Development and Manufacture of Highly Potent API Drug Products Throughout the Clinical Phases

Drug Discovery and Development, Life Sciences, Pharma Manufacturing and Supply Chain,
  • September 28, 2017

David O’Connell, Director of Pharmaceutical Development at PCI Pharma Services, will share how highly potent APIs can be developed and manufactured into suitable drug products that meet the quality target profiles. Attendees will learn about the complexities for each of the clinical phases, from drug in capsule to complex formulations, and how to guide your highly potent API, to commercial supplies for solid oral products, non-sterile oral liquid and semi-solids. PCI’s safe development and manufacture of dosage forms containing potent molecules is completed within dedicated high potency suites. These suites provide a totally engineered solution without open processing to provide a seamless service from preclinical to commercialization.

Speakers

David O’Connell, Director of Scientific Affairs, PCI Pharma Services

David O’Connell is the Director of Pharmaceutical Development at PCI Pharma Services, an integrated full-service provider expertly delivering a seamless transition from development to commercialization.

 After graduating from Glasgow Caledonian University in Scotland with a Bachelor of Science degree in applied bioscience, David spent seven years as a Supervisory Scientist working for Aptuit in Edinburgh, Scotland, before moving to Penn Pharma as Head of Formulation Development in 2009. Here he played a vital part in the design of the potent Contained Manufacturing Facility (CMF), which won the ISPE Facility of the Year award for Facility Integration (2014). In 2013, David took on the role of Director, Pharmaceutical Development at the PCI site in Tredegar, Wales, United Kingdom.

 In his current role, David aids clients with formulation development, technical transfer and scale-up of solid oral, oral liquid and semi-solid products for clinical trials and/or commercialization.

Who Should Attend?

Senior professionals from pharmaceutical & biotechnology companies working within:

  • Clinical Operations
  • Clinical Supply Chain
  • Drug Manufacturing
  • Quality Control / Quality Assurance
  • Logistics
  • Procurement
  • Project Management
  • Engineering / Packaging / Artwork
  • Technical Operations
  • Commercialization

Xtalks Partners

PCI Pharma Services

PCI Pharma Services is an integrated full service provider, a proven and trusted partner to leading companies in the global healthcare industry. We offer unparalleled expertise and experience in taking compounds from the earliest stages of development through to successful commercialization, delivering speed-to-market and commercial success for our customers.

Our core services support each stage of the product lifecycle, including drug development, clinical trial supply, commercial launch and ongoing commercial supply. We partner with clients in providing innovative technologies, flexible solutions, and an integrated supply network supporting life-saving medicines destined to more than 100 countries around the world.

We are dedicated to supporting clients with specialist experience, exemplified in our operational flexibility, delivery and commitment to safety – supported by industry-leading technologies and an exemplary quality and regulatory record. This has allowed us to be the partner of choice for leading pharmaceutical companies around the world, operating as a seamless extension of their business.

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