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From your brain to their brain: Drug development in Neuro-Oncology

Drug Development Process
by

Marlon Saria

on 13 May 2011

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Transcript of From your brain to their brain: Drug development in Neuro-Oncology

Pre-discovery Understand the disease Drug Discovery Drug
Discovery Early
Safety
Tests Lead
Optimization Nature De novo High-throughput screening Biotechnology Absorption Distribution Metabolism Excretion Toxicological
properties Pre-Clinical Testing In vivo In vitro Target
Identification Target
Validation Clinical
Trial Phase I Phase II Phase III IND Application and Safety File IND with the FDA
results of the preclinical work
candidate drug's chemical structure
mechanism of action
side effects
manufacturing information Detailed Clinical Trial Plan
Objective(s)
Design
Methodology
Statistical considerations
Organization NDA and Approval IRB An Institutional Review Board (IRB) is a review committee established to help protect the rights and welfare of human research subjects. Regulations require IRB review and approval for research involving human subjects if it is funded or regulated by the federal government. Most research institutions, professional organizations, and scholarly journals apply the same requirements to all human research. Although federal regulations refer to IRBs, an institution may have chosen a different name for this committee. Federal regulations dictate that the IRB membership will include:

At least five members.

Member of both sexes.

Members that come from varied professions.

At least one member whose primary concerns are in nonscientific areas.

At least one member whose primary concerns are in scientific areas.

At least one member who is not otherwise affiliated with the institution.

The regulations also stipulate that the IRB membership will include:

Reviewers with experience and expertise in all of the areas of research being reviewed. At its discretion, an IRB may invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB.

Diversity of backgrounds.

Sensitivity to community attitudes.

Knowledge of institutional commitments and regulations, applicable laws, and standards of professional conduct.

Knowledge and experience with vulnerable populations. Human Subjects: The Department of Health and Human Services (DHHS) regulations define a human subject as "a living individual about whom an investigator (whether professional or student) conducting research obtains:

Data through intervention or interaction with the individual.
Or
Identifiable private information." [45 CFR 46.102 (f)]

Note: Some state laws include deceased individuals and fetal materials as "human subjects." Check with the local IRB about the definition of a human subject that applies in the state where the research will be conducted. Institutions and IRBs vary in the practices that assure they meet the federal regulations and in the details of the standards they apply. What follows are the minimum federal requirements. Institutions and/or IRBs may add additional protections or procedures to these minimum requirements.

IRB applications usually contain, at a minimum, information that allows IRB members to assess:

Risk / anticipated benefit analysis.

Identification and assessment of risks and anticipated benefits.

Determination that risks are minimized.

Determination that risks are reasonable in relation to potential benefits.

Informed consent.
Informed consent process and documentation.
Assent. The affirmative agreement of a minor or decisionally impaired individual to participate in research.
Assent process and documentation.
Selection of subjects.

Equitable selection in terms of gender, race, ethnicity.


Benefits are distributed fairly among the community's populations.

Additional safeguards are provided for vulnerable populations susceptible to pressure to participate.

Safeguards that ensure that subject recruitment does not invade individuals' privacy and that procedures are in place to assure that the confidentiality of the information, collected during the research, is monitored.

Research plan for collection, storage, and analysis of data.

Clinical research studies often include data safety monitoring plans and/or data safety monitoring boards (DSMB). IRBs will review the plans to ensure they are adequate to protect human subjects.

Research design / methods that are appropriate, scientifically valid and therefore, justify exposing subjects to research risks.


Additional information about identification, recruitment and safeguards if the research involves special populations.


In addition, the IRB must review:

The qualifications of the principal investigator (PI) and scientific collaborators.

A complete description of the proposed research.

Provisions for the adequate protection of rights and welfare of subjects.

Compliance with pertinent federal and state laws/regulations and institutional policy. When IRB regulations are not followed, consequences could include:
Suspension of research project.

Suspension of all of a PI's research projects.

Inability to use data or publish results.

Notification of sponsors, regulatory agencies, and funding agencies of noncompliance.

Debarment by FDA from using investigational products.
Inability to receive funding from federal grants.

Additional monitoring and oversight by the IRB and/or third party monitoring of research activities.

Termination of employment.

Loss of licenses.

Immediate shut-down of ALL research at an organization.
These are not theoretical consequences. Some or all of these consequences have occurred at sites where human subjects research was conducted improperly or without IRB approval. Full Committee Review
Expedited Review
Review for Exemption Status The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following key decisions:

·Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.

·Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.

·Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity. FDA-approved Indication

Off-label use Is the drug available in the US market for clinical use? YES NO, but... HMO IND

NDA Is the drug available for use in the lab? Institutional
Review
Board Permission to reproduce is granted if proper credit is given.
Suggested Citation: Pharmaceutical Research and Manufacturers of America, Value of Medicines: Facts and Figures 2006, (Washington, DC: PhRMA, August 2006). Permission to reproduce is granted if proper credit is given.
Suggested Citation: Pharmaceutical Research and Manufacturers of America, Value of Medicines: Facts and Figures 2006, (Washington, DC: PhRMA, August 2006). Permission to reproduce is granted if proper credit is given.
Suggested Citation: Pharmaceutical Research and Manufacturers of America, Value of Medicines: Facts and Figures 2006, (Washington, DC: PhRMA, August 2006). Permission to reproduce is granted if proper credit is given.
Suggested Citation: Pharmaceutical Research and Manufacturers of America, Value of Medicines: Facts and Figures 2006, (Washington, DC: PhRMA, August 2006).
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