Cannabis Derived Pharmaceuticals The Next Frontier?

Posted in BioBusiness

I wrote an article on the emerging medical marijuana and cannabis-derived pharmaceuticals market for Life Science Leader.

Please click here to view!

It was a very interesting article to research and fun to write Please let me know your thoughts and feedback!!!

 

Until next time….

Good Luck and Good Job Hunting (not when you are high of course)

FDA Announces Social Media Guidelines–Yawn!

Posted in Social Media

After a very long blogging absence, I decided that it was time for me to begin to write posts on things that continue to pique my interest.  The recent announcement that the US Food and Drug Administration (FDA) has finally released its long awaited guidance on the use of social media in the life sciences industry including pharma, biotech and med. devices.

While words like long awaited have been used to describe this monumental announcement, I think nobody really cares anymore about what the agency thinks about social media!  Put simply, despite some interested starts and stops, social media is not an integral part of the life sciences industry and likely will never be.  In the beginning (about a decade ago) social media transformed a number of industries by introducing transparency and engaging stakeholders to improve their bottom lines. Unfortunately, the modus operandi in the life sciences industry, by virtue of it business model, is opaqueness not transparency. Further, life scientists and life science employees are not the most social individuals and their use of social media for business purposes is almost non-existent. Consequently, social media and the life science industry are not a good fit!!!! Finally, early players in the life science social media space including Novo Nordisk and J&J have already leveraged what they could using social media and have moved on.

In summary, while it may be a banner day at FDA because the agency finally released its social media guidelines, I do not think anybody really cares anymore. The trajectory of social media is on its downward slope and it is no longer fresh or new (except maybe in the minds of pharma/biotech executives).  In fact, social media is no longer new media and is now considered a standard staple of all communication platforms. While many industries benefited from social media it was never a priority for the life sciences industry and industry executives (and US regulators) did everything in their collective power to ensure that social media did not interfere with the secrecy and intentional opaqueness that dominates the industry.

Until next time,

Good luck and Good Job Hunting

Conference Announcement: “The Future of Healthcare Communications Summit” in NYC on July 24, 2013

Posted in BioBusiness

Many of The Affordable Care Act’s (ACA) provisions go into effect January 1, 2014. The ACA is the most significant piece of legislation that will impact the delivery of healthcare since Medicare and Medicaid. ACA’s focus on preventative care and early patient intervention will force patients to assume more responsibility for their own personal health management. Patients will need advice and information from trusted sources more than ever before. The time is now for pharmas, hospital groups, insurers, medical device companies and healthcare agencies to develop and implement strategies for communicating with patients, caregivers and healthcare professionals. Our summit will focus on how leading healthcare brands are planning for the future including integrating big data, digital, mobile and social for innovative communications that improve patient outcomes.  Paul Matsen, Chief Marketing & Communications Officer, Cleveland Clinic will deliver the keynote presentation and case study presenters will include:

  • David Blair, Head of Industry for Health, Google.
  • Ray Kerins, Senior Vice President, Head of Communications & Public Affairs, Bayer Corporation
  • Monique Levy, Vice President, Research, Manhattan Research
  • Sarah Stephens Winnay, Senior Vice PresidentEliza Corporation

New York City, 6/24/13, 8:00 a.m. – 1:00 p.m. 

Register on the event website by July 22nd to receive a discounted rate of $175 with promo code BC.

About BDI

Business Development Institute (BDI), founded in New York City by Steve Etzler in 2001 and managed by Maria Feola-Magro, produces conferences and educational programs for marketing, communications and media professionals. Over 13,000 attendees have participated in our programs. We specialize in how technology and the internet impacts marketing, communications and media. Our programs educate while providing valuable networking opportunities to our attendees. The quality of our speakers, program topics, 1/2 day format, network, and value are what differentiates BDI from its competitors. For more information, please visit our website at www.bdionline.com.

Its Official: Biosimilar Monoclonal Antibodies Will be Legal in Europe

Posted in BioBusiness

The European Medicine Agency (EMA) recommended marketing authorization for two biosimilar versions of Johnson & Johnson’s Remicade, an anti-tumor necrosis factor (TNF) monoclonal antibody (MAbs) used to Crohn’s Disease, rheumatoid arthritis and other autoimmune diseases.  One of the MAbs named Remsima was developed by South Korea-based Celltrion and the other, Inflectra, was developed by US-based Hospira.   The European Commission is expected to follow the EMA committee’s advice and approve the products for a bunch of autoimmune diseases, including rheumatoid arthritis and Crohn’s disease.

According to a report by Fierce Biotech, Kim Hyoung Ki, senior vice president and chief financial officer at Celltrion, told reporters in Seoul today, that

“The price of Remsima will be more than 30 percent cheaper than those of the original drugs,”  We’re confident in Remsima as it has price competitiveness, while it has the same effect as the original drugs.”

Other biosimilar versions of MAbs including Rituxan, Herceptin, Enbrel and Humira are in various stages of clinical development.  Many of the branded MAb products represent the only treatment for certain types of cancer and autoimmune diseases and they are expensive to use.  Consequently, biosimilar manufacturers have them in their sights because the patents for many of these products are due to expire by 2018.

Although biosimilars are not yet legal in the US, it is simply a matter of time before they will become available to American patients.  The cost of healthcare continues to spiral upward and cost-savings of 25%-30% for many blockbuster biologics can help to better control those costs.

Until next time…

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

Alternate Careers: Entrepreneurship

Posted in BioBusiness

There is no question that the US is lagging behind other nations in science, technology, engineering and math. While this may be troubling to some, Americans possess one skill that provides them with an unheralded advantage; that is entrepreneurship. Entrepreneurial skills cannot be easily taught or learned. And while most Americans don’t know it, entrepreneurship is a passively acquired trait that most non-Americans would “kill for.” Unfortunately, the recent recession and increasing global competition had dampened Americans entrepreneurial enthusiasm to the point where risk-adverse business behavior is threatening to stifle US innovation.

Peter Sims addresses this issue in a NY Times piece entitled “Daring To Stumble on the Road to Discovery” where he laments “…our education system emphasizes teaching and testing us about facts that are already known. There is much less focus on our ability to discover, create and reinvent.”

He contends that Americans can no longer expect that jobs will be waiting for them and that everyone needs to think about “inventing” their own jobs. While this may seem unlikely for many jobseekers, he offers the following to those who may be willing to try.

“INVENTION and discovery emanate from the ability to try seemingly wild possibilities; to feel comfortable being wrong before being right; to live in the world as a careful observer, open to different experiences; to play with ideas without prematurely judging oneself or others; to persist through difficulties; and to have a willingness to be misunderstood, sometimes for long periods, despite the conventional wisdom.”

Further he offers:

“All these abilities can be learned and developed, but doing so requires us to unlearn many of our tendencies toward linear planning and perfectionism.”

In other words, take risks and dare to be different. The worst thing that may is happen is that you fail. And, if you ask many successful people what contributed most to their success, they will likely tell you about their failures and how they helped them to “get it right” the next time.

Until next time…

Good Luck and Good Job Hunting!!!

Alternate Career Options: Working For CROs and Biotech Startups

Posted in Career Advice

In today’s tough economy, one of the more challenging things after graduating college or graduate school is finding a job. Many life sciences graduates are beginning to realize that skills and training that they received in college have not adequately prepared them for jobs in the real world. Furthering, “previous industrial experience” is almost always a requirement for most jobs at pharma and biotechnology companies. As many students ask me “How can we get previous industrial experience if nobody will hire us to get that experience?”

While this may appear to be a typical “Catch 22” situation, it is not an insurmountable one A convenient way to acquire the requisite previous industrial experience is to volunteer or land an internship (paid or otherwise) at a small, local life sciences company. Many of these companies can use the help and will gladly give you an opportunity as long as they don’t have to pay you much. These companies conduct research for their pharmaceutical and biotechnology clients and are frequently willing to hire relatively inexperienced but talented scientists into entry level jobs. This is because the demand for well-trained scientists continues to grow at CROs as more and more pharma and biotechnology companies outsource R&D activities and continue to shed jobs.

Another option is to look for entry-level jobs at local start up companies. Typically, most of these companies are venture-backed and have limited financial resources. Consequently, salaries offered by these companies to employees are generally lower than those at CROs, biotech and pharmaceutical companies. Nevertheless, while you may not get paid as much as you expected or like, working as a research scientist at a start up company definitely counts as industry experience and it may help to jump start your career in the life sciences industry.

If you cannot get a job at aCROor a local start up, you can always start your own company! However, while this may sound like an exciting idea, it is probably a good idea get some entrepreneurial training before you take the leap.

Finally, it you cannot land a job at aCRO, a local start up or you are not interested in starting your own company, you can always go back to graduate school (not science related) or professional school. However, if you choose this path, then I highly recommend that you do some research to determine which jobs are likely to be in high demand over the next 5 to 10 years! While going to graduate school may help to defer repaying your undergraduate students loans, you run the risk of incurring more debt and possibly not have a job after you graduate unless you choose your next career option wisely.

Until next time…

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

Some Alternate Career Suggestions

Posted in Career Advice, Uncategorized

Since 2001, 300,000 pharma employees have lost their jobs, primarily in R&D and sales. That’s according to Clifford Mintz, the founder of BioInsights, which develops and offers bioscience education and training. While the losses have been steep, they’re balanced by emerging, in-demand careers in the industry.

The industry’s struggles are well-known: Many companies are facing loss of exclusivity on their biggest sellers but have little in the pipeline to pick up the slack. Productivity is dropping as the cost of bringing a new drug to market soars. Government and payors want more effective drugs for less money. The list goes on.

Developers are looking to new markets and new technologies to address these issues. But how do these trends play out for the pharma job seeker? Many people, particularly Ph.D.s, may have to consider getting additional training if they want to land their dream job. “Companies used to be willing to just hire smart people. But with the economic downturn and global competition, companies can no longer afford to invest in people who have promise. They need to see proven skills,” Mintz explained. With the right blend of skills and experience, however, there still some pharma jobs that are in demand.

Clinical Research and Regulatory Affairs

“Clinical research is the lifeblood of the industry,” Mintz said. As developers expand in emerging markets, there’s a particular demand for people to manage and organize overseas clinical trials. “There’s a huge need for clinical research professionals worldwide,” he said, noting that most Phase I and II trials are conducted outside of theU.S.

Another one of the industry’s perennial needs is regulatory affairs professionals. “Regulatory affairs experience is a skill that all companies large and small would die to get their hands on,” explained Mintz. The increasingly complex and uncertain world of FDA regulation–particularly when it comes to new technology and science–means that companies are always on the prowl for individuals with solid regulatory knowledge and ability to interact with the FDA. You can read more about the demand for clinical research and regulatory affairs jobs here.

Biomanufacturing

The pharma industry’s interest in biologics remains strong–just look at Sanofi’s buyout of Genzyme, or Roche’s purchase of Genentech. They’re lured by disease-altering biologics that are less likely to face generic competition than traditional drugs. As a result, there’s been increased demand for professionals who can navigate the complex world of biomanufacturing. Those with a background in upstream and downstream processes, large-scale protein purification, fermentation technology and bioengineering can make the transition to biomanufacturing.

Healthcare Information Technology

The rise of bioinformatics and genomics coupled with the push for electronic medical records has created jobs in healthcare information technology. Health informatics–the intersection of healthcare and IT–is ideal for people with expertise in genomics, bioinformatics or software that understand how to work with and manipulate large data sets and databases. The Obama administration has made EHRs a priority, and there’s a need for software engineers and biologists who are comfortable working with medical information.

Medical Devices

“The medical devices industry has been experiencing explosive growth for the past decade,” Mintz said. Regulatory hurdles in the medical device industry are much lower than they are for biologics or small molecules, making the industry a more stable alternative to biotech and pharma. The demand for devices, which address problems that can’t be treated with medicine, will continue to grow as the population ages. Job seekers with strong backgrounds in bioinformatics, genomics, engineering and translational medicine are best suited to this field.

Medical Communications

Medical communications–which includes medical writing, editing, graphic design and science journalism–continues to boom. The demand for these jobs has risen because companies need a slew of communication materials to send to patients, physicians, researchers, investigators and the general public about their products and business.

Patent Law and Technology Transfer

Recent changes toU.S.patent laws have increased the demand for patent agents and patent attorneys in the life sciences field. Pharma’s growing reliance on basic research from learning institutions means that there’s a need for technology transfer experts. These experts manage the patent estate and intellectual property of universities and colleges that may engage in licensing deals with the industry. A law degree is a must to compete in this field.

Until next time…

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

Here We Go Again: AstraZeneca to Cut 1,600 Jobs

Posted in BioBusiness

Just when many pharmaceutical employees’ anxiety about  job security was beginning to wane and things appeared to returning to “normal”, yesterday AstraZeneca (AZ) announced that it was slashing another 1,600 jobs.  While this was not unexpected, these new cuts add to the massive number of pharmaceutical employees who have lost their jobs over the past five years.

According to a press release, the cuts will help AZ to save roughly $190 million per year through 2016.  Most of the lost jobs will come from restructuring of AZ’s R& D operations in the UK, Sweden and the US.  To that end, all R&D activity will stop at AZ’s Alderley Park facility in Northwest England, the former hub of the company’s R&D activities.  Az’s MedImmune subsidiary in Gaithersburg, MD will be the main center for biotech drug R&D while AZ’s research center in MoeIndal Sweden will focus on small molecule discovery and development.

AZ’s new CEO Pascal Soriot said the reorganization and restructuring were necessary to better focus the company’s R&D efforts in the key therapy areas that include cancer, cardiovascular and metabolic disorders and respiratory and inflammatory diseases. The company will reduce its efforts in the areas of neuroscience and antiinfectives.

Interestingly, many of the job cuts were made so that the company can build a new $500 million all purpose facility in Cambridge, England to leverage the R&D and clinical talent in that part of Britain.  The new facility is expected to be built by 2016.  Looking on the bright side, many of the employees who just lost their jobs, can find new ones three years from now!

AstraZeneca has already reduced its global workforce by around 10,000 as it has struggled to cope with generic competition and disappointing progress in finding new drugs. It now employs a total of 51,700 around the world.

Don’t be surprised if other big pharma companies announce new job cuts in 2013.

Until next time…

Good Luck and Good Job Hunting!!!!!

ChinaInsider: American and Chinese Views on China’s Emerging Life Sciences Industry

Posted in Uncategorized

This is an inaugural post of the ChinaInsider, an independent news service that provides commentary from an American (me) and Chinese (a scientist living in China) on life sciences issues, trends and happenings in China. Ultimately, ChinaInsider will be housed at BioCrowd, an online networking site for bioprofessionals.

In the News: Tainted Chinese Capsules

Despite big pharma’s continuing expansion intoChina, serious questions still exist about Chinese drug quality and supply chain integrity. Late last week, Xinhuanet.com reported that 12.7 percent of Chinese capsule makers (ca. 254) were producing unsafe gelatin capsules that were contaminated with excessive levels of chromium (6+) a known carcinogen that is toxic if ingested in large amounts.

The State Food and Drug Administration (Chinese FDA equivalent) identified manufacturers of the tainted capsules, issued recalls and ordered that products made with the contaminated capsules destroyed. To that end, local authorities ordered 42 capsule makers to cease operations, revoked seven manufacturing licenses and reported 13 companies to the police for prosecution.

The source of the chromium contamination was traced to the use of industrial gelatin (derived leather scraps) rather than edible gelatin which is made from bovine and porcine skin, connective tissue and bones. In 2005, the Chinese Ministry of Health banned the use of leather scraps to produce gelatin used in pharmaceutical and food products because of high chromium content.

It is unclear whether the tainted capsules were used for local consumption or whether the capsules were exported fromChinafor use in foreign markets.

China View

Fact Check:

1. Reports about tainted capsules first surfaced in China almost two months ago

2. First reports about tainted capsules were issued by academic research institute testing results; SFDA later intervened

3. There are only 117 registered medical grade capsule manufacturers in China

4. Annual output of the 117 registered manufacturers is 200 billion per year; the internal Chinese medical capsule demand is 100 billion per year

5. Substituting industrial gelatin (extracted from leather scraps) for edible gelatin can save capsule manufacturers 0.1 RMB per 10 capsules which can save capsule manufacturers millions and allow them to be very cost competitive

6. Chromium (6+)-contaminated medical capsules were also reported in China in 2004. After three months of investigation, it was determined that high levels of chromium (6+) found in medical grade capsule could only result when industrial gelatin is substituted for edible gelatin

American View

This incident, coupled with the heparin scandal of several years ago, suggests thatChinahas a long way to go before it can guarantee drug quality that meets Western standards. Until this is accomplished, the Chinese pharmaceutical and biomanufacturing industries will contain to struggle to gain global recognition.

While SFDA claims to have tightened regulations to better insure drug quality and improve supply chain integrity, it is apparent that regulatory oversight of local manufacturing plants has been lacking.

Finally, it may be prudent for pharmaceutical companies that import medical grade capsules fromChinato consider implementing chromium batch testing (for chromium 6+) even though this testing is not mandated in US or Japanese compendial methods.

The Bottom Line

It is likely that Chinese chromium-contaminated capsules were exported out ofChinaand where they wound up is anyone’s guess.

iCredibility Scoreboard

We will be happy to supply you with a list of Chinese pharmaceutical companies implicated in the capsule incident. Please provide us with your e-mail in the comments section of the blog.

 

 

Optimizing a LinkedIn Profile to Land a Job

Posted in BioEducation

Social media platforms like LinkedIn, Facebook and niche career development communities like BioCrowd are being used to identify job candidates by hiring managers, employers and professional recruiters. For those of you who may not have been paying attention, LinkedIn is the largest professional social networking site on the web today. Most companies allow their employees to post profiles on LinkedIn and many do not block access to the site during working hours. Like it or not, this means that if you are looking for a job you would be a fool not to have a complete and up-to-date profile on LinkedIn!

However, while you may think that your LinkedIn profile is sufficient to help a recruiter or hiring manager find you among the other 129 million or so LinkedIn members, it probably is not. This is because, in order to be found, your LinkedIn profile (much like your CV/resume) must contain key words that identify you as a person who possesses the right qualifications and skill sets after the hiring manager or recruiter searches the LinkedIn database using those words! This begs the question: what are the keywords to use in my LinkedIn profile so that I can be found?

The best way to identify keywords is to read as many job posting as you can with titles similar to the ones that you are interested in landing. Typically, they can be found in the qualifications and skills set requirements displayed in the ad. Many times these may be buzz words or jargon unique to your field of study. The point here is to identify the key words and then to artfully and judiciously incorporate them into your LinkedIn profile. But, most BioJobBlog readers will ask (because you are scientists) how do I know if the keywords I chose are the correct ones?

Ian Levine, who runs CareerBrander.com, offers a clever test (described below):

  1. Go to the peoples tab @ LinkedIn and hit advanced search.
  2. Now enter a keyword or keywords associated with your targeted position. Ex: regulatory affairs
  3. Now enter a geography zip code and a distance quotient.
  4. Then select an industry or multiple industries that apply to you. (Understand the broader you make your search the lower your ranking will be).
  5. Hit search. Can you find yourself in the first few pages of the LinkedIn results?

If your name appears at or near the top of the search page results (with the words that were used in the search highlighted) then your LinkedIn profile is optimized and you will likely be found. If your name is not near the top (or on the list) then you have some work to do. Not surprisingly, one way to optimize your profile is to visit the profiles of those whose names do appear on the top of the search list for the type of job that you want!

While it may take some time to fully optimize your LinkedIn profile, it will be time well spent! At present, over 80 percent of hiring managers and close to 100% of recruiters use social media platforms at some point in the hiring process.

Until next time…

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