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FDA Draft Guidance: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapies John Hyde, PhD, MD OCTGT

содержание презентации «FDA Draft Guidance: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapies John Hyde, PhD, MD OCTGT.ppt»
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1FDA Draft Guidance: Considerations for 19Selection (cont.) Describing dose
the Design of Early-Phase Clinical Trials Challenging due to different attributes of
of Cellular and Gene Therapies John Hyde, product Cellular product may be a mixture
PhD, MD OCTGT / CBER Cellular, Tissue and of cell types Different subtypes may
Gene Therapies AC February 26, 2014. 1. contribute differently Gene transduction
2Acknowledgments. Rachael Anatol, PhD rates can be highly variable Vector
Kim Benton, PhD Peter Bross, MD Wilson without gene might be relevant to safety.
Bryan, MD Kate Cook Bindu George, MD 19.
Changting Haudenschild, MD Ying Huang, PhD 20IV. Clinical Trial Design. E.
Ilan Irony, MD Ke Liu, MD, PhD Richard Treatment Plan Dosing regimen is often
McFarland, MD, PhD. Skip Nelson, MD, PhD single administration Staggering
Melissa Reisman, JD Laura Rich Michelle administration Cohort size Operator
Roth-Cline, MD, PhD Bruce Schneider, MD training Recording and evaluating
Mercedes Serabian, MS Dan Takefman, PhD procedures Subject-specific product
Celia Witten, PhD, MD Rachel Witten, MD issues. 20.
Keith Wonnacott, PhD Lei Xu, MD, PhD. 2. 21IV. Clinical Trial Design. F.
3Draft Guidance Comments. The draft Monitoring and Follow-up General
guidance document is available through the considerations Primary objective should be
FDA/CBER website: safety General safety monitoring
http://www.fda.gov/downloads/BiologicsBloo Bioactivity May develop slowly or be
Vaccines/GuidanceComplianceRegulatoryInfor delayed. 21.
ation/Guidances/CellularandGeneTherapy/UCM 22IV. Clinical Trial Design. F.
59073.pdf The draft guidance document Monitoring and Follow-up (cont.) Special
includes information on submitting considerations for CGT products
comments to Docket FDA-2013-D-0576. 3. Immunogenicity Persistence of product or
4Timeline. July 2, 2013: Draft guidance activity Migration of cells Shedding of
published for public comment February 26, microbial gene vector Growth and
2014: Advisory Committee discussion May 9, development for pediatric subjects. 22.
2014: End of comment period Plan is to 23IV. Clinical Trial Design. F.
finalize guidance as soon as feasible Monitoring and Follow-up (cont.) Duration
thereafter. 4. of Follow-up Should cover time during
5Motivation for Guidance. Cellular and which product thought to present safety
gene therapy (CGT) products have concerns For most CGT products, >1 year
distinctive features Design of early-phase is appropriate There is a guidance
trials is often different than for other document for certain gene therapy
pharmaceuticals Make IND sponsors aware of products. 23.
issues to consider in early-phase trials 24IV. Clinical Trial Design. F.
Recommend ways to address the issues Does Monitoring and Follow-up (cont.) Duration
not set forth new requirements. 5. of Follow-up (cont.) For cell harvest
6Intended Scope. Biological products using pre-treatment – may need to follow
for which OCTGT has regulatory authority donor after harvest even if product not
Not for: Tissue-based products regulated given Special considerations for pediatric
solely under section 361 Devices Biologics subjects – effects on growth and
regulated by Center for Drug Evaluation development Long-term follow-up may be
and Research (CDER). 6. less detailed than in main part of a study
7Intended Scope. Focus in on clinical Subsequent trials might proceed on interim
trial design Separate OCTGT guidances data. 24.
address Manufacturing issues 25IV. Clinical Trial Design. F.
http://www.fda.gov/BiologicsBloodVaccines/ Monitoring and Follow-up (cont.) Stopping
uidanceComplianceRegulatoryInformation/Gui rules Stipulate events that will lead to
ances/Xenotransplantation/ucm074131.htm suspending treatment pending review
http://www.fda.gov/BiologicsBloodVaccines/ Uncertainty about nature, frequency, or
uidanceComplianceRegulatoryInformation/Gui severity of adverse reactions – rules
ances/CellularandGeneTherapy/ucm072587.htm limit number exposed to an unexpected
Preclinical development safety problem Events may call for change
http://www.fda.gov/BiologicsBloodVaccines/ in enrollment, dosing, administration, or
uidanceComplianceRegulatoryInformation/Gui monitoring to mitigate risks “Stopping”
ances/CellularandGeneTherapy/ucm376136.htm rule not a study termination rule. 25.
7. 26V. Meetings with OCTGT. Encourages
8Guidance Outline. I. Introduction II. prospective IND sponsors to meet with FDA
Background III. Features of CGT Products staff Suggests several clinical topics for
IV. Clinical Trial Design V. Meetings with discussion at a meeting. 26.
OCTGT VI. Guidance on Submitting an IND 27VI. Submitting an IND. Cites
VII. References. 8. regulations and other guidances concerned
9Introduction and Background. I. with the information that should be
Introduction Purpose and scope II. provided in an IND submission Brief
Background Important early experiences general advice Suggests formulating an
with cellular and gene therapy products overall development plan. 27.
Special features of CGT products. 9. 28Discussion Topics for the Advisory
10III. Features of CGT Products. A. Committee. 28.
Product Characteristics General: relative 29Discussion Topic 1: Choice of subject
lack of clinical experience; may need population. Please discuss Sections IV.B.1
invasive procedures Cells: donors, through IV.B.3 (pp. 7-9), which address
differentiation, migration Genes: the principles of choosing an appropriate
expression control, genome alteration, subject population to study in early-phase
shedding Gene-modified cells: features of clinical trials of CGT Products. Please
both cells and genes. 10. identify any revisions or additions you
11III. Features of CGT Products. B. recommend for this section. 29.
Manufacturing Considerations Complexity 30Discussion Topic 2: Use of pediatric
May be limits on concentrations or doses subjects. Please discuss any revisions or
Logistics, possibly short “shelf life” additions that you recommend for Section
Might be subject-specific Variability May IV.B.4 (pp. 9-10). In the discussion,
be a significant delay between enrollment please consider how data in adults could
and treatment. 11. support the initiation of pediatric
12III. Features of CGT Products. C. studies. 30.
Preclinical Considerations Conventional PK 31Discussion Topic 3: Choice of control
usually not feasible Preclinical studies group. Please discuss section IV.C (pp.
may be harder to extrapolate to humans 10-11), which addresses choice of control
Species specificity Immunogenicity. 12. groups. Please identify any revisions or
13IV. Clinical Trial Design. A. additions you recommend for this section,
Objectives B. Choosing a Study Population particularly with regard to the need for
C. Control Group and Blinding D. Dose and selection of an appropriate control in
Selection E. Treatment Plan F. Monitoring early-phase clinical trials if the CGT
and Follow-up. 13. product requires an invasive procedure for
14IV. Clinical Trial Design. A. administration. 31.
Objectives Safety Dose exploration 32Discussion Topic 4: Monitoring and
Feasibility, logistics Initial assessment follow-up. Please discuss the principles
of bioactivity. 14. that should be used to decide the duration
15IV. Clinical Trial Design. B. Choosing and nature of safety follow-up for
a Study Population Will depend on product early-phase trials of cellular therapy
and disease Considerations Potential for products (IV.F, pp. 14-18). 32.
product or effect to persist Often 33Discussion Topic 5: Additional
significant uncertainly about risks May comments. Please comment if you recommend
need some potential for benefit in order modification in the draft guidance on any
to make risks acceptable Healthy topic, if the draft guidance did not
volunteers often not a suitable study address a topic in sufficient detail, or
population. 15. if there are important topics that the
16IV. Clinical Trial Design. B. Choosing draft guidance omitted. Please identify
a Study Population (cont.) Disease stage any revisions or additions you recommend
or severity Severe or advanced disease for this draft guidance. 33.
sometimes proposed as a way to make 34Conclusions. OCTGT has published this
risk-benefit balance acceptable But – draft guidance in hopes of facilitating
these subjects might also be more early-phase clinical development of
vulnerable, less likely to benefit, or cellular and gene therapy products OCTGT
less informative Such subjects should not is looking forward to receiving public
be an automatic choice Pediatric subjects comments in the docket and to discussions
Specific regulations regarding pediatric by this Advisory Committee in order to
research. 16. make the guidance as useful as possible.
17IV. Clinical Trial Design. C. Control 34.
Group and Blinding Controls can be of 35Comments on the Guidance Docket
value for safety and preliminary activity FDA-2013-D-0576 (open until May 9).
assessments Blinding helpful but less Electronic comments:
critical in early phase than for http://www.regulations.gov Written
late-phase trials Invasive procedure in comments: Division of Dockets Management
the control group might not be appropriate (HFA-305) Food and Drug Administration
in early-phase trials. 17. 5630 Fishers Lane, Rm. 1061 Rockville, MD
18IV. Clinical Trial Design. D. Dose 20852 Questions: Office of Communications,
Selection Role of preclinical data Outreach and Development:
Allometric scaling for CGT products may be ocod@fda.hhs.gov, 1-800-835-4709,
less precise than for small molecules May 301-827-1800, or
be difficult to establish safe starting http://www.fda.gov/BiologicsBloodVaccines/
dose Previous clinical experience with uidanceComplianceRegulatoryInformation/Gui
related products might be useful. 18. ances/default.htm. 35.
19IV. Clinical Trial Design. D. Dose
FDA Draft Guidance: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapies John Hyde, PhD, MD OCTGT.ppt
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FDA Draft Guidance: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapies John Hyde, PhD, MD OCTGT

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900igr.net > Презентации по английскому языку > Курсы английского > FDA Draft Guidance: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapies John Hyde, PhD, MD OCTGT