Autumn Introductory Course 2018 - Day 2 Handouts

24/10/2018

What are some of the key aspects considered as contributing to a Successful Global Development?

Why is Successful Global Development Important?

 Recoup Costs  R&D Spending Rising  Typical NCE Costs $1 Billion plus* and rising  Marketing becoming more difficult and expensive  Competitors  Regulatory hurdles, eg Regulatory Commitments, RMP  Treatment guidelines / formulary committees  Pricing pressures from payors *Herper,Matthew (11August 2013). "TheCostOfCreatingANewDrugNow $5Billion, Pushing BigPharmaToChange". Forbes, Pharma&Healthcare. Retrieved 17 July 2016.

 Regulatory Submission in all major territories (USA, Japan, Europe and others) within one year  A label and promotion claims to support successful launch  Health economics, health outcomes and pricing data to support formulary committee acceptance and target price  The patient receives the drug

Drug Discovery & Development Process

Overview of Discovery Research

Identify Disease (Medical & Market need)

File Patent

Years

15 14

0

5

6

7

9

12 13

DISCOVERY

Candidate Nomination

HITS

Clinical Development

TOX

Idea

I

Hits to Lead, Optimise Lead Candidate

Hits (Identify compounds)

II

PK & Safety

III Pilot Efficacy Full development Comparative

Validate Target

Identify Target (role in disease)

agents Filing

(confirm role & develop screen for search)

Approval Process

Non-clinical

Clinical

Registration (Approval)

Drug Discovery & Development Process

Preclinical Safety Evaluations To proceed - appropriate safety profile & ideally:  Target organs identified  Methods identified for monitoring toxicity & blood drug levels in the clinic  Type of toxicity observed in animals is predictive of toxicity in human  There are adequate exposure & dose safety margins for the patient population & for the indication involved  Don’t forget the guidelines  never be afraid to consult them  and be warned!!!!! always go back to the source rather then keeping copies as they do change  Justify any deviations from the guidelines  Preclinical development not about ticking boxes!  what mitigation do you have in place or planned for the holes

File Patent

Years

15 14

0

5

6

7

9

12 13

DISCOVERY

Candidate Nomination

TOX

Idea

I

II

PK & Safety

III Pilot Efficacy Full development Comparative

agents Filing

Approval Process

Non-clinical

Clinical

Registration (Approval)

2

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