Outsourced Pharma Newsletter
Departments:
Primary Process Development Clinical Development Logistics
Discovery Research Preclinical Development Drug Substance Production
Dosage Form Development Dosage Form Production Packaging/Assembly
Featured Focus: Primary Process Development
ADC: The Next Big Opportunity For Oncology Drugs
By Cliff Mintz, Ph.D., Contributing Editor, Life Science Leader
The commercial success of mAb products, such as Rituxan for B cell lymphomas, Erbitux for colon cancer, and Herceptin for breast cancer, has catapulted mAbs to the forefront of modern molecular medicine. According to a recent report by GBI Research entitled "Monoclonal Antibodies Market to 2017," the size of the global mAb market was estimated at $16 billion in 2011 and is expected to grow to almost $32 billion by 2017.
» Clinical Development
ARTICLE: Bridging Clinical To Commercial: The Important Evolution Of Observational Research
By Leanne Larson, MHA, Vice President, Evidence Development, PAREXEL
Biopharmaceutical product development today faces a very different set of challenges and drivers than in the past. In addition to the purely scientific challenges in developing new and innovative treatments for diseases of staggering complexity, the market today is demanding answers far beyond those that the traditional clinical development and clinical trial processes can deliver.
ARTICLE: Candid Insight On Working With CROs From Sangart VP Of Clinical Operations
By Mary Rose Keller, Sangart
Mary Rose Keller is the VP of Clinical Operations for Sangart, Inc. and is responsible for the execution of all clinical programs, including sickle cell, trauma, and future treatments at Sangart. Keller has over 25 years of experience in clinical research and clinical trial execution and has been involved with numerous, successful regulatory submissions for companies such as Agouron, Pfizer and Shire Pharmaceuticals. Keller provides her candid insight on working with CROs.
ARTICLE: Challenges, Prechallenges, Dechallenges, And Rechallenges
By Bart Cobert, Sentrx
This is an interesting topic about which several confusing points have arisen and which merits an in-depth look. These concepts are frequently used in the discussion of causality, and regulatory agencies pay particular attention to them in assessing individual case safety reports, particularly in the post-marketing setting.
ARTICLE: Perceived Barriers To eCOA Adoption In Clinical Trials
By Kai Langel, Senior Director, Technical Support, CRF Health
In many cases, we on the eCOA service provider side might not even be fully aware of all of them, perhaps because we have worked out solutions to most of the key concerns. But if we're not aware of the user's concerns, we might never get the opportunity to address them.
ARTICLE: Lessons In Medical Image Transfer Security From A Smartphone Crash
By Chris Englerth, BioClinica
When it comes to data security, most people fall into one of two categories: those who constantly fear the loss of data, and those who don't realize it can be lost. For those of you in the second category, make no mistake — your data can be lost!
» Logistics
WHITE PAPER: Best Practices In Cold Chain Logistics Planning
By Dan Catizone, VP Of Business Development, QuickSTAT
Planning is the key to successful and efficient cold chain distribution. Yet even with careful planning, many companies still miss out on opportunities to save money, streamline processes, and increase overall efficiency.
CASE STUDY: All-Season Containment Approach Maintains Product Integrity Even At Extreme Temperatures
CASE STUDY: Special Handling Delivers U.S. Launch
CASE STUDY: How DSC Helped Bristol-Myers Squibb Satisfy Customers With Customized Service
VIDEO: ShockWatch Cold Chain Services Video
PODCAST: The Importance Of Asset Tracking In The Pharmaceutical Supply Chain
» Discovery Research
WHITE PAPER: Assay Showcase: Delivering Globally Consistent Data From In-House ANA-IFA Assays
By Maria Teresa Less, M.D., FCAP, Director, Medical Affairs
Simply meeting regulatory standards is not enough for you to remain competitive in today's evolving immune-mediated inflammatory disease (IMID) drug market. When it comes to FDA approval and successful commercialization of IMID drugs, the consistency of your data is critical. In addition, biopharmaceutical companies such as yours need the ability to detect and quantify small effects, secondary results, potential additional indications, and other insights that can enhance the value of your products.
» Preclinical Development
ARTICLE: So You Want To Be A Preclinical CRO Study Director?
By Chris Papagiannis, MPI Research
The scientist or toxicologist working as a study director (SD) in a preclinical CRO can find it to be a rewarding and also continually challenging career. The research for which you are responsible is critical in the development of new drugs for the treatment, cure, or management of many diseases or physical conditions.
» Drug Substance Production
ARTICLE: How The FDASIA Can Affect Your Supply Chain
By Dr. Guo, VP Of Pharmaceutical and Quality Services, AMRI
The supply chain for active ingredients and drug products in the pharmaceutical industry is becoming more complex as globalization in the world economy continues. Globalization provides benefits for cost-effective solutions, enhanced security, and stability for the supply chain. On the other hand, companies therefore need a more sophisticated approach to manage their global supply chain.
» Dosage Form Development
WHITE PAPER: Collaboration Conundrum: How To Share Content In Today's Global Life Sciences Industry
By Veeva Systems
Ten years ago, life sciences companies were largely autonomous. Drug development, research, manufacturing, and marketing were often handled in-house. Today, it's another story. Expiring patents, the rise of generic competition, the growth of more specialized and personalized medicine, and the fall of blockbuster drugs have caused the industry to shift both in its approach to innovation and its approach to operations.
» Dosage Form Production
PRODUCT: Biopharmaceutical Process Development
PRODUCT: Aseptic Fill And Finish
PRODUCT: Lyophilization
» Packaging/Assembly
PRODUCT SERVICE: QCanywhere Cloud-Based Quality Control