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IPA'S ANNUAL STABILITY PROGRAM CONFERENCE
MAY 31 - JUNE 2, 2017 | MONTREAL, CANADA
Preliminary Conference Agenda & Contents:
  • 7:45 AM – 8:30 AM
  • Registration, Networking and Continental Breakfast

  • 8:30 AM – 8:45 AM
  • Chair’s Welcome Note

  • 8:45 AM – 9:45 AM
  • Designing Stability Studies in Support of Early Development

    Geoff Carr, Ph.D., Director, Analytical Development, Patheon Inc.

    Although the ICH Q1 series of Guidelines provide an excellent basis for the design of stability studies, they were essentially developed to deal with Registration Stability programs. However during the development stages for pharmaceutical products it is also necessary to conduct a number of stability studies for which little regulatory guidance is available. So in this session it is intended to provide some examples as follows:
    • Stability Studies for Phase 1

      • Dealing with powder in bottle presentations

      • Importance of appropriate reconstitution media

      • Designing in-use stability studies

    • Studies to Support Blinded Clinical Programs

      • The CMC significance of clinical double blinded studies

      • Dealing with placebo stability

      • Challenges of working with clinical comparators

    • Blinded Clinical Comparator Example

      • o An example will be provided of a situation where we need to establish analytical procedures to support a stability study to support a blinded comparator


  • 9:45 AM – 10:30 AM
  • Forced degradation studies: practical considerations for biopharmaceuticals development

    Christine P. Chan, Ph.D., Principal Scientist, Global Manufacturing Science and Technology, Specialty Care Operations, SANOFI, MA, USA

    Forced degradation studies are very important to demonstrate that analytical procedures are suitable for monitoring stability studies. It is strongly recommended that rational approaches are applied to the design of these studies and this presentation will discuss:

    • Some principles of chemistry that form the basis of the degradation processes of Active Pharmaceutical Ingredients (APIs)

    • The various environmental factors that need to be considered when designing forced degradation studies

    • Examples of some results that have been obtained during forced degradation studies


  • 10:30 AM – 10:45 AM
  • Mid-morning Refreshment Break

  • 10:45 AM – 11:30 AM
  • Quality by Design (QbD) for Combination Products – A Medical Device Perspective

    Laure L. Larkin - MSc, CPP., Associate Director of Stability, Ethicon


  • 11:30 PM – 12:15 PM
  • Stability Testing for Natural Health Products (NHP)

    Speaker information will be post shortly

  • 12:15 PM – 12:30 PM
  • Panel Q & A

  • 12:30 PM – 1:30 PM
  • Networking Lunch

  • 1:30 PM – 2:15 PM
  • Accelerated Stability Modeling

    Kenneth C. Waterman, Ph.D., President, FreeThink Technologies, Inc.

    • Using science to set shelf-life rapidly

    • How to assign shelf-life when nothing happens

    • Regulatory response to using accelerated stability modeling approaches: latest update


  • 2:15 PM – 3:00 PM
  • Protein formulations and their stability challenges

    Nila Das, Ph.D., Senior Research Investigator, Bristol-Myers Squibb

    This presentation will focus on the unique structural features of proteins, their degradation pathways, and the presently employed approaches to mitigate the stability challenges at the formulation level, distribution channels and with the end user. All these challenges will be discussed in context to case studies derived from drug product development phase and commercial arena.


  • 3:00 PM – 3:15 PM
  • Mid-Afternoon Refreshment Break

  • 3:15 PM - 4:00 PM
  • Stability Programs for Leachable Impurities

    Wayland Rushing, Ph.D., Senior Scientific Advisor, EAG Laboratories

    Leachables are impurities which originate from contact surfaces (typically the final container/closure system). Performing leachable stability studies can be challenging and is generally less understood than for typical drug product related impurities. ICH stability requirements are not directly applicable to leachables. This presentation will cover: what are leachables and where do they come from, what are the similarities and difference to drug product related impurities, what are the method and stability requirements.


  • 4:00 PM – 4:45 PM
  • User Requirements & Implementation of a Risk Based, Compliant Stability Management System based on Health Canada Data Integrity Guidelines

    Parsa Famili, President and CEO, Novatek International

    • Benefits of Compliant Stability System

    • Stability System Components

    • Stability User Requirements Based on Inherent Risks

    • Regulatory “DATA Integrity”

    • Vendors and Supplier Qualification

    • Implementation and Validation Process and Timeline

    • Preparation for Go-Live


  • 4:45 PM - 5:30 PM
  • Panel Q & A
    Interactive Round Table Discussions

  • 5:30 PM
  • Conclusion of Day 1

    Note: Agenda is subject to change without notice. Please check back regularly for updates.

  • 7:45 AM – 8:25 AM
  • Continental Breakfast and Exhibition Viewing

  • 8:25 AM – 8:30 AM
  • Chair’s Welcome Note

  • 8:30 AM – 9:15 AM
  • Antibody Drug Conjugates - A Peek into their Challenges to Successful Commercialization

    Nila Das, Ph.D., Senior Research Investigator, Bristol-Myers Squibb

    Antibody-drug conjugates (ADCs) have witnessed a lot of interest as a drug targeting technology in recent years for the treatment of cancer. This presentation will focus on the unique structural characteristics of ADCs and their degradation pathways. The successful commercialization of ADCs will be discussed in context to associated challenges at the levels of conjugation, formulation and manufacturing, and stability and analytical, citing case studies.


  • 9:15 AM – 10:00 AM
  • Development and Validation of a Stability Indicating Method

    Peter I. Tattersall, Ph.D., Principal Scientist, Chemical & Synthetic Development, Pharmaceutical Development, Bristol-Myers Squibb Company

    The small molecule stability indicating HPLC method is the cornerstone of a registrational stability study and release testing of API and Drug Products. Thorough method development requires a number of areas of study including stability indicating selectivity based on potential degradation profiles obtained from previous knowledge and a detailed forced degradation study. A quality by design approach to development is recommended to ensure the method is fit for purpose (FFP), robust and simple to transfer around the world. Validation should be performed according to ICH Q2 and formally documented with both a protocol and a report.

    The outline of the presentation is:

    • Industry guidance and recent trends

    • Internal practices

    • Method development / validation workflow

      • Forced Degradation Studies

      • ATP / QBD

      • Validation / procedure documentation

    • Illustrative examples including:

    • QBD development through to registrational stability

    • TT approaches/experiences


  • 10:00 AM – 10:15 AM
  • Mid-morning Refreshment Break & Exhibition viewing

  • 10:15 AM – 11:00 AM
  • Defining analytical testing & stability program for biologics

    Christine P. Chan, Ph.D., Principal Scientist, Global Manufacturing Science and Technology, Specialty Care Operations, SANOFI, MA, USA

    Protein therapeutics are challenging to develop due to complexity of the molecular structure as well as the manufacturing process. The Quality-by-Design approach provides a framework for integrated development of analytical testing and stability monitoring programs. This talk discusses some key elements of analytical control strategy including considerations for defining stability programs:

    • Critical quality attributes (CQAs) assessment & product quality profile

    • Analytical control strategy and test methods selection

    • Managing stability testing program: challenges & some examples


  • 11:00 AM – 11:45 AM
  • Analytical method transfers: Practice and pitfalls

    Wayland Rushing, Ph.D., Senior Scientific Advisor, EAG Laboratories

    Analytical method transfers are a very common occurrence in our industry. They can range from simple to complex in nature and unfortunately can be a source of regulatory headaches. All too often the task is approached as a check-box exercise without proper planning resulting in failures that are preventable. This presentation will cover common pitfalls that cause method transfer failures, how to decide what type of method transfer makes sense for your study, and how to implement a fail-safe communication and transfer plan that will help keep your program moving. Example case studies will be presented as well.


  • 11:45 AM - 12:00 PM
  • Panel Q & A

  • 12:00 PM – 1:00 PM
  • Networking Lunch & Exhibition viewing

  • 1:00 PM – 1:45 PM
  • Accelerated Tablet Dissolution Stability

    Kenneth C. Waterman, Ph.D., President, FreeThink Technologies, Inc.

    The Accelerated Stability Assessment Program (ASAP) approach of assigning storage times to hit the dissolution failure point at a range of temperatures and relative humidities (RHs) below the critical relative humidity (CRH) at each storage condition can be used to model the dissolution and disintegration stability of immediate-release tablet products. Ambient condition stability could be determined based on a modified Arrhenius equation using the inverse of the failure times in place of rate constants. This use of failure times, rather than a rate of change, was critical for modeling dissolution and disintegration stability because the onset of the failures was sudden. In both cases, dissolution and disintegration failures were correlated with each other, but with greater storage times needed to effect destabilization for dissolution than disintegration.


  • 1:45 PM – 2:30 PM
  • Matrixing and Bracketing in Stability Sampling Plans

    Sean D. Benedik, Principal and Subject Matter Expert, Aliquo Pharma Consulting Inc.

    Sampling plan decisions made during stability protocol design have a big impact on laboratory operations, data analysis, and sample storage requirements. In this segment we will discuss the matrixing and bracketing approach to rationalizing sampling plans that maximize logistical and data efficiency.

    Les plans d’échantillonnage élaborés pendant le design des protocoles de stabilité ont un grand impact sur les opérations du laboratoire, l’analyse des données et l’entreposage des échantillons. Nous discuteront dans ce segment des justifications de plans d’échantillonnage utilisant les approches matricielles ainsi que le ‘bracketing’.


  • 2:30 PM – 2:45 PM
  • Mid-Afternoon Refreshment Break & Exhibition viewing

  • 2:45 PM – 3:30 PM
  • Considerations in the determination of shelf life: a PQRI perspective
    Patrick Forenzo, Senior Fellow / Stability Expert, Novartis Pharmaceuticals Corporation
    • About the Working Group

    • Defining Shelf Life

      • Harmonized Guidance

      • Disharmonized Interpretation

    • Terminology and Distributions

    • It’s All about Risk

      • Shelf Life and Risk

      • Characteristics of a “Good” Shelf Life Estimation Procedure

      • ICH and Beyond


  • 3:30 PM – 4:15 PM
  • Criteria for Establishing Shelf Life of Cosmetic Products
    Karl F. Popp, R. Ph., Founder, KPopp Consulting, LLC.
    Last year’s presentation encompassed the world of unclear regulations and many, many opinions on the stability testing of cosmetics. The question left unanswered was “What are the criteria for setting a use before date, expiry date, and /or period after opening for a cosmetic product?”
    This presentation will discuss the salient aspects of establishing a point in time where a cosmetic product is no longer “suitable” to be in the marketplace. What tests are critical? What is an acceptable result? How long should a cosmetic product be stability tested? Do you need to prove your product works as claimed when first produced? at the end of its labelled life? when the package is full, half full, or almost empty? Is there a correlation between months of acceptable accelerated stability of a cosmetic product and setting of an expiry date?
    Shelf life of a product is also impacted by many factors such as distribution and shipping, store presence, and, of course, how the consumer stores and uses the product.
    Key regulatory criteria for a cosmetic product are that (a) they must be safe to use, (b) they must not be adulterated and (c) they must not misbranded. But, where does shelf life come into view? Industry practices will be shared along with examples for discussions purposes.

  • 4:15 PM – 5:00 PM
  • ICH Q1E for estimating shelf life- shelf life statistics for non-statisticians
    Patrick Forenzo, Senior Fellow / Stability Expert, Novartis Pharmaceuticals Corporation
    • Demystify the statistical terms and concepts related to Shelf Life statistics

    • Discuss poolability tests and resulting models using examples to demonstrate the concepts

    • Cover examples of the effects of length of available study data and variability on the estimated shelf life

    • Explore the ICH Q1E decision tree and its use in establishing the proposed shelf life vs the statistically estimated shelf life


  • 5:00 PM – 5:30 PM
  • Panel Q & A
    Interactive Round Table Discussions

  • 5:30 PM
  • Conclusion of Day 2

    Note: Agenda is subject to change without notice. Please check back regularly for updates.

  • 7:45 AM – 8:25 AM
  • Continental Breakfast and Exhibition Viewing

  • 8:25 AM – 8:30 AM
  • Chair’s Welcome Note

  • 8:30 AM – 9:15 AM
  • Integrating Pharmaceutics, Analytics, and Biology to Develop Stable Biologics and Biosimilars

    Zahra Shahrokh, Ph.D., CMC Consultant, ZDev Consulting Chief Development Officer, STC Biologics, Inc.

    Development of a stable product begins with the molecule’s design. Forgotten stability profiling often leads to the selection of a drug candidate that faces development hurdles and possibly barriers to commercialization. For Biosimilars, where the molecule’s design is fixed and little is known of the originator’s drug substance stability characteristics, unique challenges arise, requiring creative process engineering solutions.

    In this talk case examples of stability challenges of biologics and biosimilars will be presented, with solutions that did or could have prevented slowed progress. An outline of best practices will be presented which integrates analytics, biology, and pharmaceutics.


  • 9:15 AM – 10:00 AM
  • Analytical Investigations on GMP Release / Stability Testing Out of Alert, Trend and Specification Results

    Peter I. Tattersall, Ph.D., Principal Scientist, Chemical & Synthetic Development, Pharmaceutical Development, Bristol-Myers Squibb Company

    Analytical investigations are performed on out of alert, trend and specification (OOA, OOT and OOS) results as part of due diligence and policy for release of clinical/manufacturing material and formal stability studies. These investigations are part of a systematic framework of quality assurance that is fundamental to the quality and integrity of pharmaceutical products.

    The outline of the presentation is:

    • Industry guidance on OOA / OOT / OOS investigations

    • Investigation workflow

    • Steps for analytical investigations

    • Root Cause, CAPAs, next steps and trending

    • Setting alert limit criteria for registrational studies

    • Case Studies from stability / reapproval testing

    • Situation appraisals

    • Investigation path and conclusions

    • Learnings and corrective actions


  • 10:00 AM – 10:15 AM
  • Mid-morning Refreshment Break & Exhibition viewing

  • 10:15 AM – 11:00 AM
  • Design, Implementation and Calibration of GMP Controls for ICH Rooms

    Glen McCarthy, P.Eng., Founder and President , Labworks International Inc.

    Jacques-Marcoux, Viking Technical Services inc.

    Critical to the successful operation of ICH rooms are controls which meet the requirements of GMP / ISO guidelines while being resilient and easy for operators to use correctly. This presentation will cover the design and operational requirements of control system for ICH Chambers with a focus on regulatory compliance, design for certification, redundancy, and maintenance. There will be discussion on the calibration of systems to meet ISO 17025 and GAMP Best Practice Guidelines.


  • 11:00 AM – 11:45 AM
  • Statistical Analysis (Stability Data)

    Speaker information will be post shortly

  • 11:45 AM – 12:00 PM
  • Panel Q & A

  • 12:00 PM – 1:00 PM
  • Networking Lunch & Exhibition viewing

  • 1:00 PM – 2:00 PM
  • Interactive Exercise – Interpretation of Stability Data

    Geoff Carr, Ph.D., Director, Analytical Development, Patheon Inc.

    In accordance with ICH Guidelines on Stability Studies, we need to present data in an orderly manner which is generally achieved in the form of trend tables. Statistical analysis is then applied to generate a proposal for product shelf life. However, as well as all this, a report should be generated that provides interpretations of the analytical results obtained. This session will provide an exercise in data interpretation

    • Trend tables will be provided for up to 12 months real time data and 6 months accelerated data for a tablet product in 2 different packs

    • Working in Groups the challenge will be to identify various results that require further attention or investigation

    • Groups will be invited to suggest explanations for these observations

    • Recommendations should then be proposed for ways to continue development to achieve a product that is suitable for marketing


  • 2:00 PM – 2:45 PM
  • Testing for Packaging Failures during Stability Testing of Consumer Products

    Karl F. Popp, R. Ph., Founder, KPopp Consulting, LLC.

    Consumers of non-prescription and cosmetic products expect the product- package combination they purchase not to fail, especially when stored and used under the labelled conditions. We, as consumers, expect no less. The challenge to the product development scientist is selecting which tests to complete during the developmental product stability study to ensure data generated supports package will remain intact and function properly during its life cycle.

    The types and number of tests one needs to perform on a package during stability testing depends on the package construction, design, directions for use, labelling, and storage conditions, both at retail and in the home. Packaging from glass and plastic bottles, foil and laminated pouches, to aerosols in glass, steel and plastic tubes, to individual use packs in a variety of materials have led to numerous challenges, and opinions, as to what confirms a product is acceptable to place on the market. No regulatory statute currently exists that speaks directly to package defects or what testing should be performed on a specific product-package configuration.

    This presentation will discuss common tests used to verify the integrity and functionality of package formats common to both non-prescription and cosmetic products, and to some that are unique to their unique product category.


  • 2:45 PM – 3:00 PM
  • Mid-Afternoon Refreshment Break & Exhibition viewing

  • 3:00 PM – 3:45 PM
  • Enhancing Shelf Life and Simplifying Package Design and Production for Transdermal and Oral Solid Dose Drug Delivery with Engineered Polymers for Head-Space Management
    Craig Voellmicke, Vice President, Business Development, Advisory board of the Active & Intelligent Packaging Industry Association (AIPIA) CSP Technologies
    Transdermal patches and oral solid doses are two very different drug delivery technologies that can face very similar packaging head-space challenges that impact shelf life; moisture, oxygen, VOC's and other gases can interact with drug product of either technology and impact stability.
    Engineered polymers utilized within a pouch, blister packaging and standard bottles can be an effective and efficient head-space management solution, addressing a wide range of desiccant and scavenging needs, without the use of adhesives, purging, or drop-in sachets and canisters, among other benefits.

  • 3:45 PM – 4:30 PM
  • Leveraging Stability Data for Cold Supply Chain Quality

    Sean D. Benedik, Principal and Subject Matter Expert, Aliquo Pharma Consulting Inc.

    Product knowledge and cycling stability data can save batches from unfavorable outcomes when excursions happen. This talk will discuss acquiring and interpreting the information you need to make science-based decisions.

    Une bonne compréhension de votre produit et des données de stabilité aux extrêmes de température peuvent prévenir des dispositions de lot défavorables. Nous discuteront l’acquisition et l’interprétation de l’information nécessaire pour prendre des décisions scientifiques.


  • 4:30 PM – 4:45 PM
  • Panel Q & A, Wrap Up

  • 4:45 PM
  • Conclusion of Conference

    Note: Agenda is subject to change without notice. Please check back regularly for updates.

SILVER SPONSOR
  • Intertek


BRONZE SPONSOR
  • SGS


EXHIBITORS & MEDIA SPONSORS
  • Labworks
  • Sotax
  • Novatek


  • Branal Scientific
  • AAPS