Biopharmaceutical Companies Organizations and Opportunities - - PDF document

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Biopharmaceutical Companies Organizations and Opportunities - - PDF document

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3/23/16 You Drive Innovation. Well Navigate . Biopharmaceutical Companies Organizations and Opportunities Materials Developed by Laurie Halloran CEO & President Halloran Consulting Group, Inc Proprietary & Confidential 1

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You Drive Innovation. We’ll Navigate.

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Biopharmaceutical Companies Organizations and Opportunities

Materials Developed by Laurie Halloran CEO & President Halloran Consulting Group, Inc

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Critical Attributes of Life Science Business Success

  • Define and adhere to a focused business strategy
  • Build a flat, flexible organizational structure tied to

the strategy

  • Rigorously focus on flawless execution
  • Create and maintain a performance driven culture

within the firm

  • Recognize that the company will need to change as

it moves through stages

  • Hire the best talent with an eye on the next stage
  • Deliver real leadership

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Characteristics of the ‘Best in Class’

  • Operating Philosophy
  • Crystal clear customer driven

context

  • Every action tested by its value

added

  • Information is shared openly
  • Decisions are made locally
  • Employees are appreciating

resources

  • Architecture
  • Dense, mission focused structures
  • Emphasis on value added processes
  • Flat organization with few levels
  • Multifunctional and team based
  • Work design precedes technology
  • Partnerships are the norm
  • Leadership
  • The vision is evocative and inspiring
  • The vision is communicated

endlessly

  • The mission and goals are

congruent

  • Initiate strategies and ensure

execution

  • Secure and develop resources
  • The structure is in alignment
  • Develop continuous learning

systems

  • Business Strategy
  • Overlapping problem solving
  • Pursue process development
  • Time/Cost/Quality sensitive

performance metrics

  • Focus on cycle time

Modified from Rick Sidorowicz:The CEO Refresher, http://www.refresher.com/!fast.html

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Asking Questions to Define a Focused Business Strategy

  • What do we want to be when we ‘grow up’?
  • Where do we see our exit?
  • How will we organize for the most effective results and encouraging

technological innovation, while effectively licensing and preserving intellectual property for a competitive edge?

  • What is the best business model?
  • Should we plan for partnerships and/or alliances?
  • How will we stay competitive in a quickly shifting industry, including

managing product life cycles and determining market positioning and pricing?

  • What are appropriate financial strategies and control systems that

incorporate risk management?

  • How can we create sustainable leadership within the organization to

encourage managerial stability?

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Strategy Should Drive Growth and Structure

  • Executive Management should have overall exit plan in

parallel with an organizational strategy in mind from early days

– Timing and stage for exit

  • IPO
  • Partner and grow
  • Be acquired
  • Bootstrap it
  • Plan A and Plan B

– VIPCO vs. FIPCO vs. Hybrid

  • Resource plan tied to the exit
  • Core competencies to build vs. buy
  • Outsourcing Strategy
  • Change management plan
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What the IPO Market looks like historically

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Management Life Cycle in Life Science Companies

Core activities: Discovery, early development Staffing: <100 employees, emphasis on scientific skills Challenges:

  • Fostering creativity

while avoiding chaos

  • Meeting partners

demands if relevant* Management Informal, vision driven and ad hoc processes* plus ability to meet partner’s expectations Cone activities Preclinical/phase I and II Staffing: 75-200 employees, still emphasis on scientific skills, but adding development capabilities and some business professionals Challenges: Focusing on priorities Management: Initial attempts to structure work, define roles and increase discipline without adding bureaucracy

Source: Mardis, Aibel & Associates, LLC Biotechnology Management Practices 2003

Core Activities Late clinical/early commercialization Staffing: 150-500 employees; balance of scientific, technical and professional business skills Challenges: Confront growing complexity—deal with need for integration Management: increasingly formal business structures, processes, systems and practices

Time Size & Complexity

Core Activities Full pipeline, including significant approved products Staffing: 250-1000 employees in multiple functions and disciplines Challenges: transition the business into a commercial enterprise without losing creativity Management: extensive planning, defined accountabilities, and structured processes. “managers manage” Stage 1 Start-Up Stage 2 Focus Stage 3 Integration Stage 4 Optimization Core activities: Operate as FIBCO Staffing: >1000 employees Challenges: Maintaining profitable growth Meeting investor expectations Management: Remove management using complex business systems and practices Stage 5 Maturity

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Climbing the Ladder… Be Sure You’re on the Right One!

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Roles Within a Program Team

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Small BioPharma vs. Big BioPharma

Small Pharma

  • Specialty

pharmaceuticals, start- ups, biotechs, mid-sized drug companies

  • Closely associated with

academia; more experimental (risky) approach to drug development

  • Heavily utilize CROs due

to lack of resources and global presence

Big Pharma

  • Top earning companies

(over $2 billion per year), large scale, international

  • perations
  • Focus on drugs that will

have blockbuster status (at least $1 billion in sales); risk adverse approach

  • Fully integrated

pharmaceutical operations including internal R&D, manufacturing, clinical, regulatory, marketing and sales

Levinson, A.D. (2005). What distinguishes biotech from big pharma. Beyond Borders: The Global Biotechnology Report. Rosen, M. (2005). Top 20 big Pharma represents majority of world pharma market. The Wisconsin Technology Network.

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  • No. of Employees

Number if Clinical Experts Corporate Status Portfolio Size Risk Board of Directors Material News Decision Time 3-5 None Private 1 product High Active operationally Lower threshold Seconds! 1000-2000 Hundreds Public R & D portfolios Lower Directs strategy Higher threshold Months Skill Req’ments for CR Position Impact Style Accountability Access to Senior Mgmt Decision-making process >15 years Critical Directive To SVP CEO, BOD Immediate, fewer hoops Immediate 10-15 years High Participative To Development Head Through reporting channels, committees Committee or Functional evaluations

Management Capabilities in Clinical Research

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Discovery/Early Stage Companies

Research & Development Operations Quality Finance & Administration

VP ¡of ¡Research ¡& ¡ Development ¡ Discovery ¡Research ¡

  • Sr. ¡Scien@st ¡
  • Scien@st ¡
  • Sr. ¡Research ¡Assoc. ¡
  • Research ¡Assoc. ¡
  • Veterinarian ¡
  • Lab ¡Assistant ¡/ ¡ ¡

¡ ¡Glass ¡Washer ¡ Process ¡/ ¡Product ¡ Development ¡

  • Process ¡Dev. ¡Associate ¡
  • Process ¡Dev. ¡

Technician ¡ Director ¡of ¡Product ¡/ ¡ Process ¡Development ¡ Director ¡of ¡Quality ¡ Director ¡of ¡Finance ¡ Quality ¡Control ¡(QC) ¡ Chemistry ¡

  • QC ¡Analyst ¡
  • QC ¡Technician ¡

Quality ¡Assurance ¡(QA) ¡

  • QA ¡Documenta@on ¡

Coordinator ¡ Microbiology ¡

  • QC ¡Analyst ¡

Finance ¡

  • Accoun@ng ¡Clerk ¡/ ¡ ¡

¡ ¡Payroll ¡ Business ¡Development ¡

  • Director ¡of ¡Bus. ¡Dev. ¡

AdministraAon ¡

  • Human ¡Resources ¡Rep. ¡
  • Purchase ¡Agent/Buyer ¡
  • Recep@on/Admin. ¡
  • Asst. ¡

InformaAon ¡Systems ¡

  • Analyst ¡/ ¡Programmer ¡

Legal ¡

  • Patent ¡AQorney ¡

FaciliAes ¡Management ¡

  • Facili@es ¡Manager ¡
  • Shipper ¡/ ¡Receiver ¡

Possible to rent vs. own

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Proprietary & Confidential Research & Development (Pre-Clinical) Operations Quality Finance & Administration VP of Research & Development Discovery Research

  • Scientific Director
  • Assoc. Scientific Dir.
  • Principal Scientist
  • Sr. Scientist
  • Scientist II
  • Scientist I
  • Sr. Research Assoc.
  • Research Assoc.

Process / Product Development

  • Director of Process /

Product Development

  • Proc. Dev. Supervisor
  • Proc. Dev. Associate
  • Proc. Dev. Technician

Director of Product / Process Development Director of Quality Chief Financial Officer Quality Control (QC) Chemistry

  • QC Analyst
  • QC Technician

Quality ¡Assurance ¡(QA) ¡

  • QA ¡Mgr/Supervisor ¡
  • QA ¡Documenta@on ¡

Specialist ¡

  • QA ¡Documenta@on ¡

Coordinator/Assoc. ¡

  • Clinical ¡QA ¡capabili@es ¡

Microbiology

  • QC Analyst

Finance ¡

  • VP ¡of ¡Finance ¡& ¡Admin. ¡
  • Accoun@ng ¡Manager ¡
  • Accoun@ng ¡Clerk ¡

Business Development

  • Director of Bus. Dev.

Administration

  • Director of HR
  • Human Resources

Rep.

  • Safety Manager
  • Purchase Agent/

Buyer

  • Receptionist
  • Administrative Asst.

Information Systems

  • Manager of IS
  • Systems Analyst
  • Analyst / Programmer

Legal

  • Patent/IP Attorney

Facilities Management

  • Facilities Manager
  • Facilities Technician
  • Shipper / Receiver

Clinical ¡-­‑Regulatory ¡

Clinical ¡Research ¡

  • Clinical ¡Research ¡Mgr/
  • Dir. ¡
  • Clinical ¡Research ¡Assoc ¡
  • Clinical ¡Coordinator. ¡

Medical ¡Director ¡ VP ¡of ¡Reg/Clin ¡Ops ¡ Program ¡Management ¡ Regulatory ¡Affairs ¡

  • VP ¡of ¡Reg. ¡Affairs ¡
  • Mgr. ¡of ¡Reg. ¡Affairs ¡
  • Reg. ¡Affairs ¡Associate ¡

Bioinformatics

  • Scientist / Engineer
  • Analyst / Programmer
  • Molecular Modeler

Lab Facilities

  • Facility Manager /

Supervisor (Animal Sciences)

  • Veterinarian
  • Lab Assistant /

Glass Washer Manufacturing & Production

  • Mfg. Supervisor
  • Mfg. Associate
  • Mfg. Tech. (Operator)
  • Mfg. Instrumentation/

Calibration Technician

Possible to rent vs. own

Development Stage Companies

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Big Company Global Product Development Team Structure

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Translating Challenges into Big Pharma

  • Small Pharma allows for creativity, risk taking,

collaborative approach to drug development – all roles work closely together

  • Big Pharma is frequently more bureaucratic and

has many roles working alongside one another, requiring streamlining, project management, and efficient process development

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There is no substitute for good talent and a value-based

  • rganization.
  • Hiring and retaining the best talent into the organization

is critical for future success and growth.

  • Training and continuous professional development must

be a focus

  • Diversity in backgrounds, experience and skill sets is

vital to drive innovation

  • The design of the organization has to adapt and support

productivity and clear accountability

  • The right people with the right skills have to be assigned

to the right tasks at the right level of allocation

People

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  • Pipeline products are the ‘fuel’ for clinical
  • perations.
  • Company R&D budgets and investment in pipeline

products are determining resources for clinical

  • perations (capacity).
  • Organizational infrastructure and design needs to

match company size and corporate strategy (adaptability).

Products

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A Bit about Us

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