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The Rockefeller University Center for Clinical and Translational Science Minutes of the Advisory Committee on Clinical and Translational Science (ACCTS) October 3, 2011 Voting Members Present: Robert Darnell – Chair, Ed Barbour, Iddo Ben Dov, Edgar Charles, Barry Coller, Emil Gotschlich, Peter Holt, Lisa Hudgins, Rhonda Kost, Michelle Lowes, Marty Markowitz, Barbara O’Sullivan, Neil Renwick, Terry Solomon, Mayte Suarez-Farinas Invited: Donna Brassil _______________________________________________________________________________ The meeting was called to order at 2:32 pm _______________________________________________________________________________ 1. Approve minutes from the July 20, 2011 ACCTS meeting 2. Initial Reviews Emma Guttman Analysis of Immune Reactions Occurring Upon Administration of Patch Tests and Contact Dermatitis Affected Skin [Reviewer: Michelle Lowes] Scientific Initial Review What are the background and goals of study? This is a study to understand the cellular and molecular responses of allergic contact dermatitis (ACD). Patients suspected of having ACD will be patch tested in the outpatient clinic with 15 common allergens, and a "no allergen" site. If there is a positive reaction, biopsies will be taken of baseline, no allergen control and positive allergen sites. Patients will be given information for allergen avoidance. Patients will then be able to come into the second phase of the study 2-8 weeks later, where the positive allergen is applied in triplicate, for paired LS/NL biopsies at Day 2 and 7. 400-500 patients 18-60 years will be studied over 15 years. Patients will be paid $175 for the first phase, $225 for the second. If this is a clinical trial, please specify: Intervention: N/A Primary endpoint: Clinical evaluation of reaction to allergens Secondary endpoint: Cellular and molecular evaluation of skin by IHC and microarray/PCR What are the major risks? Moderate risk: rash at site of reaction; risks of biopsy and blood draw 1 Statistical Analysis (optional: comments in addition to Biostatistician review) What is the potential significance of the study? It will be interesting to understand more about the process of ACD. Ratings: Scientific Merit: Priority: Resource Intensity: High Moderate Moderate Recommendation Reviewer's Recommendation of Submission Approve Reviewer's Comments Although this is a research protocol, there will be both a clinical results and research data. The clinical patch test results will be given to the patients by Dr Guttman, a board-certified dermatologist, as well as information on how to manage the allergy. This is written in the consent form and this approach is the standard of care for diagnosis and management of ACD. No patients with suspected occupational allergies will be studied- the allergens chosen are not commonly encountered in occupational allergy, and additional allergens pertinent to occupational exposure will not be added. This could be added to the inclusion/exclusion criteria. Indication of Review Completion Yes Date the Review was completed: 09/30/2011 Enter DSMP Review: Comment: 1. Dr. Guttman directs the dermatology clinic and plans to refer patients from the clinic and from her own practice. In order to minimize the therapeutic misconception and assure voluntariness, the consent form and consent process should explicitly address the distinction between regular care and research care. This can be confusing since patch testing is part of regular care and diagnosis in ACD, and it should be clear that patch testing undertaken at Rockefeller, is part of research care. 2. The protocol describes contact dermatitis causing intense pruritus through contact dermatitis that may "affect the quality of life", yet the study plan involves application of 15 common potential allergens to enhance the likelihood of achieving the target inflammation. The likelihood of multiple reactive test allergens, and the total number of biopsies, raise concerns both about the likelihood of successfully recruiting participants for merely $25 per allergy panel, and the risk that participants will not return for the second round of testing once they have undergone patch testing and multiple biopsies. 3. The protocol should address what measures the participant can undertake to minimize the discomfort of exuberant and/or multiple reactive test patch sites and the impact of those measures on biopsy healing and protocol retention. A participant might seek relief for 2 extremely itchy and uncomfortable test patches; presumably the application of topical corticosteroids would interfere with healing of biopsy sites and might interfere with the integrity of the immune response for stage 2. Please include discussion of managing this 'toxicity' both in approach and impact. Recommendation Reviewer's Recommendation of Submission Approve with recommendations Reviewer's Comments Recommend: 1. Revise ICF to emphasize the distinction between care and research; allergy panels alone can be part of routine care, but allergy panels conducted at Rockefeller coupled with biopsies, are a research activity. 2. Describe what measures, if any, a participant may use to alleviate intense discomfort/itching associated with exuberant patch test reactions, and whether use of those measures would terminate protocol participation for stage 2; address whether participants will be made aware of these care options. 3. Revisit the compensation scheme soon after recruitment begins; the current compensation levels are not likely to be adequate for achieving the designated sample size. Martin Markowitz The STOP Project-Screening Targeted Populations to Interrupt On-going Chains of HIV Transmission with Enhanced Partner Notification [Reviewer: Edgar Charles] Scientific Initial Review What are the background and goals of study? The goal of the project is to evaluate acute HIV infection (AHI) screening programs linked to enhanced partner services (contact tracing and partner notification services). The STOP Study will compare two methods (4th generation EIA and pooled NAAT) to detect AHI. The STOP Study will also compare the benefit (in terms of new HIV infection detected among partners) of enhanced partner services (performed by a specialist experienced in locating contacts through media such as on-line chat rooms) provided to index cases with AHI and with established HIV infection. Briefly subjects will be studied at community health clinics in San Francisco, North Carolina, and NYC. HIV testing with 4th generation EIA and/or NAAT will be performed. Tracing and notification of sexual contacts of AHI individuals will be performed either using "standard of care" or an "enhanced" strategy, as alluded to above. If this is a clinical trial, please specify: Intervention: N/A Primary endpoint: 3 1) Evaluation of the number of individuals with AHI detected with the 4th generation EIA compared with pooled NAAT. 2) The number and proportion of partners with newly diagnosed HIV infection detected with enhanced partner services among index cases diagnosed with AHI compared with partners of persons newly diagnosed with established HIV infection. Secondary endpoint: 1) Evaluation of whether molecular phylogenetic techniques confirm transmission networks identified with enhanced partner services. 2) Evaluation of the cost-effectiveness of screening for AHI with 4th generation EIA compared to pooled NAAT. What are the major risks? The study poses no more than minimal risks to subjects, who are giving their consent for HIV infection and have agreed to partner services. Molecular testing will be done on de-identified samples. Statistical Analysis (optional: comments in addition to Biostatistician review) Defer to biostatistician What is the potential significance of the study? The study could establish whether 4th generation EIA or pooled NAAT is more effective at diagnosing EIA, and whether using enhanced partner services to trace and notify sexual contacts is effective at preventing HIV transmission. Ratings: Scientific Merit: Priority: Resource Intensity: Moderate Moderate Low Recommendation Reviewer's Recommendation of Submission Approve, exempt from Review Reviewer's Comments This study poses no more than minimal risk to subjects, as described above, and should be exempt from review. Martin Markowitz A preclinical assessment of GSK1265744, and InSTI, as PrEP [Reviewer: Edgar Charles] Scientific Initial Review What are the background and goals of study? 4 Recent randomized controlled trials have demonstrated the efficacy of tenofovir alone or tenofovir and 3TC as pre-exposure prophylaxis (PrEP) in the reduction of the risk of HIV transmission. While certainly a milestone, there is a clear need to study the use of other antivirals as PrEP agents. This study aims to assess the in vitro susceptibility of a diverse panel of transmitted HIV-1 variants to GSK1265744, with the goal of determining whether this compound is a suitable PrEP candidate. Methods: a) The PI will assemble a panel of 36 transmitted HIV-1 isolates including representatives of Clades A, B and B’, C, D, G, CRF01_AE, CRF02_AG, CRF07_BC, and CRF_BF. Susceptibility defined as the IC50 and IC90 to GSK1265744 in vitro using human peripheral blood mononuclear cells will be measured. b) Viral isolates or PBMC to expand isolates will be derived from 3 sources: 1. Stored PBMC in the freezers at ADARC that were collected under study MMA-465. All participants gave permission for the storage and subsequent use of these PBMC by signing informed consents. 2. Viral isolates from African sites for the Study CHAVI001 in which ADARC participated as a US site (MMA-639). All patients will have signed consents to store and share PBMCor isolates. Specimens will be coded and the ADARC team will not be able to link specimens with individual patients. 3. Viral isolates from China will be deidentified viral isolates or peripheral blood mononuclear cells from Asian sites located in multiple provinces where HIV/AIDS are the most severe. c. Viral isolates will be expanded from provided culture isolates or peripheral blood mononuclear cells (PBMC) from newly infected individuals on PHA-stimulated uninfected PBMC in IL-2 containing media as published. d. Culture supernatants will be subtyped as per published methods and the integrase coding region sequenced. e. Expanded viral isolates will be tittered on PBMC as published and used for susceptibility assays and a minimum of 3 isolates conforming to each of the subtypes noted above will be tested for susceptibility to 744. f. For each isolate 7x106 PHA-stimulated, CCR5 wild type uninfected PBMC in a volume of 2.5 ml will be incubated with virus at an MOI of 0.1 for 2 hours at 37C and washed and plated on a 96-well plate with 5-fold dilutions of 2x-744 ranging 0.02nM to 50nM (final concentration 744 0.01nM to 25 nM) and a no drug control Final concentration of PBMC will be 2x106/ml. Cultures will be maintained as published and p24 antigen levels will be measured at day 10 and cultures will be maintained to day 21. All assays will be done in duplicate. IC50and IC90 will be based on p24 Antigen concentrations in the absence and presence of drug and determined using Prism. If this is a clinical trial, please specify: Intervention: N/A Primary endpoint: IC50 and IC90 of isolates. Secondary endpoint: None What are the major risks? As the study will utilize previously-collected, de-identified plasma and PBMCs, it poses no significant risks to human subjects. 5 Statistical Analysis (optional: comments in addition to Biostatistician review) Defer to biostatistician. What is the potential significance of the study? As mentioned above, there is a need to identify other PrEP agents that might be more efficacious in preventing the transmission of HIV. This study would provide data that would either support or disfavor the further investigation of GSK1265744 as a PrEP agent. Ratings: Scientific Merit: Priority: Resource Intensity: Recommendation Moderate Moderate Low Reviewer's Recommendation of Submission Approve with stipulations Reviewer's Comments As the study proposes to utilize previously-collected, de-identified plasma and PBMCs, it poses no significant risks to human subjects, and should be exempt from review according to Category (4). However, the term "InSTI" included in the protocol's title is not mentioned in the protocol itself. The PI needs to clarify what “InSTI” is. Since it does not appear in the protocol, it should either be deleted from the title of the study, or if the PI wishes it to be included, the protocol should be revised accordingly. Indication of Review Completion Yes No Date the Review was completed: 10/11/2011 Bernice Rumala Evaluation of SPARC Initiatives [Reviewer: Michelle Lowes] Scientific Initial Review What are the background and goals of study? SPARC stands for the Achieving Successful and Productive Academic Research Careers (SPARC), a tri-institutional initiative to engage minorities in science. Bernice Rumala wants to conduct an anonymous survey to 5000 people over 5 years. If this is a clinical trial, please specify: Intervention: nil Primary endpoint: complete evaluation data to assess the impact of the SPARC initiative, the views and needs of the participants 6 Secondary endpoint: N/A What are the major risks? NIL Statistical Analysis (optional: comments in addition to Biostatistician review) What is the potential significance of the study? May be helpful Ratings: Scientific Merit: Priority: Resource Intensity: High Moderate Low Recommendation Reviewer's Recommendation of Submission Approve Reviewer's Comments Indication of Review Completion Yes Date the Review was completed: 09/30/2011 DSMP Review Enter DSMP Review: Comment: Potential issues are – exclusion of minors, confidentiality, and survey data quality. Minors Repeat banner, “DO NOT COMPLETE IF YOU ARE <18 years old” both at the top of the first page, and near the age question box. Describe how you will assure that when audiences are mixed, minors do not contribute data? Provide a text box at the top of the form for respondent to fill in the date of the event - some events involve many more minors; excess data from a mostly-minors event would indicate that the written prohibition was not working. This is also needed to align the data with the appropriate event. Consider proposing and submitting an amendment that would allow for parental consent and the participation of minors in the research evaluation portion of the program. 7 Confidentiality – is adequately addressed with anonymous survey design. Survey data quality – The survey would benefit from another round of refinement. For example: The federal categories for Race are not always consistent, note the 2000 and 2010 Census categories, however it is common practice to offer “some other race” or “2 or more races”, and to offer “decline to answer” rather than asking “other (specify).” Some questions inherently assume that the participant has internalized a concept from the conference, such as asking about a ‘science mentor’ or a ‘research network’. These questions could be re-constructed to ask whether the participant 1) now understands what a science mentor is, 2) could now identify a potential science mentor from among his/her teachers and other contacts, or 3) has identified a new potential science mentor from the conference attendees. Some of the questions asking “as a result of the conference” seem very leading and could be rewritten to explore change of state or change of ideas without so clearly assigning causality at the asking. Co-Coded before and after evaluations might be a better way to get at some of the issues. Recommendation Reviewer's Recommendation of Submission Approve with recommendations Reviewer's Comments Add age warning banner near age-related question on survey Add date of event/evaluation to top of survey to align data with event Develop process to cross check that minors are not submitting evaluations anyway Develop amendment/protocol to include minors as they are a key target audience. Consider revision of survey questions for clarity and neutrality. Nicholas Schiff Neurological Neurophysiologic Studies of Disorders of Consciousness [Reviewer: Emil C Gotschlich] Scientific Initial Review What are the background and goals of study? This study is designed to intensively observe patients in the minimally conscious or confusional state for a period of about 4 days at the Rockefeller University Hospital. The technologies that will be employed are continuous video monitoring combined with EEG, one PET scan with fluoro deoxy glucose and a fMRI session. The overall plan is to do this with 80 patients at the rate of about 12 patients per year. The patients will be recruited from long-term care facilities with which the investigators have established relationships. Particularly in the initial phases of the study there will be close quality control of the capability of the Rockefeller University hospital to provide the extensive and highly specialized care that such patients require and this is listed in detail in section 8.5 under the secondary outcomes. On day 0 the patients will be seen in the outpatient clinic for a medical history and physical examination and a thorough neurological and/or psychological examination plus a baseline EEG to establish that there is no seizure activity. 8 Day 1 - 3 will include continuous video the EEG monitoring, neurological and neuropsychological examinations, and behavioral studies. In addition on day 3 PET scan will be performed and on day 4 an fMRI MRI study. A cohort of normal healthy individuals would be included that will have the same screening examination and then on an optional basis a MRI and an overnight sleep study with continuous video and EEG monitoring. The Hypothesis is that Physiologic measures of brain function can be tracked and will correlate with recovery of cognitive function after severe brain injury. If this is a clinical trial, please specify: Intervention: This is not a clinical trial Primary endpoint: The primary outcome will be the Association of measured brain assessments (fMRI, EEG, PET) to the changes in behavioral quantitative measures over time. The fMRI and the EEG will be done with the patients presented with tasks of increasing complexity which are outlined in section 8.7 Data analysis. Secondary endpoint: The adequacy of the care and support provided to the patients during their stay at RUH What are the major risks? There are no major risks in this study Statistical Analysis (optional: comments in addition to Biostatistician review) The methods used to analyze the data obtained by these modalities is described in their revised data plan and in the reprints that there submitted as part of the submission. What is the potential significance of the study? The significance of this study is that it will add knowledge to the as yet poorly understood neurophysiological processes involved in recovering from severe brain injuries a problem that is unfortunately very common in young individuals and increasingly so in military personnel exposed to blast injuries. Ratings: Scientific Merit: Priority: Resource Intensity: High High High Recommendation Reviewer's Recommendation of Submission Approve Reviewer's Comments Indication of Review Completion Yes Date the Review was completed: 10/03/2011 9 DSMP Review Enter DSMP Review: Application Section and comment: 7.2, 7.3: response incorrectly states that NYH/WCMC are not involved in the study; protocol is conducted in collaboration with NYH/WCMC investigators 8.9 indicate that no samples will be collected; yet the collection of venous blood for genotyping is described in section 8.6. Need correction. 9.3; 80 subjects seems like a high number for a feasibility study; if this is a smaller n pilot, within a planned 80 subject study, clarify as such. 11.2; states consenting may take place long term care facilities. What assurance is necessary, or collaboration or permission from that institution is necessary? Need to avoid therapeutic misconception; how does the doctor primarily responsible for the patient’s care factor in? Are Dr. Fins and Dr Schiff on staff at the LTC facilities? Also, who will review the appropriateness of the designated LAR, or any documentation of the LAR status? How will the legitimacy of the LAR be documented prior to considering the IC valid? RU OGC? 11.5 is incoherent/ please correct 12.3 does not describe at all how participants will be identified and/or recruited to the study. Referral? Advertisements at LTC facilities? Recruitment from the ICU/medical floor? This section is incomplete. 16.1; the point of the question is alternative to participation in terms of opportunity cost; an appropriate answer here would be to address any treatment options that the participant is foregoing while participating in the study (rehabilitative care at a LTC facility; absence of definitive treatment). 23.4 – given the list of equipment, it seems there will be storage needs. Defer to research nursing and administration. ICF For healthy volunteers: Remove the italicized instructions to the PI in the certificate of confidentiality section ICF For affected participants: Section II states ‘you will be screened in the Outpatient Clinic…” Is this correct, for a bed-bound minimally conscious person? It seems inappropriate for the OPU setting. Won’t they be screened on the IPU, though not admitted, like a Day patient? The procedures section does not mention the tube of venous blood that is noted in the protocol. Please reconcile. Remove the instruction to the PI in the Certificate of Confidentiality section. The language about what type of care, and for what conditions will and will not be provided appears to be missing The language about ‘no cost to you’ should be modified to explain that if a usual care issue arises, they might be transferred for care that they will be financially responsible, even though it arose contemporaneously with research participation. Recommendation Reviewer's Recommendation of Submission 10 Approve with stipulations Reviewer's Comments Recommend: 1. A careful read through of the protocol for minor corrections to sections, 7, 8, 9, 11, 16, and 23 as detailed in DSMP review above. 2. A clear explanation of how participants and their LAR will be identified and recruited (section 11) and where the informed consent discussions can take place (section 12). 3. Corrections to the ICF for affected participants as above in DSMP review. Indication of Review Completion Yes Date the Review was completed: 10/01/2011 Ana Tuyama Gene and MicroRNA Expression Profile of Hepatocytes and Hepatic Stellate Cells from Obese Patients in Defined Stages of NonAlcoholic Fatty Liver Disease [Reviewer: Peter Holt] Scientific Initial Review What are the background and goals of study? Background: Nonalcoholic fatty liver disease (NAFLD) is the commonest cause of chronic liver disease occurring in most morbidly obese individuals that can lead to cirrhosis and eventually the need for liver transplantation in the Unites States. NAFLD is divided into hepatic steatosis or nonalcoholic steatohepatitis (NASH) characterized by inflammation and the development of fibrosis. There is no current effective therapy except weight loss for this disorder. The key mediator appears to be activation of hepatic stellate cells (HSC), but the mechanism that is responsible for the switch from simple hepatic steatosis to steatohepatitis is not known. GWAS studies, generally, have been unhelpful and gene expression studies have to date been performed only on whole liver specimens. Study Aims: The aim of this study is to isolate hepatocytes and hepatic stellate cells from surgical liver wedge or biopsy specimens taken from patients undergoing obesity surgery at New York University Hospital by 1 surgeon and to perform microarray and micro RNA array studies on isolated cells appringed from these livers. Overall, these studies would primarily compare gene expression in hepatic stellate cells and hepatocytes from patients with simple steatosis and with NASH to gain insight on possible molecular mechanisms underlying this switch and subsequent progression to cirrhosis. Methods: This is a cross sectional single center study at NYU School of Medicine with up to 30 male or female subjects 30-60 years of age with a BMI > 35 who will be enrolled in order to find 5 subjects with simple steatosis and 5 subjects with NASH. Once these 10 subjects have been recruited no further subjects would be sought. Inclusion Criteria: BMI > 35, and evidence of the metabolic syndrome on the basis of hyperglycemia or increased fasting insulin levels plus hypertension, hypertriglyceridemia or enhanced waist circumference. Exclusion Criteria: Presence of evidence of other liver diseases, alcohol intake > 20g per day for women and >30g per day for men and medications that are associated with liver dysfunction. 11 At the time of surgery and at the surgeon’s discretion a liver wedge or surgical needle biopsy will be collected and processed immediately by the PI within the operating room permitting standard histological evaluation by a single expert pathologist. A small sample of remaining tissue will be embedded in OCT for later cryo-sectioning and the remaining liver tissue will be perfused and digested with collagenase B using a standardized protocol for separation of hepatocytes and hepatic stellate cells using a Percoll-density centrifugation gradient. Subsequently, total RNA will be isolated from the cellular sub factions and specificity analyzed by QPCR for albumin as a marker of hepatocytes and GFAP and alpha smooth muscle actin for HSC. RNA samples will be processed in The Rockefeller University Genomics Facility amplified, hybridized and evaluated by Illumina-Chip and the Agilent-Chip from micro RNA array and scanning. In order to evaluate the effect of the cell isolation system on gene and MIRNA expression laser capture micro dissection will also be performed to separate hepatocytes and HSC’s. Such laser capture methods are used routinely in the laboratory of Dr. Fisher at NYU. Principal Investigator initiated Single Center study Scientific Review Major risks Bleeding from biopsy site or leak from puncture of biliary radicles Statistics none for this pilot study Significance Better understanding of the mechanisms responsible for the switch from simple steatosis to NASH If this is a clinical trial, please specify: Intervention: Primary endpoint: Secondary endpoint: What are the major risks? Major risks bleeding from biopsy site or leak from puncture of biliary radicles Statistical Analysis (optional: comments in addition to Biostatistician review) Statistics none for this pilot study What is the potential significance of the study? Significance Better understanding of the mechanisms responsible for the switch from simple steatosis to NASH Ratings: Scientific Merit: Priority: Resource Intensity: High Moderate Low 12 Recommendation Reviewer's Recommendation of Submission Approve with stipulations Reviewer's Comments At the ACCT meeting it was suggested that the lab tests evaluating for other liver diseases should be performed at NYU to simplify the transfer of abnormal data to the patient chart Indication of Review Completion Yes Date the Review was completed: 10/06/2011 DSMP Review Enter DSMP Review: Only coded samples will be received and studied at Rockefeller. No DSMP issues identified. Recommendation Reviewer's Recommendation of Submission Approve Reviewer's Comments No issues identified. Indication of Review Completion Yes No Date the Review was completed: 10/02/2011 3. Continuing Marina Caskey MAC-0682 - A Randomized, PlaceboControlled, Phase 1 Study to Evaluate the Safety and Immunogenicity of Poly ICLC (Hiltonol) in Healthy Volunteers [Reviewer: Martin Markowitz] Δ Exempted by reviewer Ronald Crystal RCR-0391 - The Natural History of Gene Expression in Lung Cells of Non-Smokers, Smokers, and Ex-Smokers in Health and Disease [Reviewer: Lisa Hudgins] Δ Exempted by reviewer 13 Dana Orange DOR-0722 - Evaluation of Immune Activation in Rheumatoid Arthritis [Reviewer: Michelle Lowes] Δ Exempted by reviewer Mina Pastagia MPA-0677 - Eradication of Staphylococcus Aureus from Skin Lesions Through the Use of a Newly Developed Lytic Enzyme Called ClyS [Reviewer: Emil C Gotschlich] Δ Exempted by reviewer 4. Amendment Ronald Crystal RCR-4440 - Evaluation of the Lungs of Individuals with Lung Disease with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy [Reviewer: Michelle Lowes] Δ Exempted by reviewer Ana Emiliano EKE-0724 - Effect of Metabolic State on Anxiety in Human Subjects [Reviewer: Emil C Gotschlich] Peter Holt PHO-0735 - Pilot: Obesity Associated Serum Derived Factors and Cancer. [Reviewer: Neil Renwick] Δ Exempted by reviewer 5. Exempt Protocols Lindsay Lee Bellani LDI-0731 - Pilot Study: Isolation of Cues that Drive Mosquito Preference for Certain Human Hosts Jon Blumenfeld JBL-0496 - Autosomal Dominant Polycystic Kidney Disease Repository Donna Brassil DBR-0668 - A comparison of hemolysis rates and laboratory values using intravenous catheters versus venipuncture for obtaining venous blood samples Barry S Coller AMA-0692 - Assessment of bleeding symptoms in individuals with bleeding disorders using a comprehensive Bleeding History Phenotyping System Ronald Crystal RCR-0391 - The Natural History of Gene Expression in Lung Cells of Non14 Smokers, Smokers, and Ex-Smokers in Health and Disease Jan Davidson-Moncada JAD-0647 - Role of microRNA's in Lymphoma and Leukemia’s Ronald Crystal RCR-4439 - Evaluation of the Lungs of Normal (Smokers, Ex-smokers, Nonsmokers) Individuals with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing and End bronchial Wall Biopsy Haiteng Deng HDE-0680 - Crosstalk Among Oral and Gastrointestinal Soluble Innate Factors, HIV, and Microbes (2 Submissions) Winrich Freiwald WFR-0741 - The Neural Basis of Face Recognition and Social Cognition: A Magnetic Resonance Imaging Study Charles Gilbert CGI-0573 - Processing mechanisms of visual cortex Peter R Holt PHO-0735 - Pilot: Obesity Associated Serum Derived Factors and Cancer. Lisa Hudgins LHU-0616 - Fructose-Induced Palmitate Synthesis in Overweight Subjects Rhonda G Kost RKO-0679 - Research Participant Perception of Care Project, Part II: Fielding and Validation of the Research Participant Perception Survey Derived from Focus Group-Identified Key Dimensions of the Research Participant Experience (with single site Cognitive Interviewing Sub-Study) Rhonda G Kost RKO-0648 - Research volunteer screening/ recruitment data repository Ana Krieger AKR-0102 - Mechanisms of Endothelial Cell Dysfunction in Sleep Apnea James Krueger JKR-0622 - The Natural History of Pigmented Skin Lesions James Krueger JKR-0686 - Screening for entry into skin disease studies James Krueger JKR-0737 - Randomized Pilot Study of Ustekinumab for Subjects with Chronic 15 Atopic Dermatitis Who Have Suboptimal Response to Prior Therapy Dana Orange DOR-0722 - Evaluation of Immune Activation in Rheumatoid Arthritis MMA-0591 - HIV Elite Controller Study Martin Markowitz Martin Markowitz MMA-0577 - A Randomized Phase II Study of Therapeutic Immunization and Treatment Interruption Among Subjects Who Began Potent Antiretroviral Therapy Within 16 Days of Diagnosis of Acute or Recent HIV Infection (AIN504) Martin Markowitz MMA-0754 - A Phase 2b Randomized, Double-Blind, Double-Dummy Trial of 100 or 200 mg Once-Daily Doses of Cenicriviroc (CVC, TBR-652) or OnceDaily EFV, Each With Open- Label FTC/TDF, in HIV-1-Infected, Antiretroviral Treatment-Naïve, Adult Patients With Only CCR5-Tropic Virus (TBR-652-2-202) Martin Markowitz MMA-0643 - A Phase III Multicenter, Double-Blind, Randomized, Active Comparator Controlled Clinical Trial to Study the Safety and Efficacy of Once Daily Raltegravir (MK-0518) versus Twice Daily Raltegravir, Each In Combination with TRUVADA, in Treatment-Naive HIV Infected Patients (MK-0518-071) Martin Markowitz MMA-0582 - A Multi-Center, DoubleBlind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 in Combination with an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone in HIV-Infected Patients with Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiretroviral Therapies (MK-0518-019). Martin Markowitz MMA-0592 - The Transmission and Fitness of Drug Resistant HIV-1 (NIH Grant #2R01-AI-47033-06) Martin Markowitz MMA-0448 - Viral and Host Factors in the Transmission and Pathogenesis of HIV (This protocol was formerly RKO16 0201; PI has changed from Kost to Markowitz, therefore, number was changed.) Martin Markowitz MMA-0613 - A Study of the Safety, Tolerability, and Pharmacokinetics of KD-247, A Humanized Monoclonal Antibody that Recognizes the Principal Neutralizing Determinant of HIV-1 in Asymptomatic HIV-1 Seropositive Individuals Who Are Not Receiving Concurrent Anti- Retroviral Therapy KD1002 Martin Markowitz MMA-0607 - A Pilot Study of the New York HIV Transmissions Study: Project HITS-NY, Illicit Drug Use and Social Network Effects Among at Risk and Recently/Acutely HIV-1 Infected MSM Swaroop Pendyala SWP-0660 - Monocyte Intracellular Cytokine Production in Healthy Volunteers Charles Rice CRI-0657 - Isolation and Culture of Tissue Culture Infectious HCV from Blood Sarah J Schlesinger SSC-0710 - A randomized, placebocontrolled, dose-escalating, doubleblinded phase 1 study to evaluate safety and immunogenicity of anti-DEC-205 monoclonal antibody (mab) targeted HIV gag p24 vaccine (DCVax-001) with poly ICLC (Hiltonol) as adjuvant in HIVuninfected healthy volunteers Sanford Simon SSI-0725 - Characterization of the Antibody Response to Tumor Sanford Simon SSI-0624 - Imaging Single Molecular Events in the Cell Sohail Tavazoie STA-0681 - Identification of microRNAs that predict metastatic relapse and sensitivity to chemotherapy in human colorectal cancer Leslie Vosshall LVO-0684 - Genetic Basis of Odor Discrimination John Zabriskie JZA-0540 - Natural History of 17 Rheumatic Fever at Rockefeller University Hospital 6. Reports of Director and Co-Director Dr. Coller announced that the Center has received indications of our being awarded an additional supplement to Dr. Tomasz and his colleague at Cornell, but no official statement has been released. He noted that the Senate has passed the HHS appropriation of NCATS, but has also cut NIH funding. He noted that the House proposed a budget granting the NIH a one billion dollar increase, but no funding was provided to NCATS. Dr. Coller noted that he will send an email out once he has more information. Dr. Coller reminded the board that the next meeting of the Therapeutic Discovery and Development Interest Group (TD2IG) meeting is scheduled for today, Tuesday, October 4th at 4:00 pm in room 206 of the CRC. 7. Reports of Subcommittees A) Pilot Project and Collaborative Studies subcommittee (Edgar Charles) Dr. Charles presented the pilots that were recommended for funding by the review committee. – See Attached. Motion to approve funding – Approved B) Research Education Training and Career Development Subcommittee (Sarah Schlesinger) No report C) CRRF Clinical Research Resources and Facilities (Barbara O’Sullivan) Dr. O’Sullivan informed the board that at present there is an issue regarding contracted testing. Currently contracted testing takes up 4% of the lab budget, however as contracts expire the costs nearly double. Dr. O’Sullivan asked the board for their advice on the matter. Board Response – to notify PIs and request their expected usage of contracted testing for the future as new protocols come in, to project spending. 8. Review of Center Metrics and Resource Utilization 9. Assessment of Underutilization, Inappropriate Use, and Low Productivity 10. Review of Budget 11. Strategic Planning Issues The meeting was adjourned at 4:10 pm Respectfully submitted, _________________________________ Maija Williams, MPH ACCTS Administrator 18 _________________________________ Robert B. Darnell, MD, PhD Chair 19