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Day 1 | Tuesday, 20 April 2021


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The Pharma R&D Annual Review 2021

Presentation

Tuesday, 20 April 2021

2:00PM BST, 9:00AM EDT

Last year will be remembered as the most exceptional in living memory, when the pharma industry pivoted rapidly to develop new diagnostics, therapeutics and vaccines against COVID-19. Alongside tracking these much-needed new products, Pharmaprojects kept pace with the wider R&D landscape. This webinar details the important findings of our latest annual review of the industry pipeline, as overall scientific progress has been carefully balanced against the urgent necessity to overcome the pandemic, in the midst of national lockdowns and clinical trial disruption.


Speakers

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Ian Lloyd

Senior Director, Pharmaprojects


Ian oversees the content and analyst services for our drug development solution. He supports clients in their drug pipeline data requirements and drug pipeline inquiries, providing insight into the best search strategies to answer their drug research and development business questions.

His expertise includes identifying and analyzing trends in pharma R&D. For over 20 years, he has authored the “Pharma Annual R&D review” and its new active substances (NAS) launches supplement. This has become a must-have industry report for those seeking to identify the changing fortunes of drug R&D.

Ian joined Pharmaprojects in 1987, when it was part of PJB Publications. It was acquired by Informa in 2003.

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Alex Shimmings

Executive Editor, Commercial/R&D


Alex has been covering the international pharmaceutical and biotech sectors for more than 20 years. She is currently the Executive Editor - Commercial/R&D for Scrip, Pink Sheet and In Vivo and her main work interests lie in novel drugs, and developments in pharma and biotech R&D.

Alex has held a variety of editorial positions of increasing seniority on Scrip since joining the publication as a science reporter in 1998. Currently, she heads up the European editorial team coverage of commercial and R&D developments for Scrip, Pink Sheet and In Vivo, while also writing news, analysis and features for the publications.

Over the years, Alex has covered breakthroughs in R&D in a range of therapeutic areas, including infectious diseases, cardiology and cancer, and she enjoys interviewing key industry players and opinion leaders. Alex also has a keen interest in medical history, and a degree in Biochemistry and Microbiology.

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How to Apply COVID-19 Trial
Recruitment Success to Your Own Studies
Presentation & Roundtable discussion

Tuesday, 20 April 2021

3:30PM BST, 10:30AM EDT

The pressure was on for this clinical trial, part of the Operation Warp Speed program, a public–private partnership initiated by the U.S. government to accelerate the development, manufacturing and distribution of COVID-19 vaccines. In this session, you’ll hear firsthand accounts of the partnerships, procedures and platform that led to diverse enrollments in record time for this historic trial.


You’ll discover what made this recruitment effort so successful, including:

  • The importance of prescreeners
  • Repository of IRB-approved assets
  • Real-time analytics to optimize outreach

Speakers

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Mike Wenger

VP of Patient Engagement, Pharma Intelligence


A brain tumor patient and software developer, Mike is passionate about patient access to clinical trials. He is spearheading Citeline Connect (formerly TrialScope Connect), the industry’s first patient referral collective. This initiative is creating a paradigm shift for patient recruitment, focusing on collaboration vs. competition.

Mike was named one of the 2020 PM360 ELITE 100 in the Patient Advocates category and a 2020 Force for Change Illuminator. He also was a finalist in the Patient Advocate of the Year category in the 2020 Medigy HITMC Awards.

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Wes Michael

President & Founder, Rare Patient Voice, LLC


Wes Michael founded Rare Patient Voice in 2013 to give patients and caregivers with rare diseases the opportunity to voice their opinions in research studies. Rare Patient Voice has now conducted over 5,000 studies and rewarded patients with over $6 million for their participation. Many patients have been recruited in person by Wes and his team at patient events like fund-raising walks and patient conferences.

Before forming Rare Patient Voice, Wes worked in healthcare market research firm Kantar Health. He previously was a brand manager and market research manager at McCormick (the spice company) and General Mills (working on Wheaties, Total and Kix cereals). He has a BA from the University of Pennsylvania (with a year at Edinburgh University) and an MBA from the University of Chicago.

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Nazar Hembara

CEO/Co-Founder, Curify


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Clinical Trial Diversity In A Post-Pandemic World - ICON Sponsored

Roundtable discussion

Tuesday, 20 April 2021

5:00PM BST, 12:00PM EDT

Clinical trial diversity has been a major topic of discussion for years, but it took the COVID-19 pandemic for the biopharma industry to fully realize how far behind it had fallen when it came to recruiting diverse populations into studies. Since then, drug and vaccine makers have made a point of emphasizing their efforts to improve diversity in their studies. But what will happen after the pandemic is over, and what form might efforts to increase diversity take beyond the US, where much of the attention on the issue has focused?


Speakers

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Alaric DeArment

Journalist, Pharma Intelligence


Alaric DeArment is a journalist with 13 years of experience covering biopharma companies, drug development, regulatory and commercial affairs, from preclinical research to pricing and reimbursement. He previously worked for Drug Store News, BioPharm Insight (now GlobalData) and MedCity News and has routinely interviewed corporate executives and key opinion leaders while attending conferences such as the JP Morgan Healthcare Conference, BIO, ASH, ASCO and EHA, among others.

A native of Seattle and a graduate of Ball State University, he lived in China for three years before returning to the US to finish college, whereupon he moved to New York, where he has lived ever since. His interests include reading, travel, coin collecting and languages.

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Barbara E. Bierer

Faculty Director, Professor of Medicine, Harvard Medical School


Barbara Bierer, MD, is the faculty director of the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center), a Professor of Medicine, Harvard Medical School and Brigham and Women’s Hospital in Boston and a hematologist/oncologist. She is the Director of the Regulatory Foundations, Ethics and the Law Program of the Harvard Clinical and Translational Science Center and the Director of Regulatory Policy, SMART IRB. She initiated the Brigham Research Institute and the Innovation Hub (iHub), a focus for entrepreneurship and innovation. In addition, she was the Founding Director of the Center for Faculty Development and Diversity at the BWH

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Almenia Garvey

Senior Director, Site Networks, Accellacare, ICON


Almenia is Senior Director for Site Networks at Accellacare, ICON’s global clinical research network offering patients easier and faster access to innovative treatments and offering customers the option to deploy decentralised trials. Almenia has over 25 years’ experience in clinical research and during this time she has had the opportunity to work on a number of projects combining healthcare and technology. She specialises in site selection strategy, investigator identification and investigator relationship management. Almenia has a passionate interest in driving diversity in all aspects of clinical trials. She has supported a number initiative’s to increase diversity in PIs, research sites, study staff and patient recruitment. She is on the board of Directors for Nvolve, a non-profit that focuses on preparing young women for STEM careers. Almenia holds a Bachelor’s of Art from the University of North Carolina at Chapel Hill and a Master’s of Science from Ulster University, in Jordanstown, Northern Ireland.

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Nicole Richie, Ph.D.

Global Head of Health Equity and Population Science, Genentech


Nicole leads the global vision and strategy to increase scientifically driven representation of understudied patient populations throughout the clinical research lifecycle. She is the Co-Lead/Co-Founder of Genentech and Roche’s Advancing Inclusive Research Program focused on addressing disparities in clinical research to advance science, support patient access, and improve outcomes.

Nicole has over 15 years of translational and clinical research experience. Most recently, she functioned as the Clinical Science Business Strategy Leader and Chief of Staff to the Global Head of Immunology, Infectious Diseases, and Ophthalmology in Clinical Science responsible for driving business operations and strategy. Nicole also served as Clinical Science representative on the PD SSF Site Leadership Team from May 2015 to July 2017.

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Barbara Valastro

Head of the Patient Insights and Solutions team, AstraZeneca


Barbara has more than 12 years of experience in the pharmaceutical industry. After spending many years in early drug discovery in both large and medium-size companies, Barbara transited to clinical drug development, where she currently focuses on understanding how clinical trials need to adapt to reflect the demands of tomorrow patients and on making sure that patient and site insight are included by design in clinical trial programs. Using her leadership skills and project management experience, Barbara wants to be part of the clinical transformation taking place in the pharmaceutical industry, with the hope that clinical trials will become a care option for all patients rather than being the last option.

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Carlos del Rio, MD

Executive Associate Dean, Emory School of Medicine & Grady Health System


Dr. del Rio is Distinguished Professor of Medicine at Emory University School of Medicine, and professor of global health and epidemiology at the Rollins School of Emory University. He serves as the Executive Associate Dean of Emory University School of Medicine at Grady Health System and is the co-director and principal investigator of the Emory Center for AIDS Research. Outside of Emory, Dr del Rio is the Foreign Secretary of the National Academy of Medicine, Chair of the Scientific Advisory Board of PEPFAR and member of UNAIDS Scientific and Technical Advisory Committee. Dr. del Rio also works on emerging infections, epidemic and pandemics. During the 2009 Pandemic Influenza A (H1N1) he was a member of the WHO and CDC advisory teams and during the COVID-19 pandemic Dr. del Rio has been a leader locally and nationally, doing research, developing policies, writing scientific publications and making countess media appearances. Before joining Emory faculty in 1996, del Rio was executive director of CONAIDA, the agency of the Mexican government responsible for AIDS Policy.

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Kristen K. Buck MD

Chief Medical Officer, ICON plc


Kristen K. Buck MD is a board certified and licensed Internal Medicine physician serving as Chief Medical Officer of ICON Clinical Research. In this role, Kristen is ICON’s leading medical expert, representing the company’s position on key scientific, ethical and medical governance matters. Kristen provides oversight to the Drug Development Services group and supports alliance partnerships, key customers, and proposals.

Kristen started her career practicing Internal Medicine. She later served as a Medical Officer at the US Food and Drug Administration (FDA) in the GI and Haematology Division completing a number of NDA and IND reviews. She was responsible for reviewing efficacy and safety for all new indications as well as post-marketing safety for over 40 drugs.


Day 2 | Thursday, 22 April 2021


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Clinical Trial Disclosure as a Strategic Advantage

Presentation

Thursday, 22 April 2021

2:00PM BST, 9:00AM EDT

The COVID-19 pandemic has brought to light several issues that have long been simmering below the surface in the pharmaceutical industry: the public’s need for awareness about clinical trials, a lack of diversity in clinical trials and, perhaps most urgent, the demand for clinical trial transparency. What study sponsors may not realize is that, through clinical trial disclosure, they can address the call for transparency and turn compliance into a strategic advantage.


In this session, you’ll discover this and more:

  • Why disclosure is important for brand reputation/patient engagement
  • Ways disclosure compliance minimizes risk
  • How noncompliance negatively impacts mergers and acquisitions

Speakers

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Thomas Wicks

Chief Strategy Officer, Pharma Intelligence


Thomas Wicks is responsible for the strategy of clinical trial disclosure and transparency solutions. He has more than 20 years of experience with performance and content management solutions, specializing in applications for life sciences such as clinical trial disclosure, structured product labeling and submissions management. He has been on focused on trial transparency since 2007. In 2015, he was listed in the prestigious PharmaVoice 100.

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Sandi Marchese

Director of the Clinical Disclosure Office, Novartis


Sandi has over 23 years of professional experience in the pharmaceutical industry. She currently manages the registration and results disclosure for all Novartis clinical trials. She played an integral part in setting up the Clinical Disclosure Office at Novartis, assisting in the development of SOPs and training. She spearheaded an automated dashboard to track and manage disclosure deliverables which improved turnover time, data quality and resource allocation. Prior to her role in Disclosure, Sandi was a Director of Operations in Oncology Global Medical Affairs where she focused on process improvement and management in a complex global matrix. Sandi holds a Bachelor of Science from the University of Maryland.

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Katie Regan

Team Lead, Clinical Trial Disclosure Group (CTDG), Pfizer


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Minimizing Luck in Study Feasibility

Presentation & Roundtable discussion

Thursday, 22 April 2021

3:30PM BST, 10:30AM EDT

Two thirds of clinical trial sites are unable to meet original enrolment goals, with half of sites recruiting either a single patient or failing completely. Study sponsors must therefore scrutinize their current approaches to feasibility, as recruitment is such a critical part of overall trial success. This panel discussion brings together experts from the clinical trial industry and informatics to discuss best practices in study feasibility and how the field can harness big data and predictive analytics to improve the overall site selection and patient recruitment process. Innovative approaches to study feasibility promise to improve cycle times and the quality of clinical research, while also lowering cost and risk.


Speakers

Ashley Schwalje

Senior Go-To-Market Manager, Pharma Intelligence


Over the last 10 years, Ashley has held various roles related to clinical research, including R&D, clinical informatics, account management, and management consulting. She has a Master’s degree in Biotechnology and a Bachelor’s degree in Biochemistry. Ashley lives outside of Philadelphia, PA with her husband and two daughters.

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Simon Gibbs

Head of Informatics, Product Management, Pharma Intelligence


Simon is Head of Informatics, Product Management at Informa Pharma Intelligence. Having been involved across various product, technology and innovation roles over the past 20 years, Simon is currently focused on developing advanced analytic solutions that empower life science organizations to generate data-driven insights that accelerate clinical development.

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Camilla Ramdeen

Director, Strategic Feasibility, Parexel


Camilla has led the global Strategic Feasibility team at Parexel since 2015 and has 14 years of CRO-based clinical research experience in roles across Feasibility and Strategy, Study Start Up, Project Management, Investigator relationships and Patient recruitment. Prior to joining the industry, she was a clinical dietitian and academic researcher at a leading oncology hospital in London. Her direct patient-care experience has meant that patient (and caregiver)-focused thinking has always underpinned her approach and the mindset she encourages for her team in the clinical trial planning process.

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Travis Caudill

VP, Feasibility & Clinical Informatics, ICON


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Oriol Serra

Senior Director, Head of Global Site Intelligence, Pfizer


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Jamie Lorimer

Director, Delivery Optimization and Informatics Team, GSK


Jamie is currently a director within the Protocol Design Lab team at GSK. Within this group he been exploring ways to combine and evaluate disparate data sources to enhance data models that recommend options for the patient recruitment planning process by clinical project teams. Jamie has over 20 years of pharmaceutical clinical operations experience spanning across the practices of study delivery, clinical project management, patient recruitment strategy and strategic clinical planning.

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