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DDEP2011: Key Development and Commercial Parameters – Drug Delivery Enhanced Pharmaceuticals: v. 2011

DDEP2011 is the first report that critically analyzes the clinical development and commercial factors that impact the success and performance of drug delivery enabled/enhanced products (DDEP). Built on DDEP2009, this report expands and extends the information and analysis through to 2011.

Clinical Development Parameters:
DDEP2011 studies the impact of how clinical development is impacted by a variety of parameters including the time required to take DDEP from the start of clinical trials to approval in the US, the costs of clinical development and the approval success rates.
These figures are analyzed in the aggregate and by a variety of parameters including: delivery route, indication, molecule type and size, regulatory strategy, platform status, and targeted benefit. This provides the reader with clear insight into how these individual parameters are associated with development times and success rates.
DDEP2011 also reviews and estimates the cost of taking a DDEP through clinical development and approval. The costs are high; higher in fact than many companies forecast and budget.

Market Performance Parameters:
DDEP2011 examines the performance of DDEP according to a number of commercial parameters. These include: market exclusivity period (time from launch until a functional or substitutable competitor is launched), sales and prescription performance of leading DDEP, relative market shares and the uptake curves for new drug delivery enabled/enhanced products. These figures can provide valuable support fo the development of realistic sales forecasts.

The Author:
Josef Bossart, Ph.D. (Medicinal Chemistry, The Ohio State University, College of Pharmacy), is a thirty year veteran of the pharmaceutical industry. Starting as a pharmaceutical salesman for Organon in 1978, Jo has held a variety of sales, marketing, business/corporate development and general management positions with Big Pharma (Organon, Roche, RPR), Drug Delivery (Enzon, Akela) and emerging (GeneMedicine) pharmaceutical companies. In addition he has provided business and corporate development support to a variety of clients over the past ten years. He has authored more than 20 published articles examining the nature of Drug Delivery and the parameters that impact its success.

Report Details:
11 Chapters plus Appendices
>500 Drug Delivery Enabled and Enhanced Products reviewed and analyzed

Contents:

EXECUTIVE SUMMARY

Chapter 1 – OVERVIEW of DDEP CLINICAL DEVELOPMENT and APPROVAL TIMES

Chapter 2 - PARAMETER SPECIFIC DDEP CLINICAL DEVELOPMENT and APPROVAL TIMES: DRUG AND DRUG/DEVICE and DEVELOPMENT STRATEGY

Chapter 3 - CLINICAL DEVELOPMENT and APPROVAL TIMES, EXTENDED PARAMETERS

Chapter 4 - PRODUCT APPROVAL RATES

Chapter 5 - PRODUCT PHASE TRANSITION RATES and PHASE LATENCY

Chapter 6 - DDEP PHASE LATENCY

Chapter 7 - FDA DRUG APPROVALS, 2000-2010

Chapter 8 - DRUG DELIVERY DEVELOPMENT COSTS

Chapter 9 - PRODUCT EXCLUSIVITY

Chapter 10 - DDEP SALES and PRESCRIPTIONS

Chapter 11 - DDEP SALES UPTAKE MODELS

Price: $1850 PDF (single-user); $2700 PDF (multi-user, one company)

Sample Pages: DDEP2011 Chapter 1, DDEP2011 Chapter 3, DDEP2011 Chapter 5, DDEP2011 Chapter 7, DDEP2011 Chapter 8

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