{"id":7037,"date":"2026-04-20T22:15:23","date_gmt":"2026-04-21T04:15:23","guid":{"rendered":"https:\/\/allphasepharma.com\/dir\/?p=7037"},"modified":"2026-04-20T22:21:33","modified_gmt":"2026-04-21T04:21:33","slug":"new-biomarker-consortium-pros","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2026\/04\/20\/7037\/new-biomarker-consortium-pros\/","title":{"rendered":"New BIOMARKER CONSORTIUM PROs"},"content":{"rendered":"<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><a href=\"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2026\/04\/image-7.png?ssl=1\"><img data-recalc-dims=\"1\" loading=\"lazy\" decoding=\"async\" width=\"530\" height=\"149\" src=\"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2026\/04\/image-7.png?resize=530%2C149&#038;ssl=1\" alt=\"\" class=\"wp-image-7038\" srcset=\"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2026\/04\/image-7.png?w=975&amp;ssl=1 975w, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2026\/04\/image-7.png?resize=300%2C84&amp;ssl=1 300w, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2026\/04\/image-7.png?resize=768%2C216&amp;ssl=1 768w\" sizes=\"auto, (max-width: 530px) 100vw, 530px\" \/><\/a><\/figure>\n<\/div>\n\n\n<p>Aulus Cornelius Celsus wrote his famous book &#8216;De Medicina&#8217; approximately 2000 years ago.&nbsp; Living in the times of Caesar Augustus, little is known about his persona.&nbsp; We are not even sure whether he was a practicing physician.&nbsp; Many of his books were lost but Volume VIII was rediscovered in the early renaissance, around the year 1426 <a href=\"#_ftn1\">[1]<\/a>.&nbsp; A few copies survived, mostly incomplete.<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"alignleft size-full is-resized\"><a href=\"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2026\/04\/image-8.png?ssl=1\"><img data-recalc-dims=\"1\" loading=\"lazy\" decoding=\"async\" width=\"530\" height=\"455\" src=\"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2026\/04\/image-8.png?resize=530%2C455&#038;ssl=1\" alt=\"\" class=\"wp-image-7039\" style=\"aspect-ratio:1.1642103964975026;width:301px;height:auto\" srcset=\"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2026\/04\/image-8.png?w=780&amp;ssl=1 780w, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2026\/04\/image-8.png?resize=300%2C258&amp;ssl=1 300w, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2026\/04\/image-8.png?resize=768%2C660&amp;ssl=1 768w\" sizes=\"auto, (max-width: 530px) 100vw, 530px\" \/><\/a><figcaption class=\"wp-element-caption\">A C Celsus &#8211; De Medicina<\/figcaption><\/figure>\n<\/div>\n\n\n<p>Celsus described tissue reactions to insults in terms of dolor, calor, rubor, and tumor, ie., pain, warmth, redness and swelling.&nbsp; This tetrad quite adequately describes the signs and symptoms of inflammation.&nbsp;Calor locally is warmth, and systemically would equal fever.&nbsp;The term \u2018functio laesa\u2019, or \u2018functional impairment\u2019, is often added.<\/p>\n\n\n\n<p>Fast forward to 2026: The Biomarker Consortium, with contributions from FDA, NIH, CMS, FNIH and others, released a publication entitled &#8217;20 years of advancing precision medicine&#8217; <a href=\"#_ftn2\">[2]<\/a>,<a href=\"#_ftn3\">[3]<\/a>.&nbsp; Among other therapeutic areas the Consortium worked on, were several infectious disease projects (ABSSSI, CABP, VABP) with the goal of developing PROs for these infections.<\/p>\n\n\n\n<p>The Consortium developed 2 tools, called PNEUMO PRO<sup>\u00a9<\/sup> and SKINFECT PRO<sup>\u00a9<\/sup> which can be reviewed online <a href=\"#_ftn4\">[4]<\/a>.<\/p>\n\n\n\n<p>Time and space do not allow us to dig into both tools; suffice it to introduce SKINFECT PRO<sup>\u00a9<\/sup> here, a PRO tool that allows patients to record symptoms every day using a 1-to-5 scoring system of symptoms. We no longer track 4 (four) but rather a whole slew of complaints:<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"alignright size-full is-resized\"><a href=\"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2026\/04\/image-9.png?ssl=1\"><img data-recalc-dims=\"1\" loading=\"lazy\" decoding=\"async\" width=\"265\" height=\"326\" src=\"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2026\/04\/image-9.png?resize=265%2C326&#038;ssl=1\" alt=\"\" class=\"wp-image-7040\" style=\"aspect-ratio:0.8129223985045295;width:155px;height:auto\" srcset=\"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2026\/04\/image-9.png?w=265&amp;ssl=1 265w, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2026\/04\/image-9.png?resize=244%2C300&amp;ssl=1 244w\" sizes=\"auto, (max-width: 265px) 100vw, 265px\" \/><\/a><\/figure>\n<\/div>\n\n\n<ul class=\"wp-block-list\">\n<li>Local symptoms:<br \/>SORENESS \u2013 THROBBING \u2013 WARMTH \u2013 PRESSURE \u2013 TENDERNESS \u2013 ITCHINESS \u2013 HARDNESS TO TOUCH \u2013 BURNING \u2013 TIGHTNESS<br \/><\/li>\n\n\n\n<li>Systemic symptoms:<br \/>TIREDNESS \u2013 LOW ENERGY \u2013 WEAKNESS \u2013 FEVER \u2013 CHILLS \u2013 SWEATING \u2013 HEADACHE \u2013 NAUSEA \u2013 DIZZINESS \u2013 FEELING \u2018DOWN\u2019 \u2013 FEELING \u2018WORRIED\u2019 \u2013 AVOIDANCE OF SOCIAL ACTIVITIES &#8211; DIFFICULTY SLEEPING \u2013 DIFFICULTY WORKING<br \/><\/li>\n\n\n\n<li>Functional status:<br \/>DIFFICULTY WITH ACTIVITIES OF DAILY LIVING \u2013 DIFFICULTY WITH PHYSICAL ACTIVITIES<\/li>\n<\/ul>\n\n\n\n<p>In a somewhat self-congratulatory tone, the Consortium states that FDA used this PRO to establish the \u2018primary outcome measure\u2019 for numerous ABSSSI drug approvals over the last decade.<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"alignright size-full is-resized\"><a href=\"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2026\/04\/image-10.png?ssl=1\"><img data-recalc-dims=\"1\" loading=\"lazy\" decoding=\"async\" width=\"478\" height=\"363\" src=\"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2026\/04\/image-10.png?resize=478%2C363&#038;ssl=1\" alt=\"\" class=\"wp-image-7041\" style=\"aspect-ratio:1.3168180448538591;width:216px;height:auto\" srcset=\"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2026\/04\/image-10.png?w=478&amp;ssl=1 478w, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2026\/04\/image-10.png?resize=300%2C228&amp;ssl=1 300w\" sizes=\"auto, (max-width: 478px) 100vw, 478px\" \/><\/a><\/figure>\n<\/div>\n\n\n<p>Well, we truly have come a long way in the last 2000 years.&nbsp; What a marvelous achievement &#8211; chapeau! The task force came up with an elegant solution to a most vexing problem &#8211; how to assess antibiotic benefit without resorting to microbiology.<\/p>\n\n\n\n<p>There is now a quantitative scoring system that replaces Celsus and his crude criteria with a more sophisticated multi-dimensional PRO that allows investigators and regulators to calculate a comprehensive symptom score.&nbsp; This new tool is patient-centric, relevant, and validated.&nbsp; It does away with the arbitrary assessment of doctors and caregivers. Using this catalogue of 25 well-considered criteria, assessment of antibiotic efficacy is now uniform and structured.<\/p>\n\n\n\n<p>We cannot argue with this approach, but is this PRO truly a major milestone of regulatory science, or ultimately a wasted effort? Some may say there is no need for an &#8216;ABSSSI for Dummies&#8217; approach while others point out its hidden value.<\/p>\n\n\n\n<div class=\"simplePullQuote right\"><p>SKINFECT PRO provides a calculated sliding-scale symptom score The tool is objective, multi-dimensional, relevant, and validated It does away with the arguably arbitrary clinical assessment of doctors\/investigators Antibiotic efficacy can now be measured using a expanded set of well-considered criteria in a uniform and structured fashion<\/p>\n<\/div>\n\n\n\n<p>The benefits of the new system become clearer when we consider all the factors included in the new PRO but not captured in the Celsus tetrad.&nbsp; Take this real-life example of a finger abscess:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>We can remember \u2018feeling down\u2019 when we developed the abscess, easily a \u20185\u2019 on the PRO<\/li>\n\n\n\n<li>We got very anxious and had profuse sweating just thinking that someone would lance the pus collection; clearly a PRO \u20184\u2019<\/li>\n\n\n\n<li>The finger throbbed badly, and the itch prevented us from falling asleep; make this a PRO \u20183-4\u2019<\/li>\n\n\n\n<li>We got tired and felt handicapped; unable to work with the affected finger \/ hand, preventing us from filling out lengthy PRO questionnaires; make this a PRO \u20183\u2019<\/li>\n\n\n\n<li>We finally relented and answered a few questions but selected \u20183\u2019s and \u20184\u2019s rather indiscriminately because we could not tell the difference between \u2018Somewhat=3\u2019 and \u2018Quite a bit=4\u2019<\/li>\n\n\n\n<li>After some time the throbbing stopped, thank goodness, but when it came back later that day, we realized that our PRO of \u20181\u2019 rating was not the right answer<\/li>\n\n\n\n<li>&nbsp;Actually, we got worried (PRO=\u20194\u2019) that we might have been assigned to the \u2018Tylenol only\u2019 placebo group<\/li>\n<\/ul>\n\n\n\n<p>In summary, this tool captures a lot more than just Calor-Rubor-Dolor-Tumor. Nonetheless, we still have a nagging feeling that tells us that SKINFECT PRO will not replace Celsus De Medicina. You be the judge: &nbsp;Let us know what you think of SKINFECT PRO, on a scale of 1= not contributory to 5= essential. THANK YOU !<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p>Come to think of it, as an afterthought, maybe the term \u2018FUNCTIO LAESA\u2019 was not transcribed properly by the monks that copied De Medicina in the Middle Ages.&nbsp; Could it be that they left out a small pronoun by mistake and the correct transcription should have been \u2018PRO FUNCTIO LAESA\u2019?&nbsp; It would have saved the Consortium a lot of work and settled the matter once and for all.<\/p>\n\n\n\n<p><strong>ABBREVIATIONS<\/strong><br \/>ABSSSI&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; skin \/ skin structure infection<br \/>CMS&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Centers of Medicare\/Medicaid systems<br \/>FNIH&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Foundation for the NIH<br \/>PRO&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;patient related outcome<\/p>\n\n\n\n<p><a href=\"#_ftnref1\"><strong>REFERENCES<\/strong><\/a><br \/><a href=\"#_ftnref1\">[1]<\/a> https:\/\/www.historyofinformation.com\/detail.php?entryid=2111<br \/><a href=\"#_ftnref2\">[2]<\/a> Klein A.&nbsp; Comment.&nbsp; The Biomarkers Consortium: 20 years of advancing precision medicine.&nbsp; Nature Reviews Drug Discovery 25, 155-156 (2026)<br \/><a href=\"#_ftnref3\">[3]<\/a> The Biomarkers Consortium: 20 years of advancing precision medicine.&nbsp; Supplementary information.&nbsp; Nature Rev Drug Discovery.&nbsp; 2026.&nbsp; https:\/\/doi.org\/10.1038\/d41573-025-00187-8<br \/><a href=\"#_ftnref4\">[4]<\/a> https:\/\/eprovide.mapi-trust.org\/instruments\/acute-bacterial-skin-and-skin-structure-infections-symptom-diary<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Aulus Cornelius Celsus wrote his famous book &#8216;De Medicina&#8217; approximately 2000 years ago.&nbsp; Living in the times of Caesar Augustus, little is known about his persona.&nbsp; We are not even sure whether he was a practicing physician.&nbsp; Many of his books were lost but Volume VIII was rediscovered in the <a class=\"more-link\" href=\"https:\/\/allphasepharma.com\/dir\/2026\/04\/20\/7037\/new-biomarker-consortium-pros\/\">Continue reading <span class=\"screen-reader-text\">  New BIOMARKER CONSORTIUM PROs<\/span><span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[227,3,18],"tags":[81,1271,2651,783,2631,1717,2632,5,343,2654,1583,2465,2637,881,2653,2652,2638,356],"class_list":["post-7037","post","type-post","status-publish","format-standard","hentry","category-recent_literature","category-the_news","category-the_viewpoint","tag-absssi","tag-allphase-pharma-consulting","tag-biomarker-consortium","tag-cabp","tag-celsus","tag-cms","tag-de-medicina","tag-fda","tag-fnih","tag-functio-laesa","tag-harald-reinhart","tag-patient-reported-outcome","tag-pneumo-pro","tag-pro","tag-rubor-dolor-calor-tumor","tag-signs-of-inflammation","tag-skinfect-pro","tag-vabp"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-1Pv","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":5500,"url":"https:\/\/allphasepharma.com\/dir\/2025\/09\/29\/5500\/draft-fda-guidance-for-coccidioidomycosis\/","url_meta":{"origin":7037,"position":0},"title":"Draft FDA Guidance for COCCIDIOIDOMYCOSIS","author":"Harald","date":"September 29, 2025","format":false,"excerpt":"David Larwood, CEO of VFS, summed it up at the Cocci FDA workshop in 2020: \u201cWhen the market opportunity is limited, finding investment becomes the key issue\u201d.\u00a0 He mentioned other problems as well: \u201cVery low patient numbers for disseminated disease, prolonged therapy, NI trial design, definition of clinical outcome\u201d.[1] Clearly,\u2026","rel":"","context":"In &quot;Recent Literature&quot;","block_context":{"text":"Recent Literature","link":"https:\/\/allphasepharma.com\/dir\/category\/recent_literature\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/09\/Haboob.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/09\/Haboob.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/09\/Haboob.jpg?resize=525%2C300&ssl=1 1.5x"},"classes":[]},{"id":1301,"url":"https:\/\/allphasepharma.com\/dir\/2015\/03\/15\/1301\/the-new-cuti-guideline-a-look-at-the-evolving-thinking-at-fda\/","url_meta":{"origin":7037,"position":1},"title":"The New cUTI Guideline: A Look at the \u2018Evolving Thinking\u2019 at FDA","author":"Harald","date":"March 15, 2015","format":false,"excerpt":"Just to refresh everyone\u2019s memory: First, we had the Points-To-Consider document of 1993, then the 1998 Guidance, followed by the 2012 Guidance and now the 2015 Guidance for the conduct of registration studies in cUTI.\u00a0 They all have served us well and I cannot recall a situation when a drug\u2026","rel":"","context":"In &quot;The News&quot;","block_context":{"text":"The News","link":"https:\/\/allphasepharma.com\/dir\/category\/the_news\/"},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":2064,"url":"https:\/\/allphasepharma.com\/dir\/2015\/10\/22\/2064\/polyphor-pol7080-and-the-journey-to-the-land-of-pyocyanea-part-3\/","url_meta":{"origin":7037,"position":2},"title":"Polyphor POL7080 And The Journey to The Land of Pyocyanea (Part 3)","author":"Harald","date":"October 22, 2015","format":false,"excerpt":"VABP is clearly the main\u00a0indication to be pursued by a drug like POL7080.\u00a0 Here is the question: How to conduct a study demonstrating efficacy for a drug which only has a\u00a0single-organism spectrum? \u00a0Which is actually no spectrum at all. \u00a0Existing guidelines for the development of ID drugs are indication-driven, with\u2026","rel":"","context":"In &quot;QIDP Antibiotics&quot;","block_context":{"text":"QIDP Antibiotics","link":"https:\/\/allphasepharma.com\/dir\/category\/qidp_antibiotic\/"},"img":{"alt_text":"bridge Pyocyanea-P3","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/10\/bridge-Pyocyanea-P3.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/10\/bridge-Pyocyanea-P3.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/10\/bridge-Pyocyanea-P3.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":2563,"url":"https:\/\/allphasepharma.com\/dir\/2016\/06\/22\/2563\/progress-report-new-antibacterials-in-the-fight-against-mdr-bacteria\/","url_meta":{"origin":7037,"position":3},"title":"Progress Report: New Antibacterials In the Fight against MDR Bacteria","author":"Harald","date":"June 22, 2016","format":false,"excerpt":"Since the beginning of this millennium we have seen antibiotic R&D dwindle year after year. 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The document is 617\u2026","rel":"","context":"In &quot;The News&quot;","block_context":{"text":"The News","link":"https:\/\/allphasepharma.com\/dir\/category\/the_news\/"},"img":{"alt_text":"AMDAC - slider","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/11\/AMDAC-slider.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/11\/AMDAC-slider.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/11\/AMDAC-slider.jpg?resize=525%2C300 1.5x"},"classes":[]}],"jetpack_likes_enabled":true,"_links":{"self":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/7037","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/comments?post=7037"}],"version-history":[{"count":5,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/7037\/revisions"}],"predecessor-version":[{"id":7046,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/7037\/revisions\/7046"}],"wp:attachment":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/media?parent=7037"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/categories?post=7037"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/tags?post=7037"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}