Vision Shopsters Official Blog

Emerging Markets Clinical Development Series: Africa

Vision Shopsters — Mon, 09 May 2011 10:40:17 +0000

Expand Clinical Operations and Seize Opportunities in Africa

Despite maintaining regional offices within Africa, many major drug and device manufacturers frequently overlook the continent when sponsoring clinical studies. Cultural barriers, political upheaval and uneven infrastructure are certainly causes for the lack of interest. But Africa offers tremendous expertise and opportunity for drug and device companies looking for cost-effective study sites and appropriate patient populations.

As challenging as Africa may seem, drug companies have made commitments to improve healthcare across the continent, and these companies’ clinical development strategies go hand-in-hand with that improvement. In coming years, the drug and device industries will greatly expand their clinical development presence in Africa, mainly in South Africa and a select few North African nations.

Make sure that your clinical strategy team has all the knowledge available about the growth opportunities in these countries. Africa presents a unique profile that interests many multinational life sciences companies. If the following benefits outweigh the challenges for a clinical team — as they often do — trial sponsors will find value in Africa:

Boost Patient Access

Of all emerging regions, Africa has arguably the least access to quality care, ensuring a steady stream of dedicated patients to fill trial enrollments. In addition, the most advanced nations offer highly diverse patient populations that will translate well for submissions in the US and EU.

Leverage Africa’s Proximity

Many major European companies are located just across the Mediterranean from North Africa, making travel and communication easier than in Latin America, for example. For American companies, Africa is much closer than Asia.

Benefit from Underutilization

Though trial saturation is not a concern in any emerging markets yet, Africa is the least saturated of all regions. Companies that establish clinical operations bases now will be ahead of the pack when more of the industry turns to Africa.

To know more about this report & to buy a copy please visit:
http://www.visionshopsters.com/product/16445/Emerging-Markets-Clinical-Development-Series-Africa.html

Emerging Markets Clinical Development Series: Latin America

Vision Shopsters — Mon, 09 May 2011 10:30:58 +0000

Improve Trial Outcomes with Latin American Operations

As R&D costs rise exponentially and trial subjects grow scarce in the US and Europe, life sciences firms are turning to the emerging markets to supplement patient enrollment — and to reduce costs.

Latin America holds about 1/10 of the number of trials of the United States, and Brazil, numbered among the high-profile BRIC market, receives the lion’s share of attention. But savvy companies leverage other nations’ untapped promise: patient availability, advanced knowledge and infrastructure, and ease of communication. These advantages are cultivated in an environment open to clinical development, but scores of questions can create reams of data – and misperceptions – and potentially keep teams away.

Eliminate information clutter and zero in on the key emerging markets in Latin America. Access primers on individual countries that include time- and cost savings benchmarks and rankings data while learning from others’ first-hand experiences to reap the benefits of the region:
Pick the Right Market

Compare costs, timelines, regulatory environments and problem areas across countries as you discover unique benefits to each. Explore ratings for 13 elements of trial success.
Accelerate Patient Recruitment and Retention

Target markets for treatment-naive patients, and discover the factors to ensure easy recruitment and strong retention.

Navigate Tricky Issues

How do companies protect IP? How do they manage longer setup times and overcome regulatory hurdles? Discover which governments protect IP and find real-company best practices for managing different regulatory guidelines.

Master Trial Management

Balance reliance on local expertise with trial oversight to build strong partnerships. Uncover fresh strategies to prepare your teams for the challenges that will inevitably flare up.

To know more about this report & to buy a copy please visit:
http://www.visionshopsters.com/product/16442/Emerging-Markets-Clinical-Development-Series-Latin-America.html

Emerging Markets Clinical Development Series: Eastern Europe

Vision Shopsters — Mon, 09 May 2011 09:47:18 +0000

Expand Clinical Capabilities Throughout Central and Eastern Europe

The countries in Central and Eastern Europe provide ample opportunity for life sciences companies, especially in terms of clinical development. The number of treatment-naive patients in the region makes it an ideal location to host clinical studies. In fact, the population of Central and Eastern European countries exceeds that of either the United States or the five largest Western European markets combined. Furthermore, there is a lower saturation of competing trials within the region compared to other, more developed markets.

Besides a large patient population, Central and Eastern Europe offer the drug and device industries a convenient location — especially for European-based countries — to conduct clinical studies. The region has a long history of clinical development, making it easier to find and train skilled investigators.

Use this study as a resource to design and prepare your company’s clinical trials in Central and Eastern Europe. The report addresses, in detail, the challenges and clinical development opportunities that these emerging markets provide. It provides detailed benchmark metrics for Russia, Poland, the Balkans, Bulgaria, Romania, Turkey and Ukraine, all in one place. Learn the advantages and challenges that each of these countries present. Use these data and best practices to avoid common pitfalls and solidify your clinical strategy:

Improve Patient Access

Russia and Poland offer a distinct advantage as emerging markets: access to treatment-naive patients. Recruitment and retention are strong in these countries as well. This report will guide your decision-making process as you determine how to run a trial in a Central or Eastern European nation.

Protect Intellectual Property

IP issues can be daunting when working in an emerging market. This study shows you how to work with local partners to navigate culture and regulations, avoid the threat of corruption and protect your intellectual property.

Tap Geographic and Cultural Proximity

Russia, Poland and the other countries profiled in this report offer the advantage of being neighbors to Western Europe. This means that the local investigator knowledge base is similar to that of Western European countries, and EU-EC guidelines for GCP are becoming more commonplace. Learn about the other advantages that the central and eastern European countries offer to clinical development teams.

To know more about this report & to buy a copy please visit:
http://www.visionshopsters.com/product/16441/Emerging-Markets-Clinical-Development-Series-Eastern-Europe.html

Emerging Markets Clinical Development Series: Asia

Vision Shopsters — Mon, 09 May 2011 08:55:42 +0000

Harness the best of East and West to advance clinical development

Among the globe’s emerging markets, Asian countries tend to offer the highest number of available patients for trial participation. The region also hosts a thriving pharmaceutical and biotechnology industry, and medical education among investigators has come in-line with Western expectations for Good Clinical Practice. As more companies move clinical trials into this region, they will benefit for years to come from its inherent expertise.

Answer your burning questions about Asian trials with this report, which provides detailed data on China and India as well as information on trials in Malaysia, Hong Kong, Taiwan, Thailand, Singapore, South Korea and the Philippines. Learn the advantages and challenges that each of these countries presents, and use the benchmarks, metrics and best practices to avoid common pitfalls and solidify your clinical strategy:

Address Intellectual Property Concerns

Asia has a reputation for poor intellectual property protections, and this report uncovers the progress made in China, India and other Asian nations around IP protection. The report will also help you navigate regulations, healthcare infrastructure, costs and patient access.

Benefit from Strong Physician-Patient Relationships

Learn about the strong physician-patient relationships created in different Asian countries. Tap into these bonds to boost enrollment and retention for your clinical studies.

Explore Individual Country Benefits

Too often, companies approach specific emerging markets with regional strategies. This report illustrates the benefits that each individual country provides so that you can develop detailed plans for running trials in each market. Tap into the best ratios of cost, quality and timelines while using local partners to navigate culture, communication and regulations.

To know more information & to buy a copy please visit:
http://www.visionshopsters.com/product/16440/Emerging-Markets-Clinical-Development-Series-Asia.html

Emerging Markets Clinical Development Series: Brazil, Russia, China and India (BRIC)

Vision Shopsters — Mon, 09 May 2011 08:43:47 +0000

Explore Clinical Operations in Brazil, Russia, India and China

The next frontier of global industry expansion makes its home in Brazil, Russia, India and China (BRIC). Imagine the impact of a patient pool that numbers 3 billion: an immediate cure for patient shortages (or recruitment challenges) that plague studies in North America and Western Europe, unparalleled access to untapped patient populations, and new opportunities to meet the growing medical needs of these countries.

Despite vast promise as the next major growth opportunity for life sciences companies, the BRIC countries collectively represent a daunting challenge to new product development strategists and clinical operations teams. Any number of unknowns — unfamiliar regulatory guidelines, intellectual property concerns, time and distance barriers, and tolerance of dishonest business practices — can cause companies to hesitate to invest in these emerging markets or keep them out altogether.

Confidently tap into the potential of the BRIC markets, fulfill protocol, and ultimately, realize significant cost and time savings. Expand your understanding of BRIC, individually and as a whole, using rankings data and best practices to map out a winning clinical strategy:

Eliminate Confusion about BRIC

Weigh the advantages and drawbacks of different countries and examine rankings for 13 clinical factors to enable strategic decision-making. Gain quick access to relevant demographics and economics information for a comprehensive analysis of the clinical environment.

Master Trial Management in Emerging Markets

Learn from top executives’ firsthand experiences — both successes and misfires. Recommendations show your team how to improve CRO selection, management and oversight, and more. Explore 23 in-depth profiles and find one that matches your company’s situation.

Clarify Misperceptions to Boost Success

Differences in cultural attitudes and behavior impact trial success. Knowledge and awareness go a long way in cultivating strong and beneficial relationships with local CROs.

Table Of Contents :

BRIC Clinical Development Metrics
Executive Summary

* Average percentage of budget saved by running a site in BRIC markets
* Average percentage of time saved by running a site in BRIC markets
* Population comparisons between BRIC nations, the United States and Europe
* Number of registered studies across profiled BRIC countries
* Rankings from surveyed companies of benefits and challenges:
o Patient access
o Patient retention
o Regulatory environment
o Intellectual property laws/practices
o Cultural concerns
o Communication and language
o Clinical trial technology infrastructure
o Supply chain management
o Investigators’ available knowledge base
o Data standards
o Investigator standards
o Site management standards
o Anticipated cost

The four chapters in Emerging Markets Clinical Development Series: Brazil, Russia, India and China (BRIC) use primary and secondary information to provide comprehensive overviews of the clinical development environment in each of the BRIC countries. Each country overview contains these elements:

Section 1: Clinical Development Environment

* Key demographics (population/ethnic breakdowns, life expectancy statistics)
* Key economic figures (GDP, labor force, distribution of family income)
* Disease prevalence
* Politics
* Healthcare system
* Pharmaceutical market (overall picture of market, leading local companies)

Section 2: Clinical Development Strategy

* Percentage of budget saved by running a trial in this location
* Percentage of time saved by running a trial in this location
* Assigning clinical development responsibilities

Clinical Trial Environment Scores and Trial Operations Scores:
Environment

* Available knowledge base
* Regulatory environment
* Intellectual property laws and practices
* Communication/language
* Culture
* Anticipated cost

Operations

* Access to patients
* Patient retention rates
* Investigator standards
* Data standards
* Site management standards
* Trial technology infrastructure
* Supply chain management

Section 3: Individual Company Profiles

This report contains a total of 23 company profiles that contain the following components:
Company Background

* Company mindset and key clinical feasibility factors
* Factors that impact clinical environment

Clinical Environment Assessment

* Regulatory environment
* Available knowledge base
* Intellectual property laws/practice
* Communication/language
* Cultural concerns
* Anticipated cost

Trial Operations Assessment

* Access to patients
* Patient retention rate
* Investigator standards
* Site management standards
* Data standards
* Trial technology infrastructure
* Supply chain management

Experience in Region

Activity in Region: Maps the geographic scope of the company’s clinical operations within the region. Experience Specific to Country: Provides information on the company’s operations within the country, including year of entry, method of entry and current level of presence within the country.
Clinical Strategy in Country

Responsibility breakdown shows each company’s clinical operations assignments among four groups – corporate team outside country, corporate team inside country, multinational CRO, and local CRO/ vendor. The data detail 12 clinical responsibilities:

* Protocol development
* Site selection
* Investigator training
* Patient recruitment
* Site monitoring
* Investigator management
* Data collection
* Data management
* Data cleaning/analysis
* Medical writing
* Regulatory agency communication
* Health economics consideration

Clinical Environment and Trial Operations Scores

Shows a company’s score for each of the clinical environment and trial operations factors listed above.

To know more information & to buy a copy please visit:
http://www.visionshopsters.com/product/16439/Emerging-Markets-Clinical-Development-Series-Brazil-Russia-China-and-India-BRIC-.html

Specialty and Hospital Sales Force Management report added in Visionshopsters

Vision Shopsters — Mon, 09 May 2011 07:03:49 +0000

Boost Specialty and Hospital Sales Force Performance

Specialty and hospital sales forces face great challenges as economic pressures, changing regulations and self-imposed codes transform the sales landscape. Access to physicians and other staff is diminishing, and healthcare overhauls will change the way business is done — throughout hospitals and in each doctor’s office.

Successful sales professionals create personal relationships with physicians, uncover new ways to reach targets and understand how to navigate the evolving healthcare environment. As specialist targeting increases and hospital sales grow ever more intricate, the best talent — with the right support — will rise to the top.

This report will help all hospital and specialty sales groups as they gauge their own performance and prepare themselves for the next step forward.

Increase reach and access by making your team the best it can be

Compare performance metrics, explore training costs and improve reps’ business acumen as they face new healthcare legislation and increasingly complicated hospital clients.

Nail your budget needs

Explore sales spending broken down into critical budget categories. Determine your efficiency with cost-per-rep and cost-per detail benchmarks – and attract top talent with competitive compensation for all experience and performance levels.

Build — or adjust — your sales group

Specialty and hospital groups were largely right-sized even before the big PCP sales reductions. Gear up for the new sales era with headcounts and staffing ratios for reps, DMs and regional managers — and make sure your sales force is the perfect size for the challenges ahead.

To know more information & to buy a copy please visit:
http://www.visionshopsters.com/product/16436/Specialty-and-Hospital-Sales-Force-Management.html

Clinical Operations Report added in Visionshopsters

Vision Shopsters — Mon, 09 May 2011 06:48:12 +0000

The current patent cliff, shrinking pipelines, and the impact of a global recession place heightened pressure on the clinical development landscape. As competition intensifies for investigators, sites and patients, trial costs have reached unprecedented levels, causing drugmakers to adopt a bottom-line perspective and demand greater R&D efficiency. Greater efficiency leads to cost- and time-savings that could mean the difference in beating the competition to market and adding time to a drug’s lifecycle.

Successful teams win this race by minimizing risks, eliminating trial unknowns and hitting study deadlines. Supported by ample resources, they build process improvements through performance measurement and charge ahead with new techniques to accelerate trial timelines.

Designed to benefit teams and individuals in any role in the clinical trials space, this study will help teams achieve clinical operations efficiency — and realize the significant payoffs that accompany successful drug development:

* Save time through adaptive trials:
Learn how leading-edge companies use adaptive design to accelerate trials and achieve the desired endpoints. Understand the FDA’s new guidance and get a real sense of where the industry stands on this new frontier.
* Track the right metric at the right time:
Track 26 operational, timeline and resource metrics across the five development stages using realcompany data from 80-plus trials. Learn how to incorporate forecasting software into trial design and planning.

* Benchmark and manage resources:
Break out individual costs and compare per-patient investments across five major therapeutic areas for Phases 1 through 4. Track staffing trends and coordinate in-house and outsourced teams.

Table Of Contents :

Chapter 1: Clinical Trial Costs and Outsourcing
41 charts detailing these points:

* Factors most responsible for increased clinical trial costs
* Average per-patient clinical trial costs across all therapeutic areas — 2008 and 2011
* Average percentage of clinical trial costs outsourced across all therapeutic areas — 2008 and 2011
* Per-patient clinical trial costs, broken down by phase, for these therapeutic areas:
o Cardiovascular
o Oncology
o Central Nervous System
* Average percentage of clinical trial costs outsourced across all therapeutic areas — 2008 and 2011
* Diabetes
* Hematology

Chapter 2: Clinical Trial Staffing Benchmarks
31 charts focus on clinical staffing data, and 5 tables provide staffing figures broken down by phase:

* Total trial staffing by phase
* Overall percentage of staffing outsourced by phase
* Average patients and average sites per CRA, by phase

These metrics are broken down by phase:

* Actual patients/sites per CRA
* Clinical trial staffing and average staffing by position
* Average percentage of FTEs outsourced by phase:
o CRAs/monitors
o Trial managers
o Clinical directors/VPs & TA program supervisors
o Data management
o Medical writing
o Biostatistics/bioanalytics
o Average percentage of regularory FTEs outsourced by phase
o Clinical Quality Assurance (QA)
o Clinical trial supplies
o Chemistry Manufacturing and Controls (CMC)
o Contract management
o Drug safety

Chapter 3: Clinical Trial Performance Metrics
19 charts focused on these clinical development topics:

* Average number of metrics collected by phase
* Prevalence of time, operations and resource metrics collected across all clinical trials and broken down by phase

Time

* Average time to close a database
* Average time to initiate an investigational site
* On-time protocol completion
* Time to completion of clinical trial
* Time from statistical tables complete to clinical trial report complete
* Time from database lock to statistical tables complete
* Time from first patient in (FPI) to last patient out (LPO)
* Time from last patient in (LPI) to last patient out (LPO)
* Time from last patient out (LPO) to database lock
* Time from last patient out (LPO) to statistical tables complete
* Time to randomize a target number of patients
* Time to enroll a target number of patients

Resource

* Overall cost per patient enrolled
* Overall cost per patient randomized
* Cost per clean Clinical Research Form (CRF) page
* Budget to completion of a trial
* Patients per CRA
* Sites per CRA

Operations

* Investigator recruitment rates
* Case report forms collected per CRA per day
* Patient enrollment rates (per site)
* Patient retention rates
* Patient randomization rates (per site)
* Site retention rates
* Advertising/marketing results
* Data error rates

Chapter 4: Adaptive Clinical Trials
13 charts focusing on adaptive design:

* Percentage of companies using adaptive design in clinical trials
* Rating adaptive clinical trials design effectiveness versus traditional clinical trials design
* Percentage of adaptive design usage in clinical trials by development stage
* Likelihood of adaptive design usage in clinical trials by development stage
* Impact of adaptive design usage in clinical trials on trial cost, aggregate and by company
* Impact of adaptive design usage in clinical trials on trial duration, aggregate and by company
* Importance of factors for using adaptive design in clinical trials
* Percentage of companies that unblind data during interim analyses in adaptive clinical trial designs
* Percentage of companies using third party or DMC during interim analyses in adaptive clinical trial designs
* Prevalence of usage of adaptive design types, aggregate and by company

To know more information & to buy a copy please visit:
http://www.visionshopsters.com/product/16435/Clinical-Operations.html

Visionshopsters added new report on Pharmaceutical Pricing Strategy

Vision Shopsters — Mon, 09 May 2011 06:35:10 +0000

Maximize Revenue and Map the New Pricing Landscape

Set the optimal price for your product, ensure market success — and maximize profit. As market access and reimbursement grow ever more important, pricing decisions separate the winners from the rest in the global marketplace. Discover how leading life sciences companies find and justify prices in light of heightened pressures from government payers and stringent economic policies. Explore in-depth benchmarks and insights, culled from over 30 pharmaceutical, biotechnology, and medical device firms, to build an elite pricing team that can adapt and thrive in today’s uncertain pricing landscape.

Eliminate guesswork in your pricing decisions using detailed metrics and battle-tested strategies:

Win resources and stakeholder support

Empower pricing groups with staffing and spending benchmarks from companies of varying sizes and across all phases of development. Understand other functions’ involvement in pricing to strengthen coordination and build consensus at each lifecycle stage.

Learn groundbreaking techniques to maximize ROI

Analyze your product pipeline to funnel resources to your company’s most innovative and crucial products. Prove the value of your team by communicating novel ROI measures.

Navigate the currents of change

Explore eight major global trends and strategies, including risk-sharing agreements and comparative effectiveness research, and their effect on pricing — is your team prepared? Top executives share their perspectives, assessing each trend for benefits and drawbacks. And CEI analysts provide actionable recommendations to prepare your team for the future.

Master global launch sequencing

Perfect your timing in global launch sequences. Learn which countries your competitors target first — and which they avoid — as you weigh your brand’s launch sequence.

To know more information & to buy a copy please visit:
http://www.visionshopsters.com/product/16434/Pharmaceutical-Pricing-Strategy.html

Visionshopsters added new report on Pharmaceutical Brand Lift: Marketing ROI and Budget Allocation

Vision Shopsters — Mon, 09 May 2011 06:12:21 +0000

Boost marketing impact to drive brand lift

Imagine the impact of a successfully conceived and executed marketing strategy: heightened brand visibility and reputation as well as increased market share and revenue. Effective brand teams draw a direct link between investment and results — and they prioritize elements in their marketing mixes based on the impact of each activity, channel or promotional tool.

Discover how 28 top pharmaceutical and biotech teams have built their products’ marketing plans, then explore the brand lift derived from each investment decision:

Get the most out of your marketing money

See which activities generate the most revenue as you examine investments in nine key marketing activities. Follow teams as they prioritize certain channels over others — including physician and patient marketing, web-based and mobile tools, and other critical platforms.

Track ROI and brand lift to ensure effective campaigns

Explore the returns generated by those nine key marketing activities via six brand lift measures — as well as innovative techniques for building an optimal balance of hard and soft ROI metrics. Along the way, learn new strategies for overcoming common problems in proving marketing impact.

Uncover marketing spending trends

Peruse 15 brand profiles to see, on a drug-by-drug basis, how teams prioritize their marketing investments — and either benefit or suffer as a direct result. Isolate the impact of critical promotional activities, and learn how teams would allocate a 10% budget increase.

Companies Included in Report

* Alexion
* AstraZeneca
* Bausch + Lomb
* Bayer
* Ikaria
* Inspire
* Merck
* Neopharma
* Novartis
* Nycomed
* Pfizer
* Sanofi-Aventis

To know more information & to buy a copy please visit:
http://www.visionshopsters.com/product/16433/Pharmaceutical-Brand-Lift-Marketing-ROI-and-Budget-Allocation.html

Innovations in Delivery Methods for Nutraceutical Food and Drinks

Vision Shopsters — Fri, 06 May 2011 10:28:16 +0000

Introduction

This report explores the range of manufacturing technologies that are available for encapsulating ingredients to change their performance characteristics. The report focuses on innovation and the companies with the expertise to design new delivery systems with improved properties for ingredient delivery. Over the last decade, the food industry has begun to invest in delivery technologies.

Features and benefits

* Gain insight into the reasons for using delivery systems to encapsulate nutraceutical ingredients .
* Identify the key technologies available for producing encapsulated nutraceutical ingredients, their advantages, disadvantages and associated costs.
* Review regulations applicable to the use of delivery systems in food & gain insight into the effect of these regulations on the industry in the future
* Identify innovative companies and discover the potential of their approaches for delivering novel encapsulated nutraceutical products.
* Identify the areas of the nutraceutical market for which delivery systems are most important and why.

Highlights

The food market is changing: Over the past decade, consumers have become more concerned for their health and are increasingly inclined to self-medicate. Healthcare providers, too, are keen to shift some of the burden of healthcare costs to individuals and recognize that functional foods may provide alternatives to medications.Adding nutraceuticals to processed foods can be challenging: The ingredient must be delivered to the customer in a form that tastes good, feels good & is stable & bioavailable. However, many ingredients are sensitive to the manufacturing process, have their own unpleasant flavors or colors, or adversely affect product stability.The food industry has begun to invest in innovative delivery technologies to overcome these problems and thus to improve the health benefits offered by their functional foods or beverages. These delivery systems also have the potential to reduce the costs associated with food processing by reducing overages of unstable nutrients.

Your key questions answered

* Why do ingredients require modification through the use of a delivery system for inclusion in functional food products?
* How can the use of encapsulated ingredients actually reduce the manufacturing costs for a functional food product?
* What are the drivers and resistors for the functional food, and hence the functional ingredients, markets?
* How are encapsulated ingredient products regulated?
* Which companies/academic laboratories are innovating in this area and are able to provide their expertise to food and ingredient manufacturers?

To know more about this report & to buy a copy please visit:
http://www.visionshopsters.com/product/12696/Innovations-in-Delivery-Methods-for-Nutraceutical-Food-and-Drinks.html