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Key Commercialization Activities,

Resources and Partnerships

Ofer Reizes, Ph.D

Director, Skills Development January 17, 2019

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Research vs. Innovation

Research: Transforming knowledge into information

Innovation: Transforming knowledge into products to create

value for the consumer

• Medicinal Product Innovation: Chemistry (structure/drug class),

Method of Synthesis (process), Formulation, PK/PD,

Pharmacogenetic, Device design, …

• The Consumer: Patient, Physician, Third Party Payer (health-care

systems, government)

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Innovation-Novelty

Novelty and “Newness” are distinct concepts

• “Newness” implies a new creation (i.e. a new chemical entity)

• Novelty can be a NCE or it can be a new use for a known

compound, or a new method, formulation, etc.

• From a patent standpoint, it must be something that is “non-obvious”

to someone skilled in the Art

• Novelty/Newness is a key component of Innovation

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Innovation-Usefulness

Unless an invention is useful, it is not innovative

• Commercialization Activities

• What does it mean?

• How do you prioritize?

• Resources

• What are they?

• How do you identify them?

• Partnerships

• What is the purpose of partnerships?

• How to do you seek them?

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Discussion Points

Key Activities, Resources and Partners

Customer

Relationships

Value

PropositionKey

Activities

Customer

Segments

Key

Partners

Key

ResourcesChannels

Costs Revenue Streams

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• Understand to whom are you creating value?

• Patient, Hospital, Physician

• Investors

• Regulators, etc…

• Designing experiment or choosing the commercial

activities that provide the highest-possible evidence

supporting your value proposition?

• Describe your value proposition and one commercial

activity that would create value.

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How Do You Create Value?

Commercialization Activities

Customer

Relationships

Value

PropositionKey

Activities

Customer

Segments

Key

Partners

Key

ResourcesChannels

Costs Revenue Streams

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Core Question: What key development and validation

activities are required to deliver your value propositions?

• Activities are related to de-risking your program to achieve

a successful market adoption.

• What is “de-risking”?

• Examples of commercialization activities:

• Filing strong IP to protect your asset

• Generate data:

• Bench, pre-clinical, clinical

• Define a robust regulatory path

• Understand reimbursement

• Keep in mind the value proposition (improve clinical outcome or

reduce cost)

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Key Activities

Basic

Research

First in

Man

Preclinical

DevelopmentFDA Filing/

Approval

Biomarker

Selection

Mechanical

Testing

Analytical

Performance

Analytical

Validation

Sterilization

Clinical

Validation

Feasibility

Studies

Clinical

Performance

Regulatory

Review (IDE)

Prototype

Assay

Regulatory

Review

PMA/510(k)/

de novo

In Vitro Diagnostic Product Development

NCAI*

*NCAI Project Activity Areas

Medical Device Product Development

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Needs

Identification

Invention &

PrototypingRegulatoryClinical

Pre-

Clinical

Product

Launch

NCAI*

Bench Testing

Simulated

Use Testing

Tissue Testing

Human

Clinical

Testing

Acute

Non-clinical

Testing

Chronic

Non-clinical

Testing

Biocompatibility

Testing

Prototype

Iteration

*NCAI Project Activity AreasTherapeutic Product Development

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NCAI*

Target

ID Validation

Pre-

Clinical

Studies

Lead

OptimizationLead IDPhase 1

Clinical…

Medicinal

Chemistry

Pharmaco-

kinetics

In vitro

Toxicology

In vivo

Toxicology

ADME

Pre-IND

Efficacy

Studies

Two Species

Efficacy

Studies

Large

Animal

Toxicology

*NCAI Project Activity Areas

Navigating the Pathway of Translational ScienceUnderstanding your ecosystem is critical for your activities

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• Disease modifying mechanism of action

• Benchmark against competing programs• You are competing against everything including generics and pre-

clinical programs

• Generate and evaluate • Highest quality therapeutics or optimal design of your device

• Metrics need to be understood from day one and constantly

reviewed

• Your expertise must be the best in the world

Pre-clinical Models – Can you show…

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Clinical Trials are a Critical Activity

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Minimum Viable Product

• Generate prototype to demonstrate problem-solution relationship.

• Articulate a problem definition based on your understanding/experience

• Provide High-Level Engineering Specifications

• Understand the minimum feature list

• Prototype Customer Segment Value Proposition Prototype’

• Bench testing to demonstrate solution

• Simulation to aid engineering specifications (e.g. stent design, fatigue testing,…)

• Pre-Clinical model for safety and efficacy (acute & chronic models)

• Generate data to substantiate your claim and test hypothesis

• What are you trying to prove?

• To whom are you trying to prove it? (customer, VC, FDA or regulatory body)

• Think feasibility ($) versus statistical significance ($$$)

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The Critical Three Elements

Techn

olo

gical So

lutio

n

Compelling Clinical Need

Intellectual Property

Techn

olo

gical So

lutio

n

Compelling Clinical Need

Intellectual Property

MVP

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Goal of MVP Prototype

• Show-n-Tell” to your stakeholder and help envision product features

and discuss product-market fit.

• Articulate the main idea and could point-out to design risks. This is

important for Reg. activity of dFMEA for instance.

• Helps you in choosing your product features and iterate prototype to

determine the minimum features needed and not dilute your value

proposition.

• Question = What should your M.V.P prototype look like?

Commercialization Resources

Customer

Relationships

Value

PropositionKey

Activities

Customer

Segments

Key

Partners

Key

ResourcesChannels

Costs Revenue Streams

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Core Question: What key intellectual, physical, human, and

financial assets are required for your value propositions?

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Key Resources

Resources Are Put to Work within a Business Model

• What does it mean to have a Business Model?

• A business model describes the rationale of how an organization creates,

delivers, and captures value, in economic, social, cultural or other context

[Medical].

• So, what are the Most Important Resources required to make the

Business Model work?

• How much will your activities/milestones cost?

• Resources should match your critical activities• NIH, Foundation, DoD, philanthropic, SRA, etc.

• Do you need to acquire or partner with others to obtain

funding?

• What commitments must be made to obtain support?

• What human resources will you need?

• What equipment resources will you need?

• For Clinical Trials – will you need to identify a physician to

collaborate with? Do you have Clinical Trial Design training?

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Questions

• 75% of all money raised will be spent on clinical studies

and regulatory approvals

• Major factor in getting financed

• Major factor in Product Market Fit and strategy

• Customer Discovery and Interviews can help

• Identify the data set necessary to show that your invention does or

does not deliver the hypothetical value in humans

• Identify clinical trial design options

• Regulatory approval often involves the opposite of IP

goals similarity to existing approaches versus novelty

• Identify path of least resistance in getting regulatory approval

Early Determination of Regulatory

Pathway is Critical

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• Self-Funding

• Friends

• Family

• Crowdfunding

• Angels

• Grants

• Venture Capital

• High Net Worth

• Angels

• SBIR/STTR

• SBA.

• Venture Capital

• Corporate Funding

• Venture Debt

• Bank Financing

• Lease-lines

• Factoring

• Vendor Financing

Lower Magnitude High Magnitude

Financial Resources

• The system for ranking the quality of clinical evidence is

known as “Evidence-based Medicine”

• Demonstrating Safety and Efficacy of therapeutic requires

hard data with clear endpoints

• The highest level of evidence (and most expensive) is a

prospective, randomized, placebo-controlled, double blind

trial (RCT) published in a peer review journal

• The value of your company and technology will be

bracketed by the strength and clarity of your data

• Major risk to getting funding: Equivocal Data

Technologies Need to Generate

Scientific Evidence (Data)

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Typical Development Program

Nonclinical• Animal data usually surrounding safety but efficacy might be added in

POC

Clinical• Phase I Usually safety, SAD, MAD, PK/PD, very short term

• Phase II Efficacy signal studied, dose ranging, may include PK/PD

Longer than in phase I, some safety data accumulated

• Phase III More robust, larger numbers, and longer duration, would

serve as pivotal trials for approval

NDA/BLA

• * POC proof of concept; SAD single ascending dose; MAD multiple

ascending doses; PK pharmacokinetic; PD pharmacodynamic; NDA

New Drug Application; BLA= Biologic Licensing Application

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So will anyone pay for your technology?

Commercialization Partnerships

Customer

Relationships

Value

PropositionKey

Activities

Customer

Segments

Key

Partners

Key

ResourcesChannels

Costs Revenue Streams

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Core Question: What strategic engagements are required to

deliver the complete value proposition?

• Building a business is not a silo-process.

• There are dependencies to access Key Resources and Key

Activities, that might not be readily available to your current

business.

• Goal is to:

• Improve business competitive advantage, and/or

• Reduce cost when acquiring commodities or service.

• It needs to make sense to both parties:

• Economic (e.g. supplier-type relationship)

• Strategic (e.g. access to customers)

• Know-how (e.g. unique technology)

• “1+1 = 3” (e.g. joint venture, co-development, etc…)

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Why Should You Seek Partners?

● Faster time to market

● Broader product offering

● More efficient use of capital

● Unique customer knowledge or expertise

● Access to new markets

Which is most important to you as a

pre-clinical therapeutic?

Why Have Partners?

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Strategic

Alliances

Joint New

Business

Development

Efforts

Key Supplier

Relationships

Joint

Ventures

Types of Partnerships

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Coopetition

• Key Suppliers and Clinicians - the type most likely to matter

• Strategic Alliances - often less crucial for early adopter customers

• Can complement your core product

• Training, installation, services

• Strategic investment - big advantages / big disadvantages

• Joint promotion of complementary products - sometimes

• Coopetition - sometimes • Can be important to define an emerging industry standard

specification; controlled by large(r) companies

• ADVAMED; MDMA

• Joint Venture, Traffic Partners - Least likely in medtech

Types of Conventional Partnerships

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• Shared vision, Right people, Clear plan

• Established performance standards within a certain

timeframe

• Get out of the building to find these partners

• Find the partners that give an unfair advantage over the

competition

• Remain positive, your partners can be a potential acquirer

• Partnership could be strategic to your business and they

are definitely integral to your commercialization plan.

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Successful Partnerships

• Find partners who give you an unfair advantage

• Figure out what’s in it for both parties

• Don’t confuse Partnerships with strategy• You are not a peer• It is a temporary relationship

• Timing plays an important role• Partnerships aimed at mainstream customers are usually more

important than partnerships aimed at early adopters

Takeaways: Partner Strategies

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