cfo track john lawson & pierre bourassa traditional drug development process
TRANSCRIPT
CFO Track
John Lawson & Pierre Bourassa
Traditional Drug Development process
Preclinical Testing
Phase I
Phase IIA
Phase IIB
Phase III
NDA
Market
Va
lue C
reatio
n
Discovery5,000-10,000 compounds screened
250 compounds enter pre-clinical
5 compounds go to Phase I
80% pass Phase I
30% pass Phase II
80% pass Phase III
One compound makes it to Market
Source: Ernst&Young Convergence: The Biotechnology Industry Report, 2000
Risk vs. valuation correlation
Source: MDS
Retain a good investment infrastructure Agreements on market access & price Flexible competitive worker costs International respect for patents Growth in healthcare spending
Regulatory alignment with FDA Parallel approval systems Acceptability of Canadian data Similar ethnic/genetic profile to
Maintain integrated healthcare system Strong primary/secondary care links Access for strong Canadian CROs Low propensity towards litigation
Encouragement to do large clinical trials They generate income They reduce drug costs They give access to newer therapies
Economic production facilities for biologics 25% of drug pipelines involve biologics Grow expertise in adding IP to
processes Provide facilities for bio-manufacturing
Encourage research to replenish pipelines Fund basic & pre-clinical research Expand enabling technologies
(genomics) Stimulate convergence of expertise
Move core activities along drug cycle Foster clinical expertise Incentivise professionals not to migrate Share in global sales successes
Nurture SME spin-offs Provide core university/institute funding
Support a stable Canadian VC structure Provide attractive R&D credits
Bourassa & Lawson 2007
Stay focused Investors want to see steady linear progress Product valuation triples from Phase II to III Drug/market complexity increases competitive
barriersUnderstand your true worth Market ‘need’ is more important than its current
size Drug companies have declining pipelines Value increases in areas of unmet medical need
Assure the integrity of your IP Look for, and cover, potential loopholes in patents Perform good searches of competitors/channels Consider bio-production to add/extend protection
Consider niche or limited applications
Orphan drugs may be fast tracked Move further along value chain in small segments Consider niche global markets with few KOLs
Time is of the essence Every day is worth an average $1 million in sales Get adequate early funding, return visits waste
time Quick results bring investor credibility
Speak to Big Pharma early Adequately protect your conversations Use enabling technologies (eg. genomics) where
possible Stimulate convergence of expertise (local clusters)
Bourassa & Lawson 2007
Today’s panelistsBertrand Bolduc, President & CEO Mistral
Pharma
Adam Buckley, VP Variation Biotech
Jean Paul Castaigne, CEO Angiochem
Monique Letourneau, CFO Ambrilia