Blake Wilson is a Partner in Hogan Lovells’ FDA Regulatory group.  He holds a juris doctorate from the University of Pennsylvania and a master’s degree in biostatistics from Columbia University.  Prior to becoming an attorney he managed Phase I and II pharmaceutical trials at Brown University.  His legal practice focuses on FDA’s premarket approval process for drugs/biologics/devices, oversight of clinical trials including BIMO audits, as well as navigating changes in laws or regulations that govern the life sciences industry.  He also guides sponsors through the special designation programs available at the premarket stage, like RMAT, accelerated approval, and breakthrough.  In this capacity, Blake advises extensively on novel products, study design considerations, and the use of clinical data in FDA-related matters.  By stress testing clinical materials through the lens of an FDA reviewer, Blake helps sponsors avoid pitfalls that can delay or derail a project.

Kevin leads a global team providing quality oversight of GSK’s end-to-end global Human Subject Research activities. This includes QA audit, Regulatory Inspection Management and Quality Issue Management. Kevin received his honours undergraduate degree in Chemistry and Pharmacology from the University of Liverpool and started his career in Good Laboratory Practice at a mid-size CRO and then in GSK. He has since held roles of increasing seniority within GSK including establishing the Compliance Officer role for the China R&D business, before taking on his current role as the Head of Clinical QA.

Todd Georgieff has had an extensive career in the healthcare and pharmaceutical industries, spanning nearly 30 years. He holds a Bachelor of Science in Pharmacy from the University of Toronto and an MBA from York University. His professional experience includes managing global drug development programs and leading clinical operations teams across various therapeutic areas such as oncology, immunology, and ophthalmology.

Georgieff has worked on numerous high-profile projects, including digital protocol development and comprehensive genomic screening, particularly at major companies like Roche and Genentech. He has also contributed to industry collaborations, such as TransCelerate’s Digital Data Flow initiative and the Precision Cancer Consortium. Additionally, he has served in leadership roles overseeing large-scale organizational changes and process improvements, and he has a significant background in teaching graduate-level courses on health management.

Beyond his industry roles, Todd Georgieff is actively involved in the Canadian Pulmonary Fibrosis Foundation, where he serves as the board chair for Quebec. His personal connection to the disease, through his father-in-law\'s battle with idiopathic pulmonary fibrosis, drives his commitment to supporting advancements in this field​ (futurpositif)​​ (Applied Clinical Trials)​​ (Xtalks)​​ (Canadian Pulmonary Fibrosis Foundation)​.

Dr Andy Lawton is a consultant for Risk Based Approach Ltd, specialising in business changes related to ICH (E6 R2/3 and E8 R1), in particular QTL’s, QbD and RBM.

Dr Andy has been working in the clinical development arena for over 42 years and has covered most roles/tasks and was a Founding Committee Member of ACDM, Member of TransCelerate RBM, QTL, Data Transparency, eSource work streams and also a Member of EFPIA WG on Data Transparency.

A Clinician and Researcher, Dr Anupama Ramkumar is the principal consultant and CEO of Arkus Research Pvt. Ltd, a clinical consulting company engaged with pharmaceutical companies and CROs worldwide.

With over 26 years of medical experience and 22 years of experience in Clinical Research Industry she bridges the field of medicine and pharmacology effectively and is a sought after clinical development and GCP expert as well as technical strategy advisor for pharma companies and research units.

She has set up and guided clinical teams through several successful clinical development programs across multiple therapeutic areas, been led regulatory interactions and audits which include USFDA, AFFSAPS, WHO, ANVISA in companies such as Lambda Therapeutic Research, Dr. Reddy’s Biologicals, Alembic Pharmaceuticals to name a few.

 Her forte lies in demystifying GCP to build practical and effective Quality management systems for regulated drug development with a focus on compliance and operational excellence.

Her experience in clinical trials across all phases for NCEs, Biosimilars,Vaccines etc and insights from multiple interactions with regulators brings values to the projects she engages in.

Dr. Raghavendra Pai is a distinguished professional in the field of clinical research, currently serving at Norwich Clinical. With a robust academic background and extensive experience, Dr. Pai has made significant contributions to the industry. Dr. Pai began his academic journey with a Bachelor’s degree in Pharmacy, where he developed a strong foundation in pharmaceutical sciences. He further advanced his knowledge by earning a Master’s degree in Clinical Research, equipping him with the skills necessary to navigate the complexities of clinical trials and drug development. His academic pursuits culminated in a Ph.D. in Pharmacology, where his research focused on the mechanisms of drug action and the development of new therapeutic strategies.With over two decades of experience in clinical research, Dr. Pai has held various pivotal roles.In addition to his professional accomplishments, Dr. Pai is an active member of various professional organizations. Dr. Raghavendra Pai\\\'s career reflects a commitment to advancing clinical research and improving patient outcomes. His blend of academic excellence and practical experience continues to drive innovation and set high standards in the field of clinical research.