AAPS Newsmagazine

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AAPS Newsmagazine                 

October / November 2017

San Diego

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Managing Editor

Linda Brown

BrownL@aaps.org

+1.703.243.2800

COVER STORY

October 1, 2017

2017 AAPS Annual Meeting and Exposition Programming Preview

ADVANCED FORMULATION CHARACTERIZATION APPROACHES 

ADVANCED MATERIALS CHARACTERIZATION AND ROBUST DATA ANALYTICS: BENEFITS AND CHALLENGES
Recent advances in materials characterization, primarily those for solid form characterization, are regularly incorporated into product development processes. Despite their advantages, significant characterization technologies (atomic force microscopy, transmission electron microscopy, nano-indentation, terahertz spectroscopy) have not been fully embraced. Similarly, characterization techniques routinely applied to pharmaceutical powders has increased, driving the need for advanced data analysis methods, such as multivariate analysis (MVA). This session will explore advanced materials characterization in pharmaceutical manufacturing including the advantages of MVA to facilitate early risk assessment and material sparing approaches. 
This symposium will be held on Tuesday, November 14, from 9:40 am to noon.

MATERIAL CHARACTERIZATION APPROACHES TO ACCELERATE LOCALLY ACTING DRUG PRODUCTS
Assuring target delivery is a key aspect of pharmaceutical development, both for branded and generic drug product programs. For a locally acting therapeutic, this becomes more critical because delivery is a function not only of formulation but also the interaction between formulation, device, and patient. Material characterization plays an important role in guiding important formulation decisions and device choices. This session will provide information on how to link material characterization in designing better locally acting drug products to achieve better clinical results.
This sunrise session will be held on Wednesday, November 15, from 7:30 am to 8:45 am.

UTILIZING ADVANCED CHARACTERIZATION TO GET REGULATORY RELIEF IN POST-APPROVAL CHANGES
Recommendations are available that describe the data requirements for abbreviated and new drug applications for postapproval changes in accordance with section 506A of the Federal Food, Drug, and Cosmetic Act; §314.70 (21 CFR 314.70); and the International Council for Harmonisation. With the available set of advanced formulation characterization tools, significant product knowledge can be obtained that is predictive of the impact of any given change. This dialogue and debate will explore the feasibility of obtaining leniency to the data package required for a post-approval change based on supplemental evidence obtained from advanced formulation characterization.
This dialogue and debate will be held on Monday, November 13, from 1:40 pm to 3:40 pm.

ADVANCES IN SMALL SCALE POWDER  TESTING AND ITS IMPACT ON LARGE SCALE MANUFACTURE
Several recent advances in particle testing and engineering have been achieved. The rise of laboratory automation and the continued adoption of numerical methods have accelerated the gains from those tests. These advances have influenced the development of large scale manufacturing decisions since their adoption. This session will review these advances in small scale testing and discuss the synergies with lab automation tools, including integration of multiple measurements with numerical methods. Case studies of how these tools are driving projects to be faster and achieve ever higher quality standards will be included.
This symposium will be held on Wednesday, November 15, from 9:40 am to noon.

SPECTROSCOPIC IMAGING FOR IN VITRO DISSOLUTION AND FORMULATION CHARACTERIZATION
Dissolution behavior of pharmaceutical solid dosage forms is critical to formulation design, drug delivery optimization, stability studies, and manufacturing quality control. Current compendial and noncompendial dissolution methodologies rely on the measurement of drug content dissolved in media using conventional UV spectrometry or liquid chromatography. UV, Fourier transform infrared spectroscopy, Raman, and nuclear magnetic resonance imaging have been applied to characterize formulations for drug release and dissolution behaviors in both conventional and biorelevant media. This symposium will present strategies assessing dissolution mechanisms and the benefits of spectroscopic imaging technologies to characterize formulation, including case studies implementing spectroscopic imaging assessing dissolution of solid dosage forms.
This symposium will be held on Wednesday, November 15, from 1:20 pm to 3:40 pm.

ANALYTICAL METHODS FOR PREDICTING PROTEIN STABILITY IN LYOPHILIZED FORMULATIONS
Defining formulation strategies for protein-based products that ensure stability remains an empirical process. New techniques are emerging to optimize protein stability, specifically to 1) ensure lack of phase-separation from the stabilizing matrix and 2) reduce protein aggregation related to matrix mobility. These two factors are primary driving forces in stabilizing an Immunoglobulin G antibody from aggregation. This topic is particularly relevant for biosimilars, as two proteins may be identical in structure, but differences in formulation may lead to stability issues unrelated to the protein. This session will focus on analytical methods to predict protein stability.
This symposium will be held on Monday, November 13, from 1:20 pm to 3:40 pm.

METASTABLE FORMULATIONS: CAN ADVANCES IN ANALYTICAL TECHNOLOGIES MINIMIZE THE RISK?I
n the 1990s, the typical formulation strategy was to develop the most stable crystalline form to avoid conversion. Contemporary approaches develop the least stable formulation, i.e., the amorphous form of the drug, hopeful that polymers and other additives will maintain sufficient solubility. This session will focus on analytical methods available to study amorphous solid dispersions and other metastable formulations, and whether these methods are sufficiently advanced to ensure that any dispersion formed will remain stable and not crystallize or phase separate. Analytical tools that can be used to monitor supersaturation will be highlighted and discussed.
This dialogue and debate will be held on Tuesday, November 14, from 1:40 pm to 3:40 pm.

ANALYTICAL LIFECYCLE MANAGEMENT: WHAT YOU NEED TO KNOW TO BUILD AND MAINTAIN THE PROGRAM
The concept of lifecycle management as described in ICH Q8 (Pharmaceutical Development) has created a parallel phrase “Analytical Life Cycle Management (ALCM)” as analytical methods advance from the clinical to the commercial phase. Application of ALCM ensures analytical methods evolve to include increased product and process knowledge and understanding of analytical procedure variability. This sunrise session will give a tutorial on the structure of ALCM and maintenance of the program, which includes ALCM components and method assessment. Cases studies for both small and large molecules will illustrate the key analytical challenges, e.g., impurities, methods, and specifications.
This sunrise session will be held on Wednesday, November 15, from 7:30 am to 8:45 am. 
    
CANCER MOONSHOT: EMERGING MODALITIES FOR ONCOLOGY    

ONCOLOGY THERAPEUTICS: FORMULATION AND PROCESS DEVELOPMENT CHALLENGES
As new modalities are developed for cancer therapies, formulation and process development considerations become increasingly complex. For instance, monoclonal antibody (mAb) formulation and processing strategies cannot be directly employed with other modalities due to their distinct molecular characteristics and analytical considerations. This symposium will focus on the formulation, processing, and key chemistry, manufacturing and controls issues of novel modalities, as well as highlighting key aspects of commercialized mAb products. It will provide an overview of various modalities, highlighting critical issues during development through various case studies.
This symposium will be held on Wednesday, November 15, from 9:40 am to noon.

ADVANCING DEVELOPMENT OF CANCER THERAPEUTICS: TRANSLATIONAL RESEARCH ENABLED BY QUANTITATIVE PHARMACOLOGY 
This symposium highlights recent advances in quantitative methods for translational oncology research and development. Particular focus is placed on the challenges and opportunities of applying emerging next-generation biologics and immunotherapy modalities in the era of precision medicine. Speakers will provide cross-sector perspectives in emerging areas of translational and clinical oncology research. Opportunities for holistic totality-of-evidence approaches leveraging knowledge generated during preclinical evaluation in the research laboratory and real-world evidence in clinical practice will be highlighted. 
This joint ASCPT/AAPS symposium will be held on Wednesday, November 15, from 1:20 pm to 3:40 pm.

NANOMEDICINES FOR ONCOLOGY: EVOLVING PARADIGMS IN THE AGE OF IMMUNO-ONCOLOGY
Despite the inherent promise, increasing use of nanomedicines in cancer clinical trials has provided limited success. This dialogue and debate session will explore strategies that have, as well as have not, translated into clinical success. The discussion will focus on the importance of identifying key attributes of nanomedicine design and critical considerations in their preclinical safety and clinical efficacy assessments.
This dialogue and debate will be held on Wednesday, November 15, from 10:00 am to noon.

ALTERING PERSPECTIVES ON CANCER THROUGH DATA MINING: A NEW HOPE FOR PATIENTS
This session discusses how bio-statistics and data mining of patient samples are changing perspectives on the inherent risk, etiology, and mutagenesis of cancer. Combining statistical approaches with patient genomic data can identify cancer “driver” genes, as well as define the likelihood of disease onset and metastasis. Screening genomic data from patients in various stages of cancer also provides insight into genetic alterations contributing to patient chemoresistance development. The focus is primarily on bio-statistic, genomic, and proteomic research applied to understanding the basis of ovarian cancer.
This sunrise session will be held on Monday, November 13, from 7:30 am to 8:45 am.

NOVEL ONCOLOGY MODALITIES: OPPORTUNITIES AND CHALLENGES IN BIOMARKERS AND BIOPSIES
Developing novel anticancer therapies is hindered by deficiencies in early cancer type diagnosis and lack of biomarkers or other assays to assess efficacy and tumor tissue concentrations necessary for establishing exposure-response relationships. This symposium explores diverse new methods such as liquid biopsy techniques in oncology treatment, microdialysis determination of tumor drug concentrations, and the critical role of biomarkers identified and developed through quantitative systems pharmacology. The session also covers how each perspective can support early diagnosis and optimal dose selection in proof-of-concept clinical trials. 
This symposium will be held on Monday, November 13, from 1:20 pm to 3:40 pm.

NEW MODALITIES FOR CANCER MOONSHOT: UNIQUE REGULATORY, CMC, AND SAFETY REQUIREMENTS FOR ONCOLOGY DRUG DEVELOPMENT
Novel modalities for treating cancer present unique regulatory challenges. Understanding, comparing, and contrasting the appropriate regulatory requirements of both novel therapies and the more well-characterized modalities is an area of enormous discussion in the industry. This session will explore chemistry, manufacturing, and control (CMC) and safety regulatory perspectives for new modalities such cell therapy, vaccine-based immunotherapy, and oncolytic immunotherapy. Discussion topics include: pharmacogenomics, targeted delivery, CMC challenges, regulatory CMC expectations, patient characterization, collaborative interactions between pharmaceutical and clinical science, clinical protocols design, and flexibility, as well as dosing sequence/regimen/route.
This dialogue and debate will be held on Tuesday, November 14, from 1:40 pm to 3:40 pm.

MOLECULAR MODALITY DIVERSITY: HIGHLIGHTS ON INNOVATIVE CANCER THERAPIES
Cancer treatment has advanced rapidly from cytotoxic agents that show efficacy but cause significant systemic side effects to targeted therapies that can trigger cancer-cell death while leaving healthy tissues untouched. Some of the promising approaches that are discussed include: targeted therapeutics (the so-called “magic bullet” approach, selectively targeting only cancer cells), alternative drug delivery systems (including polymeric nanoparticles, micelles, dendrimers), and immunotherapies such as stem cells, chimeric-antigen-receptor-modified T-cell therapies and cancer vaccines to stimulate patients’ own cancer-destroying immune system.
This symposium will be held on Tuesday, November 14, from 9:40 am to noon. 

IMPROVING INTER-ORGANIZATION COLLABORATION

STRATEGIES FOR OUTSOURCING BIOMARKER ANALYSIS
Biomarker analysis is scientifically, operationally, and financially challenging. Combined with outsourcing, these challenges increase in complexity. Proper management of these challenges requires contract research organizations (CRO) and their pharma partners to collaborate in developing new outsourcing approaches and strategies. This symposium will present the challenges that are specific to outsourcing of biomarker analysis from a CRO and pharma perspective. In support of the changing drug development landscape and to achieve long-term success of CRO and pharma collaborations, potential best practices for overcoming the outsourcing of biomarker analysis will be presented. 
This symposium will be held on Wednesday, November 15, from 9:40 am to noon.

DRUG DISCOVERY AND/OR DEVELOPMENT:  TO OUTSOURCE OR NOT?
Outsourcing R&D represents a paradigm shift for the biotechnology and pharmaceutical industry. Companies with internal R&D capabilities may outsource part of their processes. Virtual companies outsource all drug development, clinical trials, and marketing efforts to contract research organizations and contract manufacturing organizations. There are pros and cons in outsourcing drug discovery and development with the exception of virtual companies where all activities are outsourced. This session will present and debate the two opposing views on outsourcing drug discovery and/or development.
This dialogue and debate will be held on Tuesday, November 14, from 1:40 pm to 3:40 pm.

MANUFACTURE ADCS THROUGH COLLABORATION AND INTEGRATED SUPPLY CHAIN
Manufacture of antibody-drug conjugates (ADCs) for clinical trials and commercial products requires bringing together many disparate partners with different skill sets and expertise in different geographical locations (e.g., different contract manufacturing organizations as well as different contract testing organizations for the protein, for the toxin, and/or for the linker). The success of ADC manufacture hinges on building and maintaining an integrated supply chain through collaboration. This session will present the elements of developing, managing, and maintaining this integrated supply chain and focus on process development, manufacturing/technology transfer, and product supply.
This symposium will be held on Tuesday, November 14, from 9:40 am to noon.

ACADEMIA-BIOTECH/PHARMA INDUSTRY PARTNERSHIPS: OPPORTUNITIES AND CHALLENGES
Open innovation has increased collaborations between the biotechnology/pharmaceutical industry and academia and fostered the establishment of centers of excellence and drug development consortia with the intent to identify scientific breakthroughs in basic research. Successful collaborations will leverage research capability and economic performance in organizations and benefit the patients. Federal and state governments have committed significant funds to encourage such collaborations. This symposium will address aspects regarding the operating principles and objectives of academia and industry to better understand how to execute university-industry partnering agreements and contracts for successful outcomes. 
This symposium will be held on Monday, November 13, from 1:20 pm to 3:40 pm.

GLOBAL COLLABORATIONS AND PARTNERSHIPS: SOCIOECONOMIC AND SCIENTIFIC CONSIDERATIONS
Despite their benefits and advantages, global collaborations face many practical challenges, leading to few long-lasting strategic partnerships due to cultural differences, inequality between partners in terms of intellectual inputs and commercial benefits, too many faux leaders, ethical concerns, security and safety, and relatively high administrative and other costs. From an R&D perspective, increased presence of Chinese and Indian pharmaceutical/biotechnology R&D will meet both local and global medical and market needs. This session will focus on the pros and cons of global scientific collaborations and partnerships with active participation from the audience.
This dialogue and debate will be held on Wednesday, November 15, from 1:40 pm to 3:40 pm.

EFFECTIVE PUBLIC-PRIVATE PARTNERSHIP FOR DRUG DISCOVERY AND DEVELOPMENT
Public-private partnerships are not new, but the concept of an effective partnership between for-profit organizations with organizations focused on not-for-profit motives is unique and has lessons for effective project and portfolio management spanning discovery and development. These novel collaborations have enabled sharing of data, research resources, compound libraries, and intellectual property as a means of harnessing limited resources to accelerate research of critically needed, but commercially limited, new medical products, vaccines, and devices for use in developing areas. This session will provide insight into the challenges of successful drug development.
This sunrise session will be held on Wednesday, November 15, from 7:30 am to 8:45 am.

COMPACTION SIMULATOR: A CRITICAL MATERIAL-SPARING AND RATIONAL PROBLEM-SOLVING TOOL
Die compression is one of the most important pharmaceutical processes for manufacturing tablets. With recent technology advancement, hardware and software, modern compaction simulators provide accurate and reliable data for simulating compaction behaviors under high speed manufacturing conditions. In this session, we will 1) discuss the key challenges in tablet compaction, 2) demonstrate how compaction simulation can be used to guide tablet formulation design and process development, 3) explain its applications in scaling up and solving tablet manufacturing problems, 4) highlight on-going technological development to further it, and 5) provide a regulatory perspective.
This symposium will be held on Wednesday, November 15, from 1:20 pm to 3:40 pm.  

PATIENT CENTERED INNOVATIONS IN HEALTHCARE TECHNOLOGY 

CHALLENGES AND OPPORTUNITIES FOR GENE EDITING AND DELIVERY
Recently, new genome editing technologies have been developed, including the zinc finger nucleases, transcription activator-like effector nucleases, and the CRISPR/Cas9 RNA-guided endonuclease system. These technologies use restriction enzymes to introduce a targeted DNA break, guided by homologous binding proteins or RNA, and achieve significantly higher specificity. Multiple human disorders have been studied in proof-of-concept studies, some advancing to early clinical trials. Successful delivery requires careful investigation to achieve the therapeutic potential. In this session, these gene editing technologies and their therapeutic potential will be introduced, followed by the major focus on pharmaceutical approaches and biological obstacles. 
This symposium will be held on Wednesday, November 15, from 9:40 am to noon.

IMAGING-DIRECTED CLINICAL TRIALS: EXPERIENCE FROM ALZHEIMER DISEASE
The Alzheimer Disease (AD) Neuroimaging Initiative and similar multicenter, longitudinal, observational imaged biomarker studies provide information on the development trajectory of dementia and the time-course of its pathologies (e.g., amyloid plaques, tau tangles, hippocampal atrophy). Using imaged biomarkers creates more rational drug trials and improves eligibility decisions and efficacy monitoring. This session begins with a review of the AD pathological processes, and then focuses on AD drug trial design incorporating imaged biomarkers. The public-private-philanthropic partnership model employed (e.g., A4 trial) will also be discussed.
This sunrise session will be held on Wednesday, November 15, from 7:30 am to 8:45 am.

PERSONALIZED MEDICINE: ETHNIC DIFFERENCES AND DRUG RESPONSES
This symposium will review ethnic differences in drug response and highlight acquisition of data for cardiovascular (CV) and anticancer drugs. Other known ethnic differences in pharmacotherapy will also be discussed. This field began in earnest with CV drugs in the Veteran’s Affairs Cooperative Trial and smaller studies. As a result, differences in ethnic response are well-accepted to help guide antihypertensive drug therapy. The discovery of "ethnic-specific genetic signatures," representing drug susceptibility governing polymorphisms, may result from further work. For anticancer pharmacotherapy, improved tolerability and efficacy are goals. 
This symposium will be held on Tuesday, November 14 from 1:20 pm to 3:40 pm.

FDA GUIDELINES FOR GENOMICS AND BIOMARKER DATA SUBMISSION
This session will discuss genomic and biomarker guidelines for regulatory approvals of targeted therapies. Pharmacogenomics promises to help identify sources of inter-individual variability in drug effectiveness and toxicity, but requires an accurate understanding of the response due to the genetic difference. Development of personalized medicine also requires predictive biomarkers and diagnostics to identify the genetic factor, and then measurement of the genetic factor to select patients. FDA experts on genomic information will discuss the guidelines for genomic and biomarker data submission. 
This dialogue and debate will be held on Wednesday, November 15, from 1:40 pm to 3:40 pm.

GENE EDITING IN CLINICAL DISEASE: SCIENTIFIC, ETHICAL, AND SOCIETAL QUESTIONS
Scientific advances in molecular biology have produced remarkable progress in medicine. Some of these advances, including gene editing, have also raised important ethical and societal issues. This session will address this controversial topic of the clinical use of gene editing, i.e., precisely altering genetic sequences in human cells. What are the risks for gene-editing therapies in rare and life-threatening diseases? Many nations have legislative or regulatory bans on germline modification: Is this justified? Can we reach common ground with regard to the clinical utility of gene editing? 
This dialogue and debate will be held on Tuesday, November 14, from 10 am to noon.

SMART DEVICES: PUTTING THE PATIENT INTO THE CENTER
This symposium envisions the future of drug-smart device combinations, the role of human factors, and the importance of regulation of the complex digital interactions. A smart drug device combination could dose (or remind you to take a dose), record the dose, and share clinical outcomes with healthcare systems. Truly patient-centric therapies may emerge from this. But having the technology does not always translate to utility. How to reach every patient population, guarantee a safe and accurate digital interaction, and regulate the new drug-device combinations are just a few of the questions. 
This symposium will be held on Tuesday, November 14, from 9:40 am to noon.

PRODUCTS FOR PEDIATRICS: IT’S NOT CHILD’S PLAY

STATE OF THE ART: PBPK MODELS—FETUS TO ADOLESCENCE—ARC OF DEVELOPMENT AND DRUG EXPOSURE
This symposium will highlight key advantages of physiologically based pharmacokinetic (PBPK) modeling from fetal exposure through adolescence and the importance of predicting this exposure accurately. Model performance and utility are critical when evaluating the dynamic and complex nature of pediatric development, organ maturation, and ontogeny of metabolizing enzymes and transporters. This will identify the knowledge gaps in pediatric drug development, resulting in better understanding and prediction of drug disposition in pediatrics at all stages of development. Designing efficient and informative pediatric clinical trials to meet research objectives and to ensure compliance with regulatory requirements is a must for effective pediatric drug development.
This joint ACCP/AAPS symposium will be held on Wednesday, November 15, from 1:20 pm to 3:40 pm.  

REGULATORY DISCUSSION OF HARMONIZATION FOR GLOBAL PEDIATRIC DEVELOPMENT PROGRAMS
Both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have initiatives to incentivize development of drugs designed for the pediatric population. FDA and EMA approach the issue of pediatric development from different directions with different processes despite having adopted the International Council on Harmonization guideline on clinical investigation of medicinal products in paediatric population, developed in 2000. This program aims to provide an overview of current pediatric regulations and discuss gaps as well as harmonization efforts between the two agencies.
This dialogue and debate will be held on Wednesday, November 15, from 10 am to noon.

IS BIOEQUIVALENCE ESTABLISHED IN ADULTS RELEVANT FOR PEDIATRICS?
Typically development of pediatric formulations includes a relative bioavailability/bioequivalence study in healthy adult subjects comparing pediatric and adult formulations. It has been questioned whether relative bioavailability studies in healthy adults is predictive for the pediatric population. Little data are available showing that bioequivalent products in adults are bioequivalent in children. To assess the potential risk of in-equivalence in pediatric population, increased knowledge about age-related physiological changes affecting drug absorption will help development of biopharmaceutics tools, such as in vivo predictive in vitro dissolution methods, pediatric biopharmaceutics classification system, and physiologically based pharmacokinetic absorption models. 
This dialogue and debate will be held on Tuesday, November 14, from 1:40 pm to 3:40 pm.

THE SCIENCE OF TASTE AND TASTE MASKING
Overcoming the taste of a bitter drug while maintaining its dissolution and stability presents unique challenges to the formulation scientist. Effectively masking an unpleasant taste can increase prescribing and improve commercial success. Novel taste-masked formulations can also lead to intellectual property and market exclusivity. Taste may be measured by in vivo and in vitro methods to guide the development of palatable formulations that take into consideration the preferences of patients. This symposium will discuss the perception of taste and smell and review taste masking strategies and in vitro taste masking assessment techniques.
This symposium will be held on Monday, November 13, from 1:20 pm to 3:40 pm.

WHY IS PEDIATRIC DRUG DELIVERY SO IMPORTANT—AND WHAT IS REQUIRED FOR SUCCESS?
Pediatric drug development is a growing focus area in the pharmaceutical industry. Prior to submitting a new drug application or a line extension application for a new medicine, FDA requires the Pediatric Study Plan, and EMA requires the Pediatric Investigation Plan. Both are intended to encourage development of new drugs suitable for pediatric patients. But why is this necessary and what exactly is required, where and when? Optimizing dose selection in pediatric drug development is required and demands both pharmacokinetic and pharmacodynamic inputs from the pediatric space.
This sunrise session will be held on Tuesday, November 14, from 7:30 am to 8:45 am.

HOW TO SWALLOW A BITTER PILL: A CHILD’S PERSPECTIVE
Development of pediatric formulations is much more than just scaling down adult dosage forms. It includes a broad scope of regulatory considerations, such as safety, efficacy, and patient compliance concerns associated with nonapproved indications for children. Designing age-appropriate pediatric dosage forms with acceptable texture, smell, taste, and bioavailability requires collaborative work among regulators, pharmaceutical scientists, academia, sensory researchers, and health care professionals. This symposium will raise awareness on regulatory, scientific, and technological challenges associated with pediatric formulation development and will feature the most recent technologies in pediatric dosage forms. 
This symposium will be held on Tuesday, November 14, from 9:40 am to noon.

ANALYSIS AND PHARMACEUTICAL QUALITY

CLINICALLY RELEVANT DISSOLUTION SPECIFICATIONS: IS THIS REALLY POSSIBLE?
Over the last several years there has been a push to make dissolution more clinically relevant. The term clinically relevant dissolution specifications (CRS) refers to those specifications that help establish in vitro performance as proven by their ability to reject batches with inadequate in vivo performance. Challenges to developing and implementing CRS include development of relevant aberrant batches of drug product and conducting additional bioavailability or bioequivalence studies with them, technical hurdles in development of functional models that are universally accepted, and lack of sufficient relevant CRS data at initial approval. 
This dialogue and debate will be held on Tuesday, November 14, from 1:40 pm to 3:40 pm.

PUTTING IT ALL TOGETHER: LINKING BIOCOMPATIBILITY, EXTRACTABLES, AND LEACHABLES
Biocompatibility testing comprises both in vitro and in vivo tests, which are performed to determine the potential toxicity resulting from bodily contact with a material or medical device. This session will examine regulatory expectations and industry approaches for performing biocompatibility assessment associated with packaging and container closure systems, combination products, and process/single-use systems components and how this information can be linked to extractable and leachable assessments. Challenges associated with aligning industry practice with regulatory requirements will be discussed, including the emerging expectations from the Food and Drug Administration, United States Pharmacopeia, and ISO 10993 standards. 
This symposium will be held on Wednesday, November 15, from 9:40 am to noon.

SMALL MOLECULE VERSUS LARGE MOLECULE BIOMARKER LC/MS ASSAYS
It is common to associate molecular biomarkers with exclusively biologic macromolecules, but many laboratories are tasked with small molecule biomarkers. This symposium will present latest developments of liquid chromatography–mass spectrometry (LC/MS) approaches to bioanalysis of biomarkers highlighting the opportunities and challenges presented by small and large molecules. There is ongoing interest in the LC/MS of biomarkers. Since the topic gained regulatory interest with the Bioanalytical Method Validation Draft Guidance, the bioanalysis community has engaged regulators and bioanalytical practitioners to identify appropriate strategies. The approaches share some commonality between large and small molecules but clearly differ in others. 
This symposium will be held on Monday, November 13, from 1:20 pm to 3:40 pm.

ASSEMBLING AN ADVANCED ANALYTICAL TOOLKIT TO SUPPORT LAP DOSAGE FORMS
Over the past decade there has been a marked increase in the number of new drug entities that cannot be administered orally due to low bioavailability. For many of these drugs, parenteral administration provides a delivery opportunity. Of particular interest are depot-forming and implantable formulations that can sustain therapeutic drug concentrations over an extended period of time (weeks to months to years) and reduce administration frequency, thus improving patient adherence for indications where strict dosing regimens or life-long therapies are required (HIV, HCV, diabetes, and neurodiseases).
This symposium will be held on Wednesday, November 15, from 1:20 pm to 3:40 pm.

BIOTECHNOLOGY

FORCED-DEGRADATION STUDY FOR BIOLOGICS COMPARABILITY: FROM CLINICAL TO COMMERCIAL PHASE
Forced-degradation study (FDS) is usually used for the assessment of product comparability when there are significant changes to the manufacturing process. Results shed light on potential protein stability issues, but may also reveal slight differences in the structure of the molecule that would not be detectable in stability studies. This session will go over approaches from early clinical to commercial phases, such as designing leaner FDS studies based on the existing knowledge of product physicochemical characterization, critical quality attributes, and stability information, selecting analytical testing methods and technology, and understanding external factors that can impact study results bias that cause artificial rate comparison failures.
This sunrise session will be held on Monday, November 13, from 7:30 am to 8:45 am.

USE OF SAFETY BIOMARKERS IN DRUG DEVELOPMENT
This session will focus on use of safety biomarkers for effective decision making during drug development. The application of safety markers can allow for the selection of a drug candidate and the refinement of formulation and dosing regimen. Collaborative efforts are under way between regulatory agencies and the pharmaceutical industry to accelerate discovery, qualification, and verification of predictive toxicity biomarkers. Attendees will gain an in-depth understanding of the potential use of safety biomarkers during dose escalation and early decision making. The emphasis will be on blood-based safety biomarkers using ligand binding and mass spectrometry techniques.
This symposium will be held on Wednesday, November 15, from 1:20 pm to 3:40 pm.

DELIVERY OF NUCLEOTIDE BASED DRUGS: ARE WE GOING TOO FAST?
Several small pharma, biotechnology, and large pharmaceutical companies are now in the business of developing different nucleotide-based drugs (e.g., mRNA, RNAi, DNAi). For example, AstraZeneca, together with external partners, has developed drug delivery systems for nucleotide-based drugs such as modified mRNA and antisense oligonucleotides aimed at cardiovascular, metabolic, and oncological diseases. The speakers in this session will discuss the progress and challenges related to nucleotide-based drug delivery systems.
This symposium will be held on Tuesday, November 14, from 1:20 pm to 3:40 pm.

APPROPRIATE CRITERIA AND STATISTICAL APPROACHES FOR IMMUNOGENICITY EVALUATIONS
This session will facilitate a robust discussion of unresolved issues related to immunogenicity assays. There are various white papers, U.S. Pharmacopeia chapters, and regulatory guidance documents on validation of antidrug antibody assays. Appropriate statistical evaluation form the basis for estimation of assay cut points (CPs), determination of a low positive control (LPC) concentration, and outlier identification. Speakers in this session will discuss the interpretation of statistical approaches from both scientific and regulatory perspectives. This session intends to obtain a consensus regarding statistical approaches for setting CP, LPC, and related considerations. 
This dialogue and debate will be held on Tuesday, November 14, from 10 am to noon.

ONCOLOGY THERAPEUTICS: FORMULATION AND PROCESS DEVELOPMENT CHALLENGES
As new modalities are being developed for cancer therapies, formulation and process development considerations are becoming increasingly complex. For example, strategies from monoclonal antibody formulation and processing cannot be directly employed to other modalities due to the molecular characteristics and analytical characterization considerations. This symposium will focus on formulation, process, and key chemistry, manufacturing, and controls issues of new and upcoming modalities. The session will provide an overview of various modalities, highlighting critical issues during development through various case studies.
This symposium will be held on Wednesday, November 15, from 9:40 am to noon.

CLINICAL PHARMACOLOGY AND TRANSLATIONAL RESEARCH

ARE IN-SILICO APPROACHES USEFUL IN MITIGATING AND TREATING DRUG OVERDOSE?
This session will explore some of the innovations in in-silico approaches to inform the prevention, mitigation, and treatment of drug overdose in the clinical setting. The moderator and speakers have experience developing computational or statistical modeling tools and approaches for this patient-centered application.
This sunrise session will be held on Wednesday, November 15, from 7:30 am to 8:45 am.

FINDING THE BEST RECIPE: PERSPECTIVES ON PEDIATRIC FORMULATIONS
Extensive variability in pediatric dose and dosing regimens, based on individual maturational and non-maturational differences, is part of the essence of pediatric clinical pharmacology today. Thus, drug formulations must be tailored to neonates, infants, children, and adolescents. This must include valid data on product stability, palatability, and compatibility. With medicines that were neither designed, developed, nor evaluated specifically for pediatrics, children are treated with a risk of suboptimal (too low, too high, or too variable) dosing and side effects from potentially toxic ingredients, including excipients.
This symposium will be held on Wednesday, November 15, 1:20 pm to 3:40 pm.  

PERSONALIZED MEDICINE IN TOPICAL TREATMENTS: RELEVANCE OF RIGHT DOSE IN RIGHT PATIENT?
There are nearly 300 topical drugs in development for dermatological conditions, such as psoriasis and atopic dermatitis. The relevance of a key concept of precision medicine (right dose to the right patient) is not well defined for these treatments due to limited understanding of the determinants of systemic exposure, especially the impact of disease severity and extent on systemic exposure and implications for safety. This session will highlight the critical importance of precision medicine in specific aspects of topical treatment of skin disorders.
This dialogue and debate will be held on Monday, November 13, from 1:40 pm to 3:40 pm.

DRUG DISCOVERY AND DEVELOPMENT INTERFACE 

USING PBPK MODELING AND SIMULATION TO “PERSONALIZE” MEDICINE
Modern practice encompasses “personalized medicine” (PM) as an essential strategy to drive the most effective clinical decisions for optimal patient and population health. Physiologically based pharmacokinetic (PBPK) modeling and simulation as an in silico tool can capture the biological variability and translate it into exposure and efficacious response. PBPK in PM will develop the relationship between dose, physiology, and local or systemic exposure for a given subject or sub-population. This session will discuss caveats and the collaborative and integrative nature of using PBPK for PM. 
This sunrise session will be held on Tuesday, November 14, from 7:30 am to 8:45 am.

PREDICTING INTESTINAL AND HEPATIC DRUG DISPOSITION: APPLICATION OF BDDCS VERSUS ECCS
Assessment of oral absorption and liver disposition along with potential drug-drug interactions is important in the development of viable new molecular entities (NMEs). It is helpful to have tools that enable prediction of absorption mechanisms, impact of transporters, metabolizing enzymes, and their relevant interactions on the systemic exposure of NMEs. Classification systems such as Biopharmaceutics Drug Disposition Classification System (BDDCS) and Extended Clearance Classification System (ECCS) have been proposed recently to predict the disposition of NMEs. In this debate, we will discuss BDDCS and ECCS, the pros and cons of each, and their applications.
This dialogue and debate will be held on Wednesday, November 15, from 1:40 pm to 3:40 pm.

DRUG CANDIDATE SELECTION: IT’S ABOUT THE MOLECULE, THE MEDICINE, AND THE PATIENT
Despite remarkable improvements in technologies, the rate of failure of small molecules in clinical development is staggering, and the costs are increasingly unsustainable. This symposium will provide an overview of the various aspects of translating molecules to medicines via patient-centric candidate selection integrated with drug product design. It will cover case studies describing: a) the development of PK/PD relationships, b) compound and drug product attributes based on the desired performance criteria, and c) discovery and developability assessment flow schemes and the translational elements involved. Case studies will include nonstandard delivery platforms. 
This symposium will be held on Tuesday, November 14, from 9:40 am to noon.

DEVELOPABILITY ASSESSMENT FOR PEPTIDES AND PROTEINS: TURNING DISCOVERIES INTO PRODUCTS
Development of therapeutic peptides and proteins is a long and costly process that can take more than a decade from discovery to commercialization. While the risk assessment for developability of small molecules is well established, the same cannot be said for peptides and proteins. Is it possible to generate a standard workflow for the development of peptides and proteins, or do the intrinsic complications associated with these biologic entities indicate the need for a case-by-case development assessment strategy? Speakers from biopharmaceutical sciences, pharmacokinetics, and toxicology disciplines will cover developability assessment strategies with case studies. 
This symposium will be held on Monday, November 13, from 1:20 pm to 3:40 pm.

FORMULATION DESIGN AND DEVELOPMENT 

MISSION ACCOMPLISHED OR MISSION IMPOSSIBLE? DO EYEDROPS REACH THE BACK OF THE EYE?
 
In spite of higher concentrations, larger dose volume, and frequent dosing, concentrations in the posterior segment tissues of the eye are usually very low. Often the concentration differences in the posterior segment tissues of the dosed and the contralateral eye are not statistically significant, thereby indicating systemic absorption from the dosed eye and subsequent distribution into the contralateral eye. This raises doubts over the ability of topical delivery to reach the posterior segment tissues. This session will discuss this problem with case studies to rationalize both sides of the debate.
This dialogue and debate will be held on Wednesday, November 15, from 10 am to noon.

PREDICTING PRECIPITATION OF CLASS II MOLECULES TOWARD BETTER DEVELOPABILITY
Methods for predicting the exposure of oral dosage forms in humans in advance of clinical trials are essential in pharmaceutical development. This session will focus on aspects of precipitation to include in vitro measurement of precipitation rates, in vivo precipitation kinetics, and predictive mathematical models for assessing precipitation rates. It will also provide a practical understanding of the applicability and limitation for each of these methods and the appropriate situation when these or their combinations can be effectively used. 
This symposium will be held on Monday, November 13, from 1:20 pm to 3:40 pm.

NEW GENERATION NANOMEDICINE: SCIENTIFIC AND REGULATORY CHALLENGES
Nanomedicine is the application of nanotechnology to the discipline of medicine, which is continually evolving in many directions while adopting new technology. While it is continually expanding, it is also opening doors for commercialization of new products. This session will discuss the continual evolution of nanomedicine for all routes of administration, emphasizing newer platforms for drug delivery. The Food and Drug Administration has already approved dozens of drug products containing nanoparticles and/or nanodrugs. This session will discuss major scientific and regulatory challenges in developing nanomedicines. 
This symposium will be held on Tuesday, November 14, from 9:40 am to noon.

INHALATION DRUG DELIVERY: DPI FORMULATION
This session will cover the fundamentals of pulmonary drug delivery with emphasis on emerging dry powder inhaler research on interparticle adhesion and the place of unconventional formulation ingredients (e.g., hydrophilic polymers and hydrophobic lubricants) and strategies (e.g., blended versus coprocessed particles). Critical performance attributes of the drug-device combination product will be identified and control strategies discussed. 
This sunrise session will be held on Tuesday, November 14, from 7:30 am to 8:45 am.

ORAL DELIVERY OF BCS III MOLECULES AND PEPTIDES
This symposium offers insight on the challenges and opportunities associated with oral delivery of macromolecules, formulation variables, and strategies for protecting these molecules during their voyage along the unfriendly gastrointestinal tract; the interplay between the efflux and metabolic pathways on intestinal absorption; and latest case studies, including formulation design with the Self-Microemulsifying Drug Delivery System. The program emphasizes approaches that hold promise for the future of oral peptide delivery, notably those that involve transient interactions with transporters and reversible disruption of tight junctions. 
This symposium will be held on Tuesday, November 14, from 1:20 pm to 3:40 pm.

COLLABORATIVE INNOVATION: CASE STUDIES FOR NEW METHODOLOGIES DEVELOPMENT
Innovation is a critical aspect of reducing attrition rates, improving efficiency, and reducing overall cost for drug discovery and development. Increasingly, innovation requires collaboration. In an environment that allows innovation to flourish, the key driver is talent and a creative mindset. Through case studies, we will illustrate how two or more parties work together to define a problem and develop innovative solutions. These case studies will include discussion of the trials and errors in the process. 
This symposium will be held on Tuesday, November 14, from 1:20 pm to 3:40 pm.

LIPID EXCIPIENTS FOR TASTE MASKING, PEPTIDE DELIVERY, AND CONTROLLED DRUG RELEASE 
This scientific forum will provide an overview of the latest advancements in the use of lipid excipients and lipid-based drug delivery systems for taste masking, controlled drug release, and the delivery of macromolecules. It will address three themes of the 2017 AAPS Annual Meeting and Exposition—taste masking, controlled drug release, and delivery of macromolecules. 
This scientific forum will be held on Wednesday, November 15 from 1:20 pm to 3:40 pm.

MANUFACTURING SCIENCE AND ENGINEERING 

PROCESS VALIDATION LIFECYCLE APPROACH (PROS AND CONS): CHALLENGES AND OPPORTUNITIES
The expectations for process validation and process control have changed and are continuing to change for the better. More and more global health authorities and regulators are communicating their expectations for risk- and science-based justification for process control and validation approaches. A true lifecycle approach to process validation requires gathering useful, scientific information as process and control strategies are developed, thus saving time and resources during later qualification and validation stages. The key is better understanding of the process, its sources of variation and their control, and the correlation between validation studies, sampling plans, process performance, product quality, and continued process verification.
This dialogue and debate will be held on Monday, November 13, from 1:40 pm to 3:40 pm.

CONTINUOUS CRYSTALLIZATION OF APIS TO ENHANCE FORMULATION PERFORMANCE
Development efforts over the past decade have resulted in huge advances in continuous manufacturing and the first end-to-end continuous production. For further progress, a continuous crystallization process will be an essential part for active pharmaceutical ingredient (API) isolation and purification. Continuous crystallization of pharmaceuticals provides the ability to generate an enhanced range of particle attributes for use in the manufacturing of drug products. Stirred tank crystallizers (mixed suspension, mixed product removal) have been demonstrated to selectively crystallize both stable and metastable polymorphs via a kinetically controlled crystallization. Continuous steady state crystallizations have shown the ability to increase enantiomeric purity; improve crystal size distribution, crystal morphology; and increase purification efficiency through recycling of mother liquor and operation at conditions more preferential for crystal growth. 
This sunrise session will be held on Monday, November 13, from 7:30 am to 8:45 am.

EMERGING TECHNOLOGIES TO MEET THE NEEDS OF THE PATIENT
Patient-centric drug products are designed to meet the needs of patients receiving the treatment. By designing products with the patient in mind from the beginning, pharmaceutical companies could minimize the risks they encounter on the path to market. This session will discuss innovative drug designs and manufacturing platforms that can be considered to bring patient-specific dosage form to the market. Discussions will include design of novel dosage forms that meet the needs of special populations from pediatrics to geriatrics, on-demand manufacturing, and effective packaging techniques to deliver safe and effective drugs to patients around the globe.
This symposium will be held on Tuesday, November 14, from 1:20 pm to 3:40 pm.

WEARABLE DIAGNOSTICS AND THERAPEUTIC MONITORING IN DRUG THERAPY: VALIDITY AND OUTCOMES
Wearable diagnostics are increasingly investigated in healthcare. With wearable diagnostics, constant monitoring and feedback to the physician and patient are becoming a reality, enabling the change from a reactive to a proactive drug therapy. Leveraging the potential of information and communication technology (ICT) in drug discovery and product development bears significant opportunities for new effective treatments and better health outcomes in an increasingly cost competitive environment. This symposium will provide insight into applied ICT; the future opportunities of predictive, preventive, participatory, and personalized healthcare delivery; and the legal framework. 
This symposium will be held on Monday, November 13, from 1:20 pm to 3:40 pm.

PHARMACOKINETICS, PHARMACODYNAMICS, AND DRUG METABOLISM 

ACCELERATING HUMAN ADME: WHAT DOES CARBON DATING HAVE TO DO WITH THIS?
Accelerator mass spectrometry (AMS) has been used for decades for carbon dating ancient artifacts. AMS was introduced to the pharmaceutical industry many years ago; however, with the ever-present pressures to generate human data early for decision making, AMS is gaining traction. This symposium will 1) introduce AMS, regulatory aspects, and study designs for determining absolute bioavailability, mass balance/excretion, and drug metabolism in phase 1 studies; and 2) present case studies to illustrate the utility and advantages of conducting these studies early with AMS.
This symposium will be held on Tuesday, November 14, from 9:40 am to noon.

ADVANCED 3D-BIOPRINTED IN VITRO MODELS IN TOXICOLOGY AND DISEASE MODELING
Three-dimensional bioprinted tissues successfully model cellular complexity and therefore offer major advantages over conventional in vitro systems. Bioprinted tissues incorporate key architectural features and primary cell types, which can be maintained in culture on a timescale of several days to weeks. This session will educate participants on the bioprinting process and application in the manufacture of several types of human tissues. The specific aim will be to demonstrate the value and novel insights gained from using these advanced models when studying hepato and renal toxicity.
This sunrise session will be held on Monday, November 13, from 7:30 am to 8:45 am.

THE UNFOLDED STORY OF LONG LASTING OATP TRANSPORTER INHIBITION
Inhibition of transporters, in particular organic anion transporting polypeptides (OATPs) in the liver, is associated with a number of clinically relevant drug-drug interactions (DDIs). This session will highlight the state-of-the-art research regarding the long-lasting inhibition of OATPs based on clinically relevant probes and a range of cellular systems. Regulation mechanisms affecting OATP expression and activity, together with the potential role of trans-inhibition, transporter post-translational modification, and/or internalization will be discussed. Finally, translational impact on the assessment of transporter-mediated DDI risk is discussed within a physiologically based pharmacokinetic paradigm.
This dialogue and debate will be held on Monday, November 13, from 1:40 pm to 3:40 pm.

ADDING THE "T" TO ADME: PREDICTIVE TOXICITY IN DRUG DEVELOPMENT
Drug attrition is a major roadblock in the drug development pipeline with seven out of eight drugs failing to reach clinic. The incidence of cardiotoxicity, hepatotoxicity, neurotoxicity, and immune activity are common key reasons drugs fail. Often, this results from a lack of predictive models to provide an adequate response to newly developed molecules. A drug’s pharmacokinetic and pharmacodynamic behavior in humans can be studied accurately only in human subjects. The critical need for improved model systems to predict drug bioavailability, efficacy, and safety has been widely recognized. Significant progress in development of in vitro as well as in vivo models has recently been made.
This symposium will be held on Wednesday, November 15, from 9:40 am to noon. 

ADVANCING OUR KNOWLEDGE BASE FOR FORMULATING PEDIATRIC DRUGS
This symposium will illustrate how 1) preclinical in vitro and in vivo studies provide tools for screening new pediatric dosage forms; 2) clinical bioavailability/bioequivalence studies can characterize effects of formulation, food, and dosing vehicle (if appropriate) on pediatric dosage forms; 3) modeling and simulation studies of available preclinical and clinical data can be the basis for providing dosing recommendations in pivotal pediatric pharmacokinetic and phase 2/3 studies; and 4) regulatory agencies interpret biopharmaceutics data in assessing the safety and efficacy of new pediatric dosage forms. 
This symposium will be held on Wednesday, November 15, from 9:40 am to noon. 

A PRACTICAL GUIDE TO EXTRAPOLATION OF FIRST-PASS METABOLISM FROM IN VITRO EXPERIMENTS
This forum will provide education and discussion on first-pass metabolism where leading experts will lecture and provide supporting examples. The program will provide the basic understanding of the anatomy and physiology of the liver and gastrointestinal tract, mechanisms of metabolism, and the potential role of transporters. The ultimate aim of the program is to apply in vitro to in vivo extrap-olation techniques and assess the interplay between permeability, metabolism, and biologic variability in the prediction of first-pass metabolism. 
This scientific forum will be held on Tuesday, November 14, from 1:20 pm to 3:40 pm.

PHYSICAL PHARMACY AND BIOPHARMACEUTICS

LONG-ACTING INJECTABLES: DRIVING ADHERENCE AND DISEASE ELIMINATION
With a significant interest in the anti-infective space, especially for human immunodeficiency virus and hepatitis C virus infections, various long-acting approaches are evaluated with intent to improve access and adherence to therapy. Given the resurgence of long-acting injectables and the need to shift the development mindset from an “opportunistic” to a “design for delivery” approach, the session will focus on various molecule design; chemistry, manufacturing, and controls development; preclinical and clinical evaluation considerations through examples to highlight the challenges and opportunities.
This sunrise session will be held on Monday, November 13, from 7:30 am to 8:45 am.

SUBMITTING A PBPK APPLICATION? KNOW WHAT REGULATORS EXPECT!
In this session, the application and utility of physiologically based pharmacokinetic (PBPK) and absorption models in regulatory review will be shared. Key issues and challenges, case studies, and updates to describe regulatory agencies efforts in the development and application of modeling and simulation in review of investigational new drugs, new drug applications, and abbreviated new drug applications will be provided. It will also discuss opportunities for harmonization of regulations on PBPK modeling across the regulatory agencies to enable a greater role of modeling and simulation.
This dialogue and debate will be held on Tuesday, November 14, from 10 am to noon.

BEYOND BASICS: ADVANCED CHARACTERIZATION TO ENABLE PEPTIDE MEDICINE DEVELOPMENT
Recent decades have witnessed the resurgence of oligopeptides as a highly important biopharmaceutical due to advances in peptide chemistry and opportunities in biology. To capitalize on the opportunities peptides provide, unique considerations and challenges need to be overcome during peptide pharmaceutical development. This session will discuss the current use of biophysical characterization to inform these research topics and best practices evolved from the activities. Topics will cover peptide design, formulation development, mechanism elucidation, and risk mitigation strategies.
This symposium will be held on Tuesday, November 14, from 9:40 am to noon.

TRANSPORTER ENDOGENOUS BIOMARKERS: SEARCHING FROM GENETICS TO METABOLOMICS IN HUMANS
Searches for endogenous biomarkers have become more active in the last decade. The current paradigm to evaluate potential transporter-mediated drug-drug interactions (DDI) through administration of exogenous substrate drugs confers risks to participants and consumes considerable resources and cost. Recent studies demonstrated that hepatic and renal transporters could be the rate-determining process of clearance of a drug substrate, showing a good potential as loci for potential DDIs. This symposium will provide an overview of endogenous biomarkers involving drug transporters, highlight recent findings, and summarize characterizations of in vivo preclinical model and clinical studies.
This symposium will be held on Tuesday, November 14, from 1:20 pm to 3:40 pm.

REGULATORY SCIENCES

GLOBAL PEDIATRIC PRODUCTS: LESSONS LEARNED FROM THE PEPFAR MODEL
Recognizing the devastating impact of HIV as a global health crisis, bipartisan efforts led to the passage of HR 1298 and creation of the President’s Emergency Plan for AIDS Relief (PEPFAR). PEPFAR aimed to provide $15 billion in aid, targeting 12 countries in sub-Saharan Africa. This symposium will discuss PEPFAR-related regulations, the impact of such programs, and lessons learned including applicability to other major diseases impacting global health. Symposium speakers include a Food and Drug Administration representative, an industry expert with PEPFAR-related product development, and an academician with clinical experience. 
This symposium will be held on Tuesday, November 14, from 1:20 pm to 3:40 pm.

REGULATORY OVERVIEW OF CHANGE MANAGEMENT: COMPARABILITY PROTOCOLS AND CHANGE PLANS
While International Council for Harmonisation (ICH) Q8, Q9, Q10, and Q11 provide opportunities for a more science- and risk-based approach for assessing changes across the product lifecycle, the envisioned postapproval “operational flexibility” has not been achieved. ICH has focused on early stages of the lifecycle (i.e., development through launch). A similar focus is needed for the commercial manufacturing phase. Postapproval change management plans and comparability protocols offer the flexibility to reduce the reporting category. This session will provide an overview of flexible change management pathways and provide examples utilized for small molecules and biologics.
This sunrise session will be held on Tuesday, November 14, from 7:30 am to 8:45 am.

HARMONIZED QUALITY STATE: ARE WE THERE YET? NECESSITY, CHALLENGES, AND OPPORTUNITIES
Multinational pharmaceutical companies generally manufacture the same product, the same way for every market, region, and patient around the world. However, varying global regulatory expectations and review times can ultimately lead to the introduction of medicines into various regions at different points in time. This symposium will discuss the ongoing efforts between the different regulatory agencies and industry trade organizations to harmonize regulatory expectations related to global review and inspections. The challenges discussed are relevant for global registration of pharmaceuticals and biopharmaceuticals.
This symposium will be held on Monday, November 13, from 1:20 pm to 3:40 pm

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