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Leadership, Governance and Management of
World-class healthcare companies
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THE THINKER; THE LEADER
What It Takes To Run the Show in the Biotech Industry
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Agenda
1. A Strategic Overview on Bio-Entrepreneurship & Innovation
2. Corporate Governance for Start-Ups & Spin-Offs
3. Strategic Management of Bio-oriented Technology Companies
4. Systems and Organizational Management
5. Project and Program Management
6. Regulatory and Best Practice Considerations
7. Best Practices from GMP to GCP and Beyond
8. Marketing and Sales Operations
9. Research and Development10. Strategic Alliances and Partnering
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A STRATEGIC OVERVIEW
Bio-Entrepreneurship & Innovation
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Perspectives
The tale of Spencer
Silver Chemist at the Minnesota
Mining and ManufacturingCompany
Produced fantastically weak glue
Refused to allow his failedexperiment to dissipate into theether
Placed the shoddy adhesive onthe back of yellow scratch paper,creating one of 20thcenturysmost successful franchises
People only see what they are prepared to see. - Ralph Waldo Emerson
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Growth in Biotechnology Centres
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Source: http://www.ey.com/Publication/vwLUAssets/Beyond_borders_2012/$FILE/Beyond_borders_2012.pdf
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Discard Fear
Fear of Failure
Fear of Inadequacy
Fear of Risks Fear of Financial Insecurity
Fear of What Others Will Think
Fear of Growth
Lace Up Your Nikes and Just Do It
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Source: http://www.success.com/articles/1310-the-deadly-fears-of-entrepreneurship
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Energy
An essential ingredient to any start-up is
Drive.
The founders must have sufficient energy and conviction to carry them through the ups
and downs they will inevitably face.
ability to communicate this enthusiasmto their employees in
such a way that it becomes contagious and part of the
company's culture.
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Success is due less to ability than to zeal. - Charles Buxton
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Energy: Tony Coles of Onyx
Tony Coles was selected as CEO of Onyx in
2008. It was a one-drug company then.
Under Coles' leadership, Onyx is now a three-
drug company.
The multiple myeloma drug, Kyprolis received
FDA approval in July.
Onyx is no longer the weak spouse in its
marriage to Bayer.
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Success is due less to ability than to zeal. - Charles Buxton
Source: http://www.thestreet.com/story/11787489/2/best-biotech-ceo-of-2012-your-vote-counts.html
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Wisdom
Awareness of the challenges faced Do not seek to conceal them
Knowing ones strength Partnerships in order to make up for shortcomings
Good technical background and a grasp of the
company's technology
Such wisdom is acquired from years of experience and
lessons learned
Self Awareness and Realism
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Types of Biotechnology
Agricultural Green-energy Pharmaceutical
Aqua-Marine Industrial
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Agricultural Biotechnology
Agricultural Green-energy Pharmaceutical
Aqua-Marine Industrial
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Agricultural biotechnologyis a set of tools and disciplines meant to
modify organisms for a particular purpose. That purpose can include
anything from coaxing greater yields from food crops to building in anatural resistance to certain diseases. Though there are multiple ways to
accomplish this goal, the method that tends to get the most attention
from the public is genetic modification.
Source: http://science.howstuffworks.com/life/genetic/agricultural-biotechnology.htm
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Green-energy Biotechnology
Agricultural Green-energy Pharmaceutical
Aqua-Marine Industrial
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Green-energy biotechnologyis sustainable bioenergy system which has:
1. resource efficiency
2. a high energy efficiency3. maximized environmental benefits and
4. cost efficiency
Source: http://www.biotek.lu.se/research/renewable_energy/
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Pharmaceutical Biotechnology
Agricultural Green-energy Pharmaceutical
Aqua-Marine Industrial
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Source: http://www.uic.edu/depts/cphb/CPB/Welcome.html
Pharmaceutical Biotechnology is an increasingly important area of science
and technology, and contributes to design and delivery of new therapeutic
drugs, the development of diagnostic agents for medical tests, and thebeginnings of gene therapy for correcting the medical symptoms of
hereditary diseases.
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Aqua-Marine Biotechnology
Agricultural Green-energy Pharmaceutical
Aqua-Marine Industrial
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Marine biotechnology is an emerging field encompassing marine
biomedicine (new pharmaceuticals discovery), materials technology,
bioremediation, marine biomedical model organisms, molecular genetics,
genomics, bioinformatics and much more.
Source: http://cmbb.ucsd.edu/
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Industrial Biotechnology
Agricultural Green-energy Pharmaceutical
Aqua-Marine Industrial
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Industrial biotechnology(also known as white biotechnology) is the
application of biotechnology for industrial purposes, including
manufacturing, and biomaterials. It includes the practice of using cells or
components of cells like enzymes to generate industrially useful products.
Source: http://en.wikipedia.org/wiki/Industrial_biotechnology
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Characteristic of a Biotechnology Firm
Larger boards as a consequence of employing
more non-executive directors
Much heavier use of market-based incentives.
Significantly more likely to employ high
quality auditors.
Feature the following capital structure less debt finance
lower levels of block ownership
less managerial ownership
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CORPORATE GOVERNANCE
Start-ups & Spin-offs
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Information Asymmetry
Financial statements are unlikely to convey
much information that is useful.
Most R&D assets are non-tradable
Share prices of bioscience companies,
particularly emerging companies, have been
volatile
Understanding final success probabilities
requires considerable scientific sophistication
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Code of Practice
The BioIndustry Association (BiA) Code of
Practice (2001) Independent, non-executive directors for their strategic and
monitoring function Separating roles of chairperson and chief executive
Equity financing is appropriate, as debt is more suitable for
redeployable assets
Managerial ownership can play a central role in reducing theagency costs of equity
Use of large auditors reduces earnings management in firms
with large investment opportunity sets
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Source: http://www.liv.ac.uk/managementschool/research/working%20papers/wp200405.pdf
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Essential Elements
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Source: http://www.oecd.org/chemicalsafety/risk-management/49865614.pdf
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Essential Elements
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Source: http://www.oecd.org/chemicalsafety/risk-management/49865614.pdf
Leadership and Culture Keep process safety on their agenda, prioritise it strongly and
remain mindful of what can go wrong.
Encourage people to raise process safety concerns, or bad
news to be addressed. Take every opportunity to be role models, promoting and
discussing process safety.
Delegate appropriate process safety duties to competentpersonnel whilst maintaining overall responsibility and
accountability.
Promote a safety culture that is known and acceptedthroughout the enterprise.
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Essential Elements
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Source: http://www.oecd.org/chemicalsafety/risk-management/49865614.pdf
RiskAwareness Understand the critical and different layers of protection that
are in place between a hazard and an accident and seek to
strengthen those layers continually.
Ensure appropriate and consistent management systems for
analysing, prioritising and managing the risk, including strong
management of change processes for people, technology and
facilities.
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Essential Elements
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Source: http://www.oecd.org/chemicalsafety/risk-management/49865614.pdf
Information Ensure that the organisation analyses audit and assessment
results.
Establish safety management systems and monitor/review their
implementation. Seek continuous improvement
Have metricswhich help to monitor the health of the process
safety culture and management systems.
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Essential Elements
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Source: http://www.oecd.org/chemicalsafety/risk-management/49865614.pdf
Competence Ensure there are competent management, engineering, and
operational personnel at all levels.
Provide resource and time for
Expertise-based hazard and risk analyses,
Effective training and
Comprehensive scenario planning for potential accidents.
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Essential Elements
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Source: http://www.oecd.org/chemicalsafety/risk-management/49865614.pdf
Action Assure practices are consistent with corporate process safety
policies
Monitor that corrective actions are applied and closed out
promptly following audits and after thorough root cause
investigations of all incidents or potentially high consequence
near misses
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STRATEGIC MANAGEMENT
Bio-oriented Technology Company
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Drivers of Biotechnology Industry
Internalisation Cooperative Activities
Amgen with Kirin Brewery
Biogen with Schering-Plough
Genentech with Hoffmann La Roche
University of Maryland (UM) Ventures with RexahnPharmaceuticals, Plasmonix, IGI Technologies, A&GPharmaceuticals, and BioAssay Works
Merger and Acquisitions Amgen is closing in on a deal for Onyx Pharmaceuticals for a
$130-per-share offer, or about $9.5 billion in total
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Source: http://commercialbiotechnology.com/article/viewFile/436/432
http://www.fiercebiotech.com/topics/ma
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Venture Funding in Biotechnology
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Source: http://www.patentdocs.org/biotechpharma_business_news/
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Venture Funding by Industry
Biotechnology funding Medical devices Software
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Q3 2009 to Q2 2013
Source: http://www.patentdocs.org/biotechpharma_business_news/
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Strategic Planning Process
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Source: http://commercialbiotechnology.com/article/viewFile/436/432
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SWOT Analysis
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Source: http://commercialbiotechnology.com/article/viewFile/436/432
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GAP Analysis
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Source: http://commercialbiotechnology.com/article/viewFile/436/432
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SYSTEMS &ORGANISATIONAL MANAGEMENT
People Make the Firm
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Systems Management
6 Sigma Break down business process flow into individual steps
Define what defects there are
Measure the number of defects Probe for the root cause
Implement changes to improve
Re-measure
Take a long-term view of goals
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Source: http://www.abahe.co.uk/business-administration/Quality-Management-Systems.pdf
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Systems Management
Data Development and Statistics Statistical analysis is the measurement portion of quality
systems and allows it to be managed.
Statistical process control (SPC) was what Duran taught as a
decision maker in quality systems.
You cannot manage what you cannot measure
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Source: http://www.abahe.co.uk/business-administration/Quality-Management-Systems.pdf
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Systems Management
ISO 9000 QMS standards It is a series of quality management systems (QMS) standards
created by the International Organization for Standardization, a
federation of 132 national standards bodies.
The standards are not specific to products or services, but apply
to the processes that create them.
The standards are generic in nature so that they can be used by
manufacturing and service industries anywhere in the world.
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Source: http://www.abahe.co.uk/business-administration/Quality-Management-Systems.pdf
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Systems Management
What is Quality? Based on customers perceptions of a product/services design
and how well the design matches the original specifications
The ability of a product/service to satisfy stated or implied
needs
Achieved by conforming to established requirements within an
organization
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Source: American Society for Quality
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Systems Management
What is Quality Systems Management?
A management technique used to communicate to employees what is
required to produce the desired quality of products and services andto influence employee actions to complete tasks according to the
quality specifications
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Source: http://www.abahe.co.uk/business-administration/Quality-Management-Systems.pdf
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Organisational Management
Maximises innovative synergies (e.g. betweenassay developers and medicinal chemists)
Ensures efficient management of resources: time,
people,
money
Ensures the right people are hired with theright skills and then deployed on the right
projects Matrix versus group/team-based structure
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Organisational Management
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Organisational Chart of Kenvos Biotech Co., Ltd
Source: http://www.kenvos.com/en/about/index.asp?itemid=66
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Leaders in Biotech and Pharma
Leonard Schleifer, Regeneron Pharmaceuticals Schleifer was the top pick of TheStreetreaders for his execution
of one of the most successful new drug launches in history
Eylea was approved in November 2011 to treat a common cause
of blindness.
In just nine months, Eylea sales have already reached $562
million with an annual run rate close to $1 billion, well above
the company's -- and investors' -- initial forecasts.
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Source: http://www.thestreet.com/story/11793709/1/the-best-biotech-ceo-of-2012-is.html
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Leaders in Biotech and Pharma
Tony Coles, Onyx Pharmaceuticals Tony Coles was about nine years old when he decided to
become a doctor. And even when teachers underestimated him,
placing Coles in a math class that he thought was too slow and
boring, he kept his eye on the prize.
He had led the company to develop a drug for kidney and liver
cancer thats approaching $1 billion in worldwide sales, and
Onyxs second act, by winning FDA approval carfilzomib with
billion-dollar potential for treating a type of cancer calledmultiple myeloma
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Source: http://www.xconomy.com/national/2011/08/18/xconomist-of-the-week-tony-coles-
journey-from-mass-general-doctor-to-sf-biotech-ceo/
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Leaders in Biotech and Pharma
Chris Garabedian, Sarepta Therapeutics In the past two years, he has taken a company that was going
nowhere fast and turned it into one of the most intriguing
biotech drug developers
One year ago, its stock was worth 69 cents. Today, it will open
trading at more than $37.
It is believed that Sarepta has come up with the first effective
drug for treating Duchenne Muscular Dystrophy, a disabling and
deadly neuromuscular disease.
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Source: http://www.xconomy.com/national/2013/06/10/profiles-in-long-termism-sarepta-
therapeutics-ceo-chris-garabedian/
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Leaders in Biotech and Pharma
John Martin, Gilead Sciences John C Martin has been CEO of Gilead Sciences (GILD) for 16
years. Dr. Martin has been with the company for 22 years.
Under his management, The company's long-awaited four-in-
one HIV pill, Stribild, finally won FDA approval.
Also known as the "Quad," Stribild was widely hailed by analysts
as a future blockbuster albeit being priced at $28,000-a-year
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Source: http://www.fiercepharma.com/special-reports/john-martin-gilead-sciences#ixzz2eZxyTZIz
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Leaders in Biotech and Pharma
Dr. Lynn Seely, Medivation Spearheads the team that took Xtandi, a likely blockbuster for
prostate cancer patients, all the way through the clinic to a first
approval.
Responsible for the strategy and execution of Orion Acquisition
Corp.
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Source: http://www.fiercebiotech.com/special-reports/10-top-women-biotech-2012
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Leaders in Biotech and Pharma
Dr. Reddy, Dr. Reddys Laboratories Limited Dr. K. Anji Reddy was the Founder-Chairman of Dr. Reddys
Laboratories Limited headquartered in Hyderabad, India.
Dr. Reddys passion for research had led Dr. Reddys Laboratories
to take up basic drug discovery research in 1993, thereby
becoming the first pharmaceutical company in India to do so.
In April 2011 the Government of India honored Dr. Reddy with
Padma Bhushan (the third highest civilian award in the country)
for his contribution to the Indian Pharmaceutical industry.
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Source: http://www.drreddys.com/aboutus/our-founder.html
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Leaders in Biotech and Pharma
Raghunath Anant Mashelkar, Council of
Scientific & Industrial Research Overcame poor science-business linkages, bureaucracy,
unionisation, low budget and morale within CSIR, to transform itinto user-friendly, performance-driven organisation.
Envisioned and convinced the Indian industry to view CSIR in the
true spirit of partnership instead of a super market where off
the shelf technologies were sold.
Worked towards building trust and confidence in Indian industry
by pledging that CSIR itself was willing to change.
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Source: Leaders on Leadership, Insights from Corporate India, All India Management Association (2012)
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Leaders in Biotech and Pharma
Olivia Lum, Hyflux Ltd Ms Lum started corporate life as a chemist with Glaxo
Pharmaceutical and left in 1989 to start up Hydrochem (S) Pte
Ltd, the precursor to Hyflux Ltd. Managing the Group for more
than 20 years
The Winner of the Regional Growth Award by Nihon Keizai
Shimbun at the 11th Nikkei Asia Prize 2006, and the Ernst &
Young World Entrepreneur Of The Year 2011.
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Source: http://www.hyflux.com/abt_mgm.html
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Leaders in Biotech and Pharma
Professor Lee Chee Wee, Lynk
Biotechnologies Professor at National University of Singapore (NUS)
Established Singapore's first privately funded biotechnologystart-up in February 2000 with a S$2 million investment fund
The company has pioneered techniques that can significantly
reduce drug development time
In September 2001, Lynk Biotechnologies announced its
discovery of a new class of compounds that are able to cure
cancer in mice
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Source: http://sciencecareers.sciencemag.org/career_magazine/previous_issues/articles/2002_03_22/nodoi.
8141079393122221611
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PROJECTS ANDPROGRAMS MANAGEMENT
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Project Management in Biotech
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The project management role in
biotechnology was created because of the
need for someone to coordinate the activities
of the many scientific disciplines that arefrequently involved in projects
Source: http://www.careersbiotech.com/careers_sample.pdf
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Goals of Project Management
Establish and follow a clear path for the
project. Developing a project scope
Identifying risks Setting common goals for the project team performance
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Source: http://www.ask-cato.com/2011/11/project-management-for-biotech-companies/
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Project Management Pipeline
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Source: http://www.careersbiotech.com/careers_sample.pdf
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Bottom-up" Entrepreneurial System
Should be constructed from several small,independent teams, or research ventures,thatform spontaneously around promising
concepts Teams should be allowed almost complete
freedomto choose their goals, supportingtechnology, personnel, working hours,
resources, and almost all other aspects Teams must be held accountable
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Source: http://www.nature.com/bioent/2003/030101/full/nbt0602supp-BE61.html
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What a Project Manager Does?
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Think about the big picture rather thanspecialize in a particular scientific discipline
Facilitatingthe decision-making process
Ensurethat projects are moving forwardaccording to pre-established timelines, scope,and budgets
Helping to define options by pulling togetherinformation from the many groups working ona project
Source: http://www.careersbiotech.com/careers_sample.pdf
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Responsibilities & Considerations
A project manager must consider thefollowing dimensions of the critical path indrug development as stipulated by FDA: Safety
in vitro and animal models, animal and human testing,
safety follow-up
Medical utility in vitro and computer model evaluation,
in vitro and animal models, and
human efficacy evaluation Industrialization
physical design,
characterization and small scale production,
manufacturing and scale-up, mass production
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Source: http://www.ask-cato.com/2011/11/project-management-for-biotech-companies/
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REGULATORY CONSIDERATIONS
Prevention Is Better Than Cure
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Adding Value through Patents
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Protecting Your Know-How
Patents on drugs are valid for 20 years from
the date on which an international patent
application is submitted.
In the EU, this 20-year time limit may beextended by up to five years to make up for
the time lost between the application's
submission and the approval of a marketinglicence.
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Adding Value through Patents
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Source: http://www.nature.com/bioent/2013/130601/fig_tab/bioe.2013.9_T1.html
Protecting Your Know-How
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Adding Value through Patents
The Art of Patenting An application patent
cannot be practiced
without a device patent,
which cannot be practicedwithout sonochemical
patent, that cannot be
practiced without method
patents
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Protecting Your Know-How
Source: http://www.arisdyne.com/vp/patents.htm
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Adding Value through Patents
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Protecting Your Know-How
Sources: www.PatentBoard.com; WSJ Market Data Group, www.patentdocs.org/biotechpharma_business_news/
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Environmental Concerns
Minimize waste generation
Choosing the right suppliers and contractors
Agricultural biotechnology: spreading genetically-engineered genes to indigenous plants
increasing toxicity, which may move through the food chain
disrupting natures system of pest control
creating new weeds or virus strains
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Source: http://www.activebiotech.com/environment-quality
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Merck & Co. & Environmental Issues
Used methylene chloride, an animalcarcinogen on the United StatesEnvironmental Protection Agency's list ofpollutants. Merck chemists and engineers subsequently replaced the
compound.
Installed a distributed control system thatcoordinates chemical reactions more
efficiently and expedites manufacturing by50%. It has eliminated the need for the disposal and storage of
harmful waste.
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Sources: http://en.wikipedia.org/wiki/Merck_%26_Co.
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Bio-safety and Bio-ethics
Cartagena Protocol on Biosafety the first international agreement specifically negotiated to deal
with products of genetic engineering
Precautionary Principle in risk assessment of genetically
modified organisms. absence or lack of scientific proof of risk should not be taken as
conclusive evidence of the safety of any given organism andrequires risk/benefit analysis.
This gives some degree of reassurance todeveloping countries that are as yet unable toundertake comprehensive risk assessments
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Source: http://unctad.org/en/Docs/poitetebd10.en.pdf
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GOOD MANUFACTURING &CLINICAL PRACTICES
Do It Right
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Good Manufacturing Practice
A good manufacturing practice(GMP) is aproduction and testing practice that helps toensure a quality product. Many countries have legislated that pharmaceutical and medical
device companies must follow GMP procedures, and havecreated their own GMP guidelines that correspond with theirlegislation.
The World Health Organization (WHO) version of GMP is usedby pharmaceutical regulators and the pharmaceutical industryin over one hundred countries worldwide, primarily in the
developing world. E.g. NHK Laboratories in America and Shandong Zhongyuan
Greentech Co., Ltd. in China
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Source: http://en.wikipedia.org/wiki/Good_manufacturing_practice
www.npainfo.org/npa/educationandcertification/gmpcertification/gmpcertifiedcompanies/npa/educationcertif
ication/gmpcertifiedcompanies.aspx?hkey=a08e5382-f52b-41a7-98a9-ee40aa93aba2
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GMP Laboratory Controls
There should be documented procedures describing sampling, testing, approval
or rejection of materials, and recording and storage of
laboratory data
appropriate laboratory tests for each batch of intermediate andAPI, conducted to determine conformance to specifications.
authentic Certificates of Analysis issued for each batch of
intermediate or API on request
stability testing
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Source: http://www.picscheme.org/publication.php
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GMP Laboratory Controls
There should be company's overall policy, intentions, and approach to validation
validation of production processes, cleaning procedures,
analytical methods, in-process control test procedures,
computerized systems, and persons responsible for design,review, approval and
documentation of each validation phase
completion of appropriate qualification of critical equipment
and ancillary systems before starting process validation activities
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Source: http://www.picscheme.org/publication.php
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Good Clinical Practice
Good Clinical Practice (GCP)is aninternational quality standard that is provided
by International Conference on Harmonisation
(ICH) Good Clinical Practice guidelines include protection of human
rights as a subject in clinical trial.
It also provides assurance of the safety and efficacy of the newly
developed compounds.
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Source: http://en.wikipedia.org/wiki/Good_Clinical_Practice
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GILSP Guidelines
Concept of Good Industrial Large-ScalePractice (GILSP) in the usage of r-DNA
organisms in industrial production.
key principle for GILSP: the r-DNA organism should be as safe asthe low-risk organism from which it is derived.
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Source: http://www.oecd.org/sti/biotech/2375496.pdf
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GILSP Guidelines
Host: Non-pathogenic
No adventitious agents
Extended history of safe use
Built-in environmental limitations
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Source: http://www.oecd.org/sti/biotech/2375496.pdf
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GILSP Guidelines
Vector Well characterised and free from known harmful sequences
Limited in size as much as possible to the DNA required to
perform the intended
Should be poorly mobilisable
Should not transfer any resistance markers to micro-organisms
not known to acquire them naturally
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Source: http://www.oecd.org/sti/biotech/2375496.pdf
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GILSP Guidelines
r-DNA organism Non-pathogenic
As safe in industrial setting as host organism or with limited
survival, and without adverse consequences in the environment
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Good Developmental Principles
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MARKETING & SALES OPERATIONS
Knowing Your Customers
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Top 8 Strategies
Think big and audit your time Spend more time with more important tasks such as marketing
strategies, improving customer relations, and implementing new
strategies to expand your services.
Collect E-Mail Addresses Get permission from your customers to use their E-mail address.
Periodically send updates and notices to your client list.
Hire top sales people A top salesperson can outsell an average one 4 to 1.
There's a lot of difference between listening and hearing. G.K. Chesterton
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Source: http://www.businessknowhow.com/marketing/top8mark.htm
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Top 8 Strategies
Build relationships with your customers For each month that goes by, customers lose 10% of their
buying power.
Create a customer database and contact them regularly.
Use customer service commandments to
create good habits Hardware store located in Atlanta created "Twenty Customer
Service Commandments" modeled after the Ritz-Carlton hotelsoutlining specific behaviors employees are to demonstrate
when dealing with customers and fellow employees.
There's a lot of difference between listening and hearing. G.K. Chesterton
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Top 8 Strategies
Be different and stand out from the
competition Jordan Furniture sells more furniture per square foot than any
other furniture store in their country.
Principle called "shoppertainment"
To surprise employees and customers, Barry and Eliot Tatleman
dressed up like the Lone Ranger and Tonto and rode horses in
their parking lot.
They built an IMax theater inside one store to entertain childrenwhile their parents shopped.
There's a lot of difference between listening and hearing. G.K. Chesterton
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Top 8 Strategies
Put a shopping cart on your website. Online sales are still growing at a dramatic pace.
Pay-per-click advertising
classified advertising is not an effective use of their marketingdollars
Pay-per-click will insure you receive top visibility on websites
driving more customers to your door.
Advertisers bid on keywords and the more popular the keyword,
the more expensive each click is.
There's a lot of difference between listening and hearing. G.K. Chesterton
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Source: http://www.businessknowhow.com/marketing/top8mark.htm
Li O i i
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Listen to Opinions
Interact with people from across the gamut Entrepreneurs,
Managers,
Professors,
Writers,
VCs,
Scientists,
even Janitors & Interns.
They can all teach you something!
There's a lot of difference between listening and hearing. G.K. Chesterton
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RESEARCH & DEVELOPMENT
A Never-ending Continuum
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K f R&D b dd d
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Key aspects of R&D to be addressed
Linear Drug R&D is conducted in a series of preclinical studies and
clinical trials in sequentially larger populations.
Inflexible There is little ability to learn continuously and adjust ones
approach based on real-time information.
Expensive On average, companies spend well over US$1 billion to bring an
approved drug to market (a number that includes the cost of
products that fail along the way).
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Source: http://www.ey.com/Publication/vwLUAssets/Beyond_borders_2012/$FILE/Beyond_borders_2012.pdf
K t f R&D t b dd d
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Key aspects of R&D to be addressed
Slow The process of taking a compound or molecule from early
research to approved product takes well over a decade. In
essence, researchers come up with an idea and then wait years
to find out whether it works.
Siloed R&D process is highly fragmented.
Needing to protect their intellectual property, companies fail to
learn from experiences and the mistakes of others.
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Source: http://www.ey.com/Publication/vwLUAssets/Beyond_borders_2012/$FILE/Beyond_borders_2012.pdf
I ith R h & D l t
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Issues with Research & Development
Most R&D assets are non-tradable and
characterised by firm-specificity,
fuzziness of property rights and contractual incompleteness
Most R&D expenditures are
firm-specific or non redeployable
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Issues with Research & Development
Go-it-aloneapproach of pharmaceutical
companies companies attempt to single-handedly discover and develop
absence of scale in an age of rapid innovation challenged for its scientific productivity and efficiency
Network innovation
Onyx Pharmaceuticals are starting to find new ways to
accelerate the development of even better therapies for unmet
medical needs.
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Source: http://www.ey.com/Publication/vwLUAssets/Beyond_borders_2012/$FILE/Beyond_borders_2012.pdf
I ith R h & D l t
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Issues with Research & Development
Stop Flying Blind and Start Observing Joshua Boger, Founder of Vertex Pharmaceuticals says drug
development as a linear process minimizes another pillar of
science, observation
The problem of the perceived need to blind Phase II trials,keeping all but the most catastrophic observations under wraps
until the process is completed and the data locked.
These data are not available for examination in real time, due to
the desire to preserve the integrity of the precious primaryendpoint and its p-value.
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Source: http://www.ey.com/Publication/vwLUAssets/Beyond_borders_2012/$FILE/Beyond_borders_2012.pdf
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Issues with Research & Development
Stop Flying Blind and Start Observing This strict blinding of Phase II trials imposes significant costs,
including:
Lengthening the development process;
Losing the ability to quickly incorporate lessons from the trial intosubsequent, even overlapping, trials; and
Losing the ability to manage overall R&D resources in a more rational and
timely fashion.
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Vi i f R h & D l t
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Vision for Research & Development
What R&D needs to be:1. Iterative
2. Fast
3. Adaptive
4. Cost efficient5. Open / networked
The HOLNet Approach Holistic
Open Learning
Network
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Vision for Research & Development
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Vision for Research & Development
To sustain innovation: Reduce redundant research
No reason every pharmaceuticals has to study fundamental biology in
every research area, wasting hundreds of millions of dollars in the
process.
Academics, NIH, pharmaceuticals and entrepreneurs should work
together to explore new biology areas and get them drug development
ready.
Pharmaceuticals and biotech can access the assays, probes, etc., and do
their own drug development.
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Vision for Research & Development
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Vision for Research & Development
To sustain innovation: Parallelize biotech entrepreneurship
Typically, solo entrepreneurs work for 2 years and then pitch to VCs, who
then pivot, work for 2/3 more years, and pitch to pharmaceuticals, who
then discard all but the one program of interest.
Instead, get entrepreneurs, VCs and pharmaceuticals working together, at
the same time, to start and fund biotech start-ups around a common
vision.
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STRATEGIC ALLIANCE &PARTNERING
Synergy
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Collaborative Power
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Collaborative Power
Pooling data in precompetitive spaces Given the diverse membership the networks formed could bring
together Genetic data from patients,
Claims data from payers,
Outcomes data from providers EHR systems,
Data on failed clinical trials from life sciences companies,
Insights from disease foundations and more.
Shared libraries and tissue banks
Creating standards Role in accelerating the creation of promising R&D tools, such as
biomarkers and disease models
The bigger your rolodex, the bigger your business
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Source: http://www.ey.com/Publication/vwLUAssets/Beyond_borders_2012/$FILE/Beyond_borders_2012.pdf
Collaborative Power
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Collaborative Power
Pharmaceutical companies have much moreto offer than just their financial capital Pharmaceutical companies should band together to create a
fund to purchase biotech IPOs.
In the 9 January 2012 issue of BioCentury, for instance, Moncef
Slaoui, John Maraganore and Stelios Papadopoulos argue that
such an approach could
Validate companies and their approaches for other investors and
Give a boost to the market for biotech public offerings
The bigger your rolodex, the bigger your business
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Collaborative Power
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Collaborative Power
You are Only a Drop of the Ocean As Moncef Slaoui, chairman of GlaxoSmithKline, Research &
Development puts it,
We have 14,000 scientists, but there are probably a million life science scientists in
the world which suggests that we will generate only 0.1% of the good ideas.
Everything a company does needs to be built on the premise
that there is a need for a strong ecosystem of biotech
companies.
The bigger your rolodex, the bigger your business
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Source: http://www.ey.com/Publication/vwLUAssets/Beyond_borders_2012/$FILE/Beyond_borders_2012.pdf
Building Connections
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Building ConnectionsThe bigger your rolodex, the bigger your business
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Building Connections
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Building Connections
Be introduced to an investor by someonethey know and respect. It is the best possible way to get funding.
Entrepreneurs should get to know the investors and VCs before
seeking funds.
Be resourceful: reach them through their portfolio companies,
contacts and advisors, through blog discussions, and at events
and conferences which they attend.
The bigger your rolodex, the bigger your business
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Thank You!The End