Learning Teams - Biologic Integrationmedia.one-map.com/uploads/159/1601/6. LearningTeams... ·...
Transcript of Learning Teams - Biologic Integrationmedia.one-map.com/uploads/159/1601/6. LearningTeams... ·...
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Learning Teams- Biologic Integration
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Expanding our portfolio to include both biologics and topicals...
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The NME Innovation Pipeline features 3 biologics, which are all at very different stages in development
This presents as an opportunity to pass on learnings across projects and within teams
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Reaching New Patients
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What’s new with Sarah?
- Focus on moderate-severedisease- Topicals have failedor are medically inadvisable
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How does atopicdermatitis differ from psoriasis?
- age of onset- clinical signs and symptoms - co-morbidities
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Atopic DermatitisDiagnosis
• AD is a clinical diagnosis
• Patient history (seasonal variation, early onset, family history)
• Characteristic morphology and distribution of skin lesions
• Associated clinical signs and symptoms
• There is no specific test that can establish a diagnosis of AD
• Formal diagnostic criteria have been developed to help Classification in clinical trials and epidemiologic studies (Hanifin 1980, Williams 1994, Eichenfield 2014)
These are not used in daily clinical practice
Acta Derm Venerol 1980; 92: 44-47. Br J Dermatol 1994; 131(3): 383-96. JAAD 2014; 70 (2): 338-51.
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Histologyp. 08
Atopic DermatitisPsoriasis
- the differences explained
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Clinical Presentationp. 09
- the differences explained
Atopic DermatitisPsoriasis
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Clinical Presentationp. 010
- the differences explained
Psoriasis
Atopic Dermatitis
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Symptomsp. 011
- the differences explained
Psoriasis Atopic Dermatitis
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Comorbiditiesp. 013
- the differences explained
Psoriasis Atopic Dermatitis
Psoriatic arthritis
Chrohn’s disease
Uveitis
Vitiligo
Cardiovascular diseases
Diabetes
Hypertension
Obesity
Metabolic syndrome
Depression
Asthma
Conjunctivitis/blepharitis
Rhinitis and Chronic Sinusitis
Allergies (false positive prick test)
Vitiligo
Alopecia Areata
Urticaria
Depression
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Therapies p. 014
- the differences explained
Psoriasis Atopic Dermatitis
Emollients
TCS, TCI
Tar
Dithranol, vitamin D, Tarzarotene
salicylic acid and urea
Phototherapy
MTX, CyA, Retinoids, Apremilast
Biologics
Emollients
TCS, TCI, Crisaborole
Tar
Phototherapy
Azathioprine, MTX, CyA,
Mycophenolate,
Glucocorticosteroids
Biologics
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Immune Responses- the differences explained
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Psoriasis Atopic Dermatitis
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IL-13 in AD and tralokinumab
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TRALO-KIN-U-MABMonoclonal
Antibody
Variable
INN
Cytokine target
Ki(n) denotes the
target is an
interleukin
Human
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How does tralokinumab work?
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Clinical Development Program
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FSFV achieved on 29-May-2017Dr Zirwas, Bexley OH, USA
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Clinical Development Program- the overview
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12 month activity plan- all ongoing / new clinical activities in this period
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Description / Rationale Subjects FSFV
The phase 3A clinical program provides pivotal data from 2
replicate Phase 3 Monotherapy RCTs which support BLA,
MAA and JNDA submissions. Endpoints a 16W and
maintenance claim at 52W
780 30/05/2017
780 29/06/2017
Subjects from ECZTRA1/2 may be invited to join a LTE
protocol [ECZTEND] 320 - 1600 02/10/2018
FDA cite a disease-drug-drug interaction potential through
cytokines affecting CYP450 30 16/05/2018
Trial included in adult program to ensure that no limitation is
placed in label, needed for Paeds 200 09/05/2018
CHMP guided that ‘real-life’ use in combination with TCS to
be studied 369 08/02/2018
Confirmatory trial in adolescents, including 2 doses; 150mg
and 300mg 294 24/05/2018
Trial planned to provide data required for access from a
‘more severe’ sub-population. 200 19/09/2018
The plan for paediatric research must be approved by time
of submission (but we should not start trials that would not
be accepted). We need to align in EU and USA
-Submission
Nov 2017
LP0162-1325ECZTRA1
LP0162-1326ECZTRA2
LP0162-1337LTE ECZTEND
LP0162-1342DDI
LP0162-1341Vaccine Response
LP0162-1339ECZTRA 3 (Combo)
LP0162-1334Confirm- Adolescents
LP0162-1346Cyclosporin Failures
Re-submission of PIP / PSP
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Identical monotherapy trials
• Topicals have failed or aremedically inadvisable
• Primary Objective◦ To evaluate the efficacy of
tralokinumab compared with
placebo
• Primary Endpoints◦ IGA score 0 (clear) or 1 (almost
clear) at Week 16
◦ EASI 75 at Week 16 • 780 subjects per trial
IGA: Investigator’s Global Assessement; EASI: Eczema Area and Severity Index
LP0162-1325ECZTRA1
LP0162-1326ECZTRA2
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• 369 subjects
• Topicals have failed
• Primary Objective◦ To demonstrate that
tralokinumab + TCS is superior
to placebo + TCS
• Primary Endpoints◦ IGA score 0 (clear) or 1 (almost
clear) at Week 16
◦ EASI 75 at Week16
Combination with topical corticosteroidLP0162-1339TCS Combination
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Other trials for initial regulatory submission
• Randomized double-blind, placebo controlled, Vaccine trial, n=200
• Primary Objective◦ To demonstrate immune
responses to vaccines during
tralokinumab treatment
• Primary Endpoints ◦ Positive anti-tetanus response
◦ Positive meningococcal
serogroup C serum bactericidal
assay response at Week 16
• Open label, drug-drug interaction trial, n=30
• Primary Objective◦ To evaluate if tralokinumab after
14 weeks of treatment (steady
state) changes the metabolism of
substrates of CYP 1A2, 2C9,
2C19, 2D6 or 3A4 pathways
• Primary Endpoints◦ Ratio of AUClast and Cmax at Day
105 and Day -7 for the five
substrates
LP0162-1342DDI
LP0162-1341Vaccine Response
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• 294 subjects
• Topicals have failed or aremedically inadvisable
• Primary Objective◦ To evaluate the efficacy of
tralokinumab compared with
placebo
• Primary Endpoints◦ IGA score 0 (clear) or 1 (almost
clear) at Week 16
◦ EASI 75 at Week16
Monotherapy adolescent trialLP0162-1334Confirm- Adolescents
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So what makesthis project so complex?
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Operational Complexity- the number of handovers/touch-points/interfaces
p. 030
LEO
Sites
iLab
National Eczema
Association
Quanticate
Oracle Inform
Oracle IRT
PRO Licencees
Patients
BanookECG
Almac
MedimmuneAstraZeneca
WorldCourier
Covance Labs
ACM Labs
Intellim CROJPN&KOR
DMC Members
CRF HealthPRO
Cook Pharma
Signifikans
C3i Healthcare
LionBridgeTranslations
ITF Printers
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Operational Complexity- examples of the challenges that are being overcome
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• Delivery of dataset to medical monitoring• EDC access & training• IMP supply chain • ePRO equipment & data upload• Updating lab kits because of CTP amendment• CMC amendment, EU• IMP import • Recruitment planning• CRO access to CTMS and eTMF• AZ collaboration of RSI
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The ‘Learning Team’
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Multiple Sources of New Information- opportunities to learn
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2016 2017 2018
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Plan
ExternalInfluence
Execution / Implementation
- AZ experience (e.g phase 2b)- Competitor intelligence- FDA, EMA, PDMA advice- Advisory Boards
- FDA review- protocols- trial outlines
- PIP / PSP negotiation- New dupixent data- KOL input
- Update plan - Amend protocols- Adapt new trials
Flow of information & project integration
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Capture key data for all subjects, regardless of IMP discontinuation – an example of project learning
• FDA raised questions to monotherapy protocols with regard to sensitivity analyses◦ How to evaluate sensitivity of primary analysis results to
deviations from underlying assumptions and limitations in the
data
• Team decision◦ Amend protocol and eCRF to ensure capturing of key data at
time point of primary endpoints
◦ Update statistical methodology incl implementation of draft ICH
E9 addendum terminology on Estimands
◦ Develop a ‘’standard’’ for new trials
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Clarification of exclusion criteria– an example of project learning
• Based on feedback during trial execution, exclusion criterion 18 has been modified ◦ from History of anaphylaxis to History of anaphylaxis following any
biologic therapy
• Rationale: ◦ A large proportion of subjects with moderate to severe AD will have
had food allergies and other allergies during childhood with no
relevance for later risk of anaphylactic reactions to tralokinumab
• Team decision◦ Amend current protocols and adapt in new protocols
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Mastering Internal Changes- circumstances in which we’ve learned
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• New Processes
• New Project Organisation
• New Team Members
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‘Dynamic Team’- The team’s knowledge has to grow in order for it to
deal with current problems in new ways and to increase it’s capacity to deal with the future.
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Tralokinumab Innovations- Investigator Meeting
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Tralokinumab Innovations- Studies&Me
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Pilot:- Dr Saddick – NYC- Dr Papp- Dr Katz
Possibility to move from pilot to regional roll out:- San Diego- Los Angeles- Miami
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Why do we do what’s difficult?
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AD is now where psoriasis was 15 years ago…
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Systemics, Injectables
Phase 1 Phase 2 Phase 3 Marketed
XmAb7195 / Xencor / IgELebrkizimab / Demira (bought from
Roche 1.4bn) / IL-13
Tralokinumab / LEO Pharma
/ IL-13
Dupixent® / Sanofi-Regeneron / IL-4
R & IL-13 R
Bertillibumab / Imm. Pharma / CCL11Nemolizumab / Galderma/Maruho JP/
Roche(Chugai) / IL-31 R
CNTO-7160 / Janssen / IL-33 R Tezepelumab / AZ/Amgen / TSLP
ANB 020 / Anaptysbio / IL-33GBR-830 / Glenmark
OX-40
MEDI-931 / AZ/MedImmune / IL-4Ra Mepolizumab / GSK / IL-5
KHK 4083 / KHK / OX-40 R
MOR 106 / Morphosys-Galapagos /
IL-17C
ADSTEM Stem Cells / EHL Bio.
PF 6817024 / Pfizer
Launch 2021
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However…• Unmet Need• Patient and Clinician awareness
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During the last year we have achieved a lot through learning.
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AchievementsFirst subjects in Phase 3, less than12 months after acquiring tralokinumab- >10 HA interactions- First LEO tralokinumab protocol, final within 3 weeks of last HA input- First CRFs live before FSFT- First class Investigator Meetings (x4)- First use of iLab innovations to support patient recruitment via telemedicine- First roll-put of ECZchange, Investigator Portal- First Japanese subjects in global program- First S. Korean HA approval for LEO- First use of RACT and associated procedure- First use of Data Flow Plan procedure