Picture this: A party on World Yacht...New York, early December...more than 60 clients and friends of MetaSystem Consulting Group and Face the Music...great views of the Manhattan skyline...music (including some Face The Music blues tunes and “roasts”) and dancing...and old and new friends talking about business, teamwork and much, much more.

The evening officially got underway around 7:00pm, when MetaSystem Consulting Group’s own Lisa Murrell welcomed the guests aboard World Yacht’s Cabaret vessel. She thanked clients, colleagues and staff (including the indispensable Carol Scalzo, Office Manager, and Alain Cardon, the founder of MCG) who have contributed to MCG and FTM success over the last ten years.

Clients and associates onboard included Endo Pharmaceuticals, Ernst & Young, Chase, Pfizer, Tonner Doll Company, McNeil Consumer and Specialty Pharmaceuticals, Club Med, CDR International, Wiedenbach-Brown Company, Silvermine Consulting, Con Ed, Telx, Watkins and Associates, Guttman Development Strategies, JP Studio...just to name a few. There were also members of the extended MCG and FTM families, including spouses and children of current/former clients and colleagues. Each guest received a “goodie bag” of gifts from MCG and FTM including a Sneak Preview of What’s Your Lie?: Honest Leadership from the Game of Golf, MCG’s new book on bookshelves in 2005, Business Blues, CD highlights from the first five years of Face The Music, and a white chocolate golf ball.

Party-guests then heard an impromptu history and “roast” of MCG that was given by old friends and colleagues. Curtis Watkins, an O.D. consultant and friend who has known them from the beginning, joked that he was amazed at how Paul Kwiecinski, a musician and former carpenter and Lisa Murrell, a model, successfully transformed themselves to do coaching, training, consulting and team development work. John Graham, former client with Aventis and now with Ernst & Young, and Scott Shively, long-time client now at Endo Pharmaceuticals, endorsed MCG’s effectiveness with team and organizational issues, and highlighted the fun they’ve had working with MCG over the years.

Lisa Murrell went on to talk briefly about MCG’s upcoming plans and activities in, including the publication of the Golf and Leadership book in 2005.

The evening moved into high gear after World Yacht’s Cabaret boat left the pier and cruised down the Hudson River and around the southern tip of Manhattan. A buffet dinner was served, and party-goers ate, drank, conversed, listened to music and saw sights such as the Empire State Building (with a festive green and red top), a glowing Statue of Liberty, the Brooklyn Bridge and the Staten Island Ferry. Dining was downstairs, where it was warm and enclosed. The better views could be seen upstairs (and outside), and many braved the cold a number of times to see and take pictures of the sights.

Meanwhile, back inside the entertainment heated up with a performance by Face the Music (including members/former members Paul Kwiecinski, Ken McGloin, Jim Curtin, Dean Sharp, Amy Fradon, and Mitch Ditkoff). They related FTM’s history, including their initial gig at GE. As the session got underway FTM invited clients and friends to go “on stage” and sing the blues. Those brave souls who were willing to spontaneously come up with lyrics, sang songs with titles such as “Pharma Blues”, “FDA Blues” and “Queen Bee Blues.” Enthusiastic singers/lyricists included the sultry sounding Lisa Murrell herself, Janine Iofrida from Pfizer, Mitch Ditkoff and Keahi Cobjugacion (see photo below) and a few others.

More than three glorious hours later, World Yacht’s Cabaret docked at Pier 81 and party-goers and friends old and new said their good-byes and journeyed home, some having traveled to New York from South Carolina, Massachusetts and Connecticut.

MetaSystem Consulting Group would again like to thank our present and former clients and colleagues for their unwavering support over the ten years. We enjoyed seeing those of you who could attend the party, and we plan to be in touch with those of you who were unable to join us. Please look for your gift package to arrive in the next few weeks.

MetaSystem Consulting Group and Face The Music wish everyone a wonderful holiday season and a very happy and prosperous 2005!

Historically there has been at least one high profile episode of a pharmaceutical product being pulled from the market in the last 3 decades.

At the recent Food and Drug Law Institute (FDLI) conference in Washington, DC in November on Current Issues in US/EU Enforcement of Pharmacovigilance/Drug Safety, it was pointed out that awareness of the issues surrounding these episodes flair up and then seem to go away. It was the feeling at this conference, which was represented predominantly from the legal, Pharma and consulting industries, that things are now moving in a different direction. Closer attention and awareness of the potential vulnerabilities in the area of patient and drug safety are making Pharmacovigilance more critical than ever before.

Some telling questions you can ask yourself and your organization are:

1.   Is your drug safe?
2.   Are you 100% compliant?
3.   When is the last time you checked that your written procedures were accurate and up to date?
4.   What influence does your marketing team have over the PV function?
5.   Is your management giving PV enough money?
6.   Does PV have easy access and support of management?
7.   How important is PV in your organization?

Lourdes Frau, former head of PV at Aventis Pharma, summed it all up in her presentation, Crossing the T’s and Dotting the I’s, by reminding everyone to get back to basics when it comes to patient and drug safety. This includes doing what you need to insure compliance with trust and integrity, and create partnerships with different functions within the organization as well as with the FDA. It makes sense that the organization, with all its parts, and the FDA are all in it together.

The MC, Maurits Lugard from Sidley Austin Brown & Wood LLP, Brussels, congratulated everyone at the end for staying for 9 hours of Pharmacovigilance! I came away from this conference not only with these 9 hours of information about patient and drug safety, but excited about creating partnerships to facilitate this safety—with PV, and all their interfaces, as well as moving the industry forward by further defining the relationship between the FDA and Pharmaceuticals. Now I know what is ahead for MCG in 2005. We look forward to the challenge!