ExcipientFest 2012 Presentations
DAY 2 Tuesday, April 24th |
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7:00 AM |
Registration, Coffee & Pastries |
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Conference Hall A (Expo Area) |
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Conference Hall B (Expo Area) |
8:30 – 9:15 AM |
KEY-NOTE SPEAKER: “Corporate Responsibility” Michael Beatrice - Abbott (IPEC) |
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9:15 – 10:00 AM |
“Risk Management for Excipients” |
“Excipient News for Novel Formulations” |
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10:00 – 10:45 PM |
“The method of fine dissolution control of tablets by direct compression in different test media using novel pregelatinized starch” |
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“What does it mean to have an IPEA Certification? (International Pharmaceutical Excipient Audit)” |
10:45 – 11:15 AM |
Coffee & Networking Break |
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11:15 – 12:00 PM |
“cGMP Enforcement for the Pharmaceutical Industry” |
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“Meeting Formulation Challenges for Poorly Soluble Drugs” |
12:00 – 1:30 PM Lunch and Networking at Vista Mar Terrace |
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1:30 – 2:15 PM |
“Up-Stream Supply, Chain Security for Excipients through Distribution” |
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“Excipact Update on Excipients” |
2:15 PM – 3:00 PM |
“Supplier Management, Assuring a Secure Supply Chain” |
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“Application Studies of L-HPC and HPMCAS for Pharmaceutical Solid Dosage forms - An Update” |
3:00 PM – 3:45 PM |
Coffee Break & Networking Break |
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3:45 – 5:00 PM |
SPEAKERS’ ROUND TABLE: |
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5:00 – 7:00 PM |
ExcipientFest Cocktail with Live Local Music |
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DAY 3 Wednesday, April 25th |
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From 7:00 AM |
Registration, Coffee & Local Pastries |
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Conference Hall A |
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Conference Hall B |
9:00 – 9:45 AM |
KEY-NOTE SPEAKER: "Future of Excipient Regulation - Revised GMPs and Excipient Expectations" |
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9:45 – 10:30 AM |
“Legislative Update; An Industry Perspective“ |
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“Innovative Techniques for Effective Cleaning of Time Release Polymers and Color Coatings” |
10:30 – 11:15 AM |
Coffee Break & Networking Break |
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11:15 – 12:00 PM |
“USP Monograph Modernization Initiative: Excipient update” |
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“Inactive Ingredient Database” |
12:00 – 1:30 PM |
Lunch and Networking at Vista Mar Terrace |
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1:30 – 2:15 PM |
“Enhancing Excipient and Raw Material Surveillance through the FDA Spectral Library Initiative” |
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“Beware of the Non-Critical Excipient in QbD” |
2:15 - 3:00 PM |
“Controlled Release the Co-Processed "Whey" |
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“NSF Reference Standards for Excipients” |
3:00 – 3:30 PM |
Coffee Break & Networking Break |
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3:30 – 4:15 PM |
“Quality by Design Approach for Determining Excipient Specifications" |
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“Elemental Impuritites - Excipient Realities” |
4:15 – 5:15 PM |
KEY-NOTE SPEAKER: “ANDA Deficiencies Related to Excipients” |
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5:15 – 7:00 PM |
ExcipientFest Cocktail with Live Music |
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This program is subject to change. Please refer to this website for updates.
Day 2: Corporate Responsibility: Supplier Selection and Supply Chain Security |
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| Day-Two: Keynote Speaker |
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Corporate Responsibility |
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| Abstract: Pending. |
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Speaker: |
Michael Beatrice - Corporate VP Quality and Regulatory, Abbott Laboratories Pending. |
Day 2 - Hall A Presentations |
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| Day-Two: Presentation 1 |
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Risk management for Excipients |
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| Abstract: Excipient technology is increasingly complex as we strive to create new and improved excipients that aid in the drug delivery and modified drug dissolution. In addition to new excipients, some of the tired and true excipients can also prove to be tenacious soils to remove from the equipment, making cleaning a lengthy challenging task. Fortunately with the recent advancements in cleaning technologies, detergents and the proper applications of T.A.C.T (Time, Action, Chemical, Temperature), cleaning and labor times for these residues can be significantly reduced, improving productivity. During this presentation we will discussing how choosing the correct detergents along with establishing the proper cleaning parameters can significantly improve the cleaning of modified release polymers and coatings containing titanium dioxide. |
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Speaker: |
Ms. Londa Ritchey - Director of Supplier Qualification, Pfizer Londa has over 20 years of experience within large and small Pharma; in Quality Operations, QC, incoming quality, GMP and GCP auditing, and Supplier Quality Management. Formal education includes a B.S. Microbiology and M.S. Biostatistics. As Director of Supplier Qualification for Pfizer, she is responsible for implementation and enhancement of the Supplier Quality Management Processes. This includes direct responsibility for Supplier Quality Risk Management process and the Quality Agreements programs for Biotech, Pharma, Consumer Healthcare, Nutritionals and Animal Health businesses, including Emerging Markets Operations. Londa is currently Co-Chairing the IPEC- Americas team working on Excipient Risk Assessment Guide. |
| Day-Two: Presentation 2 |
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Method of Fine Dissolution Control of Tablets by Direct Compression in Different Test Media Using a Novel Pregelatinized Starch |
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| Abstract: Excipient technology is increasingly complex as we strive to create new and improved excipients that aid in the drug delivery and modified drug dissolution. In addition to new excipients, some of the tired and true excipients can also prove to be tenacious soils to remove from the equipment, making cleaning a lengthy challenging task. Fortunately with the recent advancements in cleaning technologies, detergents and the proper applications of T.A.C.T (Time, Action, Chemical, Temperature), cleaning and labor times for these residues can be significantly reduced, improving productivity. During this presentation we will discussing how choosing the correct detergents along with establishing the proper cleaning parameters can significantly improve the cleaning of modified release polymers and coatings containing titanium dioxide. |
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Speaker: |
Ms. Yurika Tanaka - Assistant Manager, Ceolus R&D Department, Functional Additives Division, Asahi Kasei Chemicals Corporation In 1999 completed a master course of Factory of Science, at Kyushu University, Japan. Has worked for Asahi Chemical Industry Co., Ltd. (Now, Asahi Kasei Corp., the holding company of Asahi Kasei Chemicals Corp.) since 1999. Researching and developing new pharmaceutical additives for the past 3 years. |
| Day-Two: Presentation 3 |
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cGMP Enforcement for the Pharmaceutical Industry |
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| Abstract: Pending. |
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Speaker: |
Mr. Edwin Ramos - FDA SJDO Compliance Director (IPEC) Pending. |
| Day-Two: Presentation 4 |
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Up-Stream Supply, Chain Security for Excipients through Distribution |
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| Abstract: Upstream supply chain security is a hot topic in today’s pharmaceutical industry given several unfortunate isolated events in our recent past (i.e.: Panama) that have pushed this concern into the forefront. However, supply chain security and its monitoring are still at a very elementary stage. Distributors of Excipients are an essential part of the overall pharmaceutical manufacturing matrix in terms of getting the right-compliant materials, on time, with add-value efficiencies to the drug manufacturers. This talk will give a reality check on regulation of the distribution process and discuss the necessary initiatives a distributor must take to assure complete integrity of the Excipients. |
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Speaker: |
Ms. Griselle Vargas - Quality Manager, Mutchler Inc. Griselle Vargas-Cumba currently works as the Quality Manager of Mutchler Inc. in Puerto Rico. Prior to joining Mutchler, Mrs. Vargas-Cumba worked in the Pharmaceutical, Medical Device and Sales Industry, in the areas of Quality, Manufacturing Operations and Project Management. She has significant large-scale project management experience in a regulated industry. She holds a Bachelors Degree in Chemistry from the University of Maryland, Baltimore County. |
| Day-Two: Presentation 5 |
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Supplier Management, Assuring a Secure Supply Chain |
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| Abstract: The ultimate goal of supply chain management is to supply drug products to users that are safe and effective at all times. SISPQ – strength, identify, safety, purity and quality of drug products can only be achieved on a continuous and sustained manner if the supply chain systems and processes are in place to assure end to end integrity and security. End to end supply chain starts from the earliest raw ingredients to the point when the finished products are purchased and used by consumers. All parts of the organization involved with the full life cycle and supply chain of the product: research, development, procurement, manufacturing, labeling, art development, warehousing, distribution, retail providers all contribute to end to end supply chain integrity and security. This paper will provide examples of the harm to the company and users when gaps in the end to end supply chain process exist as well as outline the systems and processes that Perrigo puts in place to assure end to end supply chain integrity and security. |
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Speaker: |
Mr. Louis Yu, PhD - Senior Vice President, Global Quality and Compliance, Perrigo Company Prior to joining Perrigo, Dr. Yu held senior Quality and Research leadership positions with various major pharmaceutical companies, including Forest laboratories, Solvay Pharmaceuticals as well as Johnson & Johnson; with a career spanning over 30 years. Dr. Yu earned a BS in Chemistry at the University of Wisconsin, and a MS and Ph.D. in Analytical Chemistry from Rutgers University. He has served as Adjunct Professor of the School of Pharmacy, Extension Services in Pharmacy, U. of Wisconsin, Madison. He currently serves as a member of the USP Committee of Experts for small molecules. |
Day 2 - Hall B Presentations |
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| Day-Two: Presentation 1 |
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Excipient News for Novel Formulations |
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| Abstract: Many aqueous film coating formulations require an anti-tacking agent or glidant. These applications include methacrylic acid enteric formulations, drug layering, as well as many multi-particulate fluid bed applications. Traditionally the anti-tacking agent of choice has been talc. However, the use of Talc presents another set of challenges in that it must be used at very high levels . Glyceryl monostearate (GMS) is now taking the place of talc as the preferred anti-tacking agent. Studies have shown that GMS may be used at much lower levels and that it does not exhibit the same sedimentation and spray-obstruction problems that are associated with the use of talc. Traditional GMS systems require a high-shear heated emulsion step on the same day as the coating application as part of the coating preparation. Recent advances have yielded products where GMS is included along with plasticizer in the form of a stable emulsion that can be procured as an easy to use material. |
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Speaker: |
Mr. Stephen Levine - Scientific Affairs Group Leader, Emerson Resources Stephen Levine currently serves as Group Leader, Scientific Affairs, where he leads a team of formulation scientists and technicians in all aspects of their day to day activities. Stephen has worked in the pharmaceutical and chemical industries over the past 16 years in the areas of quality control, specialty coating applications, solid and liquid dose development, litigation support, clinical supplies manufacturing, new product development, process optimization, and consulting. He works with technically challenging formulations, including poorly soluble compounds, novel dosage forms, experimentally designed scale up, technical transfer problem solving, and as a troubleshooting consultant working to facilitate excellence in manufacturing. Stephen continues to lead development strategy of alternate polymer and new coating systems for taste masking, sustained release, and enteric applications. Stephen has extensive experience with CMC Project Management, designing and presenting technical training programs (internal and external), producing technical publications, and Business Development activities. Prior to his current position, Stephen served as a Formulation Scientist during which time he gained experience in a wide array of pre-formulation, granulation, tabletting, extrusion/spheronization, encapsulation, multi-particulate and API coatings, chewables, ODT tablets, and controlled release (tablet matrix and coatings), with specific expertise in taste masking, organic solvent coating, latex and pseudo-latex systems, hard capsule and softgel coatings, drug layering, and sugar coating, and cGMP documentation and clinical supplies manufacturing. Stephen has been a speaker for the AAPS, Excipientfest, and Interphex. He has had numerous technical publications and posters released in North America and Europe. Stephen holds a Bachelor of Science degree in Applied Human Anatomy and Physiology from Boston University’s Sargent College of Allied Health Professions. He also has a Master of Divinity degree from Westminster Theological Seminary. |
| Day-Two: Presentation 2 |
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What does it mean to have an IPEA Certification? (International Pharmaceutical Excipient Audit) |
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| Abstract: Pending. |
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| Speaker: |
Invited Speaker - TBD (IPEC) Pending. |
| Day-Two: Presentation 3 |
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Meeting Formulation Challenges for Poorly Soluble Drugs |
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| Abstract: This presentation will review recent trends in the Pharmaceutical Industry for formulating poorly soluble drugs, both new NCE's and in life cycle management. Technologies that are particularly suited to prepare solid solutions and solid dispersions including Melt Extrusion and Spray Drying will be described. The application of polymers, including PVP, Copovidone , Vit E TPGS and Soluplus will be highlighted and supported by case studies involving model poorly soluble APIs. |
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Speaker: |
Mr. Nigel Langley - Head Technical Sales Manager, BASF Corporation BASF provides technical support for BASF's excipients to the Pharmaceutical Industry. Prior to joining BASF Dr Langley worked for Croda Inc. as Technical Director Health Care, responsible for product and application development for both dietary supplements and Pharmaceutical excipients (liquid dosage). He has also worked in Japan and England with Croda. He gained his Chemistry (Hons) degree and PhD (Liquid Crystals) from the University of Hull, (UK) and an MBA from Leeds University (UK). This is hissecond year speaking at ExcipientFest. |
| Day-Two: Presentation 4 |
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Excipact Update on Excipients |
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| Abstract: Pending. |
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Speaker: |
Mr. Koen Bontinck - VP Sustainability & System Registration Services, NSF International Since Bontinck joined NSF in 2005 as managing director of Europe, Middle East and Africa (EMEA), he has developed and implemented a successful global strategy that better positions NSF in local markets and provides NSF clients in the EMEA region with increased levels of service and quality. Throughout his career, Bontinck has held numerous positions in business development and general management. Prior to joining NSF, he served as managing director in charge of overall performance improvement for subsidiaries in Belgium and France at the Tauw Group, a Dutch multi-national environmental consulting company offering environmental, civil engineering and laboratory services worldwide. He was also managing director for the Belgian subsidiary of Bureau Veritas Quality International (BVQI), a large multinational technical service provider offering certification and inspection services. Bontinck has a master’s degree in safety engineering from the Free University (VUB) in Brussels (BE) and an MSc degree in electromechanical engineering from the Catholic University (KUL) of Leuven (BE). |
| Day-Two: Presentation 5 |
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Application Studies of L-HPC and HPMCAS for Pharmaceutical Solid Dosage forms - An Update |
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| Abstract: Several fundamental and case studies using two pharmaceutical excipients, Low-Substituted Hydroxypropyl Cellulose (L-HPC) and Hypromellose Acetate Succinate (HPMCAS) will be discussed. L-HPC has been used as disintegrant and binder for tablets and granules for many years. The studies to be discussed include examples of regular tablet formulations and some other dosage forms such as orally disintegrating tablets (ODT). New grades of L-HPC (NBD-series) which have better flowability and improved binding capability will also be reviewed. HPMCAS is an enteric coating agent but has unique characteristics which can be applied in dry powder coating processing and in solid dispersions for solubility enhancement. Updated information for these application studies will be overviewed. |
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Speaker: |
Mr. Sakae Obara - Chief Researcher at Shin-Etsu Chemical Senior Researcher, Specialty Chemicals Research Center, Shin-Etsu Chemical Co., Ltd., Japan: Mr. Obara is responsible for Technical Service / Application Research for Cellulose Derivatives. He holds a B.S. in Pharmaceutical Science, from Tokyo University of Science, Japan and a M.S. in Biopharmaceutics, from Chiba University, Japan. He joined Shin-Etsu Chemical Co., Ltd. Specialty Chemicals Research Center in 1986 and has been working there until present. Between 1992-1994 he was Visiting Scientist in the University of Texas at Austin, USA. |
| Day-Two: Speakers' Round Table |
IPEC's Atypical Visible Particles Guideline
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Abstract:
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Moderated by Angie Drakulich – Editor of Phamaceutical Technology: Day 2: Corporate Responsibility: Supplier Selection and Supply Chain Security |
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| Day-Two: Keynote Speaker |
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Future of Excipient Regulation - Revised GMPs and Excipient Expectations |
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| Abstract: Pending. |
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| Speaker: |
Maridalia Torres - FDA Director SJDO Pending. |
Day 3 - Hall A Presentations |
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| Day-Three: Presentation 1 |
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Legislative Update; An Industry Perspective |
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| Abstract: Food and drug safety concerns have long been a focus for the food and pharmaceutical industries, but have just recently regained the attention of Congress and the Obama Administration. The issue elicits a wide range of approaches in Congress, ranging from Chairman Jack Kingston's (R-GA) concerns about the effectiveness of the FDA, and efforts by his House Appropriations Subcommittee to limit agency funding, to Representative John Dingell's (D-MI) recently introduced comprehensive drug safety bill. In his presentation, Jim Wiltraut will discuss how these divergent views provide an opportunity to advance IPEC's efforts to, among other thing, create a third-party auditing structure for excipients. |
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Speaker: |
Mr. James Willtraut - Director, Government Relations - Buchanan Ingersoll & Rooney (IPEC) Jim Wiltraut assists clients through the arduous federal legislative and appropriations process and was recognized in Stars and Stripes newspaper for his talent at navigating clients around Capitol Hill and throughout the federal government. He is not an attorney. Jim effectively takes client concerns to government officials when policies or changes in law would negatively impact their ability to do business and provides companies with access to decision makers interested in hearing from experts in a variety of fields. Though best known in Washington for representing clients in the areas of national defense and homeland security, Jim also has extensive experience representing pharmaceutical companies, as well as energy companies, including those involved in the trading of biofuels, oil, gas, coal and other commodities. Jim has helped energy companies navigate the complex web of state licensing boards and has facilitated the building of new partnerships with local, state and federal governments in order to better link companies to the communities in which they operate. |
| Day-Three: Presentation 2 |
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USP Monograph Modernization Initiative: Excipient update |
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| Abstract: As part of USP's initiative to update and improve its monographs for drug substances and products in the United States Pharmacopeia and the National Formulary (USP–NF) compendia, USP is focusing on monographs identified recently as a priority by the U.S. Food and Drug Administration (FDA) Modernization Task Group (MMTG) in need of modernization. A November 16, 2011 letter to USP from FDA listed USP monographs and several related dosage forms as high priority for updating. The letter also identified as high priority USP-NF monographs for povidone, copovidone, crospovidone, and talc for updating. A complete list of Excipients in need of modernization exists on the USP website. USP is seeking active input from industry in this monograph modernization initiative and is seeking assistance and procedures from manufacturers of products and ingredients covered by the priority monographs. The presentation provides updates on the progress made by USP resulting from the work of the two Expert Panels, Talc and Povidones, and details on proposed revisions published in PF. All four excipient monographs are part of the Pharmacopeial discussion group (PDG). The presentation will also discuss the collaborative efforts ongoing with FDA, stakeholders and USP with the modernization efforts underway for excipient monographs in PDG. |
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Speaker: |
Ms. Catherine Sheehan - Director of Excipients in the Documentary Standards Division - United States Pharmacopeia (USP) Ms. Sheehan is Director of Excipients in the Documentary Standards Division, United States Pharmacopeia, Rockville, MD. In her current role, she is responsible for development and update of excipient monographs and related chapters, and participates in the Pharmacopeial Discussion Group’s compendial harmonization of excipient monographs and excipient chapters.
Ms. Sheehan is active in AAPS and RAPS. She was a member on the Product Quality Research Institute, Excipient Working Group from 2006-2007 and was co-author of the group’s two published articles that appeared in Pharmaceutical Technology , “PQRI survey of Pharmaceutical Excipient testing and Control strategies used by excipient manufacturers, excipient distributors and drug product manufacturers”, and “PQRI Joint Position Paper on Pharmaceutical Excipient testing and Control strategies”.
Ms. Sheehan is a graduate of University College Cork, Ireland. She holds a B.Sc. Degree from University College Cork, Ireland. She holds an M.S. Bioscience Regulatory Affairs from Johns Hopkins University, USA. This is her second time speaking at ExcipientFest. |
| Day-Three: Presentation 3 |
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Enhancing Excipient and Raw Material Surveillance through the FDA Spectral Library Initiative |
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| Abstract: Over the past few years the FDA has developed rapid, spectroscopic screening methods for the surveillance of pharmaceutical raw materials and excipients. While the initial efforts employing latent variable chemometric methods have been promising, the studies have been limited by the rigorous sample preparation and model building steps that are needed to develop the methods. In order to streamline the screening of pharmaceutical materials, the FDA launched a spectral library initiative in 2011 that was designed to involve cooperation between the FDA and excipient manufacturers and distributors. Library-based spectral correlation methods are qualitative techniques that allow for rapid, nondestructive screening of pharmaceutical materials. In addition, they typically do not require sample preparation and can be easily used by investigators with little or no expertise. We will report on the progress of the spectral library initiative and focus on the development of a straightforward standardization procedure for the transferability of Raman libraries across different portable spectrometers. In addition, we will describe various challenges encountered in assembling the library with a focus on the sensitivity of Raman spectroscopic methods to detecting variability based on any number of factors (e.g., lot to lot variability, manufacturing site, vendor, season) by conventional library methods. |
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Speaker: |
Ms. Lucinda Buhse - Director FDA Division of Pharmaceutical Analysis (DPA) (IPEC) Dr. Buhse joined DPA in 2001 as Deputy Director. She was promoted to Division Director in June, 2004. Dr. Buhse received a B.A. in Chemistry from Grinnell College and a Ph.D. in Physical Chemistry from the University of California, Berkeley under the direction of John H. Clark and George C. Pimentel. Before joining FDA, Dr. Buhse worked in management positions in Production, Validation and Analytical Services at Sigma Aldrich Corporation and as a Senior Research Scientist for Rohm and Haas Company. She leads a laboratory based division in the Center for Drug Evaluation and Research (CDER) responsible for providing a strong scientific and analytical base to support FDA investigations and enforcement actions and conducting research programs to advance the application of new technologies and methods for assessing the quality and authenticity of human drugs. |
| Day-Three: Presentation 4 |
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Controlled Release the Co-Processed "Whey" |
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| Abstract: Controlled release products, and particularly tablets, are attractive because they offer extended patent life for enhanced product life cycle management, and improved patient compliance through once- or twice-daily dosage regimens. Unfortunately, controlled release tablet formulation development and manufacture is often complicated. Few excipients intended for controlled release provide a pathway to simplified tablet formulation and production. API release rate modeling is frequently difficult and extends development time. A new, co-processed excipient, designed specifically for controlled release applications, offers the ease-in-use and modeling potential to decrease development time and increase production efficiency while improving patient compliance. |
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Speaker: |
Mr. Joe Zeleznik - Manager of Technical Affairs, Meggle For the past year, Mr. Zeleznik has served as Manager of Technical Affairs with MEGGLE USA. In his role, he is responsible for providing formulation and product application guidance as well as having quality and regulatory oversight for MEGGLE USA’s North American lactose manufacture. Prior to joining MEGGLE USA, Mr. Zeleznik was Associate Director, R&D with JRS PHARMA and Research Manager with Penwest Pharmaceuticals Co. Mr. Zeleznik has over 17 years experience in the pharmaceutical industry, having specialized in the development and application of high functionality excipients and in particular, co-processing applications for the enhancement of excipient and pharmacologically active ingredients performance. He holds several patents in areas of product and process development, formulation development, and API co-processing. Mr. Zeleznik has authored or co-authored several articles published in various industry journals. He holds a Master’s Degree in Chemistry from the State University of New York. |
| Day-Three: Presentation 5 |
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Quality by Design Approach for Determining Excipient Specifications |
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| Abstract: Excipients for solid dosage forms come in different shapes, and are available in a range of particle sizes, porosities and moisture content. With the advent of co-processing of two or more excipients using a variety of unit operations, it is possible to control the physical parameters of the excipients such as shape, particle size, and loss on drying (LOD), to within certain specifications. In this article, we present a design of experiments (DOE) strategy which identifies the cause and the effect of different excipient physical parameters such as shape, particle size, and LOD. A 2-factorial design with two levels of factors was used to identify the main and interaction effect of the factors. We evaluated the effect of Particle size and LOD on flowability, blend uniformity and tabletability of a model formulation containing an active ingredient and PanExcea MHC300G, a novel MCC based co-processed excipient. The results were used to develop contour and response surface plots. The resulting data was used to determine the specifications for particle size and LOD for the co-processed excipient used in the formulation. Hence, we demonstrated that QbD principles can be used to determine excipient specifications to enable robust quality control of the final drug product. |
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Speaker: |
Mr. Madhu Kallam – Scientist Analytical Development , Avantor Performance Materials Mr. Kallam currently works as Applications Engineer at Avantor Performance Materials, Inc at its Phillipsburg plant in New Jersey. In his current role, he develops various formulations for immediate and controlled release applications using Avantor's excipients to meet the needs of clients. He has over 6 years of experience in the pharmaceutical industry and worked in both manufacturing and R&D environments. Mr. Kallam holds master's degree in Chemical Engineering from Cleveland State University. He has published contributed papers at AAPS conference. |
Day 3 - Hall B Presentations |
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| Day-Three: Presentation 1 |
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Innovative Techniques for Effective Cleaning of Time Release Polymers and Color Coatings |
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| Abstract: Both time release and color coatings are known to be difficult to clean from coating pans, fluid bed dryers and other processing equipment using traditional methods. As new more effective coatings are coming into the market place these traditional cleaning practices often provide inconsistent results coupled with time consuming and laborious cleaning processes. During the presentation, one will discussing the current best cleaning practices and instruct attendees on how to take a systematic approach to achieving an effective and reproducible cleaning program for these new challenging residues from a with a variety of process equipment. Learn how an effective cleaning process will allow you to meet your regulatory requirements and potentially increase your throughput by significantly reducing cleaning times and labor cost. Through the use of pictures and videos, we will illustrate real world examples of the importance of the proper application of the T.A.C.T. cleaning parameters and how with this knowledge you will be able to develop a successful and reproducible cleaning program. |
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| Speaker: |
Ms. Kristina Wesley, Technical Sales Manager - Dober Chemicals Pending. |
| Day-Three: Presentation 2 |
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FDA’s Inactive Ingredient Database – Update on the Substance Registration System Changes |
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| Abstract: In October 2010 the FDA implemented the Substance Registration System (SRS) which had a significant impact on how the Inactive Ingredient Database (IID) is managed and how the information in the IID is utilized for NDA and ANDA drug product reviews. Changes in the listings in the IID have caused confusion globally in the industry, particularly for generic drug companies, which has resulted in delays in the review process and in ANDA acceptance. Questions about nomenclature, UNII codes and FDA requests for additional safety data on common excipients have caused problems for excipient manufacturers and users. The presentation will provide an overview of the SRS and IID issues and an update on the situation after meetings with FDA. |
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Speaker: |
Ms. Priscilla Zawislak - Regulatory Affairs & Global GMP Manager – Ashland Functional Ingredients Currently with Ashland Inc. (formerly Hercules Incorporated) in Wilmington, DE, Priscilla is the Global Regulatory Affairs Manager for Ashland Specialty Ingredients’ (ASI) Regulated Products business. ASI is a global manufacturer of cellulosic and guar products used as excipients, food additives and ingredients in personal care products. In addition, she is responsible for GMPs, performs product risk assessments and supports other aspects of quality and regulatory compliance for ASI Regulated Products globally. Previous positions included Global Quality Leader for the Hercules Resins division, providing quality and regulatory support to the business and chemist in the Analytical Sciences division. Previously, she was Quality Manager at FMC BioPolymer, Newark, DE, a global manufacturer of cellulosic products used as excipients and food additives. Priscilla has been a member of IPEC Americas committees since 2001 and is the current Chair of the Compendial Review Committee and a member of the IPEC Americas Executive Committee. Priscilla also participates in the International Food Additives Council, the Personal Care Products Council and the Council for Responsible Nutrition. |
| Day-Three: Presentation 3 |
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Beware of the Non-Critical Excipient in QbD |
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| Abstract: The term “critical” figures prominently in the 21st Century cGMP QbD initiative. Critical Quality Attributes of the finished product are defined as part of the Target Quality Profile. With increased emphasis on understanding the impact of raw materials Critical Quality Attributes may also be defined for excipients. Excipients themselves may be categorized as critical or non-critical but it is important to understand that such categorization is application specific. Arbitrary assignment of an excipient as non-critical can lead to a tautology where the Design of Experiments is not sensitive to the impact of a “non-critical” excipient. As a result criticalities may be inadvertently built into a product which only manifest as quality or efficiency problems during Production, notwithstanding diligent product development efforts. Dr Carlin explores some of the reasons unanticipated excipient-related criticalities may arise including incomplete understanding of excipient manufacture and application, the effect of interactions, scale dependencies, and inadequate specification of fitness for purpose. |
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Speaker: |
Mr. Brian Carlin - Director of Open Innovation for the Pharmaceutical Business - FMC BioPolymer Dr. Carlin was formerly responsible for Global R&D and Technical Service. He has been with FMC for fifteen years, and is a regular presenter at Excipientfest. Dr. Carlin is chairman of the IPEC Americas Quality by Design and Excipient Composition Committees, and a former chairman of the IPEC Europe Excipient MasterFile Committee. Prior to joining FMC Dr Carlin worked at SmithKline & French/SmithKline Beecham in new product development for eleven years, after five years commercial product development experience with Richardson Vicks.He has a doctorate in Interfacial Rheology from the School of Pharmacy, University of London, and an Honours degree in Pharmacy from the University of Aston in Birmingham. He is an Adjunct Associate Professor at the University of Tennessee. |
| Day-Three: Presentation 4 |
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NSF Reference Standards for Excipients |
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| Abstract: Pending. |
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Speaker: |
Mr. Steven Lane - General Manager – Reference Standards Program, NSF International Steven Lane oversees all aspects of NSF's Reference Standards production and regulatory compliance. This includes testing , packaging and labeling and rigorous qualification processes to ensure the quality, purity, and suitability of NSF reference standards. Steven has over 22 years' experience in FDA- and DEA- regulated industries. Steven has also held a faculty position at Johns Hopkins University since January 2003, where he teaches three graduate-level courses . Prior to his current position at NSF, Steven was employed by the United States Pharmacopeia in Rockville, Maryland USA, where he was the Vice President of Reference Standards Operations, with oversight responsibility for over 175 scientific, office, and production staff in the US, India, China and Brazil. Prior to this position, Steven spent 12 years in the pharmaceutical, medical device and biotechnology industries in positions of increasing responsibility. Steven holds a BS in Microbiology and Chemistry from East Tennessee State University and an MS in Biotechnology from Johns Hopkins University. |
| Day-Three: Presentation 5 |
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Elemental Impuritites - Excipient Realities |
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| Abstract: ICH and the USP are working on developing guidelines and general chapters related to Elemental Impurities in drug products. The USP has published drafts which include test methodology concepts and approaches. However, the final identification of elements and the actual safety-based limits will not be finalized until ICH publishes their proposal as Q3D, during 2011.The limits will apply specifically to the drug products, not the excipients. However, excipient suppliers will need to inform customers on the expected levels of elemental impurities that could be present in their excipients. The reality is that many excipients probably contain some of the elemental impurities at levels higher than what the ICH proposes for the drug product. Excipient companies may not have specific test data on these levels and might not be willing to routinely test for them. Many companies will not do testing until the limits are set by ICH. Therefore, implementation of the ICH and USP requirements will demand significant time after publication to allow for appropriate assessment and communication between the excipient manufacturers and pharmaceutical users. In some cases, reformulation of the drug product may be required to meet the Elemental Impurity limits. This presentation will provide an update on the issue and discuss challenges related to common excipients prior to any official implementation of Elemental Impurities requirements. |
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Speaker: |
Mr. David Schoneker - Director Regulatory Affairs, Colorcon Mr Schoneker's responsibilities include global coordination of Colorcon’s worldwide regulatory activities and raw material assessments. He received his B.S. degree from Ursinus College and M.S. in Chemistry from Villanova University. His previous position at Colorcon was Director of Quality Assurance and Quality Control. He has been at Colorcon since 1977. Mr. Schoneker has been active in many professional organizations such as AAPS, PQRI, RAPS, ASQ, ACS, AOAC and the Delaware Valley Chromatography Forum. He also is involved with a number of trade organizations such as the International Pharmaceutical Excipients Council (IPEC), the International Association of Color Manufacturers (IACM), the Council for Responsible Nutrition (CRN) and the Institute of Food Technologists (IFT). Mr. Schoneker is the past Chairman of IPEC Americas (2007-2008) where he is actively involved with the development of Excipient GMP and Qualification related guidelines to improve Global Supply Chain Security. Mr. Schoneker is a frequent speaker at ExcipientFest. |
| Day-Three: Keynote Speaker |
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ANDA Deficiencies Related to Excipients |
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| Abstract: Pending. |
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Speaker: |
Lawrence Yu - Director for Science, Office of Generic Drugs
CDER FDA Dr. Lawrence X. Yu is the Deputy Director for Science and Chemistry at the Office of Generic Drugs, Food and Drug Administration and. He is also adjunct Professor of Pharmaceutical Engineering at the University of Michigan. Prior to joining the FDA, Dr. Yu had worked at Pfizer (Upjohn) and GlaxoWellcome for 8 years. His research interests have centered on in silico prediction and oral drug delivery. He received his B.S. and M.S. degrees in Chemical Engineering from Zhejiang University, his M.S. degree in Pharmaceutics from the University of Cincinnati, and his Ph.D. in Pharmaceutics from the University of Michigan. |
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