From Here to There and Back Again too

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From Here to There (and Back Again too)

• James Kahn MD
• Co-Director CFAR Mentoring Project

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Outline

• Working with industry from inside the world of
  academics
• Transitions from an academic position or training
  program

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Working with industry from inside the world of
academics

• Optimally everyone can find something of value to
  emerge from collaborations including that
  advances science or care
• New products or applications of products
• Novel pathways of investigations
• Access to samples, products or technologies
• Interactions to people, facilitative training,
  support or funding

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However there is Tension

• Academics are valued for their status and
  independence, but are used for advice, for
  contract research, and as a means of conveying
  messages. This is a fundamental culture clash
  since
• Independence cannot be marketed for a fee,
• Opinion too easily shades into advocacy,
• Secrecy and science do not mix.

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Case study

• Evaluation of HIV-1 Immunogen, an Immunologic
  Modifier, Administered to Patients Infected With
  HIV Having 300 to 549 x 106/L CD4 Cell Counts A
  Randomized Controlled Trial
• JAMA. 20002842193-2202.
• James Kahn et al.

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The Facts

• The company spent gt 180M to develop a product
• University Investigators formed a research
  network to study the product---contracts were
  signed.
• During the study the DSMB reviewed data and found
  no difference between placebo and product
  groups.
• Data was not supplied to publish the data
• Attempts to obtain the data led to new
  restrictions on the publishing of the data.
• Investigators published the Negative Results
  from the DSMB report.
• A legal action was begun against the
  investigators.
• Legal action was dropped without prejudice

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Issues

• Collaborative relationships need to be viewed as
  long-term activities driven by a common unifying
  goalyou need to understand the goals. Trust and
  commitment can be elusive if the goals are not
  clear and problematic even if they are clear.
• Working with industry can give you access to new
  products or new applications and funding
• Determine what is important to all parties and
  then specify the issues in a contract.
• Contracts and Grants provide key service
• Ask for advice from mentor or supervisor.

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Expectations

• No limits on intellectual freedom and everyone
  must respect intellectual property.
• No limits on student/post-doctoral involvement
• No acceptance of any financial involvement
  (consulting, lectures, fees, stock or options)
  during the conduct of the trial/study/project.
• Contracts are a mustno ad-hoc arrangements
• http//www.research.ucsf.edu/Units/Osr.asp

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What comes after Academics?

• Making Changes or Transitions
• What to consider in making decisions
• What are the options?

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When is it time to Look?

• When you are most successful
• When you are least successful
• When you have time to prioritize thinking about
  yourself
• When you think you ready for a change
• When something out there is more appealing than
  what you are presently doing.
• When someone tells you it is time.

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Gender Inequities may contribute to changes

• Female faculty were more than 2.5 times more
  likely than male faculty to perceive gender-based
  discrimination in the academic environment (Plt
  0.001). Among women, rates of reported
  discrimination ranged from 47 for the youngest
  faculty to 70 for the oldest faculty.
• Ash AS, Carr PL, Goldstein R, Friedman RH. Ann
  Intern Med. 2004 Aug 3141(3)205-12.

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Biological Sciences Careers

• Traditional career paths
• Academics instructor/asst. professor
• Federal or State or Local Government Lab or
  Public Health
• For-profit analytical laboratory CRO,
  diagnostics
• Bio suppliers Sales, RD
• The road less-known
• Computing/data management
• Project management/science administration
• Intellectual property law
• Scientific journalism
• Forensics
• Microbiology, Virology, GC/MS
• Esp. with foreign language skills

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Differences between For-Profit and Academic
Enterprises

• For-Profit Enterprises
• Applied
• Product Driven
• Employee environment
• Customer orientatedWhat does the person across
  the table wants and need
• Focus on quality control, regulatory affairs,
  Intellectual property.

• Academic Enterprise
• Hypothesis Driven
• Answer the question posed.
• Training Emphasized via Student / Fellow
  /Post-doc environment
• More independence perhaps less intra-org
  cooperation although there can be excellent
  inter-org cooperation.

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Key Drivers for Choosing the Next
Environment/Enterprise

• Level of scientific independence
• Economic risk and rewards
• Level of profitability of the Enterprise
• Opportunity for advancement
• Regional considerations
• Corporate HQ or "outpost destinations

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Research in For-profit Enterprises (and
Government)

• The Good news
•     Teamwork
•     Fewer pressures to publish
•     Planned approach
•     No budget problems
•     Access to new methodology
•     Stock options, salary
•    Administrative support
• Focused approach to applications

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Research in For-profit Enterprise (and Government)

• The Bad news
• Shared science
• Cant publish the hot stuff
• More paperwork
• Deadlines
• Ultimate control by non-scientist
• No students or fellows

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Enterprises are NOT the same

• Larger entities tend to
• Be more lumbering
• Challenges with communication
• Have more expertise on board
• More opportunity for formal training
• More options or more projects to work on
• Smaller entities tend to
• A more dynamic process
• Greater inter-dependence
• More informal
• Tends to have greater focus (why large entities
  have themes)

Size really does matter
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How Can You Evaluate a Bioscience Company?

• Scientific foundation/goals What exactly do
  they do that relates to your skills and future
  plans?
• Funding Living on borrowed time or profitable?
• Management/organizational structure
  Free-wheeling startup or lockstep control freaks?
• Proprietary position Do they have issued
  patents on the their technology platform?
• Competition How many other companies are out
  there doing exactly the same thing?
• Administrative Support Are you going to do what
  you are good at or is there non-scientific
  pressures?

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What is sought in a new employee?

• A team player
• Reliability
• On-time performance
• Good "people skills"
• Smart, self-correcting
• Able to accept criticism and make corrections
• Future potential
• Excellent scientific capabilities
• Will you fit into the organizations culture?

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The Search Committee will ask themselves Can
this person

• In Academics..
• Compete in science in your chosen field
• Anchor a key technology and/or run a core
  facility
• Teach a course, especially an entry-level
  requirement
• Self-promote to attract attention, fellows, and
  grants
• Publish often and well
• Become fully funded and stay that way

• In a Business..
• Know a competitive scientific field
• Anchor a key technology and/or run a process
• Communicate effectively by both oral and written
  means
• Get along in a team environment
• Plan and meet timelines
• Do work that makes money for shareholders

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Do Your Homework!

• Visit the Corporate website
• What is the Corporate mission?
• What is their Scientific mission?
• What is their technology base?
• Is it unique?
• Is it proprietary?
• Scientific founders
• Scientific Advisory Board Membership
• Corporate Board Membership
• Patent Estate
• How do they make money?
• What do the do with their money?

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Distinctions Early-Stage and Late-Stage
Enterprises

• Companies Early-stage (e.g., startup biotech)
• Much can be published, presented at meetings
• Latitude to pick the direction and approach
• Work much like an academic lab
• You will multi-task
• Late-stage (e.g., big pharma, big biotech)
• Key work is private
• Direction according to team needs and planning
• Stratified levels of authority like Government
• Keep eye on the ball

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Consider New Models

• Contingency Scientist--Contract work with limited
  time commitment
• Gain a toe-hold in the marketplace
• Flexible hours and work arrangement
• Visa sponsorship
• For mid or late career changes it is a time to
  enter quasi-retirement
• Test for a good fit before establishing a
  permanent situation.
• Down side too benefits are limited even if
  salaries are higher.

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Major Common Element

• The Pursuit of Discovery
• I never want to do things that somebody else can
  do equally well. I want to do things where I have
  something unique to contribute
• Perry B. Molinoff, M.D.