I always seem to start off my blogs the way I do my annual Holiday letter, with an apology…sorry I haven’t written or called or had any normal human communication with you, my family and friends. Then I go on to explain why normal human communication has escaped me. Since I don’t really see “blogging” as normal human communication (again showing my age), I will dispense with the apologies and go on to tell you about what I learned during my incredibly hectic 4th Quarter of 2008. These are the real reasons I had no normal human communication during that time.

Actually, I need to go a bit further back than 4th Quarter - to August. Now, I did blog in August, but that was before the Olympics. What, you are asking, do the Olympics have to do with anything? Nothing really, except that the day of the opening ceremonies, 8/8/08, my father (whom I have previously blogged about) received a long awaited kidney transplant. As a result, I flew to Florida to help take care of him. He really didn’t need much care, because even though he was 82 at the time, transplant surgery has come so far and so fast, that within 5 days he was home from the hospital. My main job while I was there was to help him sort out his medications. This seemed like the most logical job for me considering what I do for a living. He came home with 13 different meds and once again my worlds collided. The hospital didn’t provide the package inserts, but thanks to the Daily Med Initiative, I was able to go the National Library of Medicine website and download all the info I needed. Without belaboring the details, I do want to thank all my colleagues in industry that helped bring these medications to market. Specifically, I would like to thank the folks at Roche and Astellas - the makers of Cellcept and Prograft. These are the Immunosuppressants that my Dad will be on for life and which have given him a new lease on life in the process. I know sometimes in Regulatory there is not the connection with patients as there is in the other areas of drug development, but truly we do have an impact on people’s lives.

After that, my husband and I moved our eldest daughter to Washington, D.C. for her first apartment and job. We then moved our younger daughter to college in Vermont and officially became “empty nesters” in September. I didn’t stay in the nest too long and was soon traveling a lot and as one of my work acquaintances put it, “Still traveling and bringing the good word about eCTD to every corner of the world?” I started 4th quarter with a trip to Budapest, Hungary where TOPRA (The Organization for Professionals in Regulatory Affairs) was holding their annual Symposium. Yes, I was speaking on eCTD, but more exciting than that, was that so was the Hungarian Health Authority and others! Not one HA spoke that did not have positive things to say about going to all electronic environments. The process work that has been done at the EU level is very impressive, and although much work needs to be done on the National level for many of the member states there was a lot of really good experience represented at this conference.

[Side Note: Since I like to cross reference back to earlier blogs, it is also noteworthy to mention that I did investigate Hungarian wine making. The industry there suffered a huge setback during World War II but has continued to make a wonderful dessert wine called Tokay, a wine I brought back and shared at our Christmas dinner.]

After Budapest and a quick trip to the UK (where we have an office), I was off to San Diego for the DIA eCTD Conference where I gave a tutorial on eCTD INDs and chaired a session on process changes that result from moving to eCTD. Again, the tone of these conferences is changing. There are many more experienced voices in the room sharing their experiences. Although we don’t have all the answers yet, the spirit of cooperation is inspiring. One presentation in particular gave me reason to hope. Justina Molzon of FDA, gave a presentation called “Promoting Efficient Reviews - An Historical Perspective of Good Review Practices: The Influence of the eCTD.” In her talk she discussed the following:

* History of GRP’s at CDER
* Focus on Influence of the CTD on GRPs
* Background on ICH and CTD
* eReview Initiatives
* Expansion of ICH to Non-ICH Regions
* Global Review Ramifications

I was so excited by her topic that I asked for her slides. She graciously shared them with me, so that I could use them for my next trip which was to give a workshop on eCTD to the Asia-Pacific Clinical Congress being held in Mumbai, India in November. In addition to the talk on electronic submissions, I also gave a talk on “The Regulatory Aspects of Microdosing,” which, although pretty far outside my usual realm of expertise, went over very well. The audience in Mumbai consisted of over 100 clinical research professionals, including a large number of students.
India is attracting the pharmaceutical industry not just for contract manufacturing but for an exponentially increasing number of clinical trials. It was interesting to note that the regulatory environment there is changing as well. Since 2005, the regulatory requirements for conducting clinical trials, especially for first in human trials, has been minimized, not in terms of ethics requirements but more around the business case for sponsorship by Indian based companies. My only concern after attending this conference comes back to the fact that while the educated in India tend to be extremely well-educated, my guess is that the uneducated outnumber them a million to one. While the infrastructure for some sectors is extremely high, the country overall is still in an early development phase.

[Side Note: While in India, I felt very “cooped” up in our hotel, because of location (we were near the airport) but also because of the extreme security applied to anyone going into the gated hotel area. Three days after we left the terrorist attacks took place in Mumbai.]

My last trip of the year was to the DIA EU Electronic Data Management Conference held in Barcelona in December. Despite a surprisingly low turnout, it was an excellent conference. I was there to give a tutorial on creating compliant eCTD submissions for the US and EU, which I gave with my friend and colleague Hans Van Bruggen. I was also there to chair and speak in a session on QA in the electronic age. What surprised me about attendance is that it did not pick up after the EU had announced MANDATORY eCTD submission for Centralized Procedure (old and new Dossiers) starting in January 2010. I would have thought that would send people scurrying for instruction. Having said that, the 12 people who attended the tutorial all had some experience with electronic submissions (some with eCTD) and we had some of the most interesting exchanges of information that I have ever had at a learning event. There were also some terrific sessions on Regulatory updates from the Health Authorities, electronic trial master files and xml authoring. So what could be more whirlwind than all this . . . coming back to a December where Regulatory was getting out 12 original submissions. Needless to say, the teams back at home (including my husband) deserve more credit than they get. We worked right up until December 31st. And it truly was a Happy New Year when the last submission was sent through the Gateway that afternoon!

[Final Side Note: New Year’s Resolution for work – blog more often!]