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Samsung BIO Insight

The Value of Reducing Your Drug Development Timeline


 

SAMSUNG BIOLOGICS

SPEED MATTERS

The Value of Reducing Your Drug Development Timeline

Getting a biologic drug from development to market can be challenging

It takes at least 10-15 years form discovery to market
Average of $2.6 billion to develop a new drug

The drug lifecycle of discovery, development, and approval process is time-intensive

1. DISCOVERY/PRECLNICAL TESTING 2. DEVELOPMENT 3.APPROVAL

Average of 10-15 YEARS from Discovery to Approval

Discovery & Proof of Concept (PoC)
6.5 YEARS
Assess safety, biological activity, and formulations
Phase 1
1.5 YEARS
Determine safety and dosage
Phase 2
2 YEARS
Evaluate effectvencess, look for side effects
Phase 3
3.5 YEARS
Confirm effectvencess, monitor adverse reactions from long-term use
FDA
1.5 YEARS
Review and approval process
Additional post-marketing testing repuired by regulatory agencies

Drug approval is a long journey with countless hurdles along thw way

MORE THAN 13,583 CANDIDATES are ay the pre-IND stage for biologics
13,583
Pre-IND
31.8%
LESS THAN 1/3 CABDIDATES make it to clinical trials
4,319
clinical trials
9.6%
ONLY 3% OF THESE CABDIDATES will successfully make it to market
415
Approved

Unexpected delays during the journey causes significant cash burn and loss of opportunities

85% of clinical trials are delays

43% of companies report lacking the necessary agility and redundancy to respond to supply chain disruptions due to COVID-19

Recent research found that $600,000 to $8million is not every day due to delay in development and commercialization

According to a recent study, First-to-market entrants achieve the greatest matket share

1st pioneer
40%
2nd pioneer
33%
3rd
19%
4th
13%
5th
8%
6th
2%

Average market share (measured by sales) based on anallusis of 492 drug launches in 131 classes over a 27-year period

TIME TO MARKET MATTERS

Samsumg Biologics accelerates your journey from development to commercialization

Speed
ACCELERATED TIMELINE
From DNA to IND as fast as 9 months using our Faster & Better established processes
Infrastructure
END-TO-END MANUFACTURING CAPACITY
Multiscale capacity providing end-to-end service offerings with flexibility with utmost speed and cost-effectiveness
Expertise
ONE DEDICATED TEAM
A dedicated team to quickly drive your Projects to completion from early development through clinical and commercial manufacturing

Fast-track your pipeline with us to augment your capacity and expertise, refind your processes, and ultimately shorten your time to market

 

 

Related contents 

 

Samsung BIO Insight The Benefit of Speed, Scale & Quality | Explore Samsung Biologics' CMO Strengths

Samsung BIO Insight Advance Your Molecule to Success with a True End-to-End Partner 

Whitepapers Redefining Speed In Drug Development : Samsung Biologics' S-Cellerate™ Platform 

 


 

SAMSUNG BIOLOGICS

SPEED MATTERS

The Value of Reducing Your Drug Development Timeline

Getting a biologic drug from development to market can be challenging

It takes at least 10-15 years form discovery to market
Average of $2.6 billion to develop a new drug

The drug lifecycle of discovery, development, and approval process is time-intensive

1. DISCOVERY/PRECLNICAL TESTING 2. DEVELOPMENT 3.APPROVAL

Average of 10-15 YEARS from Discovery to Approval

Discovery & Proof of Concept (PoC)
6.5 YEARS
Assess safety, biological activity, and formulations
Phase 1
1.5 YEARS
Determine safety and dosage
Phase 2
2 YEARS
Evaluate effectvencess, look for side effects
Phase 3
3.5 YEARS
Confirm effectvencess, monitor adverse reactions from long-term use
FDA
1.5 YEARS
Review and approval process
Additional post-marketing testing repuired by regulatory agencies

Drug approval is a long journey with countless hurdles along thw way

MORE THAN 13,583 CANDIDATES are ay the pre-IND stage for biologics
13,583
Pre-IND
31.8%
LESS THAN 1/3 CABDIDATES make it to clinical trials
4,319
clinical trials
9.6%
ONLY 3% OF THESE CABDIDATES will successfully make it to market
415
Approved

Unexpected delays during the journey causes significant cash burn and loss of opportunities

85% of clinical trials are delays

43% of companies report lacking the necessary agility and redundancy to respond to supply chain disruptions due to COVID-19

Recent research found that $600,000 to $8million is not every day due to delay in development and commercialization

According to a recent study, First-to-market entrants achieve the greatest matket share

1st pioneer
40%
2nd pioneer
33%
3rd
19%
4th
13%
5th
8%
6th
2%

Average market share (measured by sales) based on anallusis of 492 drug launches in 131 classes over a 27-year period

TIME TO MARKET MATTERS

Samsumg Biologics accelerates your journey from development to commercialization

Speed
ACCELERATED TIMELINE
From DNA to IND as fast as 9 months using our Faster & Better established processes
Infrastructure
END-TO-END MANUFACTURING CAPACITY
Multiscale capacity providing end-to-end service offerings with flexibility with utmost speed and cost-effectiveness
Expertise
ONE DEDICATED TEAM
A dedicated team to quickly drive your Projects to completion from early development through clinical and commercial manufacturing

Fast-track your pipeline with us to augment your capacity and expertise, refind your processes, and ultimately shorten your time to market

 

 

Related contents 

 

Samsung BIO Insight The Benefit of Speed, Scale & Quality | Explore Samsung Biologics' CMO Strengths

Samsung BIO Insight Advance Your Molecule to Success with a True End-to-End Partner 

Whitepapers Redefining Speed In Drug Development : Samsung Biologics' S-Cellerate™ Platform 

 

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