Friday, December 19, 2014

Biotechs provide critical link to innovations for Pharma companies

Innovation in the life science industry is evolving.  With over 90% of innovations occuring outside of big Pharma's research and development labs, it's important that big pharma be in tuned with what's going on in and leverage the expertise across the value chain.  In a recent interview at partnering 360®, Jochen Maas, the General Manager of Research and Development at Sanofi Germany sat down and shared his thoughts on capitalizing on external innovation with partners and identifying the real experts in the Pharma and Biotech industry to get products to the patients as fast as possible.

Watch the interview here:

Partnering with experts in the field a company trying to excel in - especially Pharma and Biotech - is critical. What do you see are the benefits of working with the innovative biotech industry for clinical trials?

This April at Partnerships in Clinical Trials, Annalisa Jenkins, Dimension Therapeutics will join us at a session to look further into opportunities for innovation within the biotech sector. Would you like to join her April 22-24 in Boston? As a reader of this blog, you can register to join us with code XP2000BL and save $100 off current rates. Or you can enter for a chance to win a free pass when you retweet this tweet!

Wednesday, December 17, 2014

America's Highest Paid Female Executive and Her Unusual Path to Pharma

Today's guest post comes from Rahlyn Gossen. She is the founder of Rebar Interactive, a clinical trial patient recruitment and digital marketing company. Rahlyn also maintains a blog, newsletter, and Twitter profile focusing on digital strategy for clinical trials.

“Futurist, pharma tycoon, satellite entrepreneur, philosopher. Martine Rothblatt, the highest-paid female executive in America, was born male. But that is far from the thing that defines her. Just ask her wife. Then ask the robot version of her wife.”

While reading the introduction of an online New York magazine profile of Martine Rothblatt, I wondered how accurately it reflected the content of the full article. As someone who reads a lot on the Internet, I’ve come into contact with my share of sensationalistic and hyperbolic hooks. But by that point my curiosity was piqued, so I continued reading. And the article did not disappoint. Martine Rothblatt is every bit as fascinating a person as the snippet above would lead you to believe.

In the 1990s Martine’s youngest child was diagnosed with primary pulmonary hypertension, a rare and fatal disease. Martine took action. She started the PPH Foundation, educated herself about pulmonary conditions, and founded a pharmaceutical company. Her company, United Therapeutics, went public in 1999 and received approval for a PPH drug last year. Martine’s daughter, whose condition inspired her foray into pharma, turns 30 this year and works for United Therapeutics.

Prior to founding United Therapeutics, Martine was already quite accomplished and even considering retirement. She had founded Sirius Radio and took it public in 1994. Prior to Sirius, Martine founded GeoStar, a GPS-based navigation system. Martine began her career as a communication satellite lawyer after earning a combined law and MBA degree from UCLA.

Currently, Martine is expanding United Therapeutics and promoting a new book titled Virtually Human: The Promise—And Peril—of Digital Immortality. Martine considers herself a transhumanist, which according to the article, is “…a particular kind of futurist who believes that technology can liberate humans from the limits of their biology—including infertility, disease, and decay, but also, incredibly, death.” According to Martine, artificial intelligence will be the primary vehicle to enable this new future, where even the dead can be reanimated as digital beings.

The description I’ve provided is a tiny sample of the fascinating details contained within the New York magazine article. Give it a read, or better yet, see Martine Rothblatt speak in person at the 24th annual Partnerships in Clinical Trials conference taking place in Boston on April 22-24, 2015. Martine will keynote the Women’s Clinical Leadership Forum, and I have no doubt she will be a highly engaging and informative speaker.

Thursday, December 11, 2014

The state of clinical research on COPD

COPD is a disease that is quickly growing to be one of the biggest expenditures in healthcare.  According to the NIH, it's predicted that by 2020, the disease will cost the United States $49 billion.  In 2010, it cost the state of Florida $2.5 billion.

There is no cure, and the UK's NIHR points out that the only preventable cure for this disease is to quit smoking.  Over 35,000 patients have participated in research and between 2008 and 2009, there were 157 new studies that began. See World Startup Report's research here.

What other measures are being taken in COPD research? Laura Runkel, Associate Director of CNS, Autoimmune/Inflammation & Ophthalmology, Citeline, will be joining us on December 17 to look at the trends developing in clinical research for this disease. Register to join us here and mention priority code XP2000W2BLOG.

Wednesday, December 10, 2014

Catch up: Partnerships in Clinical Trials Europe 2014

Last month more than 950 of the industry’s senior professionals in clinical research and outsourcing gathered in Barcelona for the 13th Annual Partnerships in Clinical Trials Europe conference. With a packed agenda from plenary sessions to collaboration zones and a lively exhibit floor, there was something for everyone.

This year we focused on many new topics such as:
  • - Transparency:  Greater visibility, data standards, identifying trends, data privacy and anti-corruption
  • - Disruptive technologies:  How they're being used and how it’s being taken forward
  • - Patient-perspectives
  • - Impact of social media on clinical trials

Attendees heard exclusive industry updates:
  • - TransCelerate’s plans for 2014
  • - Is disruptive innovation working?
  • - Private equity in outsourcing: impact on CRO and clients
  • - Advances in patient recruitment
  • - Risk-based monitoring and compliance issues

Spotlight: The Patient Perspective 

“I like to see competitors  be in a forum that allows them to collaborate. They can share information in a very informal way. “  -Jack Whelan, Cancer Warrior & Survivor

Jack Whelan, Author, Lecturer, Research Advocate, Cancer Warrior & Survivor, ePatient
One of the most talked-about keynote sessions was Jack Whelan, Author, Lecturer, Research Advocate, Cancer Warrior & Survivor, ePatient. He gave attendees the perspective of the patient, which is invaluable. Whelan’s very personal talk examined the impact of a heavily regulated environment on sharing meaningful patient data and patient reported outcomes. He asked important questions such as ‘What steps can be taken to facilitate a follow up system that encourages continued monitoring of clinical trial participants?’ which fostered many discussions throughout the event.

But, don’t take my word for it. Watch the video below to hear what attendees and exhibitors had to say about the event and get a glimpse of the even itself.

Here is a sample of the hard work, inspiring speakers and partnership networking we saw last month in Barcelona. Check out the full album on flickr! Find yourself and your colleagues in the photos and share with your networks to keep the conversation going until next year in Hamburg! You can follow us on twitter @PartnershipsCT and use #PCTrials to make even more connections!

flickr                  twitter          linked in
 Collaboartion Zone  Collaboartion Zone  Wine Casino
 Jack Whelan  PCT Bar  Networking

Find out more about what’s coming in 2015! 
Check out for the most up-to-date information.

18-19 NOVEMBER 2015

If you want to register today – contact Michael Dunnet,

Tuesday, December 9, 2014

Investigator data could be the key to unlocking clinical trials

Clinical trial data varies between each company.  The companies also have a habit of always returning to the same clinical trial sites and investigators instead of branching out and finding the best site and investigators for their trials.  Because with out the investigators, there are no patients, recruitment costs will skyrocket, and cost and wasted time continue to grow.  But as European Pharmaceutical Contractor points out, a streamlined data system across all sites could easily open up more sites and promising investigators to conduct clinical trials faster.  By streamlining data, sponsors could see success rates of past trials, recruitment rates over periods of time and have a world of investigators open up.  This article dives into how the Investigator Databank took on the challenge and has seen success since it was implemented in April 2014.

Four key areas are identified where the streamline of data and reports can help improve the reporting and collaboration of clinical trial sites:
  • -Access to more investigators
  • -Reduction of non-performing sites
  • -Decrease in time for feasibility and site identification
  • -Expand access for clinical researchers to research opportunities
Have you participated in streamlining your clinical data?  What are some of the benefits you see in addition to the four identified by EPC?

Data transparency is rising to the top of many conversations - streamlining investigator sites is just one.  This April at Partnerships in Clinical Trials, we'll bring together some of the key companies in Pharma including Boehringer Ingelheim, Pfizer, UCB Pharma, Center for Medicine in the Public Interest and GlaxoSmithKline during the panel Show Me Your Data: How Transparency is Driving Drug Development to look at how streamlining and sharing data can improve clinical trials throughout the drug industry.  For more information on this session, download the agenda.  If you'd like to join us April 22-24 in Boston, as a reader of this blog, when you register to join us and mention code XP2000BL, you can save $100 off the current rate!

Friday, December 5, 2014

Is the answer to advancing cancer treatments giving more patients access to clinical trials?

What is the key to accessible clinical
trials for patients?
Only 10% of all cancer patients in the United States participate in clinical trials.  In a recent article from Reuters, they point to accessibility to clinical trials as one of the major barriers to participating in the trials.  In the article, Dr. Matthew D. Galsky, Icahn School of Medicine at Mount Sinai in New York, states that clinical trials are the sources of many of the major advancements in treatment for cancer, so efforts should be made to increase this number.

Not only do clinical trials for cancer treatments advance the science and lead towards cures but they also often provide better overall care for the patients.  Patients who participate in trials receive follow up, more treatment guidelines and are better able to manage treatment for their disease.  They also have frequent interaction with healthcare professionals who are closely  monitoring their disease as well as hope that traditional treatments might not provide.  By finding new and innovative ways to allow patients to participate in clinical trials, this allows patients who may not live near a trial site to access in a potentially life saving treatment.

In your opinion, what is one of the major setbacks to creating a more accessible clinical trials for patients with difficult to treat cancers?

Connecting the Innovation Dots: Solutions to the Disconnection Between the Pace of Technology and Traditional Approaches to Clinical Trials presented by by Donald Jones, Chief Digital Officer, Scripps Translational Science Institute will look at how trials can be rethought and give the opportunity to more cancer patients more access to participate in clinical trials.  For more information on this session and the rest of the Partnerships in Clinical Trials program, download the preliminary agenda.  If you'd like to join us April 22-24, 2015 in Boston, as a reader of this blog when you register to join us and mention code XP2000BL, you can save $100 off the current rate!

Thursday, December 4, 2014

Latest clinical developments showing hope in Alzheimer's research

As the population of the United States continues to age, the search is on for a cure - or even a treatment to slow down this debilitating disease.  A few doctors are making headway in the search. What types of treatments are showing promise in clinical trials?

  • -Biogen Idec is working on a a treatment that works to reduce beta amyloid levels in the brain.  As announced yesterday, Their drug BIIB037 is designed to eliminate the plaque formed by the beta amyloids.  The levels were reduced in a dose- and time-dependent fashion.  Find out more about this treatment showing success in the early Phases at the Wall Street Journal.
  • - Dr. Eva Feldman, researcher at the University of Michigan, has been working with stem cell therapies.  Fetal stem cells were injected into the brains of mice that were engineered to develop Alzheimer's.  Early studies show that the mice that received the treatment did not show the cognitive degeneration that those who used the placebo did.  Find out more about this trail at The Detroit News.
  • -The National Institute on Aging has developed a new blood test that could prove to identify Alzheimer's Disease up to ten years before symptoms are exhibited. According to USA Today,  Tests are showing 100% accuracy with all those who have tested so far.  It has only been tested in 174 individuals so far, but early tests show promise.  By identifying the disease earlier, it would allow for more individuals to participate in clinical trials before their disease progresses beyond help.

Later this month, we're pleased to team up with Citeline's Laura Runkel, Associate Director of CNS, Autoimmune/Inflammation & Ophthalmology, as she looks at other treatments that are in the pipeline to better identify and treat Alzheimer's disease.  Register to join her web seminar on December 17.  Mention priority code XP2000W3BLOG.

Wednesday, December 3, 2014

Clinical trial patient enrollment partnerships for HIV treatment

In Citeline's most recent report Collaborations in HIV treatment trials: a help or hindrance for patient recruitment?, Doro Shin, MPH, Principal Analyst, Infectious & Genitourinary Diseases looks at the enrollment rates sites and programs for HIV clinical trials in relationship to number and type of sponsors.

Here are a few of the key statistics on enrollment for the HIV trials studied:
  • -Highest trial enrollment rates were from a single industry sponsor.  Higher trail enrollment rates were not observed with a collaboration
  • -Government agencies were the only group who benefited from higher sight enrollement rates when collaborating with another party for AIDS clinical trials
  • -Site enrollment rates increased as the number of sponsors increased
  • -Collaborative trails saw a higher enrollment rate than single sponsors
  • -Collaborations saw higher sight enrollment rates across all trial sizes

See how one government organization, NCATS, is collaborating with industry to speed up drug development in the presentation How a Collaboration between the National Center for Advancing Translational Sciences (NCATS) and Transparency Life Sciences is Accelerating Drug Development this April at Partnerships in Clinical Trials.  For more information on this session and the rest of the program, download the agenda.  As a reader of this blog, when you register to join us and mention code XP2000BL, you can save $100 off the current rate.

Wednesday, November 26, 2014

Cyber Monday starts early! See details how you can save on Partnerships in Clinical Trials!

To get a head start on the holiday season, as a member of our online  Partnerships in Clinical Trials community, we’re giving you an extended chance to take advantage of our Cyber Monday sale. Register with code CYBER2014  and receive 30% off the standard rate.

Are you interested in attending on of our other events?  Head to our sister blog Future of BioPharma for a complete list of events you can save on through Monday, December 1.

*This promotion is only valid Wednesday, November 26, 2014 until 11:59PM on Monday, December 1 , 2014. Offer cannot be applied retroactively to confirmed paying registrants and cannot be combined with any other discounts or promotions. All registrants and guests are subject to IIR approval.

Tuesday, November 25, 2014

Six Questions to Determine FDA Clinical Trial Site Compliance

Drug accountability management is one of the key items that can ensure that all aspects of running a clinical trial - from data integrity, staying on a the clinical trial time line, managing costs and more.  In a recent white paper from Cenduit focusing on electronic drug accountability systems.

What are the six questions that a site can ask to ensure compliance?

  1. 1.  Who is authorized to administer or dispense the investigational drug?
  2. 2. Has the investigational drug been supplied to any unauthorized person?
  3. 3. Can the records for investigational drug inventory be reconciled, i.e., the quantities shipped, received, used, and returned or destroyed?
  4. 4. Can drug shipments, dispersals, and returns be verified?
  5. 5. Is the drug stored in the manner mandated by the protocol?
  6. 6. Does the storage of drugs with the potential of abuse meet the federal regulations for controlled substances?
In the white paper, they focus on the different aspects of keeping records to verify the questions above.  As trials evolve, they call for the evolution of record keeping as well and set forth options for the systems to keep these records electronically providing electronic drug accountability.  A simple error in a paper based system is hard to detect and trace.  As accountability becomes more complex, considering a more dynamic system is important and can help trace and keep companies compliant by doing the following:

Interactive response technology (IRT) systems are used in many clinical trials for a myriad of tasks, from patient randomization to drug supply management and allocation. IRT is ideal for drug accountability because it tracks drug dispensing units by warehouse, depot, and site location, and by batch, bulk lot, packaging step, label group, and patient allocation.

Do you use an IRT system for your drug accountability management?  What's the biggest benefit of doing this electronically?

Data keeping is just one way to optimize clinical trials.  This April at Partnerships in Clinical Trials, the track Clinical Operations Optimization will focus on how operations, including  speeding up clinical trials and the tools to do so will be covered.  For a preview of the sessions in this track, download the agenda.  As a reader of this blog, when you register to join us and mention code XP2000BLOG, you can save $100 off current rates.

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?