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  • August 25, 2017

  • PharmaTalkRadio: Why Pharma R&D has to Start Thinking Like a Service Industry and How?

    The Conference Forum is pleased to share a podcast featuring keynote speaker and world renowned customer service expert, Dr Chip Bell who spoke at the 6th annual DPharm: Disruptive Innovations to Advance Clinical Trials on the topic of service in clinical trials. To truly service our patients, we need to understand service together with science. Can service be a […]

    The Conference Forum is pleased to share a podcast featuring keynote speaker and world renowned customer service expert, Dr Chip Bell who spoke at the 6th annual DPharm: Disruptive Innovations to Advance Clinical Trials on the topic of service in clinical trials.

    To truly service our patients, we need to understand service together with science. Can service be a disrupter in clinical research? In this keynote, Dr Bell tells us how to think like a service industry, why it’s worth it for R&D and how to get started. Dr Bell gives the listener practical insights on how to give patients a great experience. Although this podcast is primarily focused on serving patients in clinical research, you will find that hospitals and physician offices/medical groups will also benefit.

    The 7th annual DPharm conference will continue to cover service, but through a patient perspective. DPharm 2017 takes place September 7-8 in Boston. For more information, click here.

    About Dr Chip Bell:
    Dr Bell is considered a world-renowned authority on customer loyalty and service innovation. He has authored eight national best-selling books. For more information visit, www.chipbell.com.

     

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  • June 12, 2017

  • CMO Speaker, Dr David Schenkein Writes About Bringing Clinical Trials to Patients

    Recently, the Conference Forum presented Clinical Research as a Care Option, which was chaired by Katherine Vandebelt, Formerly, Global Head, Clinical Innovation, Eli Lilly and Jeff James, CEO, Wilmington Health. So we were thrilled to see that Dr David Schenkein, CEO, Agios Pharma, who keynoted in 2015 at the Chief Medical Officer Summit recently published […]

    Recently, the Conference Forum presented Clinical Research as a Care Option, which was chaired by Katherine Vandebelt, Formerly, Global Head, Clinical Innovation, Eli Lilly and Jeff James, CEO, Wilmington Health. So we were thrilled to see that Dr David Schenkein, CEO, Agios Pharma, who keynoted in 2015 at the Chief Medical Officer Summit recently published on Linkedin his view on the topic of bringing trials closer to patients. See below:

    To Get Patients into Clinical Trials, We Need to Get Clinical Trials to Patients

    The other day, an Agios employee, Holly, took an Uber to make a midday meeting. The driver mentioned that he was from out of town and welcomed any shortcuts to get to their destination. She asked where he was from, and during her brief ride, she learned that he drove an elderly woman from New Hampshire to Boston twice a week so she could participate in a clinical trial for a new cancer treatment at Mass General Hospital. It was a two-hour trip each way, and the treatment took four hours, so he filled that time giving rides close to the hospital.

    For the rest of the day, this woman’s story clung with Holly, who found herself wondering if she had friends or family with her at the hospital, what investigational medicine she was taking and if it made her sick on the long drive home. When Holly shared her experience with me, despite the pangs of sympathy, I found solace in the fact that this woman lives within driving distance of one of the leading cancer centers in the U.S., giving her access to the most advanced cancer care and potentially lifesaving clinical trials.

    Though the time commitment is significant and the cost of transportation is likely high, her situation is a stark contrast to the estimated 85 percent of cancer patients around the country who receive care in a community setting, where clinical trials are less likely to be offered. I’ve written before about my own experiences with the harsh emotional reality of participating in studies of new treatments, but low enrollment can also be attributed to geography. The truth is, most patients don’t live near a hospital or academic center that offers clinical trials, which can often be life-saving options for people who have already received approved therapies. Recent studies suggest that outcomes can vary widely depending on where patients receive care.

    There are many factors driving the inequities between cancer care and clinical trial access at academic health centers vs. community hospitals – including infrastructure costs, required FDA guidelines for clinical trials, necessary staff support, etc. Bridging that divide is something a colleague and friend of mine, Keith Flaherty, M.D., has spent much of his career trying to address. Dr. Flaherty is the Director of Developmental Therapeutics Clinical Research at the Massachusetts General Hospital Cancer Center and professor of medicine at Harvard Medical School. He also serves as the principal investigator for a clinical trial called NCI-MATCH, which is a study launched in August 2015 that analyzes patients’ tumors to determine whether they contain gene abnormalities for which a targeted drug exists and assigns treatment based on the abnormality. This study brings genomic testing and access to 30 targeted therapies to 6,000 patients at hundreds of hospitals and more than 1000 healthcare locations across the U.S. at no cost to the patient or treatment center.

    I spoke with Dr. Flaherty a few weeks ago to get his perspective on NCI-MATCH and the future of clinical trial access outside of big research centers. Here’s what he had to say.

    David:
    What does the future look like for clinical trials over the next few years?

    Dr. Flaherty:
    It’s suffice to say there’s a big gap and a big unmet need, and we must figure out how to move forward given that NCI-MATCH is about to end and a large clinical investigation community is going to lose access to genetic testing and clinical trial options. I recently co-founded a company called Strata Oncology, which aims to potentially perform an NCI-MATCH-like function. We’re focusing on driving clinical trial participation in regional networks outside of academic medical centers, which allows patients to stay in their community and creates a much more efficient process for matching them to clinical trials of targeted therapies.

    David:
    Certainly this addresses one of the bigger issues of identifying patients for biomarker-driven studies, which is critical. How has NCI-MATCH created the infrastructure in smaller community settings to make it easier to put a patient on a study and/or get a sponsor to use a small hospital that may only bring in one or two patients?

    Dr. Flaherty:
    Providing small hospitals with the genomic tests to identify biomarkers is pretty straightforward and a good place to start. Creating the necessary clinical trial infrastructure piece is doable. It just requires stripping out some of the bells and whistles. Part of this is reducing the amount of data that these hospitals are required to collect for trials. With fewer resources, community centers can only do so much, so studies have to be structured in a way that allows them to capture registration-quality data, which isn’t feasible if they’re being asked for 1,000 data points per patient.

    David:
    As you look ahead of the next 5 years, in terms of a change to the model and how we conduct clinical trials, do you believe we’ll see more biomarker-driven trials being offered in communities?

    Dr. Flaherty:
    I do believe that some version of democratizing clinical trial access will happen. I think it has to start with a coalition of sponsors who are looking for sparsely distributed, genetically defined patients in order to make it reasonably efficient. Together, we need to figure out a geographically smart way to get these clinical trials to where patients are, and streamline what we’re asking for in these community settings. This could easily double the percentage of patients who enroll in trials nationwide.

    For the benefit of the millions of people with cancer who are or will be treated in a community hospital, I hope Dr. Flaherty is right.

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  • May 19, 2017

  • Clinical Trials Day, May 19th: Who was James Lind?

    Today is Clinical Trials Day, so what does James Lind have to do with it? James Lind was a Scottish naval surgeon, who is credited for doing the first randomized clinical trial in 1747 aboard a ship. James Lind used six different methods on soldiers that were diagnosed with scurvy, with one of the methods […]

    James LindToday is Clinical Trials Day, so what does James Lind have to do with it? James Lind was a Scottish naval surgeon, who is credited for doing the first randomized clinical trial in 1747 aboard a ship. James Lind used six different methods on soldiers that were diagnosed with scurvy, with one of the methods involving oranges and lemons. The oranges healed the sailors, thus becoming a breakthrough for treating scurvy, but more importantly proving the potential power of a clinical trial.

    Clinical Trials Day is celebrated in recognition of James Lind on or near May 20th annually and to highlight the importance of clinical research in improving and saving lives. Happy Clinical Trials Day!

    We also want to share a video lovingly made by TCF speaker and HealthiVibe team member, Jeri Burtchell on a message thanking and recognizing clinical researchers: https://vimeo.com/218075510

    HealthiVibe also posted a video with Patients as Partner’s speaker Kyle Bryant on why research matters: https://vimeo.com/166241979

    Kyle Bryant, Patient Advocate with Valerie Bowling, Executive Director, TCF


    On a personal note, Jeri Burtchell was our first patient speaker. She spoke at DPharm in 2013 with Pfizer’s Craig Lipset. We credit Jeri for having the biggest impact on the way we now do our research. Kyle Bryant spoke at the Patients as Partner’s event in 2016 and is a Rare Disease Patient Advocate.

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  • May 18, 2017

  • CISCRP Launches Clinical Trial Awareness Campaign Nationwide with T.J. Sharpe

    We are pleased to share that one of our partners, CISCRP, has launched the National Clinical Trial Outreach and Awareness Initiative to reach millions of Americans to inform the public and patients about the clinical research process. We are delighted to see that their first ad features one of our patient advocate speakers, TJ Sharp. […]

    We are pleased to share that one of our partners, CISCRP, has launched the National Clinical Trial Outreach and Awareness Initiative to reach millions of Americans to inform the public and patients about the clinical research process. We are delighted to see that their first ad features one of our patient advocate speakers, TJ Sharp. TJ is a metastatic melanoma survivor and medical hero. To learn more about the campaign, read the press release.

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  • April 5, 2017

  • Clinical Research as a Care Option (CRAACO) Recap

    The Conference Forum presented an afternoon program on April 4th dedicated to Clinical Research as a Care Option (CRAACO). How can CRAACO become a reality? To find out, let’s take a look at the highlights from CRAACO: Keynote Speaker Panel Explores Bridging Healthcare to Life Science  The CRAACO portion of the CTC conference launched with […]

    The Conference Forum presented an afternoon program on April 4th dedicated to Clinical Research as a Care Option (CRAACO).

    How can CRAACO become a reality? To find out, let’s take a look at the highlights from CRAACO:

    1. Keynote Speaker Panel Explores Bridging Healthcare to Life Science

     The CRAACO portion of the CTC conference launched with a keynote speaker discussion about how to bridge healthcare to life science.

    Panel discussion participants included:

    Moderator:

    Jennifer Byrne, Founder, Greater Gift Initiative

    Panelists: 

    John McConnell, MD, CEO, Wake Forest University Medical Center

    Tom Pike, Life Science Advisor, Former CEO, Quintiles

    According to McConnell, it is paramount for healthcare organizations to think about all aspects of the healthcare system relative to CRAACO. By doing so, these organizations can identify clinical trial problems and address such issues before they escalate.

    “We need to think about making that whole system of clinical trials as a care option work,” McConnell said.

    In addition, effective data management and education are key tenets to link healthcare to life science, McConnell stated.

    “We need more data,” he noted. “More education and support are needed to make clinical trial a valuable experience for organizations and patients.”

    1. Healthcare Experts Discuss Accountable Care Organization (ACO) and Clinical Research As a Counter Measure

    Healthcare is shifting toward a value-based system where quality, cost and experience are transparent to the patient. As such, the link between clinical research and population health and value is becoming increasingly important to healthcare organizations and patients alike.

    Several healthcare leaders discussed how organizations are using clinical research in conjunction with their ACO to drive value during a CRAACO panel discussion that featured insights from:

    Moderator:

    Jeff James, CEO, Wilmington Health

    Panelists:

    Kenneth Bilger, CEO, Christie Clinic

    Robert Matthews, President and CEO, Medisync

    Matthews defined value as “the amount a group is paid for medical services and/or number of patients that can be gained with access to care.” He also indicated the value-payment model offers enhanced measurement and transparency – both of which are exceedingly valuable for patients and healthcare organizations.

    Data may transform the way that healthcare organizations analyze value as well, Matthews stated. If healthcare organizations embrace data management and discover ways to get doctors to engage on data, these organizations may be able to optimize the value of their clinical research efforts.

    1. Leadership Panels Analyzes Value-Based Healthcare Delivery

    What is value-based healthcare, and how can it help deliver improved patient outcomes? Healthcare experts explored these topics as part of a CRAACO panel discussion that included insights from:

    Moderator:

    Meredith Alger, Healthcare Researcher, Program Manager, Harvard Business School

    Panelists:

    Christina Akerman, MD, President, International Consortium of Health Outcome Measurements (ICHOM)

    Toyin Okanlawon, MD, Senior Researcher, Harvard Business School, Institute for Strategy & Competitiveness

    How value-based healthcare can be delivered often is debated, according to Okanlawon. But healthcare organizations cannot debate the importance of healthcare quality and the accountability factors associated with it.

    “Value is not synonymous with quality,” Okanlawon said. “Value embeds itself with accountability. … At the end of the day, we’re all going to disagree on how to measure costs. But we can’t really disagree on whether someone is dead or alive.”

    Furthermore, healthcare organizations must prioritize value-based outcomes over costs, Akerman stated. This approach will enable healthcare organizations to define patient standards and ensure both organizations and patients can optimize the value of healthcare treatments.

    1. Healthcare Leaders Discuss Data Science for Clinical Research and Care Delivery

    The final CRAACO leadership panel discussion examined opportunities for life science organizations to create value from data science and align incentives to help physicians conduct clinical research, improve data quality and preserve patient safety.

    Discussion participants included:

    Moderator:

    Craig Lipset, Head of Clinical Innovation, R&D, Pfizer

    Panelists:

    William Crown, PhD, Chief Science Officer, Optum Labs

    Kenneth Mandl, MD, Director, Computational Health Informatics Program/Professor, Boston Children’s Hospital/Harvard Medical School

    Kyu Rhee, MD, Chief Health Officer, IBM

    Data and analytics together drive healthcare enablement. These technologies empower healthcare organizations with insights into patient behaviors and trends and can help these organizations uncover meaningful insights to drive CRAACO.

    “There are many hooks into data and analytics, and there is also a decision support network developing from it,” Mandl said.

    The role of technology in advancing key healthcare insights continues to expand, Rhee indicated.

    Cloud, content and cognitive technologies help healthcare organizations gain insights from a large assortment of data. Yet collaborations may have the greatest impact on healthcare organizations because they allow these organizations to look beyond the healthcare setting and find innovative ways to engage all stakeholders, Rhee said.

    Thank you to everyone who made the CRAACO event possible, especially Eli Lilly and Company and PMG Research, Inc.

    Read More

  • April 5, 2017

  • Clinical Trial Collaborations (CTC) Conference Re-Cap

    Clinical Trial Collaborations (CTC) conference has reached its conclusion and many thanks to all participants for insights and support. Below you will a rec-cap of the highlights of the event: April 3rd, 2017 Here are five highlights from Day One’s keynote presentations and leadership panel discussions. Eli Lilly’s Global Head of Clinical Innovation Explores the […]

    Clinical Trial Collaborations (CTC) conference has reached its conclusion and many thanks to all participants for insights and support.

    Below you will a rec-cap of the highlights of the event:

    April 3rd, 2017

    Here are five highlights from Day One’s keynote presentations and leadership panel discussions.

    1. Eli Lilly’s Global Head of Clinical Innovation Explores the Importance of Collaboration and Innovation in Clinical Trials

    Katherine Vandebelt, Global Head of Clinical Innovation at Eli Lilly & Company, analyzed the importance of collaboration in clinical trials in her introductory address to CTC conference attendees.

    According to Vandebelt, a recent Harvard Business Review study showed only 3 percent to 5 percent of organizational staff members can collaborate successfully. This indicates many organizations are missing out on opportunities to foster collaboration and promote growth and development.

    Ultimately, collaboration is a difference-maker in clinical trials. With the right commitment and attention to detail, contract research organizations (CROs) and pharmaceutical companies can drive collaboration with staff at all levels and across all departments.

    “Collaboration is something we should strive to do and strive to do well,” Vandebelt said. “If we can get great minds to come together, great things will happen that are very powerful.”

    1. Fireside Keynote Emphasizes Models for Exquisite Project Delivery with Internal and External Partners

    What does it take to develop the right project delivery model for drug development? Andy Lee, Senior Vice President and Head of Global Clinical Operations at Merck, and Ken Getz, Director of Sponsored Research Programs at Tufts CSDD, explored the topic in detail as part of a fireside keynote.

    Lee pointed out how a large CRO and a small CRO approach drug development may vary – and perhaps it is easy to understand why.

    “Big companies and small companies have very different psychologies,” Lee told CTC conference attendees. “Big companies are like stock brokers who manage a fund, and small companies are like stock owners.”

    However, Lee said a CRO must be able to identify and address drug development challenges, regardless of the organization’s size or stature. With an agile project delivery model in place, a CRO will be able to optimize the time and resources at its disposal and get the best results possible.

    “You’re in a model in every company where you have a set amount of resources. … In larger companies, you may have different levels of flex,” Lee stated. “You really need to figure out how to put that jigsaw puzzle together in the most productive way.”

    1. ICON’s CEO Discusses Major Trends in Clinical Development

    ICON CEO Steve Cutler explored the biggest trends in clinical development in his keynote address to CTC conference attendees.

    Productivity and cost, reimbursement and patient engagement represent the key trends that are impacting clinical development today, Cutler stated.

    In addition, Cutler pointed out there is a discrepancy between the value of pharmaceuticals and how they are viewed by the general public.

    “The value of pharmaceuticals is undoubted, but we’re not seeing that reflected in the pharmaceutical industry or the CRO industry,” he said.

    Pharmaceutical companies are operating in an increasingly complex global marketplace, Cutler stated. But patient collaborations may help these businesses overcome many marketplace challenges.

    “The opportunity to connect with patients is significant, and it is an opportunity that we need to embrace,” Cutler indicated.

    1. Takeda’s Chief Medical and Scientific Officer and PRA Health Sciences’ EVP of Business Development Review the True Value of Transformative Partnerships

    Andy Plump, MD, Chief Medical and Scientific Officer at Takeda, and Tami Klerr, Executive Vice President of Business Development at PRA Health Sciences, examined the power of transformative partnerships during a joint presentation at the CTC conference.

    Plump suggested a highly networked model can drive transformative clinical trial partnerships between healthcare organizations and patients. To develop this model, an organization must build a culture that promotes agility and openness, Plump said.

    “We can’t build an organization that has deep vertical expertise across every modality. What we need to do is create an agile organization … that partners,” he stated.

    Klerr pointed out that improving cost savings and increasing efficiency are top priorities for many CROs and pharmaceutical companies. Meanwhile, transformative partnerships can provide support in both areas if all parties involved maintain ongoing communication and alignment.

    “You have to be patient and keep everyone aligned from the top down,” Klerr said.

    1. Janssen’s Global Patient Engagement Leader and Senior Director for Benefit-Risk Assessment Take a Look at Patient Engagement

    What is patient engagement, and how can CROs and pharmaceutical companies drive patient engagement day after day? Katherine Capperella, Global Patient Engagement Leader at Janssen Pharmaceuticals, and Bennett Levitan, MD, PhD, Senior Director for Benefit-Risk Assessment and Department of Epidemiology at Janssen R&D, defined patient engagement during their presentation at the CTC conference.

    Capperella noted patient engagement involves “systematically interacting directly with patients, obtaining expressed and inferred insight from patients and acting on patient perspectives.” She also stated that patient engagement is a continuous process that requires CROs and pharmaceutical companies to connect with patients and learn from them consistently.

    At the same time, growing regulatory and patient momentum for patient-focused drug development/benefit-risk provides numerous external collaboration opportunities, Levitan said. If CROs and pharmaceutical companies embrace patient-focused drug development/benefit-risk, they may be able to reap the benefits of long-lasting patient partnerships.

    Tuesday marks Day Two of the CTC conference and will feature keynote presentations, leadership panels and much more – click here for full details.


    April 4th, 2017

    Clinical Trial Collaborations (CTC) Conference Day Two Recap

    Day One of the CTC conference featured lively discussions and presentations about the importance of collaboration and innovation, major trends in clinical development and much more.

    What happened at Day Two of the CTC conference? Here are the highlights.

    1. Director of Fairmount Partners Discusses the State of Collaboration in Clinical Trials

    Fairmount Partners Director Michael Martorelli explored the current state of collaboration in clinical trials – and what it takes to drive effective collaboration in clinical trials – in his keynote presentation to CTC conference attendees.

    According to Martorelli, effective collaborations features the following characteristics:

    Completely aligned goals

    High level of support and leadership

    Trust (free flow of data and positive working relationships)

    Formal governance structures

    Ultimately, Martorelli concluded that all organizations collaborate in one way or another, yet some collaborations are more effective than others. To optimize the value of clinical trial collaborations, organizations must prioritize innovation and execution, regardless of clinical trial model.

    “There are new companies creating something out of nothing but an idea,” Martorelli stated. “They try to get involved – not resolve – the issue of getting clinical research done faster. They try to innovate to solve a part of it.”

    1. Leadership Panel Discusses the CRO of the Future

    What does the future of the CRO need to look like? A clinical research leadership panel examined the topic in detail during the CTC conference.
    The leadership panel included the following participants:

    Moderator:

    Murray Abramson, MD, Vice President, Global Clinical Operations, Biogen

    Panelists:

    Pablo Lapuerta, MD, Executive Vice President and Chief Medical Officer, Lexicon Pharmaceuticals

    Adrian McKemey, PhD, Senior Vice President, Consulting Services, QuintilesIMS

    Ross Pettit, Senior Vice President, Development Operations, BeiGene

    Stephanie Petrone, Executive Director, Medical Operations, Novartis

    Jim Roach, MD, FACP, FCCP, CMO, Veristat

    Bill Row, Divisional Principal, Real World Evidence Solutions, ICON

    CROs often face a major dilemma: even though they want to allocate time and resources to innovation, doing so may require these organizations to make various sacrifices along the way.

    “We struggle between the yin and yang. We want to do all of these things to innovate, but trying to fit them into our core deliverable of getting our drug to market can be difficult,” Petrone stated.

    At the same time, developing goals remains a major challenge, particularly for small and evolving CROs.

    “There is a correlation between the size, history and infrastructure of a company and its ability to develop well-defined goals. … I find that larger companies have this process pretty well worked out, whereas smaller companies don’t, and they look to us for help,” Roach noted.

    Moreover, a strong partnership between an investigative site and CRO is essential and may dictate the success of both parties.

    “Even in small companies, you can develop good partnerships, and I think we’ve been successful in developing partnerships that drive collaboration and teamwork,” Lapuerta indicated. “You can really accomplish a lot as a small company as part of a partnership with a CRO.”

    1. PAREXEL’s Strategic Director Describes How to Optimize Collaborations in Different Outsourcing Models

    James Anthony, Corporate Vice President and Strategic Account Leader at PAREXEL, discussed what it takes to optimize collaborations in various outsourcing models in his presentation to CTC conference attendees.

    Anthony emphasizes the “4 C’s” to drive successful collaborations:

    Consistency

    Culture

    Collaboration

    Change

    Also, Anthony pointed out that data and relationship management play key roles in collaborations in all outsourcing models.

    If organizations learn about data and know how to visualize it effectively, they can maximize the value of this information, Anthony said.

    Meanwhile, organizations also must be able to maintain consistent communication with partners to get the best results possible.

    “Make sure that you’re controlling the data,” Anthony told conference attendees. “And make sure you’re spending time on relationships.”

    1. Duke University’s Robert Califf Outlines the Current State of Clinical Trials and Pathways to Transformation

    Robert Califf, MD, MACC, Professor of Cardiology, Duke University School of Medicine, offered his perspective on the present state of clinical trials and how to foster transformation in his CTC conference presentation.
    Califf indicated the key challenge in clinical trials revolves around the integration of multiple data sets for discovery and implementation. “As our understanding of the [clinical trial] ecosystem grows, it is clear that it is delivering a fraction of the reliable actionable evidence that we need,” he stated.

    To overcome data analysis challenges, Califf recommended the following pathways to transformation:

    Education

    Continuation on the path to data transparency

    Human adaptation to the power of computation

    Deployment of information and analytics

    Califf also noted that log order improvement “is within sight” for late phase and health delivery clinical improvement trials.

    1. Leadership Panel Reviews the Challenges and Competition Associated with Collaboration

    Several clinical trial leaders examined the complexities associated with global collaborations during a panel discussion at the CTC conference.
    The leadership panel featured:

    Moderator:

    Ken Getz, Director of Sponsored Research Programs, Tufts CSDD

    Panelists:

    Mike Collins, Head of R&D Vendor Management, Alexion Pharmaceuticals

    Deborah Howe, Associate Director, Vendor Alliance Lead, Central Clinical Planning & Solutions, R&D, Bristol-Myers Squibb

    Veronica Ludensky, Senior Manager, Clinical Outsourcing, Takeda Pharmaceuticals

    Adrian Otte, MB, BCH, FFPM, Vice President, Global Development Operations, Amgen

    Joel Rothman, Vice President, Development Operations, Cytokinetics

    Globalization is a top consideration for many CROs and pharmaceutical companies, but implementing clinical trials around the world sometimes can be difficult. However, these organizations must consider ways to deploy global clinical trials – or risk falling behind the competition.

    “It’s really about finding out where are the patients and how fast you can get them. And in many rare clinical trial cases, you have to go global,” Rothman stated.

    On the other hand, logistics and compliance issues may hinder an organization’s ability to perform clinical trials in different countries.

    Many technologies are available that may help CROs and pharmaceutical companies reap the benefits of global clinical trials. Conversely, organizations must consider their technology investments closely, as some technologies may make it more difficult for these organizations to accomplish their immediate and long-term goals.

    “As we add more technology and more things that are supposed to simplify things, they can actually make things more complicated,” Ludensky noted. “We have all these bells and whistles that are going to make site trials better, but they can actually make site trials last longer.”

    1. Keynote Speaker Panel Explores Bridging Healthcare to Life Science

    The Clinical Research as a Care Option (CRAACO) portion of the CTC conference launched with a keynote speaker discussion about how to bridge healthcare to life science.

    Panel discussion participants included:

    Moderator:

    Jennifer Byrne, Founder, Greater Gift Initiative

    Panelists:

    John McConnell, MD, CEO, Wake Forest University Medical Center

    Tom Pike, Life Science Advisor, Former CEO, Quintiles

    According to McConnell, it is paramount for healthcare organizations to think about all aspects of the healthcare system relative to CRAACO. By doing so, these organizations can identify clinical trial problems and address such issues before they escalate.

    “We need to think about making that whole system of clinical trials as a care option work,” McConnell said.

    In addition, effective data management and education are key tenets to link healthcare to life science, McConnell stated.

    “We need more data,” he noted. “More education and support are needed to make clinical trial a valuable experience for organizations and patients.”

    1. Healthcare Experts Discuss Accountable Care Organization (ACO) and Clinical Research As a Counter Measure

    Healthcare is shifting toward a value-based system where quality, cost and experience are transparent to the patient. As such, the link between clinical research and population health and value is becoming increasingly important to healthcare organizations and patients alike.
    Several healthcare leaders discussed how organizations are using clinical research in conjunction with their ACO to drive value during a CRAACO panel discussion that featured insights from:

    Moderator:

    Jeff James, CEO, Wilmington Health

    Panelists:

    Kenneth Bilger, CEO, Christie Clinic

    Robert Matthews, President and CEO, Medisync

    Matthews defined value as “the amount a group is paid for medical services and/or number of patients that can be gained with access to care.” He also indicated the value-payment model offers enhanced measurement and transparency – both of which are exceedingly valuable for patients and healthcare organizations.

    Data may transform the way that healthcare organizations analyze value as well, Matthews stated. If healthcare organizations embrace data management and discover ways to get doctors to engage on data, these organizations may be able to optimize the value of their clinical research efforts.

    1. Leadership Panels Analyzes Value-Based Healthcare Delivery

    What is value-based healthcare, and how can it help deliver improved patient outcomes? Healthcare experts explored these topics as part of a CRAACO panel discussion that included insights from:

    Moderator:

    Meredith Alger, Healthcare Researcher, Program Manager, Harvard Business School

    Panelists:

    Christina Akerman, MD, President, International Consortium of Health Outcome Measurements (ICHOM)

    Toyin Okanlawon, MD, Senior Researcher, Harvard Business School, Institute for Strategy & Competitiveness

    How value-based healthcare can be delivered often is debated, according to Okanlawon. But healthcare organizations cannot debate the importance of healthcare quality and the accountability factors associated with it.

    “Value is not synonymous with quality,” Okanlawon said. “Value embeds itself with accountability. … At the end of the day, we’re all going to disagree on how to measure costs. But we can’t really disagree on whether someone is dead or alive.”

    Furthermore, healthcare organizations must prioritize value-based outcomes over costs, Akerman stated. This approach will enable healthcare organizations to define patient standards and ensure both organizations and patients can optimize the value of healthcare treatments.

    1. Healthcare Leaders Discuss Data Science for Clinical Research and Care Delivery

    The final CRAACO leadership panel discussion examined opportunities for life science organizations to create value from data science and align incentives to help physicians conduct clinical research, improve data quality and preserve patient safety.
    Discussion participants included:

    Moderator:

    Craig Lipset, Head of Clinical Innovation, R&D, Pfizer

    Panelists:

    William Crown, PhD, Chief Science Officer, Optum Labs

    Kenneth Mandl, MD, Director, Computational Health Informatics Program/Professor, Boston Children’s Hospital/Harvard Medical School

    Kyu Rhee, MD, Chief Health Officer, IBM

    Data and analytics together drive healthcare enablement. These technologies empower healthcare organizations with insights into patient behaviors and trends and can help these organizations uncover meaningful insights to drive CRAACO.

    “There are many hooks into data and analytics, and there is also a decision support network developing from it,” Mandl said.

    The role of technology in advancing key healthcare insights continues to expand, Rhee indicated.

    Cloud, content and cognitive technologies help healthcare organizations gain insights from a large assortment of data. Yet collaborations may have the greatest impact on healthcare organizations because they allow these organizations to look beyond the healthcare setting and find innovative ways to engage all stakeholders, Rhee said.

    Preparations are underway for the third-annual CTC conference – stay tuned for updates.

    Read More

  • April 4, 2017

  • Clinical Trial Collaborations (CTC) Conference Day One Recap

    Day One of the second-annual Clinical Trial Collaborations (CTC) conference has reached its conclusion. Here are five highlights from Day One’s keynote presentations and leadership panel discussions. Eli Lilly’s Global Head of Clinical Innovation Explores the Importance of Collaboration and Innovation in Clinical Trials Katherine Vandebelt, Global Head of Clinical Innovation at Eli Lilly & […]

    Day One of the second-annual Clinical Trial Collaborations (CTC) conference has reached its conclusion.

    Here are five highlights from Day One’s keynote presentations and leadership panel discussions.

    1. Eli Lilly’s Global Head of Clinical Innovation Explores the Importance of Collaboration and Innovation in Clinical Trials

    Katherine Vandebelt, Global Head of Clinical Innovation at Eli Lilly & Company, analyzed the importance of collaboration in clinical trials in her introductory address to CTC conference attendees.

    According to Vandebelt, a recent Harvard Business Review study showed only 3 percent to 5 percent of organizational staff members can collaborate successfully. This indicates many organizations are missing out on opportunities to foster collaboration and promote growth and development.

    Ultimately, collaboration is a difference-maker in clinical trials. With the right commitment and attention to detail, contract research organizations (CROs) and pharmaceutical companies can drive collaboration with staff at all levels and across all departments.

    “Collaboration is something we should strive to do and strive to do well,” Vandebelt said. “If we can get great minds to come together, great things will happen that are very powerful.”

    1. Fireside Keynote Emphasizes Models for Exquisite Project Delivery with Internal and External Partners

    What does it take to develop the right project delivery model for drug development? Andy Lee, Senior Vice President and Head of Global Clinical Operations at Merck, and Ken Getz, Director of Sponsored Research Programs at Tufts CSDD, explored the topic in detail as part of a fireside keynote.

    Lee pointed out how a large CRO and a small CRO approach drug development may vary – and perhaps it is easy to understand why.

    “Big companies and small companies have very different psychologies,” Lee told CTC conference attendees. “Big companies are like stock brokers who manage a fund, and small companies are like stock owners.”

    However, Lee said a CRO must be able to identify and address drug development challenges, regardless of the organization’s size or stature. With an agile project delivery model in place, a CRO will be able to optimize the time and resources at its disposal and get the best results possible.

    “You’re in a model in every company where you have a set amount of resources. … In larger companies, you may have different levels of flex,” Lee stated. “You really need to figure out how to put that jigsaw puzzle together in the most productive way.”

    1. ICON’s CEO Discusses Major Trends in Clinical Development

    ICON CEO Steve Cutler explored the biggest trends in clinical development in his keynote address to CTC conference attendees.

    Productivity and cost, reimbursement and patient engagement represent the key trends that are impacting clinical development today, Cutler stated.

    In addition, Cutler pointed out there is a discrepancy between the value of pharmaceuticals and how they are viewed by the general public.

    “The value of pharmaceuticals is undoubted, but we’re not seeing that reflected in the pharmaceutical industry or the CRO industry,” he said.

    Pharmaceutical companies are operating in an increasingly complex global marketplace, Cutler stated. But patient collaborations may help these businesses overcome many marketplace challenges.

    “The opportunity to connect with patients is significant, and it is an opportunity that we need to embrace,” Cutler indicated.

    1. Takeda’s Chief Medical and Scientific Officer and PRA Health Sciences’ EVP of Business Development Review the True Value of Transformative Partnerships

    Andy Plump, MD, Chief Medical and Scientific Officer at Takeda, and Tami Klerr, Executive Vice President of Business Development at PRA Health Sciences, examined the power of transformative partnerships during a joint presentation at the CTC conference.

    Plump suggested a highly networked model can drive transformative clinical trial partnerships between healthcare organizations and patients. To develop this model, an organization must build a culture that promotes agility and openness, Plump said.

    “We can’t build an organization that has deep vertical expertise across every modality. What we need to do is create an agile organization … that partners,” he stated.

    Klerr pointed out that improving cost savings and increasing efficiency are top priorities for many CROs and pharmaceutical companies. Meanwhile, transformative partnerships can provide support in both areas if all parties involved maintain ongoing communication and alignment.

    “You have to be patient and keep everyone aligned from the top down,” Klerr said.

    1. Janssen’s Global Patient Engagement Leader and Senior Director for Benefit-Risk Assessment Take a Look at Patient Engagement

    What is patient engagement, and how can CROs and pharmaceutical companies drive patient engagement day after day? Katherine Capperella, Global Patient Engagement Leader at Janssen Pharmaceuticals, and Bennett Levitan, MD, PhD, Senior Director for Benefit-Risk Assessment and Department of Epidemiology at Janssen R&D, defined patient engagement during their presentation at the CTC conference.

    Capperella noted patient engagement involves “systematically interacting directly with patients, obtaining expressed and inferred insight from patients and acting on patient perspectives.” She also stated that patient engagement is a continuous process that requires CROs and pharmaceutical companies to connect with patients and learn from them consistently.

    At the same time, growing regulatory and patient momentum for patient-focused drug development/benefit-risk provides numerous external collaboration opportunities, Levitan said. If CROs and pharmaceutical companies embrace patient-focused drug development/benefit-risk, they may be able to reap the benefits of long-lasting patient partnerships.

    Tuesday marks Day Two of the CTC conference and will feature keynote presentations, leadership panels and much more – click here for full details.

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  • April 3, 2017

  • Congratulations to Conference Forum Speakers Dr Robert Califf, Craig Lipset, and Marc Boutin on their Leadership Roles in the Newly Formed People-Centered Research Foundation

    Source: Healthcare Informatics March 27, 2017 by David Raths Robert Califf, M.D., who stepped down as commissioner of the U.S. Food and Drug Administration in January, has been named chair of a new nonprofit organization, the People-Centered Research Foundation, which has been created to sustain and expand a national network for clinical research that originated […]

    Source:
    Healthcare Informatics

    March 27, 2017
    by David Raths

    Robert Califf, M.D., who stepped down as commissioner of the U.S. Food and Drug Administration in January, has been named chair of a new nonprofit organization, the People-Centered Research Foundation, which has been created to sustain and expand a national network for clinical research that originated with funding from the Patient-Centered Outcomes Research Institute (PCORI) and studies conducted by the national Patient-Centered Clinical Research Network (PCORnet).

    The PCORI web site said its board of governors has agreed to provide up to $25.4 million in additional infrastructure-building funds to support the long-term sustainability of PCORnet through PCRF, which was formed by PCORnet investigators to advance and support the network’s sustainability.

    On its web site, PCRF said it would provide retrospective observational research using its data network, prospective research that collects new data from patients, and high-impact clinical trials. “Each study will deeply engage patients and clinicians in its design, conduct, and dissemination. A balanced mix of support from government, foundations, and industry will sponsor the studies. All projects will be aligned with the foundation’s mission of centering projects around the needs of people and their health.”

    Califf also has returned to the Duke Clinical Research Institute, which he founded in 2006, as the Donald F. Fortin professor of cardiology. In a letter on the nonprofit’s web site, he said that PCRF would integrate people into all phases of research and the learning health system. “Patients, participants, patient advocates, and caregivers will constitute a meaningful percentage of our board; be involved in leadership roles in all committees; and participate in the development and execution of the research.”

    He added that PCRF has a robust business plan in place, with seven members of what could grow to be a 13-member board, and plans to build a program management office that will be led by an executive director.

    The other board members are:

    • Richard Bankowitz, MD, MBA, FACP, Executive Vice President, Clinical Affairs, America’s Health Insurance Plans (AHIP)
    • Josephine P. Briggs, MD, Director, National Center for Complementary and Integrative Health (NCCIH)
    • Marc M. Boutin, JD, Chief Executive Officer, National Health Council (NHC)
    • Donna Cryer, President & CEO of the Global Liver Institute
    • Craig Lipset, MBA, Head of Clinical Innovation, Worldwide Research & Development, Pfizer Inc.
    • Joanne Waldstreicher, MD, Chief Medical Officer, Johnson & Johnson

    Dr Robert Califf recently spoke at the R&D Leadership Summit and spoke at the Clinical Trial Collaborations conference. Marc Boutin also recently spoke at the R&D Leadership Summit and is a lead advisor and speaker at the Patients as Partners US conference. Craig Lipset is the co-chair of the DPharm: Disruptive Innovations to Advance Clinical Trials conference and spoke at the inaugural Clinical Research as a Care Option program.

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  • March 20, 2017

  • Takeda Pharmaceutical Company and PRA Health Sciences will Jointly Present at CTC

    PRA Health Sciences, Inc. and Takeda Pharmaceutical Company announced in September that the companies have entered into a new partnership agreement under which PRA will serve as Takeda’s primary strategic partner to deliver on the company’s pipeline and marketed products clinical development and post-approval needs. “This partnership is a fundamental part of Takeda’s R&D transformation […]

    PRA Health Sciences, Inc. and Takeda Pharmaceutical Company announced in September that the companies have entered into a new partnership agreement under which PRA will serve as Takeda’s primary strategic partner to deliver on the company’s pipeline and marketed products clinical development and post-approval needs.

    “This partnership is a fundamental part of Takeda’s R&D transformation and represents a truly innovative approach to clinical development, unprecedented in our industry,” said Andy Plump, MD, PhD, Director, Chief Medical and Scientific Officer at Takeda.

    The idea of the partnership is to provide a flexible operating model that combines operational expertise, transferred from Takeda to PRA. This model is aimed to improve operating efficiencies and provide a flexible approach to facilitate the development of new medicines by focusing resources, teams and activities where needed.

    On April 3rd at the CTC conference, both Andy Plump, MD, PhD, Chief Medical and Scientific Officer, Takeda and Tami Klerr, EVP, Business Development, PRA Health Sciences will jointly present an update on how their collaboration is going. It is a great opportunity for industry to learn from their experience.

    CTC is in its 2nd year and gives the industry a strategic look at how to collaborate in primarily needed outsourced functions to advance drug development. The CTC agenda takes a careful look at three alignment factors: resources, technology and processes along with time, cost, service, and scientific integrity. Depending on the stage of the company and therapeutic area, speakers help guide industry on what to prioritize and how collaborate to fit the need of the organization. For more information, visit: http://theconferenceforum.org/conferences/clinical-trial-collaborations/overview

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  • March 20, 2017

  • Merck’s Head of Global Clinical Trials, Andy Lee to keynote CTC this April

    Andy Lee, SVP, Head of Global Clinical Trial Operations, Merck, challenged the research team at The Conference Forum to bring a session to CTC (Clinical Trial Collaborations) that speaks to what it really means to truly collaborate for exquisite project delivery. We are delighted to welcome Andy in a keynote discussion with Tufts, Director of […]

    Andy Lee, SVP, Head of Global Clinical Trial Operations, Merck, challenged the research team at The Conference Forum to bring a session to CTC (Clinical Trial Collaborations) that speaks to what it really means to truly collaborate for exquisite project delivery. We are delighted to welcome Andy in a keynote discussion with Tufts, Director of Sponsored Research Programs, Ken Getz as he shares his insights, concerns and suggestions for working more effectively to strike a better balance in the delivery model for effective drug development. Discussion points include:

    • How do companies of different sizes find the model to the get the work done?
    • How do sponsors manage a flexible portfolio; How to best navigate the ups and downs?
    • What’s needed to cover the depth and breadth of projects across the globe?
    • How do you establish partnerships?
    • What is the right model for an organization (fully internal, fully external or a hybrid?)
    • Challenges the CROs have created and their immense capabilities

    Ken Getz will also present at CTC with an industry update on how the clinical collaborations landscape is changing and its impact on R&D operations. Both of these sessions will happen on April 3rd at CTC.

    CTC is in its 2nd year and gives the industry a strategic look at how to collaborate in primarily needed outsourced functions to advance drug development. The CTC agenda takes a careful look at three alignment factors: resources, technology and processes along with time, cost, service, and scientific integrity. Depending on the stage of the company and therapeutic area, speakers help guide industry on what to prioritize and how collaborate to fit the need of the organization. For more information, visit: http://theconferenceforum.org/conferences/clinical-trial-collaborations/overview

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  • March 16, 2017

  • Clinical Trial Collaborations Press Release

    The 2nd annual Clinical Trial Collaborations event will take place in Boston on April 3-4, 2017 New York, New York, March 16, 2017 – The Conference Forum has announced the launch of the 2nd annual Clinical Trial Collaborations (CTC) conference in Boston on April 3-4, 2017. Led by Co-Chair Katherine Vandebelt, Global Head of Clinical […]

    The 2nd annual Clinical Trial Collaborations event will take place in Boston on April 3-4, 2017

    New York, New York, March 16, 2017 – The Conference Forum has announced the launch of the 2nd annual Clinical Trial Collaborations (CTC) conference in Boston on April 3-4, 2017.

    Led by Co-Chair Katherine Vandebelt, Global Head of Clinical Innovation at Eli Lilly, the CTC conference is the only strategic-level event in the US entirely focused on collaborations needed for 21st Century drug development.

    Valerie Bowling, Executive Director of the CTC event, said, “The future of collaborations in drug development will require partners we never thought of before and new models for outstanding project delivery.”

    The CTC conference offers a variety of sessions that illustrate new collaboration techniques to drive improved clinical trial outcomes and bring clinical trial professionals closer to patients. Ken Getz, Director of Sponsored Research Programs at Tufts CSDD, will kick off the event with a presentation titled, “How the Clinical Collaborations Landscape Is Changing and Its Impact on R&D Operations.” The CTC conference also will feature three first-time keynote presentations:

    Takeda on their Transformational Clinical Development and Marketed Product Partnership with PRA Health Sciences with Dr Andy Plump, Director, Chief Medical and Scientific Officer, Takeda

    Models for Exquisite Project Delivery with Internal and External Partners with Dr Andy Lee, Senior Vice President, Head of Global Clinical Trial Operations, Merck

    Big Trends Impacting Clinical Development with Dr Steve Cutler, Chief Operating Officer and CEO Designate, ICON

    In addition, the CTC conference will feature:

    • Technology Needs and Solutions Discussion: Judith Dunn, Vice President, Global Head of Clinical Development and Head of Innovation Center at Roche, will lead an interactive session on identifying technology needs and solutions.
    • Partnering Tool: All conference attendees can access a partnering tool and partnering facilities to host small group and one-on-one meetings.
    • Clinical Research as a Care Option: This collaborative session scheduled for the entire afternoon of April 4 shows us how clinical trial professionals can bring patients closer to clinical research and can find ways to make clinical trials a care option. It is considered one of the biggest topics for the future of healthcare. Dr John McConnell, CEO, Wake Forest University Medical, is confirmed to keynote this section of the conference.

    The CTC conference offers presentations that deliver insightful clinical trial ideas and challenges for R&D operations, contract resource organizations (CROs) and site executives. It serves as an ideal event for senior-level clinical operation executives from large, medium and small pharmas, CROs, sites and patient advocacy organizations.

    The CTC event is proud to have CenterWatch as its exclusive lead media partner. CenterWatch is the leading source of clinical trial information for both clinical research professionals and patients. For more information about CenterWatch, click here.

    To find more about the CTC conference, click here.

    About The Conference Forum
    The Conference Forum is a drug development industry research firm and presents specialized events for professionals in the life science and healthcare industries. The company currently offer conferences for R&D leaders, clinical development professionals, biotech executives, VCs, drug delivery specialists, patient advocates and FDA executives. The Conference Forum’s mission is to create the best content, exchange ideas and provide quality networking to help move therapeutics to patients faster. To learn more about The Conference Forum, click here.

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  • January 20, 2017

  • 2nd annual Clinical Trial Collaborations Launches

    2017 Clinical Trial Collaborations Conference: Here’s What You Need to Know Want to find out how to foster collaboration to deliver improved clinical trial outcomes? Check out the 2nd annual Clinical Trial Collaborations (CTC) conference in Boston on April 3 and 4. Led by Co-Chair Katherine Vandebelt, Global Head of Clinical Innovation at Eli Lilly, […]

    2017 Clinical Trial Collaborations Conference: Here’s What You Need to Know

    Want to find out how to foster collaboration to deliver improved clinical trial outcomes? Check out the 2nd annual Clinical Trial Collaborations (CTC) conference in Boston on April 3 and 4.

    Katherine_Vandebelt_bw

    Led by Co-Chair Katherine Vandebelt, Global Head of Clinical Innovation at Eli Lilly, the 2017 CTC conference offers a can’t-miss event for senior-level clinical operation executives at a variety of organizations, including:

    ● Large, medium and small pharmas

    ● Contract resource organizations (CROs)

    ● Sites

     Patient advocacy organizations

    Ultimately, there are many reasons to attend this year’s CTC conference, including:

    1. Kick-Off Presentation from Ken Getz

    ken-getz-2017-bwKen Getz, Director of Sponsored Research Programs at Tufts CSDD, will kick off the CTC conference with a presentation titled, “How the Clinical Collaborations Landscape Is Changing and Its Impact on R&D Operations.”

    The opening presentation will deliver insightful clinical trial ideas and challenges. As such, attendees will be able to gain outstanding insights into a number of key clinical trial topics.

    1. Keynote Presentations

    The CTC 2017 conference will feature three keynote presentations:

    Models for Exquisite Project Delivery with Internal and External Partners

    Andy_Lee_bw

     

    Dr Andy Lee, Senior Vice President, Head of Global Clinical Trial Operations, Merck

     

    Takeda on their Transformational Clinical Development and Marketed Product Partnership with PRA Health Sciences

    Andrew_Plump_bw

     

    Dr Andy Plump, Director, Chief Medical & Scientific Officer, Takeda

     

    Big Trends Impacting Clinical Development

    Steve Cutler B&W

     

    Dr Steve Cutler, Chief Operating Officer and CEO Designate, ICON

     

    In addition, Judith Dunn, Vice President, Global Head of Clinical Development and Head of Innovation Center at Roche will join with Dr Amir Kalalai, VP, QuintilesIMS will lead an interactive session on identifying technology needs and solutions.

    1. Clinical Research as a Care Option

    Clinical Research as a Care Option will require a complex collaboration, but arguably the best way to bring patients closer to clinical research and clinical research closer to patients. The entire afternoon of day two is dedicated to understanding how to work through the process in this unprecedented session.

    1. Partnering Tool

    CTC conference attendees can enjoy enhanced networking opportunities with the event’s partnering tool.

    All conference attendees can access a partnering tool and partnering facilities to host small group and one-on-one meetings. That way, attendees can collaborate with one another and lay the foundation for long-lasting partnerships.

     

    The second annual event takes place at the Renaissance Boston Waterfront hotel. CenterWatch is the exclusive lead media partner and for full details about the CTC conference, click here.

    Take advantage of the launch rate discount of 20% with code ELCTC until January 27, 2017.

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  • May 13, 2016

  • PharmaTalk Radio Looks at Puerto Rico as an Option for Clinical Trials

    PharmaTalk Radio producer, Valerie Bowling welcomed Dr Myrto Lee, Director, PwC’s Strategy&, UK and Dr Kosmas Kretsos, Executive Director of the Puerto Rico Consortium for Clinical Investigation to learn about key initiatives and outcomes so far to make running clinical trials more attractive in Puerto Rico. They discussed  the quality, capacity and efficiency of running […]

    PharmaTalk Radio producer, Valerie Bowling welcomed Dr Myrto Lee, Director, PwC’s Strategy&, UK and Dr Kosmas Kretsos, Executive Director of the Puerto Rico Consortium for Clinical Investigation to learn about key initiatives and outcomes so far to make running clinical trials more attractive in Puerto Rico. They discussed  the quality, capacity and efficiency of running clinical trials in Puerto Rico along with:

    • Why consider Puerto Rico for clinical trials?
    • Status of new sites to expand clinical trial networks
    • Status of a central coordinator with sites to reduce bureaucracy e.g. central IRB, central invoicing
    • Patient access and costs
    • Access to new technologies
    • Training

    Click here for the program.

     

    For more information about conducting clinical trials in Puerto Rico, please visit www.PRCCI.org.

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  • April 12, 2016

  • Conference Forum Speaker, Ken Getz quoted in WSJ on the Challenges of Patient Recruitment

    Conference Forum Speaker, Ken Getz, Tufts CSDD quoted in the Wall Street Journal article on the challenges of patient recruitment and the longstanding issue of excessively expensive clinical trials. From the WSJ: Researchers conduct clinical trials to test new drugs and medical treatments, but the rate at which they are able to recruit and retain […]

    Conference Forum Speaker, Ken Getz, Tufts CSDD quoted in the Wall Street Journal article on the challenges of patient recruitment and the longstanding issue of excessively expensive clinical trials.

    Jamie Macdonald and Kenneth Getz at Patients

    Jamie Macdonald, INC Research (Left) with Kenneth Getz, Tufts CSDD (Right) at the Patients as Partners in Clinical Research Conference

    From the WSJ:

    Researchers conduct clinical trials to test new drugs and medical treatments, but the rate at which they are able to recruit and retain patients is at an all-time low.

    Studies indicate that fewer than 10% of Americans participate in clinical trials, and only 3% to 5% of patients sign up for trials of new cancer therapies. Patients often aren’t aware that trials are an option, and their doctors may not suggest them.

    Some patients mistrust the research process and fear being a guinea pig, but for patients who do want to volunteer, complicated protocols and eligibility requirements can be discouraging. About 40% of clinical trials don’t recruit enough patients to meet their goals.

    “The challenges of identifying, recruiting and retaining volunteers for clinical trials drive up the direct and indirect costs of drug development and significantly delay the introduction of new medical interventions,” says Ken Getz, an associate professor at Tufts University School of Medicine’s Center for the Study of Drug Development and board chair of the nonprofit Center for Information & Study on Clinical Research Participation.

    Read the rest of the article here: http://www.wsj.com/articles/clinical-trials-need-more-subjects-1460407076

    Ken will be speaking at the upcoming Chef Medical Officer Summit East (May 11-12, 2016, Boston).

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  • February 16, 2016

  • Clinical Trial Collaborations: What Needs to Change Now to Prepare for the Future of the Clinical Research Enterprise

    Clinical Trial Collaborations focuses on the future of clinical collaborations, research and outsourcing BOSTON–(BUSINESS WIRE)–Clinical Trial Collaborations, presented by CenterWatch and The Conference Forum, is focused on finding strategic solutions in clinical outsourcing to drive more efficient R&D operations. Impactful insights on the current clinical trials environment will be presented as we ask the big […]

    Clinical Trial Collaborations focuses on the future of clinical collaborations, research and outsourcing

    BOSTON–(BUSINESS WIRE)–Clinical Trial Collaborations, presented by CenterWatch and The Conference Forum, is focused on finding strategic solutions in clinical outsourcing to drive more efficient R&D operations. Impactful insights on the current clinical trials environment will be presented as we ask the big questions on what needs to change now to prepare for the future demands of science, patient needs, new technologies and access to data as well as the changing landscape of R&D infrastructure in both the pharmaceutical and biotech industries. An impressive speaking faculty will share powerful ideas and challenges for R&D operations, CRO and site executives to find new ways to collaborate today and in the next several years.

    Co-chaired by Ken Getz, Director, Sponsored Research Programs Tufts CSDD, the program opens with a keynote on, “How the Drug Development Landscape is Changing and the Impact on R&D Operations.” Robert M. Califf, MD, MACC, Deputy Commissioner for Medical Products and Tobacco, FDA, is a confirmed keynote speaker who will present on the FDA 2016 goals and challenges. Quintiles’ CEO, Tom Pike, will provide insights and advice to pharma on addressing global R&D operation realities and how sponsors can better leverage their CRO. Komathi Stem, Strategic Innovation Leader, Genentech/Roche will address the call for greater collaborations between clinical research and clinical care.

    The Boston Marriott Cambridge Hotel, in the heart of Kendall Square, is hosting this one-of-a-kind strategic level clinical outsourcing event on March 21-22, 2016.

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  • December 8, 2015

  • Making Clinical Trials a Care Option for Patients on PharmaTalk Radio

    At Dpharm US 2015, Katherine Vandebelt, Global Head, Clinical Innovation, Eli Lilly hosted a talk show on Making Clinical Trials a Care Option for Patients to fantastic reviews. Dpharm Director, Valerie Bowling, welcomes Katherine as she hosts a similar session on Pharma Talk Radio. Katherine (Kathy) discusses how an organized multispecialty healthcare system, clinical research […]

    Katherine

    Katherine Vandebelt, Global Head, Clinical Innovation, Eli Lilly at DPharm US

    At Dpharm US 2015, Katherine Vandebelt, Global Head, Clinical Innovation, Eli Lilly hosted a talk show on Making Clinical Trials a Care Option for Patients to fantastic reviews. Dpharm Director, Valerie Bowling, welcomes Katherine as she hosts a similar session on Pharma Talk Radio. Katherine (Kathy) discusses how an organized multispecialty healthcare system, clinical research site network and pharma company used clinical research as a tool and connector to help improve patient engagement in their overall healthcare management and compliance.

    More specifically:

    – Healthcare System: improving health and service to patients and advocators of clinical research participation

    – Clinical Research Site Network: bringing the right patients to the right trials with increased quality of data and engagement of patients

    – Pharma: expanding our reach to patients and getting trials done faster

    – Shifting the paradigm: Applying a Value Based Health Care Delivery Framework to improve outcomes and reduce healthcare costs

    Panelists

    Panelists at DPharm US

    Radio Show Participants:

    – Host: Katherine Vandebelt, Global Head, Clinical Innovation, Eli Lilly and Company

    – Jeff James, MBA, CEO, Wilmington Health

    – Jennifer Byrne, CEO, PMG Research

    – Allen Buechler, MBA, Advisor, Strategy and Operations, Eli Lilly and Company

    – Toyin Okanlawon, MD, MPH, Senior Health Care Researcher, Harvard Business School Health Care Team


    Click Here to Listen to the Show


     

    Upcoming Clinical Research/Trial Conferences:

    DPharm Europe Logo NewDpharm: Disruptive Clinical Trials Europe, February 9-10, 2016, London, UK

    PatientsAsPartnersLogoPatients as Partners, March 14-15, 2016, Philadelphia, PA

    Collaborations logo 210 x 62 new
    Clinical Trial Collaborations, March 21-22, 2016, Boston, MA

    For information, visit www.theconferenceforum.org

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  • December 3, 2015

  • Robert M. Califf, MD, MACC is Confirmed to Keynote at the Launch of Clinical Trial Collaborations

    We are delighted to announce that Robert M. Califf, MD, MACC, Deputy Commissioner for Medical Products and Tobacco for the FDA is confirmed to keynote at Clinical Trials Collaborations on March 22nd in Boston, MA. Dr Califf will provide insights into the vision, goals and challenges for the FDA in 2016 as well as provide […]

    We are delighted to announce that Robert M. Califf, MD, MACC, Deputy Commissioner for Medical Products and Tobacco for the FDA is confirmed to keynote at Clinical Trials Collaborations on March 22nd in Boston, MA. Dr Califf will provide insights into the vision, goals and challenges for the FDA in 2016 as well as provide thoughts on the outsourcing environment and what industry can do to help.

    Clinical Trial Collaborations is presented jointly for the first time by Centerwatch and the Conference Forum. The Summit is chaired by Ken Getz, Director, Sponsored Research Programs at Tufts CSDD and provides a truly strategic level event on clinical outsourcing and the future of collaborations to drive more efficient R&D operations. The conference presents powerful ideas for R&D operations, CRO and Site executives to find new ways to collaborate.

    Clinical Trial Collaborations will be held at the Boston Marriott Cambridge Hotel on March 21-21, 2016 in Cambridge, MA. In the spirit of the biopharma boom and intellectual power between Harvard and MIT, Cambridge seemed the logical choice for a clinical operations conference.

    About Robert M. Califf, MD, MACC

    UPDATED_Califf photoRobert M. Califf, MD, MACC, was named Deputy Commissioner for Medical Products and Tobacco for the Food and Drug Administration (FDA) in February of 2015. Dr. Califf provides executive leadership to the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products. He also oversees the Office of Special Medical Programs and provides direction for cross-cutting clinical, scientific, and regulatory initiatives, including precision medicine, combination products, orphan drugs, pediatric therapeutics, and the advisory committee system.

    Prior to joining the FDA, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. He also served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. A nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, Dr. Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature.

    Dr. Califf has served on the Institute of Medicine (IOM) committees that recommended Medicare coverage of clinical trials and the removal of ephedra from the market, as well as on the IOM Committee on Identifying and Preventing Medication Errors and the IOM Health Sciences Policy Board. He has served as a member of the FDA Cardiorenal Advisory Panel and FDA Science Board’s Subcommittee on Science and Technology. Dr. Califf has also served on the Board of Scientific Counselors for the National Institutes of Health and the National Library of Medicine, as well as on advisory committees for the National Cancer Institute, the National Heart, Lung, and Blood Institute, the National Institute of Environmental Health Sciences and the Council of the National Institute on Aging.

    While at Duke, Dr. Califf led major initiatives aimed at improving methods and infrastructure for clinical research, including the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by the FDA and Duke. He also served as the principal investigator for Duke’s Clinical and Translational Science Award and the NIH Health Care Systems Research Collaboratory coordinating center.

    Dr. Califf is a graduate of Duke University School of Medicine. He completed a residency in internal medicine at the University of California, San Francisco and a fellowship in cardiology at Duke.

    About CenterWatch

    CenterWatch logoSince 1994, CenterWatch, has been the recognized global leader in providing clinical trials information to a broad and influential spectrum of clinical research professionals ranging from sponsors and CROs to research sites and niche providers. For more information, visit www.centerwatch.com.

    About The Conference Forum

    conference-forumThe Conference Forum has a very specific focus – developing specialized events, both public and private as well as research groups and advisory boards, for professionals in the life science and healthcare industries. Their mission is to create the best content, exchange ideas and solutions among peers and provide quality networking for Pharmaceutical and Biotech professionals. For more information, visit http://theconferenceforum.org.

     

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  • November 4, 2015

  • The Conference Forum and CenterWatch Collaborate to Present Strategic Level Clinical Outsourcing Event in Cambridge, MA

    Clinical Trial Collaborations focuses on strategic solutions in clinical outsourcing to drive more efficient R&D operations. The Conference Forum, a specialized life science research and conference development firm, today announced their collaboration with CenterWatch, a leading publisher of clinical trials information. Together they are presenting the first summit chaired by Ken Getz, Director, Sponsored Research […]

    Clinical Trial Collaborations focuses on strategic solutions in clinical outsourcing to drive more efficient R&D operations.

    The Conference Forum, a specialized life science research and conference development firm, today announced their collaboration with CenterWatch, a leading publisher of clinical trials information. Together they are presenting the first summit chaired by Ken Getz, Director, Sponsored Research Programs at Tufts CSDD that provides a truly strategic level event on clinical outsourcing and the future of collaborations to drive more efficient R&D operations.

    The conference, Clinical Trial Collaborations, presents powerful ideas and challenges for R&D operations, CRO and Site executives to find new ways to collaborate.

    Clinical Trial Collaborations will be held at the Boston Marriott Cambridge Hotel on March 21 and 22, 2016, in the heart of Kendall Square in Cambridge, MA. In the spirit of the biopharma boom and intellectual power between Harvard and MIT, Cambridge seemed the logical choice for a strategic level clinical outsourcing conference.

    About CenterWatch
    Since 1994, CenterWatch, has been the recognized global leader in providing clinical trials information to a broad and influential spectrum of clinical research professionals ranging from sponsors and CROs to research sites and niche providers. For more information, visit www.centerwatch.com.

    About The Conference Forum
    The Conference Forum has a very specific focus – developing specialized events, both public and private as well as research groups and advisory boards, for professionals in the life science and healthcare industries. Our mission is to create the best content, exchange ideas and solutions among peers and provide quality networking for Pharmaceutical and Biotech professionals. For more information, visit http://theconferenceforum.org.

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