Tuesday, November 18, 2014

Web Seminar: Global Rise of Chronic and Age related Diseases: Trends in Clinical Development Globally

Global Rise of Chronic and Age related Diseases: Trends in Clinical Development Globally
Presenter: Laura Runkel, Associate Director of CNS, 
Autoimmune/Inflammation & Ophthalmology, Citeline
Join us for a webinar on Dec 17, 2014 at 2:00 PM EST.
Register now!
Mention priority code XP2000W3BLOG

About the web seminar:
Chronic and age related diseases are on the rise globally. Given the demographics of an aging population and life style changes in the high income countries, this marked rise in chronic diseases is projected to continue into the future. Clinical trial activity in these diseases has increased globally as treatments are sought to address the substantial unmet need. Case studies for drug and clinical trial activity in two serious diseases, chronic obstructive pulmonary disease (COPD) and Alzheimer’s disease, will profile the current therapeutic landscape to gain key insights into successful programs and to gauge future prospects.

Several novel fixed-dose combination (FDC) therapies were approved in 2013 for COPD maintenance therapy. The analysis of study design and timelines provides a current snapshot of the COPD landscape and a look at the future for pipeline FDC competitors still in development. Standard of care for Alzheimer’s disease includes cognition enhancing drugs that provide limited symptom relief and have no impact on disease progression. Hope for a treatment that halts or slows the progression of Alzheimer’s disease lies with the development of disease modifying therapeutics. The early clinical disappointments for beta amyloid antagonists have created an opportunity to improve clinical trial design and AD diagnosis. A paradigm shift is reflected in current AD clinical trial design by top industry sponsors.

What you will learn:
  • • The utility of Citeline’s integrated drugs, trials and timelines solutions for analysis of clinical development status/trends
  • • Key insights into the success of COPD FDC clinical programs
  • • The current competitive landscape for pipeline FDCs in COPD
  • • How treatment of earlier stage Alzheimer’s disease is occurring for disease modifying drugs
  • • What are the top industry sponsors, drugs, and clinical timelines for pipeline Alzheimer’s disease therapies

This web seminar is produced in coordination with Partnerships in Clinical Trials. 

Wednesday, November 5, 2014

Steps towards Risk Based Montioring

In the November 2014 International Clinical Trials Journal, Andrew Newbigging, the Senior Vice President of Research and Development at Medidtat outlined many of the elements of risk based monitoring, how traditional procedures are holding things back and how the new, updated approach can bring costs down on a monitoring budget.

To get a RBM project started, Newbigging outlined these steps:

  • 1) Identify attributes of a clnical protocol
  • 2) Identify key risk areas
  • 3) Categorize risks into an Integrated Quality Risk Management Plan

After these things are set into play, a trial can then be monitored by both operational data and and trial data.  KRIs can then allow the monitors to identify the risks of each trial and change them from afar.  By using RBMs and the three criteria above, fewer sight visits will have to be made and will reduce the over all cost of site monitoring.  It will also improve the quality and security of the projects in the long run.

Read the full article here.  Do you feel that the high cost of implementation for risk based monitoring will be outweighed by the benefits that central monitoring brings to a clinical trial?

This April at Partnerships in Clinical Trials, we will have the full day working group dedicated to Risk-Based Study Management.  For more information and a preview of this study, download the agenda.  As a reader of this blog, when you register to join us and mention code XP2000BLOG, you can save $100 off the current rate.

Tuesday, November 4, 2014

Optimizing clinical trials for better outcomes and best use of available funding

This week, our partner conference Bio-EUROPE®, is taking place in Frankfurt, Germany.  We had the chance to sit in on a few sessions including "Optimizing your clinical trials for better outcomes and best use of available funding." Quintiles hosted the panel and shared how they are able to help many small an midsized biotech companies maximize the clinical trials they are conducting on their molecules.

Josh Rose, the Vice President of Enterprise Offering Development shared perspective on how small and midsized biotechs can get the most out of their clinical trials after securing investment.

A few factors to consider include:
  • - The data and technology being leveraged to optimized the clinical planning and protocol well before the trail begins. 
  • - On a global basis, what are sites – do they have capacity to match your needs? 
  • - Do they have the right markets? Another key for data usage is to figure out if your patients are there. 
  • - Consider cost at the site level. Line item cost have a significant impact on the cost of the trial. These things can lead to great savings. With this knowledge from data you can save.
Rose also spent time discussing some of the trial initiatives that are being adopted by the industry to increase efficiency and save costs.
  • Utilities of adaptive trail design: There are so many great technologies that have a big impact in improving probability of success. Examples include:
    • 1) Adaptive dosing: Find the optimal dose 
    • 2) Sample re-estimating: Find arms that aren’t as beneficial – terminate those 
    • 3) Sample enrichment – Modify trial to move patients towards promising areas 
    • 4) Adaptive biomarker strategy: You may have 5 biomarkers that you think are benefitial but what is really working? 
    • Benefits of this strategy include: Early termination if the trial is not producing results, testing for the optimal dose, identifying and narrowing in on the correct sample size

  • Risk based monitoring: Changing the way data is used by the sponsors
    •  Only a small percentage – 2% – of data is incorrect after being collected. RBM would allow trial sponsors to rethink data collection.
      • - Sponsors could identify risks and develop a plan to only look at data where the risk is. Real time monitoring of trial and look for red flags in data t respond to in real time. Move from data varificaiton to lower levels. This drives 25% reduction in cost on average – quality also improves. 
      • - Potential drawback to effectivly using this applicaiton in clinical trials include the right mindset, tools and methodology at the beginning are critical.
Brad Smith, the Vice President of  Translational Medicine at the Center for Integrated Drug Development for Quintiles discussed finding the right number and the correct patients and the right number of them for clinical trials.  He suggested addressing standard of care and look at tools to to reach desired endpoints - including how the trial is run in the first place. Screening patients is one method that can be used - identify patients through screening can lead to the right patients on the studies. Registries are another great way to identify patients.

 Christoph Schnorr, the Vice President of Drug Development Consulting in Europe briefly discussed integrating payor perspectives.  It's important to understand that delivering the best treatment options to patients also means understanding the needs of stakeholders across the entire clinical trial chain - including payors. Increasing the value of the asset means thinking about physicians and patients. Integrate those persepctives in the product development model and how data ans aspects of the trial can generate the evidence needed to promote these goals. He also pointed out that treatment paradigms are changing quickly. It’s extremely important to know what compounds are coming to the market so a company prepare for and understand the design and landscape of the field when molecules are scheduled to hit the market.

Monday, November 3, 2014

Ebola Clinical Trials: Why now is the time to conduct them properly

In a recent column at Nature Magazine, David L Heymann, who has worked with Ebola outbreaks in Africa, shares his perspective on why now is the time to act to prevent this disastrous disease from spreading in the future.  Our current efforts should focus on curbing the outbreak and figuring out how to treat this deadly disease.  This should double with efforts to figure out how the diesase works and how to better preventing it from spreading in the future.

By combining potential treatments that western countries have developed over the past few years with education on prevention, Heymann shares some of the ways we can prevent spreading in the future and possible outbreaks.

How can outbreaks be curbed in the future?
  • - Community knowledge to prevent transmission in the future
  • - Safe transport for those potentially affected to a proper isolation place 
  • - Education on symptoms for prevention in rural areas to prevent spreading of the disease to densely populated areas
This past August, the WHO came to a consensus that conducting clinical trials in the affected areas would be ethical.  This is the only time that clinical trials can be conducted, however, setting them up in systems where hospital protocol are already reeling will prove to be difficult.  It is still up for debate as to whether the clinical trials will be randomized or if they would have widespread use due to the dire situation.  

Do you think that clinical trials during this outbreak should be randomized?  Or should they be conducted by working with those who need the treatments should receive them?

Wednesday, October 29, 2014

Clinical developments in Asian Cancers

Our partners at Citeline recently released the white paper Top Five Asian Cancers – Trends in Clinical Development.  The top five cancers in Asia are Lung, Gasteric, Breast, Colorectal and Liver.  White paper author Rachel Meighan-Mantha, PhD found that, as illustrated by this chart, that the  majority of clinical trials in this region are taking place the outlined countries below.

Other interesting facts on the region includes:
  • -Most ongoing clinical trials are taking place in these countries: Japan, Malaysia and Singapore
  • -Japanese sites participated in 61% of phase I and 52% of phase I/II trials
  • -Non-industry trial sponsorship was highest in Japan, China and South Korea - which is attributed to the high involvement of government sponsored agencies
  • -The top two clinical trials for industry are in the areas of breast and lung cancer for the top 10 industry sponsors are focusing clinical development 
Download the full white paper to gain more insights on the above points as well as the incorporation of pharmacogenomic biomarkers, primary drugs and mechanisms of action, deeper insights into Sponsor types and more.

Tuesday, October 28, 2014

FDA aims to better communicate with trial sponsors through out trial process

The FDA is striving to meet a newer, emerging market of drug development by establishing an open line of communication so that sponsors of clinical trials can maintain an efficient and effective drug discovery and trial process.

On this timeline, by the end of this fiscal year, here are a few of the items that the FDA has set up in order to better facilitate clinical trials:

  • - Timely interactive communication with sponsors during drug development is a core activity to help achieve our mission to facilitate the conduct of efficient and effective drug development programs
  • -Set up best practices for triage of sponsor requests for advice from the review team and timely communication of responses
  • - OND liaison staff in facilitating overall enhanced drug development communication between CDER and the drug development sponsor community

And more. You can see the entire report on the goals for this effort at the FDA's release.

Will having direct access to communicate with the FDA during clinical trials will enhance the process?

Wednesday, October 15, 2014

Web Seminar: Patient-centric to the Core: Setting a New Standard for Engagement Strategies in Clinical Research

Today, we're excited to host the web seminar Patient-centric to the Core: Setting a New Standard for Engagement Strategies in Clinical Research today at 2:00PM.  Our speakers Bonnie A. Brescia, Founding Principal, BBK Worldwide: Patient Recruitment and Engagement; Christel Aprigliano, CEO, The Diabetes Collective; and Claire Meunier, Vice President, Research Engagement, The Michael J. Fox Foundation will host a panel discussion looking at:
  • • How we as an industry should be defining the “new standard”
  • • Thoughtful patient-centricity in an increasingly regulated environment
  • • Effective strategies to ensure rapid program adoption
  • • Adaptive engagement tactics in an ever-changing retention landscape
  • • Using innovative and technological solutions to balance immediate expectations with long-term needs
  • • Warning signs that your study is not patient-centric, and actionable solutions to enhance engagement

Tuesday, October 14, 2014

Complex data collection for clinical trial approval

Uwe Albrecht, MD, the Managing Director at Mediconomics, recently sat down with partnering 360® to share what his company is focusing on and how they're helping companies with clinical trials traverse the difficult waters of international regulation.  Regulations have caused ongoing safety reporting to take more time - and this is where the company comes into play.

Mediconomics has developed a program that allows for companies to know they can have all the data they need from their clinical trials when they need it.  The company also prides itself on understanding and turning around projects for clinical trials in Germany - a country whose regulations are far stricter than many other countries most companies work in.  Find out more about the company's specialty in clinical trials at Insight.

What do you find is the most difficult part of data collection when applying for clinical approval across multiple countries?

Thursday, October 9, 2014

Preliminary Partnerships in Clinical Trials 2015 Agenda is Now Available!

See what's new at the upcoming 24th Annual Partnerships in Clinical Trials where you'll get access to unfiltered, unedited and unscripted content only available LIVE in Boston on April 22-24, 2015.

We are focused on bringing you new, unique solution-oriented sessions designed to showcase real insights that will foster tangible, cost-saving and innovative changes in your clinical trials and operations.

Join us for:
• Real-Time Case Insights • Round Table Discussions • Hands-on Workshops • Challenge Sessions • Think Tanks • Working Groups • Updated Tracks • And much, much more •

Stay-tuned for more program updates. Sign up for your own email alerts in one minute!

Wednesday, October 8, 2014

Patient communities can help draw patients to clinical trials

Recently, Genentech shed light on the power they've seen spread to patient recruitment in clinical trials by focusing their efforts on creating a patient centric experience.  The main goal was to help Genentech understand and work with the patients, so that the company could begin to understand who the patients are as people, what motivates them and who they are living.  They then wanted to bring that into the clinical trial design process.

In many of the scenarios, Genentech found that patients often bypassed clinical trial sites all together. If patients aren't going to the right places - and the clinical trial recruiters aren't connecting with them - how are trials going to get off the ground with the right number of patients?  After partnering with patient organization, Genentech shared three of their experiences that changed as a result of working with the patient populations their trials were aimed at.
  1. 1) When looking for immuno-compromised patients, Genentech found out that these patients were going to the pharmacy or their primary care physician and not the hospital  
  2. 2) For the rare disease ideopathic pulmonary fibrosis, patients weren't educated on the option of enrolling in a clinical trial and instead waited on the transplant list.
  3. 3) In a third trial for inflammatory bowel disease, after partnering with a patient group, Genentech was able to alter the clinical trial reporting so that patients could be monitored and minimize their fear of embarrassment.
Find out more about these trials and Genentech's experience at Mobi Health News.

Next Wednesday, October 15, we have Christel Aprigliano, CEO, The Diabetes Collective and Claire Meunier, Vice President, Research Engagement, The Michael J. Fox Foundation joining us during the web seminar Patient-centric to the Core: Setting a New Standard for Engagement Strategies in Clinical Research where they will bring their insights from their patient organizations to our audience.  Register to join us here.

Wednesday, October 1, 2014

What can patient input do for clinical trial design?

Many clinical trials do not receive enough registrants - therefore they cannot be completed. If a recent piece at the Wall Street Journal, they take a look at the new movement to include patients in the design of the clinical trials. In this piece, Brandy Parker-McFadden shares how she has contributed to the design of an epilepsy trial for children. This allows patients to contribute their side of the drug: what they want and need from a drug and how it is affecting them.

One of the main concerns of the designers is how long it could take to design the trials. But would the trade off be equal if patients were a contributing their insights and needs to the companies as they were designing clinical trials?

Watch the video here:

On October 15, we're teaming up with BBK Worldwide to present Patient-centric to the Core: Setting a New Standard for Engagement Strategies in Clinical Research. Join Matt Kibby, Principal, Technology & Innovation, BBK Worldwide as he examines the need for patient centricity in clinical trial. Register here and mention code XP2000W2BLOG.

Friday, September 26, 2014

The drive for clinical research innovation

It’s not uncommon to have months of the year dedicated to different causes. I’m sure many are familiar with the status of October as National Breast Cancer Awareness Month and April as National Autism Awareness Month. Recently, Representative Scott Peters (D-CA) in the House of Representatives took the initiative to make September Clinical Research Innovation month in America. The legislation, introduced last week, brought this response from -Association of Clinical Research Organizations (ACRO) Executive Director Doug Peddicord:

 “ACRO members take pride in the work our contract research industry does to advance health care and ultimately find cures for medical conditions that devastate far too many people around the world. Because of innovations adopted by Clinical Research Organizations, trials today are shorter, more responsive, and individualized than ever before. We are grateful to Representative Peters for his leadership in recognizing the irreplaceable role CROs play in bringing life-saving medicines and treatments to patients.” 

 In presenting his resolution, Representative Peters tried to express the importance of clinical research:
“I rise today to highlight the valuable and life-saving contributions of America’s clinical research efforts…Innovation and scientific research are critical to ensuring America’s future competitiveness. San Diego understands this and has become a hub for innovation and technology. Clinical research organizations are components of our leading innovation sector in San Diego and across the country. They’re fundamental to the development of drugs, biologics, and medical devices that are changing the face of health care in America.”

You can find Representative Peter’s full speech to the House of Representatives here.

Catch more on the latest in clinical trials at Partnerships in Clinical Trials. Join us April 22 – 24 in Boston, Massachusetts. Join our mailing list to stay up to date with what’s on tap for 2015.  As a reader of this blog, you can save $100 off the current rates! Register here and use code XP2000BLOG.

This post was contributed by @MikeMadarasz.

Friday, September 19, 2014

Web Seminar: Patient-centric to the Core: Setting a New Standard for Engagement Strategies in Clinical Research

Announcing the next web seminar from Partnerships in Clinical Trials!

Patient-centric to the Core: Setting a New Standard for Engagement Strategies in Clinical Research

- Bonnie A. Brescia, Founding Principal, Founding Principal, BBK Worldwide: Patient Recruitment and Engagement
- Christel Aprigliano, CEO, The Diabetes Collective
- Claire Meunier, Vice President, Research Engagement, The Michael J. Fox Foundation

Date: Wednesday, October 15, 2014

Time: 2:00 PM - 3:00 PM EDT
Register to join us. Mention Priority Code P2000W2BLOG

About the Web Seminar: 
If you’re not putting your patients first, someone else will. Patient-centricity is no longer a nice-to-have; it is a critical component of any study’s success. Thoughtful and effective patient engagement and retention strategies should be employed throughout the entire clinical trial process – and the patient’s contribution to clinical research and the advancement of treatment options cannot be underestimated.

Regardless of the inherent complexities of study management, clinical trial sponsors have an obligation to ensure patients have the best clinical trial experience possible.

Please join us in this complimentary webinar to discover the latest in patient engagement and retention strategies.

Our featured speakers will share valuable insights on:
  • • How we as an industry should be defining the “new standard”
  • • Thoughtful patient-centricity in an increasingly regulated environment
  • • Effective strategies to ensure rapid program adoption
  • • Adaptive engagement tactics in an ever-changing retention landscape
  • • Using innovative and technological solutions to balance immediate expectations with long-term needs
  • • Warning signs that your study is not patient-centric, and actionable solutions to enhance engagement

Register to join us. Mention Priority Code P2000W2BLOG

Thursday, September 18, 2014

Clinical Trials and Data: What's the disconnect?

A survey of 37 clinical trials conducted in the past 64 years was recently conducted to see what the results were after the trials data had been re-analyzed.  What the Journal of the American Medical Association found was that two scientists looking at the same data came to differing opinions 35% of the time.  According to the Wall Street Journal, of those 37 trials mentioned above, when re-researched with the data collected in the clinical trial, thirteen of the trials researchers came to completely different conclusions than the original.

John Ioannidis, director of the Stanford Preventative Research Center and the senior author of the study, calls for data to be made available publicly for scrutiny and analysis from different parties.  Trust of clinical trials has been questioned over the years - and data analysis from multiple parties could solve that.

The Wall Street Journal is not the only news source pointing towards a more open clinical data sharing future.  The Pharma Letter lists many of the government organizations that are calling for the sharing of clinical trial data including the World Health Organization, the US National Institute of Health, US Congress, the European Commission and others.  In addition to scientists being allowed to review the studies, doctors could make interpretation for themselves.  Patients could as well.  New treatments could be developed by fresh sets of eyes looking at the data.

Clinical data sharing has been the topic of discussion for quite some time.  What do you think will be the catalyst for Pharma sharing their clinical trial data in the future?

Wednesday, September 17, 2014

Astra Zeneca and Eli Lilly Teaming Up for Alzheimer's Disease

There are over 44 million suffering from Alzheimer's Disease, and two big Pharma companies just teamed up to find a cure for the disease.  Eli Lilly and Astra Zeneca joined forces to develop a drug that would possibly bring in $5 billion in revenue, but only has a 9% chance of making it to the market.

According to the Wall Street Journal, in this partnership, the two companies are sharing the risk of development, clinical trials, commercialization costs and any future revenue.  The BACE Inhibitor drug in development shows promise by stopping the beta amyloids- or protein fragments - that are associated with the development of the disease.

This Thursday, we're teaming up with PRA Health Sciences to see what other developments are in the works in the Pharmaceutical landscape in the web seminar Drug Development in Alzheimer’s Disease: Reasons to Remain Optimistic. Register to join speaker Frederick T. Lewis, D.O., Vice President Neurosciences, Scientific Affairs at PRA Health Sciences at 11:00AM ET. Register here and mention priority code P2000W1BLOG.

What do you see as the biggest benefits of partnering with another company to share the risk of a treatment that could save so many people who are suffering from the disease?

Tuesday, September 16, 2014

CluePoints Statistical Monitoring Used to Check Data Quality in Large Phase III Gastric Cancer Trial

CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials and partner of the Partnerships in Clinical Trials Event, has announced that its CSM platform has been used to assess the quality and integrity of data in a Phase III study of gastric cancer. The Stomach Cancer Adjuvant Multi-Institutional Group Trial (SAMIT), sponsored by the Epidemiological and Clinical Research Information Network (ECRIN) at Nagoya University School of Medicine, Nagoya, Japan, implemented the solution to check the quality of the data collated during the eight year study of 1,495 patients across 230 hospitals in Japan. The SAMIT trial is the largest ever adjuvant trial for gastric cancer.

The randomized study was conducted to elucidate the survival benefit of sequential use of paclitaxel followed by oral fluoropyrimidines in comparison with fluoropyrimidines alone, and to compare the two most commonly used oral fluoropyrimidines, UFT and S-1. The CluePoints solution enabled the investigators to check data quality across all clinical subjects in the various hospitals involved in the trial to confirm data consistency and document where any anomalies may have occurred. The information was collected and quality checked centrally at the ECRIN Data Center in Nagoya. The study findings, recently published by Lancet Oncology, show that the exhaustive analysis of the study data by CluePoints found no atypical data patterns that might have negatively affected the confidence in the study results.

"We are delighted that our CSM solution has been successfully used by the Nagoya University School of Medicine to assess the integrity of data collected in this important study", comments Franҫois Torche, CEO of CluePoints. He continues, "CluePoints' platform offers a powerful and sophisticated way of looking at the totality of data to detect anomalies. This not only helps to improve clinical data quality and contributes a significant reduction in overall submission risk, it also offers sponsors the opportunity to target their monitoring towards sites where it is most necessary.”
Professor Junichi Sakamoto, MD, PhD, Director at Tokai Central Hospital, said, "We wanted to perform an independent analysis of the quality of the data collected in the SAMIT trial prior to publication of the results in a major clinical journal. CluePoints provided us with an exhaustive and thorough review of all the data collected, and convinced us of the reliability of the findings across the investigational centers involved in the trial."

Driven by the company's sophisticated patent-pending SMART™ engine and aligned with current FDA and EMA recommendations, CluePoints' approach enables trial sponsors to identify signals in study datasets so that corrective actions are taken early and sites re-assessed periodically throughout the course of the study. This ensures the quality and integrity of the clinical data at substantially lower costs than more conventional on-site monitoring models that use extensive source data verification.

A full paper on the SAMIT study has been published in The Lancet.
For further information on CluePoints' solutions, please visit www.CluePoints.com

*The SAMIT trial is registered at UMIN Clinical Trials Registry, number C000000082.

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.

Thursday, September 11, 2014

Alzheimer's Disease Research: Setbacks and challenges

Today in the United States, five million people over the age of 65 are suffering from Alzheimer's Disease.  It's the 6th leading cause of death, and according to Medical News Today, it's the only cause of death in the Top 10 that there isn't a known way to treat, prevent or slow.  There is also evidence that the disease may start affecting the brain up to 10 years before a clinical symptom can be recognized.

What can advance our knowledge of the disease?  What we don't know about the disease, which is a big factor, is what causes it.  Two of them any things that are currently standing in the way of Alzheimer's research are lack of patients to participate in clinical trials and lack of funding.  However, that doesn't mean researchers have stopped doing research.

On September 18, Frederick T. Lewis, D.O., Vice President Neurosciences, Scientific Affairs at PRA Health Sciences, will be presenting the web seminar Drug Development in Alzheimer’s Disease: Reasons to Remain Optimistic. Join us from 10:00AM ET- 11:00 AM ET to find out more about what's going on in research for this disease and ask our expert questions you may have in our live Q&A discussion at the end of the presentation. Sign up here and mention priority code XP2000W1BLOG.

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 amar.bhat@twofourinsight.com.

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 info@twofourinsight.com. 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?