Unitrans Life Sciences Logistics Newsletter | Edition 5 | May 6, 2015
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In Edition 5:
Coldchain Comments: Navigating the Ultra Cold Chain Distribution Challenge
Industry, Carrier and Service updates
Security Updates: RVAT
Compliance Corner: 21st Century Cures Initiative

Links of the Week

RVAT

CBP

Unitrans

Coldchain Comments

In a recent blog from Fisher BioServices, author Dan H. O'Donnell looks at Navigating the Ultra Cold Chain Distribution Challenge: 5 Hidden Minefields

  1. Landmine A: Adverse Temperature Events
  2. Landmine B: Packaging and Distribution
  3. Landmine C: Clinical Site Limitations
  4. Landmine D: Patient Administration
  5. Landmine E: Establishing a Chain of Custody

Click here for link to the e-book for more insights.

Questions on Stability Testing? Visit the WHO's official guidance on Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products.


Industry, Carrier and Service Updates


AIRFREIGHT:In a fleet and network shakeup, United will transition ten Boeing 777-200 aircraft out of its international fleet and re-assign them to fly domestic routes. United did not say on what routes it intended to utilize the airplanes. The move, which is pending minor updates to the aircraft, will have a positive impact on domestic wide-bodied cargo capacity which has diminished over the last decade.

Freight operator Cargolux will be suspending transport of lithium-ion battery consignments in light of recent re-assessment of the potential hazards they pose. Lithium batteries are suspected to have been involved in two fatal cargo 747 fires in the past five years. Other equipment, for example medical devices containing Lithium-ion batteries, will be exempt from the suspension.

Malaysia airlines forced to restructure its fleet – essentially exiting the cargo business due to falling load factors. The decline in traffic follows the loss of 2 777's in 2014; one flight disappearing over the Pacific and the second flight lost over Ukraine. Passenger bookings are down significantly.

WEST COAST PORT UPDATE: Despite the recovery efforts at West Coast ports, truck turn times at the Los Angeles and Long Beach marine terminals have remained around 100 minutes. read more...

June 1, 2015 GRI: Please be advised that a majority of ocean carriers have announced a GRI in the amount of $12/CBM, $24/MT, $540/20', $600/40', $675/40'HQ, and $760/45', effective June 1, 2015. Unitrans International will continue to mitigate these charges to support our customers in every way possible. If you have any questions or concerns, please contact your local Unitrans International account manager.

TRUCKING: On May 5th, a self-driving Freightliner truck was granted the first license to operate on an open public highway in the United States. Nevada is one of four states plus the District of Columbia, with laws regulating autonomous vehicle operation.

PHARMACEUTICAL and MEDTECH DEVELOPMENTS:: Bioflash reports on Five Companies that may be looking to buy Ariad Pharmaceuticals.

Gilead reports strong earnings growth for the quarter. Ups its annual forecast on the strength of Harvoni and Sovaldi sales despite strong competition from Abbvie and Merck & Co. COO hints at increased appetite for acquisitions.

A summary report on 2014's Top-selling Drugs is out. In this market insight from Thomson Reuters News, Lisa Hodgkinson reports on the top-sellers, not surprisingly led by biologicals. Abbvie, Gilead and J&J/Merck & Co. notched the top drugs in the survey.


Security News


The Pharmaceutical Cargo Security Coalition has announced that No-Charge facility physical security assessments for businesses within the Commonwealth of Pennsylvania are available through a specialize division of the Pennsylvania State Police.The RVAT (Risk and Vulnerability Assessment Team), composed of State Troopers trained on risk assessment procedures related to physical security, explosive effects on structural design, threat analysis and other security review techniques, represent and elite team available as a security resource to PA businesses.

Drones may be invading the supply chain for better and for worse. This from EBN's Tam Harbert, looks at some positive and negative implications for drones in securing the supply chain.


Compliance Corner


On April 29th, 2015, the House Energy and Commerce committee released an initial discussion draft on it's 21st Century Cures Initiative. Ted Piper of the PA Bio organization summarizes provisions to:

  • Incorporate the patient perspective in the discovery, development, and delivery process.
  • Increase funding for the National Institutes of Health, both through reauthorization and $10 billion over five years in mandatory funding, starting in FY 2016.
  • Foster development of treatments for patients facing serious or life-threatening diseases.
  • Repurpose drugs for serious or life-threatening diseases and conditions.
  • Modernize clinical trials.
  • Break down barriers to increased collaboration and data sharing among patients, researchers, providers, and innovators.
  • Help the development of personalized and precision medicines so the right patient can receive the right treatment at the right time.
  • Provide for continued work in the telehealth space.
  • Advance a truly interoperable health care system.
  • Provide clarity for developers of software products used in health management and medical care.

Ted encourages comments and concerns be sent directly to him at: tpiper@pabio.org or if you prefer, you may forward directly to the House Energy and Commerce Committee at: cures@mail.house.gov.

Questions?  Comments? Ideas? We’d love to hear from you @ dave.janzow@unitrans-us.com

 

 

 


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