Thursday, August 28, 2014

Biobanking: The Last Three Years and the Next Five

When it comes to changes in the biobanking industry over the last few years, a variety of different trends are being observed.  Some have seen an increase in investment in proactive business and strategic planning.  Others have observed the industry beginning to leverage big data.  Sherry Sawyer, Director of the BWH at the BWH / Harvard Cohorts Biorepository, has seen some other changes and projects even more to come over the next five years.

How have you seen the industry change in the last two to three years?

Sherry: This is an industry that is changing a lot and it’s changing a lot every day. It’s really an industry that in the last two to three years has come to the forefront of global awareness, both in the academic science, big government science, as well as the industry science arenas.

biobanking future changes biorepository biobank
What do the next five years have in store for biobanking?
It’s hard to pinpoint specific changes, but I would say that one of the biggest changes that I’ve seen since working in the field of biobanking and biorepository management is really just the increase in communication among different biorepositories, the increase in collaboration among biorepositories and the increase in interest among different biorepository and scientific managers and directors and investigators. Even across institutions to find ways to better standardize the work that they do and to increase the quality of the biospecimens that they are using and to learn more about the “fit for purpose use” for the specimens they have. Or how to better manage data or collect more data or more standardized data sets around biospecimens that would increase their ability to share among different groups and in collaborative environments.

So, I think that some of the biggest changes have to do with this increase in awareness and communication among groups. That’s really something that is relatively new in the biobanking scene in terms of, I would say, three to five years’ worth of time. But, it is really starting to pick up and increase.

Going back to something else you just said. I believe you just mentioned that the industry is changing a lot. So, how do you see the biobanking management industry changing over the next five years?

Sherry: Some of the biggest years that have changed and come on the scene recently have to do with automation. So, there is a huge push to move biorepositories forward in a more automated manner.

So, running a biorepository – especially a large one – is very labor-intensive. It can utilize lots of human labor, which is a point of expense in managing biorepository. It can also be a point of time, right? Humans don’t work 24 hours a day. They can only accomplish so much in a given time period without taking a break. So, there has been this big push to include more and more robotics and robotic-assisted functions in biorepositories all the way from simple robotic solutions like tube labelers and scanners and things like that to some very elaborate robotic solutions for biobanking that have to do with automated freezer units that are really pretty crazily high-tech.

So, I think that the way that management is changing is that more and more biorepository managers are having to move from being people-centric and focused on work flows of people and how to manage teams to accomplish goals for their group to understanding how to incorporate those robotics and automated solutions into their groups. And how to manage the bridge, if you will, between samples that were collected and processed and stored and distributed prior to the introduction of automation and bridging that gap between those previous samples that were done in a more manual way to moving forward in a more automated environment. It’s clear that we’re all going to have to find a way to include some sort of automation in our groups or increase our efficiency in some way so that we can achieve our goal of sharing biospecimens more broadly.

Download Sherry’s full interview here.

You can hear more from Sherry at this year’s Biorepositories and Sample Management conference.  Join us September 8-10 in Boston, MA. Download the agenda to see what else is on tap.

SAVE $100. Register here and use code XP1998BLOG.

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Wednesday, August 27, 2014

Web Seminar: Drug Development in Alzheimer’s Disease: Reasons to Remain Optimistic

In coordination with PRA Health Sciences, ahead of World Alzheimer's Day, we're pleased to announce the following web seminar:

Web Seminar: Drug Development in Alzheimer’s Disease: Reasons to Remain Optimistic
Date: Thursday, September 18, 2014
Time: 10:00 AM - 11:00 AM EDT
Register to join us.
Mention proirity code XP2000W1BLOG

About the web seminar:
US prevalence of Alzheimer’s Disease is currently at 5 million sufferers and is set to triple by 2050. Subsequently, the quest for new symptom and disease modifying treatments is intense. Unfortunately, with more than 100 efforts to develop potential therapies in the past 15 years, only cholinesterase inhibitors and memantine have received marketing authorization, and their value as symptom treatments is considered modest at best. With a projected cost to care for all Alzheimer’s patients by 2050 expected to exceed $1 billion, continued failure to find treatments may not be a financial option, as such an outcome would threaten the sustainability of health insurers including Medicare and Medicaid.

Despite the tremendous number of failures in Alzheimer’s drug development, each of these efforts have been instructive,and there remain close to 100 compounds either in or close to being ready for human testing. The missteps of the past are enlightening some different paths forward, and while the majority of compounds in trials remain focused on the traditional amyloid models of pathophysiology, newer efforts are focused on more upstream pathways, vaccines and gene therapy. Additionally, some of the most exciting possibilities are trials focused on the at risk asymptomatic and mildly symptomatic populations, the work of the Alzheimer’s Prevention Initiative, the DIAN Network, and the funding being provided through the NAPA.

What you will learn:
1) Review of disease state and prevalence
2) Current thinking on pathophysiology and drug targets
3) Drug development review of the most promising compounds
4) Challenges to recruitment and conduct of global AD trials
5) The new focus on Alzheimer’s prevention in clinical trials

Frederick T. Lewis, D.O., Vice President Neurosciences, Scientific Affairs at PRA Health Sciences

Mention proirity code XP2000W1BLOG

PRA Healthsciences is a partner of the Partnerships in Clinical Trials Conference. Partnerships will take place April 22-24, 2015 in Boston. To stay up to date on the latest news about the upcoming event, sign up to receive email updates.

Monday, August 25, 2014

Big Data and Biobanking: The Right Theater For the Right People?

In the year 2014, the idea of big data is not exactly a novel one and as a tool, we’re starting to see that the possibilities may in fact be endless.  These possibilities include uses in the biobanking industry—many of which we’ve only begun to see in the last 18 months.  Mark Collins, speaker at this year’s Biorepository and Sample Management conference, gave us some further insight into how big data is being leveraged in the industry today.

You’ve referred to leveraging the “right theater for the right people at the right time”. So, in 2014 everyone is trying to utilize big data. What do you see as the role of big data and informatics in biobanks and biorepositories?

Mark: Really, there are two aspects to it. One is – like I said – organizations are increasingly widening the network of data that they associate with their sample from electronic medical record data, which you would argue is big data for sure – to next generation sequencing databases to public databases, as well, such as TCGA – The Cancer Genome Atlas. That is sort of an infrastructure use of big data.

Big Data and Biobanking: The Right Theater For the Right People?
The other uses of big data that we are just starting to see really only very recently – only the last 18 months – there is a lot of big data out there in healthcare that is referred to as what is called: “real world evidence”. So, it’s data that is collected not for a specific purpose of answering a specific scientific question. It’s collected in the course of things like patients coming to a hospital or patients visiting a doctor’s office. It’s things like Medicaid and Medicare reimbursement data. It’s prescription information from the UK, for example. That’s a really rich set of data that can be mined to assemble patient profiles to go and prospectively get samples from those kinds of patients. That’s a really exciting way to think about your biobank. Not only is it the sample that it contains today, but by using informatics and big data in this kind of way and because you’ve got your samples already that you have in your biobank highly annotated, if someone comes to you and says: “Hey, we’ve assembled a cohort of people that we want to use for our clinical trial. Do you have any samples from people like that so that we can maybe test out our clinical trial or do a virtual clinical trial on some samples in your biobank before we go out and recruit patients for that profile and bank additional samples?”

So, this is the biobank – again – participating in the science driven by the power of big data. Through big data being analyzed to generate profiles to look for samples in an already existing biobank, as well as annotating the samples as richly as possible with big data where you have it in the biobank that you have today.

You can download the full interview here.

You can hear more from Mark Collins at this year’s Biorepository and Sample Management conference.  Join us September 8-10 in Boston, MA.

Download the agenda to see what else is on tap.

SAVE $100Register here and use code XP1998BLOG.

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Wednesday, August 20, 2014

Is the FDA killing innovation?

In his new book Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances, Dr. Joseph V. Gulfo looks at how the FDA's approval process is affecting the new drugs that could be available in the United States.

Watch his recent interview on Fox Business:

In this interview, Dr. Gulfo states that the FDA looks at every drug as a new potential problem instead of a potential breakthrough.  What do you think?  Do you agree with this statement?

Monday, August 18, 2014

The Changing Biobanking Industry

Recent advancements in technology (and biotechnology) have changed the nature of the way we do business.  The biobanking industry has not been immune to those changes as they field continues to grow.  Lisa Miranda, President and Chief Executive Officer of Biobusiness Consulting Incorporated, sees these changes as falling into three different buckets—Operational, technical and scientific.  Check out what she had to say about the transformation in these areas:  

In your opinion, how has the industry changed in the last two-three years?

Lisa: As a general disclaimer, I should first say that in the time we have today, it would difficult to relay all the ways the industry has changed over the last two-three years. But I can offer a few impressions in the areas I mentioned above.

In the last two-three years, my general impression is that we’ve seen an increased awareness of needs around the challenges I mentioned. I believe the upward trajectory of this field’s growth is partly linked to its demonstrated success in addressing these issues more deeply.

Perhaps it may help to offer some insight into progress on those three buckets I mentioned in the first question.

Operationally, I’ve observed an increased number of biobanks investing in proactive business and strategic planning. In fact, I’ve worked with dozens of biobank clients on these kinds of projects the past seven years. It’s my impression that biobanks are realizing the value of exploring these issues.

Technically, it appears that folks are beginning to realize that quality can no longer be a general construct that they need to prioritize activities around standardization of bioprocessing and sample management to ensure they can deliver quality results.

I am seeing more dissemination of education and training in this area- e.g. workshops, discussion forums, publications, etc. On the ground, Biobankers and vendors are collaborating to utilize technology for optimization of sample management practice.  The biobanking environment is creating ideal conditions for prospective implementation of evidence based practice. We even have our first publicly available evidence based SOP- released by the US NIH/NCI BBRB in April 2014- for frozen tissue (Refer to my blog). All of this is leading to a healthy cross pollination of ideas and harmonization of schools of thought.

Scientifically, we are seeing progress in biospecimen science research-partly in the form of integration of lessons learned from analysis. Biobankers are working on advanced studies evaluating the effects of pre-analytical variation and sample processing techniques on sample quality and quantity. Furthermore, the trickle down benefits and increased knowledgebase is enabling real time application of lessons learned in biospecimen science related projects.  Some biobankers are developing tissue models while, others are working on evaluation of processes, products and technologies and models for method validation. More biobanks are making testing of protocols and conduct of biospecimen science research a priority. Quality control programs (i.e. ISBER Proficiency testing) are helping evaluate and confirm proficiency of samples.

You can download the full interview here

Hear more from Lisa at the 7th Annual Biorepositories and Sample Management conference. Join us September 8-10 in Boston, MA. 

Download the agenda to see what else is on tap.

SAVE $100. Register here and use code XP1998BLOG.

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Challenging Times for India’s CRO Industry

Today, we feature a guest post from Amar Bhat, PhD, President, TwoFour Insight Group. Amar Bhat, PhD, is the President of TwoFour Insight Group, LLC, an information and research advisory service providing western companies with regulatory and policy intelligence about the Indian life sciences market. An expert in international government relations and stakeholder engagement, Dr. Bhat has spent his career focused on global health and biomedical research policy issues while at the Pharmaceutical Research and Manufacturers Association (PhRMA) and the U.S. Department of Health and Human Services.  Dr. Bhat can be reached at

In less then two years, the clinical research industry in India has gone from boom to bust. As recently as early 2012, the country seemingly had positioned itself as an ideal destination for clinical trials for Western companies with all of the key elements in place (e.g., naïve patient population, low-cost skilled labor, etc.). Unfortunately, growth in this burgeoning industry has since come to an almost immediate standstill. The clinical research organization (CRO) industry is still trying to overcome this regulatory stalemate, especially the local (Indian) CRO companies that are heavily dependent on conducting trials in India. On the other hand, the global CRO and life sciences industry are well on their way of placing India at the bottom of their list of clinical trial destinations.

By way of recap, in January 2012, a local non-governmental organization filed a lawsuit in the Supreme Court of India alleging malpractice by the clinical research industry and the Government of India in the conduct and regulation of clinical trials in the country. As a result, the Central drug regulator (CDSCO/DCGI) has been taking steps to increase the regulatory oversight of trials conducted in India, by issuing a slew of new requirements by way of “notices”, “orders”, and “office memorandums” – as recently as July 2014. To the chagrin of industry and academic research institutions such as the U.S. National Institutes of Health (NIH), the new requirements give more pause than comfort in making investments in this industry in India. For example, a recently issued memorandum declared a list of events as automatically attributable to negligence during the conduct of the trial and thus, requiring compensation by the clinical trial sponsor/applicant (e.g., trial drug not having the intended therapeutic effect). This is clearly not any type of assurance for industry that the process has been streamlined with international best practices in mind.

In another example of what sometimes seems as if the government is issuing new rules to appease the Supreme Court without fully thinking through the consequences, CDSCO/DCGI posted a notice of a proposal to create an online portal for clinical trials in India. The preamble of this document indicates that this proposal is designed to enhance the transparency and efficiency in the approval process and oversight of clinical trials taking place in India by creating an IT-enabled “real-time” database with the obligation on industry, including, but not limited to, sponsors, investigators and ethics committees to submit daily information. Not only is this proposal ambitious, but is also very troublesome for industry in terms of the cost required for compliance, uncertainty of the safeguards available for patient information, the potential for premature decisions based on time-limited and incomplete information, and the challenge by sponsors/applicants of ensuring that all stakeholders submit information into the portal that has been properly vetted and uploaded in a timely manner.

A significant amount of information has been provided in these documents issued by CDSCO with the regulator clearly taking considerable liberty in its authority to regulate the industry. Several of these areas will require further clarification/modification and may be counterproductive to revitalizing the clinical trials industry in India. For more on these developments, feel free to monitor our website, where we post regularly on updates in India’s clinical research environment or contact us directly at A list of all our alerts regarding clinical trials can be found here. TwoFour Insight Group, LLC continues to monitor the evolving situation, including, any notices, orders and other documents issued by the Indian government that can have an impact on this industry.

*The services offered by TwoFour Insight Group, LLC are consulting services and are not and should not be considered legal services or legal advice. Neither this communication, nor any proposal nor any contract you may enter into with TwoFour Insight Group, LLC will create any type of attorney-client relationship between the parties.

Wednesday, August 13, 2014

The Data Lives On - Biospecimen Immortality Through Annotation

 Mark Collins, Ph.D, Director of Marketing, BioFortis, Inc

The idea that a specimen can achieve something akin to immortality via annotation is a somewhat radical idea, but one that is gaining interest from the biorepository community. Sample collections are increasingly viewed as dynamic resources to be used, not merely preserved, so while the lifetime of the physical sample may be finite, the data can live much longer with some measure of immortality. Such a concept is of particular interest to those organizations that consider their biorepository to be as much a knowledgebase for future biomedical research as a physical repository of samples. These organizations are establishing “next generation biobanks” where the value of the sample to scientific research is directly related to the richness of the data. However, linking of annotation data to specimens in the next generation biobank is not without challenges, namely;
  • • What annotations to collect?
  • • How best to collect annotations, e.g. vocabularies, ontologies, standards etc?
  • • How to manage consent, security and privacy issues?
  • • How to maximize the benefit of the sample-linked data?
  • • What kind of informatics infrastructure is needed?
At the 2013 IIR Biorepositories meeting I presented on some of these challenges and how to overcome them, judging by the number of views of the presentation on slideshare – it’s a topic that resonates.

At this year’s meeting I will be presenting again, expanding on the topic further. Outlined below are some thoughts on how to respond to the challenges of nnotation with a view to making your samples “immortal”.

What annotations to collect: the rule-of-thumb is to collect as much data about the sample and the donor as possible, especially if samples are being collected for general use. (Figure 1) However, even If samples are being collected as part of a specific trial or research study you still may want to collect as much as possible. It helps to categorize the data into levels;

·         Level I: Operational data
o   Sample identifiers, storage location, collection dates, type, amounts, chain-of-custody, basic donor information, visits etc
·         Level II: Specimen and donor data
o   Sample assay data (basic biochemical and pathology), donor medical history/medical record

·         Level III: ‘Omic data
o   Genomic information (SNP, CNV, NGS etc), proteomics, metabolomics etc, family history, imaging studies (MRI, PET, CAT etc)

By thinking about levels it helps then with the next challenge;

How best to collect annotations: This topic could be a series of blog posts, but in general the use of standard ontologies and vocabularies is critical to ensuring that the data can actually be searched later. Examples of such are SNOMED, ICD-9, OMOP and SPREC codes. Match the ontology/vocabulary needs with the level of data and always try to collect data electronically rather than manual entry of transcribing paper records. There are several ISBER working groups on standards and vocabularies that you should check out.

How to manage consent, security and privacy issues: Again this is a topic for multiple blog posts. Donors are rightly concerned about not just how their sample will be used, but what information will be generated and made available, to whom and for what purpose. This recent article reinforces the need to educate about biobanks, especially for these next generation biobank knowledgebases where consent, privacy and security aspects are front-and-center. There is no consent “magic bullet” here but a clear understanding of allowed use is a must. Consent needs to be dynamically updated to address changing donor consent decisions.  While an extreme example, too many people are aware of the controversy surrounding Helena Lacks, which underpins the concern about potential sample misuse.
With regard to security and privacy, the informatics infrastructure must be able to ensure security (encryption and access permissions); from a privacy perspective systems managing PHI (Personal Health Information) data must comply with regulatory rules (e.g HIPAA and 21CFRPt.11).

How to maximize the benefit of sample linked data: It is expected that the next generation biobank generates scientific insights from the rich annotations. This requires end-user tools that allow anyone with the appropriate permissions to ask questions of the biobank, without having to know about databases or query languages. As far as possible users should be able to self-serve complex questions (Figure 2)

What kind of informatics infrastructure is needed: Powering the next generation biobank requires software that is able to harmonize all sample and sample related data into a secure, flexible and complaint holistic view that allows researchers to use the biobank as a knowledgebase for future biomedical research.

For more information on the idea of sample immortality join BioFortis at the 7th Annual Biorepositories Conference, September 8-10, Boston, MA.

Download the agenda now to see what else is on tap. 

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Tuesday, August 12, 2014

White Paper: The Process of Informed Consent

Today, we feature a White Paper from the Association of Clinical Research Professionals looking at the importance of patients understanding the informed consent process.  As the paper points out, there has been no updates to the original informed consent policy since it was published in 1981.  The professionals participating in the clinical studies should make it their job to work with the patients so that they fully understand the complexities of the clinical trial.

In this white paper, the ACRP lays out the a guidance for the informed consent process.  It looks at: Environment, Assessment of Capacity to Consent, Presentation of the Elements of Informed Consent, Use of a Delayed Consent Procedure, Assessment of the Subject’s Comprehension, Documentation of Informed Consent and Ongoing Consent.

This fall at Partnerships in Clinical Trials Asia, we'll have a morning dedicated to patient recruitment, informed consent and care where we'll have a panel of experts from Cadilia Pharmaceuticals, Pfizer, Jiangsu Hengrui Medicine and The University of Hong Kong on hand to look at the informed consent process to better a patient's experience.  For more information on this session and the rest of the program, download the brochure.  If you'd like to join us in Shanghai, as a reader of this blog, when you register to join us an mention code XP1975BLOG, you can save 15% off the standard rate.

When it comes to the informed consent process for clinical trials, how involved should investigators be in the informed consent process?   And is this the common participation rate you see of investigators in clinical trials?

Monday, August 11, 2014

CluePoints Survey Reveals that Determining the Best Approach is the Industry's Biggest Challenge to Implementing a Risk-Based Monitoring Strategy

A survey by CluePoints, Partnerships in Clinical Trials sponsors and a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, has revealed that 42% of respondents from across the industry consider agreeing the best and most practical approach to be the biggest challenge their organizations are facing in implementing an effective Risk-Based Monitoring (RBM) strategy. While two years ago RBM was not at the top of many minds, today 36% of the 520 survey respondents are currently in the process of evaluating practices, calling for greater awareness of how sponsors and CROs can develop and integrate the approach at a realistic and practical level.

The new survey was developed to gain an understanding of the industry's insights into RBM and how changes to monitoring strategies are being managed at sponsor and CRO level. The research looked at the techniques that are currently available to the market with 59% of those surveyed pointing to the use of Central Statistical Monitoring as contributing major advantages from a usability perspective due to its ability to detect data accuracy and issues earlier, while requiring minimal work from study teams in gaining objective information.

"We carried out this survey to identify how people are managing making RBM a reality in their organizations and what is important to them at the moment. The survey findings have shown that the wealth of information that has been made available to the industry surrounding RBM over recent months has not armed decision makers with a clear understanding of how approaches can be practically implemented", comments Franҫois Torche, CEO of CluePoints. "Our CSM solutions have been developed to make implementing adaptive monitoring as straightforward as possible and simplify the transition for users. The new findings give insight into the needs of the industry and we are currently working with a wide range of sponsors and CROs to demonstrate how these new solutions can be pragmatically and straightforwardly included in their research designs."

The survey was conducted online as part of CluePoints' most recent addition to its 2014 webinar series, entitled 'Risk-Based Monitoring – What we’ve learnt in a year, a Large Pharma Perspective from Sanofi'. Download the webinar here.

For further information on CluePoints' solutions, please visit

About CluePoints
CluePoints® is a Central Statistical Monitoring solution that has been designed and perfected over the last 10 years. It employs unique statistical algorithms to determine the quality, accuracy and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA and EMA, CluePoints® is deployed to support traditional on-site monitoring and to drive a risk-based monitoring strategy. The value of using CluePoints® lies in its powerful and timely ability to identify anomalous data and site errors allowing improvement in clinical data quality, optimization of on-site monitoring and a significant reduction in overall regulatory submission risk.

Friday, August 8, 2014

Clinical trial recruitment leans on effective communication with the patient

Recently, Bret S. Stetka, MD sat down with Claire C. Meunier to look in-depth at how the disconnect in communication between patients and clinical trials participation is having an effect on the number of patients who are enrolling. Meunier, the Vice President of Research Engagement for The Michael J. Fox Foundation for Parkinson's Research Patients, shares that patients will participate, but aren't getting enough to get information upfront to join. Meunier thinks that three things could improve participation in clinical trials for the patients: awareness, education and actionable steps. Share with them that the clinical trials need patients and keep them informed of as to the progress of each trial.

Each trial will have a different spectrum of patients - so it is important to update the clinical trial recruitment strategy for each trial. Meuiner points out that if the patients feel empowered, educated and updated, they will return because of their positive first experience.  To find out more about her insights on engaging patients in clinical trials, read Meunier's full interview at Medscape.

This fall in Shanghai at Partnerships in Clinical Trials Asia, Yanping Zheng, Director, Clinical Affairs/Medical Monitor, Mallinckrodt Pharmaceuticals, USA, will be joining us to look at developing patient recruitment plans that will work to recruit patients in the Asia Pacific region - including overcoming the cultural barrier.  For more information on this session and the rest of the program, download the agenda.  If you'd like to join us September 22-24 in Shanghai, as a reader of this blog, when you register to join us and mention code XP1975BLOG, you can save 15% off the standard rate.

What do you think is the first step to overcoming the communication disconnect with patients in clinical trials?

Thursday, August 7, 2014

#BiorepIIR Speaker Line-up: NIH, BMS, Harvard and More

With so much going on in the biobanking field, how do you keep up with the latest advancements? With the perfect mix of networking and industry insights, we invite you to attend IIR’s 7th Annual Biorepositories and Sample Management conference taking place September 8-10 in Boston.

Explore key topics in quality-driven biobanking:

• Next-Gen Sequencing. Enrich quality control and sample integrity with case study insights into sample storage, building a multidisciplinary biorepository and core molecular laboratory quality program, performance metrics and more

• Informed Consent. Drive positive patient outcomes through an understanding of new regulatory, global and ethical updates through a new hands-on workshop

• Increase Your Global Footprint. Overcome country specific collection, reporting, and return requirements. Plus, get a look into setting up a biorepository in Latin America presented by Baylor College of Medicine

• Collaboration for Sample Quality. Case study insights from Pfizer, GlaxoSmithKline, Takeda to optimize your in-house and outsourced operations and minimize costs

• Management of Biosample Data. Take a deep dive into new technology and innovative sample management projects presented by GlaxoSmithKline, AstraZeneca, and Bristol-Myers Squibb

Gain critical knowledge and in-depth case insights from pharma, biotech, government and academic leaders:

- Simona Volpi, PharmD, PhD, Program Director, National Human Genome Research Institute/NIH
- Jonathan Yingling, PhD, Vice President, Oncology Discovery & Translational Research, Disease Sciences and Biologics, Bristol-Myers Squibb
- Melissa Rawley-Payne, BioBank Lead, Pfizer
- Sherilyn J. Sawyer, PhD, Scientific Director, BWH/Harvard Cohorts Biorepository
- Jeffrey M. Otto, PhD, MBA, National Director, CHI’s Institute for Research and Innovation

Download the agenda now to see what else is on tap.

Reminder: You can SAVE $100 as a reader of this blog. Register here and use code XP1998BLOG.

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Wednesday, August 6, 2014

India aims to move clinical trial approval process online

The shift to digital approval for clinical trials is in the future for India.  According to the Economic Times, unique ID numbers will be assigned where a running track of updates, personal details for the patients, a log of adverse effects and more will be recorded and regularly updated.  One major concern of a project like this is the safety of the patient information - which would now be available in a digital format.

India, along with Vietnam, Malaysia and Nigeria will be joining us at Partnerships in Clinical Trials Asia to review regulatory standards across countries during the panel Global Regulatory Updates for Clinical Trials.  In this panel, countries will review regulatory updates and developments, ethical and cultural diversity issues, changing regulations and localizing protocols for the different markets.  Find out more about this sessions and the rest of the program by downloading the brochure.  If you'd like to join us this September 16-18 in Shanghai, as a reader of this blog, when you register to join us and mention code XP1975BLOG, you can save 15% off the standard rate.

Monday, August 4, 2014

How do you ensure clinical data safety in the cloud?

We recently had a chance to sit down with Partnerships in Medical Device Clinical Trials partner company Clinovo to discuss some of the benefits of cloud computing for clinical trials.  Over the next few weeks, we'll examine our interview with Marc Desgrousilliers, the Chief Technology Officer of Clinovo.

Today, he answers the question:
How do you ensure clinical data safety in the cloud?

 That’s a very good question. There is a lot of hesitation and fear due to this topic because the FDA’s 21 CFR Part 11 regulation requires clinical data to be secure and private. Sponsors must audit the cloud solution provider to make sure that it has documented operational controls around data security.

For example, sponsors need to find out how, and where, the clinical data is stored. Is it encrypted on the way to the storage system? Is it encrypted at rest while the data is stored? Can it be accessed either locally in the data center or remotely on the cloud? You also have to have service level agreements with your cloud provider around your contract, but also when your contract terminates. What happens to the clinical data? How does it get destroyed? How can you ensure that no one has access to the part of the disc where the data is stored?

Another recommendation is to audit the sponsor and evaluate if it is SSAE 16 compliant. SSAE is a new standard in terms of operational controls that is replacing SAS 70. It’s also a good idea to see if they can show you their Type I, Type II report with a test of the controls that are in place to see if they are appropriately designed and can effectively protect the data against a security breach.

You can download the audio and PDF to Marc's entire interview here.

Thursday, July 31, 2014

Take the "Work" out of Networking at PCT Asia this Fall

Taking place September 16-18th at the Sheraton Shanghai Hongquio, Partnerships in Clinical Trials Asia, is the perfect mix of NEW content on the evolving landscape of clinical partnerships PLUS more networking opportunities than ever before!

We guarantee that you'll do more business in 3 days than in the rest of the year by:
  • • Networking with 150+ clinical decision makers
  • • Maximizing your engagement via speed networking, open roundtable discussions and VIP luncheon opportunities
  • • Exclusive access to the partnering360 networking tool that enables you to pre-plan the event, identify and schedule meetings with potential partners, and foster deeper delegate engagement 
Partake in Open Dialogue on the Industry's Hot Topics via Round Table Discussions:
  • • Regulatory Challenges for Clinical Trial Material Importation and Exportation
    • o Jin Shun, Head of Regulatory Affairs, Asia, Takeda Development Center Asia, Singapore and Takeda Development Center Shanhai, China
  • • Reducing Employee Turnover - What are the Incentives that Work Best?
    • o Christina Bodurow, Senior Director, External Sourcing, Eli Lilly & Co., USA
  • • How to Conduct Medical Device Clinical Trials in China
    • o Jimmy Lu, Senior Clinical Specialist, Roche Diagnostics, China
  • • Downstream Implications of Poor Data Collection
    • o Ed Jones, Global Head, Strategic Resourcing, Statistical Programming and Analysis (PDBP), F. Hoffman-La Roche and Genentech, USA
Download the brochure for the full program and speaker details.

Tuesday, July 29, 2014

Understanding culture and goals key to success in conducting clinical trials in Asia

This past April at Partnerships in Clinical Trials, speaker Patrecia Flynn Valone, Senior Director, Development Operations, Takeda took a few minutes to share some of her insights.  During our exclusive interview, Patrecia identifies many of the touch points that are critical in engaging and successfully conducting clinical trials in the Asia Pacific region.  She stresses at the beginning of the interview that it's important to recognize and embrace the fact that the region has many different cultures and is very diverse.  China is very different from Australia, Japan is very different from Malaysia.  This diversity is also important to embrace when looking at working with a CRO.  What is your strategy in the region?  Will a global, regional or local CRO suit your needs the best?

Watch the full interview here:

Patrecia Flynn Valone will be joining us this September at Partnerships in Clinical Trials Asia for the presentation How Does Risk-Based Quality Management Reduce Cost & Time of Clinical Trials? this September along with these clinical trial professionals Matthias Boedding, Global Safety Leader, Pharmacovigilance & Risk Management, Bayer Healthcare, China and Cheong Guan Leong, Regional Manager, Clinical Development Quality Assurance,Glaxosmithkline, Singapore. For more information on this session and the rest of the program, download the agenda. If you'd like to join us this September in Shanghai, as a reader of this blog, when you register to join us and mention code XP1975BLOG, you can save 20% off the standard rate.

Monday, July 28, 2014

Will the cloud make it easier to run clinical trials on mobile phones, tablets, and laptops anywhere at any time?

We recently had a chance to sit down with Partnerships in Medical Device Clinical Trials partner company Clinovo to discuss some of the benefits of cloud computing for clinical trials.  Over the next few weeks, we'll examine our interview with Marc Desgrousilliers, the Chief Technology Officer of Clinovo.

Today, he answers the question:
Will the cloud make it easier to run clinical trials on mobile phones, tablets, and laptops anywhere at any time?
Clinical teams should be able to enter clinical data directly via iPads and tablets. These devices are now natural for doctors and nurses to use. The Cloud enables user-interface services that are device-specific. Cloud architecture is built on what is called SOA (Service-Oriented Architecture) and a ‘service’ is a generic term for a set of processing functions. One of these functions could be to display the data on an iPhone and another one could be to display it on an Android. As new devices are added, we could deploy new services to display data on these devices. The same data can be seen on either a desktop or laptop, or any type of mobile device.

This being said, the real challenge for clinical trials is not technology. Cloud technology can handle different devices. The challenge is to validate the mobile devices used in the trials. eClinical system providers will need to decide which devices are going to be supported, as validation is costly and time-consuming.

You can download the audio and PDF to Marc's entire interview here.

Friday, July 25, 2014

Know when your clinical trial patients are right for social media

Recently, Partnerships in Clinical Trials partners BBK Worldwide took an in-depth look at understanding when using social media for your clinical trial studies was the right thing to do.  Of all the adults today, 75% of all adults use the internet to find out information about their health.  So is social media one of the right tools to use for your clinical trial?

BBK Worldwide shares the challenges regulatory, time and content that need to be carefully consider when using social media in your clinical trial.  Everything communicated with patients via social media must be carefully though out so that it still and reviewed by the right boards.  So the right person must be the face of the clinical trial social media who understands how to both interact with the patients and maintain the standards of the clinical trial.  In terms of time, social media must have the right amount of time allocated to its execution.  And finally, the third important component of effectively using social media for clinical trials is to have the appropriate amount of content.  A balance of informative content along with your message must be maintained.

Of the three challenges BBK Worldwide, what is the most challenging for you when it comes to social media and clinical trials? Regulatory concerns, the time requirement, or the challenge of content creation?

Wednesday, July 23, 2014

What are the top three benefits of cloud computing for clinical trials?

We recently had a chance to sit down with Partnerships in Medical Device Clinical Trials partner company Clinovo to discuss some of the benefits of cloud computing for clinical trials.  Over the next few weeks, we'll examine our interview with Marc Desgrousilliers, the Chief Technology Officer of Clinovo.

Today, he answers the question:
In your opinion, what are the top three benefits of cloud computing for clinical trials?

Marc: The first one is self-service which is essentially the removal of IT dependency. IT can sometimes be slow to respond to new business requirements seeing that they spend 70% of their budget in maintaining current systems and applications. In addition, contracting professional IT services is very expensive. In the Cloud, clinical trial professionals are able to run their own studies without any IT intervention, nor high upfront investment. They are completely independent of IT to in conducting their own clinical studies.

The next benefit is pay-as-you-go. Today, the EDC vendor, or whoever is providing hosting services, charges you for development, customization, and study build. When the EDC system goes live, it is often the case that there aren’t any subjects yet enrolled in the study. A sponsor could be paying thousands of dollars per month while subjects are slowly being enrolled. With the Cloud, sponsors pay for what they use when they use it. If you don’t have any subjects enrolled yet, you don’t pay. I believe this will go a very long way to cutting R&D costs.

The third advantage is elasticity because with the cloud you aren’t required to keep buying and deploying your hardware and resources for every clinical trial. The cost of managing this hardware is very expensive and so the question is, what happens to this hardware when the trial is done? You probably want to re-purpose this hardware, but by the time your clinical study is over, technology will have evolved: CPUs are faster, the discs are denser and the networks are faster. When the clinical trial is over, you are either stuck with this dated equipment, or forced to purchase expensive new hardware for your new clinical trials.

If you compare this to the cloud approach, the first major difference is that you don’t need to buy the hardware. This is a huge benefit, especially for start-ups because there is no need for high capital expenditure. Also, you aren’t required to purchase extra resources for your increased demand. If you do need to add additional computing resources, the Cloud infrastructure will automatically allocate said resources. When demand shrinks, resources are automatically deallocated.

This is similar to managing a corporate car fleet. Suppose your company has five employees each working in five different territories and it gives a car to each of them to cover said territory. The company has the choice to either buy the cars, or rent them. Renting the cars is very similar to the Cloud approach. For example, if your company grows to 50 sales reps, a rental company can automatically increase the number of cars you need, you don’t have to buy 50 more cars. Also, if for some reason your sales force shrinks to 20, you can simply release those cars. Elasticity is key in order to grow and shrink the computing resources as demand requires.

You can download the audio and PDF to Marc's entire interview here.

Monday, July 21, 2014

Integrating Sample Inventory and Bioprocessing Data: Collaborative Technology Solutions

This post was contributed by Lori Ball, COO, BioStorage Technologies

With an increasing amount of biomaterials collected and stored for research initiatives around the world, cataloging, tracking and ensuring chain-of-custody of these scientific assets and their associated data have become paramount to optimizing sample utility for prospective research and retrospective analysis.

Advanced technology and data virtualization can be an enabler for driving sample optimization by bridging sample data across multiple platforms. Specifically, sample management inventory databases can support the compilation and analysis of genetic and clinical data on an unprecedented scale, leading to improved sample selection and optimization in research.   

As an example, BioStorage Technologies began a collaborative partnership with one of the largest biopharmaceutical companies in the world to create a custom data management solution that integrated sample inventory data with bioprocessing data to support biomarker development.  The company’s ISISS® (IntelligentSpecimen Inventory Storage System) was leveraged by the biopharmaceutical client and expanded to support the collection and connectivity of sample inventory data with bioprocessing data. The resulting technology solution provided the research company with customized user access controls, sophisticated search functions, reporting formats, and specific tracking features.

Technology experts within the biopharmaceutical company utilized their existing systems expertise to guide the design process for this customized solution.  The development of the integrated technology solution was achieved through an innovative BioProcessing Solutions Alliance between BioStorage Technologies and RUCDR Infinite Biologics.  This alliance enabled genotype data elements and other bioprocessing data generated by the biopharmaceutical company at RUCDR Infinite Biologics to be integrated and stored with sample inventory data already being held in ISISS®. 

Integration of sample inventory and bioprocessing data through the use of innovative technologies represents an opportunity to improve the selection and maximize the utility of high quality samples in order to achieve research efficiencies and support biomarker research. The ultimate goal of leveraging technology within research is to improve decision-making and advance new therapies to the market faster.

Learn more about this collaborative case study at IIR’s upcoming Biorepositories and Sample Management Conference where we will further explore the methods and best practices used during the development of this innovative sample management technology solution:

How to Use Technology to Drive Quality: Insights into an Innovative Sample Management Project
September 9th 10:15-10:45am
Lori Ball, Chief Operating Officer, BioStorage Technologies
Phil Waters, Data and Informatics Specialist, Genetics Sample Management, GlaxoSmithKline

Want to learn more about the Biorepositories and Sample Management ConferenceDownload the agenda to see what’s on tap. 

SAVE $100 as a reader of this blog. Register here and use code XP1998BLOG.

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Friday, July 18, 2014

Who can you meet this year at Partnerships in Clinical Trials Asia?

The 6th Annual Partnerships in Clinical Trials Asia at the Sheraton Shanghai Hongqiao, China on 16-18 September 2014 addresses the partnership opportunities in Asia, the critical challenges faced and solutions to ensure the success of Clinical Trials and partnerships in Asia. 150+ attendees from 10+ countries attend this annual conference to network, partner and hear real-world insights from thought leaders from leading pharmaceutical and biotech organizations.

Do more business in 3 days than in the rest of the year by networking with 150+ clinical decision makers. PLUS! Maximize your engagement via speed networking, open roundtable discussions and VIP luncheon opportunities Partner, Network & Learn from Decision Makers from Attending Companies, including:

Allergan Biologics * Asia Training Consortium * Aslan Pharmaceutical * Astrazeneca * Baxter * Bayer Healthcare * Beigene * Beijing Jingwei Chuanqi Medicine Services Co Ltd * Boehringer Ingelheim * Cadila Pharmaceuticals * CLS Communication Shanghai Co Ltd * Covidien * Eli Lilly * F. Hoffmann-La Roche Ltd * Food & Drug Administration * Glaxosmithkline * Gorege Clinical * GSK China Investment * Hinova Pharmaceuticals * Inje University Busan Paik Hospital Clinical Trial Center * Jiangsu Hengrui Medicine * Johnson & Johnson China * King Saud University * Lundbeck * Mallinckrodt Pharmaceuticals * Mebiopharm * Merck * Ministry of Health * National Agency for Food and Drug Administration & Control (NAFDAC) * Otsuka Pharmaceuticals * Oxford University Clinical Research Unit * Peking University People's Hospital * Pfizer * Pfizer R&D Center * Proswell Medical Company * Roche * Roche Diagnostics * Sanofi * School of Medicine, Tsinghua University * Takeda Development Center Asia * The University of Hong Kong * United Therapeutics * VDDI Pharmaceuticals * Wanbang Biopharmaceuticals * WuXiPRA

Want to meet representatives from these companies and more? Register to join us. And don’t forget that as a reader of this blog, you can save 20% off the standard rate when you register to join us and mention code XP1975LINK.

Have any questions about the event or want to get involved? Feel free to email Jennifer Pereira.

Thursday, July 17, 2014

Partnerships Asia Session Spotlight: Clinical Trial Design and Compliance – Medical Devices vs. Pharmaceuticals

In 2011 in the United States alone, there was between $95 and $105 billion spent on medical devices.  This is a significant amount of the $200 billion that was spent worldwide on these devices according to  How are medical devices defined in the United States?
  • - Diagnoses, cures, lessens, treats, or prevents disease
  • - Affects the function or structure of the body
  • - Does not achieve primary intended purposes through chemical action
However, regulations across different countries present different rules and regulations for clinical trials across the world.  This September at Partnerships in Clinical Trials Asia, we'll be looking at how these devices are defined and conducted in Asia.

Featured Presentation: Clinical Trial Design and Compliance – Medical Devices vs. Pharmaceuticals
Featured Presenter: Timothy Low, Vice President, Medical Affairs Asia Pacific, Covidien, Singapore
About the session: 
  • - Examining the differences between medical device and pharmaceutical trials
  • - What are the medical device trial design considerations?
  • - Compliance – GCP vs. ISO14155
Partnerships in Clinical Trials Asia will take place this September 16-18 in Shanghai, China.  For more information on this session, download the agenda.  As a reader of this blog, when you register to join us and mention code XP1975BLOG, you'll save 20% off the standard rate.

Wednesday, July 16, 2014

Early Stage Clinical Trials

The most complete study of clinical success rates may be even lower than previous estimates. According to a report from Nature Publishing Group, Hay and colleagues conducted a detailed analysis of phase transitions of 4,451 drugs with 7,372 independent clinical development paths from 2003 to 2011. The successful transition rate from Phase I to Phase II was 60% in the period of 1991–2000. Only 32% of the drug successfully made the transition from Phase II to Phase III. On average, the likelihood of reaching FDA approval (LOA) from Phase I was about 10%. Thus, the Contract Research Organizations (CROs) outsourcing services market has witnessed significant growth in the past decade. This growth has been attributed to the rising costs involved in conducting various phases of clinical trials ranging from drug discovery up to post-marketing approvals. 

This fall at Partnerships in Clinical Trials Asia, we'll gather a group of experts including Duanghatai Chirapathomsakul, Associate Director Global Clinical Quality Assurance, Lundbeck from Thailand and John Gong, Senior Vice President, Clinical Operations, Beigene of China to participate in the panel discussion Quality Driven Drug Development in the Asia Pacific Region to talk about bringing drugs from discovery and through the clinical trial phases.  For more information on this session, download the agenda.  If you'd like to meet and network with these panelists this September 22-24 in Shanghai, as a reader of this blog, you can save 20% off the standard rate when you register to join us.