Newsletter | February 13, 2013

02.13.13 -- Developing For Fast-Failure: Clinical Development Opportunities

Pharmaceutical Online Newsletter
Clinical Development
Drug Substance Production
Preclinical Development
Dosage Form Production
Primary Process Development
Featured Focus: Clinical Development
Challenges And Opportunities Lie Ahead For Innovators And Their Clinical Suppliers
By Scott Houlton, President of Development and Clinical Services, Catalent
It's no secret that pharma and biotech companies choose to outsource the production of their clinical trials supplies largely due to the savings, efficiencies, scale, and expertise brought to bear by their clinical supply partners. But how will the key trends emerging in fast-to-fail, personalized medicine, and the regulatory environment impact the clinical supply market going forward? Below, we will discuss these three key trends and provide insight on the resulting challenges and solutions for clinical suppliers and innovators alike.
ARTICLE: Home Thoughts From Abroad: Measurement Of Cognitive Change
By John Harrison, PhD, CRF Health
March and April are traditionally two months that for me involve an unusual amount of business travel. This year has been no exception, and in the past six weeks I have visited Istanbul, Paris, Vienna, Dallas, Washington, Philadelphia, Cape Town, and, at the time of this writing I am in Tokyo with just Sydney and Melbourne to visit before returning home. The work has been varied and interesting, including advisory boards, user group presentations, and a good number of investigator meetings. What is different about this year is that the indications under discussion have included depression, schizophrenia, ADHD, Parkinson's disease, Alzheimer's disease, and a variety of other diseases, including hypertension, diabetes, and fibromyalgia.
WHITE PAPER: The Development Safety Update Report (DSUR): Perspectives And Experiences
» Preclinical Development
ARTICLE: The Impact Of DMPK Clinical Failures
By John James Vrbanac, MPI Research
According to the Pharmaceutical Research and Manufacturers of America (PhRMA), out of 10,000 compounds that begin the drug discovery process, a mere 250 make it to the preclinical stage; only five will enter the clinic; and just one will land on the shelves of pharmacists. It is a process that takes up to 15 years or more and costs more than $1B.
ARTICLE: Cellular Therapeutics And Regenerative Medicine: Preclinical Assessments For Proof Of Concept And Safety
By Thomas Vihtelic, Director, Experimental Therapeutics, MPI Research
Regenerative medicine is attracting significant attention as a medical technology capable of treating what were previously determined to be "untreatable diseases." Scientists worldwide are engaged in stem cell research that may enable the repair of damaged heart muscle after a heart attack, restore movement after spinal cord injury, regenerate pancreatic tissue to produce insulin for people with diabetes, and achieve long-sought medical remedies.
WHITE PAPER: An Efficient Synthesis Of Methyl 2-Methoxy-4-Amino-5-Chloro-Benzoate-(Carbonyl-14C)
» Primary Process Development
WHITE PAPER: Streamlining The Biological Factory: Making A Better CHO Cell For Biopharma Production
» Drug Substance Production
PRESENTATION: Sustainable Production Of Pharmaceutical Intermediates And API´s
NEWS: Lonza To Adapt Its Management Structure To Focus On Target Markets
» Dosage Form Production
POSTER: Ion Exchange Resins Used For A Controlled-Release, Orally Disintegrating Tablet (ODT)
NEWS: Study Finds Extended Release Niacin Effective In Lowering Cholesterol Levels
» Packaging/Assembly
WHITE PAPER: Why Serialize Now?
» Logistics
WHITE PAPER: Clinical Trial Logistics In Africa: Ensuring Quality, Compliance, And Control Within The Pharmaceutical Supply Chain
SERVICE VIDEO: More Than A 3PL, A BPO (Business Process Outsourcing).
SERVICE BROCHURE: ISCLabs: Thermal Packaging Design And Testing Services
SERVICE BROCHURE: Despite An Airport Strike, Marken Preserves The Data Chain
PRODUCT BROCHURE: Active Cold Chain Services: With You Every Step Of The Way
BROCHURE: Kronos For Manufacturing: Increase Productivity And Control Costs