Going Commercial in Biotech: Human Resource Considerations

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Going Commercial in Biotech Human Resource
Considerations

• Brad Hartman, Vertex Pharmaceuticals

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Introduction Brad Hartman
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Going Commercial in Biotech Overview

• Foundation Commercial Functions Overview
• Building a Commercial Team Recruiting Best
  Practices
• Partnering with the Business Opportunities to
  Maximize HR Impact
• HR Policies/Procedures Commercial Areas of
  Focus
• Developing and Sustaining your Commercial
  Organization

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Commercial Organization Functional Overview
Commercial Ops
Marketing
Managed Markets
Other Functions
Medical Affairs

• Responsible for overall strategy and direction of
  the products brand
• Physician and Patient components
• Create materials for the field sales reps to use
  with customers
• Strong project management, vendor management,
  strategic thinking and leadership skills required
• Heavy interactions with Regulatory, Medical, and
  Legal deparments for approval of brand materials

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Commercial Organization Functional Overview
Managed Markets
Commercial Ops
Marketing
Other Functions
Medical Affairs

• Responsible for ensuring profitable access of
  product to patients
• Call on Managed Care Customers to promote
  advantages of product in accordance with approved
  FDA label (Health Economics and Product
  Benefits)
• Customers include Federal/State
  (Medicare/Medicaid/DoD/VA) and Commercial Payers
  (National/Regional)
• Pricing and Contracting Group that will
  implement and manage contracts with all payers
  and ensure government of best price for the
  product
• Managed Markets (MM) Marketing Completely
  different messaging from other Marketing
  division. Knowledge of Field MM and MM customers
  essential.

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Commercial Organization Functional Overview
Commercial Ops
Marketing
Managed Markets
Other Functions
Medical Affairs

• Responsible for supporting in-house and field
  commercial functions with operations and
  analytics
• Can include Commercial Analytics/Field
  Effectiveness, Field Meeting/Event Planning,
  Fleet Services and Marketing Operations (if
  necessary).
• Responsible for the design and management of the
  Incentive Compensation Plan (key area for
  partnership with HR)
• Plans and manages national and regional events
  for the Commercial organization (National Sales
  Meeting, Speaker Events, Conference Coordination)

Sales Training can report here as well Market
Research may report into Marketing
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Commercial Organization Functional Overview
Medical Affairs
Commercial Ops
Managed Markets
Marketing
Other Functions

• New Areas for Medical Affairs
• Medical Information Responsible for responding
  to customer and patient inquiries about the
  product (routine and complex)
• Field Medical Medical Science Liaisons and
  Managed Care Liaisons
• Heavy interaction and healthy tension with
  Commercial Leadership team

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Going Commercial New Functions Overview
Commercial Ops
Other Functions
Marketing
Managed Markets
Medical Affairs

• Legal Compliance, Employment Law
• Finance/Accounting Revenue recognition,
  Financial Planning
• Investor Relations/Corporate Communications New
  and different pressure from the Street
• HR Employee Relations, Business Partner Needs
• IT Commercial CRM, Corporate/Product/Patient
  Websites

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Commercial Org Chart High Level Overview (30-60
people)
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Commercial Org Chart High Level Overview
(150-250 people)
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Overview of Field Functional Areas
Different Areas of Field Managed Markets

• Regional Account Managers Responsible for
  calling on Regional Payers (ie BC/BS of MA) and
  negotiating profitable access for the product
  post-approval.
• National Account Managers Responsible for
  working with large, nation wide payers (ie Aetna,
  Cigna, Wellpoint) and negotiating profitable
  access for the product post-approval.
• Specialty Pharmacy Account Managers Responsible
  for calling on Specialty Pharmacy customers (ie
  CVS Caremark), negotiating profitable access, and
  securing appropriate patient services to support
  the product.
• Trade and Distribution Responsible for calling
  on Wholesalers and Retail Pharmacies and
  negotiating profitable distribution channels for
  the product post-approval.

could be internal function of Managed Markets
team depending on product channel needs
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Overview of Field Functional Areas
Field Medical Affairs Roles and Responsibilities

• Medical Science Liaisons These individuals are
  scientific ambassadors for Vertex to Healthcare
  Providers (HCPs) to provide detailed scientific
  information on our product and the disease state,
  respond to Medical Information and off-label
  requests, and serve as a conduit for investigator
  initiated research studies
• Managed Care Liaisons These individuals are
  scientific ambassadors for Vertex to Managed Care
  organizations (Regional, National, and Specialty
  Pharmacy) to provide detailed scientific
  information on our product and the disease state,
  respond to Medical Information and off-label
  requests.

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Overview of Field Functional Areas
Field Sales Roles Responsibilities

• Sales Reps Responsible for calling on
  Healthcare Providers (HCPs) in assigned
  territory to promote the product within the
  approved FDA label using key messages and
  materials from Marketing.
• Sales Management Leadership/Management of 8-10
  reps with responsibilities for a particular
  region of the country.
• Other Potential Field Sales Functions
• Treatment Educators Nurse Practitioners or
  Physician Assistants responsible for educating
  mid-levels and groups of patients on what to
  expect with the new treatment, how to use the
  product (injection training), and side effect
  management.
• Field Reimbursement Specialists Most often seen
  with expensive biologic treatments in a buy
  bill environment. Responsible for calling on
  Office Managers, Nurses/Care Coordinators and/or
  Pharmacy Directors to ensure the treatment is
  properly coded, billed and reimbursed within an
  office or hospital setting.

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Building out a Commercial Team Recruiting Best
Practices

• Interview Process Design Behavior Event
  Interview (BEI)
• Model for Field Sales
• Defining Your Candidate Profile Sourcing
  Techniques
• Recruiting Operations and Offer Process
  Recommendations

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IInterview Process Design BEI Selection Method
Necessary for top performance but not sufficient
Easy to see and develop
Skill Knowledge
Social Role
Characteristics that lead to longer term success
Harder to see and develop
Self Image
Traits
Motive
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What is a Competency?

• Demonstrated characteristics of an individual
  that have repetitive capability and predict the
  likelihood of successful performance in a given
  job, role, organization, or culture.

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IInterview Process Design BEI Selection Method
10 Years Pharma GI Sales Experience, Multiple
Presidents Clubs
10 Years Pharma GI Sales Experience, Multiple
Presidents Clubs
Skill Knowledge
Social Role
Expert
Helping Patients
I help doctors treat patients more effectively
Self Image
I am the best
Confidence Resilience
Trait
Curiosity Empathy
Motive
Personal Achievement
Being a Resource For Customers
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Overview - Field Force Competencies

• Fearless Pursuit of Excellence Business Acumen
• Business Acumen is the ability to combine
  analytic skill with judgment to create business
  plans with competitive advantage to inform
  current and future decision-making. This is about
  understanding the business, connecting the dots,
  being proactive and providing strategic value.
• Dimension Degree of Proactivity in Planning for
  the Future

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Sales Force Selection Process Overview

• Phone Interview with HR and/or Hiring Manager
• 1st Round Interview (Territory based) Face to
  face with Hiring Manager and HR only
• 2nd Round Interviews (Regionally based) At
  least 3 Finalists per territory go through
• Territory Business Analysis Presentation 20
  minutes
• Behavioral Event Interview (Panel) - 2-2.5
  hours
• Hiring Manager Meeting 30 minutes
• VP of Sales/Commercial Meeting 30-45 minutes

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Defining Your Target Candidate Profile
Amgen Pfizer/Wyeth Abbott JJ (Centocor) UCB
KOL and Employee Referrals Are THEKEY!
Specialty Pharma Reps
Hospital/Account Reps
Buy and Bill
Crohns, IBD
TNF- a biologic exp

• What are similar
• products?
• Similar customer
• call points?
• Relationship
• driven market?
• Related disease
• states?

Biogen Genzyme Genentech Gilead EMD
Serono CSL Cephalon
GI Specialty Sales Exp
Biologics Experience
Hospital/Account Reps
Specialty Pharma Reps
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Sourcing Techniques for Commercial

• Linkedin Sourcing Tricks
• Keyword1 Company1 -inurljobId inurllinkedin.com
  intitlelinkedin
• "Linked in Subsidiary" city (i.e. Biotech,
  Boston)
• Will generate lists of employees from target
  companies in target locations
• Many ATS Systems will allow you to port LinkedIn
  information directly into
• your system
• Using email of company, firstname_last_at_company.co
  m,
• firstinitiallastname_at_company.com, etc you can
  then proactively hunt down
• top reps from other firms
• Candidates will often have a full list of
  Presidents Club award winners in
• their brag books another great source for top
  tier candidates!

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Recruiting Operations and Offer Process
Recommendations

• HUGE opportunity to impact nation-wide talent
  pools view of Human Resources and corporate
  employment brand
• Automated scheduling notes for interviews and
  regret letters to applicants or phone screen nos
  from ATS system. Hiring manager should call all
  first second round nos.
• Regional based interviews will minimize need for
  candidate flights and reduce overall costs.
  Expect to reimburse for gas and tolls
• Standardize base raise for sales force with
  flexibility only for those below the salary range
• Will need to offer sign-ons to cover quarterly
  bonus loss or significant
• stock vesting.

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Partnering with the Business Opportunities to
Maximize HR Impact
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Key Opportunities for Human Resources in the
Commercialization Process

• Organizational Design and Planning
• Incentive Compensation
• Launch Planning Coordination
• On-boarding
• Sales Training
• Field Employee Communication
• People Programs

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Corporate Policies and Procedures Commercial
Areas of Focus
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Corporate Policies and Procedures Commercial

• Compliance, Compliance, Compliance!!
• Car Allowance/Fleet Policy AND TE Policy
  Updates
• Harassment Policy/Code of Conduct Updates AND
  Training
• On-boarding and Off-boarding Procedures
• Performance Improvement Framework
• California State Employment Laws
• Earned Wage Laws
• Incentive Compensation Policy
• Recent Sales Force Overtime Case Law

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Image Layouts Polaroids
Developing and Sustaining Your Commercial
Organization
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Developing and Sustaining Your Commercial
Organization

• Talent Development Program
• People Reviews
• Career Paths
• Mentorship Programs
• Rotational Assignments
• Leadership Management Development

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APPENDIX
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Creating Connective Tissue Through On-boarding
Human Resources
Strategy illustration
Past
Future
Research and Development
Commercialization
On-boarding Program
Building Connections
Get Research Involved!Reps love to spend time
with your scientists and this will help break
down sales stigmas. Take new hires into the labs
and show them whats going on in RD under the
hood!
Cross-functional Training Have participants from
across the organization and new hires participate
in a cross-functional all-day training to help
create connective tissue across functional areas

Executive Team Participation
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People Review
(Use this as a framework to think through where
you see direct reports based on your assessment
of their current performance level (see
definitions in appendix) potential)
Building
Strong
Leading
High



Promotable 2 or more levels over time
Potential
Promotable 1 level over time
Grow in Place
Low
Low
High
Performance
Key Talent
Potential Concern
(Consider Results Values)
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Innovation is Our Lifeblood
We Wins
Fearless Pursuit of Excellence
How can we utilize people programs that live out
these values and deliver substantial value for
our business?
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What is a Field Ride Along and Why should we do
this?

• Simply defined In-house employees,
  therapeutic/disease state experts, and senior
  leadership spending a day in the field (riding
  along) with our CREW team members and visiting
  with customers.
• Purpose To create powerful employee experiences,
  build cross-functional connective tissue within
  the organization, and to differentiate Vertex in
  the eyes of customers.
• Key Objectives
• To help customers better understand who Vertex is
  and what our culture is all about
• Continue to deliver on the One Company, One
  Culture theme with our employees and our
  customers
• Drive cross-functional learning between in-house
  and field employees through immersion in real
  world experiences

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Three Phases of the Field Ride Along Program
Phase I
The Pilot 20-25 internal employees
(non-research personnel) travel with field
employees to meet customers
Phase II
Phase I
Executive Team/HCV Experts Connect Senior
Leadership across the organization and Vertex HCV
scientific experts with top customers through a
strategic framework
Phase II
Vertex Field Ride Along Program
Phase III
Phase III
One Company, One Culture Field Ambassadors
paired with each field employee spend one day in
the field meeting with customers and learning
about each other.
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Field Podcast Summary

• Simply-Identified
• The Field Podcast is a radio-show styled
  interview with different key stakeholders in
  Commercial, Research and Development, and other
  areas throughout the company.
• Program was designed off the existing ET Coffee
  Session concept where executives share
  information about themselves and their thoughts
  on the business with employees in a live setting.
  
• Purpose
• To provide a sense of connection between the
  field and corporate personnel in an intimate,
  informal, and entertaining format while also
  being informative and educational
• Key-Objectives
• Providing key commercial and corporate updates
  that directly impact the field employees
• Allowing Field employees a chance to submit
  questions to senior leaders and hear candid
  responses
• Humanizing the Group Leaders by making them more
  relatable and less intimidating while maintaining
  respectability
• Entertaining the listeners in a low-key, candid,
  and funny setting without mandatory time
  requirements away from the field.

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Field Podcasts Concept Outline

• 15-20 min Podcast with key stakeholders
• Radio-style Interview with 3 segments (General
  Outline)
• Intro/Get To Know
• Introduction
• Quick professional background
• Some personal background
• Business Topic Discussion
• Interviewees reflections, opinions and insights
  on their business arena
• QA from field employees
• Overall goal is a fun, upbeat, entertaining, and
  interactive experience that provides useful
  business information and personalizes leaders
  from across the company to the field
• Continues One Company, One Culture theme by
  introducing the field to leaders from across the
  company

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Advantages

• For Listeners
• Podcast is pre-recorded and posted on Navigator
  for streaming
• No mandatory attendance no time commitment
• Will not take away from time spent in the Field
• Opportunity to get own questions answered from a
  Group Leader
• Opportunity to learn about a Group Leader with
  whom the listener may not regularly interact
• For Interviewees
• Short Interview
• Minimum time taken away from key stakeholders to
  participate
• Opportunity to hear from the Field and learn
  first hand what information is valuable to them

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Compliance, Compliance, Compliance Why is it
Important?
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Two Major Areas of Compliance Concern

• Pre-approval promotion of prescription products
• Food, Drug and Cosmetic Act
• False Claims Act
• Providing kickbacks to HCPs to use or prescribe
  our products
• Federal Anti-kickback Statute
• State Laws
• restricting payments to HCPs
• requiring reports of spending per HCP
• Physician Payment Sunshine Act

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Underlying Purpose of these Rules

• Information on safety and efficacy available
  before product approval may be incomplete
• Practitioners can develop potentially harmful
  misconceptions about the product
• Can create unrealistic expectations and
  inappropriate demand by physicians and patients

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Other Compliance Considerations

• Grants, HCP payments, and other interactions
• If not executed properly, can create kickback and
  off-label promotion risks
• Commercial and Medical Affairs interactions in
  the Field are not allowed (no dual calls or
  introductions). Other Commercial/Medical
  restrictions apply (off-label questions,
  conference booths)
• Additional rules based on State laws
  institutional restrictions

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Consider the Risks

• Legal/Regulatory
• Youre in a fishbowl Bad Ad Program,
  competitors, DOJ
• Think how several independent activities can
  result in a big problem
• Possible impact criminal, civil, legislative,
  SEC or FDA filing
• Reputation/Credibility
• Perceived conflict of interest
• Lots of attention with investors, press,
  customers, advocates, FDA

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Fleet Survey - United States (all industries)
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Car Allownace/Fleet Policy Considerations

• Different Car Allowance Levels (eg management vs
  reps)
• Points System for Driving Infractions?
• Evaluating Risk/Infractions pre-hire vs post-hire
• DUI Termination? Post-conviction or immediate?
• Requirements for Accident Reporting
• Tax Implications for Employees (over certain
  mileage reimbursement )
• Transfer to Internal Role
• Corporate Insurance Implications
• Offer Letter Language on Car Allowance/Fleet
  Vehicle

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Potential Career Paths for Field Commercial
Functions
VP
Snr FTM
NAM
TAM
NAE
Snr Dir
MM Dir
SAE
FTM
SAM
Key TE Treatment Educator TS Therapeutic
Specialist KAS Key Accounts Specialist FTM
Field Training Manager TAM Trade Account
Manager TEM Treatment Educator Mgr RAM
Regional Account Mgr SAM Specialty Pharm
Mgr RSM Regional Sales Mgr RAE Regional Acct
Exec SAE Specialty Pharm Exec NAM National
Account Mgr ASD Area Sales Director NAE
National Account Exec
KAS
RAM
RAE
ASD
Exec TS
TS
RSM
DM
Senior TE
TEM
TE
Grade
Grade
Grade
Grade
Grade
Grade
Grade
Grade 8
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Field Mentorship Outline
Goal Create real-time, on the job learning
experiences and a well outlined training guide to
enable key talent to be in a better position to
seize future career opportunities in different
job functions.
Mentorship Opportunities by Function (Target
of Opportunities for a Calendar Year)
Regional Account Manager (5-6) Training
(2) Key Accounts Specialist (2)
Regional Sales Manager (3-4) Marketing (3-4)
Therapeutic
Specialist (2-3)

• Selection Criteria ?
• Mentorship Framework for each Function Key
  Learning Objectives

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Rotational Assignments Outline
Goal Give Key Talent new and challenging work
experiences through a 2-4 month rotational
assignment in a different commercial function in
order to keep them fully engaged and to prepare
them for future career development
opportunities.
Rotational Assignments by Function (Target of
Total Opportunities for Calendar Year)
Marketing (6-8)
Training (3-4) Commercial Operations (3-4)
Internal Managed Markets (3-4) Therapeutic
Specialist (5-6) larger due to high of reps
in rotational assignments Business Information(?)
(1-2)

• Selection Criteria?Logistics/Travel Policy?

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Do You Have Any Questions?
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