Friday, April 24, 2015

Live from #PCTUS: Wall Street State of the Industry Forecast for 2015

The final session of PCT 2015, "Wall Street State of the Industry Forecast for 2015 - Taking a Closer Look into the Sustainability of the Pharma/CRO Outsourcing Model" was a panel discussion to dive into the state of the industry and diagnose key themes, trends, and challenges.

Moderator: Michael Hay, Managing Director, Sagient Research

Panelists:
- John Potthoff, President and CEO, Theorem Clinical Research
- John Kreger, Partner and Healthcare Equity Research Analyst, William Blair
- Michael Martorelli, Director, Fairmount Partners

One major factor that each panelist mentioned was big data. This comes from all different levels - one key to data capture was as more companies become public, it provides the industry with much more information (growth, profitability, etc..). This information leads us to better decision making across the board.

The discussion continued onward to discuss the challenges that are currently facing this industry...

What needs to change in the industry:
- The challenge is how to keep up with evolving technology
- Clinical trials need to be much more embedded into the healthcare delivery system
- Process inefficiencies

What is the current state of the industry?
- Biotech companies are on FIRE for public investors
- Nontraditional services companies are buying traditional service companies
- Data is king

Thank you for following along with 2015 Partnerships in Clinical Trials! We hope to see you next year in Boston.








Live from #PCTUS: 2 New Patient-Centered Initiatives Announced

By Kristina Lopienski, Product Marketing Manager, Forte Research Systems, Inc.

In some of the sessions that I happened to attend, I was among the first to hear the announcements of two new and separate initiatives to better understand potential clinical trial participants. Both of them strive to address what’s unique by disease, rather than grouping everyone together in one giant all-encompassing patients bucket. They also intend for this information to be used in designing more patient-centric trials.

In the Patient Engagement in Clinical Research track, during the case insight session, “Late-Breaking Results from the Front-Lines of Trial Design: How are Patients Really Engaging in Research?”, Jeremy Gilbert of PatientsLikeMe gave an update to some of his company’s endeavors.

Surveys have been great for generalizing how patients feel about certain things, but Jeremy provided the audience with examples that show just how great patient preferences vary when you break down the answers by disease. Realizing that we need to better understand each group’s unique set of needs and preferences, Jeremy announced that he has teamed up with Ken Getz to create an on-demand patient-centricity resource center, which will be available in the near future. Jeremy said they plan to publish as much of this data and make it more accessible. Getting this information into the hands of people who are designing trials will enable them to learn how specific patient populations think about their disease.

Next, in the Clinical Operations Optimization track, a session by the name of “The Patients 2 Trials Consortium: Breaking News” featured four speakers. Three of them, Lani Hashimot of Novartis, David Leventhal of Pfizer, and Katherine Vandebelt of Eli Lilly, gave back story to the Patients 2 Trials Consortium that brought these three big pharma companies together who share a common struggle – matching patients to trials. Realizing that it does no good for a patient to get matched to their company’s trial if the trial doesn’t help the patient, they knew that by partnering sponsor to sponsor, they could bring valuable clinical trial information to patients.

The consortium agreed on target profiles that define and normalize groups of patients who might enroll for a specific trial. Pablo Graiver of TrialReach, engaged with the consortium to create an infrastructure based on their standard set of data. The result is TrialReach (which is live as of 24 hours ago).

Pablo gave a live demo of TrialReach. One by one, the user answers questions, first by condition, then location, age, etc., and as they answer each question, the list of available trials within X miles of you is narrowed down. By asking simple questions, the algorithm reads eligibility criteria and continuously reads, ranks and refines trials to display results in plain language. The results of trials are split by patient-friendly information (more than what’s available on CT.gov) with the logistics of the trial (specific procedures, number of visits, etc.).

Patient profiles are saved searches, and they have a plan for making this resource accessible to patients – by embedding it on disease-specific websites (where those potential patients already are online). In these instances, people can use the tool outside of trialreach.com, without having to leave the site they’re on. All searches, even from the embedded locations, generate the same snippets of data. Sponsors can the use these queries to show maps of matches and the information from the specific population to design better trials.

About the Author: Kristina Lopienski is the Product Marketing Manager for Overture EDC at Forte Research Systems​. In her role, she works to bring educational resources to clinical research professionals. She writes on a variety of topics affecting clinical trials on the Forte Clinical Research Blog. Kristina is currently the guest blogger covering Partnerships in Clinical Trials 2015. 






Live from #PCTUS: 3 Approaches to Speeding Up Clinical Trials

By Kristina Lopienski, Product Marketing Manager, Forte Research Systems, Inc.

In today’s Clinical Operations Optimization track, a panel discussion titled, “New Approaches to Speeding Up Clinical Trials - What Works and What Doesn’t” was a great challenge/solution session. Craig Coffman of Nektar Therapeutics, the moderator, started the session by emphasizing that running a trial according to original timelines is hard work. Most trials operate in catch up mode, so rather than being ahead of the curve, they’re just trying to stay on the curve. It’s very easy to fall behind, and very difficult to make up any time that’s been lost.

This presentation featured three speakers who gave examples of what they’ve implemented with the goal of saving time on clinical trials.

Making it more convenient for the patient

Charles Drucker of Quest Diagnostics gave an example of a trial that used a phlebotomist service for blood draws. These storefront centers were quick and convenient for the patient and could save the trial time and money. Of course, this method works better for some therapeutic areas than others and isn’t a one size fits every study.

Visiting sites to show sponsor support

Manny Lazaro of Forum Pharmaceuticals talked about taking the time to actually visit and engage with the site (not at the investigator meeting). He’s traveled as far as Serbia to provide support and show that as the sponsor, they care about the site and want to be involved, even when the trial is outsourced to a CRO. Does showing up in person really work? These visits almost always lead to increased site engagement and show an immediate upswing in activities (e.g., 10%-15% boost in recruitment), though they eventually tend to level out again. The sponsors in the room all agreed it’s worth the resources that are required to support site engagement.

The group even talked about sponsors holding “rejuvenation meetings” in which they bring together sites (both underperformers and high enrollers) to learn from each other and have them take time to pause and reflect on what’s gone right, as well as discuss any problems they’re having with getting patients in and consented. Sites appreciate this approach, as opposed to what they’re used to hearing, “When are the patients coming?” over and over again.

Setting goals and committing to bold experiments

Terri Roberson of Abbvie engaged the room with an experiment her company did, called “40 sites in 40 days” which took place between Thanksgiving and Christmas last year. The goal of this challenge was to enroll 40 sites and have them up within 40 days. Having previously taken 90 days on average to get a site up, this was a lofty goal. To save time, they did all feasibilities over phone and offered no contract negotiations. It was a “take it or leave it” offer, where the sponsor was saying we’re committed to you, you need to let us know if you’re committed to us.

The results? All 40 sites were up within 40 days, and they enrolled 100% faster than the non-experiment group of sites. Terri explained how internally they had to get a lot of people behind this effort, which ended up being a lot of work, but a huge accomplishment that really worked for them.

Craig challenged the room not to try just one of these examples, but try a combination of all three, yet recognizing that every situation is different and there’s no one silver bullet to speeding up clinical trials. One of the greatest realizations of this session was that the example methods presented weren’t due to any great new technologies – they were process improvements.


About the Author: Kristina Lopienski is the Product Marketing Manager for Overture EDC at Forte Research Systems​. In her role, she works to bring educational resources to clinical research professionals. She writes on a variety of topics affecting clinical trials on the Forte Clinical Research Blog. Kristina is currently the guest blogger covering Partnerships in Clinical Trials 2015.




Live from #PCTUS: How to Get the Most Out of Your Clinical Data Collection Practices

Linda Tedder, Director of US Clinical Project Management, DePuy Synthes talked with the PCT audience in the final session of the day for the "Best Practices in Medical Device Trials" track. Linda brought a wealth of knowledge on clinical data collection and walked the audience through a step-by-step best practices guide based on her extensive work in the field. Below you will find the key areas to focus in on and questions to raise to ensure the best outcome when planning your very own trials...

What are you required to collect by regulatory requirements?
- FDA, clinicaltrials.gov, Competent Authorities, Notified Bodies, etc...

What do you need to collect regarding you product for safety & effectiveness/performance?
- AEs, SAEs, UADEs, USADEs, device malfunctions, product complaints
- PROs/QOLs
- Validated therapeutic measurement tools
- Imaging
- Publications

What additional data are you collecting for costing benefits or because you are worried you might need it later?
- OR times, hospital stay time
- PT requirement/amount
- Return to work status
- Non-validated PROs or therapeutic specific measurement/evaluation tools
- Overall patient satisfaction

CRF Development:
- How will the steps of the study/visits be done at the sites?
- Who will be doing what for the study?
- How will the data be collected?
- What is the evidence strategy?

Opportunities for Improvements:
- Limit free text; use drop down lists or check boxes
- Eliminate duplicate/similar questions, avoid a query cycle
- Allow sites to enter values then select measurement used
- Use dynamic forms in EDC

Data Entry & Collection:
How much data are you collecting?
- Have a plan for how the data will be used

How to avoid pitfalls?
- CCGs; having a usable CRF completion guidelines/instructions
- Site training; SC at SIV & ongoing
- Re-evaluate the database as needed/make changes (poor programming with excessive queries = frustrated sites!)

Other areas to think about:
- Linking vendors & EDC, does it make sense? (ex. core labs, IVRS/IWRS)
- Ensuring ongoing contact with sites for ensuring timely entry

How to ensure data is accurate?
- Program up useful edit checks/auto queries
- Thorough database validation through; completion of multiple test patients, interactive database review, and involvement of clinical operations
- Ongoing data cleaning

Monitoring:
- Consider overall SDV requirements & risk-based monitoring
- Provide source worksheets
- Onsite vs. remote monitoring
- Ongoing collaboration with Data Management & CRAs/PMs
- Ongoing quality metrics

Thank you for following along with PCT 2015 & stay tuned for more updates and recaps from Partnerships in Clinical Trials.


Join the conversation on Twitter by following @PartnershipCROs and tracking all on site activity with #PCTUS




Thursday, April 23, 2015

Live from #PCTUS: Picking up the Pieces of Clinical Trial Failure

"From Innovation to Market: Navigating the Mine Fields"

Dr. Joseph Gulfo, Executive Director of the Rothman Institute of Innovation and Entrepreneurship at Fairleigh Dickinson University famously battled the FDA and won over a device in the late 2000s and early 2010s. His product was a melanoma detection device that would better identify melanoma in patients and effectively save more lives. This specific case is famous for the press it got and Dr. Gulfo was here today to explain to the PCT audience his battle plan and how he won the war.

Battle Plan:

·         Build up of arms - peace through strength
o   FDA decisions involve more than your product factors you don't know about
o   Regulatory counsel 
o   BPA; Binding Protocol Agreement (with the FDA) 
o   Money ( He raised nearly 160 million because of the BPA that eliminated regulatory risk for investors)
·         Strategy - sweating every detail
o   AdComm Panel briefing document –
·         Executive summary
o   Best, most knowledgeable doctors and statisticians in the field (mock panel)
o   Adaptable - change according to conditions on the ground
·         Realizing you are in a fight
o   Passion, dedication, determination
·         Define yourself by the outcome
o   Take it to Madison Square Garden (as much PR as possible, the FDA will win in a street fight - the media is your friend) 
o   Unconventional tactics - media and regulatory strategies (citizen petition) 
o   Be a leader, a powerful leader

Thank you for following along with PCT 2015 & stay tuned for more updates and recaps from Partnerships in Clinical Trials.

Join the conversation on Twitter by following @PartnershipCROs and tracking all on site activity with #PCTUS






Live from #PCTUS: Redefining Clinical Trials in the Age of Personalized Medicine

In this morning session, Donald Jones, Chief Digital Officer at Scripps Translational Science Institute led a thought provoking keynote panel discussion titled, "Redefining Clinical Trials in the Age of Personalized Medicine". Donald was joined by Isan Chen, Chief Medical & Development Officer at Mirati Therapeutics, Erynn Gordon, Medical Marketing Director at 23andMe, Niven R Narain, Co-Founder, President & Chief Technology Officer at Berg Health, and Wendy Levin, VP of Clinical Development at Fate Therapeutics, Inc. These industry leaders went back and forth discussing the future of medicine in regards to personalized medicine, their work, and where this is leading us.


Below are the key takeaways from this discussion...

The concept of personalized medicine makes one think that it should be patient specific. However, it can also be about the whole. According to global epidemiology, 600,000 new cancer cases are diagnosed every year and as baby boomers reach retirement age, this cancer explosion is expected to continue to rise.

With the data about expected cases readily available, how do we stop it? Since disease does not happen overnight, it is about identifying the patient population and understanding the full story; everything from sleep patterns, lifestyle choices, exercise history, area of residence, etc... Fundamentally, this collected data would be used to create a map on each and every patient - much like a map of airline routes. By developing these molecular maps, we can identify what is governing the healthy and correspond that with the disease population in order to identify where things have gone array.

So the goal now begins to shift towards, patient prediction. The model needs to be changed so we are no longer reacting to symptoms, but shift the paradigm to being proactive to improve overall health. Erynn Gordon used a specific example from her work at 23andMe and said; A family with a history of pancreatic cancer all seemed to have a specific genetic variant - in their massive genetic database, 127 others carried the exact same variant. 23andMe surveyed these 127 individuals about their family history of pancreatic cancer, cancer in general, and more (as well as 10,000 others as a control) and overnight were able to conclude that the specific genetic variant that this family carried had no connection to pancreatic cancer.

Tests/work like this are helping us shift towards preventative treatment rather than treatment to curve the diseases progression.

The final point brought up what by Wendy Levin and it was about comparative oncology; which provides opportunities to include naturally occurring cancer models in the study of cancer biology and therapy. The comparative oncology tests are done with companion animals with naturally occurring diseases rather than mice who have the diseases artificially implanted - there are 72 million companion animals in the US and they are susceptible to these naturally occurring cancers, and we want to cure these diseases in our pets. In that treatment process, we incorporate the success rates within the samples into new drug development and clinical trials.

Thank you for following along with PCT 2015 & stay tuned for more updates and recaps from Partnerships in Clinical Trials.

Join the conversation on Twitter by following @PartnershipCROs and tracking all on site activity with #PCTUS






Live from #PCTUS: Siteless Studies, Barriers to Patient-Centered Trials, and Recruitment for Rare Diseases

By Kristina Lopienski, Product Marketing Manager, Forte Research Systems, Inc.

Wrapping up today’s preconference activities were the Think Tank sessions. Attendees split up in open roundtable discussions to brainstorm solutions to industry challenges. In the Patient Engagement in Clinical Research track, the three topics up for discussion were “Overcoming Regulatory Barriers to Execute Patient-Centered Trials”, “Patient Recruitment Hurdles in Rare Disease Indications”, and “Exploring Siteless Studies”. Each group discussed one topic at a time, and then reconvened to share highlights and key findings.

It was fascinating to hear these topics being discussed from different perspectives, including sponsor, CRO, site, patient, among others. There were a lot of great conversations, and participants were very engaged in this interactive exercise. Here are some of the conversations that took place.

What does patient-centricity mean to you?

- Driving toward how we can communicate better with patients to help them be more compliant, improve the data we collect, and then share the results of that data with the patient
- Trials that patients are willing to enroll in
- When sponsors are willing to listen to patient feedback
- Bringing the trial to the patient
- Advocacy and engaging with patients as individuals
- Patient-centric trials aim to reduce the burden and increase the benefit to the individual patient, and doing so will improve recruitment and retention
- Creative trial design
- Helping patients with travel, stipends, and providing them with trial summaries (translated into language that’s actually understandable)

What are some regulatory barriers that stand in the way of patient-centered trials?

There are new approaches that are better, and technology is enabling us to do things differently, yet if it’s not validated, we avoid it (we don’t want to be told “no” so we don’t even ask). The FDA will have to move forward to become more patient-centered.  However, some barriers aren’t regulatory, but internal – from outdated SOPs to the excuse, “It’s always been done that way.” Old methods or resistance to change can be overcome, but it won’t always be easy. We have to push for it anyway, because it’s a fight worth fighting.

How would you define a siteless study?

- Patients don’t have to come to a central location; they can do everything remotely (from informed consent to specific procedures)
- A hybrid model where we can minimize or reduce what happens at the site
- Use of ePRO
- “Siteless” sounds like you’re giving something up. Instead, call it “site-free” or virtual site

This topic brought surfaced many other discussions, including the advantages and disadvantages of site visits, debate around if the quality and validity of data entered by a patient or parent is as credible as physician or nurse, and who would have oversight in siteless trials.

Can siteless studies work for every study?

After discussing a model that could work, it’s obvious that it doesn’t fit every study. It may be great for the right studies, but it also doesn’t mean that it’s the end of site studies (at least in the near future).

What is being done to aid in recruitment for rare disease studies?

Because extensive travel is typically involved, it’s not uncommon to use a travel concierge service, or whatever it takes to get the patient there. It’s stressful enough to travel long distances (sometimes overseas) with a sick family member, we don’t want them to worry about flights, rental cars, or where they’re going to stay. Some sites even have a “navigator” who facilitates as much or little as the patient needs.
Having someone there to guide and make arrangements is a great benefit, though it’s very time-consuming and rare outside of rare disease trials.

These topics and discussions were great reminders of how important patient-centricity remains in planning and conducting clinical trials and an excellent end to the first day of the conference. Tomorrow brings several exciting keynotes, as well as a variety of sessions and workshops. Keep following along for more #PCTUS highlights.


About the Author: Kristina Lopienski is the Product Marketing Manager for Overture EDC​at Forte Research Systems​. In her role, she works to bring educational resources to clinical research professionals. She writes on a variety of topics affecting clinical trials on the Forte Clinical Research Blog. Kristina is currently the guest blogger covering Partnerships in Clinical Trials 2015. 




Live from #PCTUS: Working Together for Risk-Based Monitoring

By Kristina Lopienski, Product Marketing Manager, Forte Research Systems, Inc.

At last! Partnerships in Clinical Trials has finally arrived, and there is plenty of excitement here in Boston. To kick off the pre-conference day were four great workshops. One of the tracks, Risk-Based Study Management, featured several presenters who were able to share each of their experiences in planning for and implementing risk based monitoring (RBM).

In his presentation titled, “The A to Z of RBM”, Andy Lawton, Global Head of Clinical Data Management at Boehringer Ingelheim, spoke on the key elements of risk management. He talked about the holistic Integrated Quality and Risk Management Plan (IQRMP), which focuses on detailing what the risks are and how to mitigate them. Andy stressed the need to incorporate feedback from as many people and perspectives for the best risk assessment possible, and so that it’s not just one person’s view.

Since no site or trial will go 100 percent error-free, it’s important to define targets for tolerance (e.g., what’s an acceptable number of missing events, the expected percentage of inclusion/exclusion violations, etc.), and then measure against those. Andy also spoke on using a tailored approach to monitoring based on the overall site risk score, specific site triggers for actions, among many other factors that help determine where and how to focus monitoring attention.

Of course, the monitoring activities include source data verification (SDV), or the direct comparison of the CRF data to the source document to detect data transcription errors, as well as source data review (SDR), a much more comprehensive review of the subject’s data across visits. SDR includes reviewing the quality of source documents (if they meet Good Documentation Practices and ALCOA criteria), ensuring source documents confirm compliance to the protocol and show PI oversight, and verifying that everything remains consistent throughout the trial. While there is still some confusion surrounding these definitions, Andy compared SDV to QC, where SDR is like QA. He talked about getting away from 100 percent SDV so that monitors can free up their time and focus on what really matters.

Ellen Kelso, Executive Director, Strategic Development of Chesapeake IRB, followed, and informed the audience, “We are more alike than you think.” IRBs have long operated with RBM concepts, and she views RBM as an opportunity to enable more effective IRB oversight and a more proactive approach for identifying noncompliance. Ellen mentioned that IRBs are a stakeholder in the process, and sponsors should engage with IRBs to receive and share learning.  

Through this workshop, it became clear that it’s important to involve several groups and incorporate their feedback into planning and implementing RBM.

Stay tuned for more coverage on Partnerships in Clinical Trials! You can follow the conference activities on Twitter using the hashtag #PCTUS

About the Author: Kristina Lopienski is the Product Marketing Manager for Overture EDC at Forte Research Systems​. In her role, she works to bring educational resources to clinical research professionals. She writes on a variety of topics affecting clinical trials on the Forte Clinical Research Blog. Kristina is currently the guest blogger covering Partnerships in Clinical Trials 2015. 




Wednesday, April 22, 2015

Live from #PCTUS: Gaining Global Efficiencies through Data Integration, Virtualization & Cloud Sourcing


Speakers:
Scott Thomas, Sr. Director of Biology, Merck & Co.
Lori Ball, Chief Operating Officer, BioStorage Technologies

In this session, Scott Thomas and Lori Ball discussed their work towards better decision making through Data Integration, Cloud Sourcing and Virtualization. These terms make up this overarching "Big Data" theme of late. The discussion began with Lori walking the audience through each of the terms as each seems to have a different meaning depending upon whom you ask.

Data Integration: many different locations, how do we use all of them?
Cloud Sourcing: consolidate all of this data into one location/data center
Virtualization: bringing together the data and making the connections to be used for better decision making, using your assets to your advantage.

As she worked through explaining these terms (presentation to be available at a later date) a very interesting statistic was mentioned...

"85% of people in the industry said their number 1 concern was consolidating data for making decisions"

Data analytics are a valuable way to drive better decision making, and as Scott put it "Sample data integration and virtualization has the potential to shorten research timelines and reduce research costs"

Creating a new way to capture, analyze and utilize all this data is the problem everyone is currently facing - Scott brought up a few slides trying to dissect this problem into a logical pathway...

Creating Modern Scientific Information Platform:
- Data stores
- Logic/Data access control
- Interface/Data delivery service

The Technical Architecture:
Research -> Development -> Commercial -> Medical

Historically he added, workflows have been very complex. These complexities which are created by multiple unnecessary steps, create voids where errors can happen. Which lead to big headaches for all parties involved.

The question arose of how can sample data integration and virtualization shorten research timelines and reduce research costs? The short answers were; 1) Automating and improving laboratory workflow processes. 2) enhancing faster research decision making. 3) Optimizing the value of research sample assets.

Thank you for following along with PCT 2015 Live from Boston.

Stay tuned for more updates & recaps from Partnerships in Clinical Trials.


Join the conversation on Twitter by following @PartnershipCROs and tracking all on site activity with #PCTUS




Live from #PCTUS: The Impacts on Clinical Operations When Getting Acquired by a Pharma Company

By: Ryan Geswell

Charlie Romano, Sr. Director, Clinical Research, Amniox Medical

In this Town Hall style session, Charlie Romano, Sr. Director of Clinical Research, Amniox Medical walked around a well-attended room talking about and asking for audience input and thoughts about what really happens when your company gets acquired. The discussion opened up with the obvious question...

What generally happens when we get acquired?

Charlie continued on to say "If your project is premier you are usually pretty safe - if your project is being acquired you should make yourself known. Not just on a personal level, but you should know more about your project than absolutely everyone and be open to new processes that help make for a better outcome."

After some audience interaction on general acquisition woes, as many in the room had either done the acquiring or been acquired, the conversation shifted to the question of during an acquisition, what can we do as clinical operations people? And this answer seemed to be unanimous for all; assess your risk and become an advocate for the new vendor.

This Town Hall style meeting sparked some very interesting debates from an audience of industry professionals from both sides of the fence. Below you will see some soundbites from the session...

Key Soundbites:

"The big CROs think the little guys have it right and the small CROs think that the big guys have it right"

"The most import thing about a clinical trial is the protocol"

"Protocol approval is king on most projects - but it is interesting how different it can be between a big company and a small company. The timeline for developing these protocols is vastly different. This can vary from a few days or weeks to 6+ months, where do you fall on this scale?"

"Timelines are life or death to both little pharma & big pharma"

"If something can help get your project/product to market sooner be sure that need is known. Timely projects are so key that any little advantage helps."

"A lesson I have learned being on both sides of acquisitions - don't act like you are the best thing since sliced bread. Be open to learn, grow, and be better from this new partnership."

Stay tuned for more updates & recaps from Partnerships in Clinical Trials.

Join the conversation on Twitter by following @PartnershipCROs and tracking all on site activity with #PCTUS






Tuesday, April 21, 2015

TransCelerate Launches Global Initiatives to Improve and Accelerate Clinical Trials

A big announcement in the pharmaceutical world has been the new establishment of two global initiatives that will improve and accelerate clinical trials. TransCelerate BioPharma Inc. unveiled that through a collaboration of participating member companies, these initiatives could be made possible.

The Placebo/Standard of Care Data Sharing Initiative and Electronic Labels for Clinical Trials (e-Labels) Initiative were announced recently and both aim to create solutions that will directly impact sponsors, patients and investigative sites. The e-Labels Initiative will support the Member Companies of TransCelerate and will seek to establish an innovative information channel: Electronic Labels. It will work to provide more consistent labeling approaches for sites that will enhance label utility for patients. The e-Labels Initiative will offer the potential to reduce clinical labeling timelines which will provide a more cost efficient solution for sponsors. The Initiative, will be working alongside Regulatory Agencies in order to develop guidance that will facilitate implementation of e-Labeling.

Craig Lipset, head of Clinical Innovation at Pfizer, and the Executive Sponsor of the TransCelerate e-Labels Initiative said “This effort aims to make product information more accessible to patients and to permit deeper engagement during the clinical trial process.” Terry Walsh, Head of Comparator Strategy and planning at GlaxoSmithKline and the lead of the initiative believes that “The time is right for pharma companies to embrace e-labeling as a critical component to their clinical supply chain strategy,” and that “The TransCelerate e-label Initiative is aligned with our primary goals of collaborating with critical stakeholders, challenging inefficiencies and driving value into the clinical trial landscape.”


The other initiative that was announced, the Placebo/Standard of Care data Sharing Initiative, has the ability to create a framework for data sharing that offers the potential to decrease the number of patients that need to be involved in a clinical trial. It will allow for the leverage of data from previous studies, respecting the confines of informed consent.  This initiative means a decrease in the amount of time that is spent on cumulative trial executive which in turn assists in acceleration of new therapies to patients. The initiative also allows the potential for more rapid understanding of safety signals in order to better manage patient safety during the clinical trial phase. Statistical techniques will be more identifiable thus to deliver more accurate study design and statistical power calculations.

Ulo Palm, MD, PhD, SV, head of Global Brands Drug Development Operations at Actavis, and TransCelerate Executive Sponsor for the initiative said of the initiative said, “Providing this platform to Member Company biostatisticians may lead to improved protocol development, reduction in protocol amendments and a better understanding of disease models to identify the right targets, including rare disease models."

The announcement is an example of partnerships being formed in order to advance the development of clinical trials and improve patient care globally. TransCelerate will be speaking at the Partnerships & Clinical Trials Conference this week. To see who else is speaking this week please visit the website: http://bit.ly/1E6raKF

About the Author: Harry Kempe, a marketing intern at IIR USA, who works on various aspects of the industry including social media, marketing analysis and media. He is a recent graduate of Newcastle University who previously worked for EMAP Ltd. and WGSN as a marketing assistant on events such as the World Architecture Festival, World Retail Congress and Global Fashion Awards. He can be reached at hkempe@IIRUSA.com




Thursday, April 16, 2015

Sponsors and CROs Collaborating in the Cloud

By: Mike Lange

The increasing adoption of cloud and Software-as-a-Service (SaaS) solutions in clinical research and development is having a profound and positive impact on clinical trials – increasing trial speed and efficiency, reducing cost, and enhancing patient safety.  Integrated cloud platforms encompassing planning and trial conduct through submission and post-marketing are helping to break down the industry’s functional silos and unlocking even greater R&D innovation.

It is, however, still early days.  Sponsor IT organizations and CROS are for the most part on board and are supporting the migration to cloud-based solutions.  Yet many trial sponsors and manufacturers are struggling to adopt to the new environment.

The reasons?

While it’s relatively easy to define best practices and improved business processes enabled by cloud-based solutions – for example, through secure, anytime/anywhere access to data and collaborative environments – it’s much, much harder to operationalize them. 

We hear a lot about transparency and better communication being keys to better sponsor and CRO relationships.  Yet legacy practices take a long time to die.  We still frequently encounter the emailing of massive spreadsheets between sponsors and CROs as the de facto “collaboration” process for planning and budgeting clinical trials – despite the inherent inefficiencies including added time and manual effort, security issues, and risk in this process.

Other reasons range from cultural – e.g., a highly risk-averse industry as a whole – as well as business interests – e.g., the tension between transactional and strategic sponsor/CRO relationships, and the drive to the lowest-cost model which may preclude a true strategic relationship.  As just one example, a research study conducted by the Tufts Center for the Study of Drug Development – supported by an unrestricted grant from Oracle Health Sciences – found a persistent and prevalent use of transactional outsourcing relationships by sponsors. 

So what is possible?  How are leading sponsors and CROs taking advantage of clinical R&D cloud solutions today?

Planning for partnership trial excellence in the cloud starts at the very beginning, during the early portfolio trial planning and forecasting between sponsors and CROs.  Replacing legacy   spreadsheets as referred to previously, innovative sponsors and CROs are embracing a clinical cloud collaboration platform for long-range trial planning and study budgeting, as well as operational planning for the actual trial being run.  Taking advantage of a secure, centralized repository for operational data accessible anytime/anywhere via the Internet, with clinical intelligence for therapeutic indications and clinical development data, these sponsors and CROs are reaping tremendous efficiencies in planning clinical trials by:

·         Engaging earlier with collaborative scenario planning to ensure trial achievability, fair market value, and operational alignment to accelerate planning and minimize downstream changes
·         Ensuring operational support of budget and resource planning by providing visibility to bidding process and results
·         Aligning trial scenarios with study contracts, bids, and internal tasks and costs
·         Simplifying the comparisons and benchmarking of bids
·         Tracking and storing bids for historical and analytical purposes

One sponsor that implemented this platform and approach with its CRO partner was able to compress the contracting cycle-time from over three months to just two weeks.  Just as importantly, CROs benefit directly as well: by building a more collaborative working relationship with their customers, maximizing margin contribution while still producing competitive bids, and responding quickly to customer requests for bids.

Faster, better, more affordable trials, with greater achievability and fewer downstream changes to add delays and cost.  The cloud beckons.

About the Author: Mike Lange is Director, Product Strategy at Oracle Health Sciences, where he helps develop the next generation of eClinical software to enable the industry transform lives for the better by delivering safer and more effective therapies at dramatically faster speeds and lower costs.






Tuesday, April 14, 2015

Pall Corporation Acquired Tarpon Biosystem’s BioSMB Technology Platform

At the recent Biopharmaceutical Development and Production Week conference that took place at the end of March there was a multitude of new insights and ideas from industry leaders during the presentations. However one piece of news that had people desperately checking smartphones in disbelief to see if it was true.

On the 3rd day of the conference it was announced by Marc Bisschops, the Scientific Director of Tarpon Biosystems and Lynne Frick, VP of Business Development at Tarpon Biosystems that Pall Corporation had acquired Tarpon Biosystem’s BioSMB technology platform for column chromatography.

Pall Corporation, a specialist company who work in filtration, separation and purification have acquired the technology which is fully scalable from process development to large-scale good manufacturing practice production. The acquisition of this cutting edge technology will allow Pall to accelerate the adoption of continuous downstream processing into biopharmaceutical manufacturing. Pall will use their current innovative single use technologies and capabilities with the new technology to expand their portfolio on different scales. The addition of Tarpon Biosystems’ technology will complement the Allegro single-use products and systems that are already in place for Pall.

Ken Frank, who is the senior Vice President at Pall Life Sciences, said “We are pleased to add this cutting-edge technology to our growing portfolio of products and services. It extends our process intensification and continuous processing capabilities to support customers as they adopt continuous downstream processing.”.

This news shows the continuous push by companies in the industry to innovate and develop its systems through partnerships in order to boost development. The chromatographic systems enable multi-column, single-use chromatography for process development. This creates good placement for multi-product and single-use facilities which will ultimately boost production.

President of Tarpon Biosystems Nelson K. Stacks stated that ”With this acquisition the strength and reputation of Pall will enable an even wider adoption of the BioSMB platform.” This acquisition then whilst on its own is a huge moment, is a starting point for further adoption that will not only improve Pall’s production but potentially others. This means overall improvements in the industry which will continue to boost manufacturing and push new development and innovations.




Monday, April 13, 2015

Unfiltered. Real Data. The ONLY Place to Unveil the Industry's Best Kept Secrets.

Are you a clinical operations or outsourcing professional working to make your trials more efficient while cutting costs?

Partnerships in Clinical Trials (PCT) provides you with the tools and strategies to benchmark best practices - you don't want to miss out!

Based on feedback directly from the pharma/biotech marketplace, we're excited to unveil a brand new experience in content delivery:

WALK AWAY WITH 80+ PHARMA PERSPECTIVES
More than any other clinical conference offers - with first-hand experience and advice from a diverse speaking faculty from companies such as Pfizer, BMS, Dimension Therapeutics, Berg Health, Voyager Therapeutics, Actavis, Alexion, Lexicon Pharmaceuticals, GSK, and more.

CURATED AND APPROVED CONTENT BY AN EXPERT ADVISORY BOARD
Members hail from pharma/biotech/CROs ...and for the first time ever, a patient perspective! 

NEW DATA UNVEILED
Featuring never before heard updates:
  • INDUSTRY REPORT: Beyond Strategic Partnerships by Parexel
  • Tufts CSDD Data Unveiled: How Pharma Sponsors Are Really Using their CRO Partners
  • Update on TransCelerate Initiatives for 2015 + Beyond featuring experts from TransCelerate Biopharma Inc.  Merck , Bristol-Myers Squibb, Pfizer

NO MORE CANNED INFORMATION
New interactive and solution-oriented session formats:
  • Challenge/Solution Sessions - extended panels with dedicated time for audience interaction and 2-3 takeaways for immediate implementation share live
  • Think Tank Sessions - where attendees split up in open roundtable discussions each based on 1 industry challenge to solve and a solution session directly following to summarize actionable items you can take back to your office and implement the next day
  • Lively Roundtable Discussions discussing the advances in clinical research in the hottest therapeutic areas including CNS, C/V and Oncology

NOT JUST SUCCESS STORIES, BUT FAILURE TOO
Walk away with lessons on what not to do:
  • First time ever! FAILURE FORUM: Learning from Ideas that Missed the Mark featuring Thomas Lawler, AstraZeneca
  • Picking up the Pieces of Clinical Trial Failure: How I Battled the FDA and Won
    • Joseph Gulfo, MD, MBA, Former President and CEO, MELA Sciences, Author, "Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances"
  • Coming Together to Share Career Lessons: Turning Failure into Success
    • Bonnie Brescia, Founding Principal, BBK Worldwide
    • Michelle Browner PhD, Sr. Director, Platform Innovation & Partnership Management, Johnson & Johnson Innovation Center, fmr. CEO, Enlight Biosciences
    • Sue Collier. BSc. MBchB. DRCOG, Head of Medical Operations, Respiratory R&D, GlaxoSmithKline


We invite you and your team to join us at this year's conference for a curated content experience guaranteed to make your studies more efficient, effective and guide you to make the best use of your clinical trial dollars. 

Join us on April 22-24, 2015 in Boston, MA. Click here to register now.

Can't make it for all three days? Click here for more information on or one-day pass options starting at $795!




Friday, April 10, 2015

What Small Biopharma Can Teach Big Pharma About Nimble

PLUS: Why Pharma Must Stop Commoditizing Clinical Sites and What Needs to Happen to Develop Rational Combination Therapies

By Marc Dresner, IIR

A couple of weeks ago, the Inside Clinical series reported on new research into the Lean outsourcing trend that has captured so much attention at large pharmaceutical companies.

As the name suggests, Lean is about efficiency, but the companies adopting the model also see it as a means to drive “nimble” product development—a faster, more flexible and adaptive way of doing things.

What remains to be seen, however, is whether or not large companies will actually take full advantage of the insight and expertise their CRO partners bring to the table to effect a truly nimble strategy.

Sponsors pay quite a bit of lip service to collaboration; anecdotally, we know that CROs are still often underutilized, especially for planning upfront.

But just as Lean outsourcing models were inspired by the small biopharmas and startups that have always used them out of necessity, it may be that large pharmaceutical companies can fashion nimble approaches by borrowing a page or two from how these small companies actually partner with CROs.
Dr. Nick Kenny

According to Dr. Nick Kenny, EVP and General Manager of Global Oncology and Hematology at INC Research, large companies can learn a great deal from the innovative startups in the oncology space.

“Small biotechs have become very nimble about applying other people’s knowledge together with their own and making rapid decisions.”

“Traditionally the thinking has been: What can Big Pharma teach biotechs?” said Kenny. “The paradigm has shifted; now it’s the innovative, small companies that are actually making good partnerships.”

“A lot of these biotechs have become very nimble about applying other people’s knowledge together with their own and making rapid decisions based upon looking at data and really being adaptive partners, as opposed to some Big Pharma companies with traditional approaches that see their external vendors more as arms and legs to do the work versus contributing some intellectual capital,” Kenny told Inside Clinical.

“There is not a huge incentive for investigators to struggle through the administrative burden to participate in trials.”

Kenny also expressed concern about what he sees as the excessive administrative burden for study sites and clinical investigators, which he says at least partially accounts for chronic low participation rates in trials.

“There is not a huge incentive for investigators to struggle through the administrative burden and actually participate in trials,” Kenny said.

In this episode of Inside Clinical—the Partnerships in Clinical Trials podcast interview series—Dr. Kenny discusses how small companies partner differently, why the industry needs to stop treating sites and investigators like commodities and what urgently needs to happen to enable development of rational combination therapies.

Editor’s note: Dr. Nick Kenny will be presenting with Dr. Pablo Lapuerta from Lexicon on patient-centric study design at the 24th Annual Partnerships in Clinical Trials Conference running April 22-24 in Boston.

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


ABOUT THE AUTHOR / INTERVIEWER
Marc Dresner is IIR USA's senior editor and special communication projects lead. He is the former executive editor of Pharma Market Research Report, a confidential newsletter for marketing researchers in the pharmaceutical industry. He may be reached at mdresner@iirusa.com. Follow him @mdrezz.




Thursday, April 9, 2015

Big Data, Social Media & Patient Engagement Keynotes Reflect Dramatic Changes in Clinical Research

BioPharma Industry Leaders and Experts Focus on Innovating and Adapting to Technological Advancement at 24th Annual Partnerships in Clinical Trials Conference

BOSTON-- Produced by IIR USA; April 22-24, 2015; Boston, MA; Visit www.clinicaltrialpartnerships.com

“Connecting the Innovation Dots: Solutions to the Disconnection between the Pace of Technology and Traditional Approaches to Clinical Trials”

Senior executives in clinical development and operations from the world’s top pharmaceutical, biotech and medical device companies will be joined by experts in medical innovation to deliver keynote presentations on a range of emerging technological and patient-centric issues at the 24th Annual Partnerships in Clinical Trials (“PCT”) conference in Boston, MA, taking place April 22-24, 2015.

According to conference co-chair Jodie Morrison, President and CEO of Tokai Pharmaceuticals, this year’s PCT keynotes—several of whom have been recruited from outside the clinical research field—and the topics they will be covering reflect an urgent need in the clinical research industry to better understand how rapid technological innovation and the changing role of the patient are revolutionizing clinical development.

“The field of medicine is evolving rapidly and the complexities of both research and clinical development are increasing as a result,” said Morrison. “There is a critical need for a much broader set of tools and an increased focus on evaluating trends to ensure the success of clinical development in this new environment.”

“This year’s Partnerships in Clinical Trials keynotes will focus on new initiatives, broadening technology options and expanded opportunities that we simply can’t afford to ignore,” she added.
PCT 2015 keynotes will include visionaries from outside the clinical development field who will speak to how medical informatics, personalized medicine, patient trends and technology are transforming clinical research, including:

● “Can Big Data Cure Cancer?”
Atul Butte, MD, PhD, Director, Institute for Computational Health Sciences, and Professor of Pediatrics, University of California, San Francisco
A world-renowned medical informatics expert, Dr. Butte explains why the title of his keynote, “Can Big Data Cure Cancer?” is an increasingly rhetorical question thanks to extraordinary advancements in computational health and how Big Data analytics will impact clinical research.

● “Fast Tracking Clinical Development in a Moment's Notice: Patient Advocacy, Social Media and the Implications of Compassionate Use”
Kenneth Moch, former CEO, Chimerix             

As CEO of a small biotech caught between the realities of getting a developmental drug approved and an aggressive social media campaign to get a seven-year-old cancer patient pre-approval access to it, Ken Moch explains how social media can derail clinical development almost overnight and what manufacturers—particularly resource-strapped biotechs—can do to prepare.

● “Connecting the Innovation Dots: Solutions to the Disconnection between the Pace of Technology and Traditional Approaches to Clinical Trials”
Donald Jones, Chief Technology Officer, Scripps Translational Science Institute

Advances in digital technology are enabling researchers to collect different kinds of outcomes data in new ways and promise to provide a more complete and accurate picture of patients and the effect of therapies in studies. Donald Jones shares the latest on connected solutions to increase patient engagement and how information tools are transforming clinical trials.

● “Picking up the Pieces of Clinical Trial Failure: How I Battled the FDA and Won”
Dr. Joseph Gulfo, former President and CEO, MELA Sciences and author of "Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances"

Small companies—typically startups—today comprise the backbone of the drug and medical device innovation pipeline. For these companies to successfully develop a breakthrough depends as much on their ability to contend with investors and regulators as it does on smart science. Dr. Gulfo imparts the survival skills necessary to innovate in a hostile environment.

Additional keynote panels featuring industry leaders, policy experts and actual patients will bring a truly unique and diverse perspective to topics crucial to the future of clinical development, including:
·         Redefining Clinical Trials in the Age of Personalized Medicine
·         Patients as Partners: Implications of Patient Opinion Leaders on Clinical Development
·         Show Me Your Data: How Transparency is Driving Drug Development

With an eye toward partnering to adapt in an increasingly complex environment, PCT 2015 will feature nearly 150 speakers in keynotes and across eight specialized breakout tracks with exciting new unfiltered, unscripted and unedited formats spanning think tanks, case insights, intensives, and other interactive sessions, alongside results-oriented, innovative networking opportunities and special events like the 4th Annual Women’s Clinical Leadership Forum.

Approximately 1100 attendees representing more than 125 biopharma and medical device companies, contract research organizations (CROs) and other suppliers from nearly 50 countries are expected to attend PCT 2015, which promises to deliver data and insights that have never been heard before and real-world solutions to pressing new challenges in the world’s largest networking forum for clinical decision makers and their partners.

For more information or to register today, please visit our website: http://bit.ly/1INvlua

ABOUT PARTNERSHIPS IN CLINICAL TRIALS

With 23 years serving professionals in clinical development and operations, trials and outsourcing, Partnerships in Clinical Trials is the world’s foremost event series for clinical development leaders and practitioners. Annually, more than 2000 executives representing biopharma sponsors, CROs and third-party services providers attend Partnerships in Clinical Trial meetings in the US, Latin America, Europe and Asia to network, learn, strategize and advance next practices. Partnerships in Clinical Trials is produced by the Institute for International Research (IIR) and committed to redefining clinical research excellence on a global scale.

Contacts
IIR USA
Amanda Caterina, 646-895-7339
Senior Marketing Manager
acaterina@iirusa.com






Wednesday, April 8, 2015

Clinical Operations Optimization is Featured at Partnerships in Clinical Trials

Applied Clinical Trials is sponsoring the Clinical Operations Optimization track at this year’s Partnerships in Clinical Trials conference taking place April 22-24 in Boston.

Partnerships describes the track as: “This track is designed for professionals in the clinical operations, site management, and patient recruitment field to improve operational practices.”

The Clin Op Op track is a great fit for Applied Clinical Trials, so we are thrilled. The first word in the title of our magazine and website says it all—Applied. The anchor articles, our peer-reviewed selections, are developed by the do-ers working in our industry and reviewed by the experts who also have worked their way up. Our readership, in print and online, is 25 percent project managers, people who are in charge of the day-to-day operations of clinical trials. The next largest group is executives, who most likely know what applied looks like on a day-to-day, as well as an overarching strategy. So we are really looking forward to sponsoring this track.

Today, optimization is a word getting a lot of play due to the statistics, which I’m sure you’ve heard, about the cost to develop one drug through trials to market authorization. Partnerships uses the word improve in the description, but I think optimization couples efficiencies with innovation, which is definitely an improvement.

These following six sessions are what represent a horizontal view of optimization in clin ops:

Thursday, 4/23
1:30-2 pm--New Data Revealed from a Sponsor Collaboration Focused on Safety of Long-Acting Opiates. Speakers Mitchell Katz, Head of Medical Research and Drug Safety Operations, Purdue Pharma and James Young, PhD, Vice President, Global Product Development, Mallinckrodt Pharmaceuticals will present.

2-2:30 pm--Moving Towards Data Transparency: a J&J Case Study with Karla Childers Director, Strategic Projects Johnson & Johnson presenting.

2:30-3:30 pm--New Approaches to Speeding Up Clinical Trials - What Works and What Doesn't. 
In the midst of the deadly Ebola outbreak and the rushing to trial of experimental treatments, the world's top life sciences services company is calling for faster drug and vaccine development. This panel discussion includes, Craig Coffman Executive Director, Clinical Business Operations & Outsourcing, Nektar Therapeutics; Manny Lazaro, Senior Director, Clinical Operations, Forum Pharmaceuticals; Patrick Nealon MBA VP, Clinical Development, Takeda Oncology; and Daniela Popescu MD, Head of Clinical Operations for Roche Romania.


4:30-5 pm--A Look Into United Therapeutics Strategy in Pharma - Investigator Collaboration: Meeting Needs Through Motivation
This session is presented by David Green Executive Director and Hassan Movhaved Senior Vice President, Global Development Operations, with United Therapeutics. This presentation is an in-depth look of a webinar David Green presented with Applied Clinical Trials last month

Friday, 4/24
11:30-12 pm
How Lexicon Achieved Efficiency in Phase 3 with a Patient-Centric Study Design, presented by INC Research and Lexicon executives.

12-1 pm
Getting to the Core of Clinical Operations: Optimizing Study Feasibility & Country Selection, presented by Mohanish Anand PhD, MS Sr. Director, Head, Feasibility-Center Of Excellence Pfizer; G. Paul Evans Vice President Global Head, Feasibility and Enrollment Solutions PAREXEL; and Daniela Popescu MD Head of Clinical Operations Roche Romania SRL.

1:45-2:45 pm
What's in Your Clin Ops Tool Belt? Weave New Technology into Clinical Development, presented by expert consultants.

Don’t forget to register now and get your all access pass to optimizing your operations: http://bit.ly/1HQDZIp