What are some of the encouraging recent developments in clinical validation of immunology biomarkers?

Carrie Brodmerkel, Director of Immunology Biomarkers at Centocor, discusses her experiences in using immunology biomarkers to improve clinical trial results--not just for predicting patient health outcomes but also for patient stratification. Most clinical biomarker applications relate to oncology, so these insights from an immunology perspective will be both novel and highly valuable. Her talk is a direct lead-in to the at-show presentation by Brandon Higgs, Bioinformatics Lead at Medimmune, who will likewise be talking about biomarkers for autoimmune diseases that can be used in clinical trials.  This podcast is presetned to you by the Biomarker Applications For Improved Clinical Trial Outcomes Event, taking place November 15-16 in Boston.  For more on the event, visit the homepage.

Download the podcast here.

This week Dr. Brodmerkel answers this question:

Could you give us your own take on what you think to have been the most encouraging recent developments in clinical validation of immunology biomarkers?

Dr. Brodmerkel: There have been very exciting findings in the last year or two. We are excited about the possibility of predicting response in autoimmune disease. We’ve published data from our studies in ulcers and colitis and we are very active in rheumatoid arthritis, both testing published signatures for replication and deriving level biomarkers in-house in respiratory. Just very recently, we have Genentech’s anti-IL 13, a clinical antibody where they’ve shown they view stratification in the development utilizing PH2 signature and periostin status to stratify their patient. That is something that I think we’ll see more and more of, particularly in respiratory. Similar approaches will have to be used for COPD because it’s such a broad population, but driven by multiple molecular pathways.

These diseases are complex and difficult, but from the data that we’re seeing really in the last year or two, we can now see personalized medicine as something that is going to be a reality.

From both a space of personalized medicine and also your work in particular, what are some of the greatest challenges to progress that you’ve faced?

Dr. Brodmerkel: Top challenge continues to be access to disease tissue. It’s very difficult to ask patients with various diseases for repeat biopsy samples from tissues or to undergo difficult procedures. Really, the only way that you’re going to understand the disease better and find the underlying pathway information that you need is to have enough patient samples to do so. This is true in all disease areas. It’s not unique to immunology. We are looking into ways of pulling resources. How can we cooperate across pharma and academia to accelerate the science? We are also working on new paradigms for data sharing. IP issues are always paramount for industry, but there’s an evolving recognition that cooperation will produce results for everyone.

We are also at a time where data generation can outstrip our capability to analyze and understand the data. So, pooled resources really would help that. An improvement in informatics and data handling technologies are also needed to help push us to that next level of understanding.

Revisiting Social Media Pharma

Partnerships In Clinical Trials 2012 Media Partner goBalto has teamed up with this blog to bring you weekly perspectives on the clinical trials and outsourcing industry. We are very excited to present you with weekly contributions leading up to this year's event.

We are all aware that the Life Sciences industry is focused on increasing /enhancing capabilities related to developing products/solutions that gain market acceptance and achieve successful commercialization.

Here Comes…the Value Proposition of Social Media…Clinical Research Alphabet Soup

Now, imagine that you could possibly reach 535 million people through Twitter, Facebook and/or LinkedIn; this is 7.8% of the world population. If you take this a step further and only count people aged 10-64, one can reach 10% of the globe. Now limit your audience to those born in 2010. A startling 96% of those who were born in 2000 have joined a social network. What if you just wanted to reach people in the US? The US has the highest adoption of social media with 46% of the population. If you then consider the 3.5 billion drugs dispensed per year in the US (11 prescriptions per person per year on average), the social media statistic becomes even more interesting, as it means that by influencing only three channels of social media, it’s theoretically possible to influence your entire target population via social media.

Let’s consider how PepsiCo used social media in increase visibility in 2009 and 2010. In 2009, PepsiCo was “accused” of “Skipping This Year’s Super Bowl” (2009). Yes, PepsiCo, being persistent in social media land, had winning ads in 2010, this time it was “The Best Part” (http://www.crashthesuperbowl.com/#/?finalist=1264). This commercial was made via a social media contest where there was a contest to create the best ad for a Super Bowl commercial. Can you imagine this kind of commercial being created for one of the most important drugs for the last ten years, what about Viagra, Zoloft, or Lipitor? What would the general public create for these drugs? Could depression drugs be socially acceptable? We think so!

With these facts and the opportunity at stake, all interactive marketing should be leveraged to the maximum, especially social media. However, since many articles have come out recently with regards to the risk of using social media in life sciences, many are acutely aware of the risk in engaging an audience in a heavily regulated industry. This lack of engagement/communication is justified. The FDA has issued no clear policy on social media activity, but, yet, has censured usage. The latest news reports the FDA has again postponed the release of its first draft guidance for social media. And, as well are acutely aware, the life sciences industry is highly regulated. This lack of guidance has many pharma companies tiptoeing in the social media space, or avoiding it altogether.

There are many ways valuable ways to safely and effectively use social media to create value for yourself and your organization.

To provide a couple of examples, imagine listening to conversations here:

Or perhaps, what if you established some videos to interact like J&J has:

And just by listening and interacting you can drive awareness:

Companies can gain competitive intelligence and begin to understand how their product is perceived in the marketplace. Moreover, the value proposition becomes very clear when you start to consider the ability to drive awareness and a possibly shape sentiment! And, this is just the beginning.

goBalto is all about harnessing the power of the web. If you like our blog postings and would like to learn more about how goBalto and the Internet can help pharma and more specifically clinical trials feel free to contact us info@gobalto.com.

About the author:

Rosemarie Truman is the President and CEO of RHT Consulting. She has 19 years of global strategy and transformation experience working with C-suites and Boards of Directors as well as senior leadership teams. She has worked for the leading companies in nearly every industry segment. One of Ms. Truman’s specialties is “growth breakthrough innovation” (GBT), where she has three patents pending. A few of the foundational capabilities required in identifying and driving GBTs include strategic marketing, innovative use of digital channels and an understanding of how to grow “share of voice”. As such, Rosemarie has led many integrated digital media strategy engagements that include the creation of viral social media platforms and subsequent execution of campaigns that lead to increased market share. Her engagements have consistently resulted in >200% increase in share of voice which has led to an increase in market share capture of >50%.

Ms. Truman uses her strategy consulting background and GBT experience to conceptualize and implement a new industry-changing framework for life science companies called Industry Leading R&D Performance (ILRDP). Rosemarie is currently working with a range of biopharmas, biotechnology and medical device companies as well as leading technology transfer government and university organizations. Key focus areas include: over arching strategy development, picking the right growth opportunities, creating breakthrough productivity in development, redefining technology transfer paradigms and workforce strategy. Ms. Truman also leads strategic and tactical marketing for a few companies; this includes three social media platforms across 36 channels.

Ms. Truman completed PhD work in Software Engineering from Oxford University. She also earned an Executive “Mini-MBA” Program, sponsored by Booz Allen & Hamilton, with instructors from Harvard Business School and INSEAD, and graduated Magna Cum Laude from Smith College and Princeton University while earning undergraduate degrees in Mathematics, Economics, and Industrial Engineering and Operations Research.

CROACROSMOGCPICHSIVTMOPSVSIQ…Clinical Research Alphabet Soup

Partnerships In Clinical Trials 2012 Media Partner goBalto has teamed up with this blog to bring you weekly perspectives on the clinical trials and outsourcing industry. We are very excited to present you with weekly contributions leading up to this year's event.

CROACROSMOGCPICHSIVTMOPSVSIQ… Clinical Research Alphabet Soup

I remember when I first heard the term: CRO. It was in the early nineties and I was a young Roche rep making a name for himself “carrying a bag” and recruiting research physicians at Mayo Clinic. I had no clue what a CRO was and doubted that it had anything to do with my business. Some ten years later when I started to manage a small Site Management Organization (SMO), I had learned what a CRO was, but to be honest – I did not know what SMO stood for.

A few weeks after starting with the SMO, contract and budget negotiation was passed to me like an unwanted desktop puzzle that befuddled our accountant beyond his tolerance level. I thought to myself, ok – I’ll do some Internet research, get some standard budget parameters, and some background on clinical research contracts and I’ll be good to go. HA!

The alphabet soup of acronyms in the industry of clinical research is enormous and for someone just starting out, acronyms are just the beginning of the quagmire. There is so much to learn, and rules and regulations are in constant flux. Where do you go for help?

From my own personal experience internal mentors did not exist. But what I did find turns out to be one of the reasons I am still in this industry 10 years later. Very characteristic of clinical research industry professionals is a willingness… eagerness, to help others. Perhaps this is because it is truly the case that if we all do better as an industry, we can all do better as individuals (interesting – the reverse is also true!).

Sadly, many companies do not have very robust training programs for the “newbies’ to the industry. Aside from the plethora of industry professionals from every sector that are both knowledgeable and willing to help there are a myriad of other training resources available to the individual.

The following list represents some of the resources we have found useful. It is our hope that this blog will foster others chiming in with their favorite resources as well!


1. All You Need to Know About Clinical Research by Sanjay Gupta:

This is a small reference book that lists lots of the fundamental basics of clinical research. One of its key sections is its extensive glossary of terms including acronyms. Also helpful is it outlines process flow in general terms and bring some clarity to the jungle of documents that are associated with clinical trials.

2. Join a class:

There are numerous on-line and face-to-face educational opportunities at various universities, from individual course work in clinical research to undergrad and graduate degree programs. Check into your company and see if they have any sort of Company University or education reimbursement to help offset your education costs.

3. Have an iPad, iPhone, or an iPod?

Try searching “Clinical Trails” on iTunes. Look at the iTunes-U (this is a free educational Podcast put out by some of the most prestigious institutions in the world) section there is a wealth of resources out there for professionals at all levels. Also look at the Podcast section of the search results you will find some resources there too. You actually don’t even need an iPod view or listen to these Podcasts, just download iTunes and start searching. Or use the iBooks app to download a wealth of information that you can have at your fingertips, literally!

4. 10 Steps to Clinical Study Start-up:

We received so many requests to organize our 10 Steps to Clinical Study Startup blog series into a single document that we did it. If the topic in which you seek more information is related to study startup, this may in fact be a good resource for you, click here.

5. Various industry publications:

Examples: The Monitor, DIA Journal, Applied Clinical Trials, PharmaVoice, CenterWatch

6. One word: Networking.

Try joining industry related groups on Linkedin, also look for conference linkedin groups. Group members share lots of good information, resources and blogs that can help both managers and staff. Also maybe look into local chapters of say, ACRP, DIA, etc. There is a world of groups out there and they are filled with people that like to help.

7. Find Relevant Conferences and Symposiums:

Some examples are: ACRP (Association of Clinical Research Professionals), DIA (Drug Information Association), Partnerships in Clinical Trials, MAGI (Model Agreement Group Initiative), and Site Solutions Summit. There are countless others that are organized by therapeutic focus or industry segments (there are conferences delegated to only study startup, or just to budget negotiation, or just for GCP training, etc.)

You do not have to spend thousands of dollars exhibiting. If you can’t exhibit at a conference of interest, try attending it. Go to the sessions and visit the exhibit hall and determine if next year you want to return. Alternatively, if you can’t go at all – sign up on line to see if you are able to glean something useful or interesting.

8. clinicaltrials.gov

The government website that list all trails that are currently running in the United States. Its great to see what is out there, you can search for similar trials and see what terms are used. The Frequently Asked Question section is great for new staff to get familiar with. Who would of thought that the government would create something so useful!

9. Last but not least, Wikipedia.org

Wikipedia is a good place to find information. Based on the concept where knowledgeable people contribute to topics. The aggregate power of collective knowledge is powerful. We all use it secretly and act like we know everything.

In Closing…

The best resources for how to do a job in clinical trials can be found within your internal team, customers, and vendors. All of these folks have vested interest in your success. If you convey sincere interest and gratitude, a sensitivity for their time, and possibly even an upside for them if they help you – you can do no harm in asking! You will find most folks have an altruistic willingness to help and when that is not the case, their egos will probably drive them to help.

If you have used other resources to help yourself or your team, please share them with us.

To learn more about what we do and how we want to help the clinical study startup please contact Leif (lerickson@gobalto.com) or Dan (dmanak@gobalto.com).

P.S. On the issue of acronyms, I am thinking of starting a new Pink Sheet –

Clinical Research Acronyms Pinksheet …

About the Authors

Dan Manak is the Director of Sales at goBalto and a graduate of the University of Wisconsin – Madison. After earning his bachelor of science degree in Molecular Biology he began his career in pharmaceuticals with Hoffman-La Roche, holding positions in sales, sales management, and training. He has worked in pharmaceuticals, health care, and clinical research for over 20 years with Fortune 100 companies as well as start-ups. For the past seven years he led a small clinical research service organization as the President and Director of Business Development. His expertise and passion exist specifically in the area of clinical study start-up, having worked on several hundred protocols and initiating close to a thousand investigative research sites. In his spare time, Dan is a volunteer EMT and martial artist/Instructor.

Leif Erickson is a Director of Business Development at goBalto. He has over 19 years of experience in the pharma and biotech industries, including 5 years of research at 2 La Jolla based biotech companies and helped start the Diversa Corporation.

Announcing the all new Partnerships in Clinical Trials 2012 Innovative Experience

Global Bio-Pharma Clinical Leaders Call for Industry Transformation at 21st Annual Partnerships in Clinical Trials

Clinical Decision Makers Respond to Radical Change Through Strategic Partnering, Business Model Innovation and Drug Development Reinvention at 2012 Conference

Produced by IIR USA; March 4-7, 2012; Orlando, Florida; Visit www.clinicaltrialpartnerships.com for information or to register.

** ** **
Orlando, FL – October X, 2011 – Clinical development, outsourcing and operations decision makers from the world’s top bio-pharmaceutical and medical device manufacturers and their clinical research partners will meet on March 4-7, 2012 at the 21st Annual Partnerships in Clinical Trials (PCT) conference in Orlando, FL with a renewed mandate for change at a critical point in the industry’s history.

For 20 years, PCT has been committed to enabling clinical research sponsors and CROs optimize strategic partnerships, forge new relationships and find collaborative solutions to perennial challenges.

But according to the conference co-chairs, this year’s program reflects a much more progressive agenda aimed at the productive disruption of conventional clinical research practices.

“The world has dramatically changed, yet this industry still more or less conducts clinical research exactly as it did 20 years ago,” said PCT Co-Chair Deirdre BeVard, Vice President of Development Operations at Endo Pharmaceuticals. “Sponsors and CROs together need to rethink our approach to clinical operations and partnering if we’re to keep up with all of the changes taking place around us.”

Pfizer SVP of Global Development Dr. John Hubbard—also a PCT 2012 co-chair—echoed this sentiment with an urgent warning: “We have to change this industry and we have to change it fast.”

Hubbard observed that the pace of change is rapidly accelerating and the industry is now beset by enormous and increasingly complex challenges that require transformative solutions.
“Business as usual is no longer an option,” said Hubbard. “We need to think beyond best practices to next practices.”

BeVard emphasized that “finding a CRO partner that will engage with the sponsor in the kind of rapid experimentation required to devise more efficient and innovative approaches to advancing clinical development is no easy task. We must break down traditional monitoring, data management and related roles, and make radical changes, not just incremental ones,” she said.

In response, Partnerships in Clinical Trials has introduced an innovation-centric program with an expanded and intensified focus on provocative dialogue, insightful education and purposeful collaboration designed to drive meaningful progress in new directions in clinical research.

Topics include:

• - Translational, personalized and “participatory” medicine
• - Reconciling reimbursement issues with novel pricing and business models
• - Change management, planning and innovation execution
• - Sponsors and CROs strategic alignment to innovate together and significantly improve trial success rates
• - Wall Street and private equity perspectives on the economic outlook of the clinical trials outsourcing Industry
• - Virtual/mobile clinical trial methodologies and technologies
• - New benchmarking approaches to data quality and patient safety
• - Next generation patient recruitment and retention strategies
• - Application of social media in clinical research
• - Disruptive drug development and future trends in clinical research
• - Managing the operations of global trials and capturing new markets
• - Navigating the changing face of regulation—both domestic and international
• - Impact of comparative effectiveness research on drug pipelines, innovation, and patient care
• - Medical device trial outsourcing and operations
• - The future of R&D and how to re-invigorate drug research

Coupled with keynotes from a world-class roster of visionary thought leaders and industry experts, PCT 2012 will feature more than 150 clinical development speakers in over 130 sessions—in a series of case study presentations, panels, summits, interactive exercises and specialized break-out tracks alongside results-oriented, innovative networking opportunities and special invitation-only sessions.
Approximately 2000 attendees representing more than 400 sponsor, CRO and related supplier organizations spanning nearly 50 countries are expected to attend PCT 2012, which promises to be the largest, yet most candid and intimate forum for clinical decision makers in the world.

For more information or to register today, please visit www.clinicaltrialpartnerships.com

ABOUT PARTNERSHIPS IN CLINICAL TRIALS
With an established history of 20 years in the clinical trials outsourcing and operations industry, Partnerships in Clinical Trials is the world’s foremost event series for clinical development leaders and practitioners. Annually, more than 2000 executives representing biopharma sponsors, CROs, and third-party services providers attend Partnerships in Clinical Trial meetings in the US, Latin America, Europe and Asia to network, learn, strategize and advance next practices. Partnerships in Clinical Trials is organized by the Institute for International Research (IIR) and committed to redefining clinical research excellence on a global scale.

ABOUT THE INSTITUTE FOR INTERNATIONAL RESEARCH
The Institute for International Research (IIR) is the world’s largest conference company and has been the leader in the provision of business information for over 25 years. IIR produces over 5,000 events annually through its network of offices in more than 35 countries. For further details, please visit us online at www.iirusa.com

CONTACT:
Danya Burakoff
Program Director, 21st Annual Partnerships in Clinical Trials
dburakoff@iirusa.com
646-895-7337

Biomarker Podcast Exclusive : Carrier Brodmerkel, Director of Immunology Biomarkers at Centocor

Carrie Brodmerkel, Director of Immunology Biomarkers at Centocor, discusses her experiences in using immunology biomarkers to improve clinical trial results--not just for predicting patient health outcomes but also for patient stratification. Most clinical biomarker applications relate to oncology, so these insights from an immunology perspective will be both novel and highly valuable. Her talk is a direct lead-in to the at-show presentation by Brandon Higgs, Bioinformatics Lead at Medimmune, who will likewise be talking about biomarkers for autoimmune diseases that can be used in clinical trials.  This podcast is presetned to you by the Biomarker Applications For Improved Clinical Trial Outcomes Event, taking place November 15-16 in Boston.  For more on the event, visit the homepage.

Download the podcast here.

In this week's portion of the podcast, Carrie was asked: Could you please discuss how your own work on immunology biomarkers may have involved using biomarker indications to stratify participants in clinical trials?

Her answer:
The immunology therapeutic area here at Centocor R&D fundamentally believes that personalized medicine and patient stratification are going to be a cornerstone of future clinical treatment paradigm. To date, the majority of therapeutic interventions in autoimmune and respiratory diseases (which are of interest to us) have targeted broad populations. As evidenced by our successes with Biologics, REMICADE and STELARA, we know that this approach of targeting a broad population has been successful. But going forward, we believe that targeting drugs is going to lead to market improvements and efficacies. So, stratification is essential for this. It is very important in respiratory indications like asthma and COPD. They are heterogeneous diseases. They are driven by multiple pathways with the same clinical manifestation. Our efforts are to understand which pathways are disregulated and test these in clinical trials. So, all of our development programs have a personalized medicine plan.

We currently have several molecules in early development where we are testing novel stratification markers. As these programs are ongoing, we don’t have outcome results today. But, we anticipate exciting data in the very near term. We certainly have examples were stratification markers have allowed us to move from phase one to phase two in development. We are committed to this approach and are expecting success.

Metrics, metrics, come get your metrics! Best served hot and fresh…

Partnerships In Clinical Trials 2012 Media Partner goBalto has teamed up with this blog to bring you weekly perspectives on the clinical trials and outsourcing industry. We are very excited to present you with weekly contributions leading up to this year's event.

Metrics, metrics, come get your metrics! Best served hot and fresh…

Introduction to Metrics

Metrics. The big thing that everyone seems to want these days is metrics and usually a lot of them. They will be able to democratize clinical research and shed a light on what has been in the shadows of gathered data for too long.
Everywhere you go everyone has a bee in their bonnet about not having enough or too much to make sense of. Webster defines metrics as “Standards of measurement by which efficiency, performance, or progress can be measured”. To push this out a bit more, metrics should be easily accessible, readily audit-able and most importantly actionable. Challenges are to take these items and to be able to apply them to improve future performance and/or address past problems.

3 questions to ask on Metrics

Anyone who has spent time in the clinical research knows how much we have all come to depend on metrics. But so often is the case one can get bogged down in to much data flow and how to adequately and efficiently harness this torrent of info. We really should distill it into 3 basic questions:

1. 1. What should we measure?
2. 2. How do we capture the metrics?
3. 3. What do we do with what has been measured?

Well, we sure know what to measure and some examples out of the myriad that can be tracked are;

• - Time to initiate a site
• - Time to complete a trial
• - Time to send contracts/get them back
• - Time for IRB approval
• - Number of contract/budget revisions
• - 1572 revisions
• - Execution of clinical trial agreement
• - # of revisions
• - length of time in sites/sponsors hands
• - Time, time, time, number of, ….

But how often are we really figuring out just how the heck to capture them properly and utilize them to our full advantage? And how often do current CTMS systems measure metrics in the most critical part of the trial, the study start-up (SSU) phase? Answer for both, not often enough if at all. And even more pressing, how much transparency do all involved have during this process? Slim to none at best! In the dark groping around trying to make sense is not the position to be in. (Think of that late night drink of water at grandma’s house. You want to make sure that its the water glass and not the one with her teeth in it…) Especially when most of the time sites and sponsors/CRO need to have the ability to access these metrics in real time. Getting the key documents sent, tracked, and signed off is the heart of the SSU process. Only when all these are in place can the trial start to bring in patients.

I can hear a lot of you saying, “But we capture metrics!”, and I am sure that you do but how many of you capture these in the moment? Over 80% of the industry still uses spreadsheets to convey info to the team members. And sure the one that is entering the data feels like he/she is capturing it in real time, sorry… you’re really not. So the WHEN is already outdated once it is sent out to the team and read by them.

How should Metrics be Captured?

The HOW of metrics are captured is also a critical component in making the most of your metrics. Spreadsheets get very big and cumbersome when you are trying to convey metrics by department, organizations, regionally, by country, across multiple countries and partners. And while this potential kaleidoscope of colors may look real pretty, it takes some time to disseminate the information. How often will this be transparent to all that are on the trial? Not often, someone is always tripping/fumbling in the dark. For the team to work as a cohesive unit and for all to work together to get the trial up and running as rapidly as possible, these metrics must be able to visualized in real-time. Lets face it, while we are in this industry as a business, the goal of all that are involved is to get critical medicine to the vulnerable people that need it. Yesterday in many cases.

Making document exchange communication and management of tasks easier for all involved is the goal of a well made system. To be able to make this simple, efficient and most of transparent is the trifecta. Metrics ultimately is what we all believe will make this happen which is why we all promote them so much. And by giving the teams full transparency to how the study is progressing, where the ball may be being dropped/juggled, and how we can improve the next study will only help to make this part of the trial better and get the study to completion faster.

To learn more about what we do and how we want to help the clinical study startup please contact Leif (lerickson@gobalto.com) or Dan (dmanak@gobalto.com).

About the author

Leif Erickson is a Director of Business Development at goBalto. He has over 19 years of experience in the pharma and biotech industries, including 5 years of research at 2 La Jolla based biotech companies and helped start the Diversa Corporation.

Could CROs double their current market penetration?

As Pharma companies come to see the lack of internal inefficiencies that come from conducting trials through their own organizations worldwide rather than outsourcing to CROs, Ed Silverman at Forbes believes that over time, Pharma companies will realize that going to the experts at the sites to conduct clinical trials will gain popularity. The recent acquisition of Pharmaceutical Product Development by private equity firms Carlyle Group and Hellman & Friedman confirms this.  As it gets more and more expensive to outsource internally, the industry has seen a 90% increase in the budgets for partnering with CROs.  Silverman even suggests that 60-80% market penetration could be in the future.  Today, we've seen the market penetration of 2011 at 38%, up 3% from 2010.

RW Baird analyst Eric Coldwell commented, “Looking ahead several years, we have generally concluded that client R&D budgets will be flattish in total, yet the CRO industry secular market move to higher involvement will continue as clients replace less efficient internal functions with more efficient and cost effective external solutions.”

Partnerships in Clinical Trials is the leading worldwide event for clinical outsourcing and development professionals. Yearly, 2000 Pharma, CROs and other clinical research partners gather under one roof, Partnerships is known for strategic program content that drives business forward and for unparalleled networking. This year, it will take place March 5-7, 2012 in Orlando, Florida.  The 2012 Agenda will be revealed shortly.

Do you agree?  Could market penetration of CROs increase from to as high as 80% at some point in the future? What do you see as the future for CROs?

Biomarker Podcast Exclusive: Carrier Brodmerkel, Director of Immunology Biomarkers at Centocor

Carrie Brodmerkel, Director of Immunology Biomarkers at Centocor, discusses her experiences in using immunology biomarkers to improve clinical trial results--not just for predicting patient health outcomes but also for patient stratification. Most clinical biomarker applications relate to oncology, so these insights from an immunology perspective will be both novel and highly valuable. Her talk is a direct lead-in to the at-show presentation by Brandon Higgs, Bioinformatics Lead at Medimmune, who will likewise be talking about biomarkers for autoimmune diseases that can be used in clinical trials.  This podcast is presetned to you by the Biomarker Applications For Improved Clinical Trial Outcomes Event, taking place November 15-16 in Boston.  For more on the event, visit the homepage.

Download the podcast here.

During the podcast, Carrie was asked:
Could you walk us through how your experiences have been used to modifiy the pipeline of drugs for autoimmune diseases? You mentioned some of the respiratory diseases before, such as asthma and COPD. From a pipeline perspective, what effect has it had?

Dr. Brodmerkel: One area that we focus on quite a bit is molecular profiling. We are utilizing that in several ways. In certain indications, we’ve created molecular phenotypes using molecular profiling to augment traditional clinical implantsand complement what we would normally do to understand mechanism of action of a drug. We anticipate that these molecular phenotypes may be more precise than some of the composite clinical end points that have softer patient-recorded or clinician-report outcome. While these are not currently accepted as surrogates, the data systems with internal decision making allowing us to make a better understanding of the activity of our drug in the disease of interest.

We also use molecular profiling to better understand the disease and what our treatments do and may not do. For example, in works that we’ve done in psoriasis, we’ve identified key pathways which are regulated in response to therapy. But, we’ve also identified genes and pathways which remain disregulated and are not corrected by existing drugs. In this way, understanding what’s not corrected by a clinically efficacious therapy, we want to get novel insights into how the disease develops. Hopefully, that will provide us with new targets and perhaps someday a means to really affect true disease cure.

Finally, we use molecular profiling in other types of information that we develop from patients from clinical trials to understand differentiation early in development. So, if a new product that we have in the pipeline has activity, but it is not superior on a molecular level from existing treatments (either from our pipeline or other products that are on the market), we can use that information to make concrete go/no go decisions for early pipeline products.

52 Perspectives: The “Perfect Storm” (aka the Life Sciences)

Partnerships In Clinical Trials 2012 Media Partner goBalto has teamed up with this blog to bring you weekly perspectives on the clinical trials and outsourcing industry. We are very excited to present you with weekly contributions leading up to this year's event.

52 Perspectives: The “Perfect Storm” (aka the Life Sciences)

Life Sciences, the Last 10 Years in a Recap –
Good or Bad for Shareholders.
The Crystal Ball, What Does the Future Hold?

Product development in the Life Sciences industry is generally a risky business… for every 25,000 compounds tested in the laboratory, 25 will enter clinical trials, 5 will be approved by regulatory authorities, and only 1 is likely to recoup the investment made.

To see how the industry and the risks involved have become so daunting, let’s examine what has occurred over the past 10 years:

a) Lack of Incentive to Invest:

i. Biotech: A cumulative operating income statement over the last 10 years for publically traded biotech companies (excluding Amgen) illustrates a loss on average of 12%

ii. Biopharma: On average, over the last 10 years, large biopharma companies have lost 50% of their market cap (even with the large number of ongoing M&A deals)

b) Herculean Effort Required to Get a Product to Market:

i. Clinical Trials: The number of clinical trials required to get one drug approved has risen by 80-100%, going from 8 clinical trials to 15-16

ii. Product Development Cost: Over the last 10 years, it has nearly doubled, going from $1 billion to $1.8 billion

c) Margin Compression:

i. Growth rates in product demand are largest in China, where a biopharma can only command a fraction of typical prices

ii. Where prices used to be “healthy” in places like the US and the UK, the US healthcare reform has also driven down prices and, in the UK, Pharmaceutical Price Regulation Scheme delivered cuts of 3.9% in 2009, followed by 1.9% in 2010

iii. In addition, health care authorities and payers are seeking significant “real life” value of drugs to justify paying a premium (e.g., they require true differentiation vs. basic efficacy)

iv. Pipeline: For all major biopharmas, with the exception of Amgen, the replacement ratio of new products coming out to those coming off patent is ~50% (“the patent cliff”), indicating possible further compression in revenues (“the patent canyon”)

v. Workforce: Over 300,000 jobs have been lost in the Life Sciences industry since the year 2000; ~235,000 of these jobs have been lost in the last 6 years. In many areas where companies pledged to hire more people in exchange for tax breaks, many like NeuroMetrix Inc. (NSDQ:NURO), GTC Biotherapeutics Inc. and Genzyme Corp. (NSDQ:GENZ) agreed in January 2011 to return $6.6 million in incentives after realizing they could not meet their job creation numbers.

We have all heard of the “perfect storm” in Life Sciences. We believe the above describes a tsunami. When a tsunami occurs, a series of mass disturbances follow. There is a lack of incentive to invest due to a lack of shareholder returns. If investment does occur, it is more cumbersome to develop — R&D continues to lose efficiency as demand from R&D increases, thereby increasing costs. When a product does reach the market, it is difficult to command a premium price to recoup the cost. As a result, the net-net is reduced, the pipelines are smaller, and the workforce is cut. That brings us back to the beginning: the lack of incentive to invest. Even the government has a lack of incentive given the fact that Life Sciences companies are having a difficult time creating jobs.

Does this leave the whole industry to doom and gloom? This isn’t the case everywhere. In China, the environment in the Life Sciences industry is “almost too hot” with not enough people to fill the jobs! A similar phenomena is happening in India where the Life Sciences industry accounts for 82%of the overall revenues of publicly listed companies. Private equity funding of $1 billion went to India as well, but, based on the year over year growth rate of 15% over the next 20 years, this is still $1 billion short and represents only 2.6% of funding that private equity is making in India.

While there is so much more to say, what does all this mean for the industry? Some have hypothesized that there is a need for a revolutionized regulatory framework surrounding patents as well as a need for a framework for clinical trials to enable drugs to get to market faster. Others have suggested that a new paradigm for getting into and conducting clinical trials could help solve the woes of the industry. Or, what if public companies were no longer allowed to develop drugs/medical products to address the same disease area, but, instead, the government created a mechanism for centralizing discovery and development? This would lead biopharma companies, as we know them today, to shift even further by becoming steadfast marketing machines… which leads to a whole new set of risks and regulatory scrutiny.

Stay tuned for our next blog, where we will share our opinion of what lies ahead!

About the Author

Rosemarie Truman is the President and CEO of RHT Consulting, a leading provider of strategy consulting services in the Life Sciences industry. She has 19 years of global strategy and transformation experience working with C-suites and Boards of Directors as well as senior leadership teams. She has worked for the leading companies in nearly every industry segment. One of Ms. Truman’s specialties is “growth breakthrough innovation” (GBT), where she has three patents pending. A few of the foundational capabilities required in identifying and driving GBTs include strategic marketing, innovative use of digital channels and an understanding of how to grow “share of voice.” As such, Ms. Truman has led many integrated digital media strategy engagements that include the creation of viral social media platforms and subsequent execution of campaigns that lead to increased market share. Her engagements have consistently resulted in >200% increase in share of voice, which has led to an increase in market share capture of >50%.

Ms. Truman completed Ph.D. work in Software Engineering from Oxford University. She also earned an Executive “Mini-MBA” Program, sponsored by Booz Allen & Hamilton, with instructors from Harvard Business School and INSEAD, and graduated Magna Cum Laude from Smith College and Princeton University while earning undergraduate degrees in Mathematics, Economics, and Industrial Engineering and Operations Research.

Parterships in Clinical Trials Asia Session Spotlight: AstraZeneca’s Strategic Use of Clinical Biomarker in Developing Oncology Clinical Trial Programs

Each week leading up to Partnerships in Clinical Trials Asia, we'll be highlighting a session from the upcoming conference. It will take place October 12-14, 2011, in Shanghai, China. For more information, visit our webpage to download the brochure. 

Featured Session: AstraZeneca’s Strategic Use of Clinical Biomarker in Developing Oncology Clinical Trial Programs
Featured Speaker:  Fred Zheng, Research Clinical Scientist, AstraZeneca
About the Session: Hear how AstraZeneca is reducing study timelines by using a clinical biomarker strategy to support their clinical trial projects, including
how to:

• • Work with providers and CROs to implement a biomarker strategy on an operational level
• • Collaborate with external groups to provide preclinical and clinical data to support the project
• • Use biomarkers for proof of concept and to prospectively select and recruit patients for a particular trial