Gen Li, PhD, MBA

Lyme, Connecticut, United States Contact Info
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Inspired to transform clinical development planning and execution, with a…

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  • Phesi

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Publications

  • Construction of a digital twin of chronic graft vs. host disease patients with standard of care

    Nature/Bone Marrow Transplantation

    There is an unmet medical need for new clinical trials to evaluate novel therapies in chronic graft-versus-host disease (cGvHD). Disease rarity, ethical issues regarding placebo arms, time, and cost impede clinical trial conduct. Digital twin (DT) technology enables virtual clinical trial arm construction using historical data, circumventing these obstacles. We evaluated the feasibility of constructing a DT trial arm using a large database of real-world clinical trial data and performed an…

    There is an unmet medical need for new clinical trials to evaluate novel therapies in chronic graft-versus-host disease (cGvHD). Disease rarity, ethical issues regarding placebo arms, time, and cost impede clinical trial conduct. Digital twin (DT) technology enables virtual clinical trial arm construction using historical data, circumventing these obstacles. We evaluated the feasibility of constructing a DT trial arm using a large database of real-world clinical trial data and performed an efficacy assessment of a standard-of-care (SOC) drug to examine agreement with literature data. We constructed a flGvHD DT cohort (cGvHD patients at first-line treatment) (2042 patients; 32 cohorts) using the Trial Accelerator™ Digital Twin platform and derived an SOC arm from this cohort (flGvHD DT SOC cohort) (438 patients; eight cohorts); we analyzed the efficacy of SOC (prednisone) (overall response rate (ORR)) at six months. Our analysis results are in agreement with literature: flGvHD DT: disease onset time: 7.58 months post-allogeneic hematopoietic cell transplantation; most used graft source: peripheral blood stem cells; flGvHD DT SOC: ORR at six months for prednisone: 52.7%. It is feasible to construct a DT cohort using existing clinical trial data; a DT SOC arm can potentially replace a control arm in clinical trials.

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  • A Digital Twin on CAR-T Cytokine Release Syndrome (CRS) Patients with Standard of Care Measured by CRS Distribution by Grade

    Applied Clinical Trials

    Using existing clinical trial data to proactively model patient safety and efficacy outcomes could aid in accelerating development for areas in need of new therapies.

    Other authors
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  • Phesi Report: Assessing Single Patient Investigator Sites in Cancer Clinical Trials

    Applied Clinical Trials

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  • Leveraging Data Insights to Address the Perils of Linear Practices in Site Identification and Activation

    Applie Clinical Trials

    Other authors
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  • A Digital Twin on KRAS G12C NSCLC Patients with SCA Measured by PFS

    Applied Clinical Trials

    Other authors
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  • Modal Value Guided Clinical Trial Design Effectively Reduces Protocol Amendments

    Applied Clinical Trials

    A planned clinical trial doesn’t have to be restricted to use industry modal values. But this integrated clinical data science approach gives the study team the opportunity to challenge why a particular value outside of modal value has been adopted. If the team is proactively aware that they are designing outside of the modal values, they can objectively and often quantitatively assess the operational risks and other associated risks with the approach. This predictive analytical approach has…

    A planned clinical trial doesn’t have to be restricted to use industry modal values. But this integrated clinical data science approach gives the study team the opportunity to challenge why a particular value outside of modal value has been adopted. If the team is proactively aware that they are designing outside of the modal values, they can objectively and often quantitatively assess the operational risks and other associated risks with the approach. This predictive analytical approach has tremendous benefits but clearly requires a significant data pool to increase confidence. It also requires an applied combination of artificial intelligence, machine learning, natural language processing, and integrated algorithms, to extract meaning from data sets.

    Other authors
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  • Resurrecting Zombie Trials Will Be Another Consequence of COVID-19 Unless the Industry Acts Now

    Applied Clinical Trials

    The impact of COVID-19 continues to be enormous; since the onset, billions of people have experienced some form of ‘lockdown’. With countries now starting to ease shelter-in-place conditions, the thoughts of many are slowly turning to getting back to ‘normal’, however long away that might be. The field of clinical trials is no exception and finds itself at a potential turning point. Although current circumstances are challenging, there is also now an opportunity, when ‘normal’ service resumes…

    The impact of COVID-19 continues to be enormous; since the onset, billions of people have experienced some form of ‘lockdown’. With countries now starting to ease shelter-in-place conditions, the thoughts of many are slowly turning to getting back to ‘normal’, however long away that might be. The field of clinical trials is no exception and finds itself at a potential turning point. Although current circumstances are challenging, there is also now an opportunity, when ‘normal’ service resumes, to make long-lasting changes that benefit biopharmaceutical companies and trial sponsors, but most importantly, benefit patients. One of the key determinants in doing this will be an improved use of data, and the current hiatus is an opportunity to embrace this approach.

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  • Save Sites Now to Preserve the Future of Clinical Trials

    Applied Clinical Trials

    Phesi analyzed data from 300,000 global sites to assess the current COVID-19 situation, which showed a 10 percent increase in site suspensions over the past two months (see chart below). This coincides with the effects of worldwide shutdowns, which have seen day-to-day life disrupted beyond recognition. Here, Dr. Li shares his insights from the data.

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  • Sponsors Must Act Now to Mitigate the Impact of COVID-19 Slowdown

    Clinical Leader

    As we progress through the COVID-19 pandemic, governments, societies and businesses are having to rapidly develop long-term plans to deal with the crisis. Globally, economies are having to make huge, once-in-a-generation adjustments, and there is no doubt that the ramifications will be unpacked for years to come in all industries. While the biopharmaceuticals sector has naturally taken center stage during recent events, it too is feeling the effects of the worldwide slowdown. From early-phase…

    As we progress through the COVID-19 pandemic, governments, societies and businesses are having to rapidly develop long-term plans to deal with the crisis. Globally, economies are having to make huge, once-in-a-generation adjustments, and there is no doubt that the ramifications will be unpacked for years to come in all industries. While the biopharmaceuticals sector has naturally taken center stage during recent events, it too is feeling the effects of the worldwide slowdown. From early-phase research to manufacturing and post-market surveillance, the impact of shelter-in-place orders and ‘lockdown’ conditions is substantial. Nowhere is this truer than within the clinical trials domain, where there is a heavy reliance on in-person interactions.

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  • Clinical Trial SOS

    Life Science Leader

    In summary, you should proactively access all the variables — trial design, investigator site selection, site activation process, and competition — before you start a trial, as well as during trial enrollment. That may not eliminate trial rescues, but it certainly can reduce the likelihood of issuing an SOS signal.

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  • Giving Data the Gift of Meaning

    The Medicine Maker

    Ever-growing datasets are a constant challenge when trying to develop efficient clinical trials. As more conventional approaches fail to give companies the competitive edge they need, can the insight provided by predictive analytical tools pick up the slack?

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  • Clinical Trials Don't Have to Cost Too Much or Take Too Long

    Pharmaceutical Executive

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  • Enrollment cycle times can and should be optimized.

    Applied Clinical Trials

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  • Forecast enrollment rate in clinical trials

    Applied Clinical Trials

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  • Performance-based site selection reduces costs and shortens enrollment time.

    The Monitor

  • Finding the sweet spot

    Pharmaceutical Executive

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  • Site activation: the key to more efficient clinical trials

    Pharmaceutical Executive

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  • Balanced Scorecard for R&D

    Pharmaceutical Executive

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