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Updated listing of COVID-19 vaccine and therapeutic trials from NIH Clinical Trials.gov

Posted in Biomarkers: Inflammation, Clinical Diagnostics, Clinical Genomics, COVID-19, COVID-19: Pandemic Surgery Guidance, Drug Development Process, Economic Impact of Coronavirus Pandemic, FDA, FDA Regulatory Affairs, Immune-Mediation (independent immunopathology: lung and reticuloendothelial system), Infectious Disease & New Antibiotic Targets, Infectious Disease Immunodiagnostics, number of asymptomatic infections, Pharmaceutical Drug Discovery, SAR-Cov-2 a vasculotropic (blood vessels) RNA Virus, SARS-CoV-2, Seasonality & Environmental Factors in Resurgence, Treatment Protocols for COVID-19, Viral diseases, tagged #COVID-19, Clinical trial, coronavirus, COVID-19, National Institutes of Health (NIH) ’s Common Fund, SARS-CoV-2 on April 16, 2020| Leave a Comment »

Updated listing of COVID-19 vaccine and therapeutic trials from NIH Clinical Trials.gov

Curator: Stephen J. Williams, PhD

The following file contains an updated list (search on 4/15/2020) of COVID-19 related clinical trials from https://clinicaltrials.gov/

The Excel file can be uploaded here: Current Covid-19 Trials

Each sheet in the workbook is separated by current COVID-19 vaccine trials, currents COVID-19 trials with the IL6R (interleukin 6 receptor) antagonist tocilizumab, and all COVID related trials. The Excel spreadsheet also contains links to more information about the trials.

As of April 15, 2020 the number of listed trials are as follows:

clinicaltrials.gov search terms	Number of results	Number of completed trials	Number of trials currently recruiting
COVID-19 or SARS-CoV-2	410	5 completed 5 withdrawn	192
1st row terms + vaccine	28	0	15
1st row terms + tocilizumab	16	0	10
1st row terms + hydroxychloroquine	61	1	22

A few highlights of the COVID related trials on clinicaltrials.gov

Withdrawn trials

Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19 (NCT04287686)

Study Description

Go to

Brief Summary:

This is an open label, randomized, controlled, pilot clinical study in patients with COVID-19, to obtain preliminary biologic, physiologic, and clinical data in patients with COVID-19 treated with rhACE2 or control patients, to help determine whether a subsequent Phase 2B trial is warranted.

Condition or disease	Intervention/treatment	Phase
COVID-19	Drug: Recombinant human angiotensin-converting enzyme 2 (rhACE2)	Not Applicable

Detailed Description:

This is a small pilot study investigating whether there is any efficacy signal that warrants a larger Phase 2B trial, or any harm that suggests that such a trial should not be done. It is not expected to produce statistically significant results in the major endpoints. The investigators will examine all of the biologic, physiological, and clinical data to determine whether a Phase 2B trial is warranted.

Primary efficacy analysis will be carried only on patients receiving at least 4 doses of active drug. Safety analysis will be carried out on all patients receiving at least one dose of active drug.

It is planned to enroll more than or equal to 24 subjects with COVID-19. It is expected to have at least 12 evaluable patients in each group.

Experimental group: 0.4 mg/kg rhACE2 IV BID and standard of care Control group: standard of care

Intervention duration: up to 7 days of therapy

No planned interim analysis.

Study was withdrawn before participants were enrolled.

Washed Microbiota Transplantation for Patients With 2019-nCoV Infection (NCT04251767)

Study Description

Go to

Brief Summary:

Gut dysbiosis co-exists in patients with coronavirus pneumonia. Some of these patients would develop secondary bacterial infections and antibiotic-associated diarrhea (AAD). The recent study on using washed microbiota transplantation (WMT) as rescue therapy in critically ill patients with AAD demonstrated the important clinical benefits and safety of WMT. This clinical trial aims to evaluate the outcome of WMT combining with standard therapy for patients with 2019-novel coronavirus pneumonia, especially for those patients with dysbiosis-related conditions.

Detailed Description:

An ongoing outbreak of 2019 novel coronavirus was reported in Wuhan, China. 2019-nCoV has caused a cluster of pneumonia cases, and posed continuing epidemic threat to China and even global health. Unfortunately, there is currently no specific effective treatment for the viral infection and the related serious complications. It is in urgent need to find a new specific effective treatment for the 2019-nCoV infection. According to Declaration of Helsinki and International Ethical Guidelines for Health-related Research Involving Humans, the desperately ill patients with 2019-nCov infection during disease outbreaks have a moral right to try unvalidated medical interventions (UMIs) and that it is therefore unethical to restrict access to UMIs to the clinical trial context.

There is a vital link between the intestinal tract and respiratory tract, which was exemplified by intestinal complications during respiratory disease and vice versa. Some of these patients can develop secondary bacterial infections and antibiotic-associated diarrhea (AAD). The recent study on using washed microbiota transplantation (WMT) as rescue therapy in critically ill patients with AAD demonstrated the important clinical benefits and safety of WMT. Additionally, the recent animal study provided direct evidence supporting that antibiotics could decrease gut microbiota and the lung stromal interferon signature and facilitate early influenza virus replication in lung epithelia. Importantly, the above antibiotics caused negative effects can be reversed by fecal microbiota transplantation (FMT) which suggested that FMT might be able to induce a significant improvement in the respiratory virus infection. Another evidence is that the microbiota could confer protection against certain virus infection such as influenza virus and respiratory syncytial virus by priming the immune response to viral evasion. The above results suggested that FMT might be a new therapeutic option for the treatment of virus-related pneumonia. The methodology of FMT recently was coined as WMT, which is dependent on the automatic facilities and washing process in a laboratory room. Patients underwent WMT with the decreased rate of adverse events and unchanged clinical efficacy in ulcerative colitis and Crohn’s disease. This clinical trial aims to evaluate the outcome of WMT combining with standard therapy for patients with novel coronavirus pneumonia, especially for those patients with dysbiosis-related conditions.


Responsible Party:	Faming Zhang, Director of Medical Center for Digestive Diseases, The Second Hospital of Nanjing Medical University
Identifier	NCT04251767 History of Changes

Study was withdrawn before participants were enrolled.

Therapy for Pneumonia Patients iInfected by 2019 Novel Coronavirus (NCT04293692)

Study Description

Go to

Brief Summary:

The 2019 novel coronavirus pneumonia outbroken in Wuhan, China, which spread quickly to 26 countries worldwide and presented a serious threat to public health. It is mainly characterized by fever, dry cough, shortness of breath and breathing difficulties. Some patients may develop into rapid and deadly respiratory system injury with overwhelming inflammation in the lung. Currently, there is no effective treatment in clinical practice. The present clinical trial is to explore the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) therapy for novel coronavirus pneumonia patients.

Detailed Description:

Since late December 2019, human pneumonia cases infected by a novel coronavirus (2019-nCoV) were firstly identified in Wuhan, China. As the virus is contagious and of great epidemic, more and more cases have found in other areas of China and abroad. Up to February 24, a total of 77, 779 confirmed cases were reported in China. At present, there is no effective treatment for patients identified with novel coronavirus pneumonia. Therefore, it’s urgent to explore more active therapeutic methods to cure the patients.

Recently, some clinical researches about the 2019 novel coronavirus pneumonia published in The Lancet and The New England Journal of Medicine suggested that massive inflammatory cell infiltration and inflammatory cytokines secretion were found in patients’ lungs, alveolar epithelial cells and capillary endothelial cells were damaged, causing acute lung injury. It seems that the key to cure the pneumonia is to inhibit the inflammatory response, resulting to reduce the damage of alveolar epithelial cells and endothelial cells and repair the function of the lung.

Mesenchymal stem cells (MSCs) are widely used in basic research and clinical application. They are proved to migrate to damaged tissues, exert anti-inflammatory and immunoregulatory functions, promote the regeneration of damaged tissues and inhibit tissue fibrosis. Studies have shown that MSCs can significantly reduce acute lung injury in mice caused by H9N2 and H5N1 viruses by reducing the levels of proinflammatory cytokines and the recruitment of inflammatory cells into the lungs. Compared with MSCs from other sources, human umbilical cord-derived MSCs (UC-MSCs) have been widely applied to various diseases due to their convenient collection, no ethical controversy, low immunogenicity, and rapid proliferation rate. In our recent research, we confirmed that UC-MSCs can significantly reduce inflammatory cell infiltration and inflammatory factors expression in lung tissue, and significantly protect lung tissue from endotoxin (LPS) -induced acute lung injury in mice.

The purpose of this clinical study is to investigate safety and efficiency of UC-MSCs in treating pneumonia patients infected by 2019-nCoV. The investigators planned to recruit 48 patients aged from 18 to 75 years old and had no severe underlying diseases. In the cell treatment group, 24 patients received 0.5*10E6 UC-MSCs /kg body weight intravenously treatment 4 times every other day besides conventional treatment. In the control group, other 24 patients received conventional treatment plus 4 times of placebo intravenously. The lung CT, blood biochemical examination, lymphocyte subsets, inflammatory factors, 28-days mortality, etc will be evaluated within 24h and 1, 2, 4, 8 weeks after UC-MSCs treatment.

Sponsor:

Puren Hospital Affiliated to Wuhan University of Science and Technology

Collaborator:

Wuhan Hamilton Bio-technology Co., Ltd

Study was withdrawn before participants were enrolled.

Prognositc Factors in COVID-19 Patients Complicated With Hypertension (NCT04272710)

Study Description

Brief Summary:

There are currently no clinical studies reporting clinical characteristics difference between the hypertension patients with and without ACEI treatment when suffered with novel coronavirus infection in China

Detailed Description:

At present, the outbreak of the new coronavirus (2019-nCoV) infection in Wuhan and Hubei provinces has attracted great attention from the medical community across the country. Both 2019-nCoV and SARS viruses are coronaviruses, and they have a large homology.

Published laboratory studies have suggested that SARS virus infection and its lung injury are related to angiotensin-converting enzyme 2 (ACE2) in lung tissue. And ACE and ACE2 in the renin-angiotensin system (RAS) are vital central links to maintain hemodynamic stability and normal heart and kidney function in vivo.

A large amount of evidence-based medical evidence shows that ACE inhibitors are the basic therapeutic drugs for maintaining hypertension, reducing the risk of cardiovascular, cerebrovascular, and renal adverse events, improving quality of life, and prolonging life in patients with hypertension. Recent experimental studies suggest that treatment with ACE inhibitors can significantly reduce pulmonary inflammation and cytokine release caused by coronavirus infection.

ACEI treatment

hypertension patients with ACEI treatment when suffered with novel coronavirus infection in China

Control

hypertension patients without ACEI treatment when suffered with novel coronavirus infection in China

Locations


China
The First Affiliated Hospital of Chongqing Medical University Chongqing, China

Sponsors and Collaborators Chongqing Medical University


Responsible PI:	Dongying Zhang, Associate Professor, Chongqing Medical University

Withdrawn (Similar projects have been registered, and it needs to be withdrawn.)

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Use of 3D Bioprinting for Development of Toxicity Prediction Models

Posted in 3D Plotting Scaffolds, 3D Printing for Medical Application, Bio-MEMS, BioBanking, Bioengineering & reverse engineering design, BioInks, Biological Engineering, Biological Networks, BioPrinting in Regenerative Medicine, CANCER BIOLOGY & Innovations in Cancer Therapy, Cell Biology, Cell Level, Disease Biology, Drug Development using MultiOrgan Chip, Drug Development/Formulation using 3D Printing, Drug Toxicity, MEMS, MicroEngineering Cell-Tissue & Systems, Organoids, Pharmaceutical Analytics, Pharmaceutical Discovery, Pharmaceutical Drug Discovery, Pharmacologic toxicities, Tissue Engineering and Regenerative Medicine, Tissue Microenvironment, Translational Research, tagged 3-D printed liver tissue, 3D bioprinting, 3D tissue, Amnion Foundation, bioprinting, Brigham & Women's Hospital, drug induced liver injury, ECM, Harvard Medical School, hepatoxicity, Liver Tissue Engineeering, National Institutes of Health (NIH) ’s Common Fund, organova, Tissue engineering, toxicology on April 27, 2019| Leave a Comment »

Use of 3D Bioprinting for Development of Toxicity Prediction Models

Curator: Stephen J. Williams, PhD

SOT FDA Colloquium on 3D Bioprinted Tissue Models: Tuesday, April 9, 2019

The Society of Toxicology (SOT) and the U.S. Food and Drug Administration (FDA) will hold a workshop on “Alternative Methods for Predictive Safety Testing: 3D Bioprinted Tissue Models” on Tuesday, April 9, at the FDA Center for Food Safety and Applied Nutrition in College Park, Maryland. This workshop is the latest in the series, “SOT FDA Colloquia on Emerging Toxicological Science: Challenges in Food and Ingredient Safety.”

Human 3D bioprinted tissues represent a valuable in vitro approach for chemical, personal care product, cosmetic, and preclinical toxicity/safety testing. Bioprinting of skin, liver, and kidney is already appearing in toxicity testing applications for chemical exposures and disease modeling. The use of 3D bioprinted tissues and organs may provide future alternative approaches for testing that may more closely resemble and simulate intact human tissues to more accurately predict human responses to chemical and drug exposures.

A synopsis of the schedule and related works from the speakers is given below:

8:40 AM–9:20 AM	Overview and Challenges of Bioprinting Sharon Presnell, Amnion Foundation, Winston-Salem, NC
9:20 AM–10:00 AM	Putting 3D Bioprinting to the Use of Tissue Model Fabrication Y. Shrike Zhang, Brigham and Women’s Hospital, Harvard Medical School and Harvard-MIT Division of Health Sciences and Technology, Boston, MA
10:00 AM–10:20 AM	Break
10:20 AM–11:00 AM	Uses of Bioprinted Liver Tissue in Drug Development Jean-Louis Klein, GlaxoSmithKline, Collegeville, PA
11:00 AM–11:40 AM	Biofabrication of 3D Tissue Models for Disease Modeling and Chemical Screening Marc Ferrer, National Center for Advancing Translational Sciences, NIH, Rockville, MD

Sharon Presnell, Ph.D. President, Amnion Foundation

Dr. Sharon Presnell was most recently the Chief Scientific Officer at Organovo, Inc., and the President of their wholly-owned subsidiary, Samsara Sciences. She received a Ph.D. in Cell & Molecular Pathology from the Medical College of Virginia and completed her undergraduate degree in biology at NC State. In addition to her most recent roles, Presnell has served as the director of cell biology R&D at Becton Dickinson’s corporate research center in RTP, and as the SVP of R&D at Tengion. Her roles have always involved the commercial and clinical translation of basic research and early development in the cell biology space. She serves on the board of the Coulter Foundation at the University of Virginia and is a member of the College of Life Sciences Foundation Board at NC State. In January 2019, Dr. Presnell will begin a new role as President of the Amnion Foundation, a non-profit organization in Winston-Salem.

A few of her relevant publications:

Bioprinted liver provides early insight into the role of Kupffer cells in TGF-β1 and methotrexate-induced fibrogenesis

Integrating Kupffer cells into a 3D bioprinted model of human liver recapitulates fibrotic responses of certain toxicants in a time and context dependent manner. This work establishes that the presence of Kupffer cells or macrophages are important mediators in fibrotic responses to certain hepatotoxins and both should be incorporated into bioprinted human liver models for toxicology testing.

Bioprinted 3D Primary Liver Tissues Allow Assessment of Organ-Level Response to Clinical Drug Induced Toxicity In Vitro

Abstract: Modeling clinically relevant tissue responses using cell models poses a significant challenge for drug development, in particular for drug induced liver injury (DILI). This is mainly because existing liver models lack longevity and tissue-level complexity which limits their utility in predictive toxicology. In this study, we established and characterized novel bioprinted human liver tissue mimetics comprised of patient-derived hepatocytes and non-parenchymal cells in a defined architecture. Scaffold-free assembly of different cell types in an in vivo-relevant architecture allowed for histologic analysis that revealed distinct intercellular hepatocyte junctions, CD31+ endothelial networks, and desmin positive, smooth muscle actin negative quiescent stellates. Unlike what was seen in 2D hepatocyte cultures, the tissues maintained levels of ATP, Albumin as well as expression and drug-induced enzyme activity of Cytochrome P450s over 4 weeks in culture. To assess the ability of the 3D liver cultures to model tissue-level DILI, dose responses of Trovafloxacin, a drug whose hepatotoxic potential could not be assessed by standard pre-clinical models, were compared to the structurally related non-toxic drug Levofloxacin. Trovafloxacin induced significant, dose-dependent toxicity at clinically relevant doses (≤ 4uM). Interestingly, Trovafloxacin toxicity was observed without lipopolysaccharide stimulation and in the absence of resident macrophages in contrast to earlier reports. Together, these results demonstrate that 3D bioprinted liver tissues can both effectively model DILI and distinguish between highly related compounds with differential profile. Thus, the combination of patient-derived primary cells with bioprinting technology here for the first time demonstrates superior performance in terms of mimicking human drug response in a known target organ at the tissue level.

A great interview with Dr. Presnell and the 3D Models 2017 Symposium is located here:

Please click here for Web based and PDF version of interview

Some highlights of the interview include

Exciting advances in field showing we can model complex tissue-level disease-state phenotypes that develop in response to chronic long term injury or exposure
Sees the field developing a means to converge both the biology and physiology of tissues, namely modeling the connectivity between tissues such as fluid flow
Future work will need to be dedicated to develop comprehensive analytics for 3D tissue analysis. As she states “we are very conditioned to get information in a simple way from biochemical readouts in two dimension, monocellular systems” however how we address the complexity of various cellular responses in a 3D multicellular environment will be pertinent.
Additional challenges include the scalability of such systems and making such system accessible in a larger way

Shrike Zhang, Brigham and Women’s Hospital, Harvard Medical School and Harvard-MIT Division of Health Sciences and Technology

Dr. Zhang currently holds an Assistant Professor position at Harvard Medical School and is an Associate Bioengineer at Brigham and Women’s Hospital. His research interests include organ-on-a-chip, 3D bioprinting, biomaterials, regenerative engineering, biomedical imaging, biosensing, nanomedicine, and developmental biology. His scientific contributions have been recognized by >40 international, national, and regional awards. He has been invited to deliver >70 lectures worldwide, and has served as reviewer for >400 manuscripts for >30 journals. He is serving as Editor-in-Chief for Microphysiological Systems, and Associate Editor for Bio-Design and Manufacturing. He is also on Editorial Board of Bioprinting, Heliyon, BMC Materials, and Essays in Biochemistry, and on Advisory Panel of Nanotechnology.

Some relevant references from Dr. Zhang

Multi-tissue interactions in an integrated three-tissue organ-on-a-chip platform.

Skardal A, Murphy SV, Devarasetty M, Mead I, Kang HW, Seol YJ, Shrike Zhang Y, Shin SR, Zhao L, Aleman J, Hall AR, Shupe TD, Kleensang A, Dokmeci MR, Jin Lee S, Jackson JD, Yoo JJ, Hartung T, Khademhosseini A, Soker S, Bishop CE, Atala A.

Sci Rep. 2017 Aug 18;7(1):8837. doi: 10.1038/s41598-017-08879-x.

Reconstruction of Large-scale Defects with a Novel Hybrid Scaffold Made from Poly(L-lactic acid)/Nanohydroxyapatite/Alendronate-loaded Chitosan Microsphere: in vitro and in vivo Studies.

Wu H, Lei P, Liu G, Shrike Zhang Y, Yang J, Zhang L, Xie J, Niu W, Liu H, Ruan J, Hu Y, Zhang C.

Sci Rep. 2017 Mar 23;7(1):359. doi: 10.1038/s41598-017-00506-z.

A liver-on-a-chip platform with bioprinted hepatic spheroids.

Bhise NS, Manoharan V, Massa S, Tamayol A, Ghaderi M, Miscuglio M, Lang Q, Shrike Zhang Y, Shin SR, Calzone G, Annabi N, Shupe TD, Bishop CE, Atala A, Dokmeci MR, Khademhosseini A.

Biofabrication. 2016 Jan 12;8(1):014101. doi: 10.1088/1758-5090/8/1/014101.

Marc Ferrer, National Center for Advancing Translational Sciences, NIH

Marc Ferrer is a team leader in the NCATS Chemical Genomics Center, which was part of the National Human Genome Research Institute when Ferrer began working there in 2010. He has extensive experience in drug discovery, both in the pharmaceutical industry and academic research. Before joining NIH, he was director of assay development and screening at Merck Research Laboratories. For 10 years at Merck, Ferrer led the development of assays for high-throughput screening of small molecules and small interfering RNA (siRNA) to support programs for lead and target identification across all disease areas.

At NCATS, Ferrer leads the implementation of probe development programs, discovery of drug combinations and development of innovative assay paradigms for more effective drug discovery. He advises collaborators on strategies for discovering small molecule therapeutics, including assays for screening and lead identification and optimization. Ferrer has experience implementing high-throughput screens for a broad range of disease areas with a wide array of assay technologies. He has led and managed highly productive teams by setting clear research strategies and goals and by establishing effective collaborations between scientists from diverse disciplines within industry, academia and technology providers.

Ferrer has a Ph.D. in biological chemistry from the University of Minnesota, Twin Cities, and completed postdoctoral training at Harvard University’s Department of Molecular and Cellular Biology. He received a B.Sc. degree in organic chemistry from the University of Barcelona in Spain.

Some relevant references for Dr. Ferrer

Fully 3D Bioprinted Skin Equivalent Constructs with Validated Morphology and Barrier Function.

Derr K, Zou J, Luo K, Song MJ, Sittampalam GS, Zhou C, Michael S, Ferrer M, Derr P.

Tissue Eng Part C Methods. 2019 Apr 22. doi: 10.1089/ten.TEC.2018.0318. [Epub ahead of print]

Determination of the Elasticity Modulus of 3D-Printed Octet-Truss Structures for Use in Porous Prosthesis Implants.

Bagheri A, Buj-Corral I, Ferrer M, Pastor MM, Roure F.

Materials (Basel). 2018 Nov 29;11(12). pii: E2420. doi: 10.3390/ma11122420.

Mutation Profiles in Glioblastoma 3D Oncospheres Modulate Drug Efficacy.

Wilson KM, Mathews-Griner LA, Williamson T, Guha R, Chen L, Shinn P, McKnight C, Michael S, Klumpp-Thomas C, Binder ZA, Ferrer M, Gallia GL, Thomas CJ, Riggins GJ.

SLAS Technol. 2019 Feb;24(1):28-40. doi: 10.1177/2472630318803749. Epub 2018 Oct 5.

A high-throughput imaging and nuclear segmentation analysis protocol for cleared 3D culture models.

Boutin ME, Voss TC, Titus SA, Cruz-Gutierrez K, Michael S, Ferrer M.

Sci Rep. 2018 Jul 24;8(1):11135. doi: 10.1038/s41598-018-29169-0.

A High-Throughput Screening Model of the Tumor Microenvironment for Ovarian Cancer Cell Growth.

Lal-Nag M, McGee L, Guha R, Lengyel E, Kenny HA, Ferrer M.

SLAS Discov. 2017 Jun;22(5):494-506. doi: 10.1177/2472555216687082. Epub 2017 Jan 31.

Exploring Drug Dosing Regimens In Vitro Using Real-Time 3D Spheroid Tumor Growth Assays.

Lal-Nag M, McGee L, Titus SA, Brimacombe K, Michael S, Sittampalam G, Ferrer M.

SLAS Discov. 2017 Jun;22(5):537-546. doi: 10.1177/2472555217698818. Epub 2017 Mar 15.

RNAi High-Throughput Screening of Single- and Multi-Cell-Type Tumor Spheroids: A Comprehensive Analysis in Two and Three Dimensions.

Fu J, Fernandez D, Ferrer M, Titus SA, Buehler E, Lal-Nag MA.

SLAS Discov. 2017 Jun;22(5):525-536. doi: 10.1177/2472555217696796. Epub 2017 Mar 9.

NIH SBIR Funding Early Ventures: September 26, 2018 sponsored by Pennovation

Posted in BioTechnology - Venture Creation, BioTechnology - Venture Creation, Venture Capital, CANCER BIOLOGY & Innovations in Cancer Therapy, FDA Regulatory Affairs, Foundations for supporting Science and Education, Global Partnering & Biotech Investment, Intellectual Property, Innovations, Commercialization, Investment in technological breakthrough, Uncategorized, Venture Capital, tagged biotech startup, Biotechnology, early ventures, national cancer institute, National Institutes of Health (NIH) ’s Common Fund, NCI, SBIR, startup on September 27, 2018| Leave a Comment »

NIH SBIR Funding Early Ventures: September 26, 2018 sponsored by Pennovation

Stephen J. Williams PhD, Reporter

Penn Center for Innovation (Pennovation) sponsored a “Meet with NCI SBIR” program directors at University of Pennsylvania Medicine Smilow Center for Translational Research with a presentation on advice on preparing a successful SBIR/STTR application to the NCI as well as discussion of NCI SBIR current funding opportunities. Time was allotted in the afternoon for one-on-one discussions with NCI SBIR program directors.

To find similar presentations and one-on-one discussions with NCI/SBIR program directors in an area nearest to you please go to their page at:

https://sbir.cancer.gov/newsevents/events

For more complete information on the NCI SBIR and STTR programs please go to their web page at: https://sbir.cancer.gov/about

A few notes from the meeting are given below:

In 2016 the SBIR/STTR 2016 funded $2.5 billion (US) of early stage companies; this is compared to the $6.6 billion invested in early stage ventures by venture capital firms so the NCI program is very competitive with alternate sources of funding
It was stressed that the SBIR programs are flexible as far as ownership of a company; SBIR allows now that >50% of the sponsoring company can be owned by other ventures; In addition they are looking more favorably on using outside contractors and giving leeway on budgetary constraints so AS THEY SUGGEST ALWAYS talk to the program director about any questions you may have well before (at least 1 month) you submit. More on eligibility criteria is found at: https://sbir.cancer.gov/about/eligibilitycriteria
STTR should have strong preliminary data since more competitive; if don’t have enough go for an R21 emerging technologies grant which usually does not require preliminary data
For entities outside the US need a STRONG reason for needing to do work outside the US

Budget levels were discussed as well as the waiver program, which allows for additional funds to be requested based on criteria set by NCI (usually for work that is deemed high priority or of a specialized nature which could not be covered sufficiently under the standard funding limits) as below:

Phase I: 150K standard but you can get waivers for certain work up to 300K

Phase II: 1M with waiver up to 2M

Phase IIB waiver up to 4M

You don’t need to apply for the waiver but grant offices may suggest citing a statement requesting a waiver as review panels will ask for this information

Fast Track was not discussed in the presentation but for more information of the Fast Track program please visit the website

NCI is working hard to cut review times to 7 months between initial review to funding however at beginning of the year they set pay lines and hope to fund 50% of the well scored grants

NCI SBIR is a Centralized system with center director and then program director with specific areas of expertise: Reach out to them

IMAT Program and Low-Resource Setting new programs more suitable for initial studies and also can have non US entities

Phase IIB Bridge funding to cross “valley of death” providing up to 4M for 2-3 years: most were for drug/biological but good amount for device and diagnostics

Also they have announced administrative supplements for promoting diversity within a project: can add to the budget

FY18 Contracts Areas

3 on biotherapies

2 imaging related

2 on health IT

4 on radiation therapy related: NOTE They spent alot of time discussing the contracts centered on radiation therapy and seems to be an area of emphasis of the NCI SBIR program this year

4 other varied topics

Breakdown of funding

>70% of NCI SBIR budget went to grants (for instance Omnibus grants); about 20-30% for contracts; 16% for phase I and 34 % for phase II ;

ALSO the success rate considerably higher for companies that talk to the program director BEFORE applying than not talking to them; also contracts more successful than Omnibus applications

Take Advantage of these useful Assistance Programs through the NIH SBIR Program (Available to all SBIR grantees)

NICHE ASSESSMENT Program

From the NCI SBIR website:

The Niche Assessment Program is designed to help small businesses “jump start” their commercialization efforts. All active HHS (NIH, CDC, FDA) SBIR/STTR Phase I awardees and Phase I Fast-Track awardees (by grant or contract) are eligible to apply. Registration is on a first-come, first-serve basis!

The Niche Assessment Program provides market insight and data that can be used to help small businesses strategically position their technology in the marketplace. The results of this program can help small businesses develop their commercialization plans for their Phase II application, and be exposed to potential partners. Services are provided by Foresight Science & Technology of Providence, RI.

Technology Niche Analyses® (TNA®) are provided by Foresight, for one hundred and seventy-five (175), HHS SBIR/STTR Phase I awardees. These analyses assess potential applications for a technology and then for one viable application, it provides an assessment of the:

Needs and concerns of end-users;
Competing technologies and competing products;
Competitive advantage of the SBIR/STTR-developed technology;
Market size and potential market share (may include national and/or global markets);
Barriers to market entry (may include but is not limited to pricing, competition, government regulations, manufacturing challenges, capital requirements, etc.);
Market drivers;
Status of market and industry trends;
Potential customers, licensees, investors, or other commercialization partners; and,
The price customers are likely to pay.

Commercialization Acceleration Program (CAP)

From the NIH SBIR website:

NIH CAP is a 9-month program that is well-regarded for its combination of deep domain expertise and access to industry connections, which have resulted in measurable gains and accomplishments by participating companies. Offered since 2004 to address the commercialization objectives of companies across the spectrum of experience and stage, 1000+ companies have participated in the CAP. It is open only to HHS/NIH SBIR/STTR Phase II awardees, and 80 slots are available each year. The program enables participants to establish market and customer relevance, build commercial relationships, and focus on revenue opportunities available to them.

I-Corps Program

The I-Corps program provides funding, mentoring, and networking opportunities to help commercialize your promising biomedical technology. During this 8-week, hands-on program, you’ll learn how to focus your business plan and get the tools to bring your treatment to the patients who need it most.

Program benefits include:

Funding up to $50,000 to cover direct program costs
Training from biotech sector experts
Expanding your professional network
Building the confidence and skills to create a comprehensive business model
Gaining years of entrepreneurial skills in only weeks.

ICORPS is an Entrepreneurial Program (8 week course) to go out talk to customers, get assistance with business models, useful resource which can guide the new company where they should focus on for the commercialization aspect

THE NCI Applicant Assistance Program (AAP)

The SBIR/STTR Applicant Assistance Program (AAP) is aimed at helping eligible small R&D businesses and individuals successfully apply for Phase I SBIR/STTR funding from the National Cancer Institute (NCI), National Institute for Neurological Disorders and Stroke (NINDS), National Heart, Lung and Blood Institute (NHLBI). Participation in the AAP will be funded by the NCI, NINDS, and NHLBI with NO COST TO PARTICIPANTS. The program will include the following services:

Needs Assessment/Small Business Mentoring
Phase I Application Preparation Support
Application Review
Team/Facilities Development
Market Research
Intellectual Property Consultation

For more details about the program, please refer to NIH Notice NOT-CA-18-072.

These programs are free for first time grant applicants and must not have been awarded previous SBIR

Peer Learning Webinar Series goal to improve peer learning .Also they are starting to provide Regulatory Assistance (see below)

NIH also provides Mentoring programs for CEOS and C level

Application tips

Start early: and obtain letters of collaboration
Build a great team: PI multi PI, consider other partners to fill gaps (academic, consultants, seasoned entrepreneurs (don’t need to be paid)
They will pre review 1 month before due date, use NIH Project Reporter to view previous funded grants
Specify study section in SF to specify areas of expertise for review
Specific aims are very important; some of the 20 reviewers focus on this page (describes goals and milestones as well; spend as much time on this page as the rest of the application
Letters of support from KOLs are important to have; necessary from consultants and collaborators; helpful from clinicians
Have a phase II commercialization plan
Note for non US clinical trials: They will not fund nonUS clinical trials; the company must have a FWA
SBIR budgets defined by direct costs; can request a 7% fee as an indirect cost; and they have a 5,000 $ technical assistance program like regulatory consultants but if requested can’t participate in NIH technical assistance programs so most people don’t apply for TAP

They are trying to change the definition of innovation as also using innovative methods (previously reviewers liked tried and true methodology)

10. before you submit solicit independent readers

NCI SBIR can be found on Twitter @NCIsbir ‏

Discussion with Monique Pond, Ph.D. on Establishment of a Regulatory Assistance Program for NCI SBIR

I was able to sit down with Dr. Monique Pond, AAAS Science & Technology Policy Fellow, Health Scientist within the NCI SBIR Development Center to discuss the new assistance program in regulatory affairs she is developing for the NCI SBIR program. Dr Pond had received her PhD in chemistry from the Pennsylvania State University, completed a postdoctoral fellow at NIST and then spent many years as a regulatory writer and consultant in the private sector. She applied through the AAAS for this fellowship and will bring her experience and expertise in regulatory affairs from the private sector to the SBIR program. Dr. Pond discussed the difficulties that new ventures have in formulating regulatory procedures for their companies, the difficulties in getting face time with FDA regulators and helping young companies start thinking about regulatory issues such as pharmacovigilence, oversight, compliance, and navigating the complex regulatory landscape.

In addition Dr. Pond discussed the AAAS fellowship program and alternative career paths for PhD scientists.

A formal interview will follow on this same post.

Funding Oncorus’s Immunotherapy Platform: Next-generation Oncolytic Herpes Simplex Virus (oHSV) for Brain Cancer, Glioblastoma Multiforme (GBM)

Funding Opportunities for Cancer Research

Team Profile: DrugDiscovery @LPBI Group – A BioTech Start Up submitted for Funding Competition to MassChallenge Boston 2016 Accelerator

A Message from Faculty Director Lee Fleming on Latest Issue of Crowdfunding; From the Fung Institute at Berkeley

PROTOCOL for Drug Screening of 3rd Party Intellectual Property Presented for Funding Representation

Foundations as a Funding Source

The Bioscience Crowdfunding Environment: The Bigger Better VC?

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NIH Common Fund announces 2016 High-Risk, High-Reward Research awards – NIH to fund 88 awards on high-impact biomedical research

Posted in NIH Common Fund, tagged High-Risk/High-Reward Research (HRHR) program, National Institutes of Health (NIH) ’s Common Fund on October 4, 2016| Leave a Comment »

NIH Common Fund announces 2016 High-Risk, High-Reward Research awards – NIH to fund 88 awards on high-impact biomedical research.

Reporter: Aviva Lev-Ari, PhD, RN

The High-Risk, High-Reward Research (HRHR) program, supported by the National Institutes of Health (NIH) ’s Common Fund, awarded 88 grants to highly creative and exceptional scientists with bold approaches to major challenges in biomedical research. The awards span the broad mission of the NIH and include groundbreaking research, such as engineering immune cells producing drugs at the site of diseased tissue; developing a sensor to rapidly detect antibiotic resistance of a bacterial infection; understanding how certain parasites evade host detection by continually changing their surface proteins; and developing implants that run off the electricity generated from the motion of a beating the heart.

“The program continues to support high-caliber investigators whose ideas stretch the boundaries of our scientific knowledge.”

—Francis S. Collins, M.D., Ph.D, Director, NIH

“The program continues to support high-caliber investigators whose ideas stretch the boundaries of our scientific knowledge,” said NIH Director Francis S. Collins, M.D., Ph.D. “We welcome the newest cohort of outstanding scientists to the program and look forward to their valuable contributions.”

NIH traditionally supports research projects, not individual investigators. However, the HRHR program seeks to identify scientists with ideas that have the potential for high impact, but may be at a stage too early to fare well in the traditional peer review process. These awards encourage creative, outside-the-box thinkers to pursue exciting and innovative ideas in biomedical research.

The NIH Common Fund supports a series of exceptionally high-impact programs that cross NIH Institutes and Centers. Common Fund programs pursue major opportunities and gaps in biomedical research that require trans-NIH collaboration to succeed. The High-Risk, High-Reward Research program, part of the NIH Common Fund, manages the following four awards:

The Pioneer Award, established in 2004, challenges investigators at all career levels to pursue new research directions and develop groundbreaking, high-impact approaches to a broad area of biomedical or behavioral science.
The New Innovator Award, established in 2007, supports unusually innovative research from early career investigators who are within 10 years of their final degree or clinical residency and have not yet received a research project grant or equivalent NIH grant.
The Transformative Research Award, established in 2009, promotes cross-cutting, interdisciplinary approaches and is open to individuals and teams of investigators who propose research that could potentially create or challenge existing paradigms.
The & Early Independence Award, established in 2010, provides an opportunity for exceptional junior scientists who have recently received their doctoral degree or completed their medical residency to skip traditional post-doctoral training and move immediately into independent research positions.

In 2016, the NIH issued 12 Pioneer awards, 48 New Innovator awards, 12 Transformative Research awards, and 16 Early Independence awards. The awards total approximately $127 million and represents contributions from the NIH Common Fund; the National Cancer Institute; National Heart, Lung, and Blood Institute; National Institute of Environmental Health Sciences; National Institute of General Medical Sciences; National Institute of Mental Health; and the Big Data to Knowledge initiative.

The NIH Common Fund encourages collaboration and supports a series of exceptionally high-impact, trans-NIH programs. Common Fund programs are designed to pursue major opportunities and gaps in biomedical research that no single NIH Institute could tackle alone, but that the agency as a whole can address to make the biggest impact possible on the progress of medical research. Additional information about the NIH Common Fund can be found at http://commonfund.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

SOURCE

https://www.nih.gov/news-events/news-releases/nih-common-fund-announces-2016-high-risk-high-reward-research-awards

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