Going Commercial in Biotech: Overview Page 3 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 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 Commercial Ops Medical Affairs Other Functions
Marketing Managed Markets Commercial Organization: Functional Overview 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 Commercial Organization: Functional Overview 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 Commercial Organization: Functional Overview 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 Ops Marketing 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 Affairs Marketing
Commercial Org Chart: High Level Overview (30-60 people) VP/SVP, Commercial Senior Director, Marketing Assoc. Director, Patient Marketing Marketing Coordinator Senior Director, Managed Markets Director, Managed Markets Operations Director, Trade and Distribution Assoc. Director, Payer Marketing Field MM Team VP, Sales Area Sales Director, East Area Sales Director, West Director, Sales Training Senior Director, Commercial Ops Director, Commercial Analytics Senior Manager, Market Research Manager, Field Meetings and Event Planning Commercial Ops + Event Coordinator Director, Program Management Executive Assistant Page 9
Commercial Org Chart: High Level Overview (150-250 people) SVP, Commercial VP, Marketing Director, Patient Marketing Director, Professional/KOL Marketing Director, Patient Services VP, Managed Markets Director, Payer Marketing Senior Director, Health Economics Senior Director, Pricing and Contracting MM Field Leaders Director, Trade and Distribution VP, Sales Area Sales Director, East Area Sales Director, West Director, Sales Training VP, Commercial Ops Director, Field Effectiveness Director, Field Services Director, Marketing Operations VP, Business Information Director, Market Research Director, Competitive Intelligence Director, Program Management Associate Director, Program Management Executive Assistant Page 10
SalesField Medical Field 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 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.
Field Managed Markets Sales Field Medical 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.
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 Skill Knowledge Easy to see and develop Necessary for top performance but not sufficient Social Role Self Image Traits Motive Harder to see and develop Characteristics that lead to longer term success
What is a Competency? Page 16 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 Skill Knowledge 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 Confidence Resilience Personal Achievement Being a Resource For 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 Page 19 Phone Interview with HR and/or Hiring Manager 1 st Round Interview (Territory based): Face to face with Hiring Manager and HR only 2 nd 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 Page 20 TNF- α biologic exp Buy and Bill GI Specialty Sales Exp Crohns, IBD Biologics Experience Specialty Pharma Reps Hospital/Account Reps Specialty Pharma Reps Amgen Pfizer/Wyeth Abbott J&J (Centocor) UCB Biogen Genzyme Genentech Gilead EMD Serono CSL Cephalon What are similar products? Similar customer call points? Relationship driven market? Related disease states? $$$$$$$ KOL and Employee Referrals Are THE KEY!
Sourcing Techniques for Commercial Page 21 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 into your system Using email of company, firstname.lastname@example.org,email@example.com firstname.lastname@example.org@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!
Recruiting Operations and Offer Process Recommendations Page 22 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.
Partnering with the Business: Opportunities to Maximize HR Impact
Key Opportunities for Human Resources in the Commercialization Process Page 24 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 Page 26 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 – Polaroids Developing and Sustaining Your Commercial Organization
Developing and Sustaining Your Commercial Organization Page 28 Talent Development Program People Reviews Career Paths Mentorship Programs Rotational Assignments Leadership & Management Development
Creating Connective Tissue Through On-boarding Strategy illustration PastFuture Executive Team Participation 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 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 On-boarding Program
31 People Review BuildingStrongLeading Potential High Low Promotable 2 or more levels over time Promotable 1 level over time Grow in Place LowHigh 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 Fearless Pursuit of Excellence How can we utilize people programs that live out these values and 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 -Interviewees 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 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
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 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
Page 43 Fleet Survey - United States (all industries)
Page 44 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 Page 45 Grade Grade 8 TS Exec TS KASRAM SAM NAM RAE SAE TE Senior TE RSM MM Dir NAE TEM ASD Snr Dir VP FTM Snr FTM TAM 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 DM
Field Mentorship Outline Page 46 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
Rotational Assignments Outline Page 47 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?