Oral Solid Dosage: The Quiet Strength in the Pharma Industry
There is a lot of press coverage regarding new and innovative technologies, from vaccine production to cell therapy, however oral solid dosage (OSD) remains one of the most effective means to administer certain pharmaceutical drugs. OSD technology has been around for generations and is still considered to be the most cost-effective and patient-friendly form of certain drugs. Submission approvals by the FDA for new drug applications (NDA’s) include many drugs based on OSD. It is a tried and true system for many drugs.
This presentation covers the basics regarding OSD products, development, equipment, and facility design. This is not an expert class but a broad overview of the value of the dosage form, latest trends, technologies, and impact on facility design. The subject matter is quite broad but we will try to cover a broad spectrum of aspects and value of the technology. This presentation is best suited for a pharmaceutical professional that would like to broaden their understanding of OSD technology.
Please join us and our panel for an evening discussing a strong but quiet pharmaceutical technology that still provides many benefits.
Speakers:
Mike Rooney
Director of Engineering Activities, Marinus Pharma
Mike Rooney directs engineering activities at Marinus Pharma and his role is to commercialize new products to commercial scale. Product technologies at Marinus include oral dose and sterile injectable products. Prior to Marinus he worked for A&E firms and led master planning and conceptual design projects for oral, sterile, and cell therapy companies. He also spend 12 years at Elan Pharmaceuticals commercializing products based on nanotechnology including oral and sterile products.
Mike has been involved in the design of oral dosage and sterile fill facilities in various world markets including China, Korea, Libya, Ireland, England, and the US. Mike has been active in ISPE throughout his career including session leader for NanoTechnology in 2006 and Lead of the Continuous Oral Dose Manufacturing in the Oral Dose COP group.
Terry Jacobs
Founder, JacobsWyper
Terry Jacobs, AIA is a founder of JacobsWyper Architects and has been active in the design of OSD facilities for his entire career. He is the Co Editor of the book “Good Design Practices for CGMP Pharmaceutical Facilities“ which is its second addition. He wrote the architectural chapter for the ISPE OSD Baseline Guide 3rd addition, as well as he is the current Chair of the ISPE OSD COP. He is a past president of ISPE DVC, past Chair of the International Education Committee as well as a past International Board member.
Jamie Frizzell
Technical Sales Group Manager, Freund-Vector Corporation
Jamie Frizzell is the Technical Sales Group Manager at Freund-Vector Corporation, a leading global manufacturer of pharmaceutical processing equipment for oral solid dosage manufacturing. Jamie manages the Technical Sales Group, which provides pre-sale process engineering support and proposals to Freund-Vector’s customers. Jamie has worked in the pharmaceutical industry in various capacities for over 27 years – starting as a Sr. Controls Engineer creating automated control systems, then as a Sr. Project Manager overseeing equipment projects from purchase order to handover and now as Technical Sales Group Manager. Jamie has a wide range of experience within the oral solid dosage realm but has particular expertise in containment of potent compounds, WIP/CIP systems, equipment and facility design and automated control systems.
Mike DeBellis
Lead Process Mechanical Engineer, Jacobs
Mike DeBellis is a Lead Process Mechanical Engineer at Jacobs with 40+ years of diversified experience in the engineering and design of pharmaceutical, biotechnology, process and utility equipment and systems for the pharmaceutical and biotech industry. Technology experience in pharmaceutical API and drug production includes weigh and dispensing, wet and dry granulation, vacuum filter drying, fluid bed drying, milling, drying, blending, tableting, roller compaction, material handling, CIP/Wash-In-Place systems, dust explosion prevention, and isolation / containment technology. He has also contributed to the ISPE Baseline Guide Volume 2 Oral Soldi Dosage Forms Second and Third Editions as Process Chapter Lead and Co-writer, Chair and Co-Chair of the OSD CoP Steering Committee and continues to be an active member of the committee.
Registration will open at 5:30pm and dinner (with a cash bar) will be served.
Dinner will be served (family style) at 6:00pm and the program will conclude at 8:00pm.
Registration Information:
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COST |
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ISPE Members |
$70 |
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Non-Members |
$90 |
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Emerging Leaders/Student |
$45 |