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Antibody Drug Conjugate Development and Manufacture - Piramal

With the recent approvals of brentuximab vedotin (Adcetris) and ado-trastuzumab emtansine (Kadcyla,T-DM1), antibody–drug conjugates (ADCs)are a rapidly growing area in oncology with great potential. Development and manufacture of ADCs can be a challenge with the requirement to handle both biologics...

24-May-2013

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On-Demand Supplier Webinars

Supply Chain Issues and Trends in Asia - Marken

Import/export of biological samples from China China: Large Pharma Reverse Logistics A Common Issue: Destruction of Drug in Taiwan J-GMP: How is GMP different in Japan? Korea: Biosimilars Hotbed India: Will Regulations Change to Allow Quicker Study Approval in 2013?

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What Non-statisticians Need to Know about Statistics in Clinical Trials - Rho

Through real-world examples, webinar participants learn strategies for choosing appropriate outcome measures, methods for analysis and randomization, and sample sizes as well as tips for collecting the right data to answer your scientific questions. 

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Industry Snapshot: Clinical Trial Trends Outline Complexity for Supply Chain - Marken

2013 Industry trends driving the scientific, logistical and regulatory complexity of supply chain industry Implement clinical development methodologies for quality, relationships, and performance Strategies to optimize drug development to reduce global trial time and costs

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Optimizing your Strategy and Budget for Clinical Trial Supply Distribution - Marken

How to determine if a depot or direct to site shipments are more efficient Calculation based on a case study How to avoid delays and assure that your shipments arrives without delays and excursions

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Working with the cold harsh reality of temperature controlled supply chains - Marken

What are the regulators telling us? Dealing with a non-harmonized, multi-agency, global challenge.    Monsters Vs, Aliens How to navigate the maze of import & export regulators. Thinking beyond the box! Packaging selection – A different horse for every course Validation & Qualification – Where are...

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Using FDA’s Draft Guidance on Risk-Based Monitoring to Improve Clinical Data Quality - Rho

The Industry’s changing approach to clinical data monitoring requires the tools and team structure to effectively plan and execute risk-based monitoring. Join Lynn King and Rob Woolson as they discuss multi-disciplinary approaches to implementing alternative monitoring plans and specialized tools...

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Lyophilized Pharmaceuticals: A Design Space Approach to Formulation and Process Development - Baxter

This webinar will discuss development of design spaces for lyophilized pharmaceutical products in the context of the Quality by Design regulatory paradigm.  Steven Nail, PhD, principal scientist at Baxter’s Lyophilization Center of Excellence with extensive expertise in the field, presents...

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Targeted Product Development: Personalized Medicine versus Orphan Product Development - Rho

The development of therapeutics for personalized medicine leverages many of the advantages of the legislation conferred upon orphan products. New products must be positioned intelligently to take advantage of this legislation. Join David Shoemaker, Ph.D. as he discusses the benefits...

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Cost Effective Data Standards Implementation: How to Integrate CDISC Standards into Your Product - Rho

Based on recent guidance from FDA, a data standards plan is now expected at the IND stage of development.  Join David Shoemaker, PhD and Jeff Abolafia, MA as they discuss cost effective methods for integrating CDISC data standards into your...

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PDUFA V: What you need to know about the upcoming Prescription Drug User Fee Act - Rho

The Prescription Drug and User Fee Act (PDUFA) IV will expire in September 2012. A new version of this legislation, PDUFA V, is expected in the coming months and may have implications for your regulatory strategy and development program. Join...

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Stop the pain: Tips for increasing patient retention and decreasing missing data in analgesia clinical trials - Rho

Analgesic clinical trials often fail, even when we know the drugs work. Join Lynn King and Karen Kesler as they share real-world solutions for trial design, execution, and analysis that will increase patient retention, minimize missing data, and help you...

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Flow Cytometry Analysis of Clinical Trial Samples - Millipore

Flow cytometry is a versatile, multiparameter technique with many applications including pharmacodynamic analysis for clinical studies.We invite you to attend our webinar where strategies will be outlined to prevent anomalous and misleading reporting.Flow cytometry is a versatile, multiparameter technique with...

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Next generation bioanalysis using the Gyrolab® platform. Developing biomarker and immunogenicity assays for clinical studies. - Millipore

High throughput screening of antibody pairs to determine best binding characteristics, and their selection for development of immunoassays. Identification of instrument considerations and representative data of sensitive cytokine assays with large dynamic ranges that can be run with high throughput...

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Continuous Process Improvement for Solid Oral Dose Development - Colorcon

Need to improve team collaboration and save time bringing products to market? Then don’t miss this insightful webinar to learn how to expedite excipient selection, transform product design, and achieve product differentiation to gain competitive advantage.

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Patient recruitment: improving access to patients - INC Research

Recruiting patients is often, if not always, the most expensive and time consuming part of a clinical trial. For oncology drug development the problem is particularly pronounced. This presentation will focus on new techniques to improve access to the right patients...

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Oncology Clinical Trials: Keys to Success in the Era of Personalized Medicine - Scimega Research Inc

This webinar will give you a better understanding of how the end of one-size-fits all medicine, and current oncology drug developments in diagnosis and biomarkers positively impact clinical trials. It will also address key oncology drug development barriers and best...

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Opportunities in Oncology Clinical Trials in Latin America - Intrials Pesquisa Clinica LTDA

Clinical trial in Oncology involves one of the most expensive and complex protocols in a research environment. For the past few years, Latin America has been included in the scenario of this study area due to its patient’s recruitment potential,...

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The Road Less Travelled – Navigation through the do’s and don’ts of running Oncology studies in Asia Pacific - Novotech

Clinical trials in the Asia Pacific are increasing exponentially. Numerous sponsors and CROs have accessed this region in recent years to take advantage of high performing, cost effective sites. To many sponsors though, Asia Pacific appears an impenetrable black box....

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Are you getting the right bioavailability and bioequivalence data for inhalation products you’re developing? - DPT

Consider the risk to your development program of not accounting for patient variation in device handling. In this webinar DPT Labs and Proveris Scientific team up to demonstrate how the Ergo system can help you develop the right actuation parameters...

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