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September 24, 2010

Evaluating Capsule Manufacturing & Comparator Blinding Techniques for Clinical Trials

Speakers for this event:
  • Dr. Colin Lorimer, Senior Formulation Scientist, Almac  Learn More
  • James Hurst, Analytical Support Manager, Almac  Learn More
  • Michael Rainey, Production Manager, Almac  Learn More
  • Richard Shannon,  Head of Business Development (Europe), Almac Clinical Services  Learn More
  • Evaluating Capsule Manufacturing & Comparator Blinding Techniques for Clinical Trials

    The cost of bringing a new drug to market today is estimated to be in the region of $1 billion - a significant investment for biopharmaceutical companies therefore making it critical from the outset to ensure superior efficacy and safety when compared to an existing commercial product.

    Having examined the physiochemical properties of the API and market requirements for the drug product and decided upon a capsule dosage form for clinical trial supplies, a sponsor would also consider blinding or masking when developing their protocol design. This integral part of blinding can help remove both investigator and patient bias due to the visibility of the marketed product and can limit a potential placebo effect. Over-encapsulation of tablets or capsules is one of the most extensively used processes available to sponsor companies to promote blinding.

    During this interactive webinar session, speakers involved will utilise their experience in the industry to explore the various mechanisms and techniques currently available in the marketplace, including capsule blinding, to promote successful clinical trial supply capsule manufacture and over-encapsulation. They will also discuss key GMP challenges that need to be overcome in order to ensure product quality and study result integrity.

    Join us to gain insight into:

    • Impact & Requirements of GMP / Annex 13
    • over-encapsulation
    • Preparation of blinded investigational medicinal products
    • Evaluation of capsule manufacturing techniques and technologies
    • The importance of analytical assessment
    • Real life clinical case study

    A live Q & A Session with the audience will also be included.

    THIS PROGRAM IS INTENDED FOR:

    • Senior level executives from global pharma / biotech companies involved in the outsourcing of formulation development and clinical supply manufacturing.
    • Procurement Managers
    • Professionals interested in capsule blinding and over-encapsulation
    ABOUT OUR SPEAKERS:

    Dr. Colin Lorimer, Senior Formulation Scientist, Almac

    Colin has a degree in Pharmacy from Queen’s University of Belfast and went on to complete a PhD in Pharmaceutics. He has worked in the pharmaceutical industry for over eight years and joined Almac in 2006. Colin has practical experience of interpreting solid state information pertinent to formulation development. Specialising in solid oral dosage forms, Colin has worked on many formulations for early stage development using various technologies. He also has previous experience of topical and controlled release formulations.

    James Hurst, Analytical Support Manager, Almac

    James is a graduate of Manchester University where he obtained a BSc (Hons) degree in Chemistry. He has worked within the pharmaceutical industry since 1997 and joined Almac in 2008. James has wide expertise in the development and validation of analytical methods and the analysis of a wide range of Pharmaceutical products including both solid oral, and inhalation dosage forms. He has supported development projects that span from early stage development right through to commercial supply.

    Michael Rainey, Production Manager, Almac  

    Michael joined Almac in 2004 as a graduate from Queen’s University Belfast where obtained a BSc (Hons) degree in Biological Sciences. He worked in Secondary Production where he was involved in the labelling, compilation and randomisation of patient kits for trials. In 2006, Michael took up his current role as Primary Production Manager for Almac Clinical Services. He is responsible for a growing Primary Production department where encapsulation, bottling, blistering, walleting and inhaler blinding operations are completed for the clinical trial market.

    Richard Shannon,  Head of Business Development (Europe), Almac Clinical Services  

    Richard joined Almac Clinical Services (formerly Clinical Trial Services) in 1999 and has served in various Business Development functions during this time. He began his Almac career in Europe, before relocating to the Almac USA in 2001 where he gained valuable insight into the US Clinical Trial Supply market and was integral in establishing a new Business Development Team. Richard returned to Almac Europe in October 2005, and was appointed Head of Business Development (Europe) with responsibility for developing strategic business relationships and leading the European Business Development team. Prior to joining Almac Richard was employed by MDS Harris (now Celerion) where he performed various clinical trial conduct roles. Richard holds a B.Sc (Hons) in Zoology from Queen’s University, Belfast. .

    ABOUT OUR SPONSORING PARTNER:

    Providing a wide range of drug development and clinical trial supply services, Almac assists global Pharma and Biotech companies reach their critical clinical milestones and ultimately commercialisation.

    Offering innovative pharmaceutical development services for solid oral dose drug products, Almac can work with client partners to produce an optimum formulation and manufacture clinical batches from initial First in Human supplies to phase IV / registration.

    Following your protocol designs, Almac can additionally provide a range of solutions for blinding and over-encapsulation from single tablet filling to multiple mixed input units and controlled powder / excipient dosing.

    Almac has invested heavily in these service areas to ensure recognition as a market leader. With processing capabilities ranging from small-scale manual filling of capsules to large-scale fully / semi automated technology, Almac ensures high quality, efficient clinical supplies to meet client / clinical requirements.

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

     
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