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April 16-17, 2008 - Puerto Rico Convention Center |
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ExcipientFest Americas 2008 Presentation Schedule |
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Day One: Wednesday- April 16, 2008
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Pharma Expo (10AM - 7PM) April 16-17
Visit the world’s top Excipient Manufacturers & Service Providers. Booths are conveniently arranged close and in route to all conferences and workshops. The Expo is an excellent environment to prearrange meetings between Key Purchasing Contacts and Suppliers in private meeting areas to effectively maximize your visit to ExcipientFest. The Pharma Expo will continue on Wednesday, 25th. (Booth List)
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Workshop I (9AM - 5PM) Conference Room: 201-A Back to presentation schedule
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Design of Experiments (DoE) as a Tool for Pharmaceutical Manufacturing, Tech Transfer & Troubleshooting
Abstract: During the development of a pharmaceutical product, a large amount of resources are spent on the formulation development as well as on a robust, scaleable process for a successful transfer to a manufacturing facility. However, what recourses does the on-site technical services scientist have if the transfer does not go as expected? This one day course explores the use of statistically based tools for designing experiments (DoE) and evaluating data as it relates to technology transfer, optimization and troubleshooting. The mathematical basis for DoE will be reviewed and various real world examples will be analyzed. This workshop is limited to 35 participants.
Presented by Emerson Resources, Inc.: An organization servicing the Pharmaceutical and Nutritional Supplement Industries. The company has three areas of focus: Formulation development and technical support Technical training and value added ingredient supply.
Workshop Leaders: Mr. Adolfo Gomez & Mr. Stephen Levine (Workshop Outline & Speaker Resumes)
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Workshop II (9AM - 5PM) Conference Room: 201-B Back to presentation schedule
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Film Coating Technology for Pharmaceutical Applications
Abstract:This full-day seminar will teach the participants a complete understanding of all film-coating
processes used in solid dose formulation. The seminar explores the influence of tablet design on formulation
of film coating quality. This includes film-coating equipment/processes, formulation of film-coating systems,
coating process optimization, printing technologies, modified release coating technologies and troubleshooting
coated tablet defects. The entire workshop is an Interactive session. This workshop is limited to 35
participants.
Presented by Colorcon Inc.: A global manufacturer and leader in Film Coating products and Excipients for the Pharmaceutical Industry.
Workshop Outline:
- Introduction
- Influence of tablet design and formulation of film coating quality
- Guidelines for tablets robustness including hardness and friability.
- Tablet shape effects.
- Proper logo design and placement.
- Effect of tablet formulation on film coating quality and stability.
- Film-coating equipment and processes
- Review of film-coating equipment-pan and fluid bed processes
- Continuous Coaters
- Spray gun optimization and troubleshooting
- Reconstitution of film coating dispersions
- Formulation on film-coating systems
- Polymer characteristics and selection
- Plasticizer effects
- Selection of pigments and colorants
- Coating process optimization
- Identification of critical, product specific control parameters
- Setting process control ranges
- Improving coating uniformity and process efficiency
- Troubleshooting coated tablet defects-Interactive session
- Participants will discuss causes and present solutions for many commonly observed coated tablet defects
- Participants are invited to bring examples of problem tablets for discussion.
Workshop Leaders:Ms. Laura Scattergood and Mr. Charlie Cunningham (Workshop Outline & Speaker Resumes)
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Poster Session (10AM - 6PM) April 16-17- Sponsored by JRS Pharma
Presented by Graduate Programs in Puerto Rico, as well as from programs in Pharmaceutics from predominant Universities in the USA and Latin America. Industry professionals from Sponsor companies are also invited to present posters. A panel of judges from JRS Pharma and the industry will select the best university posters and present awards at the cocktail on Wednesday, 25th. (Click for additional details)
Technical & Regulatory Conferences (Day-One)
(10AM - 5PM)- Conference Halls A & B
ExcipientFest 2007 features twelve x 45 minute presentations each day. These conferences will be running simultaneously in adjacent halls within the expo area. See schedule below. |
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Workshop III (9AM - 5PM) Conference Room: 201-A Back to presentation schedule
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Pharmaceutical Formulation Workshop on Tablet Dosage Forms
Abstract: This is the 4th year for this very popular full-day, hands-on workshop. The course will allow participants to develop a complete understanding of how a tablet formulation and process is rationalized. The seminar explores all areas of pharmaceutical formulation covering theory/design, raw materials, formulation/process development, production and coating. Participants will have the opportunity to develop tablet formulas within appropriate rationale. This workshop is limited to 35 participants.
Presented by Emerson Resources, Inc.: An organization servicing the Pharma and Nutritional Supplement Industries. The company has three areas of focus: Formulation development and technical support Technical training and value added ingredient supply.
Workshop Outline
- Introductions
- Instructors & Emerson Inc.
- Goals
- Expectations
- Statistics Review
- Variables
- Population
- Central tendency
- Dispersion
- Distribution
- Raw Materials Characterization
- Physical
- Chemical
- Functional
- Classification
- Review common Excipients
- Formulation Development
- Defining variables
- Variable relationships
- The hypothesis
- An initial theoretical formulation
- Experimental design
- Process Development
- Review conventional tabletting processes
- Pre-blending operations
- Granulation
- Blending
- Tabletting
- Mix time studies
- Formula & process optimization using compaction profiles
- Statistical process control
- In process specification rationalization
- Process capability
- Tablet Coating Dynamics
- The suspension formulation
- Liquid delivery
- Process conditions
- Tablet dynamics during processing
- Wrap up
- Specific questions
- Panel review
- questions
Workshop Leaders: Mr. Walter Strathy and Mr. Adolfo Gomez (Workshop Outline & Speaker Resumes)
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Comprehensive Seminar (9AM – 12PM, ½ day, Conference Room: 201-B) Back to presentation schedule
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Easy Navigation of Post approval changes of Key Excipients via SUPAC
Abstract: The FDA requires that re-formulation or process changes yield products that are at least bioequivalent to preceding formulations. This ½ day seminar investigates the levels of allowable changes, SUPAC guidance and how FDA helps to ease approval of valuable changes. FDA guidance addendums, presentations and literature on bioequivalence considerations in product development will be considered. Cases will be presented on how to navigate regulatory hurdles from the formulation and process standpoints. Excipient technology advances have a significant role to play in formulation and process development enhancements during a drug products’ commercial life. The cases will also explore how new Excipient technologies have increased opportunities in formulation and process transfer previously considered risky and unlikely to succeed.
Presented By JRS Pharma: An organization servicing the Pharma and Nutritional Supplement Industries. The company has three areas of focus: Formulation development and technical support Technical training and value added ingredient supply.
Work Shop Leaders: Mr. Alen Guy, PhD & Mr. Joseph Zeleznik (Workshop Outline & Speaker Resumes)
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Workshops- Outlines & Workshop Leaders
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Workshop I April 16 (9AM - 5PM) Conference Room: 201-A
Design of Experiments (DoE) as a Tool for Pharmaceutical Manufacturing, Tech Transfer & Troubleshooting
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Mr. Adolfo Gomez Emerson Resources Inc. |
Mr. Gomez offers 17 years of technical insight into various business sectors including: Sterile Manufacturing, Ethical/Generic/OTC Drugs as well as Nutritional and Herbal/Botanical Supplements. He has work with Lederle, Wyeth, Barr Labs, Granutec Inc., and Novopharm holding positions in QC, Tech. Services, Validation and R&D. Major accomplishments include the design and implementation of validation master plans, templates of master batch records, product development/management systems, GMP pilot facility start-up and development of traditional/novel formulations. Many formulations developed by Mr. Gomez have been successfully commercialized. Mr. Gomez holds a BS in Biochemistry from Rutgers University and a Masters in Pharmaceutics from Long Island University. He has presented research papers for the American Society for Microbiologists and the AAPS. Mr. Gomez is also a founding principal and General Manager Emerson Resources. This is Mr. Gomez’s 4th year presenting at ExcipientFest.
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Mr. Stephen Levine (Emerson Resources Inc.): |
Stephen Levine, Scientific Affairs Group Leader, has worked in the pharmaceutical and chemical industries over the past 14 years in the areas quality control, specialty coating applications, solid and liquid dose development, litigation support, analytical liaison, clinical trial manufacturing, new product development, process optimization, consulting, and in technical services and laboratory management. Mr. Levine holds degrees in applied human anatomy and physiology and divinity. Stephen started his scientific career with National Starch and Chemical and then began working with Dr. Charles Signorino in C.S. Associates and Emerson Resources in 1998. Coupling formulation development with process engineering and technical transfer Stephen is accomplished in a wide array of solid dose development including pre-formulation, granulation, tabletting, extrusion/spheronization, encapsulation, multi-particulate and API coatings, chewables, and controlled release, with specific expertise in taste masking, organic solvent coating, latex and pseudo-latex systems, hard capsule and softgel coatings, drug loading, and sugar coating. His work in coating platforms development and customized coatings is rooted in design of experiment, statistical evaluation, and quality by design. Stephen holds membership in ISPE, Controlled Release Society, and AAPS, and has also been a speaker for the American Association of Pharmaceutical Scientists, has had numerous technical publications and posters released in North America and Europe and has served as an instructor for the Emerson Science Center, Thomas Engineering, Inc., and Degussa’s Eudragit Workshop. This is Stephen’s 1st year speaking at ExcipientFest.
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| Workshop Outline: |
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1. What is “Design of Experiments”
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2. Basic Statistics
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a. Central Tendency
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b. Dispersion
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c. The Normal Distribution
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d. Central Limit Theorem
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e. Statistical Significance
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f. Analysis of Variance
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3. Full Factorials
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4. Fractional Factorials
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5. Independent Variables (examples)
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6. Dependent Variables (examples)
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7. Case Study 1 – Hardness Optimization
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8. Case Study 2 – Roller Compaction
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9. Case Study 3 – Extrusion Spheronization
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10. Case Study 4 – Coating System Optimization
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Workshop II April 16 (9AM - 5PM) Conference Room: 201-B
Film Coating Technology for Pharmaceutical Applications
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Ms. Laura Scattergood
Colorcon USA |
Laura Scattergood is an Area Technical Manager in the Pharmaceutical Technical Services Department at Colorcon. In her 10 years with Colorcon, she has held positions in both the New Product Development Group as well as the Global Technical Support Group. In these roles, she has provided technical support for film-coating processes and solid oral dose formulation using immediate and modified release technologies supplied by Colorcon. In her career at Colorcon, Laura has focused on delayed and sustained release coating process applications, as well as granulation and tabletting applications. Laura has authored several articles and presented at the American Association of Pharmaceutical Scientists national meetings. Laura received her Bachelors Degree in Biology and Environmental Science from Dickinson College. This is Laura’s 1st year presenting at ExcipientFest.
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Mr. Charlie Cunningham
Colorcon USA |
Charlie Cunningham has been with Colorcon for over 14 years and is currently the Pharmaceutical Technical Services Manager. Previously he has held the roles of Area Technical Manager and Global Technical Manager providing technical support for film-coating processes and solid oral dose formulation using immediate and modified release technologies supplied by Colorcon. Charlie began his career at Colorcon as a Sr. Research Associate in the Global Technology Development group where he focused on coating process applications (including pan and fluid bed coating) and the scale-up and optimization of aqueous film-coating processes. Charlie has published several articles in the areas of film coating and excipient technologies. He also holds 3 patents related to novel film-coating and excipient formulations. Prior to joining Colorcon, Charlie was employed by Niro and was involved in the development of spray-drying, fluid-bed coating and granulation processes. This is Mr. Cunningham’s 4th year speaking at ExcipientFest.
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1. Introduction
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2. Influence of tablet design and formulation of film coating quality
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Guidelines for tablets robustness including hardness and friability
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Tablet shape effects |
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Proper logo design and placement. |
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Effect of tablet formulation on film coating quality and stability
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| 3. Film-coating equipment and processes |
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Review of film-coating equipment-pan and fluid bed processes |
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Continuous Coaters |
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Spray gun optimization and troubleshooting |
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Reconstitution of film coating dispersions |
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| 4. Formulation on film-coating systems |
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Polymer characteristics and selection |
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Plasticizer effects |
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Selection of pigments and colorants |
| 5. Coating process optimization |
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Identification of critical, product specific control parameters |
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Setting process control ranges |
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Improving coating uniformity and process efficiency |
| 6. Troubleshooting coated tablet defects-Interactive session |
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Participants will discuss causes and present solutions for many commonly observed coated tablet defects |
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Participants are invited to bring examples of problem tablets for discussion. |
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Workshop III April 17 (9AM - 5PM) Conference Room: 201-A
Pharmaceutical Formulation Workshop on Tablet Dosage Forms
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Mr. Walter Strathy Emerson Resources Inc. |
Mr. Strathy offers more than 20 years of industrial experience in the Ethical and Generic Pharmaceutical, OTC Drug and Nutritional/Botanical Supplement business sectors. Mr. Strathy has focused mostly in solid dosage formulation development, although he has held positions in organic synthesis research and in facilities/plant operations management. Major accomplishments include: molecular/dosage form patent awards, research facilities design/construction and numerous inception-to-market formulations, including novel dosage forms. Mr. Strathy has an extensive work history with American Cyanamid., Lederle, Whitehall-Robins, Granutec Inc. and Novopharm. Walter is a founding principal of I.D.E.A.S. Inc. and is currently doing tenure at Emerson Inc. where is responsible for organizational compliance, formulation/process design, design/implementation of contract manufacturing, certification programs, novel formulation development, capability studies, scale-up and technical transfer of formulas to manufacturing. Mr. Strathy is a member of the AAPS and International Society of Pharmaceutical Engineers. This is Mr. Strathy 5th year as a speaker at ExcipientFest.
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Mr. Robert Tuohy Emerson Resources Inc. |
Mr. Tuohy offers extensive knowledge relative to the design and development of various oral solid dosage forms including immediate/control release coatings, extrusion/spheronization technology, tablet compaction optimization, unique granulation approaches, formulation rationalization through experimental design, encapsulation and more. Rob has vast experience in performing all pertinent analytical techniques required to successfully develop a viable commercial dosage form. Rob has actively served as an onsite process validation consultant and has extensive knowledge of regulatory requirements coupled with an understanding of the technical aspects of operations. Mr. Tuohy holds a Bachelor of Science in Chemical Engineering from Virginia Polytechnic Institute & State University. He as work with DuPont Pharmaceuticals and is member of the AAPS, NJPHAST and American institute of Chemical Engineers. This is Rob’s 2nd year speaking at ExcipientFest.
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1. Introductions
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Instructors & Emerson Inc.
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Goals
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Expectations
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2. Statistics Review
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Variables
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Population
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Central tendency
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Dispersion
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Distribution
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3. Raw Materials Characterizations
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Physical
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Chemical
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Functional
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Classification
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Review common excipients
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4. Formulation Development
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Defining variables
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Variable relationships
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The hypothesis
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An initial theoretical formulation
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Experimental design
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5. Process Development
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Review conventional tabletting processes
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Pre-blending operations
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Granulation
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Blending
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Tabletting
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Mix time studies
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Formula and process optimization using compaction profiles
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Statistical process control
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In process specification rationalization
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Process capability
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6. Tablet Coating Dynamics
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The suspension formulation
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Liquid delivery
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Process conditions
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Tablet dynamics during processing
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7. Wrap up
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Specific questions
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Panel review
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Questions
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Workshop IV April 17 (9AM - 12PM - 1/2 day) Conference Room: 201-B
Cleaning of Excipients: Optimal Cleaning Chemistries, Mechanisms and Validation for Difficult Insoluble Coatings & Polymers
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Mr. Alen Guy, PhD (JRS Pharma): |
Alen Guy, Ph.D. graduated Analytical Chemistry with Honours from University of Plymouth, U.K. before completing his Ph.D. in the subject of Antimony Speciation in 1998. After Postdoctoral research – Volatile Fatty Acid analysis in fermented media – he joined Penwest as Senior Manager for Commercial Development of PROSOLV SMCC®. In 2001, Alen took over the responsibility for European Sales and Marketing for Penwest. Following the acquisition of Penwest Excipients by J. Rettenmaier and Söhne, he took the position of Director for UK and Ireland Sales and Marketing. Throughout this time, Alen continued with his European responsibilities for the technical and commercial development of the PROSOLV Technology platform. In 2004, Alen joined Eurand as Associate Director of Business Development, before rejoining JRS PHARMA as VP of R&D and Commercial Development. Alen is a member of the Royal Society of Chemistry, American Chemical Society, and the American Association of Pharmaceutical Scientists (Excipient Focus Group). He has presented at numerous Drug Delivery and Pharmaceutical conferences on topics such as orally disintegrating tablet technology, taste-masking, powder flow and solid dose development. This is Alen’s 2nd year speaking at ExcipientFest.
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•Mr. Joseph Zeleznik (JRS Pharma): |
Mr. Zeleznik is the Associate Director, R&D for JRS PHARMA LP. He holds a Master’s Degree in Chemistry from the State University of New York. Mr. Zeleznik has over 13 years experience in the pharmaceutical industry. Mr. Zeleznik is a member of the American Chemical Society and the American Association of Pharmaceutical Scientists. His first nine years in the industry were with Penwest Pharmaceuticals Co. He has been with JRS PHARMA, subsequently, for the last four years. Mr. Zeleznik specializes in the development of high performance excipients and the application of processing technology for the enhancement of pharmacologically active substances. He holds several patents registered in the US and worldwide on these subjects. He has also been responsible for many publications and posters presented at the American Association for Pharmaceutical Scientists (AAPS) during his time in the industry. He has also presented at a number of conferences on the subjects of excipients and excipient technologies, and other related topics. Mr. Zeleznik is responsible for developing and promoting JRS PHARMA LP’s high-performance excipients and excipient technologies, and processing technologies. This is Joe’s 2nd year speaking at ExcipientFest.
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DAY-ONE: Technical & Regulatory Conferences
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| • CONFERENCE HALL A (Day-One) |
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Day-One: Presentation 1 (Hall A)
10:00-10:45 AM - (45 min.)
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Utilizing Raman Chemical Imaging to Monitor the Influence of Drug/Excipient Interaction
on API Bioavailability in Aqueous Nasal Spray Suspensions |
Abstract:
Interest in nasal delivery of pharmaceutical products is increasing due to the potential for increased drug uptake rates and improved bioavailability for certain drugs relative to oral dosing, the convenience of nasal delivery, and the development of new delivery platforms that may modify distribution in the nose. In this study we investigated the use of Raman Chemical Imaging (RCI) along with Brightfield reflective imaging to measure particle size, chemical identity, drug/excipient particle associations and particle size distributions (PSDs) of corticosteroids in an aqueous nasal spray suspension product. RCI, combining the capabilities of molecular spectroscopy & digital imaging, enables users to detail material morphology, composition, structure and concentration with a high degree of specificity and sensitivity at submicron spatial resolutions (<250 nm) in a non-contact, non-destructive manner. Using Beclomethasone Dipropionate (BDP) nasal spray as a test product, a Raman spectral library was developed for active & inactive compounds. ChemImage’s FALCON™ Raman Chemical Imaging microscope and ChemImage Xpert™ software were used to acquire Raman and Brightfield images of nasal sprays. The Raman images were processed to calculate the PSD of active pharmaceutical ingredient (API) as well as the PSD of the API/excipient agglomerated particles.
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Mr. Matthew Nelson PhD. – Director of Applications & Science – ChemImage Corporation: Dr. Matthew P. Nelson is currently the Director of Applications & Science at ChemImage Corporation. Dr. Nelson received his Ph.D. from the University of South Carolina in 1998. His research involved developing novel optical systems for molecular spectroscopic applications. Dr. Nelson has lectured widely (over 100 presentations), authored/co-authored 30 publications including two book chapters and has been co-inventor on 16 patents (eight pending), the majority of which are related to Chemical Imaging technology (i.e., instrumentation, methodology and applications). This is Matt’s 1st year speaking at ExcipientFest. |
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Day-One: Presentation 2 (Hall A)
11:15 AM-12:00 PM - (45 min.)
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Magnesium Stearate Dihydrate – A New-High Performance Pharmaceutical Lubricant for Lubricating Powder and making Tablets |
Abstract: Magnesium stearate (MgSt) is widely used as a pharmaceutical lubricant. The influence of MgSt on powder lubrication and solid dose properties has presented a big challenge. The purity and consistency of MgSt strongly affect product quality and process acceptability. MgSt is commercially available as the monohydrate form (MgSt-M). The variation of crystalline states and their amounts in the product often leads to inconsistency in making tablets. Among the hydrates, magnesium stearate dihydrate (MgSt-D) is a stable pseudo-polymorph and chemically different from MgSt-M and could have benefits over MgSt-M as a lubricant. MgSt-D was not commercially available until recently a pure and consistent dihydrate product was introduced by Mallinckrodt. The chemical and physical properties of MgSt-D were further verified with thermal analysis, powder X-ray diffraction, NIR spectroscopy, and SEM. In this presentation, results will show distinct benefits of MgSt-D compared to MgSt-M in direct-compressible blends containing APAP and excipients like microcrystalline cellulose, dicalcium phosphate and lactose as diluents. The benefits include improving powder flow, preserving blend uniformity, better lubricity measured by total compression forces, ejection and take-off forces, and similarity in dissolution profiles. These benefits suggest MgSt-D could provide an alternative solution for better powder blending and tablet-making.
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Mr. Stephen Wu –Technical Fellow R&D- Covidien/Mallinckrodt: Dr. Stephen Wu is a Technical Fellow in Pharmaceutical R/D Division, Covidien/Mallinckrodt. Before joining Covidien, he was responsible for Pharmaceutical Excipients Laboratory in Eastman Chemical Company. Dr. Wu obtained his Ph.D. degree from Stanford University majoring in Biophysical Chemistry. He also did his post-graduate course study in Polymer Science and Engineering in the University of Tennessee. Dr. Wu’s research interest is in innovating new excipient products and drug delivery systems including pH-dependent coatings, semi-permeable membranes for osmotic delivery, granulation process technology, microencapsulation, latex and pseudolatex technology, polymer purification, liquid crystalline materials for drug delivery, and biodegradable polymers for wound treatment. He was a pioneer of developing reverse-enteric coating, water-dispersible vitamin E derivatives for enhancing drug bioavailability and magnesium stearate dihydrate as a new tablet lubricant. Presently, he is involved in developing unconventional dosage forms for delivery in oral cavity and fast disintegrating tablets. Dr. Wu is a frequent contributor of papers in AAPS and Controlled Release Society meetings, and published a number of articles in journals and book chapters. He obtained more than 30 patents in controlled-release technology field. He traveled to Europe and Asia-Pacific regions to give seminars on excipient applications for drug delivery systems. Dr. Wu has spoken at ExcipientFest in Ireland and this is his first presentation at ExcipientFest Americas.
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Day-One: Presentation 3 (Hall A)
1:30-2:15 PM - (45 min.)
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Pharmaceutical Excipients: A New Look Into The Crystal Ball
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Excipient suppliers’ role in the overall pharmaceutical industry is changing. Pharmaceutical excipient manufacturers are no longer just specialty chemical companies supplying “inactive” ingredients to the global pharmaceutical industry. With the transition of drug delivery firms and CROs into fully integrated pharmaceutical companies, a gap has been created between chemical suppliers and finished dosage form manufacturers. The gap is now being filled by excipient manufacturers partnering with pharmaceutical companies to satisfy the technology and formulation hurdles created by the ever-more challenging APIs developed. The presenter will address many of the current challenges and discuss the role of excipient supplier as solution provider going forward. In this discussion innovation in excipient and API-excipient interaction will be addressed together with an assessment of the regulatory hurdles and manufacturing drivers for the industry, e.g. Quality by Design and the increased focus on excipient functionality.
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Speaker:
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Dr. Alen Guy, PhD (VP R&D / Commercial Development- JRS Pharma USA) Alen Guy has experience consisting of six years of business and commercial development and sales in the pharmaceutical industry. He has held positions with Eurand S.p.A, JRS Pharma in the UK, and Penwest Pharmaceuticals Co. His background includes considerable experience with PROSOLV®, JRS’s high functionality excipient, as he promoted it throughout the European pharmaceutical and nutritional markets. The University of Plymouth is where he received his Ph.D. and his Bachelor’s Degree in Analytical Chemistry. Alen’s speaking engagements include Drug Delivery conferences throughout Europe & North America, as well as the International Pharmaceutical Technology Conference. With many articles and papers to his name, Mr. Guy has the responsibility of overseeing global operations of JRS Pharma’s R&D staff, as well as developing new excipients for the pharmaceutical and nutritional industries. This is his first year speaking at ExcipientFest.
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Day-One: Presentation 4 (Hall A)
2:15-3:00 PM - (45 min.)
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Supply Chain Integrity in Excipient Distribution – Issues and Answers
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Abstract:
In 2006 and 2007, there were many major headlines regarding recalls of everyday products which contained contaminated or mislabeled raw materials. While the majority of the highly-publicized incidents involved raw materials manufactured in emerging economies, without stricter controls and industry self-regulation, such incidents could easily occur in the US and/or Europe. While some may view chemical distributors as a potential “weak link” in the supply chain, in fact the opposite is true, especially in the distribution of excipients. Distributors who follow IPEC and other accepted industry guidelines can be a valuable source of information regarding the chain of custody of excipients and their quality. This presentation will outline the existing guidelines for ensuring the integrity of the excipient distributor’s supply chain, additional guidance being considered by FDA, IPEC, and the industry, and how to verify that a distributor is protecting the integrity of the supply chain so that the end user can be comfortable with the quality of the materials supplied.
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Speaker:
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Ms. Linda Herzog – General Manager USA – Mutchler Inc. Pharmaceutical Ingredients: Linda Herzog is US General Manager of Mutchler Inc. Linda has been in the commercial side of the chemical and pharmaceutical industries for over 25 years. Since joining Mutchler in 2004, Linda has been active in advocating the regulation of Excipients and promoting Excipient GMP’s to both better assure the quality of pharmaceuticals and to “level the playing field” among Excipient producers operating in different countries. Linda has spent the majority of her career in the oleo-chemicals market where she has particular commercial and technical expertise. Linda is the Vice Chairperson of the Scholarship Committee of DCAT (Drugs, Chemicals & Associated Technologies). She holds a BA in Chemistry from the College of the Holy Cross and an MBA in Marketing & Finance from the University of Connecticut. This is Linda’s 1st year speaking at ExcipientFest.
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