April 28-29, 2021 | Virtual Event
Visit our virtual lobby and connect with fellow attendees. You can chat, video, and even make a list of the people you want to meet and knowledge you’re looking to gain through our bespoke 1:1 match-making services.
  • Discuss the current state and future directions of clinical trials in oncology to improve treatment options and the recent adoption of seamless expansion strategies to expedite drug development timelines
  • Keeping key stakeholders (patients, IRB members, referring physicians, study team members) informed and engaged as trials evolve in the drug development paradigm
  • Understanding the reasons that may have resulted in such changes in phase I trials and their implications in the drug development process
Adaoma Aigbodion, Sr. Clinical Trial Monitor, BMS
Alzheimer’s disease studies can be very long and large, making it difficult to conduct adequate Phase 2 proof of concept studies prior to embarking on Phase 3 clinical trials. A number of recent Phase 3 failures in Alzheimer’s disease studies can be partially attributed to a lack of sufficient Phase 2 proof of concept data, suggesting that a novel approach may be necessary. BAN2401-G000-201 is a Bayesian adaptive phase 2 proof of concept study that was designed to help mitigate the risk of Phase 3 failure through the most efficient use of ongoing study data. The present work highlights the development of essential design components of this Bayesian adaptive study and evaluates the final performance of the design at study completion.

  • Simulations are critical for developing essential design components of Bayesian adaptive design studies
  • Bayesian adaptive design can lessen the burden of complex studies with multiple unknowns
  • Bayesian adaptive design can provide efficiencies for study subjects
Chad Swanson, Executive Director, Clinical Research, EISA
  • Incorporating biomarkers into earlier phases of clinical development to support the development of safe and effective therapies for patients in a more streamlined and efficient manner
  • Understanding the importance of the collaboration between principal clinical investigators and laboratory researchers for successful inclusion of biomarkers in early-phase trials
  • Discussing strategies for developing protocols which will achieve maximum objectives in early phase studies
A safe space to talk candidly through your challenges, new tools/tactics. Dedicated VIDEO Q&A time to ask our presenters questions directly, share your thoughts with, and engage with your industry peers face-to-face. This is not a live chat or faceless group—a unique opportunity to replicate those hallway conversations and coffee breaks from live events.
  • Developing an adaptive dose modification design for phase I clinical trials to optimize schedule regimes
  • Employing a Bayesian hierarchical model to improve the statistical power of basket trials and efficiently assess the efficacy of therapeutics in multiple disease indications
John Caminis, AVP-Therapeutic Area Head – Medical Safety Pharmacovigilance SANOFI
  • Using Design Thinking to address challenges in a variety of domains related to the patient experience
  • Understanding how the methodology teaches empathy for the end user (the patients)
  • Leveraging empathy, collective idea generation, rapid prototyping, and continuous testing to tackle complex challenges
David Hamilton, Associate Director, Clinical Development, Analytics, Strategy, Operations, NOVARTIS
The accreditation of clinical research sites has long been discussed and attempted by various organizations throughout the last 30 years. The Site Accreditation and Standards Institute (SASI) is an independent, non-profit organization which has developed a set of standards and an accreditation scheme for clinical research sites. The standards are based on a comprehensive quality management system operating at the site to ensure 2 critical objectives: protection of the health and safety of study participants and the accuracy and reliability of the data generated. The following will be discussed:

  • Advantages to accreditation for a clinical site (WIIFM?) and for sponsor
  • Quality management concepts including Keeping the Promise and Zero Defects Attitude
  • Discussions between SASI and multiple stakeholder groups
  • The first site accreditations are expected in the late Spring and summer of 2021.
Mary Westrick, Adjunct Faculty (Phase I Clinical Trials Specialty), UNIVERSITY OF WISCONSIN, MADISON
RCTs are considered the gold standard of experimental investigation. They provide powerful, robust, and statistically significant evidence of between-treatment differences, based on data from relatively large numbers of recruited patients. However, many believe that the clinical trial landscape needs to evolve beyond RCTs so that we are less reliant on them for the regulatory approval of new medicines.

  • Is it time to go beyond randomization of clinical trials?
  • Will other types of trials ever replace RCTs?
Many small emerging biotech companies are looking to outsource expertise during the critical early study phases. Coupled with limited resources, the most cost effective route is often the most enticing but without understanding the groundwork or even the fundamentals involved, it will most often lead to costly and timely setbacks early on.

We’ll cover topics such as:
  • Sponsor’s internal issues to look for and avoid
  • So, you think your Protocol is ready to go?
  • Keep the endgame in mind. Design the EDC with submission worthy data in mind
  • Choosing a CRO who is strong in DM is just as important as their strengths in study operations
  • Having a single URL for all your studies can save you money and headaches in the future
Susmita Gupta, Clinical Scientist Consultant, CALITHERA BIOSCIENCES
  • Anticipating the realistic shift towards incorporating new technology, accelerating oncology drug development by investing in training and services
  • Investigating methods to make cutting edge digital tools more financially accessible to allow for its wider use and benefit by smaller organizations
  • Appreciating the incorporation of mobile technology in clinical trials which enables easy accessibility for patients
  • Considering the risks regarding the reliability of data and technology
  • Connecting with the right technology vendors in a growing and competitive industry to ensure that you receive the best quality service
Jill Kearney, Global Operations Onco Ed Head, Janssen
  • Telehealth adoption and long-term interest
  • Tools and technologies that impact clinical trial decision-making
  • Shifts in clinical trial interest and awareness
  • Payer landscape and reimbursement review considerations
  • Drug development timeline and impact on formulary decision making
  • Implications of clinical trial design elements on payer assessment
Darya Rose, Managed Markets Marketing, GILEAD SCIENCES

Virtual Lobby Reopens – Day 1 concludes
Visit our virtual lobby and connect with fellow attendees. You can chat, video, and even make a list of the people you want to meet and knowledge you’re looking to gain through our bespoke 1:1 match-making services.
Debiprasad Roy, Technology, Data Science, Bioinformatics & Programming Head of Research & Development, ALLOGENE THERAPEUTICS
In 2021, patients can expect more convenient access to trials, which will help increase trial participation and engagement. The COVID-19 pandemic has accelerated decentralized (also referred to as virtual, remote, or hybrid) solutions for clinical trials. With travel restrictions, office closures, and other obstacles created by the virus, decentralized clinical trials are even more center stage than ever. According to the FDA, decentralized clinical trials leverage telemedicine, virtual visits, and mobile or local healthcare providers to complete the trial. In a press release from 2019, the FDA announced, “modernizing clinical trials is an agency-wide priority.”

  • Improving patient experience to reduced burden and increase engagement
  • Keeping your clinical trials on-track during the pandemic increasing patient retention and lowering drop-out rates
  • Improving reliability and accuracy of data using technology such as wearables, apps, and smartphones keeping data organized and safe.
  • Reducing the recruitment burden on CROs and sponsors
  • Plan your DCT in compliance with the latest regulatory guidance and insight into future developments
  • The future of medicine or a disaster waiting to happen?
Panelists:
Rebecca Griffith-Eskew, Vice President, SALARIUS PHARMACEUTICALS 
Susan Manoff, Executive Director, Vaccines and Infectious Diseases | Office of the Chief Patient Officer, MERCK
Tom Heck, SVP Clinical Trial Services Operations & Sales, TRIALCARD
  • Implementing AI/ML approaches to the analysis of clinical trial data to improve survival predictability
  • Hear case studies involving neural networks and review a presentation of clustering methodologies
Vanja Vlajnic, Senior Manager, Statistics and Data Insights, BAYER PHARMACEUTICALS
Visit our virtual lobby and connect with fellow attendees. You can chat, video, and even make a list of the people you want to meet and knowledge you’re looking to gain through our bespoke 1:1 match-making services.
  • Computational Phenomics – the systematic study of human phenotypes and diseases models, are crucial to the success of data-driven clinical development
  • The future of data-driven drug discovery relies on combining trial-level and individual-level patient data with predictive analytics to expedite and minimize the time in trials by knowing the performance of historical clinical trials.
  • Preparing multiple different existing data sources to feed machine intelligence models to identify various “drivers” of parameters associated clinical trial enrollment lifecycle
Shameer Khader, Senior Director (Data Science, AI/ML, Digital Health & Bioinformatics), ASTRAZENECA
  • Review the FDA’s guidance “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs.”
  • Hear about specific case studies and strategies on how to include ethnic bridging in your early clinical development plans to hasten the regulatory acceptance of data worldwide
  • Building trust with patient advocacy groups, investigator networks, regulatory agencies, and industry partners to increase participation and retention of diverse patients in your clinical studies
Moderator:
Ubong Peters, Operations Insights Analyst – Product Development Global Clinical Operations,GENENTECH

Panelists:
LaShell Robinson, Clinical Operations Lead, Diversity & Inclusion in Clinical Trials, JOHNSON AND JOHNSON
Andrew Rosen, Director of Global Data Generation, AKCEA THERAPEUTICS
  • Increasing data accuracy and compliance with electronic diaries
  • Understanding the scenarios where it’s recommended for researchers to use eCOA, based on its significant advantages over traditional paper assessments
  • Leveraging familiar modalities such as smartphones, tablets and browsers patients can easily complete COAs, enabling sponsors to minimize the costs and potential for errors typically seen in paper-based studies
  • Regulatory agencies in Europe and the U.S. require the CMC section of applications and submissions to have detailed information regarding the drug substance and the formulated product in which the active will be administered.
  • Designing a phase-appropriate CMC analytical development strategy can be crucial to the success of a small or virtual pharma company
  • Developing an effective CMC program can offer immediate and long-term benefits including lower development costs and avoiding unnecessary delays
Howard Jan, CMC Project Manager, Pharma Technical Development, ROCHE
  • Learn how to continue to deliver safe patient care to those continuing on trials while providing the requirements of trial protocols and ensuring data integrity, following regulatory authority guidance
  • Employing risk management strategies to safeguard patient safety while ensuring integrity of trial conduct
  • Investing in digital infrastructure to propel a paperless future, with electronic site files and training documentation workflows that can simplify work processes, ensuring a robust audit trail
Philip Harder Delff, Associate Director (pharmacometrics), VERTEX PHARMACEUTICALS
  • Collaborating with service providers to create a hybrid approach that supports patient needs, data requirements, and site operations
  • Accelerating the use of digital health technologies to alleviate disruptions and mitigate risks caused by the spread of the virus
  • Moving towards virtualization allowed for clinical trials to progress with fewer interruptions, ongoing participation, and robust data
A safe space to talk candidly through your challenges, new tools/tactics. Dedicated VIDEO Q&A time, not only with the speakers but with your industry peers. This is not a live chat or faceless group. This is an opportunity to have an engaged conversation with your industry counterparts. The speakers may have questions for you as well!

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