Beyond borders: global biotechnology report 2011

Don't miss this Ernst & Young report titled, "Beyond borders: global biotechnology report 2011." The results highlighted in the Beyond borders: global biotechnology report 2011 include:

• Record-breaking profitability: Companies in the industry’s established biotech centers of Australia, Canada, Europe and the US had a record-breaking aggregate net profit of US$4.7 billion, a 30% increase from the previous year.
• Aggregate funding rebounds: Companies in Canada, Europe and the US raised US$25 billion in 2010 — equaling the average for the four years before the global financial crisis.
• Funding for innovation declines: In the US, large debt financings by mature, profitable companies grew by 150% over 2009. Conversely, there was a 20% decline in the amount of “innovation capital” for the sector, defined as total funding minus large debt financings.
• More skewed funding: 82.6% of funding went to just 20% of US companies, up from 78.5% in 2009. The bottom 20% of companies raised 0.4% of funds, down from 0.6% in 2009.
• Alliances remain strong, but not up-fronts: The total potential value of strategic alliances remained strong, totaling more than US$40 billion. However, up-front payments from partners to biotech companies dropped 37 percent to US$3.1 billion.
• Deal-making slows: Merger and acquisitions (M&As) involving European or US biotech firms dropped sharply from 58 deals in 2009 to 45 deals in 2010, while the aggregate value of these transactions remained relatively flat (after normalizing the 2009 numbers to exclude the mega-acquisition of Genentech).

You can access the report (PDF) here.

San Diego BioProcess Forum

The San Diego BioProcess Forum is dedicated to providing local biotechnology professionals an opportunity to network and discuss topics focused on bioprocess technologies and trends. Members meet during social events featuring informative industry related presentations.

San Diego BioProcess Forum Meeting
Thursday, July 14th, 2011 at 5:30pm - 7:30pm

Membership and Event admission are FREE

Learn more here: SDBioProcessForum.org

I'll be speaking at BioConference Live 2011 about biopharma careers

I'll be speaking at BioConference Live 2011. My session is titled, "Physician careers in the biopharma industry" and it will occur on Wed June 15, 2011 from 2 to 3 pm EDT.

Abstract: As the health care industry undergoes significant changes over the next several years, we can anticipate that more physicians will be eager to leave clinical medicine and pursue careers in the biopharma industry. As a result, it becomes critical for biopharma professionals to recruit the best talent and to prepare new physicians for an industry career in pharmaceutical medicine.

This presentation will reveal physician attitudes and career trends that reflect the transition process as physicians consider careers in the biopharma industry. We will also examine results from recent physician surveys and polls to explore myths and misconceptions that are highly prevalent as physicians prepare for a career transition. Finally, we will explore effective strategies that will help physicians will make a smooth and successful transition into the pharmaceutical industry.

Bio Nanotech 2011

Bio Nanotech 2011 is the premier multi-disciplinary community of nanotech advancements from lab to clinic.

Join the 9th annual Bio Nanotech with over 5,000 attendees and 300 exhibitors.

June 13-16, 2011
Boston, MA

Symposia

• Bio Sensors, Diagnostics, Imaging & Instrumentation
• Bio Nano Materials
• Materials for Drug & Gene Delivery
• Nanoparticles in Imaging Technologies
• Cancer Nanotechnology
• Neurology Nanotech
• Nano Medical Sciences
• Micro & Nano Fluidics

MIT Sloan BioInnovations Conference 2011

MIT Sloan BioInnovations Conference 2011
Register today!

The 8th Annual MIT Sloan BioInnovations Conference, taking place on March 4th at 8:30 A.M in the Boston Marriott Cambridge, brings together thought leaders from industry and academia to discuss important topics applicable across the health care industries.

Steve Rusckowski, CEO of Philips Healthcare, and Peter Hecht, CEO of Ironwood Pharmaceuticals will deliver keynote speeches in addition to our panel discussions about the challenges of regulatory uncertainty and R&D productivity as well as the opportunities of next generation technologies and emerging markets. Our panelists come from the top companies across pharma, biotech, medical devices and support services including Pfizer, Genentech, Merck and Genzyme, and innovative emerging firms like SmartCell and AMAG Pharma.

Don't forget to attend BioConference Live today

Today is the second day of BioConference Live. This is an online virtual conference for clinicians and research professionals. Here are some of the educational sessions you'll find today:

Decentralized Molecular Detection of Drug Resistant Organisms - PACE Course 538-103-10
by David Persing M.D. Ph.D.
Cepheid

Point-of-care testing: What is it and why does everyone want it? - PACE Course 538-102-10
by James Nichols Ph.D., DABCC, FACB
Tufts University School of Medicine

Here's some more information about BioConference Live:
* For research scientists, clinicians, doctors, & professionals
* Receive Continuing Education by the American Society for Clinical Laboratory Science
* Questions answered in real-time by industry experts via live videos
* Chat live with peers and speakers
* Browse a virtual exhibit floor for solution providers

Learn more here: http://www.bioconferencelive.com/

MIT Sloan BioInnovations Conference 2010

As an MIT alum, I'm always glad to promote MIT activities. In a few days, the MIT Sloan BioInnovations Conference will take place (March 12, 2010). It's a one-day event that will take place in the Boston Marriott Cambridge Hotel, Kendall Square, Cambridge MA. I really wish I could be there. I also wish I could be a member of the MIT Sloan BioMedical Business Club. Since I'm employed full-time, I can't practically go to HIMSS, the MIT Sloan BioInnovations conference, the MD/MBA conference, the Medical Fusion conference, and still have time for family vacations. My wife and I have been visiting Boston almost every year because we miss MIT so much. We look for every opportunity to visit Boston (and we'll be there in April).  

BioInnovations 2010 is the premier forum for leading thinkers from industry, academia, and government to discuss the next wave of innovations in life science technology, policy, and commercialization.

Learn more here: http://web.mit.edu/bbc/bioinnovations/2010/index.html

Access to great education on iTunes U

If you like to learn, then have you checked out iTunes U? The "U" stands for university and there's a wealth of great educational content that you can access for FREE. Yes, for FREE. Why pay tuition if you can get a free education? (as long as you don't need a diploma for anything)

I've recently downloaded some great business lectures from MIT, Stanford, and Yale. You can also listen to some fascinating lectures on biotechnology, bioengineering, medicine, and biological science. If you're a life-long learner and you have an iPod, then you should take a look at iTunes U. It's a great addition and I'm eager to continue my exploration of all the different educational resources that are freely available for the iPod.

Co-pay support program for patients taking Enbrel (Etanercept)

Amgen and Wyeth Pharmaceuticals have announced the ENBREL Support™ Co-pay Card Program for all eligible patients who take Enbrel (Etanercept). Who's eligible? Well, maybe we should start with those who are not eligible:

This program is not open to uninsured patients or patients receiving prescription reimbursement from federal, state, or government-funded insurance programs (for example, Medicare, Medicaid, etc.) or patients who live in Massachusetts (or where prohibited by law). Restrictions, including monthly maximums, may apply. Offer subject to change or discontinuation without notice.

This co-pay support program may offer:

• 6 months at no co-pay cost, and
• A co-pay of $10 or less per month thereafter (Patients will receive 50% off their co-pay or pay no more than $10 per month—whichever helps more)

The ENBREL Support™ Co-pay Card Program provides patients with up to $750 of assistance per month for months 1-12. For patients with moderate to severe plaque psoriasis who are first starting ENBREL, the program provides up to $1,500 per patient per month for months 1-3. Patient is responsible for costs above these amounts. Participation in the program can be renewed every year.

More than 45,000 people have already used a co-pay card for their ENBREL treatment.
The program is simple for you to share with patients. Direct patients to call 1-888-4ENBREL to enroll today.

Patients who lose their jobs but are covered by private insurance, including COBRA, may receive up to an additional 6 months of ENBREL at no co-pay cost. Potential help for patients who are uninsured or in need of other financial help is also available.

Here are the FDA-approved indications for ENBREL:

• ENBREL is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. ENBREL can be initiated in combination with methotrexate (MTX) or used alone.
• ENBREL is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older.
• ENBREL is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis. ENBREL can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.
• ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
• ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Click here for additional details of the co-pay support program.

Since Enbrel is a TNF blocker, make sure you read this:

• FDA: Cancer Warnings Required for TNF Blockers

FDA: Cancer Warnings Required for TNF Blockers

Here is the latest news from the FDA regarding TNF blockers and the risk of cancer:

FDA: Cancer Warnings Required for TNF Blockers

The U.S. Food and Drug Administration is requiring stronger warnings in the prescribing information for a class of drugs known as TNF blockers. The warnings, which include an updated boxed warning, highlight the increased risk of cancer in children and adolescents who receive these drugs to treat juvenile rheumatoid arthritis, the inflammatory bowel disorder, Crohn’s disease, and other inflammatory diseases.

In addition, the FDA is working with manufacturers to explore new ways to further define the risk of cancer in children and adolescents who use these drugs.

TNF blockers target and neutralize tumor necrosis factor-alpha (TNF-α), a protein that, when overproduced in the body due to chronic inflammatory diseases, can cause inflammation and damage to bones, cartilage and tissue. The drugs in this class include

• Remicade (infliximab),
  
• Enbrel (etancercept),
  
• Humira (adalimumab),
  
• Cimzia (certolizumab pegol) and
  
• Simponi (golimumab).

Today’s action is based on the completion of an investigation first announced by the FDA in June 2008. An analysis of U.S. reports of cancer in children and adolescents treated with TNF-blockers showed an increased risk of cancer, occurring after 30 months of treatment on average. About half of the cancers were lymphomas, a type of cancer involving cells of the immune system. Some of the reported cancers were fatal.

Additional required updates to the prescribing information include incorporation of reports of psoriasis associated with the use of TNF blockers.

Can you list who manufacturers the medications listed above? Eventually, I think we're going to realize that there's an increased risk of cancer with many of the biologic agents that are out there. The irony is that many biologic agents (different classes of drugs with varying mechanisms of actions) are also used to treat cancer. As we learn more about biologic agents, we may eventually complete the cancer circle. The more we understand about what causes cancer, the better we may be able to treat cancer.

The FDA is reviewing safety information on Xolair

The FDA has released an Early Communication about an ongoing safety review of Xolair (omalizumab). This is a biologic agent used for the treatment of asthma. Please note that the FDA is not recommending any changes to the prescribing information for Xolair and is not advising patients to stop taking Xolair at this time.

Here's the early communication from the FDA:

Early Communication about an Ongoing Safety Review of Omalizumab (marketed as Xolair)

FDA is evaluating interim safety findings from an ongoing study of Xolair (omalizumab) that suggests an increased number of cardiovascular and cerebrovascular adverse events in a group of patients using Xolair compared to a group of patients not given the drug (control group).

Xolair is approved for use by adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who test positive for reactivity to a perennial airborne allergen, and whose symptoms are inadequately controlled with inhaled corticosteroids.

The ongoing study, titled Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS), is an observational study of approximately 5000 Xolair treated patients and a control group of approximately 2500 non-Xolair treated patients. The primary objective of the EXCELS study is to assess the long-term safety profile of Xolair in patients followed for 5 years. Study patients are 12 years of age and older with moderate to severe persistent asthma and who have a positive skin test or blood test for an aeroallergen.

The interim data, submitted by the manufacturer of Xolair (Genentech), suggests a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events in patients treated with Xolair compared to the control group of patients not given the drug.

FDA is not recommending any changes to the prescribing information for Xolair and is not advising patients to stop taking Xolair at this time. Until the evaluation of the EXCELS study is completed, healthcare providers and patients should be aware of the risks and benefits described in the prescribing information, as well as the new information from the ongoing EXCELS study that may suggest a risk of cardiovascular and cerebrovascular adverse events.

This early communication is in keeping with FDA’s commitment to inform the public about ongoing safety reviews of drugs. FDA has not made any conclusions regarding these data. The Agency is working with Genentech to obtain further information and will continue to review the strengths and limitations of these interim results. For example, since EXCELS is an observational study, there could be differences in underlying risk factors for cardiovascular and cerebrovascular events between the two study groups. The Agency will communicate any new findings when its analysis of the interim safety data is complete. The EXCELS study is ongoing and final results are not expected until 2012.

The FDA urges both healthcare professionals and patients to report side effects from the use of omalizumab to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this page.

This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing these products. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.

Let's get the word out to healthcare professionals so that we can see what type of data comes in through MedWatch. I believe that we can improve public health by using social media outlets, including blogs, Twitter, RSS feeds, and forums. Click here to view the FDA early communication about Xolair.

Personalized Cancer Treatment

Each person who develops cancer has a unique condition. The world of oncology isn't driven by a cookbook approach (although sometimes it may seem like it). What does it mean to receive personalized cancer treatment? Are we talking about personalized medicine? Genomics? The use of biologic targeted therapies that are designed to combat cancer on the molecular level? The application of nanotechnology to improve drug delivery?

Have you heard of Champions Biotechnology? They've created a new website dedicated to the topic of Personalized Cancer Treatment.

The URL is very simple: PersonalizedCancerTreatment.com
There, you'll find information about:

• Personalized Tumorgraft™
• Personalized Vaccine™
• Personalized Oncology Panel™

Image source: GSBTM

VGX and Swine Flu Vaccines

John Gorge writes in his Philadelphia Business Journal healthcare blog about Joseph Kim. No, not me, but another Joseph Kim. Dr. J. Joseph Kim is the CEO of VGX Pharmaceuticals, a biotechnology company that uses some novel approaches to vaccine development. Dr. Kim also happens to be an MIT alumni, so we do share a few things in common. Like me, he has a strong passion for medical technology. That's what his company is about. He uses electroporation technology to develop DNA-based vaccines and it sounds like they're eager to work on a swine flu vaccine.

It sounds like VGX is merging with Inovio Biomedical Corp. of San Diego and they will operate as VGX.

Bioengineering Mosquitoes to Cure Malaria

I hate mosquitoes. I love to hike and camp, but I hate using bug spray to keep these nasty pests away. Well, scientists are growing, or actually I should say they are bioengineering mosquitoes to create a vaccine against malaria. If the vaccine is successful, then I think we'll have a really serious global population problem on our hands. It may be strange to think that malaria actually controls the world's population in certain areas of the globe. If a vaccine eradicated malaria the same way a vaccine eradicated smallpox, then the who knows what would happen to the world's population. Maybe countries may need to enforce one-child policies that are found in China. Who knows? But this would lead to a very interesting public health ethical dilemma.

Avastin in Early-Stage Colon Cancer Misses Primary Endpoint of DFS

Does Avastin plus chemotherapy improve outcomes in patients with early-stage colon cancer? These types of questions are difficult to answer because the answer depends on what you're measuring as your main outcome. Survival? Disease-free progression? Quality of life? The world of oncology is a complex one with many different measurable outcomes.

The National Surgical Adjuvant Breast and Bowel Project (NSABP) C-08 study did not meet its primary endpoint (which was improved disease-free survival or DFS) with adjuvant use of bevacizumab (Avastin) plus chemotherapy in patients with early-stage colon cancer. Avastin (or bevacizumab) is made by Genentech, Inc. (which is to be acquired by Roche). Who can keep up with all these mergers and acquisitions in the pharma/biotech world?

Interview With a Pharma/Biotech Recruiter

If you've been interested in getting a non-clinical job in pharma (pharmaceuticals) or biotech (biotechnology), you may not know where to begin, especially if you've only been in clinical practice and/or academia. You may have questions that you want to ask, like "How do I break into pharma?"

Well, I have the unique opportunity of interviewing a seasoned pharma/biotech recruiter who has extensive experience working in HR (human resources) at several major pharma/biotech companies. This individual has also interacted heavily with various executive search firms (or head hunters if you prefer) and can provide some practical tips and advice.

I'd like to give you the opportunity to ask your questions to this individual. Please either e-mail me your questions or post them as comments. Once I collect a handful of questions, I will post the responses in a Q&A format.

Ghost writing - a dying practice

The practice of "ghost writing" seems to be dying quickly. Merck is being heavily scrutinized because of everything that happened with Vioxx, and this week, JAMA has published some case studies about this very practice.

What does all this mean for those medical communication companies that develop articles for publication in peer-reviewed journals? Well, for starters, all author information will need to be fully disclosed in every publication. We've started to see this in several journals. Clinicians are listing and acknowledging the names of writers who may be employed by medical communications companies. However, some proponents are arguing that medical communications companies should not even be involved in writing any of the content for these manuscripts. Does this mean that professional medical writers may need to start looking for other opportunities?

The buzzword these days is "transparency." Companies and clinicians must fully disclose all relevant information and be completely transparent. This is happening in the world of CME. Professional education that is CME certified should be fair-balanced, free of bias, and evidence-based. All faculty members who develop or present CME programs are required to fully disclose all affiliations that may potentially influence of bias their message.

Transparency is being taken a step further these days. In a bold move, Lilly began a new CME grant transparency process and started posting data about their CME dollars. People can see how Lilly is spending CME dollars. Take a look at their grant office registry report:

https://www.lillygrantoffice.com/grant_registry.jsp

The buzzword "transparency" will continue to permeate industry. The FDA, the OIG, and all other stakeholders will demand full transparency whenever research is published. Perhaps those ghost writing companies will need to refocus and find other opportunities...

Anticytokine Therapies - confusing names?

Ever get confused with medical terminology? Happens to me all the time. Anticytokine therapies and other biologics are revolutionizing the treatment of some serious diseases. Here's an example of a patient with psoriasis who responded to alefacept.

When you're talking about some of the newer biologic agents, you may find that they're easy to mix up. Here's a helpful guide regarding nomenclature.

Abbreviations placed at the ends of the names convey specific information relating to their structure:

* "-cept" refers to fusion of a receptor to the Fc part of human IgG1
* "-mab" indicates a monoclonal antibody (mAb)
* "-ximab" indicates a chimeric mAb
* "-zumab" indicates a humanized mAb

Etanercept is a classic example of a TNF receptor fusion protein. Infliximab is a chimeric mAb directed against TNF. Certolizumab and tocilizumab are humanized mAbs.