Welcome to BioMarketing Insight's monthly newsletter.

Last month I covered "Things to Consider When You're Planning to Outsource Work to a Consulting Firm." If you missed last month's article, click here to read it. Since news headlines continue to feature the Ebola outbreak, I will cover what you need to know about Ebola regarding your health and protection.

Read on to learn more about this topic and other current news. On the right are quick links to the topics covered in this month's newsletter. The next newsletter will be published on December 15th.

We encourage you to share this newsletter with your colleagues by using the social media icons at the top left, or by simply forwarding the newsletter via email.

Please email me, Regina Au, if you have any questions, comments, or suggestions.

Sincerely,

Regina Au

Principal, Strategic Marketing Consultant

BioMarketing Insight 

I'm pleased to announce that my article on regulatory challenges entitled "Rapid Response" has been published in the October 2014 issue in European Biopharmaceutical Review. To read an electronic version, please click here, my article is on page 10. To learn more about EBR, click here.

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The Facts About Ebola  

Ebola Virus Source: Center for Disease Control.

News of the Ebola epidemic has been talked about almost 24/7, yet many people are misinformed about the basic facts, despite that there is reliable information available on line. Both the Centers for Disease Control (CDC) and the World Health Organization (WHO) websites have posted comprehensive information and timely updates concerning Ebola. Unfortunately, misinformation and incomplete information have created much hysteria and paranoia and caused some people to over - react. So here are the facts.

Definition of the Ebola Virus

According to the CDC Ebola, or Ebola hemorrhagic fever, is a rare and deadly disease caused by infection with one of five Ebola virus strains in the virus family Filoviridae, genus Ebolavirus.Ebola can cause disease in humans and nonhuman primates (monkeys, gorillas, and chimpanzees).

Four of the five identified Ebola virus species are known to cause disease in humans: Ebola virus (Zaire ebolavirus); Sudan virus (Sudan ebolavirus); Taï Forest virus (Taï Forest ebolavirus, formerly Côte d'Ivoire ebolavirus); and Bundibugyo virus (Bundibugyo ebolavirus). The fifth, Reston virus (Reston ebolavirus), has caused disease in nonhuman primates, but not in humans.

Ebola is classified under Biohazard Level 4 (BL4) - Viruses and bacteria that cause severe to fatal disease in humans, and for which vaccines or other treatments are not available. So precaution is critical when treating Ebola patients and wearing a full biohazard suit is required. More important, correctly removing the biohazard suit is required, in order to avoid contact with any fluids associated with the virus.

According to the WHO, the average Ebola Virus Disease case fatality rate for the current outbreak has been around 50% . Case fatality rates have varied from 25% to 90% in past outbreaks.

Current Status of Ebola

Ebola was first discovered in 1976 near the Ebola River in what is now called the Democratic Republic of the Congo. Since then, outbreaks have appeared sporadically in Africa. The reason those outbreaks were not heavily reported in the news is because they occurred in remote and sparsely populated areas, where outbreaks could not spread as easily as they did recently in a densely populated Sierra Leone. Moreover 40 years ago, international travel between the various African countries was comparatively infrequent.

According to WHO, "The current outbreak in West Africa, (first cases notified in March 2014), is the largest and most complex Ebola outbreak since the Ebola virus was first discovered in 1976. There have been more cases and deaths in this outbreak than all others combined. It has also spread between countries starting in Guinea then spreading across land borders to Sierra Leone and Liberia, by air (1 traveler only) to Nigeria, and by land (1 traveler) to Senegal."   

"The most severely affected countries, Guinea, Sierra Leone and Liberia, have very weak health systems, lacking human and infrastructural resources, having only recently emerged from long periods of conflict and instability. On August 8, the WHO Director-General declared this outbreak a Public Health Emergency of International Concern."

The CDC has stated that the outbreaks in Sierra Leone, Liberia and Guinea have affected the entire region. Cases in other countries have been traced back to travelers or healthcare workers from these countries.   The CDC has stated that travelers who go to these areas are not at risk of getting Ebola unless they are in direct contract with an Ebola patient.

Here are the latest numbers that was reported by Boston.com:   

Number of cases worldwide in the current outbreak: 13,042 (as of Nov. 5)

Number of deaths: 4,818 (as of Nov. 5)

Countries currently affected by Ebola: Mali, Guinea, Liberia, Sierra Leone, Spain, and the United States of America.

Countries where the outbreak has ended: Nigeria (Oct. 19), Senegal (Oct. 17)

And here's your daily reminder not to panic:

The likelihood of contracting Ebola in Massachusetts remains very low, according to the state's public health officials. You have to be in direct contact with an infected person's bodily fluids while they are contagious (displaying symptoms of Ebola). Even if someone has been exposed, symptoms may appear in as little as two days, and in as many as 21 days, after exposure. According to the CDC the average is 8 to 10 days.

How is Ebola Spread?

According to the CDC, Ebola is not air borne and cannot be caught through coughing or sneezing. One has to have direct contact with blood or body fluids (diarrhea, sweat, vomit, urine, semen, and breast milk); exposure to large droplets and sprays from an infected patient that penetrate through your mouth, nose, eyes or a break in your skin; or through sexual contact. It can also be transmitted by objects (like needles and syringes) that have been contaminated with the virus and from infected fruit bats or primates (apes and monkeys).

"Ebola is not spread through the air or by water, or in general, by food. However in Africa, Ebola may be spread as a result of handling bushmeat (wild animals hunted for food) and contact with infected bats. There is no evidence that mosquitos or other insects can transmit Ebola virus. Only a few species of mammals (for example, humans, bats, monkeys, and apes) have shown the ability to become infected with and spread Ebola virus."

The people at highest risk are healthcare workers caring for Ebola patients, people who handle burial services for Ebola patients and the patient's family.

Ebola can be transmitted when the person with Ebola is sick after symptoms begin. Symptoms may appear anywhere from 2 to 21 days after exposure, but the average is 8 to 10 days. The signs and symptoms of Ebola are the following:

• Fever (greater than 38.6°C or 101.5°F)
• Severe headache
• Muscle pain
• Weakness
• Fatigue
• Diarrhea
• Vomiting
• Abdominal (stomach) pain
• Unexplained hemorrhage (bleeding or bruising)

The controversy between the CDC guidelines and the governors of states that have received healthcare workers returning from Ebola-affected areas has been highlighted in the news. CDC guidelines recommend that state and local health authorities actively monitor these people daily "for the presence of symptoms and fever" and if a person has signs and symptoms of Ebola, the CDC then recommends that patients be quarantined.

However, the governors of New York, New Jersey and Maine want those who've come back from West Africa quarantined for 21 days. This drew criticism from the White House "as unnecessary and a threat to the fight against Ebola in Africa."  In Maine, the case of a nurse also made the news when she refused to be quarantined in her house for 21 days, since she is symptom -free and tested negative for Ebola when she was quarantined in New Jersey.

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The spreading of deadly diseases continues to be the biggest downside of globalization. Returning Crusaders kicked off the European plague epidemics of the Middle Ages. Colonizers brought smallpox to the Americas in the 1500s and severely decimated the population of two continents. The 21st century has brought Ebola to the world.

The US is on a sharp learning curve as officials grapple with how to prevent Ebola from entering the country and spreading within its borders. Currently, the US is restricting people who are traveling from affected areas to land at five designated airports (New York/Kennedy, Chicago/ O'Hare, Newark, Atlanta and Washington/Dulles), where trained personnel will monitor anyone who could be affected by taking their temperature, quarantining and testing for Ebola if there is evidence of fever or any other symptoms. Only those who are symptomatic with the Ebola virus are contagious.

Healthcare professionals who treat Ebola patients know to wear the complete personal protective equipment and to incorporate a buddy system, where each person checks the other to make sure that no skin is exposed.

"There are more than 30 steps involved in putting on and taking off the protective equipment.   The most difficult part is taking the equipment off without contaminating yourself," said Dr. Lauge Sokol-Hessner, a hospitalist at Beth Israel Deaconess Medical Center and a physicians on a short list of those volunteering to care for Ebola patients in Boston. 

The US is taking precautions to prevent the entrance and spread of Ebola in the US, but people who are either uninformed or misinformed tend to blow things out of proportion and create hysteria and paranoia. The example of the nurse in Maine who was quarantined for 21 days despite the fact that she was symptom - free and tested negative for Ebola stands as evidence.

I agree with the Obama administration that these healthcare workers should be treated with respect because they are trying to contain the outbreak in West Africa before it becomes more wide spread. They are healthcare professionals who study Ebola and are knowledgeable as to what needs to be done and the precautions to take. These healthcare professionals are volunteering at their own risk to help.

In an effort to contain any panic, Massachusetts health officials stated that "while the risk of Ebola remains very low in the state, six hospitals are prepared to handle one patient each, meaning the state could treat six patients at any given time." The announcement and plan eliminates confusion as to which hospitals are ready to care for an Ebola patient if there is a confirmed case in Massachusetts. These hospitals are not expecting to take patients who reside outside of MA because each state needs to have its own plan and protocols.

The six hospitals collaborating to provide care are Bay State Medical Center in Springfield and five Boston facilities: Boston Medical Center, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Tufts New England Medical Center and Massachusetts General Hospital. Boston Children's Hospital and UMass Memorial Medical Center in Worcester are also expected to join the list.

It is apparent that despite the abundance of good information available about Ebola, neither the federal government nor the CDC have done a good job at making the public aware of what Ebola is and quelling rumors and misperceptions. Even though the CDC has excellent information posted on its website, a public service campaign to guide and reassure the citizens would be so useful.

As of Monday, November 10, 2014, the Boston.com online news source reported that "There are no more Ebola patients in the United States."  The New York Times reported that Dr. Craig Spencer, a New York City-based doctor with Doctors Without Borders and the first person to test positive for Ebola after treating patients in Sierra Leone, will be released from Bellevue Hospital.  Dr. Spencer was diagnosed with Ebola on Oct. 23 at Bellevue after 10 days of self-monitoring.

If you are developing a product and have not conducted the business due diligence to determine commercial viability or success, contact me for an appointment.  For successful commercial adoption of your product, contact me for an appointment.

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PET Scans of healthy person and person with Alzheimer's.     Image courtesy of the National Institute on Aging/National Institutes of Health

There are two new technologies for Alzheimer's. One is a potential diagnostic to detect Alzheimer's years in advance and the other is a potential therapy for treatment.

Researchers at Melbourne University have developed a blood test that has the potential to detect Alzheimer's disease five years before patients in the study were officially diagnosed according to Dr. Lesley Cheng, from the University's biochemistry and molecular biology department. The researchers are testing for microRNA genetic signatures. They tested 100 elderly people and one in five people tested positive for this genetic signature. Brain imaging was conducted and these patients showed signs of brain degeneration. The result were published in the October issue of Molecular Psychiatry.

To read the full article in The Age online, click here. 

Tufts University professor Philip Haydon is developing a "small molecule drug to target a specific receptor on microglia, one of the types of glial cells that that serve at least two purposes. They are the "glue" in the brain that holds neurons in place and connects them to one another as they fire the electrical and chemical signals responsible for our actions and feelings."

Microglia also plays a part of the brain's specialized immune system. When inflammation occurs in the brain, such as with Alzheimer's, microglia can't clear the amyloid-beta plaques.

"Haydon believes his drug might not only stimulate the microglia's natural plaque clearing ability, but also cool off the inflammation that might be getting in their way." He believes this is what sets his company GliaCure apart from what others have tried. Their drug GC021109, began their first clinical trial.

To read the full article in Xconomy, click here.  

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We help companies de-risk their product development process by conducting the business due diligence to ensure that it is the right product for the right market and the market opportunity for the product meets the business goals of the company. We can then develop marketing strategies to drive adoption for the product.

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