Serialization, Tech Transfers & Costs Key Issues for CMOs  8/10/2017

Serialization was on the minds of almost everybody at ECRM’s recent Contract Manufacturing/Packaging/Logistics for Pharmaceuticals, OTCs and Nutritionals EPPS.

The second phase of The Drug Quality and Security Act (DQSA) -- which was enacted by Congress in 2013 to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States -- begins in November and requires manufacturers to begin affixing or imprinting a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce no later than November 27. 

The challenge with this, according to attendees, is the timely implementation of product identifier requirements, due to a limited number of vendors that have the expertise to provide solutions related to information technology systems for data management or specific equipment needed to accomplish this.

“it cost a lot of money and effort for us,” said one contract manufacturing organization (CMO) attendee interviewed by ECRM staff. “It is a huge nightmare for CMOs, and we’re having difficulty determining who should pick up the costs. Ultimately falls back on the CMOs. We already received a one-year extension.”

On June 30, 2017, FDA issued a draft guidance for the industry that says although manufacturers are to begin including a product identifier on prescription drug packages and cases on November 27, 2017, the FDA is delaying enforcement of those requirements until November 2018 to provide manufacturers additional time and avoid supply disruptions.

TIP Roundtable Discussions
Other key issues for CMOs were discussed during the Thought Interaction Pods – a series of concurrent roundtables, each related to specific topics of interest to CMOs and moderated by attendees -- that was held during the EPPS.

Following are the topics discussed and moderators:
  • Top Considerations When Selecting a CMO: Jeff Tremain and Ania VanDyke, Business Development Sales Managers, Abbvie Contract Manufacturing
  • Managing the Total Cost: From Tech Transfer Through Commercial Launch: Walter Kibbe, Head of Supply Chain, Amring Pharmaceuticals
  • Expectations of a Client from a CMO: Nath Punji, EVP - Supply Chain & Projects, Bionpharma, Inc. 
  • Tech Transfers: Kirk Seemann, Senior Vice President - Supply Chain Management, Prasco Laboratories 
  • Improving Collaboration Between the CMO and the Rest of the C-Suite: Tim Swoboda, Vice President, Magno-Humphries Laboratories 
Below are some key takeaways from the TIP sessions.
  • Strong and regular communication between the c-suite, the purchaser, and the CMO – as well as supply agreements -- are necessary to ensure each party involved is on the same page.
  • CMOs should have a top-of-the-line project manager for tech transfers into a CMO.
  • Don’t make assumptions on anything when it comes to tech transfers.
  • Understand who you are partnering with, not just from a quality perspective, but from a cultural perspective.
  • To manage the total cost from tech transfers through commercialization, share all relevant data as it becomes known.
For the full comments from the TIP session moderators, see the videos below (to view the full playlist, click on the menu icon on the upper-left corner of the video).


Michael Castillo

SVP of Pharmacy & Medical Markets

Michael can be reached at (440) 528-0441

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