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Attend the only conference to offer you access to the pharma and specialty chemical industries’ most influential thought leaders and innovators. schedule.cphinorthamerica.com schedule.informex.com FEATURED SESSIONS: FEATURED SESSIONS: • Innovative Breakthrough Technologies for Drug Targets and Emerging Pathways • Formulation Trends for Topical Dosage Forms • Regulatory Update on US Toxic Substances Control Act-Current Interpretations and the Impact on Business • Case Studies in API Continuous Processing • Discover the Latest Innovations in Green Chemistry • Economies of Capability vs. Economies of Scale – Advancing CMO Decisions • How to Create a Start-Up Environment in a Traditional Company • Utilizing Novel Technology to Improve Drug R&D Productivity and Accelerate the Development of Drug Delivery and Formulation • Plant Operations to Efficiently Meet Regulatory Requirements for Multiple Markets • The Latest Developments in Chiral Chemistry HEAR SPEAKER PERSPECTIVES FROM: AbbVie • BASF Pharma Solutions • BioSpectra • Capsugel • Codexis • Deloitte Consulting • Eli Lilly • GSK • InnoSyn • Lonza Ltd • Merck • Catalent Pharma Solutions • MIT • Pfizer Center One • Provivi • Sandoz • Seattle Genetics • And more! CPhI Connect Keynote Speaker Ronald T. Piervincenzi, Ph.D. Chief Executive Officer, U.S. Pharmacopeial Convention CPhI Connect Keynote Speaker Magid Abou-Gharbia, Ph.D., FRSC Associate Dean for Research, Director Moulder Center for Drug Discovery Research, School of Pharmacy,Temple University May 16-18 2017 Pennsylvania Convention Center Philadelphia, PA, USA Powered By: InformEx Connect Keynote Speaker John Foley CEO, ORG Chemicals Holding, LLC (KMCO LLC, KMTEX LLC) Save an extra 20% off when you use Promo Code CONF20 by May 8. Go to cphinorthamerica.com/register to save today! Sponsored By: Platinum Media Partner: Advancing Development & Manufacturing INTERNATIONAL PharmTech.com The Science & Business of Biopharmaceuticals One pass. Two conferences. Three days. 80+ hours of industry-leading educational content. Introducing the Connect Conferences! Featuring two complete programs, CPhI Connect and InformEx Connect, these forwardthinking sessions help industry professionals navigate a rapidly evolving regulatory, strategic and technological landscape. Registering for one program includes access to all eight tracks - 44+ sessions in total! Coming to Philadelphia in May 2017 is the only event which offers you access to the complete North American pharmaceutical supply chain – CPhI North America – alongside the leading fine & specialty chemical event – InformEx. Source business solutions from 450+ exhibitors Network with 6,000+ attendees See the latest innovative products and services earn from the industry’s most forward-thinking movers L and shakers – on the show floor or at one of the 44+ Connect Conference sessions! Where the Industry Meets to Foster Transformative Innovation in Drug Development, Manufacturing and Outsourcing TRACKS INCLUDE: Drug Development Quality / Regulatory Drug Manufacturing Outsourcing Who Should Attend? Mingle with key stakeholders across drug development, drug manufacturing, outsourcing and specialty chemical sectors including: C-Level Executives, VPs, Directors, and Managers responsible for: • Manufacturing • Drug Development • Procurement • Outsourcing • Formulation • Regulatory Affairs • Quality • Sourcing • Process Analytical Technology As well as: • CROs • CMOs • Regulatory Consultants The Future for Growth and Innovation in the Fine and Specialty Chemicals Industry TRACKS INCLUDE: The Business of Chemicals AgroChem Spotlight Regulatory Spotlight ChemInnovation Who Should Attend? Meet key stakeholders from the fine and specialty chemicals markets including agrochemicals, pharmaceutical, energy and personal care including: C-Level Executives, VPs, Directors, and Managers responsible for: • Manufacturing • R&D • Tolling • Procurement • Purchasing • Research • Sourcing • Outsourcing • Quality Connect Conferences: Two market-leading educational programs focused on innovation and trends in the North American pharmaceutical and specialty chemicals markets. Agenda at a Glance TUESDAY MAY 16, 2017 8:00 AM - 9:00 AM Join your colleagues for breakfast, included with all Connect Conference Passes! 9:00 AM – 12:00 PM CPhI Connect Opening Keynote InformEx Connect Opening Keynote CPhI Opening Keynote: Discovery of Innovative InformEx Opening Keynote: Accelerating Value Therapeutics: Today’s Realities Creation via Innovation and Transformation: Opportunity and Tomorrow’s Vision beyond the Laboratory Beaker 12:00 PM – 2:00 PM Join your colleagues for lunch, included with all Connect Conference Passes! 2:00 PM – 3:30 PM CPhI Connect InformEx Connect CHEMINNOVATION Powered by DRUG DEVELOPMENT Powered by How to Create a Start-Up Environment in a Traditional Innovative Breakthrough Technologies for Drug Targets Company and Emerging Pathways DRUG MANUFACTURING Powered by A Case Study in API Continuous Processing (Part I) DRUG DEVELOPMENT Sponsored by Accelerating Your Product’s Development: Practical Considerations from Pre-Clinical through Commercial 4:00 PM – 5:30 PM CPhI Connect DRUG DEVELOPMENT Sponsored by Formulation Trends for Topical Dosage Forms DRUG MANUFACTURING Powered by A Case Study in API Continuous Processing (Part II) InformEx Connect CHEMINNOVATION Powered by The Latest Developments in Chiral Chemistry REGULATORY SPOTLIGHT Chemical Regulation in the US - Toxic Substances Control Act (“TSCA”) Reform – Current Interpretations and the Impact on Business QUALITY / REGULATORY Navigating GDUFA – Reduce Cost and Accelerate Delivery 6:00 PM – 8:00 PM Mix and mingle with your peers at the Welcome Reception, taking place at the Pennsylvania Academy of the Fine Arts (PAFA), a National Historic Landmark and an important part of Philadelphia’s architectural heritage. Save an extra 20% off when you use Promo Code CONF20 by May 8. Go to cphinorthamerica.com/register to save today! WEDNESDAY MAY 17, 2017 7:30 AM - 8:30 AM Join your colleagues for breakfast, included with all Connect Conference Passes! 8:30 AM – 10:00 AM CPhI Connect InformEx Connect CHEMINNOVATION Powered by DRUG DEVELOPMENT Powered by Discover the Latest Innovations in Green Chemistry Advances in Solubility and Bioavailability DRUG MANUFACTURING Economies of Capability vs. Economies of Scale – Advancing CMO Decisions AGROCHEM SPOTLIGHT Food Sustainability Trends and Outlook OUTSOURCING Supply by Design – Global Good Supply Practices (GSPs) for Your Success DRUG MANUFACTURING Powered by Packaging Innovation 10:30 AM – 12:00 PM CPhI Connect DRUG DEVELOPMENT Legal and Policy Strategies for Drug Companies in Today’s Global Market InformEx Connect THE BUSINESS OF CHEMICALS The Changing Dynamics of Outsourcing: Strategies, Essential Elements, Advantages and Limitations DRUG MANUFACTURING The Latest Developments on Global Serialization Requirements and Implementation AGROCHEM SPOTLIGHT Help Wanted! Herbicide and GM Herbicide Trait Treadmills are Too Slow OUTSOURCING Technology Transfer Risk Mitigation Practices DRUG MANUFACTURING Process Development and Quality by Design Case Study 12:00 PM – 2:00 PM Join your colleagues for lunch, included with all Connect Conference Passes! 2:00 PM – 3:30 PM CPhI Connect InformEx Connect THE BUSINESS OF CHEMICALS DRUG DEVELOPMENT Making the Business Case for Occupational Health & Utilizing Novel Technology to Improve Drug R&D Safety Productivity and Accelerate the Development of Drug Delivery and Formulation CHEMINNOVATION DRUG DEVELOPMENT Drug Product Development and Biophysical Characterization of Protein Therapeutics OUTSOURCING Sponsored by Determining the Value of Re-Shoring Drug Ingredient Manufacturing DRUG MANUFACTURING Powered by Drug Manufacturing: Quality Risk Assessment Management and Supply Chain Sourcing Strategies for APIs and Excipients Save an extra 20% off when you use Promo Code CONF20 by May 8. Go to cphinorthamerica.com/register to save today! Continuous Manufacturing of Fine Chemicals WEDNESDAY MAY 17, 2017 CONT. 4:00 PM – 5:30 PM CPhI Connect DRUG DEVELOPMENT Understanding Critical Excipient Properties to Ensure Consistent Quality of Amorphous Solid Dispersion and Extended-Release Products InformEx Connect THE BUSINESS OF CHEMICALS Catalyzing Innovation in the Chemicals Industry by Maximizing R&D Tax Credits DRUG MANUFACTURING Continuous Solid Dose Manufacturing – Analytics to Support the Supply Chain DRUG DEVELOPMENT Pediatric Formulation Development Innovation DRUG MANUFACTURING Continuous Manufacturing of (Bio)Pharmaceuticals THURSDAY MAY 18, 2017 7:30 AM - 8:30 AM Join your colleagues for breakfast, included with all Connect Conference Passes! 8:30 AM – 10:00 AM CPhI Connect InformEx Connect THE BUSINESS OF CHEMICALS Powered by DRUG DEVELOPMENT USP <232> Elemental Impurities -Limit chapter Implement Novel Container/Closure Technologies Requirements Update - Best Practices and Standardized DRUG MANUFACTURING Methods for Metals Testing Applied Biocatalysis for the Synthesis of Industrial CHEMINNOVATION Relevant Pharma Compounds Nanotechnology DRUG DEVELOPMENT Discover the Latest in Inhalation Product Development and Regulatory Standards 10:30 AM – 12:00 PM CPhI Connect InformEx Connect THE BUSINESS OF CHEMICALS DRUG DEVELOPMENT Powered by Circular Economy Bioconjugate and Biotherapeutics: Present and Future DRUG MANUFACTURING Pharmaceutical Impurities THE BUSINESS OF CHEMICALS NDAs - Legal Strategies to Mitigate Risk QUALITY / REGULATORY The World of Quality Metrics – Yesterday, Today and Tomorrow 12:00 PM – 2:00 PM Join your colleagues for lunch, included with all Connect Conference Passes! Save an extra 20% off when you use Promo Code CONF20 by May 8. Go to cphinorthamerica.com/register to save today! Drug Development Track Innovative Breakthrough Technologies for Drug Targets and Emerging Pathways Tuesday, May 16, 2017, 2:00 PM – 3:30 PM Powered by Peter D. Senter, Ph.D., Vice President, Chemistry and Senior Distinguished Fellow, Seattle Genetics A review of innovative technologies for drug targets including gene editing/CRISPR, immunotherapy, gene therapy and antibody drug conjugates. Accelerating Your Product’s Development: Practical Considerations from Pre-Clinical through Commercial Tuesday, May 16, 2017, 2:00 PM – 3:30 PM Sponsored by Ron Vladyka, Director of Research & Development, Catalent Pharma Solutions Stephen Tindal, Director of Science & Technology, Catalent Pharma Solutions Kunal Jaiswal, Vice President, Global Strategic Development Solutions, Catalent Pharma Solutions I. DEVELOP: Getting your product to Phase I quickly and efficiently (30 min) • Overcoming challenges facing developers: molecule, money, market approvability • Biggest known challenges for drug formulation • Best practices for optimizing your API for formulation • Latest thinking on strategies for poorly soluble molecules • Utilizing an integrated, parallel screening approach for preclinical development II.DELIVER: Keeping your Clinical Trial on Track from Phases to Finish (30 min) • Scrutinizing partner selection: what capabilities do you need? • Managing products with special needs: potent and cold-chain handling • Improving efficiency with demand-led clinical supply III.SUPPLY: Tools and Technologies to Get to Dose Form and Scaled for Launch (30 min) • Scale up for success • Flexible manufacturing – technologies, potency, volumes • New Product Introduction Excellence – best practices for product launch For the most up-to-date program, go to schedule. cphinorthamerica.com or schedule.informex.com. Formulation Trends for Topical Dosage Forms Tuesday, May 16, 2017, 4:00 PM – 5:30 PM Sponsored by Norman Richardson, Global Technical Development and Marketing Manager, Skin Delivery, BASF Pharma Solutions Amy Ethier, PhD, Formulation Scientist, Skin Delivery, BASF Pharma Solutions In topical drug formulations the selection of excipients, the amount of each excipient and the complexes and phases that they form in the formulation are collectively responsible for all of the performance attributes of the final product. By their physicochemical nature different classes of topical excipients (e.g. high melting point lipidic materials, oils, hydrophilic fluids, linear and globular polymers, nonionic and anionic and cationic emulsifiers, etc.) perform different functions in the topical dosage form. Excipients contribute to or influence viscosity, spreadability, aesthetic properties, API solubilization and/or solid state, as well as the physical and chemical stability of the formulation, dermal drug permeation and many other attributes. Formulators seek to leverage excipient functionalities to develop products with specific performance attributes that (1) allow for aesthetically acceptable application to the treatment area, (2) deliver the active to the appropriate location (e.g. surface of the skin, epidermis, dermis, systemic, etc.), (3) enable the active to permeate the stratum corneum barrier, when necessary, (4) prevent irritation and maintain mildness throughout the use of the product and (5) maintain chemical and physical stability of the product throughout its shelf life. To achieve these objectives a variety of dosage forms are available to the topical drug formulator (e.g. emulsions, gels, ointments, foams, solid sticks and balms, sprays, patches, etc.). How excipients are chosen to achieve various dosage forms will be discussed. A hands-on, interactive session will explore the different dosage forms that are available in the market place. Some examples from the BASF Global Skin Delivery Lab will also be available for evaluation. Learn how and why to select a specific dosage form including: I. What are the design criteria for your topical formulation • Ease of application • Good sensory properties • Drug delivery options • Retain on surface of skin • Deposit into epidermis, scalp, nail or mucosal membrane Drug Development Track • Penetrate skin for systemic delivery • Controlled release • Mildness, impurities and support of healing of compromised skin • API solubility, stability and compatibility and dosage strength II.What dosage forms are available and which one should you use? • Emulsions (biphasic creams and lotions) • Gels (single phase aqueous semi-solid) • Foams (aerosol and non-aerosol, aqueous and anhydrous) between capitalism, good economics, corporate interests, and altruism? Do these paradigms apply to both established and emerging markets? What are the legal frameworks surrounding these decisions? What are the ethical debates underpinning these decisions? What are the legal ramifications of approaching it incorrectly? I. Drug pricing: • How is it set? • Is it set accurately? • Is it set appropriately? • What do those even mean? II.Why does levothyroxine matter? Reimbursement. • Ointments (hydrophobic and hydrophilic) • What’s happening with reimbursement in 2017? • Solid sticks and balms (hydrophobic and hydrophilic) • What does a new presidential administration mean for drug prices? • Film forming topicals •Sprays •Patches III.Interactive Session Participants will observe, touch, feel and evaluate the application and performance of products from the market place and placebo dosage forms from the lab. In some cases systematic sensory evaluations may be employed. III.The Heinz Dilemma • Separating ethics and morals from business, enterprise, and economics IV.Interactive Exercise • Develop regionally-specific pricing models to create a visual worldwide market that encourages competition, growth, and sustainability. Advances in Solubility and Bioavailability Utilizing Novel Technology to Improve Drug R&D Productivity and Accelerate the Development of Drug Delivery and Formulation Wednesday, May 17, 2017, 8:30 AM – 10:00 AM Powered by Wednesday, May 17, 2017, 2:00 PM – 3:30 PM Moderator: Sunny Bhardwaj, Senior Scientist, Merck Panelists: Elanor Pinto-Cocozza, NA Technical Specialist, Science and Technology for DDS & OFSS, Catalent Pharma Solutions Rodney Ketner, Director, Pharmaceutical Business Development - Global Accounts, Capsugel D. Jeffery Liu, PhD, MBA, MS, Director/Clinical Development Head, ID/IIDPH, RD, GSK I. Explore and apply new technology to accelerate drug development pipeline and develop a novel formulation II.Delivering benefit to the patient while creating novel formulations III.Translating the technology from use in R&D to clinical output Discussion to include the following topics: Legal and Policy Strategies for Drug Companies in Today’s Global Market • Drug delivery and formulation for the future - challenges and opportunities Wednesday, May 17, 2017, 10:30 AM – 12:00 PM • Preparing for new drug delivery strategies Thomas Fox, Principal, Advanced Compliance Solutions Ben Locwin, PhD, MBA, MS, President, Healthcare Science Advisors & Former Director, Biogen This session is centered directly on the diametricallyopposed viewpoints of strategic drug pricing. How are prices set? How should they be set? What’s the balance For the most up-to-date program, go to schedule. cphinorthamerica.com or schedule.informex.com. • The evolution of formulation challenges for improved optimum outcome Drug Development Track Drug Product Development and Biophysical Characterization of Protein Therapeutics Wednesday, May 17, 2017, 2:00 PM – 3:30 PM Haripada Maity, Ph.D., Research Advisor, Eli Lilly and Company Arvind Srivastava, Ph.D., Research Advisor, Formulation Development, CMC Development, Eli Lilly and Company Protein instability may occur at different stages of development, including bioprocessing, purification, formulation, and during storage and delivery. Enthalpyentropy compensation makes protein structure to be marginally stable and it is stabilized by higher enthalpic contribution to the free energy of unfolding. A major physical degradation pathway of a therapeutic protein during its life cycle is aggregation which strongly depends on both conformational (thermodynamic) and colloidal stabilities. Higher free energy of unfolding corresponds to higher conformational stability and higher colloidal stability of a protein solution corresponds to higher protein-protein repulsive electrostatic interactions compared to attractive interactions (Derjaguin-Landau-VerweyOverbeek theory). The primary objective of a robust formulation development is to reduce the rate of change of both physical and chemical degradation of a protein by optimizing conformational and colloidal stabilities. Uncluttered experimental strategy using both biophysical and analytical methods and correct understanding of complex data are critical for optimal formulation development and characterization of proteins. In addition, dosage form selection, container closure integrity, and in-use stability are critical for the overall drug product development. This presentation will address the following: • Stability challenges in protein therapeutics • Rational formulation development strategy • Selection of biophysical and analytical methods • Utility of these multidimensional approaches and the connectivity of these data in terms of thermodynamic/ conformational stability and kinetic stability of protein. • Characterization of Higher Order Structure (HOS) and its effect on protein stability • Dosage form selection • Container closure selection and drug wastage • Temperature excursion • In-use stability Understanding Critical Excipient Properties to Ensure Consistent Quality of Amorphous Solid Dispersion and Extended-Release Products Wednesday, May 17, 2017, 4:00 PM – 5:30 PM Yihong Qiu, Oral Drug Products, Manufacturing Science & Technology, AbbVie, Inc. Assessing variation of critical excipients properties is an essential element in: I. Developing a product of consistent quality, II.Establishing appropriate specifications to assure quality and, III.Building robustness into manufacturing process, especially for dosage forms based on more sophisticated drug delivery technologies, such as extended-release and amorphous solid dispersion systems. This presentation intends to examine the crucial role excipients and their “natural” variability may play in affecting product quality and highlight the importance of understanding variability of key functional excipients and continuous learning & improvement through application of the new knowledge to ensure consistent product quality and performance and minimize patient risks in commercial manufacturing. An overview of the basic principles and key functional excipients of extended-release and amorphous solid dispersion systems will be provided. Case studies will be shared to demonstrate: • How critical material properties and variation within and outside of compendial and/or supplier’s specifications can influence product quality and performance, such as in vitro dissolution, stability and in vivo absorption, during manufacture of marketed products; and, • Continuous monitoring, accumulating knowledge of raw materials, product and process are imperative in maintaining production consistency. It is also shown that the susceptibility of a particular quality attribute to variation of excipient properties and extent of the impact often depend on the API, product design and operating principles, manufacturing process and test method. Therefore, it is important to apply systematic approach in evaluating material properties on product quality and performance via an integrated evaluation of drug substance, formulation, process, test method and their interactions. Drug Development Track Pediatric Formulation Development Innovation Wednesday, May 17, 2017, 4:00 PM – 5:30PM Implement Novel Container/Closure Technologies Thursday, May 18, 2017, 8:30 AM – 10:00 AM Satish K Singh, Drug Product Services. Lonza Pharma and Biotech, Lonza Ltd Delivery systems are being increasingly used for parenteral products as a way to add value in terms of convenience, patient compliance as well as product differentiation. These systems, oftentimes encompassing the primary container/ closure system, must be considered an integral part of parenteral products and not an afterthought. The choice of the system and the assessment of its suitability, functionality and manufacturability are key aspects of the development process. A range of technologies are available for selection, depending on the user requirements. This session will cover container/closure requirements in general, address the requirements for qualification of such systems including compatibility, integrity testing (in the context of the new USP requirements) and manufacturability. The session will cover the major systems with a focus on pre-filled syringes which are by far the most common system being used after vials. Beyond the primary packaging, the secondary packaging may also have functional requirements in specific application. Examples of such systems will be discussed. Discover the Latest in Inhalation Product Development and Regulatory Standards Thursday, May 18, 2017, 8:30 AM – 10:00 AM Jennifer Yaping Zhu, Ph.D., Executive Director, Inhalation Product Development, Sandoz Inc. Overview of inhalation therapies • What are the US regulatory pathways for inhaled products • Why we like 505(b)(2) and 505(j) inhaled products • Latest cGMP requirements for combination products II.Development of generic inhaled products: • How to select formulations and devices • What analytical methods are typically required for development and quality control • How to qualify packaging components • Challenges with in-vitro and in-vivo bioequivalence studies for US filing III.Interactive Exercise: For the most up-to-date program, go to schedule. cphinorthamerica.com or schedule.informex.com. Compounds with known toxicity can potentially be leached from packaging components into an MDI, leading to a great concern to regulators. Routine testing for component extractables is typically required on those MDI components which contact either the drug product and/or the patient’s mucosa. We’ll discuss how to effectively deal with extractables and leachables in MDIs to ensure consistency and safety of the container closure system. Bioconjugate and Biotherapeutics: Present and Future Thursday, May 18, 2017, 10:30 AM – 12:00 PM Powered by Moderator: Richard Silva (full title and company to be provided by ACS – waiting to hear from team ) Robert Garbaccio, Executive Director, Merck Jagath Reddy Junutula, Cellerant Therapeutics David Rabuka, PhD, Global Head of R&D, Chemical Biology, Catalent Biologics - West (formerly Redwood Bioscience), Catalent Pharma Solutions I. An Antibody-Drug Conjugate Approach to Tissue-Selective Glucocorticoids • Investigation of the targeted delivery of glucocorticoids using the ADC modality • Discovery of a novel linker design that provided optimal properties for payload conjugation & delivery • Lessons learned from investigation of novel linkerpayload combinations II.Engineering Antibody Based Designer Drugs for Cancer Therapy Antibody therapeutics has revolutionized the treatment of a number of diseases including cancer and inflammation. Antibody engineering methods have been used to improve the efficacy, safety, and half-life of antibody-based drugs to ensure the clinical success. There are about 470 antibody-based therapeutic molecules are currently in the clinical testing, which is a testimony to the applications of antibody engineering that played a major role in expanding this family of large of molecule therapeutics over the past two decades. Several applications of antibody engineering will be presented and discussed on how these tools are applied to further expand in developing next generation antibody therapeutics, such as site-specific Antibody Drug Conjugates (ADCs), Bi-specific ADCs, Bi-specific T-cell Engagers (BITE), Immune mobilising monoclonal Drug Development Track TCRs Against Cancer (ImmTACs), Chimeric Antigen Receptors (CARs). Oncology drug development recently witnessed an unprecedented improvement in overall survival of patients with the certain type of cancer indications upon treatment with immunooncology (IO) molecules, such as anti-PD-1 or antiPD-L1 antibodies. such as antibody-drug conjugates (ADCs), where the proteins are chemically elaborated. The application of these chemistries to generate site-specifically modified bioconjugates with improved efficacy and safety profiles will be highlighted. The presentation highlights the rapidly evolving IO combo trials in conjunction with above described next generation antibody therapeutic molecules that may further raise the bar of overall survival, thus benefiting the cancer patients. III.Novel Bioconjugation Strategies Used in Biotherapeutic Development This is an overview of chemical methodologies that are currently used in the development of bioetherapeutics, Drug Manufacturing Track A Case Study in API Continuous Processing (Part I) Tuesday, May 16, 2017, 2:00 PM – 3:30 PM Powered by Economies of Capability vs. Economies of Scale – Advancing CMO Decisions Wednesday, May 17, 2017, 8:30 AM – 10:00 AM Moderator: David Conlon, Senior Principal Scientist, BristolMyers Squibb Pete Stevenson, Vice President and General Manager, Pfizer CentreOne Panelists: Tom Wilson, Vice President, Contract Manufacturing Operations, Pfizer Global Supply & Pfizer CentreOne Klavs F. Jensen, Warren K. Lewis Professor of Chemical Engineering, and Professor of Materials Science and Engineering, MIT Timothy Braden, Research Scientist, Eli Lilly A Case Study in API Continuous Processing (Part II) Tuesday, May 16, 2017, 4:00 PM – 5:30 PM Powered by Moderator: David Conlon, Senior Principal Scientist, BristolMyers Squibb Panelists: Ian W. Davies, Department of Process and Analytical Chemistry, Merck Research Laboratories, Merck and Co. Inc. Christian Oliver Kappe, Professor of Chemistry, University Of Graz • Defining ‘economies of capability’ and the drivers of its increased importance • A look at challenging market conditions; increased regulatory scrutiny and industry consolidation • How evolving product and market trends are changing CMO partner selection considerations • Matching your compound’s unique needs and business strategy with the specialized strengths of the right CMO • Analyzing the criteria for selecting potential CMO partners in an evolving supply environment • How to ensure supply chain reliability Packaging Innovation Wednesday, May 17, 2017, 8:30 AM – 10:00 AM Powered by Save an extra 20% off when you use Promo Code CONF20 by May 8. Go to cphinorthamerica.com/register to save today! For the most up-to-date program, go to schedule. cphinorthamerica.com or schedule.informex.com. Drug Manufacturing Track The Role of Track and Trace in a Post-Serialized World Wednesday, May 17, 2017, 10:30 AM – 12:00 PM Brad Pedrow, Manager, S&O Supply Chain Strategy, Deloitte Consulting Rajesh Singh, Senior Manager, Supply Chain Technology, Life Sciences, Deloitte Consulting I. Recognizing the Changes and Impact • Current global snapshot; US current situation and implementation challenges • Current technology developments; preparing for the next round • Forward thinking to leverage value from investments II.Driving Value • Recognize the progression from product security to value-driving capabilities • Recognize the relative value of returns processing, chargeback accuracy and recall management • Chart out the evolutionary journey III.Interactive Exercises Audience polling to occur throughout Sections I and II. The session concludes with Q&A and audience crossfertilization of ideas. Process Development and Quality by Design Case Study Wednesday, May 18, 2017, 10:30 AM – 12:00 PM Drug Manufacturing: Quality Risk Assessment Management and Supply Chain Sourcing Strategies for APIs and Excipients Wednesday, May 17, 2017, 2:00 PM – 3:30 PM Powered by Stephen Andruski – Verification Manager, USP Pharmaceutical companies are required by FDA to control the supply chain for all of the ingredients used in their products. Often, this translates into pharmaceutical companies conducting numerous and redundant GMP audits of their suppliers. Recently, several third-party GMP certification programs have introduced business models designed to help reduce the number and frequency of these audits. New proposals and guidelines suggest a dedicated risk assessment strategy can further help to improve efficiencies in resources and activities. This is an approach currently employed by FDA to determine the audit frequency and urgency in many regulated industries. This presentation will provide an overview of the advantages of different Certification business models, including the USP Verification program and how inclusion of Quality risk assessment management strategies can be used to help focus resources to the most critical ingredients in the supply chain. Continuous Solid Dose Manufacturing – Analytics to Support the Supply Chain Wednesday, May 17, 2017, 4:00 PM – 5:30 PM Stephen V. Hammond, Senior Director/ Team Leader of the Process Analytical Sciences Group, Pfizer Global Technology To be an effective contributor to a transformed “low inventory - pull” medical products supply chain, manufacturing of pharmaceuticals must also transform. The large scale batch processing, in centralized facilities does not serve the new supply chain well. The need for flexibility and localization of manufacturing in Emerging Markets is becoming a primary objective for the development of new processing technologies in the pharmaceutical industry. This paper will describe some of the efforts that Pfizer and the industry in general, are putting into the concepts of continuous manufacturing, married together with integrated analytics and Advanced Control Systems. The combined technologies allow for rapid response to demand, through flexible low inventory supply streams that occupy a small footprint, and can be rapidly deployed to markets anywhere in the world. Interfacing PAT’s into a continuous manufacturing system requires consideration of patient safety, compliance to existing standards but also supply flexibility and reliability. This paper will describe the on-going efforts to develop analytics and controls to respond to these considerations. Emphasis will be placed on the need for a measurement and control system that is based on the business need, as well as satisfying the need for patient safety and compliance. Continuous Manufacturing of (Bio)Pharmaceuticals Wednesday, May 17, 2017, 4:00 PM – 5:30 PM Richard D. Braatz, Ph.D., Edwin R. Gilliland Professor of Chemical Engineering, Massachusetts Institute of Technology I. Comparison of Batch and Continuous Unit Operations • What are the advantages of batch operations • What are the advantages of continuous operations • Learn about specific processes that are operated more effectively in continuous flow • Learn how to achieve tighter control of product characteristics using continuous manufacturing • Learn how continuous operations can streamline process development Drug Manufacturing Track II.Plant-wide Control Approach • Learn about requirements to run a successful bioprocess (e.g. regulatory) • Build first-principles dynamic models for each unit operation • Design control systems for each unit operation to meet local material attributes • Exploit the potential of biocatalysis in the industry III.Interactive Exercise • Evaluate performance in simulations and proposed design modifications as needed Discuss how to accelerate application of biocatalysis in the future. Hear the perspective of leading researchers from industry what the biggest hurdles to develop industrial bioprocesses are. Increase your biocatalysis network by meeting colleagues working in the different fields applying biocatalysis (large pharma, technology providers, CROs and CMOs). • Implement and verify the control system for each unit operation • Design and verify plant-wide control system to ensure that the product quality specifications are met III.Interactive Exercise Using a real-life example of a continuous drug manufacturing plant, participants will study how material attributes during continuous operations are affected by design changes. Pharmaceutical Impurities Thursday, May 18, 2017, 10:30 AM – 12:00 PM Powered by Antonio Hernandez-Cardoso, Senior Scientific Liaison, USP Applied Biocatalysis for the Synthesis of Industrial Relevant Pharma Compounds Thursday, May 18, 2017, 8:30 AM – 10:00 AM Kahkashan Zaidi, Principal Scientific Liaison, USP I. USP Chapters <232> and <233> -- Key changes, Harmonization and Implementation Strategy Moderator: Iwona Kaluzna, Ph.D., NBD Manager InnosynTM Route Scouting Services, InnoSyn • An update on chapter <232> and where we are with its harmonization with ICH-Q3D Panelists: • Impact of <232> on other USP chapters and how it will be addressed Jim Lalonde, SVP of R&D, Codexis Inc. David Rozzell, SVP, Provivi, Inc Matthew Truppo, Executive Director, Head of Chemical Biotechnologies and Head of Global Structural Sciences at Merck The aim is to promote developments in applied biocatalysis through science and engineering of useful biological catalysts and their commercial applications in the production of small molecule pharma products. I. How to identify, optimize and develop biocatalysts and biocatalytic processes • Biocatalyst discovery, optimization and design of new processes • Elemental impurities implementation plans II. Modernization of Organic Impurities testing in Drug Substances and Drug Products • Justification for modernization of organic impurities testing • Industry survey results and Stimuli article content • Proposed content of the new chapter <476> and revised chapter <1086> • Proposal for introduction of cross references in monographs, in a case-by-case basis • Next steps and implementation plan • Emerging strategies for improving the characteristics of biocatalysts in industrial setting • Reaction engineering for enzyme catalyzed reactions • Pragmatic downstream processing technologies • Biocatalyst production and formulation II.Application of biocatalysts in industrial processes • Demonstration of diversity of reactions enabled by enzyme catalysis • Understanding of the boundaries for application of enzymes in chemical process • Recent advances and current trends in industrial biocatalysis Save an extra 20% off when you use Promo Code CONF20 by May 8. Go to cphinorthamerica.com/register to save today! Outsourcing Track Supply by Design – Global Good Supply Practices (GSPs) for Your Success Determining the Value of Re-Shoring Drug Ingredient Manufacturing Wednesday, May 17, 2017, 8:30 AM – 10:00 AM Wednesday, May 17, 2017, 2:00PM – 3:30PM Sponsored by Marla Phillips, Director, Xavier Health, Xavier University Jack Solomon, Practice Leader – Supply Chain, Core Risks, Ltd. (A JLT Company) I. Understand the Root Causes of Supply Chain Failure • What actionable steps did the gap analysis reveal? • What can you do in your organization to reduce risk? II. Richard Mutchler, President, BioSpectra, Inc. Dora Meissner, Director of Regulatory Affairs, BioSpectra, Inc. Sarah DeMaio, General Manager, BioSpectra, Inc. I. Knowing when to consider Re-Shoring drug ingredient manufacturing • What can you implement across organizations to partner for supply chain success? • Pros and cons of investing to improve your existing manufacturer Solutions You Can Implement Today • Pros and cons of qualifying a new manufacturer • Supplier-Qualification vs. Self-Qualification II.Selecting the safest and most sustainable drug ingredient manufacturing source • Relationship Risk • Business Smart Transparency – how to decide • Right-First-Time Supplier Selection III. Interactive Exercises • Ensuring your decision actually improves your supply chain • The surprising financial impact of Re-Shoring your drug ingredient • Work with your colleagues to uncover hidden gaps in your supply chain practices. III.Ensuring your supply chain decision is beneficial to end patients and shareholders • Table discussions to put your learning into action before you return to your organization • Clearly communicating Regulatory and Quality benefits • Quantifying short term and long term Return on Investmen Technology Transfer Risk Mitigation Practices Wednesday, May 17, 2017, 10:30 AM – 12:00 PM Save an extra 20% off when you use Promo Code CONF20 by May 8. Go to cphinorthamerica.com/register to save today! For the most up-to-date program, go to schedule. cphinorthamerica.com or schedule.informex.com. Quality / Regulatory Track Navigating GDUFA – Reduce Cost and Accelerate Delivery The World of Quality Metrics – Yesterday, Today and Tomorrow Tuesday, May 16, 2017, 4:00 PM – 5:30 PM Thursday, May 18, 2017, 10:30 AM – 12:00 PM Jonathan S. Helfgott, Adjunct Professor, Johns Hopkins University Graduate Program in Regulatory Science & Former Acting Associate Director, Office of Scientific Investigations, CDER, FDA In this session, our expert explores the role of FDA CDER’s Office of Generic Drugs (OGD) in its review and approval of Abbreviated New Drug Applications (ANDAs). Topics covered include: • Tips for a successful ANDA submission Marla Phillips, Director, Xavier Health, Xavier University I. Why is there so much attention on metrics? • How does the FDA want to use metrics and why? • How does industry NOT want FDA to use metrics and why? • What is driving the need for metrics for FDA and industry? II.What are the metrics FDA is considering? • FDA’s focus during an ANDA review • CDER’s approach to metrics and what they are • The role of GDUFA and it’s impact on reviews and timelines of ANDAs • CDRH’s approach to metrics and what they are • When a Bioequivalence study is required to support an ANDA • Conducting a high-quality Bioequivalence study • FDA site inspections of Bioequivalence studies • Role of technologies used to support Bioequivalence studies • Why is there a difference across CDER and CDRH? • How can industry use the metrics to inform decision and trigger action? III.How to quantitate a commitment to quality • The role of Culture in an organization’s commitment to quality • How to quantitate the commitment to quality • How to improve the reliability of your product IV.Interactive Exercises • Work with your colleagues to explore successful practices on metrics • Table discussions to articulate cultural impact AgroChem Spotlight Track Food Sustainability Trends and Outlook Wednesday May 17, 2017, 8:30 AM – 10:00 AM Help Wanted! Herbicide and GM Herbicide Trait Treadmills are Too Slow Wednesday May 17, 2017, 10:30 AM – 12:00 PM Jerry Green, President, Green Ways Consulting Glyphosate and glyphosate-tolerant crops had a revolutionary impact on weed management and new combinations of herbicides and traits will help continue their utility. However, the epidemic of herbicide-resistant weeds is rapidly decreasing their value and threatening high production agriculture. The chemical company solution is to combine glyphosate with other herbicides, while the seed company solution is to combine glyphosate resistance with other traits to enable more herbicide options. Unfortunately, no new commercial mode-of-action for over 30 years and current herbicide types all have problems with For the most up-to-date program, go to schedule. cphinorthamerica.com or schedule.informex.com. weed resistance. New traits for glufosinate, auxin, HPPDinhibiting and PPO-inhibiting herbicide traits will help when combined with glyphosate resistance, but are temporary solutions. The process to develop new herbicides and their associated traits is too slow and expensive to support what critics call the chemical and transgenic treadmills. The lack of new herbicide types and the epidemic of multiple herbicideresistant weeds is forcing growers to spend more money to manage weeds, creating a best of times, worst of times predicament for the crop protection industry. New research efforts have already produced some results, but much more technology wanted! AgroChem Spotlight Track Food Sustainability Trends and Outlook Wednesday May 17, 2017, 8:30 AM – 10:00 AM Help Wanted! Herbicide and GM Herbicide Trait Treadmills are Too Slow Wednesday May 17, 2017, 10:30 AM – 12:00 PM Jerry Green, President, Green Ways Consulting Glyphosate and glyphosate-tolerant crops had a revolutionary impact on weed management and new combinations of herbicides and traits will help continue their utility. However, the epidemic of herbicide-resistant weeds is rapidly decreasing their value and threatening high production agriculture. The chemical company solution is to combine glyphosate with other herbicides, while the seed company solution is to combine glyphosate resistance with other traits to enable more herbicide options. weed resistance. New traits for glufosinate, auxin, HPPDinhibiting and PPO-inhibiting herbicide traits will help when combined with glyphosate resistance, but are temporary solutions. The process to develop new herbicides and their associated traits is too slow and expensive to support what critics call the chemical and transgenic treadmills. The lack of new herbicide types and the epidemic of multiple herbicideresistant weeds is forcing growers to spend more money to manage weeds, creating a best of times, worst of times predicament for the crop protection industry. New research efforts have already produced some results, but much more technology wanted! Unfortunately, no new commercial mode-of-action for over 30 years and current herbicide types all have problems with ChemInnovation Track How to Create a Start-Up Environment in a Traditional Company Tuesday, May 16, 2017, 2:00 PM – 3:30 PM Powered by The Latest Developments in Chiral Chemistry Tuesday, May 16, 2017, 4:00 PM – 5:30 PM Powered by • Hardware; Existing & New developments; Mixing devices II.Applying continuous flow for the manufacturing of fine chemicals • Chemistries particularly suitable for continuous manufacturing • Hazardous chemistry and reagents • Highly exothermic reactions Discover the Latest Innovations in Green Chemistry • Showcasing real life examples Wednesday May 17, 2017, 8:30 AM – 10:00 AM Powered by • On-line analysis and in-process controls Continuous Manufacturing of Fine Chemicals Wednesday May 17, 2017, 2:00 PM – 3:30 PM André H.M. de Vries, PhD, Business Director, Innosyn I. How to decide between continuous and batch wise manufacturing • Advantages and disadvantages of both types of operation • Defining parameters, such as safety, control, quality and cost • Environmental advantages • License to operate For the most up-to-date program, go to schedule. cphinorthamerica.com or schedule.informex.com. III.Interactive Exercise Plenary discussion between panelists and attendees on how to accelerate implementation of continuous manufacturing of fine chemicals, especially if one can gain advantages in safety and environment. Are non-competitive collaborations possible? Sharing best practices of other industries. Nanotechnology Thursday, May 18, 2017, 8:30 AM – 10:00 AM Regulatory Spotlight Track Manufacturing Plant Operations to Efficiently Meet Food and Drug Regulatory Requirements for Multiple Markets Tuesday, May 16, 2017, 2:00 PM – 3:30 PM Powered by Chemical manufacturers are faced with operating their plants in a quality environment driven by a multitude of governmental regulations, voluntary industry programs and customer requirements. Because they serve a variety of market segments, it often seems each segment has different, and in some cases incompatible and/or redundant, requirements that drive up complexity and cost. Some manufacturers choose to abandon niche markets, forgoing high margin markets for what are perceived to be less complex quality regulatory requirements. Some choose to operate at a very high level of quality such as Pharmaceutical GMP regulatory requirements, believing such a level will inherently meet all requirements. Others choose to operate in smaller, batch style production, applying specific GMPs regulatory requirements on a batch by batch basis. This session seeks to provide a unified view of how to meet regulatory requirements across multiple end user markets, hopefully minimizing complexity and cost. Topics will include: • Legal requirements to operate a plant that simultaneously serves the Industrial, Food, Dietary Supplements and Pharmaceutical markets • How a commodity plant can operate to satisfy multiple markets • Advantages and challenges to meeting multiple markets using a batch style production plan Chemical Regulation in the US - Toxic Substances Control Act (“TSCA”) Reform – Current Interpretations and the Impact on Business Tuesday, May 16, 2017, 4:00 PM – 5:30 PM Brendan K. Collins, Partner, Ballard Spahr I. Overview of the Lautenberg Act (30 minutes) • The presentation will provide a brief overview of TSCA and the Frank R. Lautenberg Chemical Safety for the 21st Century Act (“Lautenberg Act”), adopted in 2016. • Learn how r the Lautenberg Act will affect your business. For the most up-to-date program, go to schedule. cphinorthamerica.com or schedule.informex.com. • Understand the calendar: the Lautenberg Act imposes strict deadlines for EPA rulemaking affecting new and existing chemicals in the marketplace. • Discover the Loopholes: Important provisions of the Lautenberg Act are subject to different interpretations that can dramatically affect impacts on business. II.Roundtable Discussion • The Most Wanted List - EPA Selects the First Ten Chemicals for Risk Evaluation • On November 30, 2016, EPA announced the initial list of 10 “high priority” chemicals subject to its risk evaluation as required by the Lautenberg Act. • Learn about EPA’s risk evaluation process and the progress of EPA’s ongoing review. • Panelists will share their insights on the risk evaluation prospects of other chemicals listed in the EPA TSCA Work Plan. • Casting Call - EPA’s Proposal to Reset the TSCA Chemical Inventory • On January 13, 2017, EPA proposed to subdivide the TSCA Chemical Substance Inventory into “active” and “inactive” substances. • Learn how EPA intends to approach the notification process. • Panelists will share their insights on preparing for the notification rule, discuss key issues that emerged during the public comment process. • Keeping Secrets - EPA’s Guidance on the New Substantiation Requirements for Confidential Business Information (“CBI”) Claims • On January 19, 2017, EPA published a guidance document interpreting the new substantiation requirements for CBI claims submitted under section 14 of TSCA. • Learn strategies for complying with the new requirements. • Panelists will share their experience in submitting CBI claims and thoughts on the possibility of change in the guidance under the new Administration. III.Q&A with the Audience The Business of Chemicals Track The Changing Dynamics of Outsourcing: Strategies, Essential Elements, Advantages and Limitations Wednesday May 17, 2017, 10:30 AM – 12:00 PM Lalit Baregama, PhD, General Manager-Global Business Development, Cadila Pharmaceuticals Ltd I. Outsourcing - Current scenario • Transformational shifts of Pharma/Chemical industry • Mergers and acquisition • Reshaping of development strategy • Core sectors become the growth strategy II.Essential elements for successful partnership • Strategic intent of outsourcing • Nature of business • Risk tolerance • Mode of partnership: single transduction or long term III.Advantages, Challenges and Limitations • Partner selection: Location, opportunities, risk and cost • Preference advantages • Challenges and Limitations: competition, policies, pricing, EHS IV.Future Perspective 2.Grassroots Awareness Programs – Multiple “off the shelf” programs exist that industry professionals can utilize both within their companies and in their local communities. Attendees will learn about these initiatives and how they can implement them immediately. • NIOSH Safety Matters Campaign – This new program aims to raise awareness among young people about workplace safety and health and to provide an understanding of the skills they need to become active participants in creating safe and healthy work environments. Chemical and other industry professionals are already taking these materials to classrooms across the country. • OSHA Safe and Sound – This new program focuses on the three pillars of all safety and health programs: management commitment, employee involvement, and a systematic method for finding and fixing hazards. Attendees will learn how they can participate in a nationwide event planned for the 2nd week of June (6/12 – 6/16). • #IamIH -- Sponsored by AIHA, this new public awareness campaign kicked off last fall and strives to educate industry stakeholders and students alike about the integral role professionals engaged in the field of environmental and worker health and safety play in corporations and the communities in which we live. Making the Business Case for Occupational Health & Safety Catalyzing Innovation in the Chemicals Industry by Maximizing R&D Tax Credits Wednesday May 17, 2017, 2:00 PM – 3:30 PM Wednesday May 17, 2017, 4:00 PM – 5:30 PM Lawrence Sloan, CAE Chief Executive Officer, AIHA Steven Lacey, PhD, CIH, CSP President, AIHA, Associate Professor and Chair Dept. of Environmental Health Science, Indiana University Fairbanks School of Public Health The purpose of this presentation is to draw awareness about compelling business case that can and should be made for ensuring a company is committed to a structured comprehensive worker health and safety program, recognized from the C-suite down. A brief introduction to AIHA and our affiliate group, Product Stewardship Society, will be followed by a review of two main strategic areas: 1.Center for Safety & Health Sustainability -- Launched in 2011, CSHS is a 501(c)3 nonprofit organization committed to advancing the safety, health and sustainability of the global workplace. Unfortunately, when an organization considers the “social” aspect of its own sustainability picture, occupational safety and health receives very little attention, if any at all. Yet more than 2 million people die from occupational accidents or work-related diseases each year. Attendees will learn about the Center’s initiatives and hear results from an insightful new Harvard University study on Human Capital, worker health and safety, and its impact on a company’s capital valuation. For the most up-to-date program, go to schedule. cphinorthamerica.com or schedule.informex.com. Yair Holtzman, CPA, MBA, MS, CGMA, Partner, R&D Tax Credits Practice Leader, Global Chemicals & Life Sciences Practice Groups Leader, Anchin, Block & Anchin LLP Accountants and Advisors Has your company developed new or improved compounds or other chemical products recently? Have you experienced failed batch trials or experimented with scale-up processes? Have your employees modified product formulations and/ or production techniques and processes to increase yields, reduce waste, improve product performance, or made other improvements to the efficiency of your manufacturing operation? If so, your company may qualify for Research and Development (R&D) Tax Credits, often an overlooked and misunderstood opportunity for taxpayers. Our expert shares specific industry examples that are common to the chemicals industry, and helps participants understand the qualification process, and discuss the four-part test including how different activities qualify for the credit. The Business of Chemicals Track USP 232 Heavy Metals Mandate Update – Compliance Best Practices and Standardized Methods for Testing for Metals Thursday, May 18, 2017, 8:30 AM – 10:00 AM Powered by Gain the latest insights into regulatory changes on the horizon for elemental impurities standards and what you need to know in order to be prepared for the implementation deadline. Circular Economy Thursday, May 18, 2017, 8:30 AM – 10:00 AM Julie B. Manley, President, Guiding Green LLC NDAs - Legal Strategies to Mitigate Risk Thursday, May 18, 2017, 10:30 AM – 12:00 PM NDAs and supplier agreements are getting more complex. Hear from legal experts on how contractors and toll manufacturers can build in protections to mitigate risk. Vet sample NDA scenarios from both sides of the negotiating table during this interactive session. Save an extra 20% off when you use Promo Code CONF20 by May 8. Go to cphinorthamerica.com/register to save today! For the most up-to-date program, go to schedule. cphinorthamerica.com or schedule.informex.com.