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The EU legislative framework is currently undergoing a period of substantial change to react to a seismic shift in scientific and technological advancements. During this three-part webinar series, we will cover three key areas sponsors must be mindful of during drug development in preparation for filing successful regulators submissions: decentralized clinical trials, CMC requirements for first-in-human trials and cell and gene therapy. Have your questions answered by experts in the field to make your processes more efficient, compliant and competitive in an evolving landscape.


May 26th, 10am EST, 4pm CET

The Future Of Decentralized Clinical Trials In An Evolving EU Regulatory Landscape

The COVID-19 pandemic has demonstrated the feasibility of adapting clinical trials from site-based endeavors to fully decentralized or hybrid models and has increased global acceptance of decentralized trials as a safe and effective option for accelerating clinical research. Enabled by digital, technological, and logistical innovations, decentralized clinical trials offer advantages to both patients and sponsors that will endure beyond the pandemic. In addition to the development of a well-conceived operating model, successful implementation of partially or fully decentralized clinical trials (DCTs) requires a cohesive, coordinated regulatory strategy.

This webinar will review the regulatory and geographic factors that can influence the adoption of DCTs, and provide a roadmap for implementing these trials within the current legal environment in Europe. It will address the critical importance of:

  • Advantages of DCTs for patients and sponsors, as well as increased operational (and thus research cost) efficiency
  • The nuances of the evolving EU regulatory landscape and how to ensure compliance with differing good clinical practice (GCP) requirements and relevant legislation at national levels
  • The importance of a robust and secure technology architecture for trial related data acquisition, storage, and communication
  • How to implement a drug distribution and management strategy that meets all stability, storage, and dosing access and administration requirements

Speakers

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Aruna Talapatra

Director of Product Management, Thermo Fisher Scientific


Aruna Talapatra focuses on securing market and customer insights on decentralized trials and is working on strategic development and deployment of Thermo Fisher Scientific’s digital supply chain platform clinical trials. Aruna brings over 12+ years of product management experience in the medical device industry and has worked at companies such as GE Healthcare, Fujifilm and Hill-Rom where she has developed Healthcare ecosystems for Medical devices such as MR, Ultrasound, Diagnostic and Non-Diagnostic Cardiology products and Hospital EMR systems. Aruna holds a Master of Science degree in Computer Science from Emory University, Atlanta, Georgia.

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Scott Emery

Global Director, Total Transportation Management, Thermo Fisher Scientific


Scott Emery holds the position of Global Director of Total Transportation Management (TTM) at Thermo Fisher Scientific. Scott joined Thermo Fisher Scientific in 2013 and was responsible for their global transportation network including the management of offices located in the United States, United Kingdom, Switzerland & Singapore, prior to moving into his current role. Scott has 21 years of experience in global transportation and logistics. Previous to Thermo Fisher Scientific, Scott held leadership roles in global development, sales and operations at DHL Express & National Air Cargo.

JUNE 29th 10am EST, 4pm CET

Entering First-In-Human Clinical Trials: A 5-point Strategy For Robust CMC Dossiers

Getting biological drug products to first-in-human (FIH) trials requires a deep and nuanced understanding of the scientific and regulatory challenges unique to these complex large molecule substances. Prioritizing regulatory CMC guidance and careful preparation of quality dossiers are integral to success from the very early stages and throughout clinical development. A robust CMC package provides health authorities with the information to assess the quality of material entering clinical trials. Inadequate CMC supportive evidence or insufficient detail can delay the go-ahead to enter the clinic. At the same time, unnecessary granularity can impact the lifecycle management of the dossier.

This webinar discusses the five strategies to implement to build a robust CMC package, help streamline the path to FIH trials for biologics and establish the quality foundation needed to support all of the development phases toward commercialization:

  • Including regulatory CMC in early development teams
  • Keeping patient and clinical experience in mind
  • Building a phase-appropriate dossier
  • Considering and conveying the basis for the strategy
  • Obtaining regulatory advice at every opportunity

Speakers

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Clara Ferloni

Sr Manager, EU Regulatory Affairs, Thermo Fisher Scientific


Pharmacist by education, with a PhD in enzyme technology, Clara has worked in the pharmaceutical and in the CDMO industry for 18+ years and has a wealth of experience in regulatory Chemistry, Manufacturing and Controls (CMC) support of clinical and commercial products of different modalities. Clara currently holds the position of Senior Manager, EU Regulatory Affairs, supporting, amongst others, sites specialized in the manufacture of biological products.

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Frederique Chazot

Sr. Manager, EU Regulatory Affairs, Thermo Fisher Scientific


Pharmacist by education, with a Master’s Degree in Analytical Chemistry, Frederique has worked in the pharmaceutical and CDMO industry for 25 years+. Frederique currently holds the position of Senior Manager, EU Regulatory Affairs supporting, amongst others, sites specialized in small molecule development and manufacturing. Frederique has a wealth of experience in regulatory Chemistry Manufacturing and Controls (CMC) support of clinical and commercial products and modalities. Frederique is a member and trainer for pharma industry associations, Leem & A3P.

SEPTEMBER 29th 10am EST, 4pm CET

Regulatory and CMC Considerations for Cell and Gene Therapy Commercialization

The rapid expansion of the cell and gene therapy pipelines in recent years offers significant potential to cure diseases with great unmet medical need. However, the unique nature of these therapies poses challenges to regulating them within traditional frameworks and regulatory expertise is not uniform across regions.

This webinar will provide key advice for determining and navigating the regulatory pathway for any cell and gene therapy, including the following:

  • Early, proactive engagement with the established regulatory authorities that specialize in the evaluation of cell and gene therapies
  • The key components of programs to accelerate application review within major regulatory jurisdictions
  • Critical considerations for site selection and CMC development of viral vectors for cell and gene therapies

Speakers

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Monica Commerford, Ph.D.

Head of Regulatory Affairs, Vital Vector Services, Thermo Fisher Scientific


Monica Commerford is the Head of Regulatory Affairs, Viral Vector Services at Thermo Fisher Scientific. Having gained significant experience while working as a Product Quality Microbiology Reviewer and Pre-licensing Inspection lead at the Center for Drug Evaluation and Research at the Food and Drug Administration, Dr. Commerford is an expert in microbial control, product quality microbiology, and sterility assurance of Investigational New Drug Applications and Biological License Applications submitted to CDER. She's also performed pre-license inspections of biological product manufacturing facilities

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Clara Ferloni

Sr Manager, EU Regulatory Affairs, Thermo Fisher Scientific


Pharmacist by education, with a PhD in enzyme technology, Clara has worked in the pharmaceutical and in the CDMO industry for 18+ years and has a wealth of experience in regulatory Chemistry, Manufacturing and Controls (CMC) support of clinical and commercial products of different modalities. Clara currently holds the position of Senior Manager, EU Regulatory Affairs, supporting, amongst others, sites specialized in the manufacture of biological products.

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