PAREXEL

Articles

Data linking in Clinical Trials

http://www.appliedclinicaltrialsonline.com/act_w/enable_data

The benefits of leveraging real-world data (RWD) in clinical research are increasingly recognized and endorsed by regulators. As with any innovation, there is a gap between RWD availability and effectively leveraging the data, especially in the context of a randomized controlled trial (RCT). One answer to this conundrum is to tokenize clinical trials data to enable connectivity to RWD. This webinar will focus on the operational processes to implement tokenization within a clinical trial to enable the ability to link to real–world data to answer research questions which could not previously be answered from traditional RCT designs.

Reducing the burden of tokenization for sponsors sites and patients

How to maximize the value of tokenized RCT data

Devin Gilliam is Head of Clinical Trials at Datavant, where he leads solutioning for R&D offerings, helping partners connect real world data to the clinical studies they are conducting. Datavant is the leader in healthcare data connectivity, with the mission of "Connecting the World's Health Data to Improve Patient Outcomes".

He oversees Datavant’s trial tokenization and external control arm solutions and has scaled the implementation of Datavant products in over 50 clinical trials, to support regulatory submissions utilizing RWE, develop long-term follow-up programs built on connected data, and power pragmatic clinical trials.

Devin led life sciences at the health technology company Syapse, where he focused on real world evidence product offerings spanning clinical development, from trial design, patient recruitment, external control arms, and analytics platforms. Devin received a BA in Neuroscience from Pomona College.


Director, Real World Data Solutions
Parexel

Luke has more than 12 years’ experience in the life sciences trade, and more than 8 years in the CRO industry. As a summa cum laude graduate of NC State University-Raleigh, Luke has focused his career path on significant experience in data analytics and real-world data technologies. He has a B.S. in genetics with a minor in biotechnology and nutrition. He is the resident subject matter expert in tokenization at Parexel. During his time at Parexel, Luke has managed and led several scientific data solution development projects and start-ups, from implementation to closeout.

Webcasts

Available On Demand

The use of real-world data in clinical research is on the rise – but what are the logistics of tokenizing and linking RCT data? Parexel and Datavant discuss how to implement tokenization within a clinical trial in an informative webinar. Tune in to learn more!

Data Linking in Clinical Trials

http://www.appliedclinicaltrialsonline.com/act_w/oncology

The industry-wide focus on cancer has placed it at the forefront of regulatory, scientific, and clinical advances, from expedited mechanisms to biomarkers to adaptive trials. And the coronavirus pandemic has accelerated adoption of further innovations, such as decentralized clinical trials (DCTs) and real-world evidence (RWE), that regulators and payers are increasingly accepting. There will be no going back to a pre-COVID world. To succeed, developers need to create cancer drugs that are both approvable and reimbursable. This requires a solid, integrated evidence strategy that accommodates the data to support the safety, quality and efficacy requirements of regulators, a coherent, data-driven value story for payers, and one that ultimately demonstrates how your new therapy is relevant to patients’ real lives.

The benefits of early advice in oncology strategy development

Regulator and payer acceptance of novel trial designs versus traditional evidentiary standards

Evidence considerations in more expensive cancer types (immuno-oncology, precision medicines, and cell and gene therapies)

Options for filling evidence gaps in late-stage development

Clinical Operations, Regulatory, HEOR and Market Access and Medical Affairs functions

Amy has 11 years of experience in the U.S. Food and Drug Administration, most recently in the role of Deputy Center Director, Oncology Center of Excellence (OCE) and Supervisory Associate Director, Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research (CDER). She was the signatory authority for products within OHOP, responsible for four divisions performing the scientific review and evaluation of hematology and oncology therapeutic drugs and biologics subject to regulation by the CDER. Amy received her M.D. from Tulane University.


Vice President, Pricing & Market Access
Parexel


Sangeeta has more than 16 years of experience of working within market access and health economics and outcomes research (HEOR), helping companies position their products for maximum uptake at an optimal price in the shortest possible time. She develops global strategies, including pivotal clinical trials, long-term data collection studies, real-world evidence generation plans, and HEOR strategies prepared for the reimbursement challenges that each product will face. Sangeeta holds a Ph.D. from the University of Otago.

Tuesday, April 12, 2022 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST ** Tuesday, April 19, 2022 at 8:30am CST | 5:30pm PDT | 8:30PM EDT This webinar will include an educational session with Parexel experts, who will address how to build an evidence strategy for your cancer drug that is both approvable and reimbursable.

Oncology Drug Development: Identifying Regulator and Payer Evidence Needs

Videos

This video series discusses the impact of implementing risk-based quality management (RBQM) and decentralized clinical trials (DCTs) from the clinical operations point of view.

Practically Speaking: Driving Clinical Transformation 

http://www.appliedclinicaltrialsonline.com/act/drug_development

There are thousands of identified rare diseases today, yet only a small percentage of them have treatments readily available. Drug development is complex and presents specific challenges: many rare disease patients are children, the patient pool is often very limited for any one disease, and patients are often geographically dispersed. Selection of a development partner with strong patient recruitment and global operational capabilities is extremely important for success. What are the challenges and opportunities in accelerating RD studies?

This panel discussion with Parexel experts will address:

Building partnerships and relationships between physicians, site staff, patients, and families

Considerations for conducting Rare Diseases trials

Strategies for accelerating pathways and natural history studies

Marketing authorizations with specific indications for rare diseases

Partners and partnerships: Building relationships and utilizing advocacy groups

Quality natural history studies for FDA approval

Considerations for conducting pediatric Rare Diseases trials

Regulatory strategies for accelerating pathways and natural history studies

The usage of real-world evidence (RWE) and synthetic control arms in trials

Identifying the right evidence for marketing approval

Small to mid-sized biotech and pharma companies


Vice President, Integrated Strategic Solutions
Parexel


Recently designated the honor of being named to the list of the 100 Most Inspiring People by PharmaVoice, her breadth of experience encompasses more than 20 years of clinical research experience in all phases of drug development. Ms. Dilworth is a passionate collaborator committed to working directly with patients and their families, physicians, sponsors, and other key stakeholders in the rare and orphan disease space. Ms. Dilworth has extensive experience in study design, eligibility criteria, feasibility, endpoint selection, operations/project management, and overall project/program strategy. She combines her prior work as a study coordinator and neurophysiology technician with a patient-focused mindset and strong relationships with advocacy groups to ensure that the appropriate strategies are employed to successfully execute trials.


Vice President, Regulatory Consulting
Parexel

Lucas has more than 15 years of industry experience. He was the former Director of Rare Disease program Office of New drugs and former team lead for Psychiatric Products for the CDER FDA. He co-authored inter-center and intra-center draft and final Guidances to Industry on drug development for common issues for rare diseases drug development, natural history studies, pre-IND meetings, rare pediatric priority review voucher programs, and eligibility criteria, among other specific rare disease guidances.


Senior Vice President, Real-World Evidence and Access
Parexel

Leanne brings over 25 years’ experience in healthcare, featuring extensive work in pharmaceutical product development and commercialization, and in healthcare technology and operational consulting. Leanne is an industry leader in designing and leading observational / non-interventional studies and in advancing the science of outcomes research, and publishes and speaks widely on a variety of topics in this area.


Vice President, Patient Innovation Center
Parexel

Rosamund has spent more than 15 years devoted to simplifying the patient journey in clinical trials, with a focus on reducing geographical, financial, and practical barriers to study participation. Her first job in an oncology clinic at Massachusetts General Hospital sparked her passion for putting patients at the center of clinical trial planning and implementation. Subsequent patient recruitment roles in both the pharma and CRO industries allowed her to explore better ways to communicate with patients. Her current emphasis is on addressing literacy and health literacy, exploring technological advances, and generating new ideas to make clinical trial participation more accessible and convenient for patients.

Available On Demand

This panel discussion will include an informative conversation among Parexel experts, who will share key considerations in accelerating drug development for rare diseases.

Key Considerations Accelerating Rare Disease Drug Development

http://www.appliedclinicaltrialsonline.com/act_w/pathways

Expedited programs can potentially cut years from the average overall time to market. But they are most useful for companies that have defined a target product profile (TPP) and identified the right mechanism or a combination of mechanisms. With many differing expedited regulatory mechanisms available across the globe, how can you select the right pathway and make it work simultaneously in different regions? This panel discussion will include a lively conversation with Parexel regulatory experts from USA, Europe, and China, who will draw upon their experience as former regulators and share their first-hand experience of regulator expectations. The discussion will address:

Selecting the right expedited regulatory pathway for a global program

Overcoming challenges of expedited mechanisms in different regions


Vice President, Regulatory Consulting
Parexel, United States


Lucas has over 15 years of industry experience. He was the former Director of Rare Disease program Office of New drugs and former team lead for Psychiatric Products for the CDER FDA. He co-authored inter-center and intra-center draft and final Guidances to Industry on drug development for common issues for rare diseases drug development, natural history studies, pre-IND meetings, rare pediatric priority review voucher programs, and eligibility criteria, among other specific rare disease guidances.


Vice President, Regulatory Consulting
Parexel, China

Yajie leads China regulatory strategy consultation, responsible for providing strategic technical guidance on various clinical and regulatory aspects of drug development. Yajie has over 20 years of clinical and drug development experience. She has held several senior positions at Merck (China), Innovent (Suzhou), Johnson & Johnson (China), and Xuanzhu Pharm and also worked as a senior clinical reviewer in the Center for Drug Evaluation (CDE) at the China NMPA.


Vice President, Regulatory Consulting
Parexel, UK/EMEA

Bridget advises clients on their clinical development plans, performs gap analyses, and supports with the writing and reviewing of MAAs, NDAs, scientific advice briefing documents, ODD applications, and responses to clinical questions from regulatory authorities. Prior to joining Parexel, Bridget was a senior clinical assessor in the biological unit at the MHRA, chaired the Rheumatology Immunology Working Party at the EMA and the UK delegate for the Committee for Advanced Therapies. She was also a consultant clinical immunologist in the NHS.

Europe & US: Wednesday, September 22, 2021 at 1:30pm BST | 8:30am EDT
Asia & US: Tuesday, September 28, 2021 at 7:30am CST | 4:30pm PDT
This panel discussion will include a lively conversation with Parexel regulatory experts from USA, Europe, and China, who will address how to utilize simultaneous expedited approvals to accelerate global drug development.