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