Are you feeling like the global pandemic makes it hard to keep your finger on the pulse of things? Do you have questions about the latest in CDMO trends, best practices, and technologies within the pharmaceutical and biotechnology industries?

Join AMRI’s experts for a Casual Nexus – an informal, discussion-based 30-minute webinar series where great minds come together to learn more about the ideas, topics, and trends that are driving the industry.

Each week AMRI will present a fresh, exciting topic; you bring the questions! Connect with AMRI’s panel of experts who will share what’s new in their field of expertise, in a discussion driven by you.


Formulation Development and Clinical Supply of Aseptic Liposomal Formulations

Thursday, Sept. 24 | 11:30AM ET / 8:30AM PT

Iain MacGilp, Ph.D., Director, GMP Production, AMRI
Amber McFarlane, Head of Formulation Development, AMRI

In this session we’ll discuss:

  • The importance of an integrated formulation development and clinical supply function that can support accelerated timelines to clinic, including complex formulations
  • Recent and ongoing experiences in liposomal formulations, with focus on high pressure homogenization
  • Linearity of laboratory to clinical supply scale-up with supporting analytics
  • Broad applicability to variety of product types and presentations (liquid, lyophilized, potent compounds, cytotoxics)
T3P® - A Versatile Peptide Coupling and Water Removal Reagent

Thursday, Oct. 1 | 11:30AM ET / 8:30AM PT

Peter Talbiersky, Ph.D., Manager Fine Chemicals Sales, AMRI

In this session we’ll discuss:

  • The importance of a green and versatile condensation reagent
  • Safe alternative for commonly used condensation reagents like dicyclohexyl carbodiimide (DCC)
  • Examples showing the advantages of T3P vs commonly used coupling agents
Sterile Drug Product Manufacturing During a Global Pandemic

Thursday, Oct. 8 | 11:30AM ET / 8:30AM PT

Ankit Agrawal, Senior Director, Commercial Strategy
Anish Parikh, Vice President, Drug Product Sales & Marketing, AMRI

In this session we’ll discuss:

  • The shortage of sterile manufacturing capacity within CDMOs given the Covid-19 pandemic
  • The push to keep manufacturing within US borders
  • The immense coordination to work with our clients to find a vaccine for Covid-19
  • The shortage of supplies (components, gowning, etc.)
The Handling of Highly Potent APIs in Single-Use Manufacturing

Thursday, Oct. 15 | 11:30AM ET / 8:30AM PT

Iain MacGilp, Ph.D., Director, GMP Production, AMRI
Brian Haney, Ph.D., Director of Technical Operations, AMRI

In this session we'll discuss:

  • More details to come!

View the Webinar Today

Access this exciting webinar series on-demand!

Register for 10/1 Event
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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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Register for 9/24 Event

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