By Rob Wright, Chief Editor, Life Science Leader
Follow Me On Twitter @RfwrightLSL
Thanks to Outsourced Pharma chief editor Louis Garguilo taking the lead on serving as host of Life Science Leader magazine’s annual CMO Leadership Awards celebration and reception in New York City, my time was suddenly freed up to explore for new educational opportunities. And while I will admit to being biased as to the quality of educational opportunities offered by our own Outsourced Pharma conferences, I recently got back from an event best described as one of the best pharmaceutical manufacturing educational conferences you have probably never heard of. Now truth be told, I had been invited to PharmaLink (an event produced by Xavier University and the FDA) in the past. Further, I have had a number of executives (e.g., David Lowndes, SVP supply chain and quality at Shire) not only tell me about the value of the conference but even suggest that I attend. However, it wasn’t until this year that I was successful in working it in to my schedule, but I am glad I did, and here’s why.
Are You A Fan Of Talking Heads?
While The Talking Heads may have been one of my favorite bands in college (seriously dating myself here), when at a conference, listening to a “Talking Head” is one of the last things I want to do. I believe that one of the reasons audience members often turn to their cell phones during a presentation is because once they realize they are being read (verbatim) some legally approved two-year old slides that won’t offer any new insights, they feel their time could be better spent dealing with more pressing matters. At PharmaLink 2016, catching someone staring down at a mobile device tended to be more of a rarity than the rule. You might find this surprising considering that many of the speakers were from regulatory offices, often known for having lengthy PowerPoint presentations, and perhaps, a preference for working from prepared talking points. However, folks like CDER FDA deputy director Ilisa Bernstein, FDA field investigator and drug pre-approval manager Kathleen Culver, as well as the UK’s MHRA (Medicines & Healthcare products Regulatory Agency) senior GMDP inspector and operations manager Tracy Moore, actually dug deep into their bags of experience and shared both personal and professional experiences as a means of imparting wisdom to PharmaLink attendees. For example, during Moore’s presentation on data integrity, she shared a story from her prior industry experience. Apparently, one of her former pharma colleagues was accused of submitting fraudulent data. At the time when the person explained the situation to Moore, it seemed clear to her that the intent was not fraud. Nonetheless, it was still a data integrity (DI) issue, which can have very serious consequences. On page four of Moore’s PharmaLink 2016 presentation she notes that 35 percent of EU statements of noncompliance (SNC) for biopharmaceutical manufacturing companies (the equivalent of receiving a U.S. FDA 483 warning letter) were attributed to DI issues. In fact, of the 121 major SNCs, 20 of these DI deficiencies resulted in regulatory action, and 10 DI deficiencies resulted in the manufacturer being placed under regulatory compliance management (similar to working under an FDA consent decree in the U.S.).
Want Safe, Effective, And Unadulterated Drugs? Apply The Hospital Room Test
PharmaLink’s 2016 co-chair Kathleen Culver also conducted a presentation on data integrity. While the 20-year FDA inspection veteran provided a detailed explanation of the Application Integrity Policy (AIP) which sets forth the FDA’s general approach in dealing with applicants that seek to subvert the agency’s review and approval processes for premarket applications, it was her personal experience that proved most interesting. According to inspector Culver, the “hospital room test” is real life teaching her about real life. Culver shares that 15 years ago she found herself in a hospital room with a daughter who had a very serious case of pneumonia. Upon discharging the child, the doctor gave Culver some very specific instructions (i.e., the patient not leaving the house for anything but doctor’s office visits, and being compliant with all prescribed medications). The doctor explained to Culver that one of the drugs he was prescribing was very new, so much so, that she probably never even heard of it. However, Culver, upon hearing the drug name, knew more about it than the doctor could possibly imagine, for not only had she conducted the preapproval inspection of the facility about three and a half years earlier, she had actually met the woman who had discovered the medicine. As she waited in the hospital room, she reflected on her preapproval inspection of that facility. She recalled how the company was very scientific, possessing a systematic culture for how it handled data records. Her point to attendees — whether a regulatory inspector or someone working at a manufacturing facility — if you put yourself in the hospital room and consider that a family member or loved one may someday be the patient taking that medication, it will serve you well in creating and adhering to systems and processes that result in a drug being safe, effective, and unadulterated.
What Else Did I Like About PharmaLink?
There were a number of other things I really enjoyed about PharmaLink, such as its attention to the little things. For example, if you have ever gone to an event with a few of your colleagues, despite your best efforts to proactively manage the expectation of splitting up to better network, there is always a tendency to sit together as a team. However, upon arriving at PharmaLink, you are greeted by an Xavier Health associate holding a tray containing small folded pieces of paper that have a number corresponding to a round table within the meeting room. To me this is one of those little things that brilliantly facilitated better networking. Such a simplistic approach removes the decision making burden of separating from the company flock, giving attendees a permissive nudge to step outside their comfort zones. If you have ever attended a multiple-day conference that doesn’t take a similar proactive approach, you probably noted how most people sit in the exact same spot on day two as on day one. However, at PharmaLink you can expect to sit somewhere different each day. And while you are free to ignore this networking nudge, by doing so (in my opinion) you are inhibiting a wonderful experience.
Another component I enjoyed at this conference (wanting at most others) is active audience engagement. Speakers have a tendency while presenting to ask the tables to “talk amongst themselves” about information being presented, and then call on a table number to share what was discussed. On day three, a time when most conferences are winding down and people seem most ready to leave, PharmaLink continues to raise the bar. One of the sessions I suspect received the highest attendee ratings took place on the last day. It involved speakers presenting a limited amount of info on case studies, having the tables discuss and present, provide a little more information, have tables discuss and present, and so on. Allocated for an hour and a half, the time seemed to fly by with most folk continuing to discuss the cases well into a scheduled break.
Finally, when most conferences conclude, you often find people jetting for the door. However, at PharmaLink I noticed many lingering, working collaboratively on action plans for what they intend to do differently upon getting back to the office.
Bottom line, if you are looking for a conference that engages participants to develop solutions that can reduce risk throughout your company’s supply chain, I encourage you to check out Xavier Health’s PharmaLink in Cincinnati, scheduled for March 14 – 17, 2017. Will I see you there?