Making the Move from the Academic Making the Move from the Academic to the Commercial Lab: to the Commercial Lab:

What You Should Know Before You Go “All In”What You Should Know Before You Go “All In”

Brought to you by Principal Investigators AssociationBrought to you by Principal Investigators Association

Presented by: John W. Ludlow, Ph.D.Presented by: John W. Ludlow, Ph.D.

Live Webinar Live Webinar Thursday, January 17, 2013 at 2:00 PM ESTThursday, January 17, 2013 at 2:00 PM EST

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This insightful Webinar will cover areas to be considered when making the career change from an academic setting to the commercial lab, including the culture of the commercial laboratory working environment, career advancement, scientific recognition, mentoring, and availability of opportunities.

5 Key Take-Aways:

•Similarities and differences between academic and commercial laboratory working environments•Suggestions on how to increase your autonomy and independence in conducting research at a commercial laboratory •How to ‘hedge your bets’ so that deadlines and milestones are reached•Balancing publishing and intellectual property generation•The difference in costs between academic and commercial laboratory research

5 Key Take-Aways:

•Similarities and differences between academic and commercial laboratory working environments•Suggestions on how to increase your autonomy and independence in conducting research at a commercial laboratory •How to ‘hedge your bets’ so that deadlines and milestones are reached•Balancing publishing and intellectual property generation•The difference in costs between academic and commercial laboratory research

Thursday: January 17, 20132:00 PM EST | 11:00 AM PST

Attend the Live Webinar and receive a free recording in Attend the Live Webinar and receive a free recording in CD-ROM, MP4 or PDF Transcript.CD-ROM, MP4 or PDF Transcript.. .

For More Information visit For More Information visit http://bit.ly/LabCareerFor More Information visit For More Information visit http://bit.ly/LabCareer

Making the Move from the Academic to the Commercial Lab: Making the Move from the Academic to the Commercial Lab: What You Should Know Before You Go “All In”What You Should Know Before You Go “All In”

Erosion of academic research support contributes to a Erosion of academic research support contributes to a career change to commercial laboratoriescareer change to commercial laboratories

Desire to pursue science having a more direct Desire to pursue science having a more direct applicationapplication

Career advancementCareer advancement

Political environment Political environment

Compensation considerationsCompensation considerations

Time and EffortTime and Effort

Presentation GoalsPresentation Goals

1.1. Points to consider when Points to consider when contemplating a change from an contemplating a change from an academic to a commercial academic to a commercial science career science career

2.2. Similarities and differences Similarities and differences between the two laboratory between the two laboratory settingssettings

3.3. Career advancement in the Career advancement in the commercial sectorcommercial sector

Areas of emphasis are highlighted in Areas of emphasis are highlighted in yellowyellow

1. Introduction1. Introduction

• Current landscapeCurrent landscape

• Large vs. small companiesLarge vs. small companies

• Contract researchContract research

2. The two cultures2. The two cultures

• AcademicAcademic

• CommercialCommercial

3. Making the move3. Making the move

• DecisionDecision

• ActionAction

4. Advancement after the move4. Advancement after the move

5. Suggested resources5. Suggested resources

6. Summary and closing remarks6. Summary and closing remarks

Presentation OutlinePresentation Outline

Current LandscapeCurrent Landscape

The FrameworkThe Framework

• Biotechnology leverages our understanding of Biotechnology leverages our understanding of the natural sciences to create novel solutions the natural sciences to create novel solutions

• Biotechnology is grounded in the pure Biotechnology is grounded in the pure biological sciences of genetics, microbiology, biological sciences of genetics, microbiology, animal cell cultures, molecular biology, animal cell cultures, molecular biology, embryology and cell biologyembryology and cell biology

• The foundation of biotechnology is based in our The foundation of biotechnology is based in our understanding of cells, proteins and genesunderstanding of cells, proteins and genes

• The discoveries of biotechnology are intimately The discoveries of biotechnology are intimately entwined in the industry sectors for entwined in the industry sectors for development in agricultural biotechnology, development in agricultural biotechnology, biofuels, biomanufacturing, human health, biofuels, biomanufacturing, human health, nanobiotechnology, vaccines, tissue nanobiotechnology, vaccines, tissue engineering and regenerative medicineengineering and regenerative medicine

Current LandscapeCurrent Landscape

We have all heard about the challenges of We have all heard about the challenges of changing career paths ‘in this changing career paths ‘in this environment’environment’

• Unemployment among scientists tends to Unemployment among scientists tends to be less than in other fields be less than in other fields

• Opportunities tend to be more available Opportunities tend to be more available the closer you are to the benchthe closer you are to the bench

• There are geographical differences in There are geographical differences in opportunities for those wanting to move to opportunities for those wanting to move to a commercial laboratorya commercial laboratory

• Research and development dollars in Research and development dollars in commercial laboratories are not at the commercial laboratories are not at the levels they were in the pastlevels they were in the past

• The landscape is dynamicThe landscape is dynamic

• Part of a not-yet profitable company to conduct Part of a not-yet profitable company to conduct research and development studies for a repeatable research and development studies for a repeatable and scalable business modeland scalable business model

• Perform fee-for-service analysis for healthcare, Perform fee-for-service analysis for healthcare, environmental, and veterinary organizationsenvironmental, and veterinary organizations

• A division in a profitable company to carry out A division in a profitable company to carry out research and development studies for pipeline research and development studies for pipeline productsproducts

• A service company providing biological products for A service company providing biological products for the academic and other private sector laboratoriesthe academic and other private sector laboratories

Commercial Biotechnology LabsCommercial Biotechnology Labs

Large CompaniesLarge Companies

• May be publicly traded or privately May be publicly traded or privately heldheld

• May have multiple geographic May have multiple geographic locations, holdingslocations, holdings

• Not always easily defined by number Not always easily defined by number of employees of employees

• Often have multiple products on the Often have multiple products on the market, or many services which they market, or many services which they offeroffer

• Usually have multiple divisionsUsually have multiple divisions

• Clear delineation of responsibilitiesClear delineation of responsibilities

Small CompaniesSmall Companies

• May be publicly traded or privately May be publicly traded or privately held, often privately heldheld, often privately held

• Usually have a single locationUsually have a single location

• At the low end, less than 10 At the low end, less than 10 employeesemployees

• Often have a few select products on Often have a few select products on the market, or limited services which the market, or limited services which they offerthey offer

• Startup companies fall in this Startup companies fall in this categorycategory

• Employees often wear ‘multiple hats’Employees often wear ‘multiple hats’

Startup CompaniesStartup Companies

• In the phase of research In the phase of research and development for and development for marketsmarkets

• High risk / high reward High risk / high reward profileprofile

• ScalableScalable

• Value often based on IPValue often based on IP

• Founder, Venture Capitol, Founder, Venture Capitol, Angel Investor fundedAngel Investor funded

Startup Company ConsiderationsStartup Company Considerations

• How secure is the IPHow secure is the IP

• What are the plans for growthWhat are the plans for growth

• Track record of the foundersTrack record of the founders

• Current financingCurrent financing

• Burn rateBurn rate

• Projected runway to cash Projected runway to cash extinguishmentextinguishment

• Plan for continued fundingPlan for continued funding

• Recognize that many startups failRecognize that many startups fail

Contract Research Organization (CRO)Contract Research Organization (CRO)

• Offers fee-for-services support Offers fee-for-services support primarily to manufactures of primarily to manufactures of medicinal products and medicinal products and biotechnology companiesbiotechnology companies

• Current Good Laboratory Current Good Laboratory Practices (cGMP) compliantPractices (cGMP) compliant

• Follow Standard Operating Follow Standard Operating Procedures (SOP) for work Procedures (SOP) for work performedperformed

• Provide quality assured Provide quality assured documentation to clientdocumentation to client

Contract Research Organization (CRO)Contract Research Organization (CRO)

Depending on the organization, services provided may include, Depending on the organization, services provided may include, but are not necessarily limited to:but are not necessarily limited to:

•Laboratory analysisLaboratory analysis

•Experimental design Experimental design

•Product developmentProduct development

•ManufacturingManufacturing

•Pre-clinical studiesPre-clinical studies

•Clinical trial managementClinical trial management

•Project managementProject management

•Data entry and statistical analysisData entry and statistical analysis

•Institutional review board (IRB) approvalInstitutional review board (IRB) approval

•Document preparation and submission to regulatory agenciesDocument preparation and submission to regulatory agencies

Contract Research CompaniesContract Research Companies

• May be large or smallMay be large or small

• Defined scope of workDefined scope of work

• Defined deliverables Defined deliverables

• Timelines may be rolling Timelines may be rolling

• While no true ‘ownership’ of the While no true ‘ownership’ of the projects, opportunities to work projects, opportunities to work in a variety of areasin a variety of areas

The Two Cultures The Two Cultures

AcademicAcademic

• Knowledge for Knowledge for knowledge sakeknowledge sake

CommercialCommercial

• Having profit as Having profit as the chief aimthe chief aim

The Two Cultures The Two Cultures

AcademicAcademic CompanyCompany

Freedom to choose pursuit Defined pursuitFreedom to choose pursuit Defined pursuit

Intellectual curiosityIntellectual curiosity Product development Product development

Prestige of independence Corporate identityPrestige of independence Corporate identity

PublicationsPublications PatentsPatents

GrantsGrants Corporate support Corporate support

Build a group Build or join a groupBuild a group Build or join a group

Soft timelines Fixed timelinesSoft timelines Fixed timelines

Success is determined by financesSuccess is determined by finances

The Two Cultures The Two Cultures

Freedom to choose pursuit vs. defined pursuitFreedom to choose pursuit vs. defined pursuit

• Arguably one of the most critical differences to Arguably one of the most critical differences to consider when deciding to move from academics to consider when deciding to move from academics to a commercial settinga commercial setting

• Can you get excited about projects that you did not Can you get excited about projects that you did not design?design?

• Do you see an opportunity to ‘make it your own’?Do you see an opportunity to ‘make it your own’?

The Two Cultures The Two Cultures

Intellectual curiosity vs. product developmentIntellectual curiosity vs. product development

• Ideally the project will satisfy bothIdeally the project will satisfy both

• Development tends to be more predictableDevelopment tends to be more predictable

• Do you see an opportunity to pursue curiosities?Do you see an opportunity to pursue curiosities?

Publications

• Publications are still important for validating company’s technology

• Need to be vetted by legal before submission

• Timing may be linked to milestones and press releases

• Same considerations for poster and podium presentations

Intellectual Property (Patents)

• Intellectual property is defined as creations of the mind for which property rights are recognized under intellectual property law

• Owners of IP are granted certain exclusive rights

• A patent by itself does not grant the inventor the right to commercialize the protected technology; a patent grants the right to exclude others from commercializing it

• Continuing to secure additional IP, as well as leverage existing IP, are critical to a company’s success

• Ultimately, IP needs to be translated into a revenue-generating product for a company to enjoy some degree of financial stability

Decision MakingDecision Making

• Confirm there is a viable marketConfirm there is a viable market

• Is there sufficient capitalizationIs there sufficient capitalization

• What are the competitive advantagesWhat are the competitive advantages

• Will there be competition with industry leadersWill there be competition with industry leaders

• Is the technology niche too smallIs the technology niche too small

• Assess the founding team stabilityAssess the founding team stability

• Is the growth pace too rapidIs the growth pace too rapid

• Have trust in the sources utilized to answers these Have trust in the sources utilized to answers these questionsquestions

AttitudeAttitude

Entrepreneurial spiritEntrepreneurial spirit

Balance competing prioritiesBalance competing priorities

Risk / Reward toleranceRisk / Reward tolerance

Taking ActionTaking Action

• Are there any conflict of interest Are there any conflict of interest issues to be addressed? issues to be addressed?

• Determining what belongs to you Determining what belongs to you and what belongs to the academic and what belongs to the academic institutioninstitution

• Release from your academic Release from your academic responsibilitiesresponsibilities

• Notifying granting agencies of Notifying granting agencies of your academic departureyour academic departure

AdvancementAdvancement

• Rank initially assessed by length of Rank initially assessed by length of serviceservice

• Responsibilities similar to Responsibilities similar to academic positions, with different academic positions, with different nomenclaturenomenclature

• Success rate for deliverablesSuccess rate for deliverables

• Organization size dictates Organization size dictates advancement opportunitiesadvancement opportunities

• Local biotechnology environmentLocal biotechnology environment

Suggested Resources

• Colleagues who have ties to industry• Faculty at colleges and universities with

biotechnology programs• University Technology Transfer Office• State Biotechnology Office• Networking events at scientific meetings• Industrial internship, fellowship, apprenticeship• Visiting a biotechnology company

Summary and Closing Remarks

• Milestone driven Milestone driven

• Product development or service providerProduct development or service provider

• Patents Patents

• Commercial success Commercial success

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The NSF Grant Application Mentor: An Educational How-to Manual, 2013 Edition includes 7 unique sections. Each section instructs on a separate, important aspect of the NSF grant application process. These include:Section 1: Preparation—What Every Researcher Should Know Before You Start ApplyingSection 2: Knowing Your Audience: Understand NSF’s Review Criteria and ReviewersSection 3: Successfully Present Your Project and Your Individual QualificationsSection 4: How to Document Your Resources and Your Commitment to the Research CommunitySection 5: Demonstrating the Significance of Your Research TopicSection 6: NSF Special Considerations: Reporting and Compliance Essentials for Human Subjects and AnimalsSection 7: The NSF Review Process: Tactics for Submitting a Winning Proposal

The NSF Grant Application Mentor: An Educational How-to Manual, 2013 Edition includes 7 unique sections. Each section instructs on a separate, important aspect of the NSF grant application process. These include:Section 1: Preparation—What Every Researcher Should Know Before You Start ApplyingSection 2: Knowing Your Audience: Understand NSF’s Review Criteria and ReviewersSection 3: Successfully Present Your Project and Your Individual QualificationsSection 4: How to Document Your Resources and Your Commitment to the Research CommunitySection 5: Demonstrating the Significance of Your Research TopicSection 6: NSF Special Considerations: Reporting and Compliance Essentials for Human Subjects and AnimalsSection 7: The NSF Review Process: Tactics for Submitting a Winning Proposal

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