PROPOSAL Early Phase Clinical Trials 2015

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "PROPOSAL Early Phase Clinical Trials 2015"

Transcription

1 PROPOSAL Early Phase Clinical Trials 2015 DEADLINE: Tuesday, January 12 th, 2016, 2:00 p.m. EST Award announcements will be made in February This Proposal is an example only. Do not complete this paper application. Please submit the Proposal online through the Institute s grant management system at Application Number: Project Title: Applicant Details Team Members Organizations Primary Contact Information 1. Salutation: Primary Address: Organization: Role in Project Principal Applicant Estimated Time Spent on Project % First Name: Position Title: Phone: Co-Applicant Last Name: Other Affiliations/ Position Titles: Collaborator 2. Salutation: Primary Organization: Address: Principal Applicant % First Name: Position Title: Phone: Co-Applicant Last Name: Other Affiliations/ Position Titles: Collaborator Note: Projects are not limited to two team members as laid out on this sample application form; projects may include as many team members as needed for the successful execution of the project. A Curriculum vita (NIH biosketch or equivalent) of five pages or less is required for each team member. Application Number: 1 of 17

2 Application Overview Keywords to describe the proposed work: What type of therapeutic(s) is/are being developed as the main goal of the project? (please select all that apply) Biologic Cell therapy Electrical brain stimulation Magnetic brain stimulation Medical device Small molecule Surgical intervention Active immunotherapy Passive immunotherapy Other Please specify: What clinical trial phase(s) of development does the project cover? Please explain your choice in 1-2 sentences. (please select all that apply) Phase I Phase IIa Other Please specify: Explanation: Research will have a significant impact in which neurodegenerative disease(s) of aging? (Please select all that apply. There is no benefit to selecting more diseases than fewer diseases.) Alzheimer s disease Amyotrophic lateral sclerosis Dementia with Lewy bodies Frontotemporal dementia Multiple system atrophy Parkinson s disease Progressive supranuclear palsy Mild cognitive impairment as prodromal to one of the other listed diseases Have you applied to other funding agencies with the same proposed work? (This information will not be used to assess the application) Yes Please specify: No Application Number: 2 of 17

3 Is this your first time applying for a neuroscience grant from the Institute? (This information will not be used to assess the application) Yes No Is this your first application for a research grant specifically in the area of neurodegenerative diseases of aging? (This information will not be used to assess the application) Yes No Other funding support: What percent of the proposed work is being funded by other grants (0-100%)? Location of work: what proportion of the proposed work is being carried out outside of Canada? If any, please explain how this will bring unique resources into Canadian-led work. Application Number: 3 of 17

4 Project Information 1. Abstract: Please summarize your proposed early phase clinical trial. (maximum 250 words) 2. Goals and specific aims: (maximum 500 words) 3. Experimental approach 3.1. Experimental design: Please include details of the trial design and methods, such as: a) the length of the trial (including regulatory and REB milestones); b) rationale for all primary and secondary outcome measures/endpoints c) rationale for the use of certain tools, techniques, or protocols (e.g. PET imaging, biomarker analysis, cognitive tests); d) the target population, and the inclusion/exclusion criteria, e) justification for the proposed dosage, formulation, frequency and route of administration. If there is no sufficient evidence for a particular dose, please explain how the current study will determine the optimal dosage. (maximum 2700 words) 3.2 Description of the power analysis: Please include detailed power calculations that provide justification for the number of subjects in each condition (ie. adequacy of the sample size for statistical analysis of the proposed study). Calculations should also include details on effect size, simulation software, the source of parameter estimates and the primary analytic technique (e.g., t-test used or a mixed model repeated measures analysis?). (maximum 250 words) 3.3 Rationale for testing in humans: Please provide the rationale for testing this therapeutic or intervention in humans including: a) preclinical efficacy, PK/PD, and results from IND-enabling studies (if available); b) any known mechanisms of action; c) toxicity, adverse events, safety concerns, and contraindications; d) If this trial proposes a repurposing/repositioning of the therapeutic or intervention, please provide the relevant results from other indications. (maximum 1500 words) Note: PK/PD data can be uploaded as a PDF to a maximum of 1 page under the Supplementary Materials section Plan for acquiring the study therapeutic: Please describe the plan for obtaining the therapeutic (small molecule, biologic, device, equipment and control, as applicable) including any cross-border or intellectual property considerations. (maximum 250 words) Application Number: 4 of 17

5 3.5 Recruitment plan: Please describe the plan for recruiting subjects. a) sources of patients, b) approach to attracting and retaining subjects, c) justification for the number of clinical sites used, d) justification for any assumptions made to estimate the rate of recruitment, e) expected drop-out rate, f) contingency plans and a list of anticipated challenges. (maximum 500 words) 3.6. DSMB: Please provide information on the composition, roles, schedule of meetings, and reporting activities of the DSMB. The DSMB should be composed of at least 3 and no more than 7 members (typically an odd number for voting purposes) who are independent of running the trial, and are free of conflicts of interest with the co-applicants. (maximum 250 words) 4. Limitations of the proposal: What do you consider to be the limitations of this proposal (this refers to the proposal overall and is not limited to the experimental approach)? (maximum 250 words) 5. Development plan: What is your administrative and experimental plan for advancing this line of inquiry (e.g. if current trial is successful, how will larger trials be funded, in which countries can commercialization of the drug be pursued)? (maximum 250 words) 6. Team and environment: please describe the roles of the principal applicant and co-applicants regarding governance, biostatistical analysis, data management, study sponsoring, administrative oversight, data safety monitoring and advisory committee, as applicable. How are the investigator(s), environment and collaborations (if applicable) particularly suited to achieve the aims of the proposed work? Does any team member have previous experience with clinical trials of similar complexity? (maximum 250 words) List of publications cited in the application and other publications directly relevant to the proposed work: Please include full citations and PMID. Application Number: 5 of 17

6 Small Molecule Profile Applications proposing a small molecule as a potential must complete this section for the proposed small molecule. Please fill in all known information pertaining to the indication and dosing that you are pursuing, except where noted. Small Molecule Profile Acronym Legend: BID IND IV MTD QD two times per day investigational new drug intravenous maximum tolerated dosage four times per day PD PK SC TID pharmacodynamics pharmacokinetics subcutaneous three times per day What stage(s) of development have been completed for the small molecule? (please select all that apply) Animal Model: Efficacy studies PK/PD Toxicity studies Safety studies Humans: Clinical Phase I Clinical Phase IIa Clinical Phase IIb Clinical Phase III Other Model Please specify which models: Efficacy studies PK/PD Toxicity studies Safety studies Drug-target relationship Selectivity Untested/unknown Non-selective; hits many targets Non-selective; hits within a general class of targets Selective for targets family/isoforms Selective for target In vitro potency Untested/unknown Micromolar Please specify: Nanomolar Please specify: Cellular potency Untested/unknown Micromolar Please specify: Nanomolar Please specify: Application Number: 6 of 17

7 Efficacy in preclinical models Is there a PK/PD relationship? Not done yet Yes No What is the BBB bioavailability of the small molecule? Has efficacy been tested in models? Not tested Tested Please specify which models: What is the BBB penetrability in the target region (as a % of serum exposure)? Clinical experience with the small molecule (please select all that apply) Pharmacodynamic outcome Unknown/untested Not possible to determine Suggested by the PK Tested Phase I: Have you tested dose ranges? Not tested Currently being tested Completed Please specify dose ranges: Phase I: Safety and tolerability MTD identified Please describe: MTD not yet identified - further studies Please describe: MTD not identified - no further study needed Please describe: Phase II: Dosing Untested/unknown IV dosing for efficacy studies SC dosing for efficacy studies BID/TID oral dosing for efficacy studies QD oral dosing for efficacy studies Phase II: Safety and tolerability Untested/unknown Dose limiting safety/tolerability identified Safety/tolerability of significant concern Safety/tolerability of minor concern Phase II: Efficacy Untested/unknown Not established Supports advancement to Phase III Please describe the relevant details of any other clinical trials done on the small molecule at other doses or for other indications, including where applicable the stage, indication, dosing regimen, route of administration, contraindications and brief results (including whether and where the small molecule has been given marketing approval by a regulatory body such as the FDA). Application Number: 7 of 17

8 Therapeutic Profile If you are not proposing a small molecule, do not fill out the Small Molecule Profile. Instead, provide any similar information needed to supplement the Project Information below. Application Number: 8 of 17

9 Budget Year 1 (please use this same form to complete the budgets for Years 2 to 4, if applicable) Personnel Costs Name Role in Project Estimated Time Spent on Project 1. % 2. % Laboratory Supplies Base Salary Salary Requested Benefits Requested Subtotal Description Unit Cost Number of Units Animal Costs Subtotal Description Unit Cost Number of Units Patient Care Costs Subtotal Description Unit Cost Number of Units Other Costs Subtotal Description Unit Cost Number of Units Subtotal Total Requested Budget Total Total Total Total Total Budget Justification: How do the budget items appropriately support the work proposed? Please note that: - Funds will be granted only for direct costs that are appropriate and justifiable for the work Application Number: 9 of 17

10 proposed. - Each item and its cost must be clearly described in the budget. - Funds cannot be used for equipment purchases, computer purchases, travel expenses to scientific conferences/meetings, administrative costs or indirect costs, unless prior written approval from the Institute has been obtained. - The grant amount may not be for the full amount requested. - Up to 35% of the funds can be used to bring unique international resources into Canadian-led work. Application Number: 10 of 17

11 Milestone Instructions Information Required Start-Up Funding Amount requested Payment Date Descriptions/Explanations If justified, a small amount of funding may be released to support initial milestones that must occur before work starts, such as hiring staff or obtaining research ethics board approvals. Milestones in this category must be completed before payment for the 1 st tranche of funding can be released and the project can begin. Date requested to receive payment relating to Start-Up Funding milestones. Format: e.g., February 17, 2015 Project Start and End date Format: e.g., April 17, 2015 Excludes Start-Up Funding Tranches Amount requested for each tranche Indicate the amount of grant funds required to complete listed milestones within each tranche. Funding requested between tranches should match the budget requested. Start and End Date for each tranche Milestones List milestones that will be completed within each tranche Indicate relevant aims for each milestone within each tranche under Project Aim Provide quantifiable milestones in each tranche If work is ongoing or covers multiple tranches (e.g., recruiting patients), please provide interim milestones for The Start Date is the date by which funding is expected to be released. Previous milestones (including Start-Up Funding milestones, if any) must be completed before the next tranche payment is released. Format: e.g., April 17, 2015 Milestones should be tailored to the project and work proposed, and designed so that whether or not they have been met can be clearly determined. See milestone template example on the next page. Examples: Recruitment of 20 patients; generation of animal colony of 50 mice; perform power analysis; hire 1 post-doctoral student to perform mouse behavioural testing Example: Recruiting 30 patients across 1 year for CSF collection can be divided into milestones as follows: Application Number: 11 of 17

12 each tranche. Include running totals. 1 st tranche CSF collected from 20 patients (running total: 20/30) 2 nd tranche CSF collected from 10 patients (running total: 30/30) Example: Start-Up Funding (optional) Description 1. Research ethics board approvals Amount: 5,000 Payment Date: June 01, st Tranche of Funding Amount: 50,000 October 01, 2015 March 31, 2016 Project List of milestones to be completed with the 1 st Tranche of funding Aim 1 Generation of 3xTg AD mice, N=50 (running total=50/100) 1 Generation of Control mice, N=50 (running total=50/100) 2 Complete setup of behavioural suite for object recognition test 2 nd Tranche of Funding Amount: 50,000 April 01, 2016 October 31, 2016 Project List of milestones to be completed with the 2 nd Tranche of funding Aim 1 Generation of an additional 3xTg AD mice, N=50 (running total=100/100) 1 Generation of an additional Control mice, N=50 (running total=100/100) 2 Perform object recognition test on 3xTg AD mice, N=25 (running total=25/100) 2 Perform object recognition test on 3xTg AD mice, N=25 (running total=25/100) 3 Measure tau phosphorylation levels from 3xTg AD mice brain soluble fractions following behavioural testing, N=25 (running total=25/100) 3 Measure tau phosphorylation levels from Control mice brain soluble fractions following behavioural testing, N=25 (running total=25/100) Application Number: 12 of 17

13 Milestones Please list key milestones for your project. Milestones will be used to help follow the progress of the proposed project. Funds will be disbursed in tranches, linked to the completion of these milestones. Funds should be disbursed in approximately 2 tranches per year (e.g., a total of 3 tranches for a 1.5 year grant); however, alternatives can be proposed (please describe why under Notes). Start-Up Funding (optional) Amount: Payment Date: Description Project Month, Day, Year Project Month, Day, Year 1 st Tranche of Funding Amount: Project Aim List of milestones to be completed with the 1 st Tranche of Funding 2 nd Tranche of Funding Amount: Project Aim List of milestones to be completed with the 2 nd Tranche of Funding 3 rd Tranche of Funding Amount: Project Aim List of milestones to be completed with the 3 rd Tranche of Funding 4 th Tranche of Funding Amount: Application Number: 13 of 17

14 Project Aim List of milestones to be completed with the 4 th Tranche of Funding 5 th Tranche of Funding Amount: Project Aim List of milestones to be completed with the 5 th Tranche of Funding 6 th Tranche of Funding Amount: Project Aim List of milestones to be completed with the 6 th Tranche of Funding 7 th Tranche of Funding Amount: Project Aim List of milestones to be completed with the 7 th Tranche of Funding 8 th Tranche of Funding Amount: Project Aim List of milestones to be completed with the 8 th Tranche of Funding (Include additional tranches of funding if needed, i.e., 9th Tranche of Funding, etc.) Additional milestone related information (if needed): Application Number: 14 of 17

15 Supplementary Materials (optional) You may submit supplementary materials to a maximum of 20 pages. The content included under Supplementary materials should be directly relevant to the proposed work or cited in the Proposal. Any materials beyond 20 pages, and/or that are not relevant will not be reviewed. Supplementary materials should not contain additional text for the application. Supplementary materials may include: Photographs, figures, tables cited in the Proposal Preliminary data Up to 1 manuscript relevant to the project Any patents (pending or granted) related to the project Application Number: 15 of 17

16 Principal Applicant/Institutional Signatures Please ensure the necessary parties sign this page. Per signatures cannot be accepted. Signatures can be submitted on separate pages. This Proposal may be executed by the parties in counterparts and may be delivered in electronic format, with all counterparts and electronic transmissions being as effective as a manually executed copy and together will constitute one and the same Proposal. I declare that to the best of my knowledge the statements and other information contained in this application are truthful, complete, and accurate. I further understand that an incomplete application will not be reviewed. Signature Print Name Date Official institutional signature of Principal Applicant s institution: Signature Print Name Date Application Number: 16 of 17

17 Co-Applicant/Collaborator Signatures Please have all co-applicants and collaborators sign this page. Per signatures cannot be accepted. Signatures can be submitted on separate pages. This Proposal may be executed by the parties in counterparts and may be delivered in electronic format, with all counterparts and electronic transmissions being as effective as a manually executed copy and together will constitute one and the same Proposal. I am aware that I am a collaborator on this grant and I declare that to the best of my knowledge the information contained in this application are truthful, complete, and accurate. Co-Applicant/Collaborator: Signature Print Name Date Co-Applicant/Collaborator: Signature Print Name Date Co-Applicant/Collaborator: Signature Print Name Date Co-Applicant/Collaborator: Signature Print Name Date Co-Applicant/Collaborator: Signature Print Name Date Application Number: 17 of 17

Fast Forward Proposal Template - January 2016

Fast Forward Proposal Template - January 2016 Fast Forward Proposal Template - January 2016 NOTE: A new grants management system called MS Grants has been implemented for preparation and submission of research proposals to the Society. MS Grants can

More information

Research Study Protocol Template

Research Study Protocol Template Research Study Protocol Template (For clinical trials) Instructions This protocol template is a tool to facilitate the development of a research study protocol specifically designed for the investigator

More information

ALS Canada-Brain Canada Discovery Grants

ALS Canada-Brain Canada Discovery Grants ALS Canada-Brain Canada Discovery Grants Terms of Reference I) OVERVIEW The Discovery Grants program has been established to encourage new basic research focused on identifying causes of, or treatments

More information

University of Hawai i Human Studies Program. Guidelines for Developing a Clinical Research Protocol

University of Hawai i Human Studies Program. Guidelines for Developing a Clinical Research Protocol University of Hawai i Human Studies Program Guidelines for Developing a Clinical Research Protocol Following are guidelines for writing a clinical research protocol for submission to the University of

More information

Challenges in the Regulation of Pediatric Clinical Trials

Challenges in the Regulation of Pediatric Clinical Trials Challenges in the Regulation of Pediatric Clinical Trials Wilson W. Bryan, M.D. FDA / CBER / OCTGT wilson.bryan@fda.hhs.gov National Institutes of Health Recombinant DNA Advisory Committee (RAC) Meeting

More information

Ethics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong. Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015

Ethics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong. Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015 Ethics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015 Clinical Trials at HKU Phase 1 Phase II Phase III Phase IV Conducted on patient

More information

Pharmacology skills for drug discovery. Why is pharmacology important?

Pharmacology skills for drug discovery. Why is pharmacology important? skills for drug discovery Why is pharmacology important?, the science underlying the interaction between chemicals and living systems, emerged as a distinct discipline allied to medicine in the mid-19th

More information

The Promise and Challenge of Adaptive Design in Oncology Trials

The Promise and Challenge of Adaptive Design in Oncology Trials THE POWER OFx Experts. Experience. Execution. The Promise and Challenge of Adaptive Design in Oncology Trials Clinical oncology trials are more complex and time consuming than those in any other therapeutic

More information

Newsletter. WntResearch AB, Medeon Science Park, Per Albin Hanssons väg 41, 205 12 Malmö, Sweden. Primary Objective:

Newsletter. WntResearch AB, Medeon Science Park, Per Albin Hanssons väg 41, 205 12 Malmö, Sweden. Primary Objective: Newsletter This resume of the results from the phase 1 study with Foxy-5 is based on clinical and laboratory data from the study, and these data have now been locked into the database. The full report

More information

4.1 Objectives of Clinical Trial Assessment

4.1 Objectives of Clinical Trial Assessment L1 4.1 Objectives of Clinical Trial Assessment Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD, Manager, Clinical Group I Office of Clinical

More information

Overview of Phase 1 Oncology Trials of Biologic Therapeutics

Overview of Phase 1 Oncology Trials of Biologic Therapeutics Overview of Phase 1 Oncology Trials of Biologic Therapeutics Susan Jerian, MD ONCORD, Inc. February 28, 2008 February 28, 2008 Phase 1 1 Assumptions and Ground Rules The goal is regulatory approval of

More information

CTC Technology Readiness Levels

CTC Technology Readiness Levels CTC Technology Readiness Levels Readiness: Software Development (Adapted from CECOM s Software Technology Readiness Levels) Level 1: Basic principles observed and reported. Lowest level of software readiness.

More information

Guidance for Industry

Guidance for Industry Guidance for Industry End-of-Phase 2A Meetings U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) September 2009 Procedural Guidance

More information

Brief Communications. Awad Mohamed Ahmed, MD. Abstract

Brief Communications. Awad Mohamed Ahmed, MD. Abstract Awad Mohamed Ahmed, MD Professor of Medicine, University of Bahr Elghazal, Khartoum, Sudan For correspondence Professor Awad Mohamed Ahmed E-mail: awad.sd@gmail.com Tel.: +249 912344936 Abstract Randomized

More information

Proof-of-Concept Studies and the End of Phase IIa Meeting with the FDA

Proof-of-Concept Studies and the End of Phase IIa Meeting with the FDA Medpace Discovery Series presents Proof-of-Concept Studies and the End of Phase IIa Meeting with the FDA DR. JIM WEI: Today my topic is going to be Proof-of-Concept Studies and FDA End of Phase 2a Meetings

More information

Free to Breathe 2015 Research Grant To Prevent or Stop Lung Cancer Metastasis. Request for Proposals

Free to Breathe 2015 Research Grant To Prevent or Stop Lung Cancer Metastasis. Request for Proposals Free to Breathe 2015 Research Grant To Prevent or Stop Lung Cancer Metastasis Request for Proposals Award Overview Free to Breathe has a new funding opportunity solely focused on research to prevent or

More information

2016 Call for Projects on ALS Research

2016 Call for Projects on ALS Research 2016 Call for Projects on ALS Research 2016 AriSLA Call for Research Projects: PROMOTING RESEARCH EXCELLENCE IN THE FIGHT AGAINST ALS Deadline: at 1.00 pm, March 17 th 2016 1. Aims of the 2016 AriSLA Call

More information

From The Lab To Your Medicine Cabinet:

From The Lab To Your Medicine Cabinet: From The Lab To Your Medicine Cabinet: A Pharmaceutical Drug s Journey Presented by: Dr. Steven Hansel Sr. Director; Pfizer Moderated by: Sam Gilchrist Ph.D. Candidate; UBC The Drug Development Process

More information

The Clinical Trial Protocol Guide. BioStrategics Consulting Ltd.

The Clinical Trial Protocol Guide. BioStrategics Consulting Ltd. The Clinical Trial Protocol Guide 2011 BioStrategics Consulting Ltd. BioStrategics Consulting Ltd THE CLINICAL TRIAL PROTOCOL The clinical trial protocol to test one s product, to confirm or reject a specific

More information

CROHN S & COLITIS FOUNDATION OF AMERICA. Senior Research Award INSTRUCTIONS. Effective September 2013

CROHN S & COLITIS FOUNDATION OF AMERICA. Senior Research Award INSTRUCTIONS. Effective September 2013 CROHN S & COLITIS FOUNDATION OF AMERICA Senior Research Award INSTRUCTIONS Effective September 2013 Crohn s & Colitis Foundation of America National Office Research & Scientific Programs Department 733

More information

Not All Clinical Trials Are Created Equal Understanding the Different Phases

Not All Clinical Trials Are Created Equal Understanding the Different Phases Not All Clinical Trials Are Created Equal Understanding the Different Phases This chapter will help you understand the differences between the various clinical trial phases and how these differences impact

More information

Guidance for Industry

Guidance for Industry Guidance for Industry IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer U.S. Department of Health and Human Services Food and Drug Administration Center

More information

Vertex Investigator-Initiated Studies Program Overview

Vertex Investigator-Initiated Studies Program Overview Vertex Investigator-Initiated Studies Program Overview Our Goal To support independent, investigator-initiated research designed to advance scientific knowledge of disease states, patient populations,

More information

Template for essential information to be provided for proposals including clinical trials / studies / investigations

Template for essential information to be provided for proposals including clinical trials / studies / investigations Template for essential information to be provided for proposals including clinical trials / studies / investigations Document history Version 2016callsV1 September 2015 Modifications (compared to previous

More information

Cancer Clinical Trials. Canadian Dream Team Supplementary Funding

Cancer Clinical Trials. Canadian Dream Team Supplementary Funding SU2C Canada-OICR Cancer Clinical Trials Canadian Dream Team Supplementary Funding Call for Ideas and Full Application Guidelines 9861 Leslie St Richmond Hill, ON L4B 3Y4 416-797-5366; 905-883-6800 (FAX)

More information

REQUEST FOR APPLICATIONS

REQUEST FOR APPLICATIONS REQUEST FOR APPLICATIONS Issued By Parkinson Society Canada / La Société Parkinson Canada CLINICAL RESEARCH FELLOWSHIP PROGRAM (July 2016 June 2018 Cycle) Release Date: 23 November 2015 Application Deadline

More information

For personal use only

For personal use only 6 July 2015 KEY ADVANCEMENT TOWARDS COMMENCEMENT OF PHASE 1 CLINICAL STUDY OF ORAL FORMULATIONS Highlights PhytoTech Medical has submitted key documents to the Institutional Review Board (IRB or Helsinki

More information

Clinical Pilot Research Grant and Frontiers Pilot and Collaborative Studies Funding Program (FY 2016)

Clinical Pilot Research Grant and Frontiers Pilot and Collaborative Studies Funding Program (FY 2016) Clinical Pilot Research Grant and Frontiers Pilot and Collaborative Studies Funding Program (FY 2016) REQUEST FOR PROPOSALS SIXTH FUNDING ROUND (Please Read Very Carefully and Take Note of Deadlines) Announcement

More information

AST Transplantation and Immunology Research Network (TIRN) 2016 Allied Health Professional Research Grant

AST Transplantation and Immunology Research Network (TIRN) 2016 Allied Health Professional Research Grant AST Transplantation and Immunology Research Network (TIRN) 2016 Allied Health Professional Research Grant If you have any questions, please email TIRN@myAST.org. The application deadline is 11:59 pm Pacific

More information

POLICY AND PROCEDURES OFFICE OF NEW DRUGS. Good Review Practice: Management of Breakthrough Therapy-Designated Drugs and Biologics.

POLICY AND PROCEDURES OFFICE OF NEW DRUGS. Good Review Practice: Management of Breakthrough Therapy-Designated Drugs and Biologics. POLICY AND PROCEDURES OFFICE OF NEW DRUGS Good Review Practice: Management of Breakthrough Therapy-Designated Drugs and Biologics Table of Contents PURPOSE...1 BACKGROUND...2 POLICY...3 ROLES AND RESPONSIBILITIES...4

More information

Priority Program Translational Oncology Applicants' Guidelines

Priority Program Translational Oncology Applicants' Guidelines Stiftung Deutsche Krebshilfe Dr. h.c. Fritz Pleitgen Präsident Spendenkonto Kreissparkasse Köln IBAN DE65 3705 0299 0000 9191 91 BIC COKSDE33XXX Priority Program Translational Oncology Applicants' Guidelines

More information

Primary Endpoints in Alzheimer s Dementia

Primary Endpoints in Alzheimer s Dementia Primary Endpoints in Alzheimer s Dementia Dr. Karl Broich Federal Institute for Drugs and Medical Devices (BfArM) Kurt-Georg-Kiesinger-Allee 38, D-53175 Bonn Germany Critique on Regulatory Decisions in

More information

J D R F R E Q U E S T S E X P R E S S I O N S O F I N T E R E S T F O R : C O M B I N AT I O N T H E R AP I E S I N T Y P E 1 D I A B E T E S

J D R F R E Q U E S T S E X P R E S S I O N S O F I N T E R E S T F O R : C O M B I N AT I O N T H E R AP I E S I N T Y P E 1 D I A B E T E S J D R F R E Q U E S T S E X P R E S S I O N S O F I N T E R E S T F O R : C O M B I N AT I O N T H E R AP I E S I N T Y P E 1 D I A B E T E S PURPOSE JDRF, the world s leading non-profit organization with

More information

ECZEMA SOCIETY OF CANADA ECZEMA RESEARCH & EDUCATIONAL PROJECTS GRANT PROGRAM APPLICATION

ECZEMA SOCIETY OF CANADA ECZEMA RESEARCH & EDUCATIONAL PROJECTS GRANT PROGRAM APPLICATION ECZEMA SOCIETY OF CANADA ECZEMA RESEARCH & EDUCATIONAL PROJECTS GRANT PROGRAM APPLICATION Application Details Application and all supporting documents must be received at the ESC office no later than October

More information

Careers in Biostatistics and Clinical SAS Programming An Overview for the Uninitiated Justina M. Flavin, Independent Consultant, San Diego, CA

Careers in Biostatistics and Clinical SAS Programming An Overview for the Uninitiated Justina M. Flavin, Independent Consultant, San Diego, CA PharmaSUG 2014 Paper CP07 Careers in Biostatistics and Clinical SAS Programming An Overview for the Uninitiated Justina M. Flavin, Independent Consultant, San Diego, CA ABSTRACT In the biopharmaceutical

More information

LCFA/IASLC LORI MONROE SCHOLARSHIP IN TRANSLATIONAL LUNG CANCER RESEARCH

LCFA/IASLC LORI MONROE SCHOLARSHIP IN TRANSLATIONAL LUNG CANCER RESEARCH LCFA/IASLC LORI MONROE SCHOLARSHIP IN TRANSLATIONAL LUNG CANCER RESEARCH FUNDING OPPORTUNITY DESCRIPTION 2016 REQUEST FOR APPLICATION (RFA) Lung Cancer Foundation of America (LCFA) and the International

More information

NATIONAL HEALTH COUNCIL RESOLUTION Nº 251, DATED 7 AUGUST 1997

NATIONAL HEALTH COUNCIL RESOLUTION Nº 251, DATED 7 AUGUST 1997 NATIONAL HEALTH COUNCIL RESOLUTION Nº 251, DATED 7 AUGUST 1997 Plenary of the National Health Council in its 15 th Special Meeting, held on 5 August 1997, in the exercise of its competencies, as set forth

More information

RESEARCH GRANT Sponsored by the Pedal-with-Pete Foundation

RESEARCH GRANT Sponsored by the Pedal-with-Pete Foundation RESEARCH GRANT Sponsored by the Pedal-with-Pete Foundation Introduction A key mission of the Academy is to promote excellence in research for the benefit of persons with cerebral palsy and childhood-onset

More information

exactly. The need for efficiency in developing effective new therapeutics has never been greater.

exactly. The need for efficiency in developing effective new therapeutics has never been greater. exactly. The need for efficiency in developing effective new therapeutics has never been greater. As demands on the global healthcare system increase and treating disease becomes more complex, the research,

More information

Clinical trials preclinical requirements. Clinical trials - legislation

Clinical trials preclinical requirements. Clinical trials - legislation Clinical trials preclinical requirements Mikael Andersson, PhD Senior Expert Medical Products Agency, Sweden Tallinn 9/10 2009 Clinical trials - legislation Directive 2001/20/EC Clinical trial directive

More information

GRANTS IN AID OF RESEARCH APPLICATION GUIDELINES / LES DIRECTIVES POUR LA SUBVENTION EN AIDE À LA RECHERCHE

GRANTS IN AID OF RESEARCH APPLICATION GUIDELINES / LES DIRECTIVES POUR LA SUBVENTION EN AIDE À LA RECHERCHE Promise/Mission The Crohn s and Colitis Canada Promise Statement is to cure Crohn s disease and ulcerative colitis and improve the lives of children and adults affected by these chronic diseases. Crohn

More information

Multiple Myeloma Research Foundation. 2015 Senior Research Award. Program Guidelines

Multiple Myeloma Research Foundation. 2015 Senior Research Award. Program Guidelines Multiple Myeloma Research Foundation 2015 Senior Research Award Program Guidelines MULTIPLE MYELOMA RESEARCH FOUNDATION 2015 SENIOR RESEARCH AWARD Program Description: The Multiple Myeloma Research Foundation

More information

Multiple Myeloma Research Foundation. 2015 Research Fellow Award. Program Guidelines

Multiple Myeloma Research Foundation. 2015 Research Fellow Award. Program Guidelines Multiple Myeloma Research Foundation 2015 Research Fellow Award Program Guidelines Program Description: MULTIPLE MYELOMA RESEARCH FOUNDATION 2015 RESEARCH FELLOW AWARD The Multiple Myeloma Research Foundation

More information

1.2 - Overview of Regulation of Clinical Trials in Canada

1.2 - Overview of Regulation of Clinical Trials in Canada 1.2 - Overview of Regulation of Clinical Trials in Canada Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD, Manager, Clinical Group I Office

More information

Movember Clinical Trial Award (CTA)

Movember Clinical Trial Award (CTA) Movember Clinical Trial Awards Part 1: Overview Participating Organisation (s) Funding Category Description The Movember Foundation and Prostate Cancer Foundation of Australia Movember Clinical Trial Award

More information

PA 14-01: CIRM Accelerated Development Pathway

PA 14-01: CIRM Accelerated Development Pathway PA 14-01: CIRM Accelerated Development Pathway I. Purpose Through the Disease Team (Disease Team Research or Therapy Development) and Strategic Partnership Award programs, the California Institute for

More information

Clinical Trials in Thalassemia Cell and Gene Therapy Grant Award

Clinical Trials in Thalassemia Cell and Gene Therapy Grant Award Clinical Trials in Thalassemia Cell and Gene Therapy Grant Award The Cooley s Anemia Foundation invites national and international applicants to apply for grants to facilitate clinical trials in Cell and

More information

CLINICAL TRIALS SHOULD YOU PARTICIPATE? by Gwen L. Nichols, MD

CLINICAL TRIALS SHOULD YOU PARTICIPATE? by Gwen L. Nichols, MD CLINICAL TRIALS SHOULD YOU PARTICIPATE? by Gwen L. Nichols, MD Gwen L. Nichols, M.D., is currently the Oncology Site Head of the Roche Translational Clinical Research Center at Hoffman- LaRoche. In this

More information

Operational aspects of a clinical trial

Operational aspects of a clinical trial Operational aspects of a clinical trial Carlo Tomino Pharm.D. Coordinator Pre-authorization Department Head of Research and Clinical Trial Italian Medicines Agency Mwanza (Tanzania), June 11, 2012 1 Declaration

More information

GENERAL CONSIDERATIONS FOR CLINICAL TRIALS E8

GENERAL CONSIDERATIONS FOR CLINICAL TRIALS E8 INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE GENERAL CONSIDERATIONS FOR CLINICAL TRIALS E8 Current

More information

2015 AriSLA Ice Bucket Call for Clinical Projects

2015 AriSLA Ice Bucket Call for Clinical Projects 2015 AriSLA Ice Bucket Call for Clinical Projects Deadline: at 1.00 pm, May 12 th, 2015 1. Background AriSLA, Italian Foundation for research on ALS Amyotrophic Lateral Sclerosis, opens its 2015 Call for

More information

CCFC GRANTS IN AID OF RESERACH APPLICATION GUIDELINES / FCMII LES DIRECTIVES POUR LA SUBVENTION EN AIDE À LA RECHERCHE

CCFC GRANTS IN AID OF RESERACH APPLICATION GUIDELINES / FCMII LES DIRECTIVES POUR LA SUBVENTION EN AIDE À LA RECHERCHE Promise/Mission The Crohn s and Colitis Colitis Foundation of Canada s (CCFC) Promise Statement is to cure Crohn s disease and ulcerative colitis and improve the lives of children and adults affected by

More information

SCHOOL OF MEDICINE OFFICE OF RESEARCH ADMINISTRATION

SCHOOL OF MEDICINE OFFICE OF RESEARCH ADMINISTRATION SCHOOL OF MEDICINE OFFICE OF RESEARCH ADMINISTRATION Step By Step Guide for: Coeus Proposal Development (Coeus PD) (in place of eis) for Paper (Hard) Copy and Electronic (non Grants.gov) submission Effective

More information

Mission The mission of the Alliance for Lupus Research is to prevent, treat and cure lupus through medical research.

Mission The mission of the Alliance for Lupus Research is to prevent, treat and cure lupus through medical research. ALLIANCE FOR LUPUS RESEARCH TARGET IDENTIFICATION IN LUPUS APPLICATION PROGRAM GUIDELINES Effective June 5, 2014 Letter of Intent Due July 10, 2014 APPLICATION DUE DATE August 25, 2014 Applications will

More information

MULTIPLE SCLEROSIS SOCIETY OF CANADA OPERATING GRANT PROGRAM GUIDE CLINICIAL AND POPULATION HEALTH

MULTIPLE SCLEROSIS SOCIETY OF CANADA OPERATING GRANT PROGRAM GUIDE CLINICIAL AND POPULATION HEALTH MULTIPLE SCLEROSIS SOCIETY OF CANADA OPERATING GRANT PROGRAM GUIDE CLINICIAL AND POPULATION HEALTH Revised August 2015 Multiple Sclerosis Society of Canada Research Department 250 Dundas Street West Suite

More information

CLOSED REQUEST FOR APPLICATIONS RFA C-15-NEWCO-2. New Company Product Development Awards

CLOSED REQUEST FOR APPLICATIONS RFA C-15-NEWCO-2. New Company Product Development Awards REQUEST FOR APPLICATIONS RFA C-15-NEWCO-2 New Company Product Development Awards Please also refer to the Instructions for Applicants document, which will be posted August 25, 2014 Application Receipt

More information

Subject: No. Page PROTOCOL AND CASE REPORT FORM DEVELOPMENT AND REVIEW Standard Operating Procedure

Subject: No. Page PROTOCOL AND CASE REPORT FORM DEVELOPMENT AND REVIEW Standard Operating Procedure 703 1 of 11 POLICY The Beaumont Research Coordinating Center (BRCC) will provide advice to clinical trial investigators on protocol development, content and format. Upon request, the BRCC will review a

More information

Introduction to pharmaceutical technology

Introduction to pharmaceutical technology Introduction to pharmaceutical technology Marie Wahlgren Chapter 1 What is the topics of today Introduction to the course Introduction to the project assignment How to choose a new drug formulation 1 Contacts

More information

The Clinical Trials Process an educated patient s guide

The Clinical Trials Process an educated patient s guide The Clinical Trials Process an educated patient s guide Gwen L. Nichols, MD Site Head, Oncology Roche TCRC, Translational and Clinical Research Center New York DISCLAIMER I am an employee of Hoffmann-

More information

Overview of Drug Development

Overview of Drug Development Overview of Drug Development Namrata Bahadur Head of Clinical Development & Medical Affairs Emerging Growth Markets 17 th 21 st March, Bangkok 2008 Novartis The information within this presentation is

More information

OCT Practical Aspects of Conducting Clinical Trials for Russian Innovative Companies

OCT Practical Aspects of Conducting Clinical Trials for Russian Innovative Companies OCT Practical Aspects of Conducting Clinical Trials for Russian Innovative Companies Innovative Drug Research and Development in Russia 2012 OCT: CRO in Russia, Central and Eastern Europe Russian Innovative

More information

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR GUIDANCE ON THE PRE-CLINICAL EVALUATION OF ANTICANCER MEDICINAL PRODUCTS

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR GUIDANCE ON THE PRE-CLINICAL EVALUATION OF ANTICANCER MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit London, 23 July 1998 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR GUIDANCE ON THE PRE-CLINICAL

More information

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP) NOTE FOR GUIDANCE ON PROCESS VALIDATION

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP) NOTE FOR GUIDANCE ON PROCESS VALIDATION The European Agency for the Evaluation of Medicinal Products London, 1 March 2001 CPMP/QWP/848/96 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP)

More information

The Trials and Tribulations of the CRM: the DFO Experience

The Trials and Tribulations of the CRM: the DFO Experience The Trials and Tribulations of the CRM: the DFO Experience Yuko Y. Palesch, PhD Professor and Director, Division of Biostatistics and Epidemiology Department of Medicine. Medical University of South Carolina

More information

Quality and Safety Evaluation of Gene Therapy Products in Japan

Quality and Safety Evaluation of Gene Therapy Products in Japan Quality and Safety Evaluation of Gene Therapy Products in Japan Review Mechanism for Gene Therapy in Japan The review mechanism for gene therapy in Japan was partially amended to simplify the necessary

More information

Jornada Informativa en Bioeconomía. Retos Colaboración 2016

Jornada Informativa en Bioeconomía. Retos Colaboración 2016 Jornada Informativa en Bioeconomía. Retos Colaboración 2016 Novel Multifunctional Nanoplatform as Theranostic Technology for the Alzheimer Disease. NANOTHERAD autor: María del Carmen Dona MD PhD PROPOSAL:

More information

Sheffield Kidney Institute. Planning a Clinical Trial

Sheffield Kidney Institute. Planning a Clinical Trial Planning a Clinical Trial Clinical Trials Testing a new drug Ethical Issues Liability and Indemnity Trial Design Trial Protocol Statistical analysis Clinical Trials Phase I: Phase II: Phase III: Phase

More information

Formal FDA Meeting Request: Guidance and Template

Formal FDA Meeting Request: Guidance and Template Formal FDA Meeting Request: Guidance and Template ICTR Navigators July 23, 2011 Version 2.0 Page 1 of 20 1.0 Table of Contents Section Page 1.0 Table of Contents 2 2.0 Abbreviations 2 3.0 FDA Regulations

More information

Application Guide. 2015 Global Awards in Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) Research

Application Guide. 2015 Global Awards in Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) Research Application Guide 2015 Global Awards in Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) Research A Competitive Grants Program Supported by Pfizer www.aspireresearch.org Table of Contents THE ASPIRE

More information

Session 6 Clinical Trial Assessment Phase I Clinical Trial

Session 6 Clinical Trial Assessment Phase I Clinical Trial L1 Session 6 Clinical Trial Assessment Phase I Clinical Trial Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD, Manager, Clinical Group I Office

More information

RE AP QUE PLIC FOR IONS. Compa CPRIT RFA C 12 FORM 2. Company. p.1/17

RE AP QUE PLIC FOR IONS. Compa CPRIT RFA C 12 FORM 2. Company. p.1/17 RE AP QUE ST PLIC AT RFA C 12 FORM 2 FOR IONS Compa any Formation Awards FY 2012 Fiscal Year Award Period September 1, 2011 Augustt 31, 2012 CPRIT RFA C 12 FORM 2 (Rev 6/ /30/11) Company Formation Awards

More information

GUIDELINES AND INSTRUCTIONS FOR 2-YEAR GRANT APPLICATIONS

GUIDELINES AND INSTRUCTIONS FOR 2-YEAR GRANT APPLICATIONS GUIDELINES AND INSTRUCTIONS FOR 2-YEAR GRANT APPLICATIONS IMPORTANT NOTICES Check if you are using the correct grant application form, Standard or Pilot. These documents are updated for each grant cycle.

More information

https://syracuseuniversity.qualtrics.com/controlpanel/ajax.php?action=getsurveyprintpre...

https://syracuseuniversity.qualtrics.com/controlpanel/ajax.php?action=getsurveyprintpre... Page 1 of 7 SU - UMU Pilot Grant Program Driving Inspiration and Innovation through Collaboration Syracuse University- Upstate Medical University 2015 Pilot Grant Application Responding to society s most

More information

Morris Animal Foundation

Morris Animal Foundation General Information: Morris Animal Foundation First Award Proposal Morris Animal Foundation (MAF) is dedicated to funding proposals that are relevant to our mission of advancing the health and well-being

More information

NCT Preliminary Report: Phase I Dose Escalating Study to Evaluate the Safety,

NCT Preliminary Report: Phase I Dose Escalating Study to Evaluate the Safety, NCT02020291 Preliminary Report: Phase I Dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles of Foxy-5 in Patients with Metastatic Breast, Colon or Prostate

More information

GT-020 Phase 1 Clinical Trial: Results of Second Cohort

GT-020 Phase 1 Clinical Trial: Results of Second Cohort GT-020 Phase 1 Clinical Trial: Results of Second Cohort July 29, 2014 NASDAQ: GALT www.galectintherapeutics.com 2014 Galectin Therapeutics inc. Forward-Looking Statement This presentation contains, in

More information

Achieving Regulatory Success: Areas of focus for biotechnology companies. Michael J. Schlosser, PhD, DABT April 21, 2013

Achieving Regulatory Success: Areas of focus for biotechnology companies. Michael J. Schlosser, PhD, DABT April 21, 2013 Achieving Regulatory Success: Areas of focus for biotechnology companies Michael J. Schlosser, PhD, DABT April 21, 2013 Regulatory Success Outline Regulatory Initiatives Regulatory Science Pre-Regulatory

More information

ARQUIVOS BRASILEIROS DE CARDIOLOGIA (BRAZILIAN ARCHIVES OF CARDIOLOGY) GUIDELINES FOR PUBLICATION

ARQUIVOS BRASILEIROS DE CARDIOLOGIA (BRAZILIAN ARCHIVES OF CARDIOLOGY) GUIDELINES FOR PUBLICATION 1 ARQUIVOS BRASILEIROS DE CARDIOLOGIA (BRAZILIAN ARCHIVES OF CARDIOLOGY) GUIDELINES FOR PUBLICATION 1. The Brazilian Archives of Cardiology (Arq Bras Cardiol) is a monthly publication of the Brazilian

More information

2015 Grant Application Guidelines for A Awards

2015 Grant Application Guidelines for A Awards 2015 Grant Application Guidelines for A Awards In this packet you will find the following: Award Overview and Eligibility - page 2, 3 Application Information and Outline - pages 4, 5 Important Dates and

More information

Alliance4U - The collaboration initiative to move drug candidates forward

Alliance4U - The collaboration initiative to move drug candidates forward - The collaboration initiative to move drug candidates forward Introduction What are we offering? How? Why apply? Terms Background For grant applications and to attract venture capital start-up companies

More information

Scleroderma Foundation Research Grant Application Instructions

Scleroderma Foundation Research Grant Application Instructions 1. Application Scleroderma Foundation Research Grant Application Instructions Grant applications that do not meet these guidelines will not be reviewed. Please download our text format version. Grant Application

More information

Adaptive and Innovative Study Designs to Accelerate Drug Development from First-In- Human to First-In-Patient

Adaptive and Innovative Study Designs to Accelerate Drug Development from First-In- Human to First-In-Patient Adaptive and Innovative Study Designs to Accelerate Drug Development from First-In- Human to First-In-Patient Michelle L. Combs, PhD Vice President, Clinical Pharmacology Sciences Definition of Adaptive

More information

Call 2014: High throughput screening of therapeutic molecules and rare diseases

Call 2014: High throughput screening of therapeutic molecules and rare diseases Call 2014: High throughput screening of therapeutic molecules and rare diseases The second call High throughput screening of therapeutic molecules and rare diseases launched by the French Foundation for

More information

2014 Application Guidelines for Reach Awards

2014 Application Guidelines for Reach Awards 2014 Application Guidelines for Reach Awards In this packet you will find: Description and Criteria: pages 2, 3 Application Outline and Format: pages 4, 5 Important Dates & Submission Information: page

More information

BIOTECHNOLOGY OPERATIONS

BIOTECHNOLOGY OPERATIONS BIOTECHNOLOGY OPERATIONS Principles and Practices Michael J. Roy TECHNISCHE INFORMATION SBIBLIOTHEK UNIVERSITATSBIBLIOTHEK HANNOVER CRC Press TaylorStFrancis Croup Boca Raton London New York CRC Press

More information

ICH Topic E 8 General Considerations for Clinical Trials. Step 5 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS (CPMP/ICH/291/95)

ICH Topic E 8 General Considerations for Clinical Trials. Step 5 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS (CPMP/ICH/291/95) European Medicines Agency March 1998 CPMP/ICH/291/95 ICH Topic E 8 General Considerations for Clinical Trials Step 5 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS (CPMP/ICH/291/95) TRANSMISSION

More information

Clinical Trial Protocol Development. Developed by Center for Cancer Research, National Cancer Institute Endorsed by the CTN SIG Leadership Group

Clinical Trial Protocol Development. Developed by Center for Cancer Research, National Cancer Institute Endorsed by the CTN SIG Leadership Group Clinical Trial Protocol Development Developed by Center for Cancer Research, National Cancer Institute Endorsed by the CTN SIG Leadership Group Objectives The clinical trial protocol is the heart of any

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.

More information

BNC105 CANCER CLINICAL TRIALS REACH KEY MILESTONES CLINICAL PROGRAM TO BE EXPANDED

BNC105 CANCER CLINICAL TRIALS REACH KEY MILESTONES CLINICAL PROGRAM TO BE EXPANDED ASX ANNOUNCEMENT 3 August 2011 ABN 53 075 582 740 BNC105 CANCER CLINICAL TRIALS REACH KEY MILESTONES CLINICAL PROGRAM TO BE EXPANDED Data from renal cancer trial supports progression of the trial: o Combination

More information

RADIOPHARMACEUTICALS BASED ON MONOCLONAL ANTIBODIES

RADIOPHARMACEUTICALS BASED ON MONOCLONAL ANTIBODIES RADIOPHARMACEUTICALS BASED ON MONOCLONAL ANTIBODIES Guideline Title Radiopharmaceuticals based on Monoclonal Antibodies Legislative basis Directives 65/65/EEC, 75/318/EEC as amended, Directive 89/343/EEC

More information

Discovery Grants. 2015-2016 Request for Applications

Discovery Grants. 2015-2016 Request for Applications The mission of the American Brain Tumor Association is to advance the understanding and treatment of brain tumors with the goals of improving, extending and, ultimately, saving the lives of those impacted

More information

A Guide to the ABTA s 2013 Medical Student Summer Fellowship Application

A Guide to the ABTA s 2013 Medical Student Summer Fellowship Application A Guide to the ABTA s 2013 Medical Student Summer Fellowship Application Please be aware the submission process has changed. All applications for the 2013 American Brain Tumor Association Medical Student

More information

STTR PROGRAMMATIC INVESTMENT GRANT APPLICATION

STTR PROGRAMMATIC INVESTMENT GRANT APPLICATION 2016 STTR PROGRAMMATIC INVESTMENT GRANT APPLICATION Application Deadline: November 16, 2015 November 30, 2015 BLADDER BRAIN BREAST COLORECTAL HEAD & NECK LUNG OVARY PANCREAS PROSTATE SARCOMA APPLICATION

More information

Written Example for Research Question: How is caffeine consumption associated with memory?

Written Example for Research Question: How is caffeine consumption associated with memory? Guide to Writing Your Primary Research Paper Your Research Report should be divided into sections with these headings: Abstract, Introduction, Methods, Results, Discussion, and References. Introduction:

More information

Page 191 TITLE 21 FOOD AND DRUGS 355 1

Page 191 TITLE 21 FOOD AND DRUGS 355 1 Page 191 TITLE 21 FOOD AND DRUGS 355 1 APPEALS TAKEN PRIOR TO OCTOBER 10, 1962 Section 104(d)(3) of Pub. L. 87 781 made amendments to subsec. (h) of this section inapplicable to any appeal taken prior

More information

MICHIGAN PRE-SEED 2.0 UNIVERSITY COMMERCIALIZATION FUND Administered by Invest Michigan

MICHIGAN PRE-SEED 2.0 UNIVERSITY COMMERCIALIZATION FUND Administered by Invest Michigan MICHIGAN PRE-SEED 2.0 UNIVERSITY COMMERCIALIZATION FUND Administered by Invest Michigan Introduction The University Commercialization Fund is a $1 million program funded by the Michigan Strategic Fund

More information

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE S1A. Current Step 4 version

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE S1A. Current Step 4 version INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE GUIDELINE ON THE NEED FOR CARCINOGENICITY STUDIES

More information

ICH Topic S 1 A The Need for Carcinogenicity Studies of Pharmaceuticals. Step 5

ICH Topic S 1 A The Need for Carcinogenicity Studies of Pharmaceuticals. Step 5 European Medicines Agency July 1996 CPMP/ICH/140/95 ICH Topic S 1 A The Need for Carcinogenicity Studies of Pharmaceuticals Step 5 NOTE FOR GUIDANCE ON THE NEED FOR CARCINOGENICITY STUDIES OF PHARMACEUTICALS

More information

Carolina KickStart Commercialization Award Program

Carolina KickStart Commercialization Award Program Carolina KickStart Commercialization Award Program Request for Applications Description The Carolina KickStart Commercialization Award Program will provide up to $50K in non-dilutive funding to UNC faculty-led

More information