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!!!!!!

Some Good and Bad Investment News for Biotech Companies

Posted in BioEducation

Let’s start with the good news first. A report issued by the National Capital Association and PricewaterhouseCoopers found that venture capital investment in biotechnology grew 22 percent in 2011. And, now the bad news; initial funding for biotechnology startups seeking investment hit a 16 year low last year. The consensus among financial analysts is that life science investors are increasingly focusing on later stage companies because they carry less clinical and regulatory risks as compared with early stage ones. Put simply, VCs, like everyone else, have become much more risk adverse and do not want to invest in companies that don’t have a minimum history of success.

According to the report, venture firms spent $4.73 billion on 446 biotechnology companies in 2011, the highest dollar amount since 2007. Approximately, 153 biotechnology and medical devices companies received their first round of funding last year.

Finally, the US Food and Drug Administration approved 30 drugs in 2011; 13 of which were developed in part by venture funding.

Until next time…

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

 

Emerging Job Opportunities in the Life Sciences Industry

Posted in BioJobBuzz

I just returned from the American Association of Pharmaceutical Scientists (AAPS) meeting in Washington DC where I gave three talks about biocareer development strategies. One of the talks, "Emerging Job Opportunities in the Life Sciences Industry" was reported on (see below) by a writer from Fierce Pharma.  While I don’t usually "too my own horn." about my achievements, I thought a Number 2 ranking in the publications daily top 10 list was certainly worth a mention.  

 
New job opportunities emerging in Big Pharma
October 26, 2011 — 7:24am ET | By Maureen Martino

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. Mintz spoke at a session on new job opportunities in biotech and pharma at the annual AAPS meeting in Washington, D.C. 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 the U.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 to U.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!!!!!!
 

Social Media Update: US Food and Drug Administration To Regulate Mobile Apps?

Posted in Social Media

Mark Senak, author of the highly informative and well written Eye on FDA blog, reported today that a recent article that appeared on the American Medical News website suggests that the US Food and Drug Administration (FDA) may be considering regulating mobile apps that contain medical or clinical components. While the agency has yet to officially publish guidance on the use of social media in the life sciences industry, it now appears that FDA may be turning its attention on the development of mobile apps; one of the fastest growing segments of the social media movement.

The reason why FDA is taking notice of mobile apps is because a handful of app developers have sought and received FDA clearance for their mobile apps that—because of clinical components —are considered to be “medical devices.” As many of you may know, medical devices which include band-aids, surgical instruments, heart monitors, cardiovascular stents and diagnostic kits, all must receive marketing approval by the agency before they can be sold in the US. Although the agency yet to craft any guidance for clinical/medical app development, it makes sense that FDA ought to evaluate and regulate these products to insure that they are medically-effective and safe. 

According to the American Medical News article, the first app developer to receive FDA market clearance was AirStrip Technologies in San Antonio, for its AirStrip OB application. The app, which was approved in 2009, allows physicians to monitor mother and newborn remotely during delivery. In February, the FDA granted clearance to MobiUS, an app developed by Mobisante, a medical device company in Redmond, Wash. The app permits viewing of medical images for diagnostic purposes. Mobile MIM, a remote diagnostic imaging tool developed by Cleveland-based MIM Software, was also granted market clearance that month. A number of pharmaceutical companies, most notably Pfizer, have been extremely active in the mobile clinical app development space.

The reason why it makes sense for FDA to regulate certain clinical/medical apps is because physicians will rely on them to make medical decisions. For example, the AirStrip OB mentioned above will ostensibly allow physicians to remotely monitor a mother and neonate during delivery. Consequently, the app, aka device, must be evaluated by the agency to determine whether or not it can be used safely and effectively by physicians during childbirth. In this case, the app is similar to a heart monitor that is used during childbirth. And, like all other medical devices, the heart monitor required FDA clearance to determine its safety and effectiveness, before it could be used in real-life childbirth situations. To that end, the agency has hinted that it will be much more proactive in monitoring this new class of devices.

I have no doubt that many pharmaceutical companies and medical devices manufacturers will not be pleased when they learn that the agency is going to “stick its nose” into mobile app development. Nevertheless, in my opinion, if a mobile app is going to be used in possible “life or death” situation, then it ought to be regulated by FDA—the agency that is legally responsible for regulating these types of products. That said, Eye on FDA’s Mark Senak raises a number of valid and insightful points about FDA and its possible role in mobile app development.

“Related to a possible guidance for apps, there are a lot of questions that need to be answered when considering its development – when is an app a medical app?  When does it require regulation?  Who will pay for the oversight – will there be App Developers User Fee Act (ADUFA?) and if so, what will that do to the price and to access.  Will insurance companies have to cover apps?  And what will the process for approval be – something like a 510(k)?”

Finally, I think that the app developers who proactively approached FDA for guidance abut the clinical apps that they were developing “got it right.” This will get the agency “thinking” about clinical/mobile apps and how they ought to be approved and regulated in the future. In turn, this will provide future app developers with a clear regulatory framework that will guide the development of cost effective, safe and efficacious mobile clinical apps.

Until next time…

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

 

Alternate Career Options for Life Scientists: Persons Able to Manipulate "Big" Data Sets Will Be In High Demand Says New Report!

Posted in BioJobBuzz

An article in today’s NY Times entitled “New Ways to Exploit Raw Data May Bring Surge of Innovation, a Study Says” suggests that persons with quantitative skills and a firm grasp of the scientific method will be in high demand in the near future. This is because there is a current data surge coming from “sophisticated tracking of shipments, sales, suppliers and customers, as well e-mail, Web traffic and social network comments.” And, the quantity of business data has been estimated to double every 1.2 years!

According to the report “Big Data: The Next Frontier for Innovation, Competition and Productivity” put together by the McKinsey Global Institute, harvesting, managing, mining and analyzing “big new data sets” can lead to a new wave of innovation, accelerated productivity and economic growth. And, the place where this may be felt first is the US healthcare system. The report asserts that better management of big data sets can lead to as much as $300 billion in savings. Also, American retail companies could possibly increase their operating profit margins by as much as 60 percent. However, one of the major hurdles to this paradigm shift is a talent and skills gap. The US alone will likely need 140,000 to 190,000 with expertise in statistical methods and data-analysis skills. McKinsey also notes that an additional 1.5 million data-literate manages will be required. Accordingly, “Every manager will really have to understand something about statistics and experimental design going forward,” noted one of the report’s authors.

As far as jobs for scientists in the healthcare realm are concerned, the report suggests that

“….the biggest slice of the $300 billion gain is expected to come from more effectively using data to inform treatment decisions. The tools include clinical decision support to assist doctors, and comparative effectiveness research to make more informed decisions on drug therapy.” That said, life scientists with backgrounds in statistical analyses, bioinformatics, genomics, public health, epidemiology and quantitative analysis will be ideal candidates for these new job opportunities."

While these types of jobs (mainly health informatics) are certain to available in the future, it isn’t clear how soon. This is because the big-data trend has just begun and, according to economists, it may take years to recognize its financial advantages and benefits. In any event, it is something for life scientists who may be considering alternate career options, to think about. To that end, if you begin to train for these opportunities now, you may find yourself in the right place at the right time in the not-to-distant future.

Until next time….

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

 

Is GSK Really Backing Away from Neuroscience R&D?

Posted in BioJobBuzz

Ask any pharmaceutical industry pundits about the “next big thing” in life sciences R&D and most will invariably say neuroscience indications like Alzheimer’s, Parkinson Disease and the like. Curiously, despite these prognostications, GlaxoSmithKline (GSK) today announced that it would lay off 50 employees involved in neuroscience R &D.

The affected workers, all of whom are scientists working on late stage clinical development at various sites throughout the US, were first notified about the layoff on Valentine’s Day (nice gift). Interestingly, a GSK spokesperson was quick to point out that other neuroscience employees including marketing and sales would not be affected by the layoffs. Hm mm, I always thought you needed scientists to discover the drugs that will ultimately be marketed and sold by a company? In any event, no GSK operations outside of the US were affected by this round of layoffs.

The reason why the layoffs only affected clinical scientists is because GSK scaled back its investment into early stage research. And, according to the GSK spokesperson this means that “there’s not as much coming through that needs later stage clinical trials.” Also, last year, after GSK released fiscal 2009 results, the company announced it would “cease discovery research in selected neuroscience areas, including depression and pain.” I guess most of the layed off scientists worked on depression and pain (two emotions that layed off workers frequently suffer).

In case you haven’t noticed (because you spend too much time in the lab and on Facebook), most major pharmaceutical and biotechnology companies have slashed their investments into new drug discovery and development. This means that the demand for R&D scientists (in the US anyway) is much lower than ever before. Consequently, as I have stated numerous times in the past, now may be the time for graduate students and postdocs considering industrial R&D careers to re-evaluate their plans (unless R&D careers in emerging markets like Brazil, Russia, India and China are attractive).

Until next time ….

Good Luck and Good Job Hunting

 

Merck Gets Serious About Biosimilars

Posted in BioBusiness

Two years ago Merck formed a new division called BioVentures ostensibly to develop and manufacture biosimilar drugs. Interestingly, the announcement preceded creation of a regulatory approval pathway for biosimilars in the US.  While the approval pathway still isn’t in place, many regulatory experts expect the US government to issue the guidelines by mid-2011 after a meeting that was held on biosimilars by the US Food and Drug Administration last month.

Late last year, the company scuttled its plan to develop a PEGylated version of EPO which was to be its first so-called biosimilar. Unfortunately, PEG-EPO would not be allowed to be approved as a biosimilar via any existing or newly divined pathway because it is actually a new molecular entity and, therefore, would require numerous clinical trials to garner regulatory approval (maybe that is why Merck canceled development).

Nevertheless, Merck expects to have no fewer than 5 biosimilar molecules in clinical development by 2012. To that end, Merck  that it had created an alliance with Parexel International Corp—a global clinical research organization—to help to conduct the clinical trials necessary for regulatory approval of the biosimilars that Merck is developing. The financial terms of the deal were not disclosed.

Michael Kamarck, President of Merck BioVentures, declined to specify the products but did mention that the terms of the deal terms were intended to “motivate Parexel to enroll patients quickly and generally execute the clinical trials in a speedy fashion.” He also noted that the Parexcel deal is only “one of an number of strategic steps: that Merck is pursuing in the biosimilar field.

Let’s see whether or not Merck can meet the lofty goals that it has set for itself. Hopefully biosimilar legislation will be in place by 2012!

Until next time….

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

 

Study Finds Pharma Wrongdoing on the Rise

Posted in BioBusiness

In a first-of-its-kind study, researchers at the Public Citizen’s Health Research Group tracked the civil and criminal financial penalties levied against the pharmaceutical industry for wrongdoing over the past 20 years. 

The main findings of the study revealed:

  1. Of the 165 settlements comprising $19.8 billion in penalties during this 20-year interval, 73 percent of the settlements (121) and 75 percent of the penalties ($14.8 billion) have occurred in just the past five years (2006-2010).
  2. Four companies (GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough) accounted for more than half (53 percent or $10.5 billion) of all financial penalties imposed over the past two decades. These leading violators were among the world’s largest pharmaceutical companies.
  3. The practice of illegal off-label promotion of pharmaceuticals has been responsible for the largest amount of financial penalties levied by the federal government over the past 20 years. This practice can be prosecuted as a criminal offense because of the potential for serious adverse health effects in patients from such activities.
  4. Deliberately overcharging state health programs, mainly Medicaid fraud, has been the most common violation against state governments and is responsible for the largest amount of financial penalties levied by these governments. This type of violation is also the main factor in the considerable increase in state settlements with pharmaceutical companies over time.
  5. Former pharmaceutical company employees and other “whistleblowers” have been instrumental in bringing to light the most egregious violations and have been responsible for initiating the largest number of federal settlements over the past 10 years. From 1991 through 2000, qui tam (whistleblower) cases made up only 9 percent of payouts to the government, but from 2001 through 2010, they comprised 67 percent of total payouts.

The companies, their missteps and the fines imposed are shown below:

The authors conclude:

"Over the past two decades, especially during the past 10 years, there has been a marked increase in both the number of government settlements with pharmaceutical companies and the size of the accompanying financial penalties. Given the relatively small size of current financial penalties when compared to the perpetrating companies’ profits, both increased financial penalties and appropriate criminal prosecution of company leadership may provide a more effective deterrent to unlawful behavior by the pharmaceutical industry."

Interestingly, about a month ago officials at the US Food and Drug Administration signaled that were willing to prosecute company executives to the fullest extent possible (including criminal prosecution) to reduce the incidence of fraud, off-label marketing and manufacturing violations that have become commonplace in the pharmaceutical industry in the past five years.

Until next time….

Good Luck and Good Job Hunting!!!!

Meeting Update: BioConference Live:Clinical Diagnostics

Posted in BioEducation

The fourth BioConference Live: Clinical Diagnostics meeting will be taking place on October 20-21, 2010.   This online-only, live, interactive virtual event will cover new technologies, best practices and other pertinent topics for Clinical Diagnostics professionals. Registration is free and all interested persons can attend!  The conference is accredited by the ASCLS American Society for Clinical Laboratory Science and Professional Acknowledgment for Continuing Education (P.A.C.E.).

Therapeutic areas to be covered include: Infectious Diseases, Cancer, Diabetes, Allergy & Immunology, Cardiology, Point of Care, Automation, Molecular Diagnostics, Hematology, Laboratory Testing, Stem Cells, Protein Arrays, and Clinical Chemistry.

Some of the featured speakers include:

  1. Alan Wu Ph.D., Chief of Clinical Chemistry & Toxicology & Prof. Laboratory Medicine, San Francisco General Hospital and University of California, San Francisco
  2. Steven Burrill, CEO Burrill & Company
  3. David Persing M.D. Ph.D., Chief Medical and Technology Officer, Cepheid
  4. Peter Gilligan Ph.D., Professor of Microbiology-Immunology UNC Hospitals
  5. Thomas Goodwin Ph.D., Project Scientist (NxPCM) and Director Disease Modeling & Tissue Analogues Laboratory NASA
  6. Steven Binder, Director Technology Development Bio-Rad Laboratories
  7. Brad Karon M.D., Ph.D., FCAP, FACB, Vice Chair of Education in the Department of Laboratory Medicine Mayo Clinic
  8. Alex Rai Ph.D., Director, Specialty Laboratory, Chief Scientific Officer, Center for Advanced Laboratory Medicine, Columbia University
  9. Robert Fitzgerald Ph.D., Associate Professor, University of California San Diego

Login will take place on October 20th and 21st between 9 AM and 6 PM EST.

Sign Up Now and have a chance to win an iPad if you refer a friend!

Until next time…

Good Luck and Good Learning!!!!!!!!

 

Pharma Edges Closer to Using Social Media for Non-Promotional Purposes

Posted in Social Media

Pharmaceutical giant GlaxoSmithKline (GSK) and MedTrust Online, an online oncology information site announced the development of CancerTrials App, the first free geo-locating oncology clinical trials application for the Apple iPhone and iPad platforms.

According to a press release, oncologists can easily find and share information about experimental therapies in clinical trials with their patients. CancerTrials App provides a quick search menu based on 12 common cancers and more advanced features that refine searches based on criteria such as gender, age, trial status and more. Once relevant clinical trials are found, results can be mapped relative to the location of the iPhone or iPad running the application. These features should help oncologists connect patients to appropriate regional and local clinical trials for which they may be eligible. Obviously, the app will help to bolster clinical trial enrollment in the oncology space.

While not a full blow geo-based social media platform like FourSquare,the Cancer Trials app is a step in the right direction and demonstrates the power of mobile medical applications and the potential of social media to improve clinical drug development. 

CancerTrials App for the iPhone and iPad is the first release of the application that connects to MedTrust Online’s proprietary databases of oncology information. Other apps for RIM’s BlackBerry and Google’s Android operating systems will be released over the next several months.

Hat tip to GSK which has boldly gone where no other pharma company has gone before!

Until next time….

Good Luck and Good Job Hunting!!!!!