going commercial in biotech: human resource considerations brad hartman, vertex pharmaceuticals

Going Commercial in Biotech: Human Resource Considerations

Brad Hartman, Vertex Pharmaceuticals

Introduction: Brad Hartman

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

Managed Markets Marketing

Commercial Organization: Functional Overview

Responsible for overall strategy and direction of the product‘s 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

Commercial Ops Medical Affairs Other Functions

Marketing Managed Markets


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.

Commercial Ops Medical Affairs Other Functions

Managed Markets Commercial Ops


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)

Marketing Medical Affairs Other Functions

* Sales Training can report here as well* Market Research may report into Marketing

Medical Affairs Managed Markets


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

Commercial OpsMarketing Other Functions

Managed Markets Other Functions

Going Commercial: New Functions Overview

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

Commercial Ops Medical AffairsMarketing

Commercial Org Chart: High Level Overview (30-60 people)

Commercial Org Chart: High Level Overview (150-250 people)

SalesField MedicalField Managed Markets

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

Field Managed Markets Field Medical Sales


Field Medical Affairs: Roles and Responsibilities

Medical Science Liaisons: These individuals are scientific ambassadors for Vertex to Healthcare Providers (HCP’s) 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.

Field Managed Markets SalesField Medical


Field Sales: Roles & Responsibilities

Sales Reps: Responsible for calling on Healthcare Providers (HCP’s) 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.

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

IInterview Process Design: BEI Selection Method

SkillKnowledge

Easy to see and develop

Necessary for top performance but not sufficient

Social Role

Self Image

Traits

Motive

Harder to see and develop

Characteristicsthat lead to longer term success

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.

IInterview Process Design: BEI Selection Method

SkillKnowledge

10+ Years Pharma GI Sales Experience,Multiple Presidents Clubs

Social Role

Self Image

Trait

Motive

Expert Helping Patients

10+ Years Pharma GI Sales Experience,Multiple Presidents Clubs

I am the best I help doctors treat patients more effectively

Curiosity Empathy

ConfidenceResilience

Personal Achievement

Being a ResourceFor Customers

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

Overview - Field Force Competencies

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

Defining Your Target Candidate Profile

TNF- αbiologicexp

Buy and Bill

GI Specialty Sales Exp

Crohn’s, IBD

Biologics Experience

Specialty Pharma Reps

Hospital/Account Reps

Hospital/Account Reps

Specialty Pharma Reps

AmgenPfizer/WyethAbbottJ&J (Centocor)UCB

BiogenGenzymeGenentechGileadEMD SeronoCSLCephalon

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

$$$$$$$KOL andEmployeeReferralsAre THEKEY!

Sourcing Techniques for Commercial

Linkedin Sourcing Tricks:

Keyword1 Company1 -inurl:jobId inurl:linkedin.com intitle:linkedin ["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 intoyour system

• Using email of company, [email protected], [email protected], etc you can then proactively hunt downtop 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!

mailto:[email protected]

mailto:[email protected]

Recruiting Operations and Offer Process Recommendations

• HUGE opportunity to impact nation-wide talent pool’s view of Human Resources and corporate employment brand

• Automated scheduling notes for interviews and regret letters to applicants or phone screen no’s from ATS system. Hiring manager should call all first & second round no’s.

• 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 significantstock vesting.

Partnering with the Business:Opportunities to Maximize HR Impact

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

Corporate Policies and Procedures:Commercial Areas of Focus

Corporate Policies and Procedures: Commercial

• Compliance, Compliance, Compliance!!

• Car Allowance/Fleet Policy AND T&E 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

Image Layouts – PolaroidsDeveloping and Sustaining Your Commercial Organization

Developing and Sustaining Your Commercial Organization

Talent Development Program

• People Reviews

• Career Paths

• Mentorship Programs

• Rotational Assignments

• Leadership & Management Development

APPENDIX

Creating Connective Tissue Through On-boarding

Strategy illustration

Past Future

Executive TeamParticipation

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 what’s going on in R+D 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

Research and Development Commercialization

Human Resources

Building Connections

Building Connections

On-boarding Program

31

People Review

Building Strong Leading

Po

ten

tia

l

High

Low

Promotable 2 or more levels

over time

Promotable 1 level over

time

Grow in Place

Low High

Performance(Consider Results & Values)

(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)

= Key Talent

= Potential Concern

32

Innovation is Our Lifeblood

“We” Wins

FearlessPursuit ofExcellence

How can we utilize people programs that live out these valuesand deliver substantial value for our business?

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

Three Phases of the Field Ride Along Program

34

Executive Team/HCV Experts:

Connect Senior Leadership across the organization and Vertex HCV scientific experts with top customers through a strategic framework

“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.

“The Pilot”: 20-25 internal employees (non-research personnel) travel with field employees to meet customers

Vertex Field Ride

Along Program

Phase III:

Phase I:

Phase II:

35

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.

36

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- Interviewee’s reflections, opinions and insights on their business arena

- Q&A 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

37

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 InterviewMinimum time taken away from key stakeholders to participate

- Opportunity to hear from the Field and learn first hand what information is valuable to them

38

Compliance, Compliance, Compliance: Why is it Important?

39

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

40

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

41

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

42

Consider the Risks

Legal/Regulatory You’re 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

Fleet Survey - United States (all industries)

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

Potential Career Paths for Field Commercial Functions

Grade Grade Grade Grade Grade Grade Grade

Grade 8

TS Exec TS

KAS RAM

SAM

NAM

RAE

SAE

TESenior TE

RSM

MMDir

NAE

TEM

ASD

Snr Dir

VP

FTM

SnrFTMTAM

KeyTE = Treatment EducatorTS = Therapeutic SpecialistKAS = Key Accounts SpecialistFTM = Field Training ManagerTAM = Trade Account ManagerTEM = Treatment Educator MgrRAM = Regional Account MgrSAM = Specialty Pharm MgrRSM = Regional Sales MgrRAE = Regional Acct ExecSAE = Specialty Pharm ExecNAM = National Account MgrASD = Area Sales DirectorNAE = National Account Exec

DM

Field Mentorship Outline

Goal: Create real-time, on the job learning experiences and a well outlinedtraining guide to enable key talent to be in a better position to seizefuture 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

Rotational Assignments Outline

Goal: Give Key Talent new and challenging work experiences through a 2-4 month rotational assignment in a different commercial functionin 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?

Do You Have Any Questions?

going commercial in biotech: human resource considerations brad hartman, vertex pharmaceuticals

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