How Quality by Design Is Changing Drug Development

pharmaQbD.com, August 2008

“No More Approvable Letters: An Expert’s Take”,

PharmExecBlog, July 16, 2008

Wyeth Gets Exclusive License for Mochida’s Painkiller Drug

Wyeth has acquired global rights to Mochida Pharmaceutical's preclinical transient receptor potential vanilloid sub-family 1 (TRPV-1) antagonist molecule for treating pain, the companies announced Jan 9. In retum , Tokyo-based Mochida will be paid developmental milestones, an up-front fee and royalties on future sales.

Development Knowledge Can Increase Manufacturing Capability and Facilitate Quality by Design

This article explores the processes used in developing a market formulation and requisite supportive data, particularly in light of the industry’s current movement toward submissions based on quality by design (QbD).

FDA’s “Approvable” Problem

Approval letters delay NDAs, cost pharma plenty, and are at an all-time high

Using Technology Transfer to Maximize Business Efficiency

This article presents a technology transfer approach that can help prevent costly delays, leverage the ability to change, and speed time to market ...

Aspects of Non-Invasive Drug Therapy – a Technology Viewpoint

The need for self-administered, non-invasive drug therapies is growing due to the decreased time patients remain in hospitals and to an increased array of large molecule or new medications brought about through the use of biotechnology...

Developing and Implementing a Certification Program to Drive Change in the Pharmaceutical Industry

Pharmaceutical Engineering Supplement  May/June 2006

In vitro dissolution and in vivo oral absorption of methylphenidate from a bimodal release formulation in healthy volunteers

Biopharmaceutics and Drug Disposition, (25) 2,91 (2004)

Novartis using PAT with aid of IVIVC; exec. Sees continued three batch validation

Validation Times, June 2003

Complete list...

Influence of Physicochemical Variability of Magnesium Stearate on its Lubricant Properties: Possible Solutions

Using Development Knowledge To Enhance Manufacturing Capability For Novel Dosage Forms

Using Development Knowledge To Manage Facility and Capacity Needs

Tensile Strength of Fatty Alcohol Sustained Release Matrices as a Function of Heat of Freezing

Proceedings of the Sixth Wisconsin Update Conference, Tabletting

Complete list...

2008 ISPE Annual Meeting -- Competing in the Global Market Place

October 27, 2008, 13.30-17.00
Boca Raton, FL

Regulatory Affairs Professionals Society's (RAPS) Annual Conference, "Quality by Design: ICH Q8, Q9 and Q10."

September 16, 2008, 3:00-5:00pm (EDT)
Boston, MA

Live audio conference: “How to Use Quality-by-Design (QbD) to Design Efficient Pharmaceutical Manufacturing Processes and Facilities”

ExpertBriefing - April 23, 2008, 2-3 PM (EDT)

5th ANNUAL NASSAU INN MEETING: FORMULATION & PROCESS DEVELOPMENT FOR ORAL DOSAGE FORMS
"A 5-Day Modular and Case Study Oriented Training Program”

April 27 - May 2, 2008,
Nassau Inn, Princeton, New Jersey

Webinar: "Business Solutions for Understanding and Implementing the New FDA GMP's for Nutritional Supplement Manufacturing"”

Contract Pharma, September 25, 2007

In-House Training Program at Merck & Co, “Basic Principles of Solid Dosage Formulation & Process Development”

October 10 -11, 2007, West Point, PA

ISPE Workshop with FDA participation to discuss the issues and gain industry input on the implementation of new quality guidelines (Q8 and Q9) developed by ICH,

June 4 - 7, 2007
Crystal Gateway Marriott in Alexandria, Virginia.

2007 Rutgers PAT Conference 
“Road Map to Successful PAT Applications,

June 18-20, 2007Caesar’s Palace, Las Vegas, Nevada

4th Annual Nassau Inn Meeting:
Formulation & Process Development For Oral Dosage Forms

April 22 - 27, 2007,
Nassau Inn, Princeton, New Jersey

Technology Transfer or Knowledge Transfer for Solid Oral Dosage Forms,

ISPE NJ Chapter
Holiday Inn Raritan, NJ, November 16,2006.

Complete list...

Quality by Design Expert, Russ Somma, Ph.D., Selected as Editorial Advisory Board Member
for New Industry Website, PharmaQbD.com

ISPE Awards Russ Somma, Ph.D. Max Seales Yonker Member of the Year

ISPE Launches PQLI Initiative to Facilitate Implementation of ICH Q8 and Q9 Guidelines

SommaTech, LLC. Adds Drug Formulation Experts

SommaTech Consulting Announces Strategic Collaboration With Pharmaceutical Technologies, Inc.

ISPE to Work on Implementation Documents for ICH Q8

SommaTech Consulting Announces Formation of Technical Advisory Board

SommaTech, A Pharmaceutical Technology Consulting Firm, Formed >

Russ Somma, Ph. D. Appointed to ISPE

Complete list...

What Happens in Vegas Doesn’t Stay in Vegas

It was a struggle whether or not to use this rather tired commercial line but hey in this case it works.
We are all industry professionals whose jobs involve moving our company’s visions to market fulfillment and an improved quality of life for our patients...

Complete list...