ExcipientFest 2010 Schedule & Presentations



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Educational Sessions

DAY 1

Wednesday, May 5th

 

 

From 7:00 AM

Registration, Coffee & Local Pastries

 

 

 

Conference Hall A

 

Conference Hall B

9:15 – 10:00 AM

1

Preparation of MUPS (Multiple Unit Particles System) Tablets using Celphere and Preliminary Blend of Microcrystalline Cellulose and Pregelatinized Starch
Mr. Masayuki Kakizawa  - Asahi Kasei

 

IPEC's Excipient Composition Guideline
Ms. Priscilla Zawislak - Ashland (IPEC)

10:00 – 10:45 AM

2

Magnesium Stearate; Let’s play cards

Mr. Pieter Gommans - Peter Greven

 

IPEC's New Excipient Evaluation Procedure

Mr. Christopher DeMerlis -  Colorcon (IPEC)

10:45 – 11:15 AM

Coffee & Networking Break

 

 

11:15 – 12:00 PM

3

Assuring Supply Chain Security

Mrs.Rosa J. Motta – FDA CDER (IPEC)

 

IPEC's Excipient Stability Guideline

Mr. Phil Merrell -  Jost Chemical (IPEC)

12:00 – 1:30 PM

Lunch (Ball Room I)

 

 

1:30 – 2:15 PM

4

Excipients for Future – Identification of the Need, Discovery, and the Regulatory Journey to Market 

Dr. Ranga Velagaleti - BASF, Dr. Sherry Ku – Wyeth,  Dr. Harpreet Sandhu  – Hoffmann La Roche

 

Conforming to the IPEC CoA Guide

Mr. David Klug - sanofi aventis (IPEC)

2:15 – 3:00 PM

5

3rd Party  and Shared Supplier Audits

Mr. Eric Berg - Amgen & Mr. Irwin Silverstein - IPEA

 

Co-processing: A Versatile Pathway to Modify Excipients: Lactose Excipients from Fast Disintegrating to Modified Release 

Mr. Franz Penz - Meggle

3:00 - 3:30 PM

Coffee Break & Networking Break

 

 

3:30 P- 4:15 PM

6

Orally Disintegrating Tablets

Mr. Joseph Zeleznik -  JRS Pharma

 

Best Practices for Assuring Supply Chain Security Including Quality Agreements Mr. Dale Carter - JM Huber & Alexa Smith - Colorcon (IPEC)

4:15 – 5:00 PM

7

Formulation Facilitation of Powder Blends, Sugar-Free Film Coatings and HME with a unique Polyol 

Mr. Bodo Fritzsching - Beneo Palatinit

 

Quality by Design and Formulation Development

Mr. Bill Busch - Dow Chemical (IPEC)

5:00  – 7:00 PM

ExcipientFest Cocktail with Live Local Music (Foyer)

 

DAY 2

Thursday, May 6th

 

 

From 7:00 AM

Registration, Coffee & Local Pastries

 

 

 

Conference Hall A

 

Conference Hall B

9:15 – 10:00 AM

1

Commercially available options for BCS Class II, III & IV compounds in all Dosage Forms

Dr. Guido Baumoeller – Cognis

 

The Future of Co-Processed Excipients

Mr. Brian Carlin, PhD  -  FMC BioPolymers USA (IPEC)

10:00 – 10:45 AM

2

New Tests for Identifying Harmful and Potentially Deadly Adulterants in Pharmaceutical Ingredients: The Role of USP NF in Setting Revised Standards

Ms. Catherine Sheehan - USP

 

Change Control in Excipient Manufacturing – The Importance in a Quality by Design World

Mr. Dave Schoneker - Colorcon (IPEC)

10:45 – 11:15 AM

Coffee Break & Networking Break

 

 

11:15 – 12 PM

3

Bringing Added Value to the Excipient Supply Chain

Ms. Elizabeth Plaza – PharmaBioServ & Mr. Dwight Mutchler - Mutchler Inc. PR

 

Regulation  & QA of Excipients in the Nutraceutical/Dietary Supplement  Industry:  Importance of Ingredient Supplier Qualification

Mr. Ed Wyszumiala - NSF & Dr. Andrew Shao - CRN (IPEC)

12:00 – 1:30 PM

Lunch (Ball Room I)

 

 

1:30 – 2:15 PM

4

Excipient DMF's in China

Mr. Sun Huimin - Chinese National Institute of Control of Pharmaceutical & Biological Products  (IPEC)

 

Solubility Enhancement with Methacrylates

Dr. Abhishek Kathuria - Evonik Polymers

2:15 P- 3:00 PM

5

FDA - PR Investigator’s Perspective on Review of Supplier Qualification Programs during Audits

Mr. José Meléndez- FDA PR

 

Excipient GMPs and The Global Certification Project

Mr. Dale Carter - JM Huber (IPEC)

3:00 - 3:45 PM

Coffee Break & Networking Break

 

 

3:45 – 4:45 PM

6

SPEAKER’S ROUND TABLE: Leveling the Playing Field for Excipients (Moderated by Pharmaceutical Technology)
Speakers from FDA, BASF, Pfizer, USP, Warner Chilcott, IPEC, RX360

4:45 – 5:00 PM

Academic Poster Awards & Closing Remarks

5:00  – 7:00 PM

ExcipientFest Cocktail with Live Music (Foyer)

 

 


Full-Day Workshops

 

 

DAY ONE - May 5th- Wednesday

9:00 AM – 5:00 PM

I

 Design of Experiments (DoE) as a Tool for Pharmaceutical Manufacturing, Tech Transfer & Troubleshooting
(Conference Room: La Luna)

Abstract: During the development of a pharmaceutical product, a large amount of resources are spent on the formulation development, though frequently in an inefficient manner. The QbD initiative has made policy out of what has long been considered simply good science. This one day course explores the use of statistically based tools for designing experiments (DoE) and evaluating data as it relates to formulation and process development.  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 industry with three areas of focus: Formulation development and technical support, technical training and value added ingredient supply.

Workshop Leaders: Mr. Stephen Levine and Mr. Robert Tuohy

Workshop Outline & Speaker Resumes)

II

Film Coating Technology for Pharmaceutical Applications
(Conference Room: El Morro)

 

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 Leaders:
Mr. Jeff Moore and Mr. Gus LaBella

(Workshop Outline & Speaker Resumes)

 

 

       DAY TWO - May 6 th- Thursday

9:00 AM – 5:00 PM

III

Pharmaceutical Formulation on Tablet Dosage Forms
(Conference Room: La Luna)

Abstract: This is the 4rd year for this very popular full-day 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 solid dose formulation covering theory/design, raw materials, formulation/process development, production and coating. This workshop is limited to 35 participants.

Presented by Emerson Resources, Inc.: An organization servicing the pharmaceutical industry with three areas of focus: Formulation development and technical support, technical training and value added ingredient supply.

Workshop Leaders: Mr. Stephen Levine and Mr. Robert Tuohy

 

(Workshop Outline & Speaker Resumes)

IV

The Role of Supplier Audit in Supplier Qualification, Supply Chain Security, and Incoming Ingredient Approval
(Conference Room: El Morro)

Abstract: The qualification of ingredient suppliers is critical to accepting incoming components through their Certificate of Analysis and to assuring the security of the excipient supply chain. While pharmaceutical companies in the past have used questionnaires to assess conformance to GMP by the excipient supplier, recent reports of sub-standard excipient demonstrate the necessity of site audits. This workshop provides suggestion on the assessment of an excipient manufacturer in the 6 hours typically allotted. The workshop also describes alternative methods of such assessment that have been received favorably by the FDA. Finally, the workshop will integrate the supplier assessment into a comprehensive incoming ingredient inspection program.

Presented by IPEA (International Pharmaceutical Excipient Auditing)

Workshop Leaders:
Mr. Irwin Silverstein

(Workshop Outline & Speaker Resumes)
 

 

 
Workshops - Outlines & Workshop Leaders

Workshop I

Design of Experiments (DoE) as a Tool for Pharmaceutical Manufacturing, Tech Transfer & Troubleshooting

Workshop Outline:

1.     What is “Design of Experiments”

2.     Basic Statistics

  •   Central Tendency
  •   Dispersion
  •   The Normal Distribution
  •   Central Limit Theorem
  •   Statistical Significance
  •   Analysis of Variance

3.     Full Factorials

4.     Fractional Factorials

5.     Independent Variables (examples)

6.     Dependent Variables (examples)

7.     Case Study 1 – Hardness Optimization

8.     Case Study 2 – Roller Compaction

9.     Case Study 3 – Extrusion Spheronization

10.  Case Study 4 – Coating System Optimization

11.  Process Development 

11.1    Review conventional tabletting processes

11.1.1   Pre-blending operations

11.1.2   Granulation

11.1.3   Blending

11.1.4   Tabletting

11.2. Mixing time studies

11.3. Formula and process optimization using compaction profiles

11.4. Statistical process control

11.5. In process specification rationalization

11.6. Process capability

12.  Tablet Coating Dynamics 

12.1    The suspension formulation

12.2    Liquid delivery

12.3    Process conditions

12.4    Tablet dynamics during processing

13.  Wrap up

13.1    Specific questions

13.2    Panel review

13.3    One-to-one questions



Mr. Stephen Levine
Emerson Resources Inc.

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.



Mr. Robert Tuohy
Emerson Resources Inc.

Rob Tuohy currently serves as Manager, Scientific Affairs at Emerson Resources, Inc. and offers extensive knowledge relative to the design and development of various dosage forms.  Mr. Tuohy has overseen numerous drug development projects ranging from early phase development of NCEs, patent circumvention for first-to-file generics, and cost saving formulation improvements for OTC products. His experience includes immediate and control release coatings, extended release matrix formulations, extrusion/spheronization technology, tablet compaction optimization, unique granulation approaches, formulation rationalization through the use of experimental design, and encapsulation.




Workshop II

Film Coating Technology for Pharmaceutical Applications

Workshop Outline:

  1. Introduction
  2. 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.
  1. 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
  1. Formulation on film-coating systems
  • ·         Polymer characteristics and selection
  • ·         Plasticizer effects
  • ·         Selection of pigments and colorants
  1. Coating process optimization
  • ·         Identification of critical, product specific control parameters
  • ·         Setting process control ranges
  • ·         Improving coating uniformity and process efficiency
  1. 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.


Mr. Jeff Moore
Colorcon USA
Jeff Moore has been with Colorcon since 2008 and has been in the pharmaceutical industry for more than 16 years.  During his career he has worked primarily for contract research organizations to assist with late-stage product and process development leading up to and through scale-up and regulatory approval.  Since joining Colorcon, he has continued to be a formulation partner with the industry by providing technical support with regard to sustained release matrices, barrier membrane and enteric coating applications.  In addition, his role encompasses working with the Colorcon team of technical experts focusing upon coating process applications and optimization of film-coating processes.


Mr. Gus LaBella
Colorcon USA
Gus LaBella, Formulation Technologies Manager at Colorcon, has more than 23 years experience in solid oral dosage form development. He is responsible for providing customer support and generating applications data for core formulation excipients and modified release film coating products offered by Colorcon. His prior experience includes various positions within the Research and Development group at McNeil Consumer Products, a Johnson & Johnson company, including Product Development, Investigational Supplies, Support to Marketed Products, and R&D Technologies. His skills range from pre-formulation of novel dosage forms to post launch support of marketed products. His areas of interest are wet granulation, compression instrumentation, and design of experiments. Gus holds a BS in Materials Engineering from Drexel University in Philadelphia, Pennsylvania.





Workshop III
Pharmaceutical Formulation Workshop on Tablet Dosage Forms

Workshop Outline:

 

1.     Introductions

  • Instructors & Emerson Inc.
  • ·Goals
  • ·Expectations

2. Statistics Review

  • Variables
  • Population
  • Central tendency
  • Dispersion
  • Distribution

3. Raw Materials Characterization

  • Physical
  • Chemical
  • Functional
  • Classification
  • Review common Excipients

 

4. Formulation Development

  • Defining variables
  • Variable relationships
  • The hypothesis
  • An initial theoretical formulation
  • Experimental design

 

5. 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

 

6. Tablet Coating Dynamics

  • The suspension formulation
  • Liquid delivery
  • Process conditions
  • Tablet dynamics during processing

 

7. Wrap up

  • Specific questions
  • Panel review questions



Mr. Stephen Levine Emerson Resources Inc.

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.



Mr. Robert Tuohy Emerson Resources Inc.
Rob Tuohy currently serves as Manager, Scientific Affairs at Emerson Resources, Inc. and offers extensive knowledge relative to the design and development of various dosage forms.  Mr. Tuohy has overseen numerous drug development projects ranging from early phase development of NCEs, patent circumvention for first-to-file generics, and cost saving formulation improvements for OTC products. His experience includes immediate and control release coatings, extended release matrix formulations, extrusion/spheronization technology, tablet compaction optimization, unique granulation approaches, formulation rationalization through the use of experimental design, and encapsulation.


Workshop IV
The Role of Supplier Audit in Supplier Qualification, Supply Chain Security, and Incoming Ingredient Approval

Workshop Outline:

1.     Establish FDA expectation for qualification of suppliers

2.     Present the prime areas of concern in auditing an excipient supplier for qualification

a.     Recommend operational areas of emphasis and procedures of particular interest

b.     Discuss recent findings and their importance

c.     Review expectations for auditing the entire supply chain

d.     Discuss various operational activities that may be performed by a “distributor” vs. broker and trader.

3.     Discuss the use of COA in approval of ingredients

4.     Review FDA expectations for periodic qualification of COA

5.     Present a holistic approach to approval of incoming ingredients:

a.     Review of COA

b.     Sampling plan and identification testing

c.     Review of packaging

d.     Review of labeling

e.     Review of tamper-evident seals



Mr. Irwin Silverstein IPEA

Irwin Silverstein is a consultant specializing in quality assurance and regulatory compliance for pharmaceutical excipient ingredients. He also has experience in quality assurance for API, medical device and drug products. He was formerly the Corporate Director of Quality Assurance for International Specialty Products (ISP) where he spent 17 of his 22 years leading the Quality Unit responsible for excipients, API, and medical devices. He has worked for over 18 years with the International Pharmaceutical Excipients Council (IPEC) developing guidance documents for excipient GMP compliance. In addition to working as a consultant to the industry, he is the VP and Chief Operating Officer of International Pharmaceutical Excipients Auditing Inc (IPEA). He began consulting as an expert consultant hired by pharmaceutical firms under FDA Consent Decree. Recent consulting includes pharmaceutical firms where he assesses conformance to site requirements and GMP gap assessments of excipient manufacturers. As an experienced GMP auditor, with American Society for Quality (ASQ) Certified Quality Auditor (CQA) status as well as ISO 9000 Certified Lead Auditor training, he has developed IPEA auditor training programs for hourly and supervisory personnel. He is establishing IPEA as an accredited organization to issue certification to excipient GMP in conformance with ANSI requirements.








DAY-ONE: Technical & Regulatory Conferences

CONFERENCE HALL A
Day-One: Presentation 1 (Hall A)

Preparation of Multiple Unit Particles System Tablets using Celphere, MCC and Pregelatinized Starch


Abstract:
To prepare MUPS tablet containing sustained release and enteric release pellets without film damage and segregation of the pellets and excipients, we examined formulation of films and excipients. First, we obtained sustained release and enteric release film coated pellets each other with little agglomeration due to high water absorption of Celphere (MCC sphere). After coating, 49.95% coated pellets, 49.95% preliminary blend of 2 types of MCC with different shape and pregelatinized starch (PH-200/KG-802/PC-10 = 56/24/10) and 0.1% Magnesium Stearate were mixed and MUPS tablet (250mg, 8mm) was compressed. As a result, we obtained sustained-release and enteric-release MUPS tablet with high tablet weight uniformity (RSD ≦1%) and high drug content uniformity (RSD ≦2%). This is because the preliminary blend of excipients has high effect of preventing segregation of pellets and excipients. Moreover, drug dissolution rate of MUPS tablet was almost the same as the coated pellets and dissolution profile hardly changed after 6 months because of high flexibility and stability of the film.


Speaker:


Mr. Masayuki Kakizawa – Assistant Manager R&D – Asahi Kasei: Mr. Kakizawa completed a master degree at Faculty of Engineering The University of Tokyo, Japan in 2000. Immediately afterwards he began work in Functional Additives Division with Asahi Chemical Industry Co., which is now Asahi Kasei Chemicals Corporation. Mr. Kakizawa has been researching and developing new pharmaceutical additives for the past 10 years. He has been responsible for several posters presented at the American Association of Pharmaceutical Society. He gave some presentations in The Symposium on Particulate Preparations and Designs and The Conference on Pharmaceutical Technology in Japan. This is the first time speaking at ExcipientFest.




Day-One: Presentation 2 (Hall A)

Magnesium Stearate; Let’s play cards


Abstract:
Magnesium Stearate is the most widely used lubricant in Solid Dosage Forms. Despite its low use of levels, it has earned a reputation as one of the most difficult excipients to use. This presentation highlights how Magnesium Stearate works and how to evaluate it as a tablet lubricant. It contains information on the different types of Magnesium Stearate and what triggers its functionality; how to overcome problems between development and scale up to production. Also, information on important factors regarding selecting the type of Magnesium Stearate and the level of use will be presented.



Speaker:


Mr. Pieter Grommans – Global Quality Manager – Peter Greven: Mr. Pieter Gommans is Quality Manager at Peter Greven Nederland C.V. located in Venlo, Netherlands, which is a dedicated manufacturing plant for vegetable based stearates such as Magnesium Stearate. His area is ISO/GMP/HACCP and Kosher compliance for the plant as regulatory affairs, product development and technical sales service. He has 20 years experience in the field of QC, QA and GMP
auditing as well as product applications. When the plant makes the transfer from animal based raw material to vegetable based products in 1995, he was coordinating validation information as chemical and physical comparison and
functional aspects of the products. This is his third year speaking at ExcipientFest.




Day-One: Presentation 3 (Hall A)

Assuring Supply Chain Security


Abstract:
PENDING

Speaker:


Rosa J. Motta - Senior Compliance Officer, CDER, FDA
Rosa J. Motta has worked for ten years with the U.S. Food and Drug Administration (FDA). This includes working at both the field and headquarters operations. She started her FDA career as a chemist in the San Juan District (Puerto Rico) where she worked for approximately three years. Subsequently Ms. Motta worked in FDA headquarters for the Division of Field Science (DFS) where she served as a scientific coordinator between the Centers, the Field Laboratories, and Office of Regulatory Affairs (ORA), for a variety of FDA programs. Since July 2001, she works as a Compliance Officer for the Office of Compliance at the Center for Drug Evaluation and Research (CDER). In this position, Ms. Motta is responsible for evaluating, handling and providing final recommendation for cases involving regulatory action such as seizure, injunction and warning letters and advisory opinions to the regulated industry.



Day-One: Presentation 4 (Hall A)

Excipients for Future – Identification of the Need, Discovery, and the Regulatory Journey to Market (Shared Presentation by BASF & Wyeth)


Abstract:
Critical to the identification of delivery-enabling excipients is a clear understanding of the life cycle of the drug discovery and development. It is not a secret that ~40% NME has delivery issues such as low solubility and/or low permeability. Functional excipients are in a unique position that can help active pharmaceutical ingredients (APIs) to express therapeutic efficiency better by delivering them to the target organ for the benefit of human health.  Excipient innovators are generally located in bulk excipient/chemical companies and far removed from the drug discovery companies.  Excipient innovation today is often restricted to few excipient companies that have not only financial resources but have knowledge of chemistry of APIs for various therapies; elements of possible excipient-API interactions; and bioavailability and expression of functionality/efficacy within the human body. Identification of the current and future therapeutic target areas, API properties, and new and novel excipients as drug enabler will be described.  We will review the regulatory strategies for new and novel excipients based on our experiences with selected excipients in our portfolio.  We will identify approaches which will enable these excipients for acceptance by drug product formulators and regulatory groups within drug companies and ultimately the regulatory authority’s worldwide.


Speaker:





Mr. Ranga Velagaleti PhD– Manager Regulatory Affairs - BASF: Ranga Velagaleti obtained his Ph. D. in Microbial Biochemistry and worked for more than 25 years in Pharmaceutical R&D, Quality, and Regulatory environments.  Experienced in quality, regulatory, chemistry, manufacturing, and controls (CMC) areas of pharmaceutical excipients and active ingredients, as well as tablet, capsule, liquid, and topical cream dosage forms. Developed and assisted in implementation of registration strategies for excipients, actives and finished products, and contributed to writing of CMC sections for several NDAs, and excipient and drug substance drug master files. Author of more than 20 publications in Pharmaceutical area including peer reviewed research papers, reviews, and book articles.  Invited speaker on Pharmaceutical CMC and regulatory topics at DIA, ACS, University Symposia, AAPS, trade associations, and Institute of Validation Technology seminar series. This is Dr. Velagateti first second year speaking at ExcipientFest.


Ms. Sherry Ku PhD – Chief Scientific Officer, for Anchen Pharmaceuticals
.

Dr. Sherry Ku is currently Chief Scientific Officer, for Anchen Pharmaceuticals Sherry worked previously for Pfizer where she developed seven (7) commercial products including Suprax, Zosyn/Tazocin, Zebeta, Isovorin, Thioplex, Sonata and most recently Tygacil encompassing discovery, development and tech transfer, validation, NDA filing and pre-approval inspection activities. Her responsibilities include discovery support, lead selection, phase 0 and IND submission until clinical proof of concept. With the recent trend of new clinical leads becoming less soluble with poor oral bioavailability, Sherry’s emphasis has been in drug delivery and solubilization technology. Since 2001, her group is responsible for the development of over 100 new clinical leads resulting in 79 initial IND filings. In this process, her department has become one of the key engines in the generation of intellectual properties (IP) for Wyeth. She currently holds over 70 patents/invention disclosures and has additional 55 publications. She is the chair elect of AAPS Physical Pharmacy and Biopharmaceutical section and the Vice Chair of NJ Pharmaceutical Discussion Group. This is her first time speaking at ExcipientFest.



Day-One: Presentation 5 (Hall A)

3rd Party and Shared Supplier Audits (Shared Presentation by RX360 & IPEA)


Abstract:
Abstract: Rx-360 is a non-profit consortium involving pharmaceutical and raw material supplier companies.  This consortium has been established to share market surveillance, develop operating standards, create an independent supplier audit function to improve the efficiency, oversight and accountability of the pharmaceutical supply chain, and advance technologies for detection and prevention of material adulteration. This talk will focus on the supplier audit aspect of the consortium This Deming-based approach promises the benefits of cost reduction in the supply chain, standardization of best practices, and monitoring of quality and security.  Participants are invited to learn more about the consortium by visiting www.Rx-360.org.

IPEA offers two services for the assessment of conformance to excipient GMP requirements; a one-day audit and Excipient GMP Conformance Certification. The IPEA one-day site audit for a single excipient is a direct substitute for the pharmaceutical company supplier qualification audit where the excipient user can assess the adequacy of GMP conformance based upon observations made by trained and qualified IPEA auditors. However, Excipient GMP Conformance Certification is a comprehensive examination of the excipient quality system that requires four times as long at the site to establish GMP compliance. This presentation will provide information on these two audit services so that you can determine which meets your needs.



Speaker:


Mr. Eric Berg – Director Supplier Quality – Amgen (RX360) Mr. Berg has been with Amgen since 1992 and has worked in manufacturing, operations project management, and quality administration. For five years he has led Supplier Quality, a group that is responsible for managing the quality aspects of Amgen’s raw material suppliers. In order to continue to advance Supplier Quality at Amgen and within the Pharmaceutical industry, he actively participates in industry wide focus groups, PDA, is a member of the IPEC-Americas Executive Committee, and serves as a volunteer for the emerging industry wide Rx-360 consortium. Mr. Berg holds a Bachelor of Science degree in Biology from California Lutheran University. This is his first time speaking at ExcipientFest.

Ms. Irwin Silverstein – VP & CEO – IPEA Irwin Silverstein is a consultant specializing in quality assurance and regulatory compliance for pharmaceutical excipient ingredients. He also has experience in quality assurance for API, medical device and drug products. He was formerly the Corporate Director of Quality Assurance for International Specialty Products (ISP) where he spent 17 of his 22 years leading the Quality Unit responsible for excipients, API, and medical devices. He has worked for over 18 years with the International Pharmaceutical Excipients Council (IPEC) developing guidance documents for excipient GMP compliance. In addition to working as a consultant to the industry, he is the VP and Chief Operating Officer of International Pharmaceutical Excipients Auditing Inc (IPEA). He began consulting as an expert consultant hired by pharmaceutical firms under FDA Consent Decree. Recent consulting includes pharmaceutical firms where he assesses conformance to site requirements and GMP gap assessments of excipient manufacturers. As an experienced GMP auditor, with American Society for Quality (ASQ) Certified Quality Auditor (CQA) status as well as ISO 9000 Certified Lead Auditor training, he has developed IPEA auditor training programs for hourly and supervisory personnel. He is establishing IPEA as an accredited organization to issue certification to excipient GMP in conformance with ANSI requirements. He has spoken numerous times at ExcipientFest.



Day-One: Presentation 6

Orally Disintegrating Tablets: Bridging the Divide for Compliance


Abstract:
With the increasing cost of healthcare, governments across the world have looked to the pharmaceutical industry as a opportunity for cost containment and improvement over time.  Non compliance by patients costs taxpayers due to increased hospitalizations and the associated costs.  Improving dosage form design and drug delivery vehicles for all patient populations, particularly pediatric and geriatric, can aid in decreasing these costs and improving the results of pharmaceutical products.  Orally disintegrating tablets (ODTs) offer an advantage in helping to improve patient compliance, which directly relates to reducing unnecessary hospitalization.  Additionally, ODTs are becoming of increasing importance to organizations such as the World Health Organization due to the dosage form’s convenience and the ability to dose patients without requiring water.  This is particularly important in regions where water quality issues prevail.  This presentation will provide an overview of ODTs, discuss the various patient classes and disease states that can benefit from ODT drug delivery, and examine ODT limitations and advantages.


Speaker:


Mr. Joseph Zeleznik – Associate Director R&D – 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 his second year speaking at ExcipientFest.




Day-One: Presentation 7

Formulation Facilitation of Powder Blends, Sugar-Free Film Coatings and HME with an unique Polyol


Abstract:
Launched in 2005, pharmaceutical grade isomalt (galenIQ™) – an alternative, highly functional filler-binder – has found its way into direct compressed tablets at first.While isomalt is known for its excellent compactibility, flowability, blend uniformity and very low hygroscopicity, the combination of its other important properties facilitates the application of this excipients in various technologies used in the manufacture of oral solid dosage forms. In powder blends, the unique morphology of isomalt eases the formulation of dry blends with different API particle sizes at the same time. Moreover, its sweet taste gives a suitable platform, e.g. for sachet products for direct oral application. The ability of isomalt to crystallize easily from aqueous solutions gives new opportunities in sugar(free) coatings. Automated processing and significant time savings compared to traditional pan coating technologies makes it an interesting alternative. Applied as a copolymer in film coating suspensions, isomalt improves the film adhesion and leads to significant cost savings. As the only polyol, which gives a stable amorphous glass, isomalt is used as a matrix for APIs in hot melt extrusion.The presentation will outline the properties, formulation and application of this polyol in various key technologies for oral solid dosage forms.




Speaker:


Mr. Bodo Fritzsching – Director Sales & Technical Services Pharma – Beneo-Palatinit: Bodo Fritzsching graduated as a Nutrition and Equipment Technology Engineer from the University of Applied Sciences, Trier, in 1992. He subsequently joined Palatinit GmbH, a subsidiary of Suedzucker AG Mannheim/Ochsenfurt, Germany as a representative of the Technical Services Department to advise the food and pharmaceutical industry about the properties and applications of isomalt, a sucrose derived polyol. Between 1992 and 1995 he was in charge of Technical Application Services within Europe. Thereafter, until 1999, he was responsible for the Technical Application Services of NAFTA/North America, supporting Palatinit of America, Inc. as Area Manager Technical Services. From 1999 to 2004, Bodo became Area Manager Sales and Technical Services to develop the companies business in Middle East and Africa. Since 2005 Bodo is heading up the Pharma Sales Unit of BENEO-Palatinit GmbH as Head of Sales & Technical Services PHARMA. The Unit is dedicated to the pharmaceutical industry focusing on the worldwide marketing of BENEO-Palatinit’s new pharmaceutical grade isomalt product range “galenIQ™”, which is used as a filler-binder in oral solid dosage forms. Bodo has participated in ExcipientFest as a speakers for several years.





• CONFERENCE HALL B
Day-One: Presentation 1

IPEC's Excipient Composition Guideline

Abstract:
IPEC Americas and IPEC Europe have worked together to complete a new guideline on excipient composition. This new guideline which was published in Fall 2009 includes information describing various types of components that are present in excipients. The guide also discusses how to develop and evaluate a composition profile of excipients. This type of compositional profile may be useful in gaining a fuller understanding of excipient characterization and when evaluating significant excipient manufacturing changes. The guideline addresses the need for confidentiality for some of this information in certain circumstances and is intended to foster good communication between the user and maker about key compositional information that may be important from a Quality by Design perspective. The presentation will provide an overview of the guideline and discuss the next steps IPEC plans to take to implement the use of this guideline throughout industry and determine a method for how this type of information can be exchanged between user maker and regulator.


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 Regulatory Affairs & Global GMP Manager for Ashland Aqualon Functional Ingredients’ pharmaceutical, food and personal care products business. Aqualon is a global manufacturer of cellulosic and guar products used as excipients, food additives and ingredients in personal care products. In addition, she performs product risk assessments and supports other aspects of regulatory compliance for Aqualon products globally. Previous positions in Hercules included Global Quality Leader for the 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. She is the IPEC representative on the USP Project Team for Elemental Impurities. Priscilla also participates in the International Food Additives Council and the Personal Care Products Council. This is her first year speaking at ExcipientFest.




Day-One: Presentation 2

The IPEC Novel Excipient Evaluation Procedure


Abstract:
In general, new or novel excipients are only approved throughout the world within new drug applications, i.e., there is no independent regulatory approval process for new or novel excipients. IPEC-Americas proposed and developed the IPEC Novel Excipient Safety Evaluation Procedure, which is an independent excipient review that evaluates the safety and regulatory acceptance of a new or novel excipient. The IPEC Procedure is anticipated to reduce the cost and uncertainty related to use of novel excipients in pharmaceutical formulations, thereby encouraging their use in drug development programs. The goal of the IPEC Procedure is to provide an independent evaluation of a novel excipient before a regulatory filing. Usually co-processed excipients or chemical/physical modifications of existing excipients are introduced as new excipients and it has not been common to introduce a new chemical entity as a new excipient.


Speaker:


Mr. Christopher DeMerlis – Manager Regulatory Affairs - Colorcon: Christopher C. DeMerlis is currently the Manager of Regulatory Affairs for Colorcon, Inc., West Point, PA. Mr. DeMerlis previously held various positions at FMC Corporation including Manager of Global Regulatory Affairs for FMC's Pharmaceutical Division and Entec Drug Delivery Technologies. Mr. DeMerlis is active in the International Pharmaceutical Excipients Council (IPEC) and is Chair of IPEC's Safety Committee and is the recipient of the 2009 Marshall Steinberg Memorial Prize for outstanding contributions and achievements in excipient safety. This is his first year speaking at ExcipientFest.




Day-One: Presentation 3

IPEC's Excipient Stability Guideline


Abstract:
Most excipients are successfully stored in environmentally uncontrolled warehouses. No guide existed for excipients’ stability studies, so IPEC decided to write a guide that describes a reasonably scientific approach for the study of their stability. The only current guide for stability (Q1A) is suitable for final drugs that are normally stored and handled under controlled conditions. That guide requires stability studies using room temperature and humidity (25°C and 60% RH). Controlled storage conditions are not the practice for almost all excipients so data from this type of controlled study is scientifically invalid. IPEC has written a guide that wrestles with the concept of storage under the uncontrolled environmental conditions of warehouses across the world. It is true that excipients have a long history of being successfully stored in warehouses with no environmental controls. So, what studies must be done to assure that the excipient remains viable when opened by the customer after its normal storage? The guide itself is intended to cover air- and moisture-sensitive compounds as well as inherently stable excipients. It describes the types of studies a manufacture must perform to demonstrate that the product will be viable when the customer opens the excipient package.


Speaker:


Mr. Phil Merrell PhD – Technical Marketing Manager – Jost Chemical Co.: Dr. Merrell has been the Technical Marketing Manager for Jost Chemical Co. in St. Louis, MO for three years. Before that he worked as a scientist for Mallinckrodt for nearly 30 years specializing in Inorganic Salts. He has been active in IPEC since 1995 where he has served on the Compendial Review, Excipient Qualification, GMP, and Regulatory Affairs Committees. He has participated in the writing of most of the IPEC Guidance Documents, including: Significant Change, Certificate of Analysis, the GMP Guide, the GDP Guide, Qualification of Excipients and, of course, the new Stability Guide. This is his first time speaking at ExcipientFest.




Day-One: Presentation 4

Conforming to the IPEC COA Guide


Abstract:
The IPEC-Americas Certificate of Analysis Guide for Bulk Pharmaceutical Excipients, was initially published ten years ago and is currently being revised to address supply chain security issues.  The revised guideline includes several important updates and is of international applicability.


Speaker:


Mr. David Klug – Senior Manager, Supplier Audit – sanofi-aventis: David Klug has been with sanofi-a ventis since 1995.  In his current role, David is responsible for GMP compliance audits of suppliers of materials used in U.S. marketed products.  He currently serves on the IPEC Americas' Executive Committee and as Chair for the Excipient Qualification committee, which is completing a revision to the IPEC Certificate of Analysis Guide.  David has participated in development of numerous IPEC guides, including Qualification of Excipients for Use in Pharmaceuticals; 2008, IPEC Excipient Information Package (EIP): Template and User Guide, 2009 and The IPEC Quality Agreement Guide and Template, 2009.  Formerly employed by Mallinckrodt, David holds an MS degree in Chemistry from the University of Missouri - Columbia. This is his first year speaking at ExcipientFest.




Day-One: Presentation 5

Co-processing: A Versatile Pathway to Modify Excipients: (Lactose Excipients: Fast Disintegrating to Modified Release)


Abstract:
Direct Compression is the preferred way to form tablets, mainly for economic reasons. In this process nature of each single component within a formulation plays a significant role. To achieve superior functionality for excipients, co-processing is an elegant way to combine useful properties of single partners, hence. Synergistic effects of co-processing can even overcome disadvantages of an individual ingredient. In pharmaceutical practice the variety of co-processed excipients is numerous, for the most widely-used filler lactose limited, however. Lactose is well established in co-processed forms with cellulose derivatives, lactitol, PVP and starch. Those materials show advanced performance e.g. in compressibility, disintegration, inertness, low segregation and flowability. Recently, a co-processed material consisting of lactose and HPMC for modified release has been presented. It showed to be helpful in development of direct compression matrix tablet using HPMC.


Speaker:


Mr. Franz Penz PhD – Applications Manager – Meggle GmbH: Dr. Franz Penz started in hospital pharmacy and consecutively focused on research in protein chemistry. Since 2007 he is application manager at Meggle GmbH & Co. KG, Excipient and Technology, Wasserburg (Germany). This is his first time speaking at ExcipientFest.





Day-One: Presentation 6

Best Practices for Assuring Supply Chain Security Including Quality Agreements (Shared presentation by Huber & Colorcon)


Abstract:
Presented will be an overview of current best practices for assuring supply chain security. The key points from IPEC Guidance documents and the IPEC Pedigree white paper will be highlighted. Potential hazards to supply chain security will be reviewed with an emphasis toward preventative measures designed to mitigate risk.


Speaker:







Mr. Dale Carter – Director of Global Quality, Silica – Huber Engineered Materials: Mr. Dale Carter Mr. Carter is the Chair Elect and GMP Committee Chair for the International Pharmaceutical Excipient Council of the Americas. He is the Global Director of Quality for the Silica Business Unit of Huber Engineered Materials. He is responsible for quality systems, product quality and compliance with IPEC/PQG GMPs for the manufacturing of Silica products at facilities in Tennessee, Maryland, India, Finland, and China. Prior to joining Huber he was the Manager Product Quality and Management Systems in the Office of Compliance and Ethics for the Archer Daniels Midland Company where he supported processing and business operations in the development and improvement of quality management systems to ensure sustainable quality, regulatory compliance, effective risk management, and customer satisfaction. With ADM he supported excipients, bulk APIs, food ingredients, dietary supplement ingredients, biofuels, animal feeds, and specialty grains products. He holds a Bachelors of Science degree from Davidson College in Chemistry and a Masters of Science degree from North Carolina State University in Chemistry. This is his first year speaking at ExcipientFest but has spoken many times at IPEC events.

Ms. Alexa Smith – Global Regulatory Service Manager – Colorcon:
Alexa Smith is the Global Regulatory Services Manager for Colorcon. She has been with Colorcon since June of 1997. In her current role, Alexa is primarily responsible supporting customer’s regulatory needs related to their use of Colorcon products. Alexa is also active in IPEC’s Excipient Qualification Working Group and was the Chair of their sub-committee working on Standardized Supplier Questionnaire Development. Currently, she is Co-Chair of their Quality Agreement Template sub-committee. She was recently selected to participate in USP’s Compendial Process Improvement Project Team, representing IPEC. In 2005, she was appointed as President of the Philadelphia Chapter of the Regulatory Affairs Professional Society (RAPS). Alexa is also active in the Regulatory Affairs Committee of the Council for Responsible Nutrition. She further holds a position as Adjunct Assistant Professor at Temple University and will be teaching a class in excipient regulation this spring. Alexa holds a M.S. in Quality Assurance and Regulatory Affairs from Temple University, a B.S. in Animal Sciences from Virginia Polytechnic Institute and State University and is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professional Society.




Day-One: Presentation 7

Quality by Design and Formulation Development


Abstract:
As pharmaceutical companies begin to implement Quality by Design principles in their drug applications for the FDA, there is a need to understand the variability inherent in the various excipients that they may use in their formulation and what impact, if any, this variability has on excipient performance in the drug product. One key issue that most excipient suppliers face is the inability to obtain consistent properties of excipients on a lot–to–lot basis. This inherent variability in the excipient places a burden on the drug manufacturer to utilize process controls to “dampen out” the variability present in the excipient in order to produce consistent dosage forms. An alternative or adjunct method to adjust for excipient variability is to develop a formulation which will allow for the drug manufacturer, utilizing their knowledge of excipient properties of various grades and the effect they have on the finished dosage form, to allow for the use of multiple lots or grades to be blended to a more consistent critical quality attribute prior to use in drug product manufacture. This reduces the burden on process control to produce a consistent dosage form. This concept is a natural extension of the early formulation work that most drug manufacturers undergo, where a variety of different excipient grades may be trialed to obtain the desired dissolution profile.



Speaker:


Mr. William Busch – Senior Applications Development Specialist – Dow Wolff Cellulosics: William is a Senior Application Development Specialist with Dow Wolff Cellulosics, a business unit of The Dow Chemical Company. He is an active member of the International Pharmaceutical Excipients Council – Americas, where he participates on several committees, including the Quality by Design Committee. This is his first time speaking at ExcipientFest.

DAY-TWO: Educational Sessions

• CONFERENCE HALL A (Day-Two)
Day-Two: Presentation 1

Commercially available options for BCS Class II, III & IV compounds in all Dosage Forms


Abstract:
As API’s become more complex, formulating water-insoluble compounds has become a major issue. Each dosage form seems to have developed specific options, but solubalization remains the cornerstone of formulation.  This presentation would focus on the solubility performance of TPGS for BCS class II, III, IV compounds and present data on the performance of synergistic mixtures of Compendial and/or Food/cosmetic grade products. This presentation will also provide information on the application of Chitosan, a newly monographed excipient, with negatively charged API’s. Lastly, PIT emulsions as a mechanism for those impossible to solubalize materials will be discussed.



Speakers:



Mr. Guido Baumoeller PhDTechnical Director for Pharma - Cognis:  (Bio Pending)



Day-Two: Presentation 2

New Tests for Identifying Harmful & Potentially Deadly Adulterants in Pharmaceutical Ingredients:  The Role USP NF in Setting Revised Standards


Abstract:

The adulteration of drugs and all of their ingredients is a critical public health issue. Adulterations of cough syrups and other oral products with diethylene glycol (DEG) and/or ethylene glycol (EG), industrial chemicals commonly used in antifreeze, have occurred many times and in many countries, including recent tragic episodes in Nigeria and Bangladesh, where many children died after exposure to an adulterated teething syrup.  USP, responding to a request from FDA and in close collaboration with manufacturers, other national and international parties and regulatory agencies, is addressing this by updating our excipient standards for at risk ingredients.  Revisions to high priority excipients; Glycerin, Propylene Glycol and 4 sugar alcohols, Sorbitol Solution, Noncrystallizing Sorbitol Solution, Sorbitol Sorbitan Solution, and Maltitol Solution to include limits for DEG and EG can help prevent future episodes of deliberate adulteration with these inappropriate and injurious chemicals.  The updated high priority standards for the pharmaceutical excipients will help ensure the absence of DEG and EG, each at a level of not more than 0.10 percent in the Identification test.  



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 first time speaking at ExcipientFest.





Day-Two: Presentation 3

Bringing Added Value to the Excipient Supply Chain


Abstract:

Excipients are crucial ingredients in any pharma formulation given that they define the drug application and control the functionality of the API. A secure and quality-compliant supply chain of Excipients is a key factor in the success of the drug manufacturing. For many years, drug manufacturers have been asking for leaner and more efficient processes to remain competitive, especially in Puerto Rico. The search for strategic partners and suppliers to help achieve these efficiencies is never ending. This presentation will examine Added Value Services (AVS) designed to be integrated into the Excipient supply chain to create efficiencies for the drug manufacturer and ultimately create leaner, shorter-production cycle times. From a supplier-distribution perspective, big pharma can now outsource sampling, testing, weighing and controlled storage allowing first-time delivery of “production ready” Excipients. The quality assurance and process validation of AVS procedures are imperative to win the confidence of the drug manufacturer and allow for the implementation of these efficiencies into the Excipient supply chain. This talk will also address how outsourced AVS’ in the distribution process are validated and quality-controlled in order to consistently comply with the requirements of the pharma industry and the end-user.



Speaker:












Ms. Elizabeth Plaza – President & CEO – PharmaBioServ: Elizabeth Plaza, a graduate Pharmacist from the University of PR is the President of PharmaBioServ, a consulting and contract services organization which provides on-site support to regulated life sciences industries. Mrs. Plaza expertise focuses in the areas of pharmaceutical technology transfer, GMP compliance systems, project management and validation life cycle. With twenty (22) years of hands on experience, Mrs. Plaza held senior positions in pharmaceutical technology and technical services directing efforts to transfer new products and technologies at companies such as Warner Lambert and McNeil Pharmaceutical. Since 1993, Mrs. Plaza is the founder and current President and CEO of PharmaBio Serv, a leader compliance service company which counts with over 100 associates dedicated to support pharmaceutical, medical device, chemical, biotechnology and food manufacturing companies. Services include, regulatory/compliance, Quality Risk Management, Commissioning, Qualification, Validation, Technology Transfer, Process Improvement, Project Management, laboratory testing through its Scienza Labs facility, Engineering, Information Technology through its Integratek division and Technical Training through PharmaServ Academy. Under the leadership of Elizabeth, PharmaBioServ has been positioned as a Global Supplier of consulting services with presence in the US mainland, Puerto Rico, Ireland and more recently, Asia. The company was recognized last year as the Minority Exporter of the Year by MBEC and by Johnson & Johnson as the Partner of the Year in the Professional Services category. This is Elizabeth’s 2nd year speaking a ExcipientFest.



Mr. Dwight Mutchler – President & General Manager – Mutchler Inc. Puerto Rico:  Dwight has over 20 years experience working with the supply and distribution of Excipients to the pharmaceutical industry. He is co-owner of Mutchler Inc. USA and PR, which is dedicated to the distribution, sales and marketing of Excipients from world-class suppliers to the end user. His main responsibilities are management of the PR operation and overall strategic direction of the company and if very knowledgeable on Excipient functionality, regulatory issues and the needs/requirements of big pharma. He has lived and worked in Puerto Rico for the past 27 years. Dwight is also the president and creator of ExcipientFest, producing the event for over 10 years in Puerto Rico and Ireland. He holds a MBA from the American Graduate School of International Management (Thunderbird) and previously has worked for many years in the advertising industry in Latin America and Spain.



Day-Two: Presentation 4

Excipient DMF's in China


Abstract:
PENDING


Speaker:


Mr. Sun Humin  – Chinese National Institute of Control of Pharmaceutical & Biological Products:

Professor Huimin Sun is the deputy division director (executive) of pharmaceutical excipients and packaging materials in National Institute for the Control of Pharmaceutical & Biological Products, State Food and Drug Administration in China. He graduated from ShanDong Medical University with Bachelor degree of pharmacy in 1986, and obtained his Master degree of Pharmacy in the Chinese University of Hong Kong in 2001.
He serves as an expert of State Food and Drug Administration for evaluating pharmaceutical packaging materials and healthcare products, also, the expert of Center for Medical Devices Evaluation, SFDA. And, he is the technical observer of IPEC-CHINA.
He has been engaged in quality control and standardization of chemical drugs and traditional Chinese medicine for 22 years, especially did a remarkable job in the analysis of pharmaceutical excipients and pharmaceutical packaging materials. As a project manager, he is responsible for a key project in the National Science & Technology Pillar Program in the 11th 5-year Plan Period in China. The key project is known as preclinical evaluation of new pharmaceutical excipients and compatibility evaluation between drugs and their pharmaceutical packaging materials. He also has drafted a lot of monographs of pharmaceutical excipients for Chinese Pharmacopoeia (2010 version).



Day-Two: Presentation 5

FDA - PR Investigator’s Perspective on Review of Supplier Qualification Programs during Audits


Abstract:
PENDING

Speaker:


Mr. José Meléndez – FDA Puerto Rico – (Invited Speaker)

José E. Meléndez is a Drug Specialist Investigator from the San Juan District Office. Mr. Meléndez, has served in several positions since he joined FDA in 1996: Chemist, Investigator, Acting Supervisor and Drug Specialist Investigator since 2005. He also worked as a Chemist and Validation Technician for a pharmaceutical company before joining FDA. He received her BS in Industrial Chemistry from the University of Puerto Rico. He has been a member of FDA's Foreign Inspection Cadre since 2006, and
has conducted inspections of pharmaceutical, APIs and Biologic products manufacturers in several countries of Europe and South America. He is certified as member of FDA's Pharmaceutical Inspectorate. He has participated in numerous conferences and training to the pharmaceutical industries and to regulators. His current responsibilities include training and advice FDA SJN-DO staff in drug inspections.



Day-Two: Presentation 6

Speaker’s Round Table: Leveling the Playing Field for Excipients

Abstract of Discussion Points:

Raising the bar for excipient GMP requirements and registration fees: A discussion of pending US legislation

The case for novel excipients: A discussion on evaluating and submitting for approval new excipients outside the NDA process

Beyond inactive ingredients: A discussion on excipient functionality and variability

Testing: A discussion on how to secure the excipient supply-chain before ingredients enter the laboratory

Pricing: A discussion of excipient quality versus price

Audience participation and Q&A

Moderated by Angie Drakulich – Editor of Phamaceutical Technology:

Invited participants Speakers from FDA, BASF, Pfizer, USP, Warner Chillcot, IPEC, RX360

The Round Table will finish with the Academic Poster Awards & Closing Remarks






• CONFERENCE HALL B (Day-Two)
Day-Two: Presentation 1

The Future of Co-Processed Excipients


Abstract:

Dr. Carlin, chairman of the IPEC Excipient Composition Committee, will review IPEC activities on coprocessed excipients, which seek to clarify the regulatory position and facilitate their adoption by the pharmaceutical industry. Co-processing is the combination of two or more excipients designed to physically modify their properties without chemical change, in a manner not achievable by simple physical mixing.  Such composite materials and particle engineering will be required to benefit from the greater materials characterization and functional insight inherent in Quality by Design. Recent initiatives in this field will be highlighted, including compositional profile, safety assessment and monography.



Speaker:


Mr. Brian Carlin, PhD. – Director of Open Innovation for the Pharmaceutical Business - FMC BioPolymer: Dr. Carlin MRPharmS, MRSC CChem is the Director of Open Innovation for the Pharmaceutical business of FMC BioPolymer, Princeton NJ. He 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-Two: Presentation 2

Change Control in Excipient Manufacturing – The Importance in a Quality by Design World


Abstract:

To properly utilize Quality by Design (QbD) principles in drug development and manufacturing, it is more critical than ever to have a good understanding of how excipient properties and variability may impact the drug manufacturing process, drug performance and drug product stability for every specific application. If significant investment is to be made in gaining this understanding, it is also critical that a good control system is in place to handle change control at the excipient manufacturing site and that significant changes be communicated to the drug product manufacturers who use the affected excipient in a timely manner. Changes can then be proactively evaluated by the user to determine what impact might be expected in each drug product where the excipient is used. IPEC Americas published a guideline on Significant Change Notification in 1999 (revised in 2008) which is commonly used throughout the industry to improve communication on excipient changes. IPEC is currently involved in updating this guideline to address the current needs when applied to Quality by Design thinking.  Additionally, the guideline is being harmonized with IPEC Europe to begin globalizing the document. This presentation will discuss why there is a growing need for improved change control and user notification to address QbD issues.  IPEC’s global efforts to revise the current Significant Change guideline will also be reviewed.


Speaker:


Mr. David Schoneker – Director Regulatory Affairs-Colorcon: David R. Schoneker is the Director of Global Regulatory Affairs at Colorcon. His 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-Two: Presentation 3

Regulation & QA of Excipients in the Nutraceutical/Dietary Supplement Industry: I mportance of the Ingredient Supplier (Shared Presentation)


Abstract:

(NSP) The scope of this presentation will give a background to the work NSF is performing with the dietary supplement industry in the areas of standards development and certification services. Since 2001, NSF has worked with the dietary supplement industry in the development of a national standard  for Dietary Supplements (NSF/ANSI Standard 173) with participation of a balanced stakeholder group, including FDA, NIH, other federal agencies, state regulatory agencies, foreign regulatory agencies, manufacturers, product retailers, industry trade associations and consumer groups.  NSF/ANSI 173 references all of the 21 CFR requirements for supplements, including label accuracy for contents, product hygiene (no contaminants or adulterants), product disintegration, product security and as well as facility GMPs and AER reporting. This standard is the basis for all of the NSF Certification programs, including, GMP, products and ingredient certification.  The certification programs are accredited by ANSI (American National Standards Institute), SCC (Standards Council of Canada) and CNCA (Certification and Accreditation Administration of China).

(CRN) Today, emphasis on raw material supplier qualification by the FDA in the dietary supplement GMPs, concerns over food safety concerns and imported raw materials have elevated interest in supply chain management to an all-time high.  Qualifying raw material suppliers and their ingredients is a complex and resource-intensive process.  However, there are few resources available to dietary supplement manufacturers to assist with the supplier qualification process.  In 2006, the Joint Standardized Information on Dietary Ingredients (SIDI) Working Group, a collaboration of four dietary supplement industry trade associations developed the SIDI™ protocol, a self-regulatory guideline intended to facilitate the efficient exchange of information between raw ingredient suppliers and finished product manufacturers and other users.  SIDI is based on the excipient industry’s Excipient Information Protocol (or EIP) and outlines the type and scope of information that ingredient suppliers should provide on their ingredient to their customers.  More recently the working group has developed other guideline documents, including a Certificate of Analysis (COA) Guideline, COA Verification Guideline and GMP Guideline for Dietary Ingredients.  These guidelines provide minimum standards for ingredient supplier qualification and are intended to assist dietary supplement manufacturers with the supplier qualification process, and compliance with GMP and food safety requirements.



Speaker:





Mr. Edward Wyszumiala –  General Manager – NSF International: Ed Wyszumiala is the general manager for NSF International’s dietary supplement and functional food certification programs. As part of his duties he heads NSF's dietary supplements strategic initiatives, including the development of NSF’s certification programs and implementation of NSF’s integrated business strategies. Ed is also involved in various in industry organizations, including CRN, UNPA, AHPA and IADSA. Prior to joining NSF International, Mr. Wyszumiala was the Chief Operating Officer for Graminex L.L.C. where he oversaw international business development and operations and prior Graminex he served at the Office of Budget and Management for State of Ohio. This is his first year speaking at ExcipientFest.

Mr. Andrew Shao PhD –  VP of Scientific & Regulatory Affairs – Council for Responsible Nutrition: The Council for Responsible Nutrition (CRN) is a dietary supplement industry trade group in Washington, DC (www.crnusa.org).  Dr. Shao earned an undergraduate degree in Biology from Brandeis University, and a Masters degree in Human Nutrition in 1996, and Ph.D. in Nutritional Biochemistry in 2000, both from Tufts University.  Dr. Shao possesses a broad background in human nutrition science and an in-depth knowledge of nutrition policy, dietary supplement regulatory affairs and product development.  Dr. Shao’s experience in the industry encompasses a wide range of commerce, including basic research and development, ingredient manufacturing, finished product development, and retailing. At CRN Dr. Shao’s primary responsibilities include development and communication of position statements on scientific and policy issues and submissions to government agencies on proposed regulatory actions pertaining to nutrition and dietary supplements.  He is also responsible for analyzing emerging research results and placing new data into context for key industry stakeholders, including CRN member companies, regulators, legislators, the media and the public.  Finally, Dr. Shao leads several collaborative efforts with other trade, academic, professional, and consumer organizations with an interest in nutrition and dietary supplements in the execution of initiatives of mutual interest.  Specific accomplishments at CRN include establishment and leadership of CRN’s Senior Scientific Advisory Council, staff liaison to the CRN Regulatory Affairs Committee, leadership of the four-trade association Joint SIDI™ Working Group, establishment of the American Society of Nutrition’s Mary Swartz Rose professional research awards sponsored by CRN and Research Watch, CRN’s scientific newsletter.  He is responsible for planning CRN’s scientific and regulatory meetings and workshops and regularly assists member companies with compliance issues related to critical regulations such as good manufacturing practices (GMP) and mandatory serious adverse event reporting.  He regularly contributes to the literature, authoring or coauthoring peer-reviewed articles for scientific journals or for trade journals on topics including nutrient risk assessment, evidence-based nutrition and GMP compliance.  In addition to his role at CRN, Dr. Shao also serves on several industry-related committees and working groups, including those involved with the USP, AOAC International and NSF International.

Prior to joining CRN Dr. Shao was with General Nutrition Corporation (GNC) in Pittsburgh, PA., where he was a senior scientist, reviewing new products and ingredients to determine scientific viability and applications.  Prior to his employment with GNC, Dr. Shao worked as technical services manager for Kemin Consumer Care, and before that as section manager for Kemin Foods, now known as Kemin Health, in Des Moines, IA. Dr. Shao is a member of the American Society of Nutrition, the American College of Nutrition, the Institute of Food Technologists and the National Strength and Conditioning Association. This is his first year speaking at ExcipientFest.





Day-Two: Presentation 4

Solubility Enhancement with Methacrylates


Abstract:

Lack of drug solubility is a persistent challenge for pharmaceutical scientists. This presentation discusses using Methacrylates for solubility enhancement. In this presentation, hot melt extrusion of API with a methacrylate polymer base as means to enhance API solubility will be discussed. A solubility parameter approach to identify methacrylate polymer base to increase the chances of successful extrusion will be presented. Case studies where solubility parameter was utilized to identify solubility of API in methacyrlate polymer base and data on the subsequent solubility enhancement achieved will be presented. Cases where it may be possible to carry out the extrusion process below 100° C – “Low Temperature Extrusion” will be discussed as well. This technique may also provide for taste masking as an additional benefit. A short reference to this application of the techniques will be made.



Speaker:


Mr. Abhishek Kathuria – Senior Scientist – Evonik Industries: Abhishek Kathuria has been with Evonik since March of 2009. He has a background in Chemical Engineering and obtained a graduate degree in Quality Management from Pennsylvania State University, PA. Previously he worked in formulation development and scale up/process optimization areas with GSK, Sandoz and Covidien. Abhishek has about 8 years experience in pharmaceutical industry. He is also ASQ certified Six Sigma Green belt. This is his first year speaking at ExcipientFest.





Day-Two: Presentation 5

Excipient GMPs and The Global Certification Project


Abstract:
Presented will be an overview of the Global Certification Projects for Excipient GMP Certification.  The content of both the ISO 9001 Excipient GMP Annex, designed for companies with an ISO 9001 registered quality system, and the ANSI Standard NSF 363 - Good Manufacturing Practices for Pharmaceutical Excipients, designed for companies without an ISO 9001 registered quality system, will be reviewed.  Comparisons to the common source document for both, the 2006 IPEC PQG Excipient GMP Guide, will be shown.  Key GMP requirements necessary for certification will be highlighted.

Speaker:


Mr. Dale Carter  – Director of Global Quality, Silica – Huber Engineered Materials: Mr. Dale Carter Mr. Carter is the Chair Elect and GMP Committee Chair for the International Pharmaceutical Excipient Council of the Americas.  He is the Global Director of Quality for the Silica Business Unit of Huber Engineered Materials.  He is responsible for quality systems, product quality and compliance with IPEC/PQG GMPs for the manufacturing of Silica products at facilities in Tennessee, Maryland, India, Finland, and China.  Prior to joining Huber he was the Manager Product Quality and Management Systems in the Office of Compliance and Ethics for the Archer Daniels Midland Company where he supported processing and business operations in the development and improvement of quality management systems to ensure sustainable quality, regulatory compliance, effective risk management, and customer satisfaction.  With ADM he supported excipients, bulk APIs, food ingredients, dietary supplement ingredients, biofuels, animal feeds, and specialty grains products.  He holds a Bachelors of Science degree from Davidson College in Chemistry and a Masters of Science degree from North Carolina State University in Chemistry. This is his first year speaking at ExcipientFest but has spoken many times at IPEC events.






Day-Two: Presentation 6

Speaker’s Round Table: Leveling the Playing Field for Excipients

Exclusively Sponsored by:

 

 



Abstract:

Excipients are used in all pharmaceutical formulations to perform a number of different functions.  In the past, excipients were merely thought of as the inactive part of a formulation and relatively unimportant.  However, in recent years, it has become obvious that controlling the quality and consistency of excipients and making sure that the grades of the excipients used are globally acceptable has had a major impact on dosage form development. 
It is important to utilize a standardized approach to properly qualify excipients for their intended use.  This process should include gaining an understanding of the GMPs and GDPs used to manufacture and distribute the excipient and the development of appropriate specifications to control both the compendial requirements and the additional non-compendial requirements which may be needed to qualify an excipient’s functionality for specific applications. 
Drug product formulation is becoming more and more complex, especially in the area of controlled release.  These new applications are creating a demand for novel excipients that can perform functions not typically available from existing excipients.  Pathways have recently been worked out to make it easier to utilize these new excipients without significant regulatory burden.
The Speaker’s Round Table will discuss many of the new concepts and issues being addressed by IPEC and others to level the playing field for excipients and improve the quality of the excipients used in drug products.

AngieDrakulichModerated by Angie Drakulich – Editor of Phamaceutical Technology: Angie joined Pharmaceutical Technology in 2007. She previously served as editor and assistant communications director at the United Nations Association of the USA where she directed a quarterly magazine, among other publications, on US-UN relations. Angie has worked an editor, writer, and researcher for Grunar & Jahr USA, Time Inc., and Rodale publishing. She holds a Master of Arts from Seton Hall University’s John C. Whitehead School of Diplomacy and International Relations and a bachelor’s degree from James Madison University. Her articles have appeared in The InterDependent, UN Chronicle, Rosie, McCall's, Parenting, Travel Holiday, Bridal Guide, The Washington Times, and U.S. News & World Report.

Invited participants Speakers:

Rosa Motta (FDA), Eric Berg of AMGEN and Rx-360; USP’s Catherine Sheehan, BASF’s Ranga Velagaleti and Sherry Ku, CSO of Anchen Pharmaceuticals,  Janeen Skutnik of IPEC and Pfizer, and Dale Carter of IPEC and Huber Engineered Materials.

The Round Table will finish with the Academic Poster Awards & Closing Remarks


EXCIPIENTFEST is a Registered Trademark ® 2002, Excipientfest Inc., All rights reserved

 
DAY 1 - Tue. May 10
  • Workshops I & II
  • Educational Sessions
  • Pharma Expo
  • Poster Sessions
  • Lunch
  • Cocktail & Live Music

DAY 2 - Wed. May 11
  • Workshops I & II
  • Educational Sessions
  • Pharma Expo
  • Poster Sessions
  • Lunch
  • Speakers' Round Table
  • Cocktail & Live Music