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Welcome to ExcipientFest Americas


April 24 (Workshops)
April 25 - 26, 2017 (Expo & Educational Sessions)

Rhode Island Convention Center, Providence, RI


Excipient Industry's Leading Expo and Conference for Regulatory, Science and Supply Chain Education

Educational Sessions (Scroll down for abstracts and speakers info)

*Invited Speaker

Day 1     Tuesday, April 25th  

From 7:00 AM

Registration, Coffee & Pastries

 
 

Conference Hall A (Expo Area)  

Conference Hall B (Expo Area)

8:15 AM

Welcome Speech
Dwight Mutchler – ExcipientFest President and Priscilla Zawislak – IPEC Americas Chair

8:30 – 9:15 AM

KEY-NOTE SPEAKER: Before you click "Print": Regulatory considerations for 3D printed oral drug products – Ahmed Zidan, FDA

9:15 – 9:30 AM

Coffee & Networking Break

 

9:30 – 10:15 AM

Organic Taste Modulation (Bitterblock): Improved tastemasking with less sodium and sugar – Jim Langan, CellMark

A pragmatic approach to Atypical Actives – Priscilla Zawislak, IPEC Americas

10:15 – 11:00 AM

Materials for use in formulating combination products – *Thinh Nguyen, FDA Combination Drugs Office

Direct compressible excipients for ODT formulations: comparison of traditional and innovative solutions – Javier Camargo, OMYA

11:00 – 11:15 AM

Coffee & Networking Break

 

11:15 – 12:15 PM

Novel Docusate Excipients for Poorly Soluble APIs – Nimal Jayasuriya, Cytec Solvay

Managing the delicate balance between Purchasing Strategy and Quality RequirementsJon Gawlak, Par Pharmaceuticals

12:15 – 1:30 PM        

Lunch and Networking

1:30 – 2:15 PM

USP Update on excipient standard setting activities – the importance of stakeholder engagement with USP – Hong Wang, US Pharmacopeia

Advanced Polymer Technologies – New Frontiers in Drug Delivery Systems Meera Raghuram - Lubrizol

2:15 – 3:00 PM

Multiples Uses of Poloxamer 188 – Nigel Langley, BASF Corporation

Multivariate analysis to enable product understanding in a QbD era – Bastiaan Dickhoff, DFE Pharma

3:00 – 3:30 PM

Poster Q&A Session & Coffee Break

 

3:30 – 4:15 PM

KEY-NOTE SPEAKER: Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing - Geoff Wu - FDA OPS Emerging Technology Team

4:15 – 5:00 PM

SPEAKERS’ ROUND TABLE: Science (Non) Fiction: 21st Century Medicines   Virginia Wotring - NIBSP, Ahmed Zidan -FDA, Geoff Wu - FDA Emerging Technologies Office, Meera Raghuram - IPEC Americas

5:00 – 6:30 PM

ExcipientFest Cocktail with Live Music

 
6:30 PM  IPEC-Americas Soiree
       

Day 2 Wednesday, April 26th

From 7:30 AM

Registration, Coffee & Local Pastries

 
 

Conference Hall A (Expo Area)  

Conference Hall B (Expo Area)

8:30 – 9:15 AM KEY-NOTE SPEAKER: Longterm Space Flight and its challenges for Pharma and Biotech Industries –  Virginia Wotring, National Space Biomedical Research Institute

9:15 – 9:30 AM

Coffee Break & Networking Break

 

9:30 – 10:15 AM

Excipients:  Critical Components of the Biomanufacturing Process  – Jeff Shumway - MilliporeSigma

Ensuring Patient Safety through Appropriate Impurity Evaluation – Chad Pezoldt - BioSpectra

10:15 – 11:00 AM

Fingerprinting Biologics Drugs Using Drop Coat Deposition Confocal Raman (DCDCR) Spectroscopy - Ravi Kalyanaraman - BMS

Novel Excipients Safety Qualfication - IPEC Americas/IQ Proposal- David Schoneker and Nigel Langley, IPEC Americas

11:00 – 11:15 AM

Coffee Break & Networking Break

 

11:15 – 12:00 PM

A Review of NSF / IPEC / ANSI 363 GMP Standard for Pharmaceutical Excipients – Findings and Best Practices – Jim Morris, NSF

Sugar Spheres: Improving clinical effectiveness with Multiparticulate drug delivery systems – Philipp Werner, pharm-a-spheres

12:00 – 1:30 PM

Lunch and Networking – Award Presentation for Academic Postersy

1:30 – 2:15 PM

MRI Traceable Protein Biomaterials for Drug Delivery – Jin Montclare, New York University

Understanding the Filmcoating Process – Anthony Carpanzano - JRS Pharma LP

2:15 - 3:00 PM

Medical Marijuana: Improving Stability with Novel Delivery Method Lekhram Changoer - AXIM Biotechnologies

Safety and quality control of pharmaceutical excipients for injectables in China –Song Xiaosong - NIFDC

3:00 – 3:15 PM

Coffee Break & Networking Break

3:15 – 4:00 PM

KEY-NOTE SPEAKER: Progress made implementing FDASIA and GDUFA, Impact on Excipients Use – *Lawrence Yu - FDA

4:00 – 6:00 PM

ExcipientFest Cocktail

 

This program is subject to change. Please refer to this website for updates.

 


Abstracts coming soon

Day 1 Presentations and Speakers
Day-One: Keynote Speaker

Safety and quality control of pharmaceutical excipients for injectables in China

ABSTRACT:  Injectables are of the most high-risk dosage forms due to its clinical application, the quality of pharmaceutical excipients used for injectables may have a great effect on their safety. The requirement of the excipients for injectables are different from the excipients for common use, especially in safety parameters, such like allergic protein, impurities, bacterial endotoxins, microorganism, and sterility, to mention a few. The quality standard of excipients should be established and regulated in classification, based on their different functions, applications and dosages. Injection manufacturers should use the excipients for injection rather than common excipients, in order to ensure safety. Currently, the excipient monographs for injectables are not separated from the excipients for common use in most national pharmacopeias. However, 23 monographs of excipients “for injectables” were collected in Chinese Pharmacopeia 2015, including macrogol 300, polylactide-co-glycolide, soya lecithin (Injectables), egg yolk lecithin, and polysorbate 80, which have already been used in injectable formulations, and also contributed to improving the drug safety in China.

 

Speakers:

 



Song Xiao-Song, PhD, is currently working in Institute for Packaging Material and Pharmaceutical Excipient Control, National Institutes for Food and Drug Control (NIFDC), who is mainly focus on the quality control, function research of pharmaceutical excipients. He has also worked as Postdoc at Tsinghua University (China) for two years. He obtained his PhD degree in Pharmacy from Aston University at Birmingham (UK).



Day 1 - Hall A Presentations
Day-One: Presentation 1

 Organic Taste Modulation (Bitterblock): Improved tastemasking with less sugar

ABSTRACT:   Know about the first organic bitter blocker, ClearTaste™, which is derived from a mushroom fermentation process. ClearTaste is capable of mitigating bitter, astringent and sour off tastes from a wide variety of applications. For Pharma applications, It is particularly effective in high intensity sweeteners, vitamins, and supplements to name a few. By eliminating the perception of the flavor defects, formulators can drastically reduce or eliminate the sugar requirements in their products.

Speaker:

 Jim Langan

Jim Langan, CELLMARK - Jim is a scientist with background in biology, chemistry and physics, holding a degree in Chemistry from Hamilton College. Some of his prior research includes studying nanophotonic pathways in silica gels doped with rare earth ternary chelates and the effect of chronic hypoglycemia on age related macular degeneration in mice. As a dynamic problem solver, Jim has played a foundational role in developing products at MycoTechnology, providing fundamental solutions to issues in the development of natural, organic, bitter blockers. He has been instrumental in developing and obtaining intellectual property and in assisting sales, operations, marketing and regulatory as a subject matter expert. As a founder at MycoTech, Jim has displayed a focused drive to help make the company mission a successful reality.

Day-One: Presentation 2

Materials for use in formulating combination products

ABSTRACT: How are atypical actives being managed and regulated by FDA? Overview of activities from the Atypical Actives Coalition, an industry group created to define reasonable requirements and controls which establish regulatory flexibility by FDA, EMA and other global agencies for the use of certain excipients used as atypical actives in drug products. The coalition seeks use of appropriate GMPs based on risk rather than full ICH Q7 API GMP compliance.

Speaker:


FDA Combination Drugs Office - Coming Soon.

 

Day-One: Presentation 3

Novel Docusate Excipients for Poorly Soluble APIs

ABSTRACT: Docusate, a surfactant for the pharmaceutical market, has been demonstrated to be an outstanding solubilizing agent for poorly soluble API’s while providing additional processing benefits in drug formulation. DocuSolv™s are new forms of Docusate which have been developed to overcome handling issues with Docusate. They are granular, free flowing forms of Docusate with fine particle size which dissolve significantly faster and additionally have higher solubility than Docusate itself. This presentation will focus on various forms of Docusate, their characterization and properties.


Speaker:

 

Nimal Jayasuriya, Cytec Solvay - Nimal Jayasuriya is a Senior Research Scientist with the Novecare business of Solvay and is based in Stamford, CT. Prior to that he worked for 20 years at Cytec in the Specialty Additives business group focusing mainly on development of Sulfosuccinate surfactants. He obtained his MS and PhD degrees in Chemistry from the University of Illinois at Chicago.

 

 

 
Day-One: Presentation 4

USP Update on excipient standard setting activities – the importance of stakeholder engagement with USP

ABSTRACT: The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that publishes monograph standards for identification and testing of drug products, excipients, foods and dietary supplements, among other related products.  USP’s monographs and over 3500 reference standards are used in more than 140 countries for regulatory and industry quality control.  Supported by FDA and by public and industry outreach efforts, the USP monograph Up-to-Date initiative continues to improve the relevance and quality of excipient standards to help qualify excipients for their intended use and assure the quality of pharmaceutical products, in furtherance of USP’s stated mission of improving global public health.  USP welcomes participation and contribution - including revisions to monographs, donation of bulk material to be developed into reference standards, and shared expertise - from interested parties in our collaborative standards-setting activities.  This presentation provides examples of recent collaborative efforts for excipient revision proposals published in the Pharmacopeial Forum (PF). 

 

Speaker:

Hong Wang USP

 

Hong Wang, US Pharmacopeia- Dr. Wang is the scientific liaison to the Excipients Expert Committee, the General Chapters–Physical Analysis Expert Committee, and the General Chapters–Chemical Analysis Expert Committee. Currently, she is leading excipient compendial science subteam under excipient program unit, and managing development and modernization of monographs and excipient related general chapters and introduction of USP Reference Standards into documentary standards. Before joining USP, Dr. Wang worked at Bioprocess and Bioanalytical Research Department at Merck Research Laboratories in PA, in new vaccine development. Prior to starting an industrial career at Merck, Dr. Wang worked as a postdoctoral fellow at Brandeis University in MA. Dr. Wang holds an M.Sc. in Organic Chemistry from Sichuan University, China; an M.Sc. in Analytical Chemistry from Seton Hall University, USA; and a Ph.D. in Physical Chemistry from University of Basel, Switzerland.


Day-One: Presentation 5

Multiples Uses of Poloxamer 188

ABSTRACT: The goal of this presentation is to discuss results from a series of recent clinical studies (J. Pharm. Sci. 105:996-1005, 2016) and considerations for BCS class 3 biowaivers. In a series of recent clinical studies, the objective was to assess the impact of larger than conventional amounts of 14 commonly used excipients on BCS class 3 drug absorption in humans. Cimetidine and acyclovir were used as model class 3 drugs across three separate four-way crossover bioequivalence studies (n=24 each) in healthy human volunteers, denoted study 1A, 1B, and 2. Overall, 12 common excipients were found in large amounts to not impact BCS class 3 drug absorption in humans, such that these excipients need not be qualitatively the same nor quantitatively very similar to reference, but rather simply be no more than the quantities studied here. Meanwhile, for each HPMC and microcrystalline cellulose, BCS class 3 biowaivers require these two excipients be qualitatively the same and quantitatively very similar to the reference.

 

Speaker:

Nigel Langley, BASF Corporation

Nigel Langley, Global Technical Marketing and Technical Service – BASF Pharma Solutions, provides technical support to the pharmaceutical industry and helps solve drug development challenges with BASF's platform solutions. 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).



Day-One: Keynote Speaker

Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing

ABSTRACT: This presentation will provide an update on the CDER Emerging Technology Program. Specifics include:

1) the current guidance, policy, and thinking about emerging technology

2) how the CDER Emerging Technology Team (ETT) works;

3) a high level overview of past and current ET projects and topics;

4) points to consider when working with ETT during the process of adopting emerging technology.

 

Speakers:

Geoff WU FDA

Geoff Wu, Associate Director for Science and Communication, Office of Lifecycle Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Lieutenant Commander Geoffrey K. Wu, Ph.D., PMP, CPH, is a scientist officer in the United States Public Health Service.  He is currently the Associate Director for Science and Communication in the Office of Lifecycle Drug Products (OLDP), Office of Pharmaceutical Quality (OPQ). He is also a current member on the OPQ Emerging Technology Team (ETT). Geoff has been deeply involved, leading or co-leading regulatory review and research for controlled correspondence, ANDAs, and supplemental ANDAs and NDAs in the past seven years. Geoff has training and education in pharmacy, pharmaceutical science, protein chemistry, polymer chemistry, and process analytical technology.

Geoff has training and education in pharmacy, pharmaceutical science, protein chemistry, polymer chemistry, and process analytical technology. He received his Ph.D. degree in Pharmaceutics and Pharmaceutical Chemistry from University of Utah, and BS. in pharmacy and MS. in pharmaceutics from Peking University, China



Day-One: Speakers Roundtable

SPEAKERS' ROUNDTABLE: Science (Non) Fiction: 21st Century Medicines

ABSTRACT: Pharmaceutical technology has been advancing in ways that could not have even been imagined as recently as 20 years ago. From “personalized drugs” or pharmacogenomics to 3D printing drug manufacturing techniques, the possibilities for pharmaceutical discovery, development and manufacture are exploding! The speakers round table will explore what’s next in terms of pharmaceutical development opportunities (both real/current and future/imagined), barriers (economic, regulatory, technological, etc.) and how excipient manufacturers/distributors, users, and other stakeholders can help shape their own destinies in exciting yet uncertain times.

 

Speakers:

  • Virginia Wotring - TRI/NIBSP
  • Ahmed Zidan - FDA
  • Geoff Wu, FDA
  • Meera Raghuram - IPEC Americas


Moderated by Linda Herzog (IPEC Americas)

.

Day 1 - Hall B Presentations
Day-One: Presentation 1

A pragmatic approach to Atypical Actives

ABSTRACT: How are atypical actives being managed and regulated by FDA? Overview of activities from the Atypical Actives Coalition, an industry group created to define reasonable requirements and controls which establish regulatory flexibility by FDA, EMA and other global agencies for the use of certain excipients used as atypical actives in drug products. The coalition seeks use of appropriate GMPs based on risk rather than full ICH Q7 API GMP compliance.

Speaker:

Priscilla Z IPEC 

Priscilla Zawislak, IPEC Americas - Currently with The Dow Chemical Company. Priscilla was the Global Regulatory Affairs Manager for Ashland Specialty Ingredients’ Pharmaceutical and Nutrition business and is responsible for regulatory compliance of ASI’s excipient and food additives products globally. Other previous positions include quality and regulatory support for other Ashland (formerly Hercules Incorporated) businesses and Quality Manager at FMC BioPolymer. Priscilla has been a member of IPEC Americas committees since 2001 and is the current Chair of IPEC-Americas, a member of the IPEC Americas Executive Committee and the Vice-President of the IPEC Federation. Priscilla has also participated in the International Food Additives Council since 2007, where she is Vice-Chair of the Board of Trustees. Priscilla earned her Bachelor degrees in Biological Sciences and Chemistry from the University of Delaware.

Day-One: Presentation 2

Direct compressible excipients for ODT formulations: comparison of traditional and innovative solution

ABSTRACT: Orally Dispersible tablets (ODTs) are innovative drug delivery systems used to improve patient compliance. For instance, they are an excellent solution for paediatric formulations, which currently have to be thoroughly considered from a regulatory perspective when developing a new drug product. In addition, ODTs are an interesting alternative for life cycle management and brand differentiation. Currently, most large excipient companies offer ODTs platforms, in order to formulate a wide range of active pharmaceutical o nutraceutical ingredients. In this presentation, traditional direct compressible ingredients for ODTs are compared in terms of critical parameters: hardness; friability; disintegration time. Among them, Omya’s innovative mineral-based solution, Omyapharm, is evaluated. Thanks to its extremely porous structure, excellent compatibility and compressibility properties and high drug load capacity, Omyapharm is an ideal excipient for formulation of ODTs providing extremely fast disintegration.

 

Speaker:

Javier Camargo OMYA

Javier Camargo, OMYA - Dr. Javier Camargo is Pharma Global Business Development Manager at Omya International AG. He did his Postdoctoral research at the Freie Universität Berlin in the field of controlled release oral and injectable pharmaceutical dosage forms. He holds a Ph.D. in Pharmacology and Drug Formulation from Nancy University (France) and a Master degree in Biopharmacy, Formulation and Drug Product Manufacturing from Paris XI University (France). Dr. CAMARGO has more than 13 years’ experience in the Pharmaceutical Industry working as a Formulation Manager and Business Development Manager. One of his fields of expertise is the development of Orally Disintegrating Tablets (ODT)..



Day-One: Presentation 3

Managing the delicate balance between Purchasing Strategy and Quality Requirements

ABSTRACT: The current political environment, social climate, and economic challenges are creating enormous pricing pressures on the finished drug products marketed by the pharmaceutical industry regardless of branded formulation or a generic product.  These extraordinary pricing pressures are applying greater pressure on the profitability of finished drug products.  The need to maintain the profitability of the finished drug product is in turn driving the purchasing or sourcing strategy for lower cost active pharmaceutical ingredients (APIs) and excipients.  The drive for lower cost raw materials is creating the need to maintain a delicate balance between the Purchasing Strategy and the Quality Requirements during the supplier selection process.  The maintenance of the balance between the Purchasing Strategy and the Quality Requirements requires the use of quality risk management tools and a holistic approach to supplier qualification.


Speaker:

Jon Gawlak PAR

Jon Gawlak, PAR Pharmaceuticals - Jon Gawlak is a Certified Manager of Quality/Organizational Excellence, a Certified Pharmaceutical GMP Professional, a Certified Quality Auditor, and a Certified HACCP Auditor through the American Society for Quality.  He is currently a Manager, Compliance and Supplier Quality at PAR Pharmaceutical in Huntsville, AL where he is responsible for supplier quality management and distribution center quality assurance.  Jon has over 27 years of quality experience with over 25 years of Pharmaceutical quality experience including over 21 years of quality management and CMC project management experience.

 


Day-One: Presentation 4

Multivariate analysis to enable product understanding in a QbD era

ABSTRACT: In the pharmaceutical industry excipients are added to pharmaceutical dosage forms for multiple reasons. Commonly, they are included to aid the processing or enhance stability and/or bioavailability of a drug in a patient. Excipients do not exhibit a medical function, but are proven essential in both biopharmaceutical and technical aspects. A key attribute of excipients besides functionality is their consistency. In recent years, the pharmaceutical industry is not only evaluating the lot-to-lot variability but also analyzing excipients from a quality-by-design ‘QbD’ perspective. This as the pharmaceutical industry is more and more researching the effects of variation of critical quality attributes (CQAs) of excipients used in their formulations. This trend is in light of the Food and Drug Administration (FDA) request for understanding the impact of raw material variation on the performance and manufacturability of new drug products[1,2]. Also the principles of QbD described in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use (ICH) guideline Q8 are key[3]. Main objective of this work is to present an excipient supplier’s view on how to support ‘QbD’ using Multivariate Analysis (MVA) utilizing large multi-year excipient data sets. MVA has been successfully applied to (experimental) data, since the 1970’s and are ideally suited to deal with large complex data sets.

 

Speaker:

Bastiaan DFE

Bastiaan Dickhoff - DFE Pharma, joined the T&I department team at DFE Pharma in 2014 in the capacity of Senior Product Application Specialist. Bastiaan has been working on assisting in application development of excipients in area of Oral Solid Dose Forms based upon fundamental knowledge of DFE Pharma’s excipients and advances in powder technology. In addition, he is from a Technology and Innovation point of view responsible for the outcome of external collaborations. Prior to working at DFE Pharma Bastiaan held two (2) roles concerning the effect of powders in food and pharma at RSSL (which is part for Mondelez International (UK)) and prior to that Bastiaan has worked between 2005-2012 for GlaxoSmithKline (UK) in various roles.
Day-One: Presentation 5

MRI traceable protein biomaterials for drug delivery

ABSTRACT: Through centuries of evolution, nature has developed biopolymers capable of folding and assembling into discrete structures with a functional consequence. Inspired by this, our lab focuses on engineering “intelligent” protein materials with entirely new properties and function. In particular, our lab has fabricated protein-derived nanomaterials: helix-elastin block polymers and coiled-coil fibers. We investigate the fundamental self-assembly and molecular recognition capabilities of these systems. More importantly, we are able to harness these structures to interface with small molecule therapeutics, cells and inorganic metals as theranostic agents.

 

Speaker:

Jin Montclare NYU

Jin Montclare - New York University Jin is an Associate Professor in the Department of Chemical and Biomolecular Engineering (CBE) at NYU Tandon School of Engineering (NYU SoE), who is performing groundbreaking research in engineering proteins to mimic nature and, in some cases, work better than nature. She works to customize artificial proteins as biomaterials and catalysts with the aim of targeting human disorders, drug delivery and tissue regeneration. Using multidisciplinary expertise in synthetic biology and protein engineering, these results have already been realized.

Day 2 Hall A Presentations
Day-Two: Keynote Speaker

Longterm Space Flight and its challenges for Pharma and Biotech Industries

ABSTRACT: Coming Soon

 

Speaker:

Virginia Wotring, National Space and Biomedical Research Institute

Virginia Wotring is the Science and Technology Integration Manager (STIM) within the National Space Biomedical Research Institute’s Headquarters, a nonprofit associated with NASA’s Johnson Space Center. She is Assistant Professor at the Center for Space Medicine and the Department of Pharmacology at Baylor College of Medicine and conducts research on the use and actions of medication in the unusual environment of spaceflight. Her currently funded projects include the design and implementation of a new iOS-based app for iPad collection of medication use data directly from crewmembers during spaceflight missions and an examination of potential alterations in pharmacokinetics associated with the spaceflight environment.
Day-Two: Presentation 1

Sugar Spheres: Improving clinical effectiveness with Multiparticulate drug delivery systems

ABSTRACT: The upcoming of biopharmacy in the 1950s resulted in various delayed, prolonged, sustained, extended, repeat action or in one word controlled release formulations. The establishment of those formulations is strongly connected to the development of multiparticulate drug delivery systems as they are especially suitable for achieving controlled release formulations with low risk of dose dumping while offering high flexibility in blending and outstanding reproducibility.
The drug release and thus clinical effectiveness of multiparticulate drug delivery systems depends on various factors including especially the carrier. Sugar spheres are widely used as carriers due to the fact that they combine important characteristics in respect to pharmaceutical technology. Their high sphericity results in unique flow abilities which maximize the usability in filling and dosing processes while their high usability in coating processes offer great opportunities for multilayer applications often used in controlled release formulations. In respect to patient related facts much emphasis is being laid on multiparticulate drug delivery systems showing increased bioavailability, reduced risk of systemic toxicity and reduced risk of local irritation in preference to single unit (monolithic) systems. In conclusion multiparticulate dosage forms were and will be the first choice for the development of demanding controlled release formulations.

 

Speaker:



Philipp Werner, pharm-a-spheres Born in 1987 in Hamburg, Philipp studied food chemistry at the University of Hamburg. He is state certified food chemist and earned a fellowship for his PhD studies on mass spectrometry based Metabolomics. After his work in the Quality department of the ”pharm-a-spheres” GmbH he currently broadens his experience in the quality department of  “Glatt Pharmaceutical Services” GmbH. Philipp Werner is laureate of the Phoenix Pharmacy Science Award 2014 and the Competence in Food Award of the Hamburg School of Food Science.


Day-Two: Presentation 2

Fingerprinting Biologics Drugs Using Drop Coat Deposition Confocal Raman (DCDCR) Spectroscopy

ABSTRACT: Counterfeit drugs pose a significant and fast-growing threat to public health and safety. The incident of counterfeit Avastin® in the United States demonstrates the vulnerability of the supply chain even in developed countries. Government health agencies and pharmaceutical manufacturers are finding ways to fight counterfeit and substandard drugs by identifying them from manufacturing, throughout the supply chain, and eventually when they reach the public in the retail pharmacies.
In 2009, Partnership for Safe Medicines (PSI) reported 1,700 counterfeiting incidences worldwide out of which 60 incidences were biologics, compared to only 10 incidences in 2006. With the recent FDA guideline for biosimilar approval and the counterfeit Avastin® reported in the United States, it is becoming increasingly important that pharmaceutical companies find ways to rapidly fingerprint and detect counterfeit biologics.
Counterfeit biologics are, in a way, difficult to detect since they are administered by injection (white powder or clear liquid) and cannot be distinguished by smell, taste, and appearance. This, along with the sizeable cost, makes counterfeiting biologics an attractive illegal business.
This presentation demonstrates that Drop Coat Deposition (DCD) technique for the biologics drug product sample, coupled with confocal Raman spectroscopy can be effectively used to fingerprint protein based biologics pharmaceuticals. These spectral fingerprints can be used routinely to screen and detect biologics counterfeits.

 

Speaker:

Ravi Kalyanaraman, BMS

Ravi Kalyanaraman is an Associate Director at Bristol-Myers Squibb Company in the Global Analytical Technology group within Quality, Global Manufacturing and Supply. He received his Ph.D. from the University of Idaho in 1995 and did his postdoctoral work at the University of Puerto Rico. He served as a faculty member in the department of chemistry at Bemidji State University in Minnesota from 1996 to 2001. He has been with Bristol-Myers Squibb since 2002. His laboratory work in the past with Bristol-Myers Squibb was primarily in developing, validating and transferring chromatographic and MS methods for Quality control laboratories. In the last eight years he has focused on developing new and novel techniques to detect pharmaceutical counterfeits and raw material identification using vibrational spectroscopic techniques, such as Raman, mid-, and near-infrared (NIR). Currently, he leads a team of analytical scientists that are involved in the forensic and manufacturing investigation for products received from product complaints, corporate security and also from various manufacturing sites including third party manufacturing. Also, his laboratory is currently developing new and novel Raman spectral fingerprint techniques for biologics drugs which can be used to screen counterfeit biologics.

 


Day-Two: Presentation 3

A Review of NSF / IPEC / ANSI 363 GMP Standard for Pharmaceutical Excipients – Findings and Best Practices

ABSTRACT: Two year look back at the status of the NSF / IPEC / ANSI 363 GMP Standard for Pharmaceutical Excipients. What are we seeing as a certification body including best practices around risk assessment, quality improvement, the role of management and feedback from companies that have worked to meet the requirements of this GMP standard?

 

Speaker:

Jim Morris NSF



Jim Morris - NSF Health Sciences - Jim has significant experience in plant operations and has 25 years of industry experience. His areas of focus include Aseptic Operations, Quality Management Systems, specifically in the areas of deviations / CAPA management and change control. Jim’s course and speaking engagements are in the areas of Human Error Reduction, Quality Management Systems, and Emerging Markets. He has held roles with Pfizer, Cilag AG and MassBiologics in the US and Europe. His positions include Deputy Director QA/QC and Regulatory Affairs at MassBiologics, Biologics Director of QA/QC at Cilag AG, and the head of Quality Assurance for Pfizer.



Day-Two: Presentation 4

Understanding the Filmcoating Process

ABSTRACT: The operator of a filmcoating process typically has no control over the properties of tablet core and filmcoating material. Thorough understanding of the flmcoating process is therefore essential for the quality of the final, coated product. This presentation will map out the variables in the coating process and show their interdependence. Guidance will be given for a rational set up of coating processes.

 

Speaker:

TonyCarpanzano JRS

Anthony Carpanzano - JRS Pharma LP Tony Carpanzano worked in pharmaceutical product development for 32 years having held positions in liquids formulation, pre-formulation, exploratory development, technical services and clinical manufacturing, with a major focus on advanced solid dosage form and modified release dosage form development. He holds patents on modified release technologies and abuse-resistant / abuse-deterrent technologies. He has worked in companies including Richardson-Vicks, Procter & Gamble, generic companies, Schein and Copley Pharmaceutical, Purdue Pharma and Penwest, and has spent the last five years working in the excipents industry for JRS Pharma, LP, as Director of R&D. He is also a licensed Pharmacist.

Day-Two: Presentation 5

Medical Marijuana: Improving stability with novel delivery methods

ABSTRACT: Medical Marijuana products can be one of most promising therapeutics in the near future. However, its pharmaceutical use poses many formulation challenges: absortion, dosage variability, strain differences, extraction methods makes it potentially unpredictable. The purest and more effective forms of THC (99.9%) are highly unstable due to oxidation on room air, AXIM Biotechnologies patented a micro-encapsulation technology using gum base that preserves its integrity while ensuring drug delivery in 20 minutes or less (compared to previous efforts where chewing gum retained up to 50% of the APIs since cannabinoids are highly hydrophobic and lipophilic, they were adhering too much to the gum base and not being released properly).

Speaker:

Lekhram Changoer AXIM



Lekhram Changoer, AXIM Biotechnologies - Mr. Lekhram Changoer serves as the Chief Technology Officer of Axim International Inc. He also is Chief Technology Officer of Canchew Biotechnologies, a subsidiary of Medical Marijuana, Inc. Mr. Changoer serves as a Member of Advisory Board at Medical Marijuana, Inc. Mr. Changoer has over 20 years of experience in the area of Sales & Marketing, R&D, Product Development and quality assurance of technical, consumer healthcare and pharmaceutical products. He started his career in 1992. He joined IWC Chemical Products BV, where he was responsible for the development of functional coatings and corrosion inhibitors. Afterwards, he joined Scott Specialty Gases BV, where he was responsible for managing the R&D, QC and QA of functional calibration gases for the petrochemical and automotive Industry. In the area of consumer healthcare products, he worked on the development of cosmetics and medical device products for various retail chains and consumer healthcare companies. At Codi International BV, he was responsible for managing product development. In 1999, he continued his career at Royal Sanders BV in the position of R&D & QC manager and was responsible for the development of cosmetics, medical devices and other healthcare products. In 2002, he joined the Ardoz/NGen group of companies in the position of Managing Director. In 2010, he co-founded APeT BV which focuses on a first of kind patented therapy for psychiatric diseases like ADHD and Autism as a replacement for methylphenidate and analogs. Mr. Changoer has a Bachelor Degree in Analytical/Organic chemistry and Masters Degree in Organic Chemistry.


Day 2 - Hall B Presentations
Day-Two: Presentation 1

Ensuring Patient Safety through Appropriate Impurity Evaluation

ABSTRACT: The presence of undetected impurities in drug products can lead to devastating side effects. For example, Diethylene Glycol (DEG) as an impurity has troubled the drug product industry for nearly 75 years. DEG has been used as a low cost but toxic substitute for glycerin and has directly caused the death of hundreds of children and adults. Tragedies such as these are preventable.
The scope of this presentation is to discuss a scientific, collaborative and unbiased approach to the responsible evaluation of pharmaceutical ingredients. The evaluation must begin internally and extend to the outer boundaries of a drug product’s supply chain.
A weak approach to the evaluation of ingredient impurities can potentially adulterate the entire chain. Investigation of possible impurities begins with a realistic evaluation of a firm’s manufacturing environment including historical factors and inherent properties of the product and its raw materials.
Furthermore, the investigation must include in depth evaluations of raw material manufacturing paths and supplier questionnaires. These factors must be compiled to design a comprehensive impurity profile that, when combined with proper analytical techniques, supports industry’s assurance of patient safety.

 

 

Speaker:

Chad P Biospectra

Chad Pezoldt - BioSpectra, Chad Pezoldt graduated from East Stroudsburg University of Pennsylvania in 2014 with a B.S. in Biochemistry and a B.S. in Chemical Biotechnology. He joined BioSpectra as a Quality Control Analyst performing and developing analytical methods. He was recently transitioned from his role as the Quality Control Manager having extensive oversight of the testing, analysis and approval of Excipients and Active Pharmaceutical Ingredients to Compliance Manager. He is also attending Johns Hopkins University pursuing his M.S. in Regulatory Science in an effort to remain current with the evolving regulatory responsibilities in the pharmaceutical industry.


Day-Two: Presentation 2

Novel Excipients Safety Qualfication - IPEC Americas/IQ Proposal

ABSTRACT: Over the past two years IPEC-Americas and the IQ Pharma Consortium have been working collaboratively on ways to accelerate excipient innovation to help enable the development of safer and more effective drug products in the future. Working groups have been established within IQ and IPEC Americas to actively explore this topic.   This has led to an initial meeting at the FDA in June 2015 and to a recent meeting with FDA on March 10, 2017 where this topic was discussed.
This presentation will outline the need for novel excipients in drug development and the regulatory challenges that currently exist for excipient manufacturers and pharmaceutical companies in developing and utilizing novel excipients in drug formulation.  The need for novel excipients has never been greater to help get beneficial drugs to patients.  However, unless an independent program for FDA review of the safety of novel excipients (outside of the current drug approval system) can be developed which encourages the development and use of novel excipients, few novel excipients will be available in the future to solve the many formulation challenges that exist with current and future APIs or for specific patient populations.  
The presentation will discuss, in general, an approach which will be discussed further with FDA going forward to hopefully result in a workable system for both the industry and FDA.

Speakers:

Nigel Langley, BASF Corporation

David Schoneker, Coming Soon

Nigel Langley, Global Technical Marketing and Technical Service – BASF Pharma Solutions, provides technical support to the pharmaceutical industry and helps solve drug development challenges with BASF's platform solutions. 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).


Day-Two: Presentation 3

Excipients:  Critical Components of the Biomanufacturing Process

ABSTRACT: In order to properly consider excipient requirements for biopharmaceutical drug products, one must incorporate a holistic view of both the functional role of the excipient as well as the process by which excipient chemistries are incorporated into the final drug product.  This session is designed to provide an overview of excipient requirements as a critical component of the biomanufacturing process, including considerations related to functionality, regulatory requirements, critical quality attributes, and factors related to usability.

 

Speaker:

 Jeff Shumway GuestSPK



Jeff Shumway - Millipore Sigma - Coming Soon

Day-Two: Presentation 4

Advanced Polymer Technologies – New Frontiers in Drug Delivery Systems

ABSTRACT: The drug delivery field is rapidly evolving as researchers develop more efficient and convenient ways to administer APIs. In the past two decades, polymers have enabled the introduction of vaginal rings, implantable drug delivery systems, transdermal patches, and other novel combination products. These innovations improve patient compliance, delivering continuous doses of API for weeks or months at a time. They also allow pharmaceutical companies to offer maximum therapeutic effect using less API. This presentation will provide an overview of innovations in the polymeric drug delivery space, including brief case studies of particularly impactful devices that is changing the drug delivery landscape. We will delve into important design considerations when developing combination products, including material choice and formulation options. This talk will also provide insight into the unique value chain and regulatory hurdles associated with manufacturing and gaining approval for combination products in the United States.

 

Speaker:

Meera Raghuram, IPEC Americas

Meera Raghuram - Lubrizol, Manager for global regulatory affairs and strategies at Lubrizol


Day-Two: Presentation 5

Before you click "Print": Regulatory Considerations for 3D printed oral drug products

ABSTRACT: Additive manufacturing/3D printing of oral drug products and medical devices has become more attractive to shift the manufacturing strategies to support individualized medicines of the future. The US Food and Drug Administration (FDA) is charged with protecting and promoting the public health by ensuring these products are safe and effective. To that end, FDA’s recent approval of a 3D-printed drug product in August 2015 (SPRITAM®) introduced a new chapter in pharmaceutical manufacturing for solid oral dosage form. Although the first approved 3D-printed drug product is a solid oral immediate release product, the majority of 3D printing research for oral delivery has been focused on controlled release, targeting and precise delivery for extremely low dose drugs. Various principles of 3D printing of oral drug products could support production of complex and personalized medicines on demand. However, standardization of some aspects of the 3D printed dosage form and associated manufacturing process may be required to achieve this objective. In this presentation, technical and regulatory considerations for development and control of 3D printed oral products will be discussed for various 3D printing technologies.

 

Speaker:

Ahmed Zidan FDA

Ahmed Zidan, FDA CDER, Ahmed S Zidan Ph.D. has earned his Ph.D. degree in Pharmaceutics from the Zagazig University faculty of Pharmacy in 2007 through a scientific mission at School of Pharmacy, Howard University, Washington DC, USA. He has published over 60 peer-reviewed manuscripts, 2 book chapters, and has been invited to give different presentations locally and internationally. Dr. Zidan’s research focuses primarily in the area drug formulations design of both solid and transdermal formulations. It encompasses pediatric dosage forms, nanoparticles, modified release dosage forms, particulate engineering, and scientific underpinnings of Quality by Design utilizing novel Process Analytical Technologies. As a coordinator of graduate studies and research at Faculty of pharmacy of both King Abdulaziz University and Zagazig University, Dr. Zidan serves as the faculty advisor on all matters related to planning and conducting research to study the impact on product quality, changes in bulk drug substances, formulation component and composition, and manufacturing equipment and processes. As a recognized expert, Dr. Zidan participates as an editorial board member and reviewer in different international leading journals. 


Day-Two: Keynote Speaker

Progress made implementing FDASIA and GDUFA, impact on excipients use

 

ABSTRACT: Coming Soon

Speaker:

 

*Guest Speaker, FDA -Coming Soon
 
   
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2016 Key Presentation Topics: Novel Excipients - Technical Innovation - Supplier Management - Research and Development - Biopharmaceutics - EU Guidelines - ANSI Standards - Counterfeiting - New GMP Standards - Traceability - Chemical Screening - Lifecycle Supply - Chain Oversight - Cannabinoid Delivery Technology 
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