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#SocPharm Tweetchat Transcript 6/15/2011

Posted by | 11:01pm on Wednesday, June 15, 2011

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It’s time for the #biotech & #pharma marketing & social media tweetchat #socpharm! Who is on tonight? Say hello…

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I’m at the main office for Siren Interactive outside Chicago so it’s weird for me to be doing #socpharm at 7 pm CST!

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We’ll assume that all tweets within #socpharm are your own and not your employers (unless you specifically declare them).

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@ Good to be here! #socpharm

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@ Hi Craig, thanks for joining #socpharm in between putting kids to bed!

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Hi Eileen I’m lurking tonight for the first part. Pharma call center expert, MBA in Health Care Management, sm advocate #socpharm

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@ Thanks so much for saying hello! You are welcome to lurk or paticipate in #socpharm

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T1 The Pfizer virtual clinical trial is an innovative approach. @ can you share the impetus for doing trial this way? #socpharm

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Thanks! We have been closely following trends in mHealth, Health 2.0, telemedicine; looking for opportunities for R&D. #socpharm

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Together we see new opportunities to engage with patients in clinical trials #socpharm

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We pitched it internally first. Found a number of senior R&D champions. Then found a KOL at UCSF thinking the same way. #socpharm

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Hi. Ciaran Bellwoar from Siren joining. Looking forward to T1. #socpharm

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@ About how long did it take from the idea to see it to fruition? #socpharm

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Hi This is Sarika Gupta from MphasiS. Hello everyone #socpharm

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My earliest slide deck internally dates back to Oct 2007. We had support and a team within 12mo. #socpharm

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@ Welcome Sarika to #socpharm

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Since then there has been a lot of IT build up, but also a lot of legal and regulatory issues to address. #socpharm

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@ October 2007 to June 2011 — did you think it would take more time? less time? Curious :) #socpharm

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Honestly, both. I thought more time to get senior mgt buy in. But I didn’t factor in the legal issues taking so long. #socpharm

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@ So how did you address the legal & regulatory concerns? It’s hard to be the first, no example to reference. #socpharm

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Doing the project under an IND (even for an approved drug) gave us an opportunity to engage FDA. So we needed ducks in order. #socpharm

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hi- i saw this at @ has a poll http://www.pharmalot.com/2011/06/pfizer-and-a-clinical-trial-in-a-box-for-home-use/ #socpharm

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But I was naiive with regard to the state-by-state requirements around telemedicine and perceptions of broaching internet rx #socpharm

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What do you think of the pharmalot poll? #socpharm Is this really only a 50/50 good idea?

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thanks@EileenOBrien looking forward to info on virtual clinical trials tonight #socpharm

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RT @ What do you think of the pharmalot poll? #socpharm Is this really only a 50/50 good idea?

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Or is 52% in favor on pharmalot a sign of huge support? #socpharm

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I was very surprised to see on @ poll that 50% thought it was a bad idea. #socpharm

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From the pharmalot comments, I am not sure everyone followed what we were doing. There were a number of safety q’s as well. #socpharm

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not sure abt the 50/50 clinical trial in a box idea via the poll, though i think ppl are concerned over quality of data control #socpharm

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btw i’m a parent,caregiver,advocate interested in transparency,accountability and blog abt it #socpharm

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Interesting, the answer to most Q’s abt the virtual trial tends to be “how are we doing it better w/ conventional studies”? #socpharm

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one Q i would have abt the trial in a box, is how does the FDA rate the outcome data? important? useable? #socpharm

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We use PRO (patient reported outcomes) for endpoints in many disease areas today. FDA even has guidance on the topic. #socpharm

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RT @: We use PRO (patient reported outcomes) for endpoints in many disease areas today. FDA even has guidance on topic. #socpharm

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When we think about diseases like pain, overactive bladder, etc… many of these are patient self-reported. #socpharm

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Other endpoints may be diagnostic, and those too I can capture with a virtual trial approach (i.e. labs). #socpharm

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A patient can share quite a lot of data without my having to bring them into an investigator site for a visit. #socpharm

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@ What’s the question that you got asked the most about this concept? #socpharm

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so the trial is based on what phase of the trial? #socpharm

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How will we know…the patient is real? taking the meds? etc. #socpharm

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All of which we can overcome with identity verification and remote monitors. #socpharm

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This pilot is technically ph 4. But we are reproducing earlier phase studies to prove the methodology. It’s really a method study. #socpharm

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RT @ A patient can share quite a lot of data without my having to bring them into an investigator site for a visit. #socpharm

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@ Is Pfizer already planning another virtual clinical trial? #socpharm

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@ i’m in the #socpharm chat come join us talking abt ‘trial in a box’

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We are exploring our ability to bring these methods outside of the US. #socpharm

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While we have been working to understand legal/regulatory issues in Europe, we have had a lot of interest in other regions. #socpharm

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Great next step. RT @: We are exploring our ability to bring these methods outside of the US. #socpharm

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I think overactive bladder was such a good choice of disease state – non life-threatening yet embarrassing. #socpharm

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RT @ All of which we can overcome with identity verification and remote monitors. #socpharm (patient ‘real’ and taking meds)

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The pilot is really a string of modules (online consent, etc). So we also believe the pieces can be reused in conventional studies #socpharm

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@ Any other misconceptions or misinformation out there about this virtual clinical trial that you’d like to clear up? #socpharm

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Your right, OAB fit really well. Also pt-reported endpoints. And a well-characterized drug to use to test the method. #socpharm

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We are actively monitoring safety in a continuous, real-time manner. Pts are connected to us 24/7. #socpharm

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In many ways this exceeds the cyclical visit-based monitoring in conventional studies. #socpharm

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RT @ We are actively monitoring safety in a continuous, real-time manner. Pts are connected to us 24/7. #socpharm

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I’m particularly excited about our sharing data and results with patients (incl sending their clinical trial data back via PHR). #socpharm

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@ how are the patients monitored 24/7? what technology? #socpharm

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Pts are connected to us 24×7. Round the clock access to the central investigators online and by phone. #socpharm

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@ How many patients are you hoping to enroll? #socpharm

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http://t.co/Jv9DWhX Alison Bass -excellent points, but fear Greater Boston does not want to address COIs..#socpharm

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@ what abt a medical emergency, would that be anticipated? what would protocol be? #socpharm

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We are looking for around 600 women to enter the screening phase of the study (for a 200-300 to randomize). #socpharm

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When clinical trial participants have a med emergency, they are typically advised to go to the ER. #socpharm

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Last question for @ Any advice for others within pharmacos trying to get innovative ideas through? #socpharm

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A PCP or urologist as an investigator in an OAB trial is not very interested in the patient with chest pain in the office. #socpharm

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The culture question is a great one. This is a great time to innovate in pharma. #socpharm

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@ Also, since this an approved drug, there should be less surprises on AE’s #socpharm

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Certainly in R&D, we have a great sense of urgency, and still have the resources to make change happen. Innovation perfect storm. #socpharm

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@ was curious what the ER staff would need to know abt the possible drug interaction? bring info with? #socpharm

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Perhaps less surprises on AEs with an approved drug. We are collected AEs diff from most studies (ongoing, continuous, real-time) #socpharm

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RT @ @ Also, since this an approved drug, there should be less surprises on AE’s #socpharm

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RT @: Certainly in R&D, we have a great sense of urgency, and still have the resources to make change happen. Innovation perfect storm. #socpharm

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We would want ANY clinical trial participant going to the ER to notify their investigator site & bring study contact info. #socpharm

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Congrats to @ & his team – you must feel a huge sense of accomplishment #socpharm

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Sense of accomplishment getting this far, but we need to get data, learn, adapt, and scale. #socpharm

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@ It never ends, does it? Thanks again for taking all of our questions, much appreciated. #socpharm

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@ thanks for answering lots of questions, interesting discussion thanks! this clarified it more #socpharm

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Thanks…now go vote on pharmalot’s poll! #socpharm

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@ It should be the standard! Clinical trial participants going to ER <=> notification to investigator site #socpharm

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Already did :) #Socpharm

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T2: Next question “Interactive” is an ill-defined buzzword. How do YOU define it? #socpharm

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I prefer the word interactive to digital because it implies a back & forth interaction. #socpharm

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When I tell lay people that I work for an interactive or digital agency they still look at me blankly :) Anyone else get that?#socpharm

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T2 – Does it have to be real time to be interactive ? Just asking #socpharm

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Thanks @ for sharing details about Pfizer’s virtual clinical trials. #socpharm

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Good question. RT @: T2 – Does it have to be real time to be interactive ? Just asking #socpharm

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Per wikipedia: Interactive, when a message is related to a number of previous messages and to the relationship between them. #socpharm

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In the last few minutes of #socpharm anyone have any interesting articles or upcoming events to share? #socpharm

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Well, lots of #clinicaltrial folks will be in Chicago for DIA next week #socpharm

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@ MadMen with different ethnicities, religions & sexual orientation as well. #socpharm

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Very true! RT @: Well, lots of #clinicaltrial folks will be in Chicago for DIA next week #socpharm

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Next week @ from @ will be the guest moderator of #socpharm. Feel free to send us questions.

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I learned a lot in the chat tonight. I’ll let you know when I post the transcript. #socpharm

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Thanks @ for facilitating a great #socpharm

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Thanks @! #socpharm

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RT @: http://t.co/Jv9DWhX Alison Bass -excellent points, but fear Greater Boston does not want to address COIs..#socpharm

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RT @: Big Pharma Spends More On Advertising Than Research And Development, Study Finds: http://me.lt/9F0E2 #Pharma #socpharm # …

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Keep on leading Craig! RT @: The culture question is a great one. This is a great time to innovate in pharma. #socpharm

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@ bravo to you & #pfizer for innovative work that’s paving the #future of R&D / trials. I’ll be tuned in! #socpharm @

About Eileen O'Brien

Eileen has more than 16 years of digital healthcare marketing experience. She is an opinion leader on social media and biopharma, and has been invited to speak at industry conferences and quoted in publications.

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