unemployed just want to get back to work but what’s worse than not having a job, it’s having a bad boss; for the unemployed this article is worth reading http://goo.gl/kSSP9j

 

 

 

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Palliative Care

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The loss of good heath for yourself, friend or loved one, as well as, the end of life is a daunting realization but never the less something that many of us have to face during our life time. It is a very difficult decision for you and your loved ones to initiate Palliative Care but extremely important if you or a loved one has been diagnosed with a serious illness. Palliative Care and Hospice Care both focus on improving your quality of life including pain management, providing support to you and your family and providing care by a team of doctors, nurses and other specialist, as well as, providing spiritual support if requested. Although, Palliative Care and Hospice Care are very similar many individuals are most familiar with Hospice Care which is often administered in the home. Palliative Care is often administered in a hospital, extended care facility or a nursing home associated with a  Palliative Care team.

 To be considered for Hospice Care you must be considered terminal or within 6 months of death which is determined by a Physician. However, for Palliative Care there is no time limitation and therefore, at any stage in a serious illness you can request such care. Additionally, the Palliative Care team can help you understand your treatment choices and help you navigate the healthcare system.  Palliative Care is “increasingly  used with regard to diseases other than cancer”; those other diseases are, progressive pulmonary disorders, renal disease, chronic heart failure, HIV/AIDS, progressive neurological disorders and other serious conditions.

Facts and Figures

“An estimated 1.5 to 1.6 million patients utilized Hospice and/or Palliative Care in 2012 according to reports provided by the National Hospice and Palliative Care Organization”. See this information http://tinyurl.com/kkf79d8 with regard to the number Americans utilizing Hospice and Palliative Care. Unfortunately, I could not find more recent figures. Also, online resources are worth reviewing http://tinyurl.com/kpd2a9d

I have given you a very cursory overview of  Palliative and Hospice Care however, it was my intent to at least plant a seed so that you may continue your research.

Medical Marijuana – Its Time Has Come

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To date 20 states plus the District of Columbia have legalized marijuana for medical use http://tinyurl.com/y2tyn7g. The link I provided gives you the details by State of the State laws, fees, and possession limits of medical marijuana. As you are aware,  medical marijuana is also known as  medicinal cannabis and has been prescribed as a form of treatment and pain relief for the terminally ill and individuals suffering from chronic long-term pain.

There continues to be a lot of debate over the legalization of medical marijuana; Health advocates and legalization groups argue that marijuana is not only less harmful than legal substances such as alcohol and tobacco, but it has been proven to possess certain medicinal properties. A study conducted by John Hopkins University found “no significant differences in cognitive decline between heavy users, light users, and non-users of marijuana.” Some argue, that the use of marijuana really relates to the health problems it creates, like “addiction”, short-term memory loss, energy loss, and even the risk of schizophrenia.  Therefore, it should be treated as a health issue, rather than a crime issue. Lastly, the cost and time of police officers, judges, public defenders, prosecutors, juries, court reporters, and prison guards would be freed up to concentrate on more important things like terrorism, harder drugs, rape, and murder if marijuana was legalized.

Under the Federal Controlled Substances Act, marijuana is classified as a Schedule I drug. Schedule I drugs are considered the most dangerous class of drugs with a high potential for abuse and potentially severe psychological and/or physical dependence. ” it has been argued that medical marijuana is no different from standard marijuana. Those who are opposed to the legalization of marijuana also stated   “Drugs are addictive. They rob the user of free will. A drug user cannot make an informed and rational decision to continue using drugs because the use of the drug eliminates that user’s ability to think logically”.

A majority of Americans favor legalizing the use of marijuana. A national survey found that 52% of Americans surveyed favored  legalizing marijuana; this is indeed a positive change from a decade ago.

Innovation – 2014

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Because of the patent cliff, generics and the need for Pharmaceutical and Biotech companies to fill the void of lower sales and increased competition, I discussed the importance of innovation in 2013.  In 2014  top decision makers in Pharmaceutical and Biotech companies certainly are speaking of the importance of innovation because it is the primary tool that drives growth and renewal.

An article entitled “How to encourage Innovation in your company”  http://tinyurl.com/npr5wt7 , “Adding more innovation to the 2014 Honda lineup” http://tinyurl.com/n3vbfs5  and “What To Do When Your Boss Won’t Support Your Great Ideas”  http://tinyurl.com/nyyg3og  are examples that innovation is on the forefront of the employer’s mind. The questions that need to be asked regarding innovation are, have we established an innovate process? Are we trying to implement an innovative culture? Do we have defined innovative goals?  Are managers held accountable? Do we have the money in our budget set aside for innovation and are innovations that appear to be viable being evaluated and implemented? ” Programs of organizational innovation are typically tightly linked to organizational goals and objectives. These goals and objectives vary between improvements to products, processes and services”. However, we need to be open to novel ideas or methods that may not be readily tied to a company’s goals that add value.

In my opinion, nothing kills innovation faster than someone losing their job over a mistake or an innovation that does not work or is too costly. I understand that some mistakes are really unacceptable and do not fall under “innovation”; some individuals march to their own drummer. It is important to make certain that all parties involved understand  the team/company rule with regard to innovation, what it is and what it is not.

In 2014 innovation will be all of the buzz for companies and will continue to be their focus. Companies will be interested in adding value rather than just doing the same thing better or working smarter.  Also, in 2014 economic innovation/growth of our cities which will lead to positive economic performance will be an important matter for City Governments to focus on.

 

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Drug Recalls – 2013

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In 2013 there were over 50 drug recalls. As you are probably aware, there are three different types of recalls; voluntary recalls initiated by the company to remove the product from the market, those recommended by the Food and Drug Administration (FDA) and those ordered by the FDA. A complete list of drug recalls can be found on the FDA website http://tinyurl.com/7z5l4xr

  The defined classifications for market withdrawals are as follows, type I, II, or lll; assigned by the Food and Drug Administration “to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled.

(1) Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violated product will cause serious adverse health consequences or death.

(2) Class II is a situation in which use of, or exposure to, a violated product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

(3) Class III is a situation in which use of, or exposure to, a violated product is not likely to cause adverse health consequences.”

You can review the regulation, 21 CFR Part 7 http://tinyurl.com/lcjv4k9

In my opinion drug recalls speak to quality assurance or the lack there of, and the appropriate implementation of quality assurance measures particularly the principal components of Good Manufacturing Practices (GMP). You can review the industry guidance regarding Pharmaceutical Quality Systems at http://tinyurl.com/mn5e7sh. I am of the opinion that quality has taken a back seat to immediate monetary gain. Perhaps, the number of recalls in 2013 in the grand scheme of things does not seems like a lot  but when a product may cause serious adverse health consequences or death the recall in my opinion is a big deal.  A quality assurance system increases customer confidence and a company’s credibility which is actually an important goal to a company’s financial success.  What can we do to establish the correct focus on quality  the beginning to end of the development process? Most companies have a separate department devoted to quality assurance; is this enough? What is the current philosophy/implementation of Quality Management in companies?

After the heparin recall in 2008, the Director of the Center for Drug Evaluation and Research (CDER), Dr. Janet Woodcock stated pharmaceutical quality includes “the absence of contaminants.” Quality pharmaceuticals is the reproducibility of the therapeutic benefit that their labels promise to the consumer. However, it is important to realize that the American drug supply continues to be among the safest in the world.

Quality By Design (QbD) in Clinical Trials

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Quality by design is not a new concept, it was first introduced by Joseph Juran, a well known quality expert; the concept was and still is utilized by the automotive industry. Janet Woodcock of the Food and Drug Administration (FDA) defined pharmaceutical quality “as a product that is free of contamination and reproducibly delivers the therapeutic benefit promised in the label to the consumer”. The FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality. Quality is an attitude, perhaps, it is thinking without thinking.
To ensure we all have the same understanding of what QbD is; here is the standard definition for the Pharmaceutical Industry; Quality by Design (QbD) “is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management”.

How does QbD apply to clinical trials? For starters, a quality strategy has to be embraced by senior management and those involved in the clinical trial. Also, implementing a monitoring plan and a quality plan that is communicated frequently and followed consistently is essential; here is a example of a quality plan, this is only an example thus, you may want to customize this plan in order for it to meet your needs http://tinyurl.com/ofex78k .

In discussing Quality by Design in the Pharmaceutical space I must also mention the Target Product Profile (TPP). The purpose of a TPP is to provide a format for discussions between a sponsor and the FDA that can be used throughout the drug development process, from investigational new drug application (IND) through post-marketing. ” The TPP embodies the notion of beginning with the goal in mind. The ideal version of what the sponsor would like to claim in labeling guides the design, conduct, and analysis of clinical trials to maximize the efficiency of the development program”. Ideally, the final version of the TPP will be similar to the annotated draft labeling submitted with a new drug application (NDA) or biologics license application (BLA).

There was a presentation that the FDA developed several years ago about QbD that may be worth viewing, http://tinyurl.com/newa3kz