Preparing for a successful commercial launch starts long before FDA approval.


Join AMRI, PCI Pharma Services, and Cardinal Health Regulatory Sciences for this three-part webinar series as we review this complex process and identify common challenges to commercialization. We will focus on what drug synthesis, clinical logistics, packaging design, and regulatory considerations should be thoroughly planned and checked for a successful commercial drug launch.

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Session 1

Drug Synthesis Considerations for Commercial Launch


Ravi Rai, Ph.D., AMRI
  • The importance of route scouting and development while getting the drug registered and validated
  • Defining the edge of failure in the drug synthesis process and avoiding it

Session 2

Supply Chain & Packaging Design Considerations for Clinical to Commercial Launch


Greig Ross, PCI Pharma Services
  • Transitioning from clinical to commercial: safety, packaging design, and materials
  • Transitioning from clinical to commercial: distribution supply chain considerations including biologics and cell therapies

Session 3

Regulatory Considerations for Clinical to Commercial Launch


Todd Phillips, PharmD, RAC, Cardinal Health Regulatory Sciences
  • A review of the Investigational New Drug (IND) application and the FDA’s marketing authorization process, including common areas that are underestimated
  • Expedited FDA programs (i.e. Fast Track, Breakthrough, Accelerated Approval, etc.)

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Ravi Rai, Ph.D.

Presenter
Senior Research Scientist III
AMRI

Ravi Rai received his Ph.D. in carbohydrate chemistry from Utah State University in 2006. He then pursued an industrial post doctorate at a CRO called Organix Inc. in Woburn MA. Rai joined AMRI in 2007 as a Senior Research Scientist in the medicinal chemistry department where he worked on a diverse range of customer projects primarily developing an SAR based library of compounds that had the desired efficacy for the targets that were being pursued. His current role requires him to discuss pre-RFP projects with potential customers, oversee the same projects transition from various phases of development such as route scouting, process development, NCSS and finally into a GMP suite. Rai is also involved with planning and execution of late stage process development including CPP and DOE on various projects.

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Todd Phillips, PharmD, RAC

Presenter
Director, Global Regulatory Affairs
Cardinal Health Regulatory Sciences

Todd Phillips, PharmD, RAC is Director of Global Regulatory Affairs for the Regulatory Sciences division of Cardinal Health Specialty Solutions. Dr. Phillips provides strategic development and regulatory consulting services to a variety of drug and biological product manufacturers. Dr. Phillips has more than 16 years of experience in regulatory affairs, drug development, clinical project management, and product marketing. Prior to joining Cardinal Health in 2011, his experience had been gained at FDA and in varying positions in the pharmaceutical and CRO industries.

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Greig Ross

Presenter
Director of Business Development
PCI Clinical Services

Greig has over 15 years of experience guiding pharma and biotech companies through clinical trials and preparing for commercial launch. Greig’s expertise includes packaging, packaging technology, inventory management, supply planning and new technologies.

Greig has lead the project management and distribution teams for both the US and the UK. He was on the lead team establishing PCI’s clinical business in North America, developing portal design and ERP system customization specific to clinical supplies.

Greig brings a unique perspective based on his global project management knowledge from his various roles within PCI.

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Marisa Reinoso

Host
Marketing Manager
PCI Pharma Services

Marisa has over 14 years of experience bridging life science companies to patients. She began her career researching medical vaccines and solutions to infectious diseases before shifting into marketing. Prior to PCI, she was the marketing manager of Sherpa Clinical Packaging where she implemented marketing programs that established Sherpa as a premier global clinical packager. With the acquisition of Sherpa by PCI, Marisa continues to bring thoughtful educational pieces to the forefront and promote clinical trial services globally. Reinoso has a bachelor’s degree in biology from Reed College and a master’s degree in business administration from Portland State University.

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