2019 EDITORIAL CALENDAR - PharmTechfiles.pharmtech.com/alfresco_images/pharma/2018/10/02/...release formulations, traditional and emerging dosage forms, and more. Advances in API synthesis

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2019EDITORIAL CALENDAR

Covering the pharma industry since 1977

EDITORIAL COVERAGE: EXPERT INSIGHT AND ANALYSIS

www.pharmtech.com

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


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


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


TECHNICAL TOPICS

DevelopmentExcipients for Solubility EnhancementBiologic Drug Formulation

ManufacturingSolid/Semi-Solid Drug ManufacturingRefurbished Equipment

Quality/RegulationsRegulatory Focus: Emerging Therapies

AnalyticsStability Testing

OperationsLab Operations


DEPARTMENTS


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)

www.pharmtech.com


APRILAd Close: March 13

FOCUS

Patient-Centric Drug Development/Formulation


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


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)


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


TECHNICAL TOPICS

DevelopmentManaging Excipient VariabilityParticle Engineering

ManufacturingAseptic/Sterile Drug ManufacturingSingle-Use Manufacturing

Quality/RegulationsCritical Quality Attributes

AnalyticsCleaning Validation



DEPARTMENTS


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


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


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


JULYAd Close: June 11

FOCUS

Defining Good Manufacturing Practices


TECHNICAL TOPICS

DevelopmentAdvances in Small-Molecule API SynthesisSolid-Dosage Drug Forms

ManufacturingAseptic/Sterile Drug ManufacturingDigital Manufacturing Connections

Quality/RegulationsGood Automation Practices

AnalyticsEndotoxin Testing



DEPARTMENTS


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


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


VALUE-ADDED

FREE Product/Service Profile Posted Online and Listed in Special eNewsletter


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


TECHNICAL TOPICS

DevelopmentAdvances in Biologics API SynthesisTablet Formulation

ManufacturingAseptic/Sterile Drug ManufacturingTableting

Quality/RegulationsMeasuring Quality

AnalyticsContainer Closure Testing

OperationsFacility Design and Engineering


DEPARTMENTS


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.


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


OCTOBERAd Close: September 10

FOCUS

Drug Dosage Forms Trends


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


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)


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


TECHNICAL TOPICS

DevelopmentAPI Formulation TrendsTaste-masking

ManufacturingTransdermal Drug ManufacturingProcess Control/Automation

Quality/RegulationsRegulatory Focus: Solid/Semi-solid Dosage Drugs

AnalyticsLyophilization

OperationsTech Transfer


DEPARTMENTS


VALUE-ADDED

FREE Direct eResponse Ad Leads(Ask your rep for details.)

DECEMBERAd Close: November 8

FOCUS

Manufacturing Continuity Strategies


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


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.


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


Senior Director, Digital MediaMichael Kushner


Associate Marketing DirectorAmy Hurtado


Marketing Associate Brianne Pangaro


Marketing CoordinatorTara Jazikoff


Ad CoordinatorKristi Stevenson


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


Send press releases to [email protected]

Documents

2019 EDITORIAL CALENDAR - PharmTechfiles.pharmtech.com/alfresco_images/pharma/2018/10/02/...release formulations, traditional and emerging dosage forms, and more. Advances in API synthesis