1 00:00:00,000 --> 00:00:01,980 MICHAEL ROSE: Just thanks a lot, Steve, 2 00:00:01,980 --> 00:00:03,510 for filling us in on this agenda. 3 00:00:03,510 --> 00:00:07,380 We thought it was important today to get on this agenda, 4 00:00:07,380 --> 00:00:10,140 because this group, the Healthcare Business Action 5 00:00:10,140 --> 00:00:13,840 Group, has been together for 18 months or so. 6 00:00:13,840 --> 00:00:16,484 And we're actually at a point now where 7 00:00:16,484 --> 00:00:18,450 we're developing some business requirements 8 00:00:18,450 --> 00:00:22,620 and moving it onto the Hardware and Software Action Group 9 00:00:22,620 --> 00:00:25,140 for some guidance. 10 00:00:25,140 --> 00:00:28,140 And some of our colleagues here that are going to talk today 11 00:00:28,140 --> 00:00:29,940 are going to get into some of the details 12 00:00:29,940 --> 00:00:33,540 around various areas we think we can use some research help. 13 00:00:33,540 --> 00:00:37,680 And clearly, as an industry, this 14 00:00:37,680 --> 00:00:40,980 is one area that we're starting to recognize where 15 00:00:40,980 --> 00:00:42,840 we do need to start reaching out and getting 16 00:00:42,840 --> 00:00:44,490 some direct help from you all. 17 00:00:44,490 --> 00:00:46,740 So we thank you for the opportunity today 18 00:00:46,740 --> 00:00:48,300 to talk to you. 19 00:00:48,300 --> 00:00:50,700 And hopefully, this will be an ongoing dialogue 20 00:00:50,700 --> 00:00:54,450 that we entertain with this group. 21 00:00:54,450 --> 00:00:57,360 Well, I though we'd just do a quick round of introductions. 22 00:00:57,360 --> 00:01:00,330 In addition to me, we have Bob Celeste from EPCglobal 23 00:01:00,330 --> 00:01:03,270 who's the director of the business action groups, 24 00:01:03,270 --> 00:01:04,860 and he's responsible for facilitation 25 00:01:04,860 --> 00:01:06,600 of the business action groups. 26 00:01:06,600 --> 00:01:09,570 Ted Ng, who's a director with McKesson, in spite 27 00:01:09,570 --> 00:01:11,063 of what it may say in the agenda. 28 00:01:11,063 --> 00:01:13,230 I don't think, Ted, you've gotten the promotion yet, 29 00:01:13,230 --> 00:01:16,050 but maybe next week to the vice president and board member. 30 00:01:16,050 --> 00:01:18,330 But hopefully, that'll happen next week, Ted. 31 00:01:18,330 --> 00:01:20,997 But it's nice to know, you go to Cambridge, you get a promotion. 32 00:01:20,997 --> 00:01:23,940 And Chuck Schramek, who is with EPCglobal now, 33 00:01:23,940 --> 00:01:26,190 but he's actually on loan from Johnson & Johnson. 34 00:01:26,190 --> 00:01:30,840 And about a year or so ago, J&J, we 35 00:01:30,840 --> 00:01:32,670 took we took a decision that we thought 36 00:01:32,670 --> 00:01:36,360 it was very important to help the development of industry 37 00:01:36,360 --> 00:01:36,910 standards. 38 00:01:36,910 --> 00:01:42,090 So we graciously let Chuck go to EPCglobal 39 00:01:42,090 --> 00:01:45,450 to help facilitate this development of standards 40 00:01:45,450 --> 00:01:46,870 in the health care industry. 41 00:01:46,870 --> 00:01:48,537 So as you see on the agenda here, 42 00:01:48,537 --> 00:01:50,370 Bob's going to give us an overview to what's 43 00:01:50,370 --> 00:01:53,220 been going on within the BAG the Healthcare & Life Science 44 00:01:53,220 --> 00:01:54,570 Business Action Group. 45 00:01:54,570 --> 00:01:57,477 Chuck is going to talk around item-level tagging. 46 00:01:57,477 --> 00:01:59,310 We had hoped to have Tom Pizzuto here today, 47 00:01:59,310 --> 00:02:02,730 who actually was our member from the Healthcare & Life Science 48 00:02:02,730 --> 00:02:05,880 group from Wyeth who was our chairman of that group. 49 00:02:05,880 --> 00:02:09,030 But Tom couldn't get up here because of business reasons. 50 00:02:09,030 --> 00:02:12,630 Ted's going to cover pedigree and the update 51 00:02:12,630 --> 00:02:14,190 around messaging around the pedigree. 52 00:02:14,190 --> 00:02:17,650 And then we'll certainly entertain any questions. 53 00:02:17,650 --> 00:02:20,767 So we'll all participate in the panel discussion. 54 00:02:20,767 --> 00:02:23,100 I just thought maybe I would touch on a couple of points 55 00:02:23,100 --> 00:02:24,300 here. 56 00:02:24,300 --> 00:02:26,280 Why are we doing this? 57 00:02:26,280 --> 00:02:29,100 It's not like fast-moving consumer goods, 58 00:02:29,100 --> 00:02:32,850 where you've got Walmart and Target saying you must 59 00:02:32,850 --> 00:02:36,807 and the Department of Defense coming out with mandates. 60 00:02:36,807 --> 00:02:38,640 The reason why we're very interested in this 61 00:02:38,640 --> 00:02:41,625 is because of some of the regulatory requirements that 62 00:02:41,625 --> 00:02:42,590 are starting to emerge. 63 00:02:42,590 --> 00:02:45,810 So we had the FDA back in 2004 that issued some guidelines 64 00:02:45,810 --> 00:02:49,320 around widespread adoption around RFID at the item level 65 00:02:49,320 --> 00:02:52,050 to begin tracking and tracing products. 66 00:02:52,050 --> 00:02:54,870 But the reality is, the issue that we're really dealing with 67 00:02:54,870 --> 00:02:56,280 is patient safety. 68 00:02:56,280 --> 00:03:00,780 This is an issue that this industry takes very to heart, 69 00:03:00,780 --> 00:03:02,580 because frankly, we're all affected by it. 70 00:03:02,580 --> 00:03:06,480 We want to ensure that the drugs and advices that you receive 71 00:03:06,480 --> 00:03:07,692 are genuine products. 72 00:03:07,692 --> 00:03:09,150 We don't want to go down the path-- 73 00:03:09,150 --> 00:03:12,690 and clearly you all understand the issues 74 00:03:12,690 --> 00:03:15,930 that we could encounter if counterfeit products are 75 00:03:15,930 --> 00:03:16,430 out there. 76 00:03:16,430 --> 00:03:19,360 So we're very, very concerned about this. 77 00:03:19,360 --> 00:03:22,020 So we're also responding to the movement 78 00:03:22,020 --> 00:03:24,780 within the states, where they're adopting what are 79 00:03:24,780 --> 00:03:26,820 called pedigree regulations. 80 00:03:26,820 --> 00:03:28,440 Right now, we've got a large number 81 00:03:28,440 --> 00:03:30,540 of states that are moving in this particular area, 82 00:03:30,540 --> 00:03:33,510 and this requires chain of custody tracking 83 00:03:33,510 --> 00:03:35,010 of the ownership of products. 84 00:03:35,010 --> 00:03:38,880 And as a result, both the FDA and-- 85 00:03:38,880 --> 00:03:40,830 well, the FDA particularly feels that this 86 00:03:40,830 --> 00:03:44,790 could be a key element to the track and trace of products. 87 00:03:44,790 --> 00:03:49,257 So the movement within the states and the FDA, we thought, 88 00:03:49,257 --> 00:03:51,840 was very important to be able to collaborate with them to show 89 00:03:51,840 --> 00:03:53,923 some movement in the industry with the development 90 00:03:53,923 --> 00:03:55,020 of our standards. 91 00:03:55,020 --> 00:03:57,503 But this is not just a US issue, and there 92 00:03:57,503 --> 00:03:59,920 are some other motivations that are going over in Europe-- 93 00:03:59,920 --> 00:04:01,602 particularly Belgium, Italy, and I 94 00:04:01,602 --> 00:04:03,810 know we've seen some movement in some other countries 95 00:04:03,810 --> 00:04:08,400 as well, where they're expecting serialization of items. 96 00:04:08,400 --> 00:04:11,760 Now, to be very clear, Belgium and Italy, 97 00:04:11,760 --> 00:04:14,130 they're not expecting RFID to be applied to a product. 98 00:04:14,130 --> 00:04:17,010 All they're asking for is serialization of that item-- 99 00:04:17,010 --> 00:04:19,079 mass serialization. 100 00:04:19,079 --> 00:04:22,170 And the movement within Europe is primarily 101 00:04:22,170 --> 00:04:24,630 driven because of pharmacy fraud. 102 00:04:24,630 --> 00:04:27,493 That's the reason why they're looking for serialization 103 00:04:27,493 --> 00:04:29,160 of items, because they want to know when 104 00:04:29,160 --> 00:04:31,740 a particular product is dispensed 105 00:04:31,740 --> 00:04:36,720 that gets reimbursed and only for one time, not 106 00:04:36,720 --> 00:04:37,740 multiple times. 107 00:04:37,740 --> 00:04:40,800 So these are some of the emerging regulatory drivers 108 00:04:40,800 --> 00:04:43,260 that we're starting to see within the pharmaceutical 109 00:04:43,260 --> 00:04:45,970 industry. 110 00:04:45,970 --> 00:04:49,050 This is a model that the FDA'S proposed, 111 00:04:49,050 --> 00:04:53,802 and we keep this in mind as we continue our discussions. 112 00:04:53,802 --> 00:04:55,260 And I think this is very important. 113 00:04:55,260 --> 00:04:57,760 It actually fits with a lot that was said earlier, 114 00:04:57,760 --> 00:05:00,360 by the other industries that presented today of, 115 00:05:00,360 --> 00:05:02,512 to really enable safe and secure supply chain, 116 00:05:02,512 --> 00:05:04,470 you need to be able to track and trace product. 117 00:05:04,470 --> 00:05:09,120 But you also need to be able to authenticate product as well. 118 00:05:09,120 --> 00:05:10,350 So in here-- 119 00:05:10,350 --> 00:05:11,740 I've got a bit of a build here. 120 00:05:11,740 --> 00:05:14,550 But to move us along, we think it's very important 121 00:05:14,550 --> 00:05:16,890 that authentication is needed, to be able to ensure 122 00:05:16,890 --> 00:05:18,900 that the product is genuine. 123 00:05:18,900 --> 00:05:21,090 That's when it becomes a foundational element 124 00:05:21,090 --> 00:05:23,070 for any track and trace system. 125 00:05:23,070 --> 00:05:26,940 Clearly, the pedigree allows us to be able to monitor and track 126 00:05:26,940 --> 00:05:29,560 that chain of custody, and changes as that product moves 127 00:05:29,560 --> 00:05:32,530 through the pipeline. 128 00:05:32,530 --> 00:05:34,440 So when you look at authentication, 129 00:05:34,440 --> 00:05:36,850 there's also a couple of different elements of that. 130 00:05:36,850 --> 00:05:39,450 We're looking at the product identity, 131 00:05:39,450 --> 00:05:41,700 but we're also looking at the physical characteristics 132 00:05:41,700 --> 00:05:43,330 of the product as well. 133 00:05:43,330 --> 00:05:45,900 So it's not simply does it have an ID number, because if you 134 00:05:45,900 --> 00:05:48,450 think of RFID at its basic element, 135 00:05:48,450 --> 00:05:50,307 and mass serialization at the basic element, 136 00:05:50,307 --> 00:05:52,890 we've been able to identify that package and the number that's 137 00:05:52,890 --> 00:05:54,720 been assigned to that package. 138 00:05:54,720 --> 00:05:57,150 What you don't know are about the contents of the package. 139 00:05:57,150 --> 00:05:59,410 Was it potentially tampered with, things like that. 140 00:05:59,410 --> 00:06:01,890 So that becomes gets us more into the areas 141 00:06:01,890 --> 00:06:03,875 of physical features. 142 00:06:03,875 --> 00:06:05,250 Certainly in the future, it would 143 00:06:05,250 --> 00:06:10,170 be nice to see if RFID could play a role as a method 144 00:06:10,170 --> 00:06:12,910 to ensure that the product has not been tampered with. 145 00:06:12,910 --> 00:06:17,730 But right now, in its current incarnation, it cannot do that. 146 00:06:17,730 --> 00:06:19,590 But we think over time, it would be 147 00:06:19,590 --> 00:06:21,600 nice to see what role RFID could play 148 00:06:21,600 --> 00:06:24,850 there to ensure that the product has not been tampered. 149 00:06:24,850 --> 00:06:27,660 On pedigree, we talk about track and trace. 150 00:06:27,660 --> 00:06:29,820 So where is the product and where is it headed, 151 00:06:29,820 --> 00:06:31,120 and where was the product. 152 00:06:31,120 --> 00:06:33,780 So it's the element of looking where it is, but then 153 00:06:33,780 --> 00:06:35,430 also being able to look backwards. 154 00:06:35,430 --> 00:06:39,300 And that's a very large issue for us. 155 00:06:39,300 --> 00:06:43,980 Our supply chain is not directly from manufacturer to retailer. 156 00:06:43,980 --> 00:06:45,900 There is a distributor in the middle there, 157 00:06:45,900 --> 00:06:48,820 and there can also be secondary distribution as well. 158 00:06:48,820 --> 00:06:50,790 So what you find is our supply chain 159 00:06:50,790 --> 00:06:53,670 can be a bit complicated when you start factoring in also 160 00:06:53,670 --> 00:06:54,660 returned goods. 161 00:06:54,660 --> 00:07:00,810 And the retail pharmacy may not ship those returned goods back 162 00:07:00,810 --> 00:07:03,250 to the distributor who originally distributed it 163 00:07:03,250 --> 00:07:03,750 to them. 164 00:07:03,750 --> 00:07:07,260 So you get into some very complicated situations 165 00:07:07,260 --> 00:07:10,290 to figure out where the product was and from whence it came. 166 00:07:10,290 --> 00:07:14,970 So as we conducted our work over the last 18 months, 167 00:07:14,970 --> 00:07:16,410 this is the base model that we've 168 00:07:16,410 --> 00:07:18,210 been working with and trying to develop 169 00:07:18,210 --> 00:07:22,980 some specifications for our industry based upon this model. 170 00:07:22,980 --> 00:07:25,520 So with this, I'm going to turn over to Bob, 171 00:07:25,520 --> 00:07:27,860 after an intro of what's driving industry. 172 00:07:27,860 --> 00:07:31,725 And Bob's going to talk about the actions within the HLS BAG 173 00:07:31,725 --> 00:07:33,977 and how we've organized our efforts and some 174 00:07:33,977 --> 00:07:35,060 of our current activities. 175 00:07:35,060 --> 00:07:35,600 So Bob? 176 00:07:39,058 --> 00:07:42,516 [APPLAUSE] 177 00:07:47,456 --> 00:07:50,040 BOB CELESTE: Thanks, Mike. 178 00:07:50,040 --> 00:07:53,700 So I just wanted to give an overview of why 179 00:07:53,700 --> 00:07:55,650 health care is looking at RFID. 180 00:07:55,650 --> 00:07:59,050 Basically, it's to form the safe and secure supply chain. 181 00:07:59,050 --> 00:08:01,680 So you're seeing things up here about item-level tagging, 182 00:08:01,680 --> 00:08:04,980 electronic pedigree, track and trace, product authentication. 183 00:08:04,980 --> 00:08:07,500 And the group actually has a very regimented way 184 00:08:07,500 --> 00:08:08,670 of going through this-- 185 00:08:08,670 --> 00:08:11,250 of developing the capabilities that they'd 186 00:08:11,250 --> 00:08:14,340 like-- the scenarios, the use cases, and then any 187 00:08:14,340 --> 00:08:16,420 variants on those use cases. 188 00:08:16,420 --> 00:08:19,710 Our first capability that we started with 189 00:08:19,710 --> 00:08:21,480 was pedigree management. 190 00:08:21,480 --> 00:08:23,880 And as Mike talked about, that was primarily 191 00:08:23,880 --> 00:08:26,190 driven through the regulations that the industry had. 192 00:08:29,018 --> 00:08:31,560 So I'm actually going to spend most of my time on this slide, 193 00:08:31,560 --> 00:08:34,020 and I'll give you a second to soak it in. 194 00:08:34,020 --> 00:08:36,780 We're hoping that the Auto-ID members in the audience 195 00:08:36,780 --> 00:08:38,789 will take a look at some of these checkmarks. 196 00:08:38,789 --> 00:08:42,780 These are areas that we feel that Auto-ID can help us out 197 00:08:42,780 --> 00:08:44,340 with. 198 00:08:44,340 --> 00:08:47,100 Basically, this slide is broken into a few areas. 199 00:08:47,100 --> 00:08:50,342 The blue areas is our structure. 200 00:08:50,342 --> 00:08:52,800 So for each one of these blue areas, there's the co-chairs, 201 00:08:52,800 --> 00:08:56,200 and they all report up into the tri-chair area. 202 00:08:56,200 --> 00:08:59,950 So you see the strategy work group, information, technology, 203 00:08:59,950 --> 00:09:02,940 R&D, and process work groups. 204 00:09:02,940 --> 00:09:05,190 Last year, when we looked at things 205 00:09:05,190 --> 00:09:08,760 like pedigree management, one of the things we realized was-- 206 00:09:08,760 --> 00:09:12,120 and we've talked about a lot today with security, 207 00:09:12,120 --> 00:09:15,210 and the requirements are pretty clear. 208 00:09:15,210 --> 00:09:18,900 The people in the supply chain, and sometimes customers, 209 00:09:18,900 --> 00:09:21,780 would need to read and write the tags. 210 00:09:21,780 --> 00:09:23,850 The bad guys don't need to do that, 211 00:09:23,850 --> 00:09:26,910 and that's our requirement. 212 00:09:26,910 --> 00:09:28,950 To that point, because we don't have 213 00:09:28,950 --> 00:09:33,690 a very simple, cost-effective, easy mechanism for securing 214 00:09:33,690 --> 00:09:35,910 the tags and the information in the supply chain, 215 00:09:35,910 --> 00:09:38,440 there's a number of areas you see here where 216 00:09:38,440 --> 00:09:40,230 we're looking at security. 217 00:09:40,230 --> 00:09:43,620 In the areas of item-level tagging, how to physically 218 00:09:43,620 --> 00:09:44,610 secure a tag? 219 00:09:44,610 --> 00:09:47,340 In the areas of serialization, how do we 220 00:09:47,340 --> 00:09:49,680 secure the number on a tag? 221 00:09:49,680 --> 00:09:53,160 In the areas of decommissioning, how do we ensure that a tag 222 00:09:53,160 --> 00:09:56,190 does not get removed from a discarded bottle and re-enter 223 00:09:56,190 --> 00:09:57,180 the supply chain-- 224 00:09:57,180 --> 00:09:58,180 things like that. 225 00:09:58,180 --> 00:10:00,510 So security actually has broad ramifications 226 00:10:00,510 --> 00:10:04,110 as far as the areas that we're working on. 227 00:10:04,110 --> 00:10:05,760 Some of the areas that we'll be working 228 00:10:05,760 --> 00:10:09,690 on in 2006 that are interesting are track and trace. 229 00:10:09,690 --> 00:10:14,430 And I want to make a difference in your mind between what track 230 00:10:14,430 --> 00:10:16,830 and trace and what pedigree is. 231 00:10:16,830 --> 00:10:19,500 So pedigree-- and I think Chuck actually coined this phrase 232 00:10:19,500 --> 00:10:20,058 today. 233 00:10:20,058 --> 00:10:21,600 With pedigree, if you think about it, 234 00:10:21,600 --> 00:10:25,350 it's a business to regulate our message. 235 00:10:25,350 --> 00:10:27,720 Pedigree can be started by paper. 236 00:10:27,720 --> 00:10:30,360 They can be started through a EDI transaction 237 00:10:30,360 --> 00:10:32,610 or through an XML transaction. 238 00:10:32,610 --> 00:10:36,180 Not easily courierable for an industry. 239 00:10:36,180 --> 00:10:38,700 So we're also looking this year at the track and trace, 240 00:10:38,700 --> 00:10:41,370 the vocabulary that this industry will use, 241 00:10:41,370 --> 00:10:43,410 and the understanding they'll have at a business 242 00:10:43,410 --> 00:10:47,520 level of what all of the events mean when you move product 243 00:10:47,520 --> 00:10:50,680 with RFID tags on them. 244 00:10:50,680 --> 00:10:53,460 The other areas I'll point out that will be new is-- 245 00:10:53,460 --> 00:10:55,440 and we originally saw these as variants, 246 00:10:55,440 --> 00:10:57,960 so we'll be doing a little bit of a GAAP 247 00:10:57,960 --> 00:11:00,700 analysis between the requirements we have today 248 00:11:00,700 --> 00:11:04,570 and when we bring companies that focus in these areas. 249 00:11:04,570 --> 00:11:07,290 And those areas like cold chain, medical devices, 250 00:11:07,290 --> 00:11:11,040 which will start up soon, and biologics, and how they affect 251 00:11:11,040 --> 00:11:14,220 and how they add requirements to our pack. 252 00:11:14,220 --> 00:11:16,830 So I think I'm maybe done with that. 253 00:11:16,830 --> 00:11:18,640 That was my one slide. 254 00:11:18,640 --> 00:11:20,182 So we'll give Chuck the floor. 255 00:11:26,565 --> 00:11:30,002 [APPLAUSE] 256 00:11:37,367 --> 00:11:39,540 CHUCK SCHRAMEK: OK, I'm here again 257 00:11:39,540 --> 00:11:41,550 subbing for Tom Pizutto with regard 258 00:11:41,550 --> 00:11:43,050 to item level tagging in the work 259 00:11:43,050 --> 00:11:47,010 that that work group has done for the Healthcare & Life 260 00:11:47,010 --> 00:11:49,350 Sciences BAG. 261 00:11:49,350 --> 00:11:53,820 This group consisted of a series of about, 262 00:11:53,820 --> 00:11:56,400 I guess, 32 individuals that were part of the Item-Level 263 00:11:56,400 --> 00:11:58,320 Tagging work group. 264 00:11:58,320 --> 00:12:03,330 10 were from Fast Moving Consumer Goods, 265 00:12:03,330 --> 00:12:05,970 10 were from Healthcare and Life Sciences, 266 00:12:05,970 --> 00:12:11,160 and 10 were from the Hardware Action Group within EPCglobal. 267 00:12:11,160 --> 00:12:16,500 In addition to that, we had Dan Engels from Auto-ID center 268 00:12:16,500 --> 00:12:17,800 here working with us. 269 00:12:17,800 --> 00:12:21,540 And we also had an individual from the Architectural Review 270 00:12:21,540 --> 00:12:23,880 Council within EPCglobal. 271 00:12:23,880 --> 00:12:28,080 So that group was pulled together from the three BAGs 272 00:12:28,080 --> 00:12:30,870 to represent those BAGs and their interests with respect 273 00:12:30,870 --> 00:12:35,850 to turning requirements into solutions, or at least 274 00:12:35,850 --> 00:12:40,230 into understandable requirements for the Hardware Action Group 275 00:12:40,230 --> 00:12:42,660 to act upon. 276 00:12:42,660 --> 00:12:45,150 The objectives that we had before us-- 277 00:12:45,150 --> 00:12:48,270 again, because we were basically business action groups, 278 00:12:48,270 --> 00:12:51,840 was to really define the business scenarios 279 00:12:51,840 --> 00:12:54,390 and requirements that would drive 280 00:12:54,390 --> 00:13:01,980 the way we intended to deploy and adopt RFID technology. 281 00:13:01,980 --> 00:13:03,780 We started out with business scenarios, 282 00:13:03,780 --> 00:13:06,152 again focusing on item level. 283 00:13:06,152 --> 00:13:09,240 Case and pallet had been pretty well covered 284 00:13:09,240 --> 00:13:12,540 in a fine fashion from FMCG. 285 00:13:12,540 --> 00:13:14,580 Item level had not. 286 00:13:14,580 --> 00:13:18,480 It was paramount importance to Healthcare & Life Sciences. 287 00:13:18,480 --> 00:13:20,550 And yet, it was also a significant importance 288 00:13:20,550 --> 00:13:24,870 to both FMCG and DoD. 289 00:13:24,870 --> 00:13:28,380 Went into tremendous detail addressing the operating 290 00:13:28,380 --> 00:13:33,660 environments in which item-level tagging would have to perform. 291 00:13:33,660 --> 00:13:39,060 Min/max read and write ranges were critical to us, 292 00:13:39,060 --> 00:13:41,910 because it was a very different set of scenarios 293 00:13:41,910 --> 00:13:44,010 from pallet and case. 294 00:13:44,010 --> 00:13:47,820 Security requirements, which you've heard all day long, 295 00:13:47,820 --> 00:13:51,550 were as important for us as they have been for all of you, 296 00:13:51,550 --> 00:13:54,090 both in the other industry presentations, as well 297 00:13:54,090 --> 00:13:57,720 as the Auto-ID Lab's work that you've been doing to date. 298 00:14:00,600 --> 00:14:04,950 Privacy features, critical to Healthcare & Life Sciences. 299 00:14:04,950 --> 00:14:07,590 Again, we have significant concerns there that, 300 00:14:07,590 --> 00:14:09,750 unless we educate the public well enough 301 00:14:09,750 --> 00:14:15,030 to understand the value of this technology and its use 302 00:14:15,030 --> 00:14:16,950 in their best interests, it will be 303 00:14:16,950 --> 00:14:19,590 a challenge getting adoption. 304 00:14:19,590 --> 00:14:21,900 We have a number of products, controlled substances 305 00:14:21,900 --> 00:14:27,700 that, in pharma industries, we have to move out to customers. 306 00:14:27,700 --> 00:14:31,440 These need to be shielded and secured so that others do not 307 00:14:31,440 --> 00:14:34,450 know what is being sent. 308 00:14:34,450 --> 00:14:36,600 We don't want these tags going out live 309 00:14:36,600 --> 00:14:41,460 to customers and consumers, because they in turn are 310 00:14:41,460 --> 00:14:48,390 paranoid about knowledge of medication consumption being 311 00:14:48,390 --> 00:14:51,940 made available to those around them. 312 00:14:51,940 --> 00:14:53,970 And lastly, memory features-- 313 00:14:53,970 --> 00:14:57,270 this area is how do we want to use the memory that 314 00:14:57,270 --> 00:15:02,700 will be on the chip in the most efficient and effective way? 315 00:15:02,700 --> 00:15:05,130 The progress we've made to date-- 316 00:15:05,130 --> 00:15:07,860 and again, this group has been working, 317 00:15:07,860 --> 00:15:11,670 I guess, since about late July of 2005. 318 00:15:11,670 --> 00:15:16,470 We delivered a series of item-level requirements 319 00:15:16,470 --> 00:15:17,880 to that group. 320 00:15:17,880 --> 00:15:20,460 It was about 32 pages worth of requirements, 321 00:15:20,460 --> 00:15:22,680 spanning both all three-- 322 00:15:22,680 --> 00:15:28,530 HLS, FMCG, and DoD, as well as 60 business scenarios 323 00:15:28,530 --> 00:15:32,070 that we felt well demonstrated the way 324 00:15:32,070 --> 00:15:36,680 this technology needed to work for those three groups. 325 00:15:36,680 --> 00:15:40,440 On January 16 and 17, we narrowed that down. 326 00:15:40,440 --> 00:15:43,560 We winnowed all the way down to about seven critical scenarios, 327 00:15:43,560 --> 00:15:47,370 that it was the intention of the Hardware Action Group 328 00:15:47,370 --> 00:15:49,980 and the vendor community supporting Hardware Action 329 00:15:49,980 --> 00:15:54,630 Group to do demonstrations of those seven scenarios. 330 00:15:54,630 --> 00:15:58,380 And those seven scenarios are the ones listed here. 331 00:15:58,380 --> 00:16:00,690 They span, again, the three Business Action 332 00:16:00,690 --> 00:16:02,970 Groups I'm here to represent. 333 00:16:02,970 --> 00:16:08,280 Hanging garments on mobile metal hanger racks 334 00:16:08,280 --> 00:16:13,560 creates a real dilemma for the apparel industry 335 00:16:13,560 --> 00:16:16,660 from a reader perspective, a tenant perspective. 336 00:16:16,660 --> 00:16:18,420 A dock door portal, same thing. 337 00:16:18,420 --> 00:16:23,640 If you look across all three of those groups, 338 00:16:23,640 --> 00:16:26,310 we need to be able to read accurately. 339 00:16:26,310 --> 00:16:29,940 And particularly when you get to the health care side, 340 00:16:29,940 --> 00:16:33,150 we are not comfortable with 99% reads. 341 00:16:33,150 --> 00:16:36,690 We really do need 100% reads. 342 00:16:36,690 --> 00:16:39,510 Apparel point of sale, again, was a scenario 343 00:16:39,510 --> 00:16:41,670 we picked, because it represented 344 00:16:41,670 --> 00:16:45,630 one of the more challenging point of sale scenarios 345 00:16:45,630 --> 00:16:51,750 that needed to be shown to be effective. 346 00:16:51,750 --> 00:16:56,430 DVDs in adjacent shelf slots, in that particular scenario, 347 00:16:56,430 --> 00:17:01,830 again, represent close packing of a product on metal shelves-- 348 00:17:01,830 --> 00:17:06,510 a dense reader scenario, more or less. 349 00:17:06,510 --> 00:17:09,240 Vials and ampoules in a case-- 350 00:17:09,240 --> 00:17:11,790 here again, this was a read scenario. 351 00:17:11,790 --> 00:17:15,660 And for us, this represents probably one of the smallest 352 00:17:15,660 --> 00:17:18,630 products that we'll be tagging, and it 353 00:17:18,630 --> 00:17:21,210 represented a challenge for us both on a read and write 354 00:17:21,210 --> 00:17:23,940 perspective. 355 00:17:23,940 --> 00:17:29,580 The speed at which these move across the packaging lines 356 00:17:29,580 --> 00:17:33,504 is of concern, so we need real accuracy there. 357 00:17:33,504 --> 00:17:35,724 AUDIENCE: [INAUDIBLE]. 358 00:17:35,724 --> 00:17:39,680 CHUCK SCHRAMEK: Exactly, and probably the most challenging 359 00:17:39,680 --> 00:17:43,850 scenario that the Hague faces, in the work ahead of them, 360 00:17:43,850 --> 00:17:47,660 is that of the retail form a mixed tote scenario. 361 00:17:47,660 --> 00:17:51,803 This is where the wholesalers will put together-- 362 00:17:51,803 --> 00:17:53,720 particularly the wholesalers will put together 363 00:17:53,720 --> 00:17:56,720 a code of product that could represent 364 00:17:56,720 --> 00:18:01,160 a dozen or better manufacturers' products, 365 00:18:01,160 --> 00:18:04,610 all tagged differently, all kinds of different products 366 00:18:04,610 --> 00:18:09,290 of all sorts of form factors, of materials, 367 00:18:09,290 --> 00:18:15,710 and of contents, all together the orientation of antennas, 368 00:18:15,710 --> 00:18:17,600 its random orientation. 369 00:18:17,600 --> 00:18:20,180 So it's going to be truly a challenge for them 370 00:18:20,180 --> 00:18:22,350 to demonstrate that one. 371 00:18:22,350 --> 00:18:24,920 And then the last one, the vial and ampoule 372 00:18:24,920 --> 00:18:27,320 write scenario was the only write scenario 373 00:18:27,320 --> 00:18:30,735 that we did including this, because we felt that this was 374 00:18:30,735 --> 00:18:34,910 the one that represented things very close together, 375 00:18:34,910 --> 00:18:38,730 very small form factor, going at a particular pace. 376 00:18:42,020 --> 00:18:44,840 The areas of central focus and concern for us 377 00:18:44,840 --> 00:18:47,120 in these demonstrations that are coming up 378 00:18:47,120 --> 00:18:50,780 are really to look at performance considerations. 379 00:18:50,780 --> 00:18:53,060 And again, this is the operation of the tags, 380 00:18:53,060 --> 00:18:55,970 operations between tags and readers, 381 00:18:55,970 --> 00:18:59,630 operations of fixed readers, and the presence of mobile readers. 382 00:18:59,630 --> 00:19:01,910 Again, this is in the retail end of the supply chain 383 00:19:01,910 --> 00:19:03,740 that we're addressing. 384 00:19:03,740 --> 00:19:09,020 And lastly, operation in dense reader environments. 385 00:19:09,020 --> 00:19:12,230 There again, inventory tags that are 386 00:19:12,230 --> 00:19:16,310 occurring in the retail setting, either in the store 387 00:19:16,310 --> 00:19:20,420 or in the back rooms, with lots of readers, lots of antennas, 388 00:19:20,420 --> 00:19:22,460 tons of products. 389 00:19:22,460 --> 00:19:27,290 Security considerations-- here, as you've heard all day long, 390 00:19:27,290 --> 00:19:30,530 the interest here is in manageable, affordable, 391 00:19:30,530 --> 00:19:35,270 and non-intrusive security solutions. 392 00:19:35,270 --> 00:19:41,600 We just can't afford the cost of the detail or the latency 393 00:19:41,600 --> 00:19:46,820 that might be introduced with certain types of encryption 394 00:19:46,820 --> 00:19:48,150 and decryption requirements. 395 00:19:48,150 --> 00:19:49,850 So this is an area that we really 396 00:19:49,850 --> 00:19:53,570 would like to work very closely with the labs on. 397 00:19:58,010 --> 00:20:02,780 Memory read/write locking-- this is hopefully a solution for us 398 00:20:02,780 --> 00:20:05,420 as we move forward with respect to shielding 399 00:20:05,420 --> 00:20:08,210 certain pieces of information that we 400 00:20:08,210 --> 00:20:13,190 need to shield as the products move through the supply chain, 401 00:20:13,190 --> 00:20:15,800 yet make them visible at different points in the supply 402 00:20:15,800 --> 00:20:18,110 chain for efficiency and effectiveness 403 00:20:18,110 --> 00:20:20,810 of those operations. 404 00:20:20,810 --> 00:20:23,150 And lastly, decommissioning of tags-- 405 00:20:23,150 --> 00:20:25,980 Bob mentioned that earlier in the discussion. 406 00:20:25,980 --> 00:20:28,820 This is an area that, again, for the Healthcare and Life 407 00:20:28,820 --> 00:20:30,740 Sciences group is of particular concern, 408 00:20:30,740 --> 00:20:33,980 because we want to make sure that we have 409 00:20:33,980 --> 00:20:37,520 a way of either killing or partially killing tags 410 00:20:37,520 --> 00:20:41,840 as it goes out to the consuming population, 411 00:20:41,840 --> 00:20:44,750 and possibly bringing it back if we want at a later date, 412 00:20:44,750 --> 00:20:47,540 when we want to use it in a much more progressive fashion. 413 00:20:51,887 --> 00:20:54,900 The dense reader environment considerations-- here, 414 00:20:54,900 --> 00:20:59,150 we're having trouble, because every one of those scenarios 415 00:20:59,150 --> 00:21:02,960 is unique to the business or the operation that's 416 00:21:02,960 --> 00:21:06,620 performing them, and how we're going to replicate something 417 00:21:06,620 --> 00:21:07,190 like that. 418 00:21:07,190 --> 00:21:11,540 And our task coming up is going to be a real challenge. 419 00:21:11,540 --> 00:21:13,820 But we do have dense reader scenarios 420 00:21:13,820 --> 00:21:16,790 in these various locations throughout the supply chain, 421 00:21:16,790 --> 00:21:19,730 either at the dock doors, at the racking and the distribution 422 00:21:19,730 --> 00:21:22,700 centers, at the shelves in the retail store, 423 00:21:22,700 --> 00:21:25,220 and even at customer checkout. 424 00:21:25,220 --> 00:21:30,320 So it's a concern for us in terms of interference. 425 00:21:30,320 --> 00:21:34,070 And lastly are the mobile readers, 426 00:21:34,070 --> 00:21:36,720 entering the field of stationary readers. 427 00:21:36,720 --> 00:21:39,830 Again, the Nokia phone example of being 428 00:21:39,830 --> 00:21:46,550 able to go in and to read a tag, our concerns were, well, 429 00:21:46,550 --> 00:21:50,720 is this really going to impact the intelligent shelf readers 430 00:21:50,720 --> 00:21:52,950 that may be in place or not. 431 00:21:52,950 --> 00:21:54,800 And it seems like from the research 432 00:21:54,800 --> 00:21:58,310 that's been done today by Auto-ID Labs 433 00:21:58,310 --> 00:22:00,500 here, that's one that we're not going to have 434 00:22:00,500 --> 00:22:03,630 to worry too much about. 435 00:22:03,630 --> 00:22:10,380 Now, I'm not going to go into detail on these. 436 00:22:10,380 --> 00:22:14,030 But these are just to give you an example 437 00:22:14,030 --> 00:22:18,260 of the depth of detail and the comprehensiveness in which we 438 00:22:18,260 --> 00:22:22,550 defined our business scenarios to capture the operating 439 00:22:22,550 --> 00:22:25,520 environments in which these tanks would have to work. 440 00:22:25,520 --> 00:22:29,390 We measured everything from where in the scenario 441 00:22:29,390 --> 00:22:32,930 it would occur to the number of tags 442 00:22:32,930 --> 00:22:35,390 that would have to be read at that particular point, 443 00:22:35,390 --> 00:22:40,790 the interrogation region that the readers would be impacted 444 00:22:40,790 --> 00:22:44,420 by, the tag antenna sizes and the variety of those tag 445 00:22:44,420 --> 00:22:50,330 antenna sizes, maximum read ranges, maximum tag velocity-- 446 00:22:50,330 --> 00:22:53,360 or in cases when they're stationary, how long are 447 00:22:53,360 --> 00:22:58,550 they stationary to allow a read. 448 00:22:58,550 --> 00:23:01,160 The reader reliability-- again, this 449 00:23:01,160 --> 00:23:06,200 is something that we feel very strongly about being 450 00:23:06,200 --> 00:23:08,790 as close to 100% as possible. 451 00:23:08,790 --> 00:23:13,640 And then the last one were notes on the materials and make-ups 452 00:23:13,640 --> 00:23:15,770 of what these scenarios were all about. 453 00:23:19,400 --> 00:23:24,890 A good example, again, going back to the retail pharma tote, 454 00:23:24,890 --> 00:23:27,290 here again, you're looking at liquids, blister packs, 455 00:23:27,290 --> 00:23:35,660 tablets, syringes, full metal packages, all in a tote 456 00:23:35,660 --> 00:23:40,800 to be read with random oriented placement in that tote. 457 00:23:40,800 --> 00:23:45,750 So these are very, very challenging demonstrations. 458 00:23:45,750 --> 00:23:51,380 We know, hopefully, that most of it will be successful, 459 00:23:51,380 --> 00:23:54,590 and we'll move forward with getting solutions. 460 00:23:54,590 --> 00:23:57,337 And where we are now is we're proceeding 461 00:23:57,337 --> 00:23:59,420 in this second phase, which is turning all of this 462 00:23:59,420 --> 00:24:02,210 over to the Hague for them to take on. 463 00:24:02,210 --> 00:24:04,490 There is a little wrap-up work that's 464 00:24:04,490 --> 00:24:06,170 still expected of our group, and that's 465 00:24:06,170 --> 00:24:10,260 to get a better sense of what the hospital demands are. 466 00:24:10,260 --> 00:24:14,330 Unfortunately, today, we haven't had hospital representation 467 00:24:14,330 --> 00:24:17,600 as directly and strongly as what we've 468 00:24:17,600 --> 00:24:20,645 needed in the HLS community. 469 00:24:20,645 --> 00:24:22,520 But we do need to get more information there, 470 00:24:22,520 --> 00:24:25,520 because that represents a possible frequency 471 00:24:25,520 --> 00:24:30,360 issue for us, and likewise more complexity. 472 00:24:30,360 --> 00:24:33,380 So the Hague is going to confirm that the technology 473 00:24:33,380 --> 00:24:35,070 vendors that are going to work with them 474 00:24:35,070 --> 00:24:37,220 in these demonstrations, which they think 475 00:24:37,220 --> 00:24:40,220 will be somewhere between six and 12 companies 476 00:24:40,220 --> 00:24:41,482 working with us. 477 00:24:41,482 --> 00:24:43,190 We want to make sure they cover the seven 478 00:24:43,190 --> 00:24:45,860 scenarios in an equal fashion, so they don't all 479 00:24:45,860 --> 00:24:48,830 go after scenario one and five, and the others 480 00:24:48,830 --> 00:24:50,243 don't get addressed. 481 00:24:50,243 --> 00:24:52,160 That's going to be the challenge for the Hague 482 00:24:52,160 --> 00:24:54,170 to make sure they work that out. 483 00:24:54,170 --> 00:24:59,750 They're going to do the work between February and March 22, 484 00:24:59,750 --> 00:25:01,610 at which time, these demonstrations 485 00:25:01,610 --> 00:25:05,560 are going to be provided back to the three business action 486 00:25:05,560 --> 00:25:06,060 groups-- 487 00:25:06,060 --> 00:25:08,750 HLS, FMCG, and DoD. 488 00:25:08,750 --> 00:25:13,340 And then we will see where we go from there in terms of what 489 00:25:13,340 --> 00:25:15,120 they can do and what they can't. 490 00:25:15,120 --> 00:25:18,950 So out of that, we expect a lot of opportunities 491 00:25:18,950 --> 00:25:24,080 to come back to you, and ask for assistance in drilling 492 00:25:24,080 --> 00:25:26,420 down on how we can turn something 493 00:25:26,420 --> 00:25:29,000 that doesn't look like it can work today into something 494 00:25:29,000 --> 00:25:33,680 that can six or nine months, a year, year and a half out. 495 00:25:33,680 --> 00:25:35,409 OK. 496 00:25:35,409 --> 00:25:38,860 [APPLAUSE] 497 00:25:48,227 --> 00:25:49,890 TED NG: Hi, I'm Ted. 498 00:25:49,890 --> 00:25:52,400 I'm going to try to go through, with you guys, what 499 00:25:52,400 --> 00:25:56,600 we've done in the BAG for the pedigree side of the business. 500 00:25:56,600 --> 00:26:02,270 Again, Mike opened up with very leading drivers of what's 501 00:26:02,270 --> 00:26:03,200 causing us to do this. 502 00:26:03,200 --> 00:26:06,680 And really, the driver is not pedigree, 503 00:26:06,680 --> 00:26:09,960 but the driver is really patient safety in health care. 504 00:26:09,960 --> 00:26:12,710 OK, again, our lightening rod for us 505 00:26:12,710 --> 00:26:14,390 to move forward in the pedigree space 506 00:26:14,390 --> 00:26:16,550 was caused by the FDA report that 507 00:26:16,550 --> 00:26:20,750 was issued in February of 2004. 508 00:26:20,750 --> 00:26:23,682 So it appears that we do have a counterfeit problem, 509 00:26:23,682 --> 00:26:25,640 and how are we going to deal with that problem? 510 00:26:25,640 --> 00:26:27,650 And the report indicated that the best way 511 00:26:27,650 --> 00:26:31,420 to do that was to use RFID-based systems. 512 00:26:31,420 --> 00:26:33,800 So I think you guys have seen these products. 513 00:26:33,800 --> 00:26:36,098 One side is the good product. 514 00:26:36,098 --> 00:26:36,890 On the right side-- 515 00:26:36,890 --> 00:26:39,260 I mean, left or right side, depending on the product, 516 00:26:39,260 --> 00:26:41,090 is showing you the good [INAUDIBLE] 517 00:26:41,090 --> 00:26:42,230 and the bad products. 518 00:26:42,230 --> 00:26:44,063 So how are you going to tell the difference? 519 00:26:44,063 --> 00:26:46,190 So they're saying RFID is the way to go. 520 00:26:48,740 --> 00:26:55,040 The problem is we have too many cooks in the kitchen for us. 521 00:26:55,040 --> 00:26:56,080 We would love to comply. 522 00:26:56,080 --> 00:26:57,470 I think the industry wants to comply. 523 00:26:57,470 --> 00:26:59,390 I think it's the right thing to do for us, the right thing 524 00:26:59,390 --> 00:27:00,680 to do for the nation. 525 00:27:00,680 --> 00:27:06,440 But if you look at this, 30-plus states 526 00:27:06,440 --> 00:27:08,060 have written pedigree laws now. 527 00:27:08,060 --> 00:27:10,890 And I represent McKesson, and McKesson's 528 00:27:10,890 --> 00:27:12,890 a wholesale distributor of pharmaceutical drugs. 529 00:27:12,890 --> 00:27:15,710 We cannot afford to write systems for 30 different 530 00:27:15,710 --> 00:27:16,940 states, basically. 531 00:27:16,940 --> 00:27:19,970 So we really need to have a consistent model. 532 00:27:19,970 --> 00:27:22,590 The model that Mike showed would be great to have. 533 00:27:22,590 --> 00:27:24,930 But unfortunately, Florida, the first one 534 00:27:24,930 --> 00:27:26,810 that's coming up for us, which we 535 00:27:26,810 --> 00:27:29,210 put a lot of effort behind July 1st of 2006 536 00:27:29,210 --> 00:27:32,390 indicated that we have to be in compliance to their model 537 00:27:32,390 --> 00:27:36,230 first, and then followed by January 1st of 2007 538 00:27:36,230 --> 00:27:37,160 is California. 539 00:27:37,160 --> 00:27:39,530 And then there's various laws already in place, 540 00:27:39,530 --> 00:27:42,320 like in regulatory process like Nevada, 541 00:27:42,320 --> 00:27:45,680 like Texas, already in progress and writing regulations that 542 00:27:45,680 --> 00:27:48,140 may interfere with what has already 543 00:27:48,140 --> 00:27:50,150 been proposed by Florida. 544 00:27:50,150 --> 00:27:52,320 So the real benefit for us, so to speak, 545 00:27:52,320 --> 00:27:56,130 is that the models have been proposed by the other 29, 546 00:27:56,130 --> 00:28:00,170 30-plus states here differs significantly from Florida. 547 00:28:00,170 --> 00:28:03,900 So there might be some consolidation, 548 00:28:03,900 --> 00:28:06,020 so to speak, hopefully by the models. 549 00:28:06,020 --> 00:28:09,500 And what we're looking for is some federal interaction here 550 00:28:09,500 --> 00:28:11,870 that will allow us to do that. 551 00:28:11,870 --> 00:28:15,080 So really, I'll talk a little bit about the solution 552 00:28:15,080 --> 00:28:18,350 is identification and tracking. 553 00:28:18,350 --> 00:28:19,550 But how do you do that? 554 00:28:19,550 --> 00:28:21,260 I have not heard anything today that 555 00:28:21,260 --> 00:28:24,470 tells me that says that we need to do the entire supply 556 00:28:24,470 --> 00:28:26,440 chain in all products in the supply chain. 557 00:28:26,440 --> 00:28:28,190 That's not what we need to have done here. 558 00:28:28,190 --> 00:28:29,540 We've got to do some type of-- 559 00:28:29,540 --> 00:28:34,190 I don't think there's sufficient RFID capacity in the industry 560 00:28:34,190 --> 00:28:37,580 to solve and meet all of the demand necessary to enable 561 00:28:37,580 --> 00:28:40,480 the entire supply chain of pharmaceutical products. 562 00:28:40,480 --> 00:28:42,920 So there's got to be some approach, some thinking, that 563 00:28:42,920 --> 00:28:46,820 says that what's a rational adoption approach here? 564 00:28:46,820 --> 00:28:48,560 Is it high demand guys only? 565 00:28:48,560 --> 00:28:50,150 Is it the top 100? 566 00:28:50,150 --> 00:28:53,000 Is it the guys that are most counterfeited? 567 00:28:53,000 --> 00:28:56,480 So we need help and need some guidance here. 568 00:28:56,480 --> 00:28:59,150 But again, we're forced by the Florida pedigree law 569 00:28:59,150 --> 00:29:01,520 to enable the whole supply chain. 570 00:29:01,520 --> 00:29:02,570 But if you look at-- 571 00:29:02,570 --> 00:29:05,270 well, going into what Florida is all about, 572 00:29:05,270 --> 00:29:07,640 that model is fundamentally flawed, 573 00:29:07,640 --> 00:29:11,420 in the way we would think about a pure chain of custody 574 00:29:11,420 --> 00:29:14,100 and a pedigree model. 575 00:29:14,100 --> 00:29:17,520 So the Florida pedigree model says it's not the data element, 576 00:29:17,520 --> 00:29:18,020 so to speak. 577 00:29:18,020 --> 00:29:19,890 It's what you're trying to accomplish here. 578 00:29:19,890 --> 00:29:23,765 And we need this basic stuff. 579 00:29:23,765 --> 00:29:25,640 And they don't even talk about serialization. 580 00:29:25,640 --> 00:29:27,980 Obviously, when you counterfeit product 581 00:29:27,980 --> 00:29:30,560 at an item level, or a bottle level, 582 00:29:30,560 --> 00:29:34,040 and they're looking at tracking only a lot and expiration date, 583 00:29:34,040 --> 00:29:36,810 so to speak. 584 00:29:36,810 --> 00:29:38,227 So there was other industry groups 585 00:29:38,227 --> 00:29:39,977 that have come together-- not just states. 586 00:29:39,977 --> 00:29:41,690 I didn't show you the whole picture here. 587 00:29:41,690 --> 00:29:43,400 There has been NABP, then there's 588 00:29:43,400 --> 00:29:46,460 other groups in uniform. 589 00:29:46,460 --> 00:29:47,960 There's our uniform pedigree council 590 00:29:47,960 --> 00:29:50,210 that we put together by different industry groups 591 00:29:50,210 --> 00:29:52,700 representing various factions here. 592 00:29:52,700 --> 00:29:54,827 But they came up with a different set 593 00:29:54,827 --> 00:29:57,410 of data elements associated with what should be in a pedigree. 594 00:30:00,140 --> 00:30:04,180 So really, what they did was in those groups 595 00:30:04,180 --> 00:30:06,160 was define quote, "the data elements." 596 00:30:06,160 --> 00:30:09,310 Obviously, data elements are of value. 597 00:30:09,310 --> 00:30:11,570 Because I'm an IT guy, I work with data elements. 598 00:30:11,570 --> 00:30:13,540 But what's more important? 599 00:30:13,540 --> 00:30:16,150 What's the process associated with that definition 600 00:30:16,150 --> 00:30:18,790 of what a pedigree is? 601 00:30:18,790 --> 00:30:20,140 Who updates the data? 602 00:30:20,140 --> 00:30:23,530 Who says what data should be there once you update it? 603 00:30:23,530 --> 00:30:25,360 How do I share the information. 604 00:30:25,360 --> 00:30:27,610 And then from the process side, where does it 605 00:30:27,610 --> 00:30:30,940 start, who is responsible, who will enforce? 606 00:30:30,940 --> 00:30:34,760 Again, we talked about what is authentication here. 607 00:30:34,760 --> 00:30:35,750 It's not just a number. 608 00:30:35,750 --> 00:30:37,720 It's also the over and covert measures associated 609 00:30:37,720 --> 00:30:39,178 with it, and the linking of the two 610 00:30:39,178 --> 00:30:41,700 sides of the pedigree model, with a right side 611 00:30:41,700 --> 00:30:44,560 and a left side, in a logical data model. 612 00:30:44,560 --> 00:30:45,940 So who pays for the system, which 613 00:30:45,940 --> 00:30:47,500 is even a better question. 614 00:30:47,500 --> 00:30:49,080 If regulatory mandates this stuff, 615 00:30:49,080 --> 00:30:51,580 obviously, there's going to be a huge increase in cost here. 616 00:30:54,250 --> 00:30:57,160 And McKesson deals with literally thousands 617 00:30:57,160 --> 00:30:58,780 of local pharmacies. 618 00:30:58,780 --> 00:31:01,120 And in different parts of the country, 619 00:31:01,120 --> 00:31:02,980 we call them mom and pops. 620 00:31:02,980 --> 00:31:05,010 If we put in an RFID system they're 621 00:31:05,010 --> 00:31:07,180 associated with a more sophisticated system, 622 00:31:07,180 --> 00:31:10,660 can these pharmacies be able to authenticate the product 623 00:31:10,660 --> 00:31:12,370 when we receive it? 624 00:31:12,370 --> 00:31:15,790 Do they have the cost infrastructure to do so? 625 00:31:15,790 --> 00:31:19,600 I know we need standards. 626 00:31:19,600 --> 00:31:21,970 I'm also part of the Information Work 627 00:31:21,970 --> 00:31:24,650 Group working within the BAG. 628 00:31:24,650 --> 00:31:28,780 What we really need to have is the information model, 629 00:31:28,780 --> 00:31:32,458 the logical models, the flow associated with it. 630 00:31:32,458 --> 00:31:34,000 You guys, I know some of the speakers 631 00:31:34,000 --> 00:31:36,798 here today attempted to bridge into that 632 00:31:36,798 --> 00:31:37,840 without talking about it. 633 00:31:37,840 --> 00:31:41,980 But if we really need the rules as an IT organization 634 00:31:41,980 --> 00:31:44,680 to do synchronization, validation, ownership, 635 00:31:44,680 --> 00:31:47,620 retention, security, Florida says 636 00:31:47,620 --> 00:31:50,980 we have to keep the records for a pedigree for three years. 637 00:31:50,980 --> 00:31:54,093 We generate-- oh no. 638 00:31:54,093 --> 00:31:56,260 I'm not going to go through the numbers of McKesson, 639 00:31:56,260 --> 00:31:58,360 but there's a lot of orders. 640 00:31:58,360 --> 00:32:00,580 We generate an order for each customer every day 641 00:32:00,580 --> 00:32:02,110 of the year in Florida. 642 00:32:02,110 --> 00:32:04,020 We do an overnight delivery model. 643 00:32:04,020 --> 00:32:06,520 So how many pedigrees do we need to create for every product 644 00:32:06,520 --> 00:32:07,300 there? 645 00:32:07,300 --> 00:32:10,390 We cannot afford to create a paper pedigree-based system, 646 00:32:10,390 --> 00:32:12,610 and Florida allows a paper pedigree system. 647 00:32:12,610 --> 00:32:15,110 And there's no integrity in a paper pedigree system, really. 648 00:32:19,270 --> 00:32:23,567 This is a little bit about evolution of hardware, 649 00:32:23,567 --> 00:32:24,650 software, and integration. 650 00:32:24,650 --> 00:32:27,670 But if you look at all the different architectural stacks 651 00:32:27,670 --> 00:32:31,030 and stuff, really, that middleware 652 00:32:31,030 --> 00:32:34,180 is expanding to the edge, and middleware is spanning upward 653 00:32:34,180 --> 00:32:35,510 into the enterprise. 654 00:32:35,510 --> 00:32:40,840 So there's no static model, so to speak, of technology. 655 00:32:40,840 --> 00:32:43,000 Here we are, moving from gen 1 to gen 2. 656 00:32:43,000 --> 00:32:46,210 So we're talking about agile readers. 657 00:32:46,210 --> 00:32:48,070 We're talking about-- we haven't really 658 00:32:48,070 --> 00:32:49,820 come up with a sense of understanding what 659 00:32:49,820 --> 00:32:51,310 are the firm frequencies associated 660 00:32:51,310 --> 00:32:52,310 with what we're going to do? 661 00:32:52,310 --> 00:32:53,950 How are we going to write these tags, and what 662 00:32:53,950 --> 00:32:55,048 should be on the tags? 663 00:32:55,048 --> 00:32:57,340 And then we have the performance issues with item-level 664 00:32:57,340 --> 00:32:58,430 tagging still to decide. 665 00:32:58,430 --> 00:33:03,100 So I think Chuck and Mike here really 666 00:33:03,100 --> 00:33:04,210 said the same things here. 667 00:33:04,210 --> 00:33:05,740 We really need your help here. 668 00:33:05,740 --> 00:33:07,420 Help us resolve these issues here, 669 00:33:07,420 --> 00:33:11,811 so that we can get this patient safety issue addressed. 670 00:33:15,500 --> 00:33:17,590 So a summary of issues here. 671 00:33:17,590 --> 00:33:20,920 Again, top of the list is really for us in health care. 672 00:33:20,920 --> 00:33:22,150 We're guided by HIPAA rules. 673 00:33:22,150 --> 00:33:25,330 We're guided by many different privacy and security practices 674 00:33:25,330 --> 00:33:26,260 already. 675 00:33:26,260 --> 00:33:31,720 We need one that allow us to do what we need to do, and not 676 00:33:31,720 --> 00:33:35,920 lose the confidence of what we have in our health care 677 00:33:35,920 --> 00:33:37,420 consumer base today. 678 00:33:37,420 --> 00:33:41,020 We cannot allow that to erode. 679 00:33:41,020 --> 00:33:42,430 So again, where's the data? 680 00:33:42,430 --> 00:33:44,500 How are we going to hold that data? 681 00:33:44,500 --> 00:33:46,600 The health care industry model today, 682 00:33:46,600 --> 00:33:49,785 it's held very closely to the vest, the data. 683 00:33:49,785 --> 00:33:51,160 So we need to come up with models 684 00:33:51,160 --> 00:33:55,720 that allow us to expand beyond our current supply chain model, 685 00:33:55,720 --> 00:33:58,510 and to say what is the economics associated with it. 686 00:34:01,120 --> 00:34:03,610 Product identification schema-- again, 687 00:34:03,610 --> 00:34:07,480 we talked about it in many different forums here today, 688 00:34:07,480 --> 00:34:10,929 a local schema versus the global schema. 689 00:34:10,929 --> 00:34:14,380 Obviously, the manufacturers have a global business. 690 00:34:14,380 --> 00:34:18,020 And yet the NDC number, which is the primary product 691 00:34:18,020 --> 00:34:21,850 identifier here in America, is used for claims processing. 692 00:34:21,850 --> 00:34:25,150 And a pharmacy, for them not to have that number on the product 693 00:34:25,150 --> 00:34:25,929 is a big deal. 694 00:34:30,070 --> 00:34:33,460 And also, I don't know if tagging 695 00:34:33,460 --> 00:34:35,650 was talked about by Chuck, obviously, in detail. 696 00:34:35,650 --> 00:34:37,989 Forward and reverse logistics participation-- 697 00:34:37,989 --> 00:34:40,594 obviously, if you look at the Florida model, 698 00:34:40,594 --> 00:34:42,219 it doesn't start with the manufacturer. 699 00:34:42,219 --> 00:34:44,830 It starts with the wholesaler. 700 00:34:44,830 --> 00:34:47,237 There's a few supply chain participants missing there 701 00:34:47,237 --> 00:34:48,070 in the middle here-- 702 00:34:48,070 --> 00:34:50,110 [CHUCKLES] 703 00:34:50,110 --> 00:34:52,000 --Including logistics guys. 704 00:34:52,000 --> 00:34:55,840 So we believe that, really, the best pedigree model 705 00:34:55,840 --> 00:34:58,510 contains all participants in the supply chain. 706 00:34:58,510 --> 00:34:59,980 There can't be going from one step 707 00:34:59,980 --> 00:35:03,820 to step three, and step two maybe if you have the time. 708 00:35:03,820 --> 00:35:06,155 [CHUCKLES] 709 00:35:06,155 --> 00:35:09,920 So what we're looking for is really state and FDA ePedigree 710 00:35:09,920 --> 00:35:10,420 model. 711 00:35:10,420 --> 00:35:12,040 We're looking for an electronic model. 712 00:35:12,040 --> 00:35:14,860 Electronic models, I believe the pedigree model 713 00:35:14,860 --> 00:35:17,410 itself is a pretty uniform model, in the sense 714 00:35:17,410 --> 00:35:20,590 that the problem that you can address, in terms 715 00:35:20,590 --> 00:35:24,310 of a pedigree model for health care 716 00:35:24,310 --> 00:35:27,100 can apply to consumer packaged goods. 717 00:35:27,100 --> 00:35:32,200 It can apply to the clothing industry, for example. 718 00:35:32,200 --> 00:35:33,790 So the model is pretty clear, but we 719 00:35:33,790 --> 00:35:35,810 need to define one across industries. 720 00:35:35,810 --> 00:35:37,510 And I think that would add significantly 721 00:35:37,510 --> 00:35:39,520 to the adoption associated with it. 722 00:35:42,940 --> 00:35:45,970 Tag frequency, technological maturity-- 723 00:35:45,970 --> 00:35:50,800 I caution, as a business, we have x number of dollars 724 00:35:50,800 --> 00:35:53,710 each year to invest into technology. 725 00:35:53,710 --> 00:35:56,530 What we need to have is an evolutionary step. 726 00:35:56,530 --> 00:35:58,297 We can't slowly evolve. 727 00:35:58,297 --> 00:36:00,130 We've got to have checkpoints along the way. 728 00:36:00,130 --> 00:36:02,320 I was talking to John earlier over lunch 729 00:36:02,320 --> 00:36:05,380 about the concept of we have to set the future vision of where 730 00:36:05,380 --> 00:36:06,940 we're going to go. 731 00:36:06,940 --> 00:36:08,872 Where are we going to be two years from now, 732 00:36:08,872 --> 00:36:11,080 three years from now, wherever the slice and dice is? 733 00:36:11,080 --> 00:36:14,660 But the end of year 1, we have to say to ourselves, 734 00:36:14,660 --> 00:36:16,870 we're all going to be x 12 by this date, 735 00:36:16,870 --> 00:36:19,342 and be able to accomplish these type of things. 736 00:36:19,342 --> 00:36:21,550 So that's what we're looking for here as an industry, 737 00:36:21,550 --> 00:36:24,190 because we can't do this incremental adoption approach, 738 00:36:24,190 --> 00:36:25,990 because it's a huge infrastructure we 739 00:36:25,990 --> 00:36:28,150 have to change overnight. 740 00:36:28,150 --> 00:36:30,880 Took us 30 years to get the barcode maturity. 741 00:36:30,880 --> 00:36:34,810 We cannot wait 30 years for RFID to become mature. 742 00:36:34,810 --> 00:36:37,780 We all understand the product of identification strength 743 00:36:37,780 --> 00:36:39,670 and the need for product identification, 744 00:36:39,670 --> 00:36:42,700 and the glory associated with understanding what else we can 745 00:36:42,700 --> 00:36:45,220 do with additional bits of information 746 00:36:45,220 --> 00:36:47,260 that we never had with the linear barcode. 747 00:36:47,260 --> 00:36:55,450 So again, what's a rational adoptions approach? 748 00:36:55,450 --> 00:36:58,810 For McKesson, a wholesale distributor, 749 00:36:58,810 --> 00:37:02,120 what percentage of product has to be enabled for us 750 00:37:02,120 --> 00:37:08,620 to make that a non-parallel set of technologies, so to speak? 751 00:37:08,620 --> 00:37:11,320 I can't be scanning product with barcodes in one hand, 752 00:37:11,320 --> 00:37:13,063 and then using RFID on the other. 753 00:37:13,063 --> 00:37:14,230 It doesn't save me any time. 754 00:37:14,230 --> 00:37:16,272 If I close the tote and I have to open it back up 755 00:37:16,272 --> 00:37:19,060 to scan those products that are not RFID-enabled versus guys 756 00:37:19,060 --> 00:37:20,770 that are barcode-enabled. 757 00:37:20,770 --> 00:37:24,220 So we have to reach a level of maturity in adoption 758 00:37:24,220 --> 00:37:26,020 as quickly as possible. 759 00:37:26,020 --> 00:37:29,280 And that would be everybody in the supply chain again. 760 00:37:29,280 --> 00:37:31,090 And that goes back to the cost dollars. 761 00:37:31,090 --> 00:37:33,350 It goes back to the evolutionary aspects of it. 762 00:37:33,350 --> 00:37:38,370 So it's really not a focus on technology. 763 00:37:38,370 --> 00:37:39,560 I don't want to make-- 764 00:37:39,560 --> 00:37:41,350 I know we're a technology group here. 765 00:37:41,350 --> 00:37:44,183 We really need to focus on the long-term vision in terms 766 00:37:44,183 --> 00:37:45,600 of a business set of requirements, 767 00:37:45,600 --> 00:37:47,558 and saying we're going to sell safe and secure, 768 00:37:47,558 --> 00:37:49,470 we're going to sell reverse logistics 769 00:37:49,470 --> 00:37:51,000 or operational efficiencies. 770 00:37:51,000 --> 00:37:54,970 One make may follow the other on a logical basis. 771 00:37:54,970 --> 00:37:58,660 But when you develop a sense of solutions-- 772 00:37:58,660 --> 00:38:01,410 and when I say ePedigree, to me, that's a business scenario, 773 00:38:01,410 --> 00:38:03,540 and what are supporting technologies that 774 00:38:03,540 --> 00:38:06,480 allow us to get to step one, and then further out, 775 00:38:06,480 --> 00:38:09,810 a second step associated with it? 776 00:38:09,810 --> 00:38:11,490 And that's all I really had to say. 777 00:38:11,490 --> 00:38:13,470 I want to keep to our time here. 778 00:38:13,470 --> 00:38:17,670 So I'm sure we're up here for a few questions here. 779 00:38:17,670 --> 00:38:23,032 [APPLAUSE] 780 00:38:23,032 --> 00:38:24,490 STEPHEN MILES: Thank you very much. 781 00:38:24,490 --> 00:38:25,907 If we could come down to the front 782 00:38:25,907 --> 00:38:27,433 of the room for any questions? 783 00:38:33,360 --> 00:38:35,125 You just handed us a big menu. 784 00:38:35,125 --> 00:38:39,070 [LAUGHTER] 785 00:38:39,070 --> 00:38:42,180 Picking up on themes from throughout the day. 786 00:38:47,394 --> 00:38:50,300 AUDIENCE: Hi, I'm Alfonso Gutierrez from the University 787 00:38:50,300 --> 00:38:51,500 of Wisconsin, Madison. 788 00:38:54,110 --> 00:38:56,150 In the beginning of the presentation, 789 00:38:56,150 --> 00:38:59,180 you had a big slide saying that it's for the patient's safety. 790 00:39:01,700 --> 00:39:08,090 We're working in some of the blood products 791 00:39:08,090 --> 00:39:11,330 on a supply chain, and a big issue that we're dealing with 792 00:39:11,330 --> 00:39:15,245 is the patient identification. 793 00:39:15,245 --> 00:39:16,370 This is called the patient. 794 00:39:16,370 --> 00:39:18,140 And at the end of all of this, it's 795 00:39:18,140 --> 00:39:20,630 a patient who is receiving this. 796 00:39:20,630 --> 00:39:23,030 Different than the consumer products, 797 00:39:23,030 --> 00:39:25,100 we have to tie in with the patient. 798 00:39:25,100 --> 00:39:28,190 It's not only the consumer that we can just 799 00:39:28,190 --> 00:39:32,420 send the product out and we don't care who bought it. 800 00:39:32,420 --> 00:39:35,060 Who's dealing with this? 801 00:39:35,060 --> 00:39:39,830 Who's skinning this cat of patient identification? 802 00:39:39,830 --> 00:39:43,770 Should it be in parallel with all of this? 803 00:39:43,770 --> 00:39:46,000 [INTERPOSING VOICES] 804 00:39:46,000 --> 00:39:48,230 MICHAEL ROSE: I think it's an excellent point. 805 00:39:48,230 --> 00:39:52,540 I think this whole area of linking prescriptions 806 00:39:52,540 --> 00:39:54,350 to devices-- 807 00:39:54,350 --> 00:39:58,190 because the common connection is the patient. 808 00:39:58,190 --> 00:40:03,080 So you really don't see anyone solving that problem right now. 809 00:40:03,080 --> 00:40:05,510 One hope on the horizon, though, is 810 00:40:05,510 --> 00:40:07,730 there's quite a bit of movement in the government. 811 00:40:07,730 --> 00:40:11,150 Dr. Brailer's organization is looking 812 00:40:11,150 --> 00:40:14,600 at helping improve the health care 813 00:40:14,600 --> 00:40:18,590 system, the application of IT. 814 00:40:18,590 --> 00:40:21,960 That's an area that is taking a look at this. 815 00:40:21,960 --> 00:40:23,990 So we would expect some of the work that's 816 00:40:23,990 --> 00:40:26,360 going on there may eventually move 817 00:40:26,360 --> 00:40:29,600 in that particular direction. 818 00:40:29,600 --> 00:40:31,670 The other area, there's an association 819 00:40:31,670 --> 00:40:34,010 called NAHIT, National Association of Health 820 00:40:34,010 --> 00:40:37,483 Information Technology. 821 00:40:37,483 --> 00:40:38,900 It's certainly within their brief, 822 00:40:38,900 --> 00:40:43,460 and they commissioned a study last year 823 00:40:43,460 --> 00:40:48,890 around the adoption of RFID and other auto-ID technologies, 824 00:40:48,890 --> 00:40:51,440 not just for products, but also for patients, too. 825 00:40:51,440 --> 00:40:52,730 So I agree with you. 826 00:40:52,730 --> 00:40:55,697 It's an issue, but it's still very fragmented 827 00:40:55,697 --> 00:40:58,280 and needs to be brought together in a more coordinated manner. 828 00:41:02,200 --> 00:41:06,230 TED NG: Also, from my perspective, 829 00:41:06,230 --> 00:41:10,400 RFID and patient identification probably don't go together 830 00:41:10,400 --> 00:41:11,870 on the same chip, so to speak. 831 00:41:11,870 --> 00:41:13,470 [LAUGHS] 832 00:41:13,470 --> 00:41:17,210 I think that there's a privacy-- 833 00:41:17,210 --> 00:41:18,270 the HIPAA laws. 834 00:41:18,270 --> 00:41:18,860 I don't know if you guys are familiar 835 00:41:18,860 --> 00:41:20,150 with the federal HIPAA-- 836 00:41:20,150 --> 00:41:23,570 Health Care Insurance Portability Accountability Act. 837 00:41:23,570 --> 00:41:27,920 That requires that data be secured, and have 838 00:41:27,920 --> 00:41:31,430 privacy concerns associated with the linking of personally 839 00:41:31,430 --> 00:41:32,700 identififable information. 840 00:41:32,700 --> 00:41:36,710 So I don't think it'll be on the product 841 00:41:36,710 --> 00:41:39,350 that you get from the pharmacy. 842 00:41:39,350 --> 00:41:42,860 There might be a pharmacy number or a script number. 843 00:41:42,860 --> 00:41:45,890 But again, your patient information 844 00:41:45,890 --> 00:41:48,170 will be stored by the pharmacist. 845 00:41:48,170 --> 00:41:50,270 Additionally, again, there's another agency 846 00:41:50,270 --> 00:41:56,090 called HIMS, Healthcare Information Management and-- 847 00:41:56,090 --> 00:41:56,750 the two S's. 848 00:41:56,750 --> 00:41:58,375 [INAUDIBLE] 849 00:41:58,375 --> 00:42:00,660 Systems, Service-- yeah, systems along that line. 850 00:42:00,660 --> 00:42:02,660 Again, electronic medical records 851 00:42:02,660 --> 00:42:05,420 is the solution here somewhere along the way. 852 00:42:05,420 --> 00:42:08,030 Also in the federal bodies here, they're 853 00:42:08,030 --> 00:42:13,745 looking at trying to develop electronic medical records. 854 00:42:13,745 --> 00:42:15,200 BOB CELESTE: One of the areas that 855 00:42:15,200 --> 00:42:23,870 may be able to help you out with is that in Ireland does quite 856 00:42:23,870 --> 00:42:26,000 a bit of work [INAUDIBLE]. 857 00:42:26,000 --> 00:42:30,380 And they've got serialization in the spring of [INAUDIBLE].. 858 00:42:39,990 --> 00:42:42,990 AUDIENCE: We're all from the same school [INAUDIBLE] in MIT. 859 00:42:42,990 --> 00:42:46,560 Actually, we are doing some marketing research of the RFID 860 00:42:46,560 --> 00:42:48,900 in the drug tracking business. 861 00:42:48,900 --> 00:42:52,500 We found, actually, the business is growing very fast-- 862 00:42:52,500 --> 00:42:54,165 the market size. 863 00:42:54,165 --> 00:42:57,730 Like, in 2006, it's going to be 25%, 864 00:42:57,730 --> 00:43:00,870 and in 2007, it's going to be 30%. 865 00:43:00,870 --> 00:43:04,770 In 2011, it's going to be 40%, and it's going 866 00:43:04,770 --> 00:43:07,860 to exceed, like, $1 billion US. 867 00:43:07,860 --> 00:43:11,080 And I noticed that you have a summary of issues. 868 00:43:11,080 --> 00:43:14,150 One thing I'm specifically interested in, we obviously 869 00:43:14,150 --> 00:43:18,930 didn't get a chance to explore more, is the data network-- 870 00:43:18,930 --> 00:43:24,750 I mean, central distributor, and also the secure access, 871 00:43:24,750 --> 00:43:30,870 when you have all this networked software located everywhere, 872 00:43:30,870 --> 00:43:32,250 probably globally. 873 00:43:32,250 --> 00:43:35,040 Is there any initiation or any research 874 00:43:35,040 --> 00:43:37,050 in that area, like how you guarantee 875 00:43:37,050 --> 00:43:41,675 that data is right before you get it into the network? 876 00:43:41,675 --> 00:43:43,050 BOB CELESTE: So one of the things 877 00:43:43,050 --> 00:43:46,200 that we'll be doing this year is the track and trace effort. 878 00:43:46,200 --> 00:43:49,050 And that will, first off, define a vocabulary 879 00:43:49,050 --> 00:43:50,490 that the health care industry will 880 00:43:50,490 --> 00:43:52,710 use to identify [INAUDIBLE] events 881 00:43:52,710 --> 00:43:55,480 and understand them from a business perspective. 882 00:43:55,480 --> 00:43:57,786 Part of that again, overlaying everything, 883 00:43:57,786 --> 00:44:00,600 is the security aspect. 884 00:44:00,600 --> 00:44:03,540 And so [INAUDIBLE],, in this case a software, 885 00:44:03,540 --> 00:44:06,090 actually, we're running security around the network 886 00:44:06,090 --> 00:44:08,430 to ensure that data is safe. 887 00:44:08,430 --> 00:44:13,620 But that's part of our 2006 effort. 888 00:44:13,620 --> 00:44:19,400 TED NG: Again, it's part of the development of the entire-- 889 00:44:19,400 --> 00:44:22,730 if you're looking at just any pedigree alone, 890 00:44:22,730 --> 00:44:26,150 you're going to have to define business process rules as to-- 891 00:44:26,150 --> 00:44:28,265 at what point is it-- 892 00:44:28,265 --> 00:44:30,140 what part of record, so to speak, [INAUDIBLE] 893 00:44:30,140 --> 00:44:32,000 pedigree record is created. 894 00:44:32,000 --> 00:44:34,910 Who creates a track, who creates a trace, who 895 00:44:34,910 --> 00:44:37,920 creates the authentication side, the product identification 896 00:44:37,920 --> 00:44:38,420 side? 897 00:44:38,420 --> 00:44:40,040 And what part of the supply chain, 898 00:44:40,040 --> 00:44:41,930 in terms of the supply chain participants, 899 00:44:41,930 --> 00:44:44,930 are required to update this? 900 00:44:44,930 --> 00:44:46,640 Because if you want a good pedigree, 901 00:44:46,640 --> 00:44:48,620 all the players have to play, and each of them 902 00:44:48,620 --> 00:44:51,800 have a role to play. 903 00:44:51,800 --> 00:44:54,530 STEPHEN MILES: I've got a question regarding 904 00:44:54,530 --> 00:44:57,050 chemical and thermal stability of drug compounds. 905 00:44:57,050 --> 00:44:58,550 Can you say anything on tests you've 906 00:44:58,550 --> 00:45:00,300 done with respect to different frequencies 907 00:45:00,300 --> 00:45:04,820 of different RFID systems and their outcomes? 908 00:45:04,820 --> 00:45:06,480 MICHAEL ROSE: It's an area-- and I 909 00:45:06,480 --> 00:45:11,370 know the Auto-ID Labs here at MIT have proposed to study. 910 00:45:11,370 --> 00:45:15,090 It's an area that's still out for investigation. 911 00:45:18,800 --> 00:45:20,550 Without divulging anything, some companies 912 00:45:20,550 --> 00:45:22,800 have done some work that we're aware of. 913 00:45:22,800 --> 00:45:24,420 But it's not been made public yet. 914 00:45:27,420 --> 00:45:29,310 And I think what's going to be required-- 915 00:45:29,310 --> 00:45:30,977 and I think you're going to see, the FDA 916 00:45:30,977 --> 00:45:32,550 has a meeting on February 8 and 9. 917 00:45:32,550 --> 00:45:35,490 It's going to be another call for companies to come forward 918 00:45:35,490 --> 00:45:36,210 with public data. 919 00:45:36,210 --> 00:45:39,720 They made that call at the [INAUDIBLE] HDMA meeting back 920 00:45:39,720 --> 00:45:42,120 last fall. 921 00:45:42,120 --> 00:45:43,620 I think the challenge that companies 922 00:45:43,620 --> 00:45:46,650 have around this investigation is, what's 923 00:45:46,650 --> 00:45:48,930 the design of experiment? 924 00:45:48,930 --> 00:45:50,560 What's the endpoint of that experiment? 925 00:45:50,560 --> 00:45:54,055 And that's what everyone's struggling with right now. 926 00:45:54,055 --> 00:45:54,930 AUDIENCE: OK, thanks. 927 00:45:58,297 --> 00:46:00,730 STEPHEN MILES: So thank you very much to the panel. 928 00:46:00,730 --> 00:46:02,580 [APPLAUSE]