a virtuous balance between pure and applied science will delaat managing director apru presidents’...
TRANSCRIPT
A Virtuous Balance Between Pure
and Applied Science
Will DelaatManaging Director
APRU Presidents’ Meeting22-24 June 2006
Shifts in Biomedical Innovation
Creating Breakthrough Medicines from Cutting-Edge
Science• 9,500 research employees
• >100 years of innovation (eg antibiotics / anti-
infectives, thiazide diuretics, anti-arthritics, antihypertensives, statins, HIV medicines, vaccines)
• 250-300 patent applications per year
• Nearly $4Bn in R&D spend last year (~1% of world R&D)
• 20 new medicines / vaccines since 1995
Merck’s History of Innovation
“We try never to forget that medicine is for the people. It
is not for profits …If we have remembered that, [the profits] have never failed to appear. …How can we bring the best of medicine to each
and every person? …. We cannot step aside and say that we have achieved our
goal by inventing a new drug or a new way by which to treat presently incurable diseases …. We cannot rest till the way has been found, with our help, to bring our
finest achievement to everyone.”
- George W. Merck, 1951
Dr Randolph T Major (centre), Dr Selman A Waksman (left), Sir Alexander Fleming (1949)
Shifts in Biomedical R&D In approach & technology In partnering - the interplay
between universities, biotechs and pharmaceutical companies
In the study of life sciences.
A shift in the approach to biomedical R&D & technology
Eras in Drug Discovery
• Pre-1990’s Drugs ‘discovered not designed’ Resource intensive screening of
biologically active compounds• 1990’s Molecular biology in full swing
The Biotechnology Era begins• 2000 The Dawn of Genomics
5,000-10,000 potential drug targets identified
The 90’s – Biotechnology Era
• 500 targets identified in 1990’s (receptors + enzymes)
• Synthesis of compounds rDNA MAb Structure-based drug
design Combinatorial
chemistry• High Throughput
Screening
A ‘simple’ enzyme(alcohol dehydrogenase)
The New Millennium –The Dawn of Genomics
Genomics will have a major impact on drug discovery and development and will change the way
that medicine is practiced.
The Pace of DiscoveryAfter Human Genome comprehensive sequence was
published in 2001
Key Milestones have been:• Advances in Structural Biology
3D structures in days and weeks, not months and years• Rapid generation of Monoclonal Antibodies
humanized mice; phage libraries• RNA interference
profiles as genome sensors• Proteomics
approaching required bandwidth• Pharmacogenomics
as the basis for response/non response• Engineering Sciences, Informatics
dramatically influencing biological sciences (UHTS; Bioinformatics)
• Biomarkers Predict response, disease resistance or toxicity
A shift towards greater partnering - the interplay
between universities, biotechs and pharmaceutical companies
Professor Ian Frazer
Number of Biomedical Alliances 1990 to 2005
Number of Bio Medical Alliances 1990 to 2005
0
500
1000
1500
2000
2500
1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Drug-Biotech Biotech-Biotech Drug-Drug Uni-Biotech Uni-Drug
Source: Recap June 2006
Shifts In Pharma Value Chain
HMOs
RESULT HAS BEEN DECONSTRUCTION OF THE PHARMA VALUE CHAIN
Research Development Trials Registration Manufac-turing
Sales &marketing
PBMs
Research Development Trials Registration Manufac-turing
Sales &marketing
Academic labs
Biotech firms
Contract research organizations
CMOsJVs/
licensing
Increased development costs
Role of global launches increasing
Quality outsourcers leverage scale advantages in individual layers of value chain (specialized)
Easier IT enabled coordination and knowledge management
CSOs
Late 1990’s -Early 2000’s
1980’s -Early 1990’s
Note: PBM=Pharmaceutical benefit management, HMO=Health maintenance organization, CMO= Contract manufacturing organization, CSO=Contract sales organizationSource: BCG analysis
Five Enablers For Innovation
Merck has identified five key conditions necessary for successful innovation:
1.A market based on competition, customer choice and a pricing structure that rewards innovation.
2.Effective intellectual property protection3.Regulatory systems that put patients first
by approving effective and safe new drugs for critical diseases as rapidly as possible.
4.A global business environment based on free-market principles and the rule of law.
5.Continued government support of basic biomedical research
Bioscience ClusterMoneyMoney InfrastructureInfrastructure
ScienceScience
Talent
Life Science Cluster – Partnerships are critical
UCSDScrippsInstitute of
Oceanography
Burnham Institute
Sidney Kimmel
La Jolla Institute of Allergies and Immunology
The Scripps Research Institute
Neurosciences Institute
UCSDScrippsInstitute of
Oceanography
Salk Institute
Burnham Institute
Sidney Kimmel
La Jolla Institute of Allergies and Immunology
The Scripps Research Institute
Neurosciences Institute
San Diego Cluster Partners - Research Institutes
San Diego Cluster Partners- Pharma Companies
Pfizer Lilly
Novartis
Merck
Johnson & Johnson
Cluster Partners - Boston
This “agreement is an example of the kind of strategic partnerships that we like to build with an industrial partner to bring fundamental research forward
as a potential new therapy. By combining the licensing rights and
the expertise behind the original findings, and partnering with a leading
company such as Merck, we can advance this research into clinical development and application much
faster than would otherwise by possible.”
Isaac T. Kohlberg, Head, Technology Development Office, Harvard University -
2004
Harvard University’s View of Strategic Partnerships
A shift in the study of life sciences
State of Chemistry in Australian Universities
Chemistry, Biology and Physical Science University Studentsas a percentage of all University Students
International Perspective on Science Graduates
Within the university context, the number of science graduates as a proportion of all graduates in the US is low compared with other OECD countries. In 2000, for example, only about one-sixth of the total number of university degrees conferred was in science compared with one-quarter of all degrees in the EU and in Japan.
(OECD, 2004)
In South Korea, 38% of all undergraduates receive their degrees in science or engineering. In France, the figure is 47%, in China, 50% and in Singapore 67%. In the United States, the corresponding figure is 15%.
(National Academies of Sciences, 2006)
Some 34% of doctoral degrees in sciences in the United States are awarded to foreign-born students. In the US, science and technology workforce in 2000, 38% were foreign born.
(National Academies of Sciences, 2006)
UK Looking Overseas for Science Graduates
• UK companies are starting to recruit science graduates from overseas rather than rely on the home market because they have a larger pool of high calibre students to choose from.
• China is producing 300,000 graduates every year in science, technology, engineering and mathematics – three times the number coming through UK universities.
• India has 450,000 engineering undergraduates in the current academic year alone.
Confederation of British Industry (CBI)March 2006
Recruitment of Science Graduates to Industry
Pharma Industry – Largest Employer of Science Graduates
(USA)
Sectors employing newly graduated chemists in the US (2002).Adapted from Chemistry and Engineering News (Mehta. 2003)
Universities can help to:
• Commercialise innovations via licences, strong patents and establishing start-ups
• Assemble multi-disciplinary consulting teams for international development projects;
• Provide a wide range of consulting, testing, expert opinion and advisory services as well as research and development projects.
• Promulgate the importance of science-based careers
What Can Universities Do To Support Biomedical Innovation
In summary …
• Drug Discovery is entering an exciting new era
• It requires a healthy interplay between pure and
applied science a steady flow of talent from academia an entrepreneurial spirit the capital, know-how and creativity
of Big Pharma