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Risk Communication in NDA (New Drug Application). Massie Ikeda MD, PhD Chief Medical Reviewer P harmaceuticals and M edical D evices A gency. Standard Disclaimer. This is not an official PMDA/MHLW guidance or policy statement.

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risk communication in nda new drug application

Risk Communication inNDA (New Drug Application)

Massie Ikeda MD, PhD

Chief Medical Reviewer

Pharmaceuticals and Medical Devices Agency

standard disclaimer
Standard Disclaimer
  • This is not an official PMDA/MHLW guidance or policy statement.
  • No official support of endorsement by PMDA/MHLW is intended or should be inferred.
today s topics why do we need
Today’s TopicsWhy do we need:
  • Clinical trials ?
  • Regulatory body ?
  • Risk communication ?
new drug reminds you of
“New Drug” reminds you of・・・
  • Newspaper Articles
  • Tough Diseases: HIV, Cancer
  • High-Techs in Medicine
  • Severe Adverse Effects
  • Mega Pharma Companies
  • Clinical Trials
why do we need clinical trials
Why do we need clinical trials ?
  • Is it OK with animal data only ?
  • Let safe drugs only go into the market?
  • Are clinical trials dangerous?
  • Let us leave to the doctors?
  • Why do we need placebo ?
slide6
We humans needour own human data.You never want dog or cat food on your dinner menu.The same with your drug.
slide7
Are you happy withalternative medicine only?You probably need drugs whose data have been scientifically reviewed.
today s topics why do we need9
Today’s TopicsWhy do we need:
  • Clinical trials ?
  • Regulatory body ?
  • Risk communication ?
independent body regulatory authority
Independent BodyRegulatory Authority
  • PMDA
  • FDA
  • EMEA

In your home country?

slide12

MHLW

JPMA

ICH

EMEA

FDA

PhRMA

EFPIA

slide13

ICHInternational Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

slide14
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
  • Japan, USA, EU
  • To make common regulations and share data on clinical trials
  • It is not an academic conference
  • Working on drugs but not on devices
what is ich e5 for
What is ICH E5 for?
  • For providing good drugs faster to everybody in the world, especially ICH resions.
  • It is not intended to bypass important domestic clinical studies.
importance of ethnic differences
Importance of ethnic differences
  • Intrinsic

PK/PD, genetic analysis (in future), etc.

  • Extrinsic

differences in clinical practice, etc.

an example of difference among asians sars hla typing
An example of difference among Asians SARS & HLA typing

HLAB46

Jpn 4.4

Krn 4.4

Vtnm 13.2

Sngp 15.1

Kanton 15.4

importance of ethnic differences25
Importance of ethnic differences
  • Intrinsic

PK/PD, genetic analysis (in future), etc.

  • Extrinsic

differences in clinical practice, etc.

slide26

Japan

USA

Health insurance

system A

FDA

approval

MHLW

approval

Health insurance

system B

Universal health insurance

coverage

国民皆保険

Health insurance

system C

ctd common technical document as cv of the drug
CTD(Common Technical Document)as CV of the Drug

Our common ground to analyse the benefits and risks of the drug

ctd as a cv of the new drug

CTD as a CV of the new drug

CURRICULUM VITAE FORMATFORTENURE AND PROMOTION DOSSIERS

NAME: ___________________________________________________________

(Last)

(First)

(Initial)

EDUCATION:

UNDERGRADUATE: ________________________________________ GRADUATE: _______________________________________________POST DOCTORAL: _________________________________________

ACADEMIC APPOINTMENTS (inclusive dates):

OTHER APPOINTMENTS AND PROFESSIONAL CONSULTANTSHIPS (including other remunerated employment):

LICENSURE AND CERTIFICATION:

Disclosure & accountability is essential.

ctd as cv of the drug
CTD as CV of the Drug
  • Disclosure & Accountability
    • It is not a brochure or propaganda
    • Disclosure of not only the benefit
    • Explain why
      • The drug is indicated to the target
      • The drug overcomes the rivals
ctd is
CTD is
  • CV of the drug application
  • Common ground of communication
  • Key for disclosure and accountability
time to approval

PMDEC/MHLWNDA

FDA (CDER)

Standard NDA

approved year

approvals

median months to approval

approvals

median months to approval

1997

40

33.6

101

15.0

1998

58

36.6

65

12.0

1999

71

30.6

55

13.8

2000

84

18.8

78

12.0

2001

57

15.5

56

14.0

2002

67

15.3

Time to approval

52

15.8

today s topics why do we need32
Today’s TopicsWhy do we need:
  • Clinical trials ?
  • Regulatory body ?
  • Risk communication ?
our mission
Our Mission

Risk

Benefit

no bad news is bad news

No bad news is bad news

when people are not aware of its shadow.

why not share the bad news
Why not share the bad news ?

because it comes out sooner or later.

difficulties in risk communication
Difficulties in risk communication
  • Liability
  • Conflicts of interests
  • Uncertainty & Variety
    • Adverse events: Drug-related on not
    • One understands A causes B but others do not
    • Changes as time goes by
but we have to share bad news because
But we have to share bad news because:
  • It will come out, anyway.
  • Early intervention before disaster
  • Stay calm & avoid panic
  • To correct the system effectively
  • To make no scapegoat
common flaws in nda
Common Flaws in NDA
  • Focus only on efficacy instead of safety
  • Insisting on safety:
    • No significant difference compared with the placebo
    • No causal relationship
    • Very low frequency
    • No similar case in PMS outside Japan
our common aim regulatory authority pharma co good drugs for people

Our Common Aim-Regulatory Authority & Pharma Co-Good Drugs for People

Not conflict but Cooperation

the sooner the better the lessons from rofecoxib vioxx
The sooner, the better ?The lessons from Rofecoxib ( Vioxx)
  • Cox2 Inhibitor
    • Stomach-friendly super aspirin
    • FDA approved in May 1999
  • Voluntary withdrawal in September 2004
  • Due to an increased risk of cardiovascular events (including heart attack and stroke)
stop confrontation
Stop Confrontation

Drug Co.

Citizens

Media

Government

future issues
Future Issues
  • Synthesizing data on safety
    • Pharmacovigilance system
    • Harmonization on safety data
  • Safety and order-made medicine, e.g. SNP
  • Media Relation
    • Risk Communication with lay press & people