By Frank Leu, PhD, Novapeutics LLC, USA, and Elena Gonzalez, BioPharMatrix LLCB, USA
On May 11-12, 2017, KNect365 hosted the inaugural Trials, Tech, and Transformation (T3); a two-day conference in Orlando, Florida. The conference was attended by experts and transformational figures who presented a wide vision of innovation in the area of clinical trial processes and technologies, including mobile health, patient-centric process and mutually beneficial collaborations. The conference effectively united key stakeholders from pharmaceutical, biotech and medical device companies, as well as clinical research organizations and so on.
Through presentations, interactive panel discussions, Oxford format debate and case studies, T3 presented the current challenges and ways to overcome clinical trial obstacles through harnessing innovative technologies to ensure better trial efficiency. It succeeded in highlighting ways to better partner and collaborate through various outsourcing models for companies, as well as the use of new technologies for patient compliance.
Day One: Partnerships and Collaboration
Day One of the conference centered around Partnerships and Collaborations, opening with remarks from Greg Koski, MD, President and CEO of ACRES, who was followed by a panel discussion on global transactions in biotech and Pharma companies. The discussion evaluated trends in partnering with regards to clinical trials and new drug combinations. Statistical data was presented by the speakers - Steven Muntner from Strategic Transactions, Patricia Giglio from Medtrack and Rachel Meighan-Mantha from Trialtrove - who in summary agreed with the overall positive effects of joining forces, predicting an upward trend for M&A.
Next, an intriguing presentation by Rohan Sonawane, Principal Clinical Marketing Specialist at Medtronic Diabetes, discussed the future of clinical trials, involving new research and developing medical devices for diabetes. Sonawane spoke at length about Medtronic’s Diabetes Continuous Glucose Monitoring (CGM) called IPro2, which is a quarter-sized wearable device that takes glucose readings throughout the day. Sonawane hoped to convince the audience of the positives of investing in medical devices, despite the notion that R&D products can be financially risky.
A panel discussion on the issues with sites, sponsors, and the use of CROs as the mediator provided thought-provoking information on the necessity of outsourcing for Pharma and Biotech companies for effective clinical trials and the role each partner serves in trial success.
The conference not only gave insight about the necessity of partnering, but also raised awareness about potential issues that can arise from such interactions thanks to a fun and interactive presentation by Julianne Hull, CEO of WenStar Enterprizes, and Richard Young, VP Vault EDC at Veeva Systems. The presentation victoriously demonstrated the common reasons behind dissatisfaction of formed alliances. One of the suggested resolutions for minimizing friction was to define expectations thoroughly and communicate effectively to accomplish a well-defined goal with well thought out milestones. Working together and giving clear and honest expectations leads to long lasting alliances with fewer complaints.
Speakers Christopher Pitcherella, Director, Clinical Trial Innovation, Global Clinical Operations at TEVA, and Deborah Profit, Leader at Otsuka Information Technology, conversed in a panel discussion focused on cost, efficiency and service quality. It was said that in many cases strategic partnerships fail to live up to promises due to very little time actually spent on transformation.
The highlight of the first day was co-founder and Executive Director of the Castleman Disease Collaborative Network David Fajgenbaum who gripped the audience’s attention throughout his inspiring plenary session. The presentation focused on his personal experience as a patient with the Castleman rare disease, and his fight for finding a cure for others through assembling collaborative and funding networks among diverse global organizations.
An Oxford debate between William Jacobson from Takeda, Frank Leu from Novapeutics, Nancy Meyerson-Hess from Grunenthal, Julianne Hull from WenStar Enterprizes and Richard Young from Veeva Systems discussed whether there is a need for CROs’ services. The winning arguments came from Jacobson and Leu who argued that outsourcing is innovative and beneficial to smaller companies thanks to the additional manpower, and is overall essential.
Following the debate, Jacobson led a presentation that focused on the adoption and implementation of artificial technology for better patient compliance. The specific technology discussed involved the use of a mobile application to record subjects at required times to monitor their participation in their trial responsibilities (consuming a specific drug or during assigned activities).
Closing Day 1 an informative panel discussion and case study looked at third party vendor oversight and who is liable for sub contract work, before John Mann, VP at PRA Health Sciences, presented a case study of ICH E6 Addendum, giving information on risk control and communication.
Following the end of the agenda sessions, a cocktail hour with a wide selection of food, drinks and good company allowed for personal networking opportunities.
Day Two: Clinical Innovation
Day Two’s agenda explored The Next Wave of Clinical Innovation and outsourcing for small to mid-sized Pharma.Opening remarks were given by Judith Kornfield, Chief business and Operations Officer at ORATECH OHSU, before moving on to an enlightening panel discussion about the best outsourcing model for biotechs and SMEs. The panelists agreed there is no single specific model that meets all the needs of every company. Instead, individual company expectations have to be evaluated to correctly choose an outsourcing model sufficient for success. The speakers on the panel included a number of very experienced industry professionals.
The focus then shifted to up and coming technologies for clinical trials through a discussion on mobile health and clinical technology led by Jacob Agris from Bayer Healthcare, Stella Stergiopoulos from Tufts Center for the Study of Drug Development, Chris Adams from Andarix Pharmaceuticals, and Judith Kornfield from ORCATECH. A number of ideas were proposed, including the use of private cloud for data storage, as well as wearables and mobile devices to improve patient’s overall health.
Similarly, Kathleen Thrush, Section Manager, Clinical Researchat Abbott Laboratories, presented a case study that showed the correlation between patients using their own mobile device during trials and an increase in compliance.
Overall, T3 was led by key industry professionals and progressives presenting ideas and shared experiences for accelerating clinical development, increasing trial quality and developing stronger and lasting alliances. Improved collaboration can be developed through evaluating expectations and the needs of each partner involved to minimize friction and choose the best customized outsourcing model. Additionally, innovative technologies such as mobile apps, wearable devices and cloud storage could be the next essentials to ensure clinical success.
In sum, the interactive conference provided well-balanced and useful information. The presentations from industry thought-leaders were on engaging and thought provoking topics, and left attendees with information that is sure to be useful in one way or another.
Note: Due to dual track scheduling at the conference, this summary is by no means comprehensive. For more information, explore the complete overview of the T3 agenda and a full list of expert clinical speakers.