Learn more about our boutique management consulting firm, that assists life science companies with solutions to manage their daily business needs

1. Property of Kineticos © Copyright 2016
www.kineticos.com
Kineticos – Capabilities Overview

2. 2Property of Kineticos © Copyright 2016
Kineticos is a specialized management consulting firm serving the life science
industry. The firm is focused on identifying opportunities to drive strategic
growth and achieve operational excellence for its clients around the globe.
About Us
Key Facts
A Differentiated Approach…
 Specialized focus in life sciences
 Real world expertise from decades in industry
 Strategic thinking
 Tactical execution capabilities
 Systematic methods and processes

3. 3Property of Kineticos © Copyright 2016
Life Science
Ecosystem
Regulations
Unknown
Variables
Foreign
Exchange Risk
Geo-Political
Risk
Changing
Market Needs
Pricing
Pressures
Competitive
Threats
Market
Innovation
We view the life science
industry as an evolving
ecosystem. This ecosystem
is defined by its network of
interactions. As with any
ecosystem, there are
unpredictable emergent
properties that result from
the interactions of its
participants. A company’s
viability is dependent on its
capacity to anticipate
changes on the horizon and
respond as new challenges
emerge.
About Us
The Life Science Industry Ecosystem
CMOs CROs
Patients
Distributors
LaboratoriesProviders
Regulators
Payers
Biopharma

4. 4Property of Kineticos © Copyright 2016
As a management consulting firm with unique knowledge and experience across the
life science industry ecosystem, Kineticos—through its three practice areas—is ideally
positioned to help companies thrive.
Our practice areas and service areas include:
About Us
Our Practice Areas and Service Areas
Biopharmaceutical Biopharmaceutical Services Diagnostics
 Corporate Strategy and
Development
 Medical Affairs Strategy
 Commercial Strategy
 Regulatory
 Corporate and
Business Unit Strategy
 Sales and Marketing
 Operational Execution
 Corporate Strategy and
Development
 Technology and
Innovation
 Operational Excellence

5. Property of Kineticos © Copyright 2016
Biopharmaceutical Practice
Overview and Capabilities

6. 6Property of Kineticos © Copyright 2016
The Biopharmaceutical practice at Kineticos assists growth-oriented pharmaceutical
and biotech companies realize their commercial potential at the corporate, portfolio
and product levels.
Service areas include:
Corporate Strategy
and Development
Medical Affairs Commercial Strategy Regulatory
 Business Model
Design
 Portfolio Strategy
 Geographic Market
Entry
 Opportunity
Assessment
 In- and Out-licensing
 Private Financing
 Medical Affairs
Strategic Planning and
Operations
 MSL Architecture,
Management, and
Support
 Real World
Evidence/Registry
Study Strategy
 New Product Planning
 Strategic Launch
Planning
 Post-Marketing
Strategy and Planning
 Lifecycle Management
 Marketing Excellence
 Global Regulatory
Strategy
 Product
Development
 Regulatory
Operations and
Submission
Management
Biopharmaceutical Practice
Overview and Capabilities

7. 7Property of Kineticos © Copyright 2016
Our Corporate Strategy and Development services combine our in-depth experience and industry k
nowledge with benchmarks and competitive analysis to help biopharmaceutical companies make cr
itical strategic, financial, and, business development decisions.
Business Model
Design
Portfolio Strategy
Geographic Market
Entry Strategy
Opportunity
Assessment
In- and Out-
licensing
Private Financing
• Situational
Analysis
• Market
Segmentation
• Value
Proposition
Development
and Validation
• Target Market
Prioritization
• Business Model
Optimization
• Market
Opportunity
Assessment
• Initial Target
Product Profile
Development
• Target Product
Profile Revenue
Forecasts
• Valuation
Tradeoff
Analysis
• Strategic Plan
Development
• Geographic
Market
Opportunity
Analysis
• Competitive
Landscape
Assessment
• Market Entry
Risk Assessment
• Prioritized
Market Entry
Plan
• Situational
Analysis
• Competitive
Landscape
Analysis
• Target Product
Profile
Development and
Validation
• Target Product
Profile Revenue
Forecast
• Term Sheet
Development
• Market
Opportunity
Assessment
• Partner
Identification/P
rioritization
• Outreach
Management
and Meeting
Support
• Due Diligence
• Deal Term
Negotiations
• Investment
Strategy
Prioritization
• Investment
Package/Dossier
Development
• Investor
Outreach
Management
• Due Diligence
Process
Management
• Deal Term
Negotiations
Biopharmaceutical Practice
Corporate Strategy and Development

8. 8Property of Kineticos © Copyright 2016
Our Medical Affairs executive services help Biopharmaceutical companies strategically
plan, organize, and operate with greater efficiency. Therefore, maximizing the value of t
heir Medical Affairs function.
Medical Affairs Strategic
Planning & Operations
MSL Architecture, Management
and Support
Real World Evidence/Registry
Study Strategy
• Medical Affairs Infrastructure &
Optimization
• Medical Affairs Executive Talent
Identification & Recruitment
• IIT Study Operations Team &
Process Design
• KOL Advisory Board Design
• Cross-Functional
Communication Facilitation
• Industry Relationship
Management
• Financial Planning & Analysis
• MSL Field Deployment
Strategy
• MSL Recruiting
• MSL Outsourcing and
Training
• MSL Management
• Key Performance Indicator
Tracking
• Disease Based Registry Study
Development
• Internal Support & Executive
Sign-Off
• Field Based Execution Plan for
Registries
• Strategy & Development of
Internal Study Operations
• Investigator Steering Committee
• Vendor Selection Process &
Management
Biopharmaceutical Practice
Medical Affairs

9. 9Property of Kineticos © Copyright 2016
Our Commercial Strategy services help biopharmaceutical companies maximize the
commercial value of their products across all phases of the product lifecycle.
New Product Planning
Strategic Launch
Planning
Post-Marketing
Strategy and Planning
Lifecycle
Management
Marketing Excellence
• Situational Analysis
• Market Segmentation
• Global Opportunity
and Needs
Assessment
• Target Product Profile
Development and
Validation
• Target Product Profile
Revenue Forecasts
• Valuation Tradeoff
Analysis
• Strategic Plan
Development
• Customer
Segmentation
• Optimal Labeling
Strategy
• Revenue Target
Development
• Critical Success
Factor Prioritization
• Product Positioning
and Messaging
• Global Market
Uptake and Payer
Acceptance Modeling
• Global Market
Assessment
• Segmented Market
Action Plans
• Situational Analysis
• Product Opportunity
Prioritization
• Opportunity Tradeoff
Analysis
• Lifecycle
Management Plan
• Marketing Strategy
Development
• Marketing
Organizational
Planning
• Marketing Excellence
Training
• Project
Implementation
Support
• Post-Implementation
Feedback
Biopharmaceutical Practice
Commercial Strategy

10. 10Property of Kineticos © Copyright 2016
Our Regulatory services are designed to help biopharmaceutical companies to solve
complex regulatory challenges, as well as reduce risk and expedite the development
process, by applying a premier level of expertise to every client engagement.
Regulatory Strategy Product Development
Regulatory Operations & Submission
Management
• Regulatory due diligence
evaluations
• Regulatory strategies and
development plans (global
perspective)
• Agency interactions and meetings
(includes development/preparation
of agency meeting requests and
packages)
• Strategic labeling review and
preparation (TPP)
• Orphan Drug Designation support
and expedited programs
• Non-clincial study design and
oversight
• CMC consultation and vendor
oversight
• Clinical study design and clinical
study management/oversight
• Compliance services (GMP, GLP,
GCP, and QSR)
• Qualification/general
audits
• Pre-approval inspection
readiness programs
• Regulatory submission planning
• Regulatory submission authoring (all
CTD section for investigational and
marketing applications)
• Regulatory submission publishing
(eCTD, NeeS)
• Pre- and post-approval submission
maintenance
• Change control evaluation and
implementation
• Registration and drug listing services
• State licensing services
Biopharmaceutical Practice
Regulatory

11. 11Property of Kineticos © Copyright 2016
Our People
Mark Osterman, Senior Vice President
Mr. Osterman, Senior Vice President of Kineticos’ Biopharmaceutical Practice,
adds more than 25 years of experience in the biopharmaceutical industry to
the team.
Mr. Osterman held roles in sales, clinical, and marketing at GlaxoSmithKline
before moving to Johnson & Johnson, where he launched their stem cell
internal venture and was responsible for the cardiovascular, pulmonary,
metabolic, and mimetibody therapeutic areas in the Global Biologic Strategic
Marketing. Mr. Osterman then served as Senior Vice President responsible for
commercial operations and business development at Discovery Labs before
accepting a position as Vice President of Global Marketing at Solstice Neurosciences. Immediately
prior to joining Kineticos, he founded the Osterman Strategy Group, a boutique management
consulting firm, where he worked with large and emerging biopharmaceutical companies.
Mr. Osterman earned a dual BA in Business Management and Economics from North Carolina State
University.
Areas of Expertise:
• Global Strategic Marketing
• New Business Development
• Merger and Acquisition Strategy
• Organizational and Leadership Development

12. 12Property of Kineticos © Copyright 2016
Our People
Glen Martin, Senior Vice President
Mr. Martin, Senior Vice President of Kineticos’ Biopharmaceutical Practice,
adds more than 22 years of experience in the biopharmaceutical industry to
the team.
Mr. Martin held roles in sales for several start up Biopharma companies before
moving to Pharmion. While at Pharmion, Mr. Martin held management roles
in Sales before becoming the National Director of the US, MSL program. Mr.
Martin then moved to Celgene, as they had acquired Pharmion in 2008. While
at Celgene, Mr. Martin held multiple leadership roles in Medical Affairs.
Starting with Senior Director, Outcomes Research & Operations, and being
promoted to Executive Director, Strategic Planning &
Areas of Expertise:
• Oncology
• Commercial & Medical Affairs Field Deployment Strategy and Management
• Medical Affairs Strategic Design
• Medical Affairs Operational Excellence
Operations for US, Medical Affairs. Covis Pharma, a unique start up company, brought in Mr. Martin to
serve as Vice President of Oncology Sales. Following the acquisition of Covis, and prior to joining
Kineticos, Mr. Martin served as Senior Vice President , Medical Sciences for Ashfield Healthcare.
Mr. Martin earned his BA in Phsycology from La Salle University in Philadelphia, PA.

13. 13Property of Kineticos © Copyright 2015
Our People
Shailesh Maingi, Founder and CEO
Mr. Maingi founded Kineticos in 2012 and develops long-term
and day-to-day execution strategies. Mr. Maingi serves on the
Board of Directors at Gallus Biopharmaceutical, a
biopharmaceutical CMO, and he also serves on the advisory
boards of Novolipid and Enci Therapeutics, two startup
biotechs based in North Carolina. In addition, Mr. Maingi is a
guest lecturer for the MBA program at the Kenan-Flagler
School of Business at UNC-Chapel Hill.
Prior to founding Kineticos, Mr. Maingi was a senior executive at Cardinal Health/PTS and
Sigma-Aldrich/Supelco, where he held leadership roles in strategy, business development,
and marketing. Mr. Maingi earned a BS in Chemistry from UNC-Chapel Hill and an MBA
from Golden Gate University.
Areas of Expertise:
• Corporate Strategy and Execution
• Research and Innovation
• Business and Corporate Development
• Process Improvement / Change Management

14. 14Property of Kineticos © Copyright 2016
Project Team Members
Myung Soo Kim, PhD – Analyst
Dr. Kim is currently responsible for supporting the delivery
of customized management consulting solutions to clients
across the life science ecosystem. Additionally, he is the
lead author on several Kineticos research reports. Prior to
joining Kineticos, Dr. Kim co-founded NeuroNostix, an
innovative company focused on developing best-in-class
therapeutics for CNS disorders.
Dr. Kim graduated from the Eshelman School of Pharmacy, Division of Molecular
Pharmaceutics at UNC–Chapel Hill. Prior to earning his PhD, Dr. Kim received a
BS in Biology from UNC–Chapel Hill.
Areas of Expertise:
• Market Research
• Technical Writing
• Project Management
• CNS

15. Property of Kineticos © Copyright 2015
www.kineticos.com
Thank you!