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

How can a Clinical Trial Management System (CTMS) help an organization

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A Clinical Trial Management System is a systematic organized approach to managing your global clinical trials throughout its life cycle; Of particular importance are the following activities that a CTMS can help manage;

• Track IRB/EC Approvals
• Streamline work flow
• Track GCP training
• Track subject/patient enrollment per investigative site
• Manage/track clinical trial initiation (first patient in )
• Manage/track clinical trial close out (last patient out)
• Track timeline (milestones)
• Manages the planning, ongoing budget performance and reporting of a clinical trial
• Track clinical documents such as updates to Investigator Brochure, clinical protocol amendments IND annual safety updates and study procedure manuals
• Help in the management of regulatory compliance
• Track Investigator contracts
• Track external vendor contracts including the number of change orders

A Clinical Trial Management System is also a global communication tool which allows cross functional teams and teams in various locations to be in the loop of up to date information. A CTMS utilized effectively can streamline clinical project management activities including the frequency of clinical project meetings. It also allows an organization to proactively problem solve.

Often times an organization will start off with a “home grown” Clinical Trial Management System and then transition to a specialized vendor. However, I would not recommend such an approach. In early stage of development when patient numbers and investigational sites are small you probably will not need a system with all the “bells & whistles” however, as you move into late stage development with a large number of patients, investigational sites and data, a customized feature rich system with all “bells & whistles” will probably be essential. Why not start small with a vendor and build on as necessary. There are many vendors out there that can assist with startup needs, customize reports and thus, build to your specifications.

As we all are aware, the cost of getting a drug to market is staggering and utilizing tools to optimize the drug development process is good leadership sense.