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Bio 1 Leadershi

Jun 02, 2018

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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

    Private & Confidential 2

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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

    Private & Confidential 3

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    A STRATEGIC OVERVIEW

    Bio-Entrepreneurship & Innovation

    Private & Confidential 4

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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

    Private & Confidential 5

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    Growth in Biotechnology Centres

    Private & Confidential 6

    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

    Private & Confidential 8

    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.

    Private & Confidential 9

    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.

    Private & Confidential 10

    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

    Private & Confidential 11

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    Types of Biotechnology

    Agricultural Green-energy Pharmaceutical

    Aqua-Marine Industrial

    Private & Confidential 12

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    Agricultural Biotechnology

    Agricultural Green-energy Pharmaceutical

    Aqua-Marine Industrial

    Private & Confidential 13

    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

    Private & Confidential 14

    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

    Private & Confidential 15

    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

    Private & Confidential 16

    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

    Private & Confidential 17

    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

    Private & Confidential 18

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    CORPORATE GOVERNANCE

    Start-ups & Spin-offs

    Private & Confidential 19

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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

    Private & Confidential 20

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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

    Private & Confidential 21

    Source: http://www.liv.ac.uk/managementschool/research/working%20papers/wp200405.pdf

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    Essential Elements

    Private & Confidential 22

    Source: http://www.oecd.org/chemicalsafety/risk-management/49865614.pdf

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    Essential Elements

    Private & Confidential 23

    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

    Private & Confidential 24

    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

    Private & Confidential 25

    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

    Private & Confidential 26

    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

    Private & Confidential 27

    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

    Private & Confidential 28

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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

    Private & Confidential 29

    Source: http://commercialbiotechnology.com/article/viewFile/436/432

    http://www.fiercebiotech.com/topics/ma

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    Venture Funding in Biotechnology

    Private & Confidential 30

    Source: http://www.patentdocs.org/biotechpharma_business_news/

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    Venture Funding by Industry

    Biotechnology funding Medical devices Software

    Private & Confidential 31

    Q3 2009 to Q2 2013

    Source: http://www.patentdocs.org/biotechpharma_business_news/

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    Strategic Planning Process

    Private & Confidential 32

    Source: http://commercialbiotechnology.com/article/viewFile/436/432

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    SWOT Analysis

    Private & Confidential 33

    Source: http://commercialbiotechnology.com/article/viewFile/436/432

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    GAP Analysis

    Private & Confidential 34

    Source: http://commercialbiotechnology.com/article/viewFile/436/432

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    SYSTEMS &ORGANISATIONAL MANAGEMENT

    People Make the Firm

    Private & Confidential 35

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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

    Private & Confidential 36

    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

    Private & Confidential 37

    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.

    Private & Confidential 38

    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

    Private & Confidential 39

    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

    Private & Confidential 40

    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

    Private & Confidential 41

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    Organisational Management

    Private & Confidential 42

    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.

    Private & Confidential 43

    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

    Private & Confidential 44

    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.

    Private & Confidential 45

    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

    Private & Confidential 46

    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.

    Private & Confidential 47

    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.

    Private & Confidential 48

    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.

    Private & Confidential 50

    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.

    Private & Confidential 51

    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

    Private & Confidential 52

    Source: http://sciencecareers.sciencemag.org/career_magazine/previous_issues/articles/2002_03_22/nodoi.

    8141079393122221611

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    PROJECTS ANDPROGRAMS MANAGEMENT

    Private & Confidential 53

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    Project Management in Biotech

    Private & Confidential 54

    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

    Private & Confidential 55

    Source: http://www.ask-cato.com/2011/11/project-management-for-biotech-companies/

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    Project Management Pipeline

    Private & Confidential 56

    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

    Private & Confidential 57

    Source: http://www.nature.com/bioent/2003/030101/full/nbt0602supp-BE61.html

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    What a Project Manager Does?

    Private & Confidential 58

    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

    Private & Confidential 59

    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

    Private & Confidential 61

    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

    Private & Confidential 62

    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

    Private & Confidential 63

    Protecting Your Know-How

    Source: http://www.arisdyne.com/vp/patents.htm

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    Adding Value through Patents

    Private & Confidential 64

    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

    Private & Confidential 65

    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.

    Private & Confidential 66

    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

    Private & Confidential 67

    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

    Private & Confidential 69

    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

    Private & Confidential 70

    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

    Private & Confidential 71

    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.

    Private & Confidential 72

    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.

    Private & Confidential 73

    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

    Private & Confidential 75

    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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    Source: http://www.oecd.org/sti/biotech/2375496.pdf

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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

    Private & Confidential 79

    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

    Private & Confidential 80

    Source: http://www.businessknowhow.com/marketing/top8mark.htm

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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

    Private & Confidential 81

    Source: http://www.businessknowhow.com/marketing/top8mark.htm

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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

    Private & Confidential 82

    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

    Private & Confidential 83

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    RESEARCH & DEVELOPMENT

    A Never-ending Continuum

    Private & Confidential 84

    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).

    Private & Confidential 85

    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.

    Private & Confidential 86

    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

    Private & Confidential 87

    I ith R h & D l t

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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.

    Private & Confidential 88

    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.

    Private & Confidential 89

    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 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.

    Private & Confidential 90

    Source: http://www.ey.com/Publication/vwLUAssets/Beyond_borders_2012/$FILE/Beyond_borders_2012.pdf

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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

    Private & Confidential 92

    Source: http://www.ey.com/Publication/vwLUAssets/Beyond_borders_2012/$FILE/Beyond_borders_2012.pdf

    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.

    Private & Confidential 93

    Source: http://www.ey.com/Publication/vwLUAssets/Beyond_borders_2012/$FILE/Beyond_borders_2012.pdf

    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.

    Private & Confidential 94

    Source: http://www.ey.com/Publication/vwLUAssets/Beyond_borders_2012/$FILE/Beyond_borders_2012.pdf

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    STRATEGIC ALLIANCE &PARTNERING

    Synergy

    Private & Confidential 95

    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

    Private & Confidential 96

    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

    Private & Confidential 97

    Source: http://www.ey.com/Publication/vwLUAssets/Beyond_borders_2012/$FILE/Beyond_borders_2012.pdf

    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

    Private & Confidential 98

    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

    Private & Confidential 99

    Source: http://www.ey.com/Publication/vwLUAssets/Beyond_borders_2012/$FILE/Beyond_borders_2012.pdf

    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