January / February 2018

January / February 2018 Cover

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François Sallans, Vice President and Chief Quality Officer for Johnson & Johnson, speaks with PE about his career, dedication to preventing drug shortages, and thoughts on the ongoing hurricane-recovery efforts in Puerto Rico. Sallans was honored with the Max Seales Yonker Member of the Year Award.

François Sallans—2017 Member of the Year

COVER: François Sallans, Vice President and Chief Quality Officer for Johnson & Johnson, was honored with the Max Seales Yonker Member of the Year Award at the 2017 ISPE Annual Meeting & Expo Membership and Awards Breakfast in San Diego, California. We talked with him about his career, dedication to preventing drug shortages, and thoughts on the ongoing hurricane-recovery efforts in Puerto Rico.

Lilly Is the 2017 Overall FOYA Winner

FEATURE: Global health care leader Eli Lilly and Company was named the 2017 Overall Winner of ISPE’s Facility of the Year Awards for its Continuous Direct Compression Manufacturing Kits 2 & 3 projects in Indianapolis, Indiana, and Carolina, Puerto Rico. We take another look at these state-of-the-art GMP OSD facilities.

Serialization—A Global Transformation

SPECIAL REPORT: The development and adoption of serialization and track-and-trace programs are allowing pharmaceutical companies to identify, capture, and share data to achieve end-to-end product traceability. Our Special Report gets a bird’s-eye view of J&J’s serialization and traceability programs, and explores how Lilly leveraged serialization to secure its supply chain.

In This Issue

Special Reports
Whether serialization deadlines have arrived or are imminently approaching, smaller companies along pharmaceutical supply chains are scrambling to prepare—and for many, it’s a problem. TraceLink, a track-and-trace network for pharmaceuticals, estimates...
InTouch
They say that ongoing growth is the key to a fulfilling career. If that holds true, young professional Lise Heyninck of Belgium has the mindset and drive to build a long and successful career in the pharmaceutical industry.
Insights
  One of my key takeaways from the ISPE 2017 Annual Meeting & Expo is that as an industry, we need to focus on innovation. Keynote speakers from Pam Cheng and Roger Connor to Enno de Boer and Glenn Pierce reminded us that innovative thinking must come...
Features
Maxine Seales Yonker was an active ISPE member, leader, and contributor to the industry. When she lost her battle with cancer in 2005, her memory was honored with an annual award that recognizes the same commitment to service. As he announced this...
Insights
$38B of manufacturing value, 71% of which is exports 2nd in Europe for pharmaceutical production Italy exports 85% of the API it produces 42% of employees are women; 52% in R&D 40% of companies are Italian owned Exports have grown 52% since 2010,...
Technical
Does electron-beam surface decontamination radiation damage COC syringes? Experimental investigations confirm that no measurable dose is delivered if irradiation parameters are selected correctly. Even a dose of a few kGy (equivalent to a few 0.1 Mrad) would not cause significant change.
Insights
One year ago, I wrote about the industry’s collective pathway to hope, lit by the desire to alleviate human suffering. One year on, extraordinary forms of hope became reality with the approval of CAR T-cell therapy, emergence of CRISPR technology, and...
InTouch
ISPE was a publishing powerhouse in 2017, producing 10 documents that reflect new titles and refreshed content. Each was made possible by a group of talented professionals, both staff and members, who harnessed laser-focused determination to put current,...
InTouch
These are interesting times for the pharmaceutical industry in the United Kingdom. According to a recent report, the industry employs more than 73,000 people and contributes £30.4 billion ($40 billion) to the British economy, including £4.2 billion ($5.5...
Technical
ISPE's Process Capability team has developed an industry-specific maturity model that can help companies design a robust process-capability program and compare it to those of their peers. The model has been substantiated by surveying 15 companies.
Technical
Every business has legal, economical, and ethical objectives that range from mandatory safety to commercial goals to corporate citizenship. Businesses undertake a certain amount of risk to achieve these objectives. The balance between risk and reward is an ongoing challenge regardless of the...
Special Reports
  Deadlines Are Looming Whether serialization deadlines have arrived or are imminently approaching, smaller companies along pharmaceutical supply chains are scrambling to prepare—and for many, it’s a problem. Making a Serialization Program...
Features
Eli Lilly and Company’s continuous manufacturing (CM) kits have proven to be an important manufacturing platform for the company’s oral solid dosage products (OSD). “CM is very important to Lilly as one of our proven manufacturing platforms for...