Cannabis-Derived Pharmaceuticals: The Next Generation?

Posted in BioBusiness, Uncategorized

My colleagues AJ Fabrizio and Evan Nison of TerraTech Corp and I just published an article in the July 2015 issue of the Journal of Commercial Biotechnology entitled “Cannabis-Derived Pharmaceuticals

The paper details the emerging field of Cannabis-derived pharmaceuticals, the companies that are developing these products and an up-to-date review of US clinical trials that are being conducted to garner FDA-approval of this new class of therapeutics.

Check it out!!!!!!!!!

Until next time,

Good Luck and Good Job Hunting (there is a future in the Cannabis industry!)

An Analysis: Big Pharma and Social Media Usage

Posted in Social Media

A study conducted in November 2011 by Cegedim Strategic Data, a market research and promotional audit firm analyzed the world’s top 100 pharmaceutical companies expenditure on traditional promotional (marketing spends) and then compared that spending with their presence on Facebook and Twitter.

Not surprisingly, Pfizer, Novartis and Merck (the world’s largest big pharma companies) finished in the top three for traditional promotional spending. However, their use of social media i.e. Twitter and Facebook varied widely. For example, Pfizer—the top promotional spender—was first in its number of Twitter followers and third in the number of likes on Facebook. On the other hand, second ranked Novartis was fifth in the number of Twitter followers and in seventeenth position for likes on Facebook. Finally, third ranked Merck was fifteenth in the number of Twitter followers (third for the number of tweets) and in the tenth position for the number of likes on Facebook (but has more pages than any of its Facebook competitors).

Other notable companies included:

  • Johnson &Johnson, eleventh in promotional spending and number two on the number of Facebook likes
  • Roche, number fifteen on the promotional spending list was ranked number two for the number of Twitter followers
  • Proctor and Gamble which ranked a distant 54th in promotional spending was number four on the Twitter follower list

What does this all mean? A whole lot of nothing because nobody can determine what effects the use of social media has on the bottom line for most pharmaceutical companies. Unlike other industries, where social media can be used to sell products, it cannot be used for direct promotional purposes in the life sciences industry. While most people will tell you this is because of the lack of guidance by FDA on the use of social media, the bottom line is that social media will never be allowed for direct-to-consumer advertising in the pharmaceutical industry. That said, pharma and biotech will have to find other uses for social media including clinical trial recruitment and retention, adverse event reporting, employee recruitment and retention and education and outreach.

Until next time…

Good Luck and Good Tweeting (and Liking)

 

Maximizing Patient Engagement During Clinical Trials

Posted in BioBusiness

Recruiting, retaining and managing patients that participate in clinical trials for approval of new medicines and devices have becoming very challenging in the past decade or more. Ironically, the ready availability of experimental new medicines in the US for certain therapeutic areas including oncology, neuroscience and vaccines have forced life sciences companies and CROs to conduct many Phase I and Phase II trials outside of the US. In turn, the globalization of clinical trials has forced many sponsors to increasingly rely on e-based and mobile solutions for patient recruitment, retention and compliance.

The Advance Learning Institute’s conference entitled “Patient Recruitment, Compliance And Retention For Clinical Trials: Integrating The Latest Technologies With Traditional Tools To Maximize Patient Engagement” that will be held in Manhattan on October 24-26, 2011 will provide attendees with insights into the best practices to maximize patient engaged in clinical trials. Presentations will be given by a variety of pharmaceutical companies, CROs and academic institutions including Pfizer, Merck Research Laboratories, Shire Pharmaceuticals, Celgene Corporation, Quintiles, Omniscience Mobile, Albert Einstein College of Medicine and the Michael J. Fox Foundation for Parkinson’s Research. A complete agenda for the conference can be found here.

Those of you who mention BioJobBlog or BioCrowd when registering for the conference will receive a $200 registration discount.

See you at the meeting!!!!!!!

Until next time…

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

 

Human Clinical Trials Go Global

Posted in BioBusiness

The clinical trial phase of the drug development process is labor intensive, costly and usually takes the largest amount of time to complete. In the past, most human clinical trials for new molecular entities discovered by American scientists were conducted in the US. However, growing healthcare costs and shortages of “treatment-naive” trial participants have forced drug makers to take the effort global. To that end, many companies now routinely conduct Phase I (safety) and Phase II (proof of principle) trials in Eastern Europe, Latin America and Asia. Moreover, a growing number of pharmaceutical companies are beginning to conduct pivotal Phase III trials in which a majority of participants come from outside of the US.

Last year, a report from the inspector general of the Department of Health and Human Services revealed that in 2008 a whopping 78 percent of all subjects participating in trials to support drug applications submitted to the US Food and Drug Administration were enrolled in foreign sites. Likewise, in Europe, approximately 61 percent of patients in human trials submitted to the European Medicines Agency (EMA) from 2005-2009 were from developing countries. Additionally, 11 percent of the participants were enrolled in studies conducted in Eastern Europe. Poland and Hungary appear to have benefited the most from this trend; the number of Poles involved in trials rose fivefold over the period while Hungary was up almost fourfold.

According to a recent article from Reuters, ClinicalTrials.gov—a public website managed by the National Institutes of Health that tracks current US clinical trials—lists roughly 106,000 human clinical trials that are underway around the world. Approximately 50 percent of these trials are being conducted in the US. Interestingly, at present, only 43 percent of all pivotal Phase III trials are being conducted in the US.  Not surprisingly, China is the beneficiary of the trend and is experiencing exponential growth in the number of clinical trials conducted within its borders. To date, over 2,700 clinical trials have been performed in China and that number is likely to drastically increase over the next five years as Chinese medical and healthcare infrastructure continue to improve.

While outsourcing human clinical trials may be favorable to drug makers, the trend is beginning to anger many American physicians who previously benefited from managing US-based clinical trials. These physicians blame their misfortune on the life sciences industry’s endless pursuit to lower costs and the increasing regulatory bureaucracy and red tape surrounding clinical trial procedures in the US.

In addition to physician anger, outsourcing human clinical trials poses several other problems. First, there is a question of ethics. For example, is it right to test an expensive new drug in a country where locals may never be able to afford it if approved? And, are foreign patients always adequately informed or educated about the potential risks and side effects associated with experimental medicines? Second, can ethnic differences between patients contribute to differences in drug effectiveness and safety? In other words, will Caucasian patients respond to a new drug in the same ways as Asian patients? Finally, in the absence of rigorous regulatory inspections can Good Clinical Practices be routinely maintained across all global clinical trial sites? To that end, as pointed out in the Reuters article from 2005 to 2009 EMA inspectors only conducted 44 good clinical practice inspections (outside of the US and Europe) from a total of 44,034 clinical sites. Meanwhile, during the same period, the US FDA inspected only 0.7 percent of foreign clinical trial sites as compared with 1.9 percent of domestic sites.

Like it or not, outsourcing of human clinical trials in emerging markets is a trend that is likely here to stay. Hopefully, in the future, regulatory agencies will be able to better oversee foreign human clinical trials to insure that the drugs that they approve continue to be safe and efficacious.

Until next time…

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

 

Sanofi-Aventis' Oncology Push

Posted in BioBusiness

It is no secret that Sanofi-Aventis is facing a steep “patent cliff” in 2013 when some of its top selling drugs, most notably Plavix, will lose patent protection. Some analysts contend that the company can lose as much as a quarter of its annual revenue because of generic encroachment on blockbuster brands. Sanofi is narrowing its business to three areas — diabetes, heart problems, and cancer — and is seeking partnerships and acquisitions.

This past June, Sanofi inked a $398 million deal with US-based Ascenta Therapeutics to gain access to two experimental cancer drugs that are in preclinical development. Later that month, the company purchased TargeGen a privately held US biopharmaceutical company focusing on oncology R&D. Two months later, Sanofi announced that it had entered into a partnership with the Belfer Institute of Applied Cancer Science (part of the Dana Farber Cancer Institute) to gain access to additional experimental cancer treatments.

Today, Sanofi announced that it had reached an agreement with Germany-based  Merck KGaA to jointly study experimental cancer treatments. Both companies Merck will conduct early stage human trials of Merck’s MSC1936369B and Sanofi’s SAR245409 and SAR245408 experimental drugs. Under the terms of the agreement, each company will carry out an early-stage dosing test of the drug candidates. Sanofi will be granted a license to study the safety and effectiveness of the Merck compound when used with SAR245408. Merck will be given a license to work with Sanofi’s other medicine to study its use in combination with its experimental compound. Financial terms of the deal were not disclosed.

Yesterday, Sanofi announced that it had signed an agreement with Oxford University to conduct multi-phase clinical and translational research in oncology with INDOX, a network of cancer research centres established across India in partnership with the university’s Institute of Cancer Medicine five years ago. According to the terms of the agreement Sanofi-Aventis has agreed to provide financial support to Oxford University in managing the INDOX network of eight cancer research centres across India. 

Based on this spate of activity over the past six months it would appear that Sanofi is executing its new long term strategic plan. Stay tuned for more news!

Until next time…

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

 

Facebook Reaches 500 Million Users but Pharma Continues to be Slow to React

Posted in Social Media

An article in today’s New York Times business section loudly proclaimed that the number of people using Facebook had topped 500 million. Further, according to the article: “The company has grown at a meteoric pace, doubling in size from a year ago and each month, more than 30 billion photographs, links to Web sites and news articles are shared through the site, and its members spend roughly 700 billion minutes there.”  

While these statistics are mind boggling and represent an incredible business opportunity for any company, life sciences companies including most major pharmaceutical and biotechnology companies have largely shunned Facebook. In a post earlier this week on EyeonFDA, its author, Mark Senak rightly noted that:

 “When social media began to ebb from a media pathway for individuals to connect, to one where institutions and industry began to employ social media as a means of communicating with their constituencies Facebook has become an extremely important referral source - a driver of traffic – to Web pages.” Despite this, “the pharmaceutical industry, as a highly regulated industry, has lagged behind other sectors.”

The reasons for pharma’s reluctance to use social media to engage stakeholders are numerous. The most common ones offered include the lack of regulations guiding the use of social media and its possible effects on adverse event reporting for approved medicines. However, the lack of regulatory guidance and consequences for adverse event reporting didn’t prevent life sciences companies from building branded product websites, sponsoring patient communities or investing in social networks for physicians. Therefore, it is unlikely that the lack of regulatory guidance and fears of overwhelming adverse event reporting aren’t responsible for pharma’s reluctance to embrace social media. I suspect that the real reasons may have more to do with increasing transparency surrounding clinical testing, drug approvals and drug pricing and reimbursement. But, I digress….

Interestingly, despite the lack of regulatory guidance and concerns over adverse event reporting, some pharmaceutical companies have chosen to boldly go where no other life sciences companies have gone before on Facebook.  According to Mark, the following companies have created corporate or disease/cause-related fan pages on Facebook:

  1. Labs Are Vital sponsored by Abbott Laboratories
  2. AstraZeneca US Community Connections
  3. AstraZenecaCareers
  4. Bayer Karriere
  5. Bayer Sustainability
  6. Johnson & Johnson Network
  7. Nursing Notes by Johnson & Johnson
  8. Pfizer

While the number of person who are fans of these pages are minute (as compared with the total number of Facebook users) they likely represent highly committed and focused groups of user—any pharmaceutical marketer’s dream! Although Facebook still subscribes to the notion that “bigger is better, niche networking and social media sites are growing in popularity. This is because these sites may give marketers and advertisers a “bigger bang for their buck” as compared with larger, more unfocused and disparate user communities. In other words, penetration and uptake rates are likely to greater in focused niche populations as compared with the general population at large.

I have long contended that social media tools can be used for other than promotional purposes in the life sciences industry. To that end, the use of social media for clinical trial patient recruitment and retention is rapidly expanding and there are signs that pharmaceutical companies have finally recognized the power of social media for recruiting purposes e.g. AstraZenecaCareers .  

I have no doubt that the life science industry will eventually recognize the utility power of social media. It is no longer a question of “if” but rather ‘when” for social media and the life sciences industry?

Until next time…

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

 

Social Media, Clinical Trial Recruitment and Mobile Healthcare Apps

Posted in Social Media

About a year ago I posted an article to BioJobBlog that suggested that social media can be leveraged to improve clinical trial recruitment to test investigational new drug candidates. Yesterday, Mark Senak, author of the EyeonFDA posted an article which suggested that the use of video on YouTube and other video-viewing sites makes complete sense to recruit prospective participants for human clinical trials. Here are some of Mark’s thoughts on the topic:

“The reasons I think video is a good way to expose people to learning about clinical trials are multiple. First, it allows me as a prospective clinical trial participant to learn about a clinical trial when I want to learn about it and where I want to learn about it – a hallmark of social media.  Second, it is private – I can learn from a video that can be developed to address a wide range of issues – issues that I might not be so comfortable addressing with a live person.  Thirdly, and perhaps most importantly, I learn about the clinical trials perhaps from someone on a video who is very much like me.  He can be someone with my condition – someone who has gone through a trial, and talk about how his concerns were addressed, what his fears were and what the benefits of participation were.  That, I think, is a much more convincing way to learn about a trial than an ad in a newspaper or even a discussion with a clinical person.  Video can’t replace the medical professional, but it sure can get my interest and perhaps trust to make recruitment much easier.”

While the industry’s use of social media for this purpose is not quite there yet, there are some signs that pharmaceutical and biotechnology companies may be trending in that direction. First, a growing number of clinical research organizations (CROs) which help companies plan and manage clinical studies are already using social media tools to recruit prospective clinical trials participants. Second, as Mark reported yesterday, Pfizer launched a YouTube channel called PfizerClinicalTeam last July which presumably would bolster clinical trial recruitment. Unfortunately, as Mark pointed, its most recent video was posted in April, 2010, regarding a new study on schizophrenia. Don’t be surprised if other companies launch social media-focused clinical trials recruitment campaigns in the not too distant future. Like Mark, I believe that social media tools are ideal for this purpose!

In other news, Pfizer, a late entrant to the fledgling pharmaceutical social media space, is showing signs that it is beginning to embrace the social media web. Yesterday, Pfizer and Epocrates announced a collaboration to create an application for the iPhone that gives healthcare providers mobile access to the Pfizer Medical Information Group to obtain medical and science information about Pfizer products or to report adverse events. According to Pfizer, it is creating the app to: “enable easy, direct access to its Medical Information services, via the Epocrates channel, in an effort to enhance the safe and effective use of its medicines, and help improve the quality of patient care.”

Direct access to medical information via mobile devices is growing in popularity among physicians and other healthcare providers because it enables them to get answers on the go without wasting time to fire up a laptop or find a tethered computer to use outside of the clinic.

Despite assertions to the contrary by most pharmaceutical and biotechnology companies, social media tools are ideal vehicles for adverse event reporting and post market drug surveillance activities. Pfizer’s creation of a mobile medical information app coupled with the launch last week of a joint US Food and Drug Administration (FDA) and National Institutes of Health drug safety portal called Safety Reporting Portal (original eh?) suggest that the use of social media tools for online adverse event reporting and drug safety purposes is not too far off. Let’s see what develops over the next year or so after FDA issues regulatory guidance on the use of social media in the life sciences industry.

Until next time…

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

 

How Social Media May Be Influencing Human Clinical Trials and Access to Potentially Life-Saving Investigational New Drugs

Posted in Social Media

It’s no secret that pharmaceutical and biotechnology companies are “not in love” with social media. However, whether life sciences company like it or not, social media is beginning to affect human clinical testing with an increasing number of patients demanding access to unapproved experimental drugs to treat life-threatening illnesses. 

In a recent article that appeared in the January 15, 2010 issue of Genetic Engineering and Biotechnology News entitled “Expanded Access to Investigational New Drugs”, Natalie Douglas, CEO of UK-based Idis Pharma wrote:

"…the trend toward greater transparency of drug development pipelines and the accessibility of powerful social media tools, have led us to a more informed empowered and vocal population of patients. This, in turn, has led to increased demands for access to unapproved drugs that are in various stages of human clinical testing. “Patients can easily access information about investigational drugs via the Internet and are leveraging social media tools such as YouTube, Twitter and blog to influence companies to garner access to them” Douglas added.

This can place enormous pressure on the companies that are testing investigational new drugs because the safety and efficacy of the drug candidates has yet to be determined. Understandably, companies are loath to provide patients who don’t meet clinical trial inclusion requirements access to experimental drugs with unknown safety and efficacy characteristics. Nonetheless, if requests for access to investigational drugs are denied, social media tools can easily be used to quickly and widely publicize the denial. According to Douglas, aggressive use of social media tools by patients seeking access to investigational drugs has helped their stories make national news. This can create gargantuan regulatory and public relations problems for companies with drugs in clinical development and put them at the center of an ethical and moral firestorm—despite their best intentions to develop new drugs that eventually may help millions of patients suffering from various diseases and conditions.

Many patient advocacy groups, consumers and shareholders understand the almost limitless reach of social media and its ability to influence public opinion, discussions and trends. Whether or not drug makers are willing to use social media, many have yet to understand that they are already part of the social media conversation that is taking place daily. And, as all social media enthusiasts have realized, if you are not part of the conversation then you don’t know what is being said about you on the Internet. More importantly perhaps, is that by choosing not to participate in the conversation, companies have lost all ability to influence and manage what is being said. In other words, life sciences companies that steadfastly choose not to use social media may, paradoxically, be setting themselves up for public relations and regulatory headaches that could have easily been avoided.

While the social media frenzy may be beginning to wane, there is no question that it has changed the way people interact and influenced the way business is transacted online and in real life. Companies that insist on clinging to past business practices that are exclusive, non-interactive and designed to promote opacity are likely to lose customers and market share as 21st century technology continues to unfold.

Hat tip to Natalie!

Until next time…

Good Luck and Good Tweeting!

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Merger Aftermath: Pfizer Refocuses

Posted in BioBusiness

While I never was involved in a corporate acquisition or merger, I have many friends who have lived through them and based on their experiences it is a never a “pretty sight.” Merger aftermaths usually feature massive layoffs, executive management disputes and turf wars and corporate culture clashes tha occur when two workforces are forced to merge as one. However, sometimes mergers may be a good thing for struggling companies. To that end, Pfizer may actually benefit from it $68 billion acquisition of Wyeth late last year.

The acquisition will cost at least 20,000 employees their jobs—not a good thing in a national economy where unemployment is well over 10 percent (despite claims to the contrary). However, this merger is strikingly different than Pfizer’s questionable past mergers and acquisitions which were primarily engineered to procure one or two drugs that had blockbuster potential e.g. Lipitor and Celebrex. This time around, Pfizer’s management team is actually re-evaluating its entire drug development portfolio and attempting to expand the company’s pipeline to include vaccines, therapeutic proteins and other biologics. As I previously noted, most major pharmaceutical companies believe that biologics will be the major driver of pharmaceutical markets in the not so distant future.

According to a post on PharmaLive, Pfizer announced that it will discontinue research and development on roughly 100 experimental new drug candidates. Pfizer officials revealed that the company will continue with 500 research projects in six areas of: 1) Alzheimer’s disease, 2) diabetes, 3) pain, 4) cancer and 5) mental illness (including schizophrenia).

Of the 500 projects, 30 drugs are being tested for cancer indications, 10 for Alzheimer’s disease, eight for pain and 11 for inflammation. Further,133 are in various stages of human clinical testing, including several that are awaiting regulatory approval in the US and elsewhere. 

On the biologics front, Pfizer has six vaccines and 27 biopharmaceutical drugs in development. Prior to the Wyeth acquisition, the company only had one vaccine and 16 new biologics that it was testing. Like most other pharmaceutical companies, Pfizer wants to be a major player in the biopharmaceutical and biologics markets by 2015.

Only time will tell!

Until next time,

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

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Who's Who in the Pharma Twitterverse

Posted in Social Media

Mark Senak who writes the EyeonFDA blog has compiled a list of the life sciences companies that presently have a Twitter account and use it. While there are only 12 companies on the list, he provides a nice commentary on their use and makes some recommendations for improvement.

Although I am a staunch supporter of the use of social media in the life sciences, it appears to me that the discussion about its use has been somewhat muted since the FDA convened a public hearing on the topic last month. I suspect that many of the companies and stakeholders who participated in the discussion prior to the FDA meeting are presently in “wait and see” mode. However, don’t be surprised if the social media guidance issued by FDA is lacking and excruciatingly wanting!!!! For those of you who may not be familiar with the ways in which the agency operates, its regulators tend to craft guidance and regulation that are broad, loosely defined and open to interpretation. The agency intentionally crafts its guidance and regulations this way because it doesn’t want its rules and regulations to be “literally interpreted” by companies and other stakeholders. Generally speaking, its regulations represent the “minimum” requirements that must be met in order to insure regulatory compliance. In other words, there is no upper limit on what companies can do to insure compliance but there certainly is a minimum requirement that must be met to avoid regulatory sanctions and penalties. As one lawyer who used to work for the agency shared with me recently, “FDA crafts the regulations but it is left to the companies and courts to interpret them.”

Most of the current discussions about social media and the life sciences industry primarily focus on its use as marketing and promotional vehicle. And, as many of you may already know, FDA isn’t exactly keen or pleased with the current marketing and advertising strategies and practices utilized by a sizeable number of life sciences companies. Perhaps a shift away from marketing and advertising discussions to more regulatory-friendly and practical applications like clinical trials recruitment and public outreach may lead to a more rapid uptake of social media by FDA and life sciences companies? Just sayin’

Until next time…

Good Luck and Good Tweeting!!!!