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Clinical Trial Collaborations (CTC) Conference Re-Cap
April 5, 2017
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 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.”
- 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.”
- 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.
- 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.
- 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.
- 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.”
- 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:
Murray Abramson, MD, Vice President, Global Clinical Operations, Biogen
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.”
- 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:
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.”
- 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:
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.
- 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:
Ken Getz, Director of Sponsored Research Programs, Tufts CSDD
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.”
- 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:
Jennifer Byrne, Founder, Greater Gift Initiative
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.”
- 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:
Jeff James, CEO, Wilmington Health
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.
- 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:
Meredith Alger, Healthcare Researcher, Program Manager, Harvard Business School
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.
- 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:
Craig Lipset, Head of Clinical Innovation, R&D, Pfizer
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.