A Journal for Industry Executives

Brought to you by

By Mollie Shields-Uehling, President and CEO,
SAFE-BioPharma Association 

 As a global standards organization, SAFE-BioPharma has a unique perspective into developing and future IT trends in the life sciences, especially as they relate to use of our global digital identity and digital signature standard. Our staff works closely with member companies which are using the standard in a growing range of applications. We also work closely with non-member organizations to help them develop proof-of-concept studies and pilots utilizing the standard.

Based on these activities we have been able to identify three IT trends that will shape the life sciences in 2012.

1. STANDARDS-BASED INTEROPERABLE DIGITAL IDENTITIES

Industry leaders are rapidly increasing use of these unique digital identities among employees, collaborators, and clinical investigators. Issued once every three years, they take the place of multiple on line identities and can be used to control access to information and physical facilities. They also provide the ability to apply legally-binding digital signatures to electronic documents. The benefit of interoperability is that the digital identity is recognized and accepted by US government agencies, by other companies

2. CLOUD COMPUTING IN CLINICAL TRIALS

As demonstrated in a study between the National Cancer Institute and company-based cancer researchers, significant time and cost savings are realized when trial-related documents are accessed from the cloud rather than delivered by courier or mail. Interoperable digital identities (NCI researchers using government provided digital credentials; company researchers using SAFE-BioPharma digital credentials) give researchers access to the cloud-based electronic documents as well as the capability to apply legally-binding digital signatures. (Read The Paperless, Cloud-Based Clinical Trial; It’s Happening Now )

3. ELECTRONIC TRIAL MASTER FILES

Trial Master Files - the central record containing the files associated with clinical trials - are one of the last areas where clinical development records are primarily paper-based. Multiple pilot studies scheduled to start in the next few months indicate that pharmaceutical companies are preparing to make the process electronic. Companies will use SAFE-BioPharma digital identities to manage access to documents and to provide participants with the ability to apply legally-binding digital signatures.

The global SAFE-BioPharma digital identity and digital signature standard is used throughout the biopharmaceutical and healthcare communities to meet specific security and confidentiality needs. It was created with participation from the US Food and Drug Administration and the European Medicines Agency. The standard and its ongoing development is managed by SAFE-BioPharma Association, a non-profit supported by its members. For more information visit http://www.safe-biopharma.org/.

Mollie Shield-Uehling is President and CEO of SAFE-BioPharma Association. In this role she directs the business and strategic activities of SAFE-BioPharma Association. She has more than 20 years of international trade and biopharmaceutical industry experience. She is a member of the association’s Board of Directors.

Last month, I had the opportunity to chair the Global Pharma Sourcing Conference in Philadelphia. A recurring theme of the conference was the need to rigorously supervise and certify suppliers by implementing “trust, but verify” strategies. This got me thinking about the Kosher supervision and certification in the Food and Over the Counter (OTC) supply chain.

To learn more about how to keep a Kosher supply chain, I spoke with Rabbi Eliyahu Safran, Vice President - Communications and Marketing at Orthodox Union (OU) Kosher. OU is non-profit communal organization founded in 1898 and the world’s largest and most widely recognized kosher certification agency.

The Organization certifies more than 500,000 products produced in over 8,000 plants around the world. In today’s global environment, the OU certifies close to 300 facilities in China, as well as facilities in Argentina, India, Egypt and Turkey and some 80 other nations.

“Many of the brands you trust, rely on the OU for their kosher certification, including: ADM, Cargill, Coca Cola, DSM, General Mills, Hebei Welcome Pharmaceutical, H.J. Heinz, Hershey’s, Kraft/Nabisco, McCormick & Co., Nestlé, Novartis, Procter & Gamble, Pillsbury, Quest, Reynolds Aluminum, Rhodia, Unilever, and thousands more,” explained Rabbi Safran.

Contrary to popular belief, obtaining kosher certification does not involve a Rabbinical blessing over food products, or the manufacturing plants. So what is Kosher? The word kosher means proper or acceptable and it has entered the English vernacular with that meaning.

“Kosher laws have their origin in the Bible, and are detailed in the code of Jewish law. Kosher regulations are about the process, the purity and the traceability of ingredients. You may be surprised at the extent of Kosher regulations.” explained Rabbi Safran. “Kosherizing a food production or industrial facility requires a structured and meticulous process including equipment sterilization,” he added.

The OU inspects every facility where certified products are manufactured. It also requires the use of authorized ingredients from approved and qualified sources. To ensure compliance to its standards, the OU conducts unannounced, periodic inspections. “Our responsibility is making sure that things are done right. We answer to a higher authority, and are not motivated by profit,” said Rabbi Safran.

To achieve this goal, the OU employs over 600 Rabbinic Field Representatives located throughout the world - from Europe to Australia, from the China to South Africa. OU Field Representatives are proficient in modern manufacturing techniques, chemical & biological processes, as well as the intricacies of Jewish Kosher law. The agency’s New York headquarters staff consists of over 50 Rabbinic Coordinators supported by ingredients registry staff, ingredient specialists, flavor analysts and other support staff. To keep track of supply chain and product information the OU utilizes a comprehensive state-of-the-art computerized database that contains information on more than 250,000 food ingredients.

Like our industry, the OU uses a “Risk Based Approach” in its auditing process. “A facility producing a simple product, like spring water, may be inspected a couple of times a year. On the other hand, a product with a complex formula and many ingredients, or one with Red Flag Ingredients (like Glycerin) would be inspected a lot more frequently ” said Rabbi Safran. “For some high risk products, the OU has round the clock constant supervision of the facility” he added.

Partnering with the OU enables companies to leverage the organization’s vast resources. OU staff has a thorough understanding of manufacturing processes, ingredients, chemistry of additives and the procedures manufacturers employ in converting raw materials to finished products and incorporating all these resources in the kosher certification process. OU maintains a comprehensive database of approved and certified suppliers. Manufacturers rely on OU for recommendations on kosher ingredient as well new sources of raw materials and pre-certified alternate suppliers.

In recent years, over the counter Pharmaceutical and Nutritional companies have reached out to OU to obtain certification. Novartis was the first mainstream Pharmaceutical Company to achieve OU certification for its Triaminic Cough Syrup. The company has since added Maalox and Benefiber to the family of OU certified products.

Mead Johnson has OU certified many of its Enfamil, ProSobee and Poly-Vi-Sol Multivitamin products. OU also certifies products from Perrigo Holland, Maxx Performance, Robell Research, Health Management Resources and Soluble Products.

“Although we live in a society where trends come and go, as long as people need to eat, they are going to buy products that assure quality and integrity. As a result, they will look to the OU symbol as a clear indicator of both,” concluded Rabbi Safran.

So the next time you get a shipment from a supplier, maybe you should check if they keep a “Kosher” Supply Chain.

Last week I received an email from Jerry Hultin, President of NYU-Poly (my Alma matter) that included an interesting video “An Animated Year: Welcoming 2012 with a Look Back at 2011.”  As I looked at the video, I began to reflect Axendia’s accomplishments for 2011 as we set goals for the New Year.

I pondered how to measure accomplishments in today’s web-centric and interconnected world? I decided to go to the authoritative source and Googled “Axendia.” In 0.19 seconds I got about 7,320 results across 46 pages. That is one way to measure accomplishments.

Another way is to measure the contributions we have made and the commitment to our mission: “to be trusted advisors to Industry Executives on Business, Technology and Regulatory issues.” 

In 2011, we’ve had the privilege to advise executives at Life-Science, Healthcare and Food companies ranging from startups to Fortune 100 companies. We have also had the opportunity to counsel for leading technology and service providers. Read what some of our clients had to say about Axendia.

We began blogging at Life-Science Panorama in 2006, before blogging was cool. Five+ years and 160 articles later, we have nearly 2500 subscribers. Today, you can also follow us on Twitter and LinkedIn.

In 2011, findings from our research were presented in testimony to the Senate Committee on the Health, Education, Labor and Pensions (HELP) hearing on “Securing the Pharmaceutical Supply Chain.”

In addition to the Senate, Axendia’s Life Science Supply Chain research has made an impact on the following organizations:

• The Pew Health Group white paper: “After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs”

• CBS’ 60 Minutes segment by Dr. Sanjay Gupta titled “The difficult fight against counterfeit drugs.”

• Dr. Roger Williams, CEO of the US Pharmacopeial Convention referenced our findings in his article: “Ensuring Drug Quality: A Complex Task in a Globalized Era” 

We have conducted Primary Research, published numerous whitepapers, authored a multitude of articles and presented at leading industry conferences, and had the privilege of chairing Advamed’s Executive Workshop “Bringing Devices to the US Market” 4 years in a row.

Giving the Gift of Childhood
Continuing a 5 year old tradition, we have donated our entire holiday gift budget to the Children’s Hospital of Philadelphia (CHOP) Foundation. We believe that a healthy childhood is a gift. With this donation, we are helping CHOP continue their work to improve the health of children.
We are so pleased at the positive feedback we received, here are a few samples.

• It was heartwarming to read how you have been doing this for the last 5 years and you are SO RIGHT about how the value of that gift is SO MUCH MORE than getting a nice Holiday Card… Your contribution will have much longer term positive impact on many children and their families and what more can you ask for than that. In fact you’ve inspired me to reach out to the Foundation to make a personal gift that will hopefully have a similar impact.
• I wish everyone did this! Thanks for making a difference rather than giving another gift.
• This is one of the nicest gifts of the year. Thank you!
  

William Shakespeare wrote “What’s past is prologue.” I hope that in 2011 we have continued to earn your trust, and that in 2012 Axendia will continue to be source of trusted advice for you.

Thank you for your support and I look forward to continuing to build long-term relationships based on Axendia’s core values: Respect, Integrity and Passion.