EyeonFDA Blog: Why FDA Needs to Be Clear About Social Media

Posted in Social Media

Mark Senak, author of the EyeonFDA blog and a life sciences/healthcare social media enthusiast, wrote a fantastic piece yesterday that provides cogent ideas and insights into the need for FDA to expeditiously craft guidance on the use of social media in the pharmaceutical and healthcare industries.

Here are the facts. First, according to the Pew Internet and American Life Project, social media has fundamentally changed the way in which we interact with one another and ushered in a new era of communication. Unlike the old, so-called “broadcast communication method”—information is continuously streamed from a static source, websites, television, radio etc, to perspective customers and stakeholders—the new paradigm requires that communications must be personal, portable and participatory for effective messaging. Second, the primary source of information sought by most persons who use the Internet is healthcare and medical information. While much of the content is accurate, some is not; which may put persons seeking medical information at great risk. In other words, social media is not just about marketing and medical education; it is also about preserving public health.

The agency has historically been unable to issue guidance on new forms of communication. For example, FDA held its first public meeting in 1996 on Internet use by life sciences and healthcare companies. Sadly, the agency has yet to issue any official guidance on this topic. In late 2009, FDA held another public meeting and promised that draft guidance on the internet and social media would be forthcoming by the end of 2010. Unfortunately the guidance did not materialize in 2010 and it has been delayed twice in 2011. Recently, the agency publicly reaffirmed its commitment to issuing the guidance but without a specific timetable for its release. Consequently, it is anyone’s guess when or if the guidance will be released.

Unlike many, I do not believe that FDA guidance on the Internet and social media is absolutely necessary. However, I will admit that issuance of said guidance will provide drug and healthcare companies with some of the assurances that they need in order to actively use social media to engage patients, physicians and other stakeholders. For this reason alone, FDA ought to issue the guidance (which is never perfect and always a work in progress) and end the social media stalemate that currently exists. Failure to do so may have serious consequences on the public health of many Americans.

Hat tip to Mark!

Until next time…

Good Luck and Good Job Hunting!!!!!!!!

 

A Course That Teaches Scientists to Talk to "Real People"

Posted in BioEducation

It is no secret that one of the greatest impediments to improving the public understanding of science is the inability of scientists to articulate the importance of their work and ideas to non-scientists. 

Early in my career I was guilty like most of the rest of you. The first hint that I was not getting through to lay people was their eyes glazing over when I attempted to explain what my research was about. I quickly realized that I needed to learn how to better present my ideas to non-scientists if I wanted to engage them in casual conversations about science. 

Unfortunately, most of the persons charged with training scientists see little or no value in teaching their students to communicate to lay persons about their research or science in general. After all, they wouldn’t understand it anyway so why bother? That justification may have been valid 30 years ago but with the advent of the Internet and more recently social media, it is vitally important that the correct scientific information is disseminated to the lay public. In case you hadn’t notices, there is an awful lot of scientific misinformation out there that is being taken as “the truth” by large segments of the American public.

Recognizing this, Pat Marsteller a biologist and science educator at Emory University in Atlanta developed a course entitled “Communicating Science” which is designed to tech graduate students to write for and talk to non-scientists. She teaches the course with two chemists, mainly because the majority of students who took the class last semester (the first time it was taught) were chemists. Apparently, most of the students were “volun-told” to take the class by a chemistry adviser. This became apparent to Dr. Marsteller during the first class meeting when a chemistry student quipped: “Why Should I want to talk to anybody who doesn’t understand carbon?” Go figure….

While the course is designed to eliminate jargon and science speak so it is more comprehensible to non-scientists, it also stresses the different ways in which scientific information ought to be transmitted to different audiences that a scientist may encounter during his/her careers. For an example of this click here.

Hat tip to Dr. Marsteller for developing such a forward-thinking and necessary course.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!

 

Using Social Media Tools to Improve Information Flow At Scientific and Medical Meetings

Posted in Social Media

Science and medical conference season is in full swing and tens of thousands of persons are attending scientific and medical meeting all over the US. While social media is no longer a new “thing” only a few scientific and medical societies understand its power and ways in which it may be harnessed to improve the experiences of their members who attend their national meetings. 

At most of the scientific conferences that I attend (usually four to fiver per year), people still lug around and are tethered to printed program guides. Further there is no easily accessible electronic repository (aside from the conference website) or guide that conference attendees can use to optimize time management and see “everything” that they want to at the meeting. Unfortunately, most scientific and medical conferences are still being run the same way that they have been for the past 30 years despite improvements to internet access and bandwidth, the advent of social media and the recent explosion of mobile devices and apps.

Finally, and perhaps most egregiously, rather than publicly disseminating what is being reported at these meetings, conference attendees and the lay public must rely on carefully orchestrated press releases (chosen in advance by the organizing committees of the meetings) for information and late-breaking news from the events. This is so web 1.0 that it is almost laughable.

Until last week, I thought that I was the only person who felt this way about social media and medical and scientific congresses. Imagine my surprise when no fewer than three others social media enthusiasts including Mark Senak, author of the EyeonFDA blog, Brian Reid, author of the WCG Common Sense Blog and Sally Church, author of the Pharma Strategy Blog, last week authored posts on the topic! It is always refreshing to find like-minded individuals to confirm that you are not alone!

Unfortunately, many scientific and medical societies like to tightly control information flow, limit access to it and, not surprisingly, are quite suspicious of social media. This is because the use of social media decreases the ability of these societies and their journals to control their messaging and content dissemination. With this in mind, is it any wonder why American scientific and medical literacy is pretty much in the “toilet?”  While the lay public may not be able to understand peer-reviewed scientific and medical publications, they have grown accustomed to gathering information on Facebook, Twitter and most importantly blogs. Why not use these vehicles to better inform the public about scientific or medical breakthroughs that have been validated and generally regarded as authentic?

Like it or not, social media is here to stay. And if leveraged correctly, it can be an extremely effective educational tool. I think that it is time for scientific and medical societies to consider using social media at their annual meetings. A failure to do so may have negative consequences for future membership in these societies and also reduce their effectiveness as purveyors of timely and accurate scientific and medical information!

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!!!

 

Calling All Life Sciences Startups: Check out LifeScienceFest Americas if Your Company is looking for Investment Capital

Posted in BioBusiness

After a long drought, venture capital and private equity investments into private life sciences companies are beginning to flow again. VCs and fund managers have monies that must be invested into promising new ventures. The best way to find the right investors is to present at life sciences investment fairs like LifeScienceFest Americas. This year BioJobBlog and BioCrowd are cosponsoring the event.  

If you are interested in presenting your company to qualified investors, please read the information presented below and take advantage of discounted rates.

APPLY NOW TO PRESENT AT LIFESCIENCEFEST AMERICAS – JUNE 17, 2011
Investorfest Media is proud to announce call for nominations from promising startups for
LifeScienceFest Americas conference on June 17th.  At the 3rd annual venture conference, we will showcase up to 16 promising innovators seeking funding to active life science angels and investors.

APPLICATION DEADLINE : MAY 14, 2011
If you are a startup (seed, Series-A,B,C or restart) from the medical device, diagnostic or
healthcare technology space and you are seeking new investment to start or grow to the
next level, this is THE conference for you. You must be seeking funding from $250K to
under $20M. Learn more on the application process, segments of interest and deadlines.

CONNECT WITH LEADING INVESTORS AT LIFESCIENCEFEST
General Partners & angels from 20+ leading firms including Sand Hill Angels, Band of Angels, Keiretsu Forum, Claremont Creek Ventures, Bay City Capital,Physic Ventures, Psilos Ventures, Sofinnova Ventures,  Lumira Capital and many others will be at the event. Learn more..

WHO SHOULD ATTEND

Investors from Founders of promising innovative companies seeking capital to industry executives, investors and M&A professionals will be in attendance at this exclusive, limited seating event. Non-presenting entrepreneurs can also attend, and must register early to reserve their spot. Register Now to reserve your spot

BIOJOBBLOG BIOCROWD MEMBER DISCOUNT
A limited number of discounted tickets are available for Biocrowd members who will receive $50 off early bird registration and pay just $299. Apply code BIOCR50. Discounts are offered to qualified non-service provider professionals from the life science and med device industry and on a first-come, first-serve basis. Register Now at the discounted rate.

ABOUT INVESTORFEST MEDIA
Investorfest Media is the leading VC funding accelerator working in the life science and medical device space. Through our highly focused training and hands on support, qualified companies are put in front of specially chosen investors our annual LifeScienceFest conference. To date over 75% of presenting companies have gone on to receive funding, with over $280 million being raised since 2006. Learn more at investorfest.com

Until next time

Good Luck and Good VC Hunting!!!!!!

 

A Good Example of Why Politics and Science MUST NEVER Be Mixed

Posted in BioBusiness

Last week, the US House of Representatives voted to cut FDA funding by $220 million. The House vote was not surprising given the prevailing attitude among many pharmaceutical and biotechnology company executives that FDA approval of new drugs and devices has become increasingly difficult. While there is no question that the current approval process for new drugs and devices has become more rigorous as compared with the incredibly lax process (and in some cases, the almost non-existent process) used during the Bush Administration, the FDA is simply fulfilling the mandate for the agency when it was created in 1938. That is: to provide the American public with SAFE and efficacious drugs to treat unmet medical need. 

Until recently, the FDA had been chronically under funded. And, because of this, the American public was forced to suffer through the Vioxx scandal, the heparin scare and the appearance on the market of many unapproved medical devices. These and other events that occurred over the past decade beg the question: “Should the American public’s safety be placed in jeopardy again simply because the Republican-controlled House is looking for ways to cut deficit spending?”

Unfortunately, the activity of anti-FDA lobbyists (funded mainly by US pharmaceutical and biotechnology companies) has been ramped up ever since the Democrats lost control of the House. And, since most Republicans believe that any government regulation whatsoever is too much regulation, it is easy to understand the House would vote to cut FDA funding. Nevertheless, insufficient funding will not allow the agency to hire the number of inspectors required to insure that drug manufacturing is conducted according to FDA-mandated regulatory guidelines. These activities are essential to insure the safety of the prescription drugs and medical devices sold on the US market.

According to FDA Current Good Manufacturing Practice (CGMP) guidelines, drug manufacturing plants for all approved drugs and devices are to be inspected every two years. Inspections are required for all manufacturing plants in the US as well as FDA-approved manufacturing facilities overseas. Because of ongoing shortages of FDA inspectors (and the emergence of numerous overseas manufacturing facilities), these inspections are typically conducted every three to five years rather than every two years! Clearly, this is not in the best safety interests of the American public.

A report published by the General Accounting Organization about the heparin scare of three years ago nicely sums up the issues.

“In its response to the heparin crisis, FDA took several actions related to its responsibility to protect the public health by ensuring the safety and security of the nation’s drug and medical device supplies. FDA increased its activities related to oversight of heparin firms by conducting inspections and investigations and monitoring heparin imports, and worked with drug and device manufacturers to recall contaminated products while ensuring that an adequate supply of uncontaminated heparin was available. With the help of external entities, FDA identified the unknown contaminant and developed tests to screen all heparin products. Additionally, the agency reached out to its international regulatory partners during the crisis. However, FDA faced some limitations in its efforts to inspect heparin firms in China and collaborate internationally, and the agency was unable to determine the original source of contamination.”

Interestingly, as today reported by the EyeonFDA blog, the U.S. House of Representatives Energy and Commerce Committee announced today that it was re-opening examination of the heparin contamination issue.  A letter was sent by the Chair of the Committee, Rep. Fred Upton (R-MI) as well as other members to FDA Commissioner Margaret Hamburg requesting that the agency supply all documents in connection with the heparin investigation from January 1, 2008 until present.  In its announcement, the Committee stated:

“It has been almost three years since the FDA linked deaths and serious allergic-type reactions of patients in the United States to supplies of heparin that came from the People’s Republic of China which was adulterated with overly sulfated chondroitin sulfate (OSCS). FDA officials believe this was an instance of economically motivated adulteration,” the members wrote. “However, neither the Chinese government nor the FDA has identified those responsible for the contamination or described how the heparin actually came to be contaminated.”

Mark Senak, author of  EyeonFDA blog aptly noted:

"It is certainly important in that any public health crisis involving the contamination of food or drugs be thoroughly investigated. But the investigating body can’t have it both ways. You can’t criticize an agency for not conducting inspections that are not funded by the same members of the same investigative body."

Is this any way to run a country?

Until next time…

Good Luck and Good Job Hunting!!!!!!!

 

The First Episode of This Week in Microbiology (TWiM) Is Available @ MicrobeWorld

Posted in BioEducation

This Week in Microbiology (TMiV)—created by BioCrowd founder Vincent Racaniello and sponsored by the American Society for Microbiology (ASM)—launched today, with episode #1 posted at microbeworld.org/twim. It will soon be available on iTunes and the Zune marketplace.

The first episode focused on the antibacterial properties of metallic cooper and the discovery that Neisseria gonorrhoeae, the causative agent of gonorrhea, had somehow acquired human DNA sequences. Stan Maloy, a past President of ASM, and Michael Schmidt joined Vincent (host) and me (co-host) for the inaugural podcast.  

Future TWiM topics include the emergence of antibiotic resistant bacteria, bacterial food poisoning, adaptation of microbial life in extreme environments and the use of bacteria in green energy production.

The goal of TWiM is to improve the public understanding of microbiology and related topics. To that end, we encourage listeners to contact us with comments, kvetches, suggestions and ideas for future podcasts.

Until next time…

Good Luck and Good Listening!!!!!!

 

The Debut of This Week in Microbiology (TWiM)

Posted in BioEducation

BioCrowd co-founders Vincent Racaniello and Cliff Mintz (aka BioJobBlogger) today in association with Microbe World (sponsored by the American Society for Microbiology) created the first episode of This Week in Microbiology (TWiM), a podcast series that explores various topics in microbiology that have relevance for the lay public.

Following in the path of his successful shows ‘This Week in Virology’ (TWiV) and ‘This Week in Parasitism’ (TWiP), Vincent and his guests produce an informal yet informative conversation about microbes which is accessible to everyone, no matter what their science background.

This week’s show focused on the antibacterial properties of metallic cooper and the discovery that Neisseria gonorrhoeae, the causative agent of gonorrhea, had somehow acquired human DNA sequences. Stan Maloy and Michael Schmidt joined Vincent (host) and me (co-host) for the inaugural podcast.  

TWiM podcasts will be available at TWiV, Microbe World, BioCrowd and BioJobBlog. They can also be downloaded from iTunes and the Zune Store once we get permission to post them at those sites.

The goal of TWiM is to improve the public understanding of microbiology and related topics. While there are no exams or pop quizzes, TWiM does encourage interaction with the audience email and skype. Listeners can also use Microbe World to suggest topics for the show by submitting articles or papers to the site and tagging them with "TWiM"

I will post the first TWiV installment as soon as Vincent edits today’s podcast!

Until next time…

Good Luck and Listen to TWiM!!!!!!!!!

 

Promoting Science Literacy Among Undergraduate Humanities Students One Student At A Time

Posted in BioEducation

In 2005, The National Academy of Sciences issued a worrisome report entitled “Rising above the Gathering Storm: Energizing and Employing America for a Brighter Economic Future” that warned that America is slipping in competitiveness in all areas of science.

While this ought to have been a wake-up call for all Americans, in 2010, the Academy issued an update entitled “Rising above the Gathering Storm: Approaching Category 5." Not surprisingly, the findings in the update indicate that the US is still lagging in its capacity to innovate and compete and that the trend continues to move in a downward direction. For example, in 2006 (the most recent year for which data are available) 16 percent of American college students received undergraduate degrees in natural sciences or engineering as compared with 47 percent in China, 38 percent in Korea and 27 percent in France. Recommendations in the original report called for creation of 25, 000 undergraduate scholarships per year in math, science and engineering. Although the updated report indicated that Congress had taken some steps to implement the recommendation, progress has been severely lacking in this area.

Almost all US colleges and universities require that undergraduate students have some instruction in science. Unfortunately, most of these courses are lecture driven and lack a laboratory component (mainly because laboratory instruction is costly and time intensive). This is problematic because science is a laboratory driven discipline that requires data collection and analysis; neither of which is taught in most lecture settings. Recognizing the growing lack of science literacy among American undergraduate students, Leon Botstein—music director and conductor of the American Symphony Orchestra and President of Bard College an artsy liberal arts college in NY—decided to do something about it. To that end, he created a program at Bard called Citizen Science; a mandatory science course conducted during winter break that all Bard freshmen are required to take for graduation.

Citizen Science is a two and a half week long program in which students spend six hours per day immersed in laboratory science. The 2011 program taken by 480 students focused on the molecular biology of infectious diseases. Using laboratory equipment, computer modeling and classroom discussions, student explored various aspects of infectious disease research including bacterial and viral detection, creation of vaccines and techniques that can be used to manage global disease outbreaks. The students were taught by two dozen scientists who were recruited from all over the country. There are no grades or credits received by program participants. This was done to promote learning for learning sake according to Brooke Jude an assistant professor of biology and the director of Citizen Science.

Botstein, who incidentally is the brother of David Botstein a world renowned geneticist at Princeton University, has been an outspoken critic about deficiencies in American education. He previously has taken many of his colleagues to task for “shirking their responsibility to create a well-rounded citizenry.” Botstein, with help from his brother, decided to “put his money where is mouth is” by creating Citizen Science. 

According to Botstein, “The most terrifying problem in American university education is the profound lack of scientific literacy for the people we give diplomas to who are not scientists or engineers.” He added, “The hidden Achilles’ heel is that while we’ve found ways to educate scientists in the humanities, the reverse has never really happened. Everybody knows this, but nobody wants to do anything about it.”

Not surprisingly, the Citizen Science Program has received mixed reviews from the 480 Bard freshmen who participated in the inaugural program. After all, a majority of the students who chose to attend Bard have a decided bent toward music and the arts, not science. Nevertheless, many students suggested that their two and half week scientific sojourn has taught them to think more critically about science. Next year’s theme for the Citizen Science program may be energy or climate change.

While Bard’s Citizen Science program is a fantastic idea, not all colleges or universities have the financial largess or scientific connections necessary to create similar programs at their institutions. Perhaps Congress ought to establish funding mechanisms (in addition to the 25,000 math and science scholarships each year) for post secondary institutions interested in replicating the Bard program.

Government officials can no longer deny what the data are showing them; science literacy in the US is plummeting and we are REALLY at risk of losing our competitive and innovative edges in math, engineering and science. Put simply, it is no longer a question of “if” but “when.”

Until next time….

Good Luck and Good Job Hunting!!!!!!

 

Are Scientists Really Much Different Than "Normal" People?

Posted in Career Advice

I just returned from the American Society of Human Genetics (ASHG) annual meeting that was held this past week in Washington, DC. On the surface, the meeting was not much different from the others that I typically attend—I was providing resume critiquing services and career counseling to graduate students and postdoctoral fellows. But, this meeting felt different to me than most and I couldn’t quite explain why! That is; until I read a blog post by Magali Charmot-Sauva entitled “Are Scientist Purely Rational”

The gist of the post was that scientists are not much different than non-scientists and like most “normal” people they do have emotions and secrets that have little to do with science! In other words, scientists are “just like everyone else” as Charmot-Sauva contends. But, she posits that society has convinced scientists that they are different and most have embraced the notion. 

After reading the post, I started thinking about the different feeling that I had at ASGH this past week. Many of the graduate students and postdocs that I talked with were folks engaged in rare disease research, genetic counseling, diagnostics and epidemiology. In other words, unlike most research scientists, they were working on serious “human” diseases and closer in many ways to the people who suffer from them. Put simply, the label “human genetics” rather than molecular or biochemical etc somehow permits these scientists to more easily express their humanity and ultimately their humanness! And, interestingly enough, the ASGH leadership sponsored a symposium for students and postdocs designed to improve their communication skills with the news media and the lay public. Clearly the ASHG leadership understands that scientists and “normal people” need to communicate with and get to know one another better.

The lack of emphasis on communication and interpersonal skills in most graduate programs sends the wrong message to graduate students and postdocs. Most interpret this to mean that they are not necessary or important for a successful scientific career. And it also helps to promulgate the myth it is okay for scientists to be different than other people. While this may be acceptable for some academics (they don’t get out much anyway), it is entirely unacceptable in the non-academic science world where a premium is placed on well honed oral and written communication skills. 

For those of you who may not believe me, take a look at some of the job ads for industrial scientist positions. Invariably, all require that prospective job candidates have outstanding written and oral communication skills. In the past, companies were willing to overlook these requirements in order to acquire the requisite technical skills that they needed. However, there is currently a glut of PhD-trained bioscientists in today’s market and life sciences hiring managers no longer have to sacrifice any requirements in order to hire the best job candidates. That said, I think it is time for scientists to “come out of their ivory towers” and learn what it means to communicate and be human again!

Until next time…

Good Luck and Good Communicating!!!!

 

Social Media and Microbiology Education

Posted in BioEducation

Vincent Racaniello, a BioCrowd founder and Professor of Microbiology at Columbia University College of Physicians and Surgeons published an article on PLOS Pathogens entitled “Social Media and Microbiology.”

Vincent, a virologist by training, has spent the past 30 years at Columbia where he has been recognized for numerous achievements including identification and characterization of the human polio virus receptor, the creation of transgenic mice to study the neural tropism of the polio virus and the identification of viral virulence factors that contribute to the pathogenesis of a variety of viral infections. His contributions to the field of virology have resulted in a number of honors including the Eli Lilly Award, a Harvey Lectureship, a 10 year Merit Award from NIH and editor of the Journal of Virology and other peer reviewed microbiology journals.

While not conducting laboratory research and teaching virology to undergraduates and graduate students, Vincent spends a considerable amount of time writing for his blog the Virology Blog and creating podcasts for his award winning show entitled TWIV (This Week in Virology). He is a committed educator and firmly believes that his role as a scientist is to improve the public understanding of infectious diseases and science in general. 

The introduction to his article aptly describes his philosophy about social media and science education.

“Social media consists of Internet technologies that allow users to create and share content, and to foster dialogues among other users. Examples include software applications for communication (blogging, social networking, discussion forums), collaboration (wikis, social bookmarking), and multimedia (sharing photographs, video, and livecasting). In the world of science, social media is becoming an increasingly integral component of both research and education. My experience with two types of social media, blogging and podcasting, has convinced me that scientists must embrace these applications to enhance research, and to better communicate their work to the public.”

If you want to learn more about Vincent or chat with him, he can frequently be found at BioCrowd interacting with undergraduates, graduate students, postdocs and even colleagues from time to time.

Until next time…

Good Luck and Good Job Hunting!!!!!!!