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2019EDITORIAL CALENDAR
Covering the pharma industry since 1977
EDITORIAL COVERAGE: EXPERT INSIGHT AND ANALYSIS
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Pharmaceutical Technology sets the standard for publishing independent, industry-leading information on the technologies, strategies, and regulations crucial to professionals developing and manufacturing pharmaceuticals and biopharmaceuticals. The editorial mix of peer-reviewed papers, technical articles, technology reports, regulatory and business columns, and expert commentary provide comprehensive coverage of process and formulation development, manufacturing operations, drug delivery, packaging, labeling, and distribution.
Contributors from bio/pharmaceutical companies and industry supplier companies, columnists, and the editorial staff are experts, with specialized knowledge and experience in their fields.
EDITORIAL FOCUS
Each issue of Pharmaceutical Technology addresses a key trend in drug development and manufacturing including advances in equipment, instruments, and processes; drug formulation strategies; drug delivery trends; emerging dosage forms; biologic-drug development; CMC challenges; process development; and quality-related issues.
Through expert interviews, roundtable discussions, literature reviews, and survey analysis, the editors report on emerging trends, strategies, and best practices in these key areas.
SPECIAL COVERAGE
Throughout 2019, the editors will report on strategies bio/pharma companies can use to transform bio/pharmaceutical development and manufacturing using leading-edge technologies and methods to increase quality output and reduce costs.
PEER-REVIEWED RESEARCH
Pharmaceutical Technology publishes peer-reviewed papers in the form of data-driven research papers, literature and patent reviews, application and technical notes, and position papers on drug development topics. All papers undergo a double-blind peer-review process by the Pharmaceutical Technology Editorial Advisory Board, which comprises leading scientists, managers, directors, and consultants.
KEY TOPICS
Drug Development
Features address formulation and drug delivery challenges including solubility, controlled-release formulations, traditional and emerging dosage forms, and more. Advances in API synthesis of small- and large-molecule drug substances, as well as excipients to enhance drug properties, are also addressed.
MANUFACTURING, OPERATIONS, AND SUPPLY CHAIN
The editors examine problems and solutions for solid dosage, sterile, biopharmaceutical, and other drug forms. Experts share insights on manufacturing equipment, process controls, scale-up, packaging, tech transfer, supply chain, and facility and laboratory operations.
PLUS:
PEER-REVIEWED
Establishing Acceptance Limits for Uniformity of Dosage Units: Part 3
Freeze-Drying Process Optimization
MAY 2018 Volume 42 Number 5Cleaning Validation
Data Integrity
Single-Use Systems
FORMULATION The Role of Carriers in DPI Capsules
API SYNTHESIS & MANUFACTURING Consistent Quality Calls for Collaboration
PACKAGING Improving Visual Inspection
MAY 2018 Volume 42 Number 5
PLUS:
Emerging Technologies
Advance Oral Drug Delivery
Continuous API Processing
Curbing Opioid Use and Abuse
Dissolution Testing
JUNE 2018 Volume 42 Number 6
PEER-REVIEWEDA Study of the Effects of Histogram Binning on the Accuracy and Precision of Particle Sizing Measurements
FORMULATIONAmorphous Delivery System
QUALITYCQAs for Lyophilized Parenterals
BIOLOGICS MANUFACTURINGSubvisible Particle Imaging
EDITORIAL COVERAGE: EXPERT INSIGHT AND ANALYSIS
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ANALYTICAL TESTING
Feature articles and case studies address vital quality and characterization practices including solubility, dissolution, extractables and leachables, stability testing, protein characterization, and more.
QUALITY/REGULATIONS
Experts review current regulatory authority initiatives and offer insight on quality, critical quality attributes, good manufacturing practices, statistical analysis, and more.
The Regulatory Watch columns review legislation, court decisions, and regulatory changes in the United States and Europe.
Ask the Compliance Expert answers reader questions about good manufacturing practices and other regulatory issues.
OUTSOURCING
Trends, partnerships, and business activities in the contract services market are described by expert columnists. Other features examine best practices for working with contract service providers for drug development, manufacturing, and laboratory studies.
OTHER EDITORIAL FEATURES
New analytical instruments, automation and process control systems, information technology tools, laboratory equipment, and manufacturing equipment are described in Product Spotlight.
Business developments, new facilities, and other industry supplier activities are reported in PharmaCapsules.
Updates on global markets, industry research, partnerships/collaborations, and the drug pipeline are also featured.
CONTRIBUTION GUIDELINES
For information about contributing editorial features to Pharmaceutical Technology,visit www.PharmTech.com/pharmtech-author-guidelines.
PLUS:
PEER-REVIEWED
Evaluating the Impact of Sterilization on Gel Formulations
Modernizing Pharma Manufacturing
APRIL 2018 Volume 42 Number 4Certificates of Analysis
Protein Characterization
Electronic Batch Records
FORMULATION High-Concentration Proteins
API SYNTHESIS & MANUFACTURING API Sourcing
MANUFACTURING Inhalation Drug Products
APRIL 2018 Volume 42 Number 4
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PLUS:
EXCIPIENTS Controlled Release
BIOLOGICS Unified Process Control
DEVELOPMENT Next-Gen Expression Systems
Maintaining GMPs Requires
Continued Vigilance
JULY 2018 Volume 42 Number 7Serialization Deadline
Parenteral Packaging
Biosimilars Regulations
PEER-REVIEWED
Oral Delivery of Macromolecular Drugs
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2019 EDITORIAL COVERAGE
JANUARYAd Close: December 7, 2018
FOCUS
Transforming Bio/Pharma Development and ManufacturingAnnual Employment Survey
PEER-REVIEWED RESEARCH/TECHNICAL PAPERS
TECHNICAL TOPICS
DevelopmentAPI Development and Approval TrendsProtein/Peptide Drug Delivery
ManufacturingBiologic-Based Drug ManufacturingProcess Development
Quality/RegulationsRegulatory Outlook
AnalyticsSolubility
OperationsPackaging Trends
OutsourcingOutsourcing Outlook
DEPARTMENTS
US Regulatory WatchEuropean Regulatory WatchNew Product SpotlightPharmaCapsulesAsk the Compliance Expert
SHOWS
Pharmapack, Feb. 6–7, Paris, France
VALUE-ADDED
• FREE 3-Minute Podcast, posted on www.PharmTech.com or FREE whitepaper listing in the PharmTech Pharma Knowledge Resources Newsletter
• FREE Direct eResponse Ad Leads (Ask your rep for details.)
FEBRUARYAd Close: January 10
FOCUS
Analysis and Data Interpretation
PEER-REVIEWED RESEARCH/TECHNICAL PAPERS
TECHNICAL TOPICS
DevelopmentBiopharmaceutical APIsControlled-release Drug Formulation
ManufacturingTopical Drug ManufacturingLyophilization
Quality/RegulationsRegulatory Focus: Sterile/Aseptic Manufacturing
AnalyticsLab Data Integrity
OperationsFacility Design and Engineering
Supply ChainCold Chain
OutsourcingAnalytical Best Practices
DEPARTMENTS
US Regulatory WatchEuropean Regulatory WatchNew Product SpotlightPharmaCapsulesAsk the Compliance Expert
SHOWS
PDA Annual Meeting, March 11–13, San Diego, CA
VALUE-ADDED
PDA News Release (Print and ePT e-newsletter)
SPECIAL THEMED SUPPLEMENT
Partnering for Bio/Pharma SuccessBest practices and metrics for choosing contract service suppliers, ensuring quality control in vendor relationships, technology transfer, and intellectual property issues.
MARCHAd Close: February 8
FOCUS
Technology Drivers for Bio/Pharma Manufacturing Advances
PEER-REVIEWED RESEARCH/TECHNICAL PAPERS
TECHNICAL TOPICS
DevelopmentExcipients for Solubility EnhancementBiologic Drug Formulation
ManufacturingSolid/Semi-Solid Drug ManufacturingRefurbished Equipment
Quality/RegulationsRegulatory Focus: Emerging Therapies
AnalyticsStability Testing
OperationsLab Operations
OutsourcingOutsourcing Outlook
DEPARTMENTS
US Regulatory WatchEuropean Regulatory WatchNew Product SpotlightPharmaCapsulesAsk the Compliance Expert
SHOWS
• Pittcon, March 17-21, Philadelphia, PA• DCAT Week, March 19–22, New York, NY• INTERPHEX, April 2–4, New York, NY
VALUE-ADDED
• INTERPHEX Show Guide (Print)• INTERPHEX Show Guide (Online and special Newsletter)
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2019 EDITORIAL COVERAGE
APRILAd Close: March 13
FOCUS
Patient-Centric Drug Development/Formulation
PEER-REVIEWED RESEARCH/TECHNICAL PAPERS
TECHNICAL TOPICS
DevelopmentSourcing API Development/ManufacturingDrug Delivery Methods
ManufacturingBiologic-Based Drug ManufacturingContinuous Manufacturing
Quality/RegulationsBatch Records
AnalyticsParticle CharacterizationStatistical Solutions
OperationsTech Transfer
Supply ChainAnticounterfeiting
OutsourcingFormulation Best Practices
DEPARTMENTS
US Regulatory WatchEuropean Regulatory WatchNew Product SpotlightPharmaCapsulesAsk the Compliance Expert
SHOWS
• CPhI North America, April 30–May 2, Chicago, IL• ExcipientWorld, May 7–8, National Harbor, MD
VALUE-ADDED
• CPhI North America Exhibitor Guide (Print)• CPhI North America Exhibitor Guide (Online and special Newsletter)
SPECIAL THEMED SUPPLEMENT
Solid Dosage Drug Development and Manufacturing featuring the CPhI North America Planning GuideTrends in the development of solid-dosage drug forms, including excipients, API compatibility, formulation development, solubilization, and new manufacturing equipment.
MAYAd Close: April 9
FOCUS
Bioprocessing Productivity Enhancement
PEER-REVIEWED RESEARCH/TECHNICAL PAPERS
TECHNICAL TOPICS
DevelopmentManaging Excipient VariabilityParticle Engineering
ManufacturingAseptic/Sterile Drug ManufacturingSingle-Use Manufacturing
Quality/RegulationsCritical Quality Attributes
AnalyticsCleaning Validation
OperationsPackaging Trends
OutsourcingOutsourcing Outlook
DEPARTMENTS
US Regulatory WatchEuropean Regulatory WatchNew Product SpotlightPharmaCapsulesAsk the Compliance Expert
SHOWS
• BIO International Convention, June 3–6, Philadelphia, PA• DCAT Sharp Sourcing, June, Location TBD
VALUE-ADDED
FREE Direct eResponse Ad Leads (Ask your rep for details.)
SPECIAL THEMED EBOOK
Biologics and Sterile Drug Manufacturing eBookNovel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs including single-use systems, facilities and equipment, contamination issues, and process analytics.
JUNEAd Close: May 14
FOCUS
Advances in Drug Delivery Devices
PEER-REVIEWED RESEARCH/TECHNICAL PAPERS
TECHNICAL TOPICS
DevelopmentHigh-Potency API ManufacturingSolubility/Bioavailability
ManufacturingInhalation Drug ManufacturingScale-Up
Quality/RegulationsGood Laboratory Practices
AnalyticsGlycosylation
OperationsProcess Operations
Supply ChainTrack and Trace/Serialization
OutsourcingManufacturing Best Practices
DEPARTMENTS
US Regulatory WatchEuropean Regulatory WatchNew Product SpotlightPharmaCapsulesAsk the Compliance Expert
VALUE-ADDED
FREE 3-Minute Podcast, posted on www.PharmTech.com OR Free Whitepaper listing in the PharmTech Pharma Knowledge Resources Newsletter
BUYERS’ GUIDE
Buyers’ Guide and Best PracticesThe global resource for suppliers of chemicals, raw materials, intermediates and excipients; equipment and supplies for manufacturing, packaging, and cleanrooms; laboratory equipment; and contract services. Plus, recommended best practices for laboratory, formulation, manufacturing, and packaging functions.
www.pharmtech.com
2019 EDITORIAL COVERAGE
JULYAd Close: June 11
FOCUS
Defining Good Manufacturing Practices
PEER-REVIEWED RESEARCH/TECHNICAL PAPERS
TECHNICAL TOPICS
DevelopmentAdvances in Small-Molecule API SynthesisSolid-Dosage Drug Forms
ManufacturingAseptic/Sterile Drug ManufacturingDigital Manufacturing Connections
Quality/RegulationsGood Automation Practices
AnalyticsEndotoxin Testing
OperationsPackaging Trends
OutsourcingOutsourcing Outlook
DEPARTMENTS
US Regulatory WatchEuropean Regulatory WatchNew Product SpotlightPharmaCapsulesAsk the Compliance Expert
SHOWS
Controlled Release Society, July 21–23, Valencia, Spain
VALUE-ADDED
Double Up Ad Program: Ask you Rep for details.
AUGUSTAd Close: July 10
FOCUS
Overcoming CMC Challenges
PEER-REVIEWED RESEARCH/TECHNICAL PAPERS
TECHNICAL TOPICS
DevelopmentExcipients for Controlled-Release FormulationsParenteral Drug Formulation
ManufacturingSolid/Semi-Solid Drug ManufacturingClinical Trial Materials
Quality/RegulationsGood Manufacturing Practices
AnalyticsProtein Characterization
OperationsLab Operations
Supply ChainLogistics/Shipping
OutsourcingAnalytical Best Practices
DEPARTMENTS
US Regulatory WatchEuropean Regulatory WatchNew Product SpotlightPharmaCapsulesAsk the Compliance Expert
VALUE-ADDED
FREE Product/Service Profile Posted Online and Listed in Special eNewsletter
SPECIAL THEMED SUPPLEMENT
Outsourcing Resources: Technology and Process Support for Bio/Pharma Development and ManufacturingAn annual review of the market for outsourced resources, including analysis of contract services and business, regulatory, and supply chain issues.
SEPTEMBERAd Close: August 9
FOCUS
Right-Scaling the Drug Manufacturing Process
PEER-REVIEWED RESEARCH/TECHNICAL PAPERS
TECHNICAL TOPICS
DevelopmentAdvances in Biologics API SynthesisTablet Formulation
ManufacturingAseptic/Sterile Drug ManufacturingTableting
Quality/RegulationsMeasuring Quality
AnalyticsContainer Closure Testing
OperationsFacility Design and Engineering
OutsourcingOutsourcing Outlook
DEPARTMENTS
US Regulatory WatchEuropean Regulatory WatchNew Product SpotlightPharmaCapsulesAsk the Compliance Expert
SHOWS
Pack Expo, Sept. 23–25, Las Vegas, NVPDA/FDA Joint Regulatory Conference, Dates TBD, Washington, DC
VALUE-ADDED
Pharma Marketplace online directory program. Ask your rep for details.
SPECIAL THEMED EBOOK
PharmTech’s Regulatory Sourcebook and ReferenceA compilation of regulations, guidances, regulations, compendial documents, position papers, and enforcement actions from global regulatory authorities.
www.pharmtech.com
2019 EDITORIAL COVERAGE
OCTOBERAd Close: September 10
FOCUS
Drug Dosage Forms Trends
PEER-REVIEWED RESEARCH/TECHNICAL PAPERS
TECHNICAL TOPICS
DevelopmentDrug Stability Lipid-based FormulationsManufacturingSolid/Semi-Solid Drug ManufacturingManufacturing Data IntegrityQuality/RegulationsInspection Readiness and ResponseAnalyticsDissolution TestingStatistical SolutionsOperationsPackaging Trends Supply ChainRaw Materials TrackingOutsourcingFormulation Best Practices
DEPARTMENTS
US Regulatory WatchEuropean Regulatory WatchNew Product SpotlightPharmaCapsulesAsk the Compliance Expert
SHOWS
• AAPS 2019 PharmSci 360, Nov. 3–6, San Antonio, TX• CPhI Worldwide, November 5–7, Frankfurt, Germany
VALUE-ADDED
• AAPS Exhibitor Guide (Print)• AAPS Exhibitor Guide (Online and Special Newsletter)• CPhI Worldwide Exhibitor Guide (Print)• CPhI Worldwide Exhibitor Guide (Online and Special Newsletter)
SPECIAL THEMED SUPPLEMENT
APIs, Excipients, and Manufacturing featuring theCPhI/ICSE Worldwide Planning GuideDevelopments in the synthesis of APIs and intermediates, plus advances in formulation, development, and finished-product manufacturing.
NOVEMBERAd Close: October 11
FOCUS
Best Practices for Quality Control
PEER-REVIEWED RESEARCH/TECHNICAL PAPERS
TECHNICAL TOPICS
DevelopmentAPI Formulation TrendsTaste-masking
ManufacturingTransdermal Drug ManufacturingProcess Control/Automation
Quality/RegulationsRegulatory Focus: Solid/Semi-solid Dosage Drugs
AnalyticsLyophilization
OperationsTech Transfer
OutsourcingOutsourcing Outlook
DEPARTMENTS
US Regulatory WatchEuropean Regulatory WatchNew Product SpotlightPharmaCapsulesAsk the Compliance Expert
VALUE-ADDED
FREE Direct eResponse Ad Leads(Ask your rep for details.)
DECEMBERAd Close: November 8
FOCUS
Manufacturing Continuity Strategies
PEER-REVIEWED RESEARCH/TECHNICAL PAPERS
TECHNICAL TOPICS
DevelopmentAPI/Excipient InteractionsSolubility/Bioavailability
ManufacturingBiologic-Based Drug ManufacturingProcess Modeling
Quality/RegulationsDesign of Experiments
AnalyticsExtractables and Leachables Testing
OperationsProcess Operations
Supply ChainDrug Product Tracking
OutsourcingManufacturing Best Practices
DEPARTMENTS
US Regulatory WatchEuropean Regulatory WatchNew Product SpotlightPharmaCapsulesAsk the Compliance Expert
VALUE-ADDED
Double Up Ad Program: Ask your Rep for details.
SPECIAL SPONSORED-CONTENT ISSUE
Corporate CapabilitiesFull-page descriptions of products and services from the industry’s leading suppliers. Profiles are posted online for six months.
SPECIAL THEMED EBOOK
PharmTech’s Regulatory Sourcebook and ReferenceAn updated compilation of regulations, guidances, regulations, compendial documents, position papers, and enforcement actions from global regulatory authorities.
www.pharmtech.com
CONTACTS
NORTH AMERICA OFFICE485F US Highway 1 South, Suite 210
Iselin, NJ 08830
PublisherMike Tracey
732.346.3027 • [email protected]
Sales Manager - North AmericaJoel Kern
215.968.7720 • [email protected]
Senior Director, Digital MediaMichael Kushner
732.346.3028 • [email protected]
Associate Marketing DirectorAmy Hurtado
203.523.7118 • [email protected]
Marketing Associate Brianne Pangaro
732.346.3019 • [email protected]
Marketing CoordinatorTara Jazikoff
732.346.3023 • [email protected]
Ad CoordinatorKristi Stevenson
732.346.3031 • [email protected]
EUROPE OFFICEUBM
Hinderton Point • Lloyd Drive • Cheshire Oaks
Cheshire, CH65 9HQ, UK
Sales Managers - EuropeLinda Hewitt
44 (0) 151 353 3520 • [email protected]
European Sales Manager
Stephen Cleland
44(0) 151 353 3647 • [email protected]
European Sales Executive
US EDITORIAL OFFICE485F US Highway 1 South
Suite 210
Iselin, NJ 08830
Editorial Director
Rita Peters
732.346.3038 • [email protected]
Send press releases to [email protected]