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September 23, 2009
Unlocking the Therapeutic Potential of BCS Type II & IV Compounds: Oral Lipid-based Drug Delivery

Speakers for this event:
  • Dr. Jean Cuiné, Fellow Project Leader, Novartis Pharma AG Learn More
  • Julien Meissonnier, Director, R&D and Technical Services, Catalent Pharma Solutions Learn More
  • Dr. Jeffrey Browne, Technical Director, Pharmaceutical Softgel Business Development, Catalent Pharma Solutions Learn More
  • Norman Stroud, Director, Technology Development, Catalent Pharma Solutions Learn More
  • Unlocking the Therapeutic Potential of BCS Type II & IV Compounds: Oral Lipid-based Drug Delivery

    Reducing the attrition rate of New Chemical Entities (“NCE’s”) in today’s shrinking drug development pipelines has become an issue of paramount importance. A significant number of NCE’s offer therapeutic promise for patients, but exhibit limited physico-Chemical attributes for conventional, solid oral dose delivery. Recent estimates are that as many as 40% to 50% of NCE’s are poorly water soluble and, as a consequence, prone to oral bioavailabilty problems (BCS Type II and IV). The human gastrointestinal track (“GIT”), a complex biological system, may work for, or against, a formulator’s best intensions to deliver efficacious doses of BCS Type II and IV NCE’s. Today’s formulation scientist must have a sound working knowledge of how to develop orally-delivered, lipid-based systems that can be used advantageously to improve the bioavailability of these classes of compounds.

     

    This webinar will focus on the importance of self-emulsification (dispersion) and lipolysis (digestion) properties for achieving acceptable “in-vivo” performance of lipid-based formulations. Specifically, formulation parameters that are critical in the design of lipid-based fill systems for maintaining poorly water soluble drugs in solution throughout the GIT will be discussed.

     

    An important aspect of this discussion is the use of “in-vitro” methods that can be utilized to assess the dispersion and digestion properties of lipid-based formulations during development.

     

    As a final topic, the selection of a suitable dosage form for the oral administration of lipid-based formulations will be discussed. Given that these formulations often do not lend themselves to conventional dosage form approaches due to their liquid or semi-solid nature, the advantages of the soft gelatin capsule dosage form for encapsulation of lipid-based systems will be presented.

     

    The webinar will provide case studies of BCS Type II and IV compounds that have successfully utilized the formulation approaches presented by the speakers to improve oral bioavailability. A Q&A session will conclude the presentation. 

    THIS PROGRAM IS INTENDED FOR:

    Formulators and decision makers within pharmaceutical development/CMC units of pharmaceutical/biotech companies worldwide.

    ABOUT OUR SPEAKERS:
    Dr. Jean Cuiné, Fellow Project Leader, Novartis Pharma AG 

    Dr. Jean Cuiné, is currently a Fellow Project Team Leader in Pharmaceutical and Analytical R&D at Novartis Pharma AG, Basel, Switzerland. His responsibilities include the development of peroral formulations for poorly water-soluble drug candidates and the supervision of New Chemical Entities analytical and pharmaceutical development from early to late stage development. As a member of the Novartis oral technology platform, he is responsible to lead the innovation in the field of lipid-based drug delivery systems.

     

    Dr. Cuiné holds a Pharm D degree from Louis Pasteur University, Strasbourg, France and a Master in Biopharmacy and Pharmaceutical Technology from University of Paris XI, France. He obtained his Ph.D. in Pharmaceutical Sciences from Monash University, Melbourne, Australia in 2006. His Ph.D. research focussed on the rational design and in vitro -in vivo evaluation of lipid-based formulations for the oral administration of poorly water-soluble drugs.

     

    Dr. Cuiné was a member of the Faculty of Pharmacy board of directors and of the Scientific Advisory board of Louis Pasteur University, Strasbourg, France for several years.

     

    Dr. Cuiné has been an invited speaker to many international conferences and seminars and is author/co-author of several publications in this field.

    Julien Meissonnier, Director, R&D and Technical Services, Catalent Pharma Solutions 

    Julien Meissonnier is Director of R&D and Technical Services for Catalent Pharma Solutions in Beinheim, France and has 11 years of experience in pharmaceutical development. He provides technical and scientific leadership for the development of delivery systems for poorly soluble drugs that lead to approvable regulatory dossiers. His responsibilities include early stage screening activities, developing products, scale-up and technology transfer, directing clinical supplies and supporting product launches.

     

    Prior to joining Catalent, Mr. Meissonnier held various positions at Ethypharm within its pharmaceutical development division.

     

    Mr. Meissonnier received his Engineer degree in physico-Chemistry from the ISMRa in Caen, France.

    Dr. Jeffrey Browne, Technical Director, Pharmaceutical Softgel Business Development, Catalent Pharma Solutions 

    Since joining Catalent Pharma Solutions in 1994, Dr. Browne has held a variety of positions including Vice President Softgel R&D, Executive Director and Division Head of Pharmaceutical Development, Director of Technical Services, Account Director in Business Development, and most recently,Technical Director, Pharmaceutical Softgel Business Development.

     

    Dr. Browne began his career working for The Upjohn Co.  While there, he held various positions in Pharmaceutical Manufacturing and Technical Services and Drug Delivery R&D, with a focus on topical, transdermal, inhalation and oral liquid dosage forms.  After that, he was Director, US Technical Affairs, for Rhoto Pharmaceutical Co., a Japanese company.

     

    Dr. Browne received his Ph.D. in Industrial and Physical Pharmacy from Purdue University.

    Norman Stroud, Director, Technology Development, Catalent Pharma Solutions 

    Mr. Stroud joined Catalent Pharma Solutions in 1982, and has held various scientific and managerial positions while working in the field of softgel encapsulation, including Director, R&D Services and Special Projects, Director, AR&D and Technology Development.  In his current role as Director, Technology Development, Mr. Stroud has led the development of the innovative, novel Vegicaps® Soft capsule technology. 

     

    Mr. Stroud began his career working in the Pharmaceutics Department, School of Pharmacy and Pharmacology, University of Bath, England.  During his time in academia, Mr. Stroud held various positions in Pharmaceutical Research and Development, with a focus on the development of liquid dosage forms.

     

    Mr. Stroud received his B.Sc (Hons) degree in Biochemistry from Cardiff University, Wales.

     

    Mr. Stroud has been granted eight U.S. patents.

    ABOUT OUR SPONSORING PARTNER:

    Catalent Pharma Solutions is a leading provider of conventional and advanced dosage forms to pharmaceutical, biotechnology and consumer healthcare companies. We offer extensive development, manufacturing and packaging services for oral, sterile and inhalation routes of administration. For 75 years, Catalent’s advancements in formulation and processing technology of the soft gelatin capsule has made the dosage form the most successfully applied and globally commercialized dosage form for liquid and semi-solid pharmaceutical formulations for oral, topical and vaginal delivery. A non-gelatin alternative, Vegicaps® Soft capsule technology, was introduced in 1998. Catalent’s softgel facilities include potent, hormonal, cytotoxic and controlled drug substance handling capability within its network of ten (10) development and manufacturing sites on five (5) continents.

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