Symbiotic innovation 082015

InnVentis

Overcoming R&D challenges in the age of PRECISION MEDICINE:

Symbiotic Innovation (SI):

Symbiotic Innovation - © Thomas Wilckens

developed by: Thomas Wilckens, MD

InnVentis Disrupting Biopharmaceutical R&D: The pressing need to improve R&D of Drug and Diagnostics

Broken drug discovery paradigm, not sustainable costs in R&D

Data overflow (*omics deluge)

No standards and SOPs: Garbage in – Garbage out

The Cost Of Creating A New Drug (up to) $5 Billion US-$, Pushing Big Pharma To Change

11/2013

"One of the biggest challenges in medicine and science today is how to interpret the vast amount of biological data we are generating... To make these data interpretable and clinically actionable will require new computational tools.”

Craig Venter 08/2014


InnVentis

Overcoming R&D challenges in the age of PRECISION MEDICINE Implementing optimized value creation in verticals

Symbiotic Innovation

Precision Medicine & Complexity

Lack of ROI and selected challenges

The creation of Symbiotic Innovation

Impact on organisational measure and long term value creation

Summary and conclusions


InnVentis Precision Medicine - Paradigm Shift

Symptom-based Cohort-based Algorithm-based

Yesterday

Intuition Medicine

Today

Evidence-based Medicine

Tomorrow

Precision Medicine

DA

TA

AC

TIO

NS

Application of rules, algorithms and reference databases enables ACTIONABLE clinical decision support & PRECISE/EFFICIENT care

Reference Databases (Rules &

Algorithms)

Personal Molecular

Profiles (PMP, multi-omics)

Molecular Imaging

Non-molecular content (waveforms)

Precision Medicine

(prevention,

diagnosis, treatment)

Mobile Information

Communication Technologies

Big Data Analytics

Precision Medicine © Dr. Thomas Wilckens, InnVentis

InnVentis PRECISION MEDICINE: Integrating multi-omics, clinical and real world data

Eric Topol, CELL,Volume 157, Issue 1, 27 March 2014, Pages 241–253

‘‘omic’’ Latin suffix ‘‘ome’’ = mass or many.

Creation of topological maps

of health/disease

InnVentis The evolution of drug discovery: the complexity challenge A myriad of new converging technologies in iterative processes

Key challenges:

• Integration

• Competence

• Access

• Cost

• Keeping up with technologies

• Reliability & Validity

• Convergence Dx and drug Araz A. Raoof, , Jeroen Aerssens, Drug Discovery Today 4/2015


InnVentis The evolution of drug discovery: the complexity challenge The end of pharma versus diagnostics

Key challenges:

• Which technologies

• Inhouse or sourcing

• Average utilization

• Costs

• Reliability & Validity

Araz A. Raoof, , Jeroen Aerssens, Drug Discovery Today 4/2015


InnVentis InnVentis‘ workflow: the complexity challenge Integration of internal and external resources

InnVentis

Digitalization of society: Vertical silos versus horizontal intelligent infrastructures

Courtesy deep innovation GmbH; Munich


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Improving ROI from biomedical research forces radical changes Biomedical research consumed a disproportional amount of investment

• Many concepts in discussion, some actually request paradoxically even more funding

• All current initiatives & concepts must be considered as experiments themselves, none is validated

• Most reflect the legitimate bias of the developers, related lobbies, regional and/or political interests

• None are based on specific analyses and expertise on economic, sociologic and scientific aspects

• No model has an optimal product centric focus with scientific leadership and cost effectiveness/ROI

• Post hoc analysis of “success” or “failure” have an intrinsic bias; compare The Black Swan N.N. Taleb

The quest for the holy grail in value creation:


InnVentis

“Science Business”, Gari P. Pisano, Harvard Business School Press, 2007

Can Science be a business? It would appear that the answer, based on the experience to date would be no. This answer is, however, only correct, if we take existing organizational and institutional arrangements and existing management technologies as given.

Symbiotic Innovation: Reshaping value creation in biomedical R&D

Academia cannot replace early stage R&D but must establish essential fundaments.

Lessons from biotech should guide the creation of novel anatomies.


InnVentis The routes and development of Symbiotic Innovation: Disruptive innovation at the convergence of technologies creates new principles

Symbiotic Innovation evolves from:

• A disput between hands on experience versus published theories and academic setting

• The analysis of contemporary literature (app 300 publications on value generation etc.)

• www-based reviews and discussions on optimized value creation concepts

• Incorporation of the expertise of opinion leaders in economic and biomedical sciences

• Interviews within pharmaceutical companies

• Personal entrepreneurial experiences with a virtual company over 10 years

• Learnings @deep innovation, frm Mannesmann/Vodafone pilot development


InnVentis Symbiotic Innovation: Reshaping value creation

Current financing and business concepts fail to catch optimized

value from omics and Big-Data analysis

Our proposal:

• Vertically integrated flagships headed by experienced task forces

• Organic platform R&D hubs with advanced big data knowledge

• A solution (product of service) centric flagship

• Optimal sourcing of competence and technologies as needed

• Create incentives for long term symbiotic collaborations

• Find partners opportunistically; compare InnoCentive/Nature vision


InnVentis

Symbiotic Innovation: Facilitating CRO business model Establishing a culture of symbiotic sharing of sources and success

Management spends disproportional time/money to identify and negotiate collaboration deals with an academic leaders and the relevant technology transfer offices or biotech/pharma partners

Discussion on fictive values are waste of time before completing a PoC or Phase II

Neither scientific leadership, nor optimal motivation or critical assessment of the project are secured in consulting, collaboration or “simple” MTT agreements

Single technology CRO deals usually create suboptimal value and knowledge

Knowledge is dispersed and not part of a growing proprietary competence hub

Discovery platform companies face a conflict in resource/financing allocation between the discovery platform and more mature product opportunities

Optimized value growth requires complex technologies along the value chain and collective learning difficult to establish within one single company without a concise focus

Emerging discovery technologies show significant deficits in reliability and validity due to a lack of standardized procedures for sample collection and processing of both, sample and data.

…

A wasteful, inefficient process costing time, resources and energy


InnVentis Open Innovation versus Symbiotic Innovation: Symbiotic Innovation creates Spin-off opportunities for further development

Open Innovation: Innovations are absporbed for internal development to commericalization, Interal innovations are outsourced for external value creation

Symbiotic Innovation; SI is serving research-intensive industries to create innovation externally for internal absorption to scale in a mature stage. Promising ideas are developed in mangend organic networks with competence building and horizontal value chains Spillover high-risk project will be subject to spin-off VC/NGO financing

Competence hub

Innovation Proof of concept Products

Know-how, technologies, tacit knowledge, etc.

Innovation: Prototypte to marketable product.

Proprietary databases

biomarkers NCEs

Spillover for spin-off Drug target, NCE, nutraceutical

R&D


InnVentis Implementing Symbiotic Innovation A project’s specific tasks are posted on the web to attract scientific leaders

• Project specific teams, will orchestrate the virtual R&D process securing quality control

• Technology leaders to become part of a value chain and the ROI by participating in the project

• Participation anticipates acceptance of a master-contract a priori, which eliminates endless negotiations

Sponsor

Solution Product Service

Management team


InnVentis Future leaders in R&D management: career chameleons? Scientific training desired for translational R&D: Do we have qualified personal?

Ideal Profile

Expertise in physiology, physical chemistry, biology, informatics, therapeutics, medicine, understanding of drug discovery, development, …

ICT/Big DATA

Infrastructure, …

Machine or deep learning, …

Data safety & security

Chemical Sciences

Medicinal chemistry-cross over into biology

Chemists with core skills (broadly based synthetic organic chemists) rather than specific areas of the process (e.g. combinatorial chemistry) for large pharma

Chemists with specialized skill sets in smaller pharma and biotech

Biological & Medical Sciences

In vivo/vitro physiology and pharmacology

Molecular biology; biochemistry; cell biology

Bioinformatics

Pathophysiology

Drug metabolism

Pharmacogenetics

Clinical Pharmacology

Managerial skills

Creation of project teams

Addressing scientific needs in a development process towards a product

Orchestration of virtual projects with multiple

Defining and reaching goals & milestons

Generation of industrial standard decision matrices

Leadership

• SI provides new career tracks for entrepreneurial scientists & managers in teams, where

domain competence will be focussed according to each specific projects requirements

• Teams or task forces will be engaged repeated project along their career path

• Never change a winning team, but incentivise it


InnVentis

SI replaces random collaborations with an a priori accepted focus Trusted Interfaces generate value as result of Technology morphing and Collective Learning

NEW Business

IT-hub Services Products

Clinical data

Ontologies

Proteomics

Clinical chemistry

Antibody analysis

Genomics

Literature mining

• New horizontal/vertical synapses continue to create value beyond the completion of a single project

• SI creates long term interfaces between converging disciplines & technologies, i.e. fosters innovation

• Knowledge created by industry standards and collective learning will create a competitive USP

Realiability Validity

Proprietary Data & Algorithms Tech. leadership

Unique Services

InnVentis

Big-Pharma: Translational clinical

development; internal

leadership in drug delivery,

diagnostics, etc.

Symbiotic innovation:

Virtual preclinical/PoC

R&D creates a

sustained pipeline

Project 1 Project 2 Project n

Interactive knowledge transfer

Pharma‘s and academia‘s translational science plattform:

• in silico services, ICT, Big DATA, machine/deep learning

• research tools (*omics, NCEs, ontologies,...)

• animal or other disease models

Interdependent external

and internal review and

risk assessment

SI: Optimizing a global R&D organization for Innovation: CAVEAT project competition obviates collective learning

Input on formulation/drug

delivery/PK etc for

project review

Scientific unit

Scientist manger

Team leader

Knowledge base Technology base

Sponsor

Institution A Institution B Institution C Institution D Institution E Institution n


InnVentis

SI: reduces risks, costs, time and increases the chance for success Successful product development will require sustainable support combined with iterative project evaluation

‘It is not the strongest of the species that survives, nor the most intelligent,

but the one most responsive to change’ Charles Darwin

Imagine, what happenes, if we additionally used our intelligence optimally to create the future?

P. Talaga in Drug Discovery Today 9/2009, Share or die!:


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New anatomies foster innovation and enable Symbiotic Innovation Only engaging all leaders (academia, industry, politics) will allow to create of value from science

Innovation

&

Progress

Strategic alliances

• Optimally aligned strategic and

organizational goals and metrics

Exploit funding of common goals

• Public-private-partnerships

Patients, Pharma, Academia

Long term horizon of expectation

• NMEs entering clinical development not

sole performance criterion

• Integration of scientist thinking, motivation

and interest for recognition/reward

Dogmas, Dinosaurs & Dynasties

• Challenge research anatomies,

concepts, collaborations,

technologies, alliances, …

Creation of leadership

• Creative teams generate innovative

concepts and ideas

• Team leaders implement team ideas

Entrepreneurship & motivation

• Engage entrepreneurial leaders

and create related incentives

• Foster talents and related career

tracks in academia & industry

Exploitation

www.based opportunities

Creation of a competitive edge in globalization


InnVentis

ROI

REWARD

Long term value

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How and why should Symbiotic Innovation work and will be adopted? Current pressure is immense and evolution cannot be stopped

Incentive & Motivation

• New story; soap effect ?

• New revenue stream

• Long term business model?

• It makes sense

Pharmaceutical Industry

• Why should the pharmaceutical industry

engage in this concept?

• Why should the pharmaceutical industry

provide funding and resources?

Incentive & Motivation:

• Early access to innovation

• Diversified risk, decreased costs

• Quality control, absorptive science

• Optimized use of resources & time

• It makes sense

Academic institutions

• What is the incentive for scientists to

engage in these kind of projects

• Why should tech-transfer accept master-

contracts?

Incentive & Motivation

• Access to cutting edge converging

science and resources

• Because Asia doesn’t sleep

• More opportunities for higher ROI

• It makes sense

Media partner/publisher

• For the pilot program scientist

must be continuously attracted

• Why will publishers endorse SI?

Innovate & improve, deliver ROI

Publish & survive; generate USP

for global competition


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Facing the opportunities of omics and Big-data the transitions that take place, innovation & value creation for society and industry appears a feasible goal

Symbiotic Innovation: Fostering value creation from sciences

Big-Data

*omics data Clinical data

Precision Medicine

SI unchains the value of emerging data sets


Symbiotic innovation 082015

Health & Medicine

Transcript of Symbiotic innovation 082015