Atul Mahableshwarkar Dr. Atul Mahableshwarkar is the Senior Vice President of Drug Development at Emalex Biosciences. He is a trained psychiatrist who began his career in clinical practice and academia. Since joining the pharmaceutical industry, he has had the opportunity to learn from both successes and failures in his clinical trial work at companies of all sizes. Atul shares that early in his career, he was more interested in research than methodology. He credits his colleagues at the time with opening his eyes to the fact that incorrect operations can sink an otherwise viable product. The interest in methodology that that understanding sparked has shaped his career over the last 15-20 years. Episode Highlights The pivotal role of strong methodology in allowing good products to succeed Atul’s advice for others beginning to design clinical trials What he sees as the greatest challenges clinical trials have in common How teams can help motivate clinical trial participation Where standard concepts of patient-centricity may be lacking How collaboration can help minimize mistakes The Orphan Drug and Fast Track designations Emalex has earned from the FDA, and how other organizations can pursue Orphan Drug status How the pandemic nearly tripled Emalex’s enrollment The importance of supporting sites that may feel threatened by decentralized clinical trials The pandemic-enforced recruitment practices he plans to continue Key considerations in choosing a preferred ratings scale, and what his is Rater training as a misnomer that needs revising How to assess and manage raters appropriately The value of monitoring data and communicating insights to stakeholders in real time Links https://www.linkedin.com/in/atul-mahableshwarkar-07772338/ https://emalexbiosciences.com/ https://isctm.org https://cnssummit.org

Jennifer Brandl is the Associate Director of Clinical Operations at Kezar Life Sciences. She has 15 years of experience as a researcher and clinical operations specialist, and she is currently pursuing a Master’s degree in Data Science from the University of Wisconsin. Jennifer credits her prior experience at a smaller biotech company with giving her a critical foundation in clinical conduct and study execution. At Kezar, she leverages this expertise and her passion for research to support the company’s development of pioneering therapies and to change the lives of patients. Episode Highlights The elements of Jennifer’s expertise that have especially helped her drive success in the trials she manages The benefits of functional service provider outsourcing models How Kezar’s patient-centric nature had the company well prepared to navigate the COVID-19 pandemic The greatest challenges Jennifer and Kezar experienced due to the pandemic, and some positive outcomes Important considerations for organizations exploring home health options How communication and relationship-building form the foundation of clinical trial work The challenges and benefits she’s experienced conducting site initiation visits virtually How best to prepare before updating or transforming site initiation processes What she believes is next for decentralized clinical trials How automation and tech adoption can help extract more insight from data Resources: Kezar Life Sciences Jennifer Brandl on LinkedIn Conversations in Clinical Trial Readiness Interview Series

Ahmed Hamouda Ahmed Hamouda is the Head of Clinical Operations in the Middle East and Africa at RAY. In more than 10 years in the clinical research field, Ahmed has worked on both the CRO side and the pharmaceutical side in Europe, the Middle East, the Far East, and Africa. Ahmed brings the full range of his experience to bear at RAY, which provides outsourcing and consulting services to support pharmaceutical and biotech companies through the clinical trial development process. With RAY, Ahmed leverages his expertise to bring hope and opportunity to patient populations who would not otherwise be reached. Episode Highlights Why Africa and Middle Eastern markets represent a major opportunity for sponsors What regulations and unique requirements sponsors need to understand before moving into these markets How the site selection and preparation process is different in these markets as opposed to in the U.S. The importance of partnering with qualified regional experts The challenges involved in driving patient participation in these regions How one rare disease clinical trial was saved by a move from the U.S. to the Middle East, and how that move paid off in terms of recruitment Potential logistical issues with global trials and how RAY manages them Why continuous education is so important for sites How Ahmed and RAY estimate the timeframe for study startup in a new region The unexpected positive regional outcomes of the pandemic Resources: Ray-CRO Ahmed Hamouda on LinkedIn Conversations in Clinical Trial Readiness Interview Series

Peju Oshisanya Peju Oshisanya is a Director and Clinical Program Leader at BenevolentAI. With more than 20 years in the drug research industry, Peju is an expert in pharmaceutical organization. Her career has run the gamut from early roles as a clinical trial associate to extensive experience running a wide range of global clinical research programs. In her role at BenevolentAI, she pairs her biomedical science background with further perspective from the tech side. Peju is a passionate proponent of diversity in data and inclusion in clinical trial research. She believes that problems of diversity and inclusion are fixable, and she has determined to become a champion of that change, working to raise awareness and dedicating her own career to upend the status quo. Episode Highlights Peju’s “aha” moment that drove home the magnitude of inequity in biopharma, health, and clinical trials Why it’s crucial to really understand the communities that we want to include in research How decision-makers’ personal perspectives influence which diseases are prioritized and which treatments are funded Why representation needs to extend to the experts rather than stopping with the patient population Why it’s misleading and counter-productive to frame populations using the term “minority” How helping patients understand the importance of research in informing treatments can help motivate participation The huge potential opportunity Africa represents for clinical trials The problem of perception when it comes to African institutions’ preparedness How mining past data can create a self-perpetuating cycle that prevents capable sites from becoming experienced sites What we can do to help ameliorate diverse patient populations’ trust in the healthcare industry How anyone, regardless of their role within a company, can take steps to influence diversity in research How the pandemic has signaled hope for diversity and inclusion going forward Resources: Peju Oshisanya on LinkedIn BenevolentAI Conversations in Clinical Trial Readiness Interview Series

Ken Getz is the Director of the Tufts Center for the Study of Drug Development and a Research Professor at the Tufts University School of Medicine. Ken is an expert in drug development management and practices who has dedicated much of his career to raising awareness of clinical research enterprise. In addition to frequently speaking at industry events and publishing in peer-reviewed journals, Ken is the founder of several organizations, including the non-profit CISCRP and the publisher CenterWatch. His career is a true testament to his belief in the importance of transparency and keeping all clinical research stakeholders well-informed. Episode Highlights The takeaways, both expected and surprising, from 2020 protocol performance data The factors that are contributing to increased complexity in clinical trial protocols Why simplifying the design of a study is not the right goal The inherent benefits in complexity, and how we can reap them through proper management What drives regulatory agencies to seek to quell rising complexity in clinical trial protocols Why more data isn’t necessarily better The importance of investigating underlying causes of problems rather than defaulting to solving them with volume What happened to feasibility committees and what should replace them Why it’s critical to incorporate patient input into study design The consistent positive impact of patient advisory boards How taking the time for thoughtful advanced planning can help preclude costly unplanned amendments later on Resources: Tufts Center for the Study of Drug Development Ken Getz on LinkedIn CISCRP CenterWatch Conversations in Clinical Trial Readiness Interview Series

Rebecca Setta is an Associate Director at OncoSec whose 13 years of experience in clinical trials have given her the benefit of several different perspectives. Rebecca began her career on the vendor side, and her continuous pursuit of development and higher-level understanding led her to transition to the CRO space in 2015. Her role at OncoSec represents the natural evolution of a career shaped around an inherent desire for growth through further immersion in clinical trials. In Rebecca’s years of experience at the project level, she consistently found building effective teams to be among the most rewarding elements of her work. She now brings that expertise to bear at the department level, where she can act as a mentor, shaping a team to build on her knowledge and experience. Episode Highlights How Rebecca helps her team avoid burnout in a grueling field The common characteristics she saw across the sites that adapted best at the start of the pandemic The crucial change in mindset that she’s encouraged in her CRAs The COVID-inflicted adaptations she expects to persist post-pandemic Why it’s important to partner with sites The unexpected upside to the pandemic adjustments her sites have made What really impresses her about the industry How remote work and limited face time can impact morale, and one way she compensates for that How the weighty context of oncology research can also translate to motivation Why she is so excited about the future of the industry Resources https://oncosec.com https://www.linkedin.com/company/oncosec-medical-inc/ https://twitter.com/oncosec

Topics covered and questions you’ll uncover during this episode: The three tenets of OncoBay’s approach to cutting-edge cancer research How to prepare staff for the complexities of a 21st-century oncology trial Why we need to evolve from serial to real-time data assessment OncoBay’s “just-in-time” enrollment model (and a touching success story) Why investing up-front in site preparedness is critical to maximizing impact in research How the just-in-time model can help address diversity challenges in enrollment Why new technologies and methodologies often create discomfort, and what leaders can do about it How you can make 1 + 1 equal 3 when you combine tools effectively Why putting together the right team is both more challenging and more critical than putting together the technology What Krystyna looks for when assessing potential team members Why she’s excited for the next generation of industry employees Resources mentioned within the episode: https://www.oncobay.com https://www.linkedin.com/company/oncobay-clinical/ https://www.facebook.com/oncobayclinical https://twitter.com/OncoBay Conversations in Clinical Trial Readiness Interview Series ArcheMedX

Topics covered and questions you’ll uncover during this episode: Why brick-and-mortar and virtual constitute a continuum, not a dichotomy. What teams need to do to be successful transitioning to virtual. Why remote monitoring still poses a challenge. Why tech isn’t always optimized for the site side. How remote improves patient engagement and retention. Why the clinical research coordinator role is changing, right down to the essential skillsets. What we need to do to make sure site coordinators are comfortable enough to be effective with the tech they need to adopt. Why we’re probably a long way from seeing virtual as a money-saver, and what will need to change to make it cost-effective. How lessons learned in the late 90’s can be an instructive cautionary tale today. Resources mentioned within episode: www.velocityclinical.com www.archemedx.com www.linkedin.com/in/klritch www.linkedin.com/in/paul-evans-02118957

Topics covered and questions you’ll uncover during this episode: How excellence in site management has changed since the pandemic. Why the sites are still the lynchpin. Why anxiety around decentralized clinical trials is misplaced. How a marketing perspective can serve clinical operations and site management. What sets sites apart that will succeed and sites that will struggle in this new landscape. Why it’s important to assess a site’s tech-readiness and physical situation before handing down directions on how a study will be run. Simply providing a site with technology isn’t enough, so what else needs to be done? Why prevention and preparation beat correction and remediation. How to maximize collected data through follow-up and implementation. Resources mentioned within episode: Medable ArcheMedX Kelly Ritch on LinkedIn Mary Costello on LinkedIn Conversations in Clinical Trial Readiness Interview Series

Episode Highlights: The industry and operational challenges facing DCT adoption. How inconsistent nomenclature has contributed to widespread misunderstanding of DCT, and how misnomers have slowed adoption. The challenge of change management and how clarity and infrastructure can be an antidote. How DCT can help boost minority representation in clinical trial research, and why shifting those numbers requires time. How sponsors can get started with DCT and what they need to consider. Why organizational fit is critical and how to assess it. Why it’s so important to talk with the patients and understand the challenges they face. Why DCT and patient-centric approaches so often go hand-in-hand. How patient engagement is changing, and why clinical trials need to adapt to that. How sites have been forgotten as stakeholders and why they’re still central to clinical development. Resources: www.archemedx.com Conversations in Clinical Trial Readiness series www.revelesclinical.com www.linkedin.com/in/klritch www.linkedin.com/in/r-kes-starling-rph-mba-9996214/ www.clinicaltrialpodcast.com Reveles’ Decentralized Clinical Trial Grader: https://form.typeform.com/to/RhOpipVQ https://www.linkedin.com/company/reveles-clinical-services

Episode Highlights: Why it’s vital to adapt—during the pandemic and always. Why clarity around workflow is critical to adaptation. What sponsors and CROs can do to reduce the burden on their sites, and why it’s their responsibility. How “making the sites our heroes” can help with patient recruitment. The importance of creating ways for your sites to exchange information with each other. How the CRA role is evolving. How tech vendors can address the biggest obstacle to adoption. Why video is the best tool for training and communication, and how to leverage it. What the future of effective clinical operations will look like. Kunal’s favorite resources for staying up-to-date. Resources you need to check out: www.archemedx.com Free FDA learning activity www.linkedin.com/in/klritch/ www.fda.gov/industry/fda-basics-industry/guidances www.acrpnet.org www.ceribell.com www.linkedin.com/in/kunalsampat clinicaltrialpodcast.com Video version

Welcome to Conversations in Clinical Trial Readiness, a series featuring life science executives who share their stories and insights related to clinical operations and clinical trial readiness. Listen in to hear how health and life science organizations can better equip teams and clinicians to accelerate the development and adoption of new clinical treatments and best practices. Learn from our experts as they share their key learnings, obstacles, and success stories. Join us as we talk to clinical trial executives from different corners of the industry.