Did you hear the news?

INTERPHEX 2013 saw a remarkable 20% increase over last year’s show!

Anticipation was at an all-time high over new technologies and featured products with a vast array of equipment and demonstrations on the Show Floor, far more than in previous years.  Buyers had the opportunity to connect and network with new suppliers displaying the latest technologies.

This unique opportunity for industry experts to connect with vendors, suppliers and product champions, while receiving the latest information on tools, methodologies and regulatory knowledge, made INTERPHEX 2013 an especially compelling event.

Read the rest of the press release here>>

I had just finished catching up on things Monday evening and was closing open windows on my computer when I glanced at one of my feeds and caught the news that there had been a terrorist attack at the finish line of the Boston Marathon. When I got into my car to start my commute home I turned on the radio to get more information. Two bombs exploded, three deaths and some 130 wounded.

My emotions cycled between relief at the modest death toll, anger at the perpetrator(s), dismay and that awful powerless fatalism that perhaps we all feel in the face of this insidious form of warfare against, in my humble opinion, modern civil society, the rule of law (rather than the gun), religious freedom and the liberty our democratic republic offers us.

As I continued to listen to the reports on TV, later that evening and then on the radio during my commute to work Tuesday, pundits repeated that much like our collective experience in the wake of 9/11, we are united by this event and that we are “All Bostonians Now.” As I pondered the significance of this, I listened to reports, information gleaned from witnesses and first responders.

One string of commentary in particular caught my attention. One commentator attributed the low death toll to the fact that present at the scene were hundreds of physicians, nurses and similar health care professionals who sprang to immediate action, providing first aid and delivering stabilizing trauma care virtually within minutes. I listened on and in one of the official first press conferences, I heard (I believe) the mayor of Boston acknowledge and praise the extremely professional response by the hospitals and the doctors and nurses in the trauma care facilities.

As I pondered the significance of that, I pictured in my mind these professionals at work, triaging patients, cleaning wounds, prepping victims for surgery and administering everything from pain medications to antibiotics.

Then it kind of hit me; the pharmaceutical industry was right there too. Not only were the physicians, nurses and EMTs intervening but “we” as in the collective activities of those involved in the development and production of pharmaceuticals were on the scene responding to the tragedy as well.

I am certainly not diminishing the efforts of the medical community; I’m just trying to point out that their life-saving efforts were made all the more effective through the work the pharmaceutical industry does every day.

Think about all the pharmaceutical therapies that are available to treat the wounds physical and otherwise, caused by those bombs. From the traditional opiates to treat pain and shock, anesthetics for surgeries, the antibiotics to prevent infection, saline to shore up blood loss and more; regardless, the list is a long one. And it will continue to grow. A quick look at pharmaceuticals being developed to treat Traumatic Brain Injury for example, point to the industry’s ongoing fight to mend (among other things) what terrorism aims to break: both our bodies and our minds.

But we aren’t going to let them win because there will always be more good people then there are bad. I’m willing to bet there were many hundreds of people from the pharmaceutical industry involved in the Boston Marathon one way or the other. The region’s concentration of professionals serving the industry is well known. But even if you are working in the Illinois, out in California, or Atlanta (anywhere pharmaceuticals are made) you were there. You are a first responder too, and we are all Bostonians now.

Steven E. Kuehn
Editor-in-Chief
Pharmaceutical Manufacturing

Innovators are actively seeking solutions to tablet manufacturing challenges, including perennial sticking issues and the newer challenge of designing tablets for functional scoring that have appropriate mechanical properties and content uniformity. Recent focus on tablet scoring by FDA, which is working on draft guidance, is driving companies to look more closely at tablet splitting. Both the European Pharmacopoeia (Ph. Eur.) Commission and the United States Pharmacopeia Convention (USP) are also working on tablet-splitting issues.

The Ph. Eur. Commission recently created chapter (2.9.47, “Demonstration of Uniformity of Dosage Units using Large Sample Sizes”) as an addition to the existing binding requirements in Chapter 2.9.40, “Uniformity of Dosage Units.” The new chapter discusses using process analytical technology (PAT) to assess content uniformity, explained Susanne Keitel in a Pharm Tech artile.

USP is interested in developing a general chapter to provide a test that would define specifications for demonstrating that a tablet is functionally scored, said USP’s Anthony DeStefano in another article.

Pharmaceutical Technology also spoke with several industry experts about tablet splitting and scoring. Their comments on handling the increased manufacturing and testing complexities involved in scored tablets can be read here.

Another tableting concern under investigation is sticking. I Holland, for example, is conducting a tableting science anti-stick research (TSAR) project in collaboration with the University of Nottingham in the United Kingdom. In a recent article, I Holland explained that the goal of the project is to develop a predictive tool for identifying anti-stick coating solutions without full-scale trials using the customer’s equipment. The TSAR project is about halfway through, and more will be published on this work in the future.

INTERPHEX is a great place to see firsthand what tablet equipment companies, such as
l Holland Limited, Fette Compacting America, and Thomas Engineering Inc. are up to. See them on the show floor, or attend conference sessions on tableting, such as Fette’s Technical Workshop; A Compressed View of Modern Tableting Technology, or Cetin Cetinkaya’s Conference Program presentation on Mechanical Characterization, Testing, and Defect Monitoring of Tablets.

Jennifer Markarian
Manufacturing editor, Pharmaceutical Technology

“It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness, it was the epoch of belief, it was the epoch of incredulity …” Pharmaceutical Manufacturing’s newest contributing editor, Charles Dickens submitted that opener to me for the magazine’s April cover story, describing the state of the industry 10 years after the FDA introduced Pharmaceutical GMPs for the 21^st Century – A Risk-Based Approach. OK, with the exception of the part about the 10^th anniversary of the FDA’s sweeping policy mandate, that last sentence was factually incorrect.

But what is true, is that over the past 10 years, the pharmaceutical industry has changed dramatically and is at a point where the next 10 years are likely to set the tone and direction for the 50 following it. Actually, Pharmaceutical Manufacturing’s April cover story on the state of the industry, by contributor Angelo DePalma posits: “GMPs for the 21^st Century has profoundly influenced how drug companies manage risk, particularly but not exclusively with regard to manufacturing. The risk-based approach becomes particularly challenging given the backdrop of merger and acquisition activity and a heavier reliance on outsourcing for manufacturing and R&D. For manufacturing, this means negotiating the moving targets of productivity and supply chain demands.”

And like Dickens’ famous opening line in Tale of Two Cities, the industry is at once experiencing the best of times with fast-paced advancements and dramatic impacts on global disease, particularly in the biopharmaceutical space, and the worst of times, with Big Pharma restructuring HARD and facing some the toughest economic and regulatory hurdles it’s ever encountered. To my mind, never have the risks, or the potential of reward been in such sharp contrast. Pharma’s near future is dependent on getting GMP right—and in the process (pun sort of intended) driving manufacturing, process and data management efficiencies in, while driving cost and complexity out. I think most would agree, that is indeed our best foot forward when it comes to managing through uncertainty to achieve and sustain better outcomes for patients and the industry alike.

I continue to see the industry’s technical community responding to these challenges in ways big and small. Regardless of what side of the aisle one’s on, the collaboration between those with the capital and a vision and those with vision-answering technologies and services (in pursuit of said capital) have never played a more critical role in delivering the industry’s tremendous promise or sustaining its long-term health. Fortunately, many of those seeking solutions and those providing them will have a chance to put their heads together at INTERPHEX 2013, indeed fertile grounds for collaboration. I’ll be there too, seeking those telling stories of collaboration and success; and that, dear colleagues, is the tale I want to tell.

Steven E. Kuehn
Editor-in-Chief
Pharmaceutical Manufacturing
Putman Media, Inc.
630.625.1135
847.975.4405 (M)
skuehn@putman.net

In February, China’s State Food and Drug Administration (SFDA) announced its implementation of a national track-and-trace strategy, leaping ahead of the United States in national serialization efforts. The agency felt its current good supply practices (GSPs) weren’t on pace with the rapid growth of China’s economy and society, not to mention evolving drug regulatory and pharmaceutical distribution requirements.  Regulators revised the GSPs to provide much-needed clarity through a three-year implementation plan that begins June 2013. So, what do these provisions mean to U.S. and global track and trace endeavors? To find out more, I talked with Michael Stewart, VP of track and trace projects for PharmTech, Inc., a consulting group which has been involved in serialization projects with pharmaceutical manufacturers since the development of the California ePedigree mandates.

“Although we applaud China for taking measures to safeguard their pharmaceutical supply chain, now the global discussion should not be whether item-level serialization should occur, because that’s a given,” Stewart explained. “Rather, the questions that should be asked are: What are we trying to accomplish? Is ePedigree or authentication the end goal, and why?” For example, in the United States and California, ePedigree essentially identifies counterfeit drugs that have infiltrated the legitimate supply chain and eventually tracks where they were introduced into the supply chain and by whom.  Unfortunately, that doesn’t always solve the problem. This is where China’s authentication methods come into play. The authentication process checks the validity of the serial number at the point the drug is dispensed to the patient, not during its travels.  Wouldn’t the best solution be a hybrid of both, where fake products could not enter the supply chain and also could be detected at the point of dispense?  Sure, but Stewart emphasized that “we need to ensure that the cost of the solution is not more costly than the problem.”

You can read more of this article, as well as other articles concerning serialization, in Pharmaceutical Online: The Magazine — when it debuts at INTERPHEX 2013 ! We’ve focused this issue on important aspects of product protection through a track and trace system.  You can look forward to a step-by-step breakdown for serialization implementation from now through January 1, 2015, read insights from Dirk Rodgers from Rx Trace, and find tips on how to be a better project leader — just to give you a little taste of what to expect.

Since the California ePedigree law deadline is now less than 21 months away, track and trace should be top of mind and planning needs to start at your company, if it hasn’t already.  INTERPHEX is also on top of the issue,  featuring a mini-course on serialization.  I’m particularly looking forward to hearing what experts in the field have to say about item-level implementation,  process improvement, and the economic impact of serialization. (you might want to add this to your “Registration” before you attend!)

And, as you are visiting the exhibition hall, be sure to stop by the Life Science Connect booth #4117 and pick up a copy of the magazine.  And, look for follow-up interviews and videos from INTERPHEX on Pharmaceutical Online after the show!

By Lori Clapper, editor, Pharmaceutical Online

Over the years, we’ve seen INTERPHEX broaden its focus beyond manufacturing and packaging equipment and consumables to cover IT systems, outsourcing and contract services (with the Sourcing & Services Pavilion that Contract Pharma helped develop), and other key areas of drug development and commercialization.

When I write, “over the years,” I mean I’ve covered every INTERPHEX since 2000, except for the one in ’05 when my dad needed emergency bypass surgery and my publisher rightly recognized that I would be a little . . . distracted . . . if I tried to walk the Javits Center and interview exhibitors and attendees during that week. (Dad came through fine, btw, and just celebrated his 75th birthday.) I think we can all agree that the span of 2000-2013 has been tumultuous, to say the least. The world has been reshaped and pharma/biopharma has been no exception. The changes in INTERPHEX mirror the shifts going on in the larger industry.

As a business magazine editor, one of my tasks is to try to envision What Comes Next, whether that be in terms of new outsourcing models, or adoption of a new technology, or regulatory guidance. (There are a slew of other tasks I need to take care of, most of them far less fun.) One of the best ways to do that is simply to meet people and talk to them. INTERPHEX, with its mix of exhibitors, its diverse array of attendees and its multiple tracks of conference sessions, helps me do that. The event offers great opportunities not just for doing business, but for gaining perspective.

If you  are at the show solely for business, do yourself a favor and strike up a conversation with someone you don’t know, maybe over lunch in the food court. Ask them why they’re at INTERPHEX, what they hope to get out of the show, and how the show compares to past years. You can leave the reporting to the professionals (I’m waiting for my fedora with the “PRESS” tag in the band to come back from the hat-cleaner), but ask a non-conventional question or two while you’re at the show, and see what you learn. Chances are, you’ll see the rest of the event differently.

What comes next? Let’s talk about it and find out. If I’m not at the Contract Pharma booth, leave me a card and I’ll get in touch.

Gil Roth has been the editor of Contract Pharma magazine since its debut in 1999. Contact Gil at groth@rodmanmedia.com. Contract Pharma is the premier magazine covering contract services and outsourcing for the pharma and biopharma industries. For more information, visit www.contractpharma.com.

We are excited to provide you with the first look of our Conference Brochure for INTERPHEX New York 2013, hitting your mailbox soon! Download or print the 2013 Conference Brochure for a detailed look at the conference sessions that will be part of this year’s Show. We also have all the details about our keynote speakers, special conference sessions, key Show features and much more.

Check it out and let us know what you think!