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Embedding Time-Critical Scheduling In Drug Production
Drug manufacturing is a multifaceted undertaking in which numerous parallel processes, activities and resources must be marshaled and reconciled within a high-pressure environment where human errors inevitably occur.
Articles & Features
Byondis: Taking Precision Medicine To The Next Level
Breakthrough solutions based on new biological entities (ADCs and mAbs) are making hope real for patients with conditions of high unmet medical need. Byondis is developing therapies that target intractable cancers and autoimmune diseases and taking precision medicine to the next level.
STADA Strengthens Specialty Partnership Role Via US Filing
Working with US commercial partner Supernus to file an NDA for an apomorphine infusion pump is testament to how Germany’s STADA Arzneimittel is increasingly a go-to-partner for specialty pharmaceuticals, as well as generics and consumer healthcare products.
Amgen Takes on One of Cancer’s Toughest Challenges
Discusses KRAS G12C and the importance of biomarker testing in non-small cell lung cancer (NSCLC).
Best Practices In Seasonal Vaccine Efficacy Studies: Tips For Successful Planning And Execution
Classical, randomized placebo-controlled efficacy studies of vaccines for seasonal illnesses, such as influenza and respiratory syncytial virus (RSV), must conform to the calendar and run like clockwork. Typically, they are very large studies – with tens of thousands of subjects – and operate within a compressed timeframe dictated by the respiratory season. Thus, they cannot be undertaken as “business-as-usual,” but rather require accelerated processes, rapid decision-making, and a different approach to risk. Here, we outline the challenges in these studies and share our recommendations for study planning, enrollment, surveillance and study closeout. With the right planning and support, these challenging studies can be completed successfully within the narrow seasonal window.
Rethinking Patient And Site Engagement
Drug development costs are increasing annually, with clinical trials identified as one of the most expensive and time-consuming stages of the development process. One factor contributing to this cost inflation is more complex study protocols, which can lengthen trial times while increasing the burden on sites and patients.
Planning For Regulatory Variation In NDA To BLA Transitions
The deadline is fast approaching for biological products approved as New Drug Applications (NDAs) in the US to transition to Biologics License Application (BLA) approvals under the Biologics Price Competition and Innovations Act of 2009 (BPCIA). As of 23 March 2020, NDAs for insulins, human growth hormones, and other proteins authorized under Section 505 of the Federal Food, Drug and Cosmetics Act (FFDCA) will be ‘deemed to be biologics licenses’, and regulated as such, by the US Food and Drug Administration (FDA) under the Public Health Services Act (PHSA).
A Reflection On BTD And RMAT Designations
The continuing interest in cell and gene therapies is reflected by the 800+ active investigational new drug (IND) applications within the field that are on file with the US Food and Drug Administration (FDA).1 This trend is only set to increase, with the FDA foreseeing the approval of 10–20 cell and gene therapy (CGT) products per year by 2025.2
Mapping The FDA Approval Path: 20 Years Of Precedent With RxTROSPECT
The pace of innovation in oncology, with aggressive drug development, new approaches such as immunotherapies, increasing patient segmentation and multiple drug targets even within a single cancer type demands equally creative responses from regulators. The US Food and Drug Administration (FDA) has expedited cancer-drug development through mechanisms and incentives such as the accelerated approval program, the breakthrough therapy designation and the Orphan Drug Act. Associated initiatives such as adaptive study endpoints, reliance on earlier evidence supplemented by real-world data and less complex trial designs have helped to ease the pathway for cutting-edge cancer therapies.
LabTwin Voice Activated Lab Assistant To Launch At BIO
The German tech company LabTwin is launching its voice-activated (VA) lab assistant at BIO in Philadelphia in June. The technology is a game-changer for scientists working in labs and is a major advance in the digitization of the laboratory.
Downloads & Multimedia
eBooks | ||
Orphan Drug Market Access: Opportunities & Challenges | Download PDF ![]() |
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Key Market Access Considerations for the Asian Market | Download PDF ![]() |
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Evolving Regulatory Landscape In APAC Points To Regional Medtech Growth | Download PDF ![]() |
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EU Medtech Regulation: Uncertainty, Delays and Brexit Create the Perfect Storm | Download PDF ![]() |
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The Intersection of AI, Data and Health Care – Is Medtech Ready? | Download PDF ![]() |
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Pharmaceutical Development And Manufacturing: Challenges And Opportunities | Download PDF ![]() |
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Taming the Deluge: How Automation and Real-Time Data Access Will Reshape Clinical Trials | Download PDF ![]() |
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Trends in Generics 2019 | Download PDF ![]() |
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Clinical Solutions In The Digital Era: Why OEMs Are Partnering To Deliver Breakthrough Technologies | Download PDF ![]() |
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Cell Therapy | Download PDF ![]() |
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Drug Safety eBook | Download PDF ![]() |
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Pharma Asset Insights eBook | Download PDF ![]() |
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Early Drug Development: Considerations When Planning & Conducting Early Stage Trials | Download PDF ![]() |
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Value-based Healthcare: Executing On The Vision | Download PDF ![]() |
Research Reports | ||
Identifying Challenges and Opportunities in Stage III NSCLC Treatment | Download PDF ![]() |
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Achieving Launch Excellence In The Challenging Healthcare Markets Of Today | Download PDF ![]() |
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Research Report: Challenges And Opportunities In Clinical Data Management |
Download PDF ![]() |
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Addressing the Data Challenges of Pharmacovigilance | Download PDF ![]() |
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How to Efficiently Manage Clinical Trial Comparator Sourcing Challenges | Download PDF ![]() |
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Value-Based Care: How To Enable The Medical Device Organization Of The Future | Download PDF ![]() |
Videos | ||
Clinical Trial Randomization and Supply Management Systems of Tomorrow | View Video ![]() |
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Addressing the Data Challenges of Pharmacovigilance | View Video ![]() |
Webinars | |
Optimizing Clinical Trials for Commercial Success | Register ![]() |
It’s Never Too Late: Improve Clinical Trial Processes with a Unified Platform | Register ![]() |
Realizing The Opportunity To Increase Quality And Improve Efficiency Of Safety Data Collection Within Patient Support Programs | Register ![]() |
The Current State of Gene Therapy Trials | Register ![]() |
Future Directions - Formulation in the Drug Development Process | Register ![]() |
The Template for a Successful Digital Trial | Register ![]() |
Pediatric Drug Development: Unique Considerations and Challenges | Register ![]() |
Simplifying Regulatory Processes For Post-approval Changes With Unified RIM | Register ![]() |
More Patients, Faster. The Next Evolution Of Oncology Drug Development | Register ![]() |
Disrupting The Status Quo Of eClinical Identity Management: Removing The Burden At Clinical Trial Sites | Register ![]() |
Does the UK’s Life Sciences Industrial Strategy And Sector Deal Make Brexit Easier to Swallow? | Register ![]() |
Addressing Key Challenges In The Clinical Development Of Combination Immuno-oncology Therapies | Register ![]() |
eConsent: Better For The Patient, Better For The Site | Register ![]() |
What's Next In eCOA? - New Insights Into Equivalence Testing Methodology And Implications For BYOD | Register ![]() |
Using Innovative Materials To Drive Medical Device Design | Register ![]() |
Using Innovative Materials To Drive Medical Device Design - Part 2 | Register ![]() |
Body Fluids Analysis With Linearity Down to Zero | Register ![]() |
Modernising Clincal Trial Processes | Register ![]() |
Optimizing Medtech Companies For A New Era | Register ![]() |
2020: Top MedTech Priorities. Critical Action Steps Forward | Register ![]() |
A Patient-centric Approach to Digital Value Added Medicines | Register ![]() |
Inflammatory Bowel Disease (IBD) Update | Register ![]() |
Patient Selection/Outcomes using Machine Learning for Precision Oncology: A pipedream or a reality? | Register ![]() |
Bringing In Silico Immunogenicity Prediction into the 21st Century with Augmented Intelligence | Register ![]() |
Improving Drug Candidate Success Through Evaluating Specificity, Immunogenicity, Functionality & Manufacturability | Register ![]() |
Accelerating Clinical Development in the Asia-Pacific Region | Register ![]() |
Ensuring Rapid Response: Intelligent Automation for Covid-19 | Register ![]() |
Real-World Evidence for Regulatory Decision-Making, In the Era of Covid-19 |
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Multiomics and Biomarkers in Rare Diseases Supporting Development and Commercialization of Orphan Drugs | Register ![]() |
Beyond Skin: Accelerating product development for non-traditional routes of delivery | Register ![]() |
Using Specific Productivity Optimization Technology During Cell Line Development To Achieve High Titres | Register ![]() |
Meeting the Challenges of Regulatory Information Management | Register ![]() |
Leveraging A Partner Research Organization In Response To A Global Health Emergency | Register ![]() |
In-home visits to reduce patient burden and improve retention in clinical trials |
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Keeping your trial on track in the evolving environment of COVID-19 | Register ![]() |
Meeting the Challenges of Regulatory Information Management: Executive Summary | Download PDF ![]() |
Whitepapers & Special Reports | ||
The Art Of Gene Therapy | Download PDF ![]() |
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Finding Growth In A Tough Environment | Download PDF ![]() |
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Delivering Patient-centric Care with Digitalization in MedTech | Download PDF ![]() |
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How Medtech is Responding to Changes Set To Reshape the Industry | Download PDF ![]() |
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Harnessing AI And Machine Learning To Improve R&D Efficiency And Reproducibility | Download PDF ![]() |
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Use of Real-World Evidence Expands To Transform Drug Development | Download PDF ![]() |
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Boosting R&D Productivity With Pooled CRISPR Screening | Download PDF ![]() |
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One Route, Many Languages: Managing Translation Complexities in the EMA Centralised Procedure | Download PDF ![]() |
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Infographic: Managing Clinical Trial Data In An Era Of Abundant Information | Download PDF ![]() |
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Releasing The Potential: How Novel Drug Delivery Technologies Can Deliver Competitive Advantage In The Solid Oral-dose Sector | Download PDF ![]() |
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How To Run Successful Clinical Trials In Japan | Download PDF ![]() |
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Releasing The Brakes: How New RTSM/IRT Solutions Will Accelerate Drug Development | Download PDF ![]() |
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Biosimilars Review: Impact of increasing Global Competition on Biosimilars | Download PDF ![]() |
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Achieving Translation Quality Through Process Design | Download PDF ![]() |
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Managing Cold Chain Risk Through Appropriate Packaging: One Size Doesn't Fit All | Download PDF ![]() |
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Optimizing Global Safety Reporting in Clinical Trials | Download PDF ![]() |
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Special Report Disruptive Innovation – The Impact | Download PDF ![]() |
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Getting The Words Right: Device Documentation And Translation in Asia | Download PDF ![]() |
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Precision Medicine Research: How Advanced Data Analytics Support The Journey From Clinic To Bedside | Download PDF ![]() |
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Getting It Right – Drawing Together Key Stakeholders To Shape The Real-World Data Revolution | Download PDF ![]() |
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Accelerating Cancer Drug Development | Download PDF ![]() |
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Improving Pharma R&D Efficiency: The Case for a Holistic Approach to Transforming Clinical Trials | Download PDF ![]() |
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Meeting Growth Challenges Roundtable | Download PDF ![]() |
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Innovation UK: Pushing life science frontiers in the North of England | Download PDF ![]() |
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Medical Devices Aren’t Luxury Goods, So Why Does Medtech Try to Sell Them That Way? | Download PDF ![]() |
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Translating Innovation Medtech Made Local | Download PDF ![]() |
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Positioning Key Accounts at the Center of Medtech’s Commercial Model | Download PDF ![]() |
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Assessing Patient Availability | Download PDF ![]() |
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Adaptive Design Years Later; What have we learned? | Download PDF ![]() |
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Applying Disruptive Innovation in CNS Clinical Trials to Reduce Variability | Download PDF ![]() |
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Cell And Gene Therapy Rapid Approvals Can Pose Commercialization Challenges | Download PDF ![]() |
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Successful Linguistic Validation of Clinical Outcomes Assessments | Download PDF ![]() |
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Generics In The US 2018 | Download PDF ![]() |
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Improving Subject Selection and Endpoint Management in Alzheimer’s Trials | Download PDF ![]() |
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RTSM/IRT: A Roadmap For Developing Systems That Address Current Frustrations | Download PDF ![]() |
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Addressing the Data Challenges of Pharmacovigilance | Download PDF ![]() |
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Meeting the Challenges of HPAPI Production | Download PDF ![]() |
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FROM HUMAN TO MACHINE: AI And RPA Are Kick-Starting Productivity To Fuel Medical Breakthroughs | Download PDF ![]() |
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A Reflection On BTD And RMAT Designations | Download PDF ![]() |
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BLURRED LINES: Is The Generics Industry Moving Into Big Pharma’s Space? | Download PDF ![]() |
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Value and Differentiation: Planning for Successful Oncology Market Access | Download PDF ![]() |
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Reconciling Price and Value: Reimbursement Strategies for Gene Therapies | Download PDF ![]() |
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NASH Pricing Strategies Infographic | Download PDF ![]() |
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Denials, Delays and Deep Discounts. Poor Insurance Coverage for Pharmaceuticals at Launch | Download PDF ![]() |
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A New Frontier In Digital Health Care: Software As Medical Devices | Download PDF ![]() |
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Rethinking Medical Device Go-To-Market Strategies | Download PDF ![]() |
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Changing Approaches to Global Development of Medical Device Products | Download PDF ![]() |
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An Idea Whose Time Has Come: Why Now Is The Point To Integrate Clinical And Commercial Teams | Download PDF ![]() |
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Regulatory Requirements for Medical Devices in China | Download PDF ![]() |
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MEDTECH IN 2020: The Key Themes Shaping An Industry In Transition | Download PDF ![]() |
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DESIGNING THE FUTURE OF LIFE SCIENCES: How Automation And AI Are Creating A More Efficient Industry | Download PDF ![]() |
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Advancing Precision Medicine – Challenges And Opportunities | Download PDF ![]() |
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The Challenging Environment Of Clinical Trial Oversight | Download PDF ![]() |
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Improving Clinical Trial Oversight Infographic | Download PDF ![]() |
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Excellence In Payer Engagement: Strategic Outputs From A Roundtable Discussion | Download PDF ![]() |
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Using Differentiated Drug-Delivery Technologies To Deliver Competitive Advantages | Download PDF ![]() |
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Accurate PGx Testing: The Gateway To Personalized Medicine | Download PDF ![]() |
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Drug Manufacturing And Development In The Age Of Precision Medicine | Download PDF ![]() |
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BASE EDITING: An Innovative Player Driving Cell And Gene Therapy To New Frontiers | Download PDF ![]() |
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The Future for Pharmacovigilance Is End-to-End Outsourcing | Download PDF ![]() |
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Perfusion: A Biologic Production System Tailor-Made for Difficult-to-Express Molecules | Download PDF ![]() |
Special Edition eBooks | ||
Digital Scrip Awards 2020 eBook | Download PDF ![]() |
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OTC Marketing Awards 2020 eBOOK | Download PDF ![]() |
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Clinical Trials in Asia | Download PDF ![]() |
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Clinical & Research Excellence Awards 2019 eBook | Download PDF ![]() |
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Clinical & Research Excellence Awards 2018 eBook | Download PDF ![]() |
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Global Generics & Biosimilars Awards 2018 | Download PDF ![]() |
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Pharma Asset Insights eBook | Download PDF ![]() |
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CPhI Preview North America 2019 | Download PDF ![]() |
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OTC Awards ebook 2019 | Download PDF ![]() |
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Scrip Awards eBook 2018 | Download PDF ![]() |
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MTI Awards eBook 2018 | Download PDF ![]() |
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CPhI Preview 2018 | Download PDF ![]() |
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Digital Citeline Awards 2020 eBook | Download PDF ![]() |
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