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T. Gottwald, ovesco

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From Blue Skies to Pots of Gold:<br />

"Picking the Winners - Risk Analysis and Product<br />

Development in the Pharmaceutical Industry”<br />

Brussels, November 3rd, 2009<br />

Thomas <strong>Gottwald</strong><br />

Thomas <strong>Gottwald</strong> Ovesco Endoscopy AG<br />

From Blue Skies to Pots of Gold Brussels Nov 2009


Numerous obstacles and risks alongside the value chain<br />

Disease<br />

selection<br />

Target<br />

family<br />

selection<br />

Decision<br />

Points<br />

Source: in part GSK<br />

Genefunctiontarget<br />

association<br />

Commit<br />

to product<br />

type<br />

Target to<br />

tractable<br />

hit<br />

Commit to<br />

target<br />

Thomas <strong>Gottwald</strong> Ovesco Endoscopy AG<br />

From Blue Skies to Pots of Gold Brussels Nov 2009<br />

Phases of product development<br />

Tractable<br />

hit to<br />

candidate<br />

Tractable<br />

hit<br />

• Numerous players:<br />

Pre-clinical<br />

Candidate<br />

selection<br />

1st in<br />

man<br />

to<br />

PoC<br />

PoC to<br />

commit to<br />

Phase III<br />

Phase III<br />

1st in man PoC Commit<br />

to<br />

Phase III<br />

File and<br />

launch<br />

Commit to<br />

launch/<br />

NDA filing<br />

academia, clinicians, financial world, foundations and<br />

grants, governments, industry, insurers, media, mother<br />

nature, patients, regulatory bodies...<br />

• Each player pursuing their own agenda!<br />

Life cycle<br />

management<br />

Marketing<br />

approval &<br />

launch


Do the right thing !<br />

Strategic Focus and Portfoliomanagement define the „What“?<br />

Define strategic<br />

focus in R&D<br />

Thomas <strong>Gottwald</strong> Ovesco Endoscopy AG<br />

From Blue Skies to Pots of Gold Brussels Nov 2009<br />

Do we do the right thing?<br />

Portfoliomanagement<br />

in R&D


Portfolio-management: business specific evaluation criteria<br />

Portfolio-management: Criteria for assessing competitive business specific intensity evaluation (2) (1)<br />

criteria<br />

Criteria Criteriato to assess assesstechnical economicrisk risk<br />

Portfolio-management: Criteria to assess strategic „fit“ business High specific Industry Attractiveness evaluation criteria<br />

Low<br />

Criteria / Rating 1 2 3 4 5 Percentage<br />

Criteria / Rating 1 2 High 3 Industry4 Attractiveness 5 Percentage Low<br />

Low Competitive Intensity High<br />

Criteria Criteria / Ratingto assess 1economic 2 attractiveness<br />

Low 3 Competitive 4 Intensity 5 High Percentage<br />

Criteria Criteria/Rating / Rating 1 2 3 4 5 Percentage Criteria/Rating 1 2 3 4 5 Percentage<br />

Uncertainty 1. 3. Threat Power regarding of buyers new entrants (entry barriers)<br />

Weighted result<br />

Weighted result<br />

Weighted Competitive result<br />

Weighted Intensity result<br />

Weighted result Intensity<br />

Summary<br />

sales by units high medium low<br />

Probability - Economies Importance of success of sale single buying not important large small very<br />

(< 40%) (> 90%)<br />

Fit<br />

Criteria<br />

for-to realization the business<br />

/ Product Industry Rating<br />

of the differentiation as strategy a customernone<br />

1<br />

< 20%<br />

2<br />

20-40% medium<br />

3<br />

40-60% high 4<br />

60-80% high<br />

5<br />

80-100% low Percentage<br />

Criteria objective Uncertainty / Rating as described regarding in 1 high 2 3 medium 4 5 low Percentage<br />

- Capital Concentration requirements of buyers large (> $1B) low small not important ($ 1MM)<br />

the cost project estimate plan<br />

(< 40%) (> 90%)<br />

Potential - for Cost Importance market/ disadvantages of Industry`s lowproduct to buyer medium many very high few not important<br />

Sales<br />

technology<br />

potential<br />

Third Market position leadership weak tenable favourable strong dominant<br />

(mio € - party<br />

p.a.) (independent Threat patent of backward of size) < Integration broad based/<br />

20 to buyers 20-50 50-100 not limited, likely none<br />

100-500 > 500credible<br />

threat<br />

situation strong possible to<br />

Type - of Technology Access Threat of of forward distribution Integration Base- channels by Industry credible<br />

bypass Emerging- difficult threat Key- easy not likely<br />

Return<br />

Advantage - on investment*<br />

compared Government Buyer´s cost topolicy of switching < 5<br />

techn. low<br />

% supplier 5-10 % 10-15 antagonistic medium techn.<br />

% high 15-20 % >20<br />

techn.<br />

%<br />

high supportive low<br />

exist. products/technologies<br />

(patent Platform Match - of<br />

situation, of available Past Industry`s further behaviour share in<br />

economic<br />

of of incumbents total none house cost of not buyers`s in possible house fights low not in yes house acquiescens<br />

high<br />

factors) expansion resources and project available, available, available<br />

- Maturity materials<br />

aging embryonic/growth<br />

Maturity requirements business segm. Age difficult to Mature Embryonic can be foundGrowth<br />

early Growth<br />

- Profitability of buyers find outside outside high low<br />

Synergies 2. Power to otherof suppliersnone<br />

medium high<br />

projects<br />

Development -4. Importance Threat cycle of substitution of single supplier<br />

no known<br />

not<br />

potential<br />

important very<br />

currently losing volume<br />

Market Own -Market growth patent with rate situation low(xGDP**) < 1 none - 1 - 1,5 >10 1,5 - 2,0 limited, 5-10 2,0 - 3,0 3-4 > broad 3.0<br />

Sum<br />

20 5-10 bypass<br />

slightly few/large 3-5 low - high10 Threat Capacity of increment forward integration size3-10 - small not


R & D portfolio – selection process<br />

Portfolios can be tailored to reflect the situation. Specific decision to be made with<br />

regard to...<br />

Attractivity<br />

Economical attractivity<br />

Economical risk<br />

Know-how position<br />

Annual budget<br />

Annual budget<br />

Thomas <strong>Gottwald</strong> Ovesco Endoscopy AG<br />

From Blue Skies to Pots of Gold Brussels Nov 2009<br />

Risk<br />

Strategic fit<br />

Technical risk<br />

Attractivity<br />

Type of technology<br />

Time frame


Pick the right thing and decide !<br />

Thomas <strong>Gottwald</strong> Ovesco Endoscopy AG<br />

From Blue Skies to Pots of Gold Brussels Nov 2009


Prioritize !<br />

Thomas <strong>Gottwald</strong> Ovesco Endoscopy AG<br />

From Blue Skies to Pots of Gold Brussels Nov 2009


Partner !<br />

Thomas <strong>Gottwald</strong> Ovesco Endoscopy AG<br />

From Blue Skies to Pots of Gold Brussels Nov 2009


...with partners of these qualities<br />

• Solid drug discovery engine/pipeline<br />

• Capability of developing compounds to proof of concept<br />

• A growing asset portfolio, ideally close to or in the<br />

clinical phase (phase II ?!)<br />

• Leader in a specific technology or therapeutic area<br />

based on solid science<br />

• A strong management team<br />

• Solid financial situation<br />

Thomas <strong>Gottwald</strong> Ovesco Endoscopy AG<br />

From Blue Skies to Pots of Gold Brussels Nov 2009


You have to take risks…<br />

Risk ?<br />

Thomas <strong>Gottwald</strong> Ovesco Endoscopy AG<br />

From Blue Skies to Pots of Gold Brussels Nov 2009<br />

Yes<br />

No


…but wisely!<br />

The triangle of constraints<br />

Thomas <strong>Gottwald</strong> Ovesco Endoscopy AG<br />

From Blue Skies to Pots of Gold Brussels Nov 2009<br />

Time<br />

Scope<br />

Resources


All players got to learn their lesson !<br />

Thomas <strong>Gottwald</strong> Ovesco Endoscopy AG<br />

From Blue Skies to Pots of Gold Brussels Nov 2009<br />

Pitfalls and problems at a glance<br />

– Lack of Communication: pyramid versus permeability<br />

– Lack of sense for innovation<br />

– Risk aversion versus vision<br />

– Resistance to change<br />

– Partnering as a paralyzing process<br />

– Founder syndrome<br />

– Overregulation<br />

– Shyness of competition in almost all segments<br />

– Eminence versus evidence<br />

– Lack of entrepreneurship<br />

– Chasing the “3 month target” versus strategy<br />

– Stubbornness<br />

– Producing the compound<br />

– Structure and organization<br />

Size


…and the winner is ?!<br />

Academia<br />

Industry<br />

„Environment“<br />

Thomas <strong>Gottwald</strong> Ovesco Endoscopy AG<br />

From Blue Skies to Pots of Gold Brussels Nov 2009<br />

Prerequisites for success<br />

“Ivory tower”<br />

Solid IP-strategy<br />

Business plan competitions, grant applications<br />

Open-minded founders and universities<br />

Partnering conferences<br />

Coached scientists (finance, QM & structure, focus, production)<br />

Visionary CEOs and CSOs<br />

Strategy<br />

Solid IP and contracts<br />

Entrepreneurship<br />

Facilitating governments and regulatory bodies<br />

Grants and programs<br />

Human factor<br />

Communication, communication, communication<br />

Success


You have to take risks…<br />

Thomas <strong>Gottwald</strong> Ovesco Endoscopy AG<br />

From Blue Skies to Pots of Gold Brussels Nov 2009<br />

…Pots of Gold !

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