MAGNATAS AUGUST 2015

Introduc)on to MAGNATAS, LLC

AUGUST, 2015

1 Introduc+on to Magnatas, LLC

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Our Competencies

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Our Clients

Our Case Studies

AGENDA


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Our Competencies

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Our Clients

Our Case Studies

AGENDA

Magnatas, LLC

•  Magnatas is short for “Magnanimitas” which means “striving for greatness” in the work we do and the character we display

•  Our scien+fic exper+se and commercial experience allows a convergent scien+fic and commercial approach

•  Our goal is to support ins+tu+ons that focus on advancing healthcare through innova+ve science and service

•  We help entrepreneurs develop appropriate business prac+ces that allow for coordinated growth of their organiza+on

•  We are part of a global consor+um to develop and execute plans without borders

Magnatas, LLC

•  Science has provided significant new targets for therapies resul+ng in unprecedented numbers of molecules in development –  There are over 4,500 compounds in pre-‐clinical development –  Close to 1,000 compounds are in Phase I, more than twice the number

than 20 years ago (PharmaFutures)

•  The paradigm shiR towards evidence-‐based medicine requires a greater science – commercial convergence during product development and proof of value at +me of launch

The Paradigm ShiR

Value is not new

technology

Value is not a code for

cost reduc)on

“Achieving High Value for Pa)ents must become the

overachieving goal of health care delivery” Michael E. Porter,

NEJM 12/23/2010

“Four to five years ago, external assets were defined by scien+fic merits. However, today, asset value is driven by the ability to differen+ate and demonstrate

pa+ent benefit”.

Comments by Major Pharma to entrepreneurs. Center of Entrepreneurial Development annual meeting (2/2011)

Mission and Vision

•  MAGNATAS, LLC provides strategic guidance and consulta+on that can be implemented by clients who want to thrive.

•  We use a convergent approach that brings scien+fic and commercial data together on a +mely basis for be\er decision making

•  Our “thinking and doing” approach makes us a true ally for innovators and those who support them

•  The Business Accelerator/Mentorship Process allows the entrepreneur to focus on the technical task at hand in developing the asset or services

Mission and Vision

•  Mission: MAGNATAS, LLC will provide proven scien+fic exper+se, experienced business leadership and mentorship to Life-‐Sciences Companies, Venture Firms and Service Companies on an as needed basis allowing our customers to thrive in their field of exper+se

•  Vision: We are in the business of realizing the dreams of

entrepreneurs, scien+sts, investors and companies. All our ac+ons are measured by their success

Magnatas, LLC

Magnanimitas, La)n for “Striving for Greatness”

Scien)fic Exper)se •  Trained in basic research and

problem solving in the area of immunology

•  Fogarty Interna)onal NIH Fellow •  Authored and co-‐authored 32 ar)cles

and abstracts

Commercial Experience •  Strategy Development •  Opera)onal Excellence •  High-‐performance team approach •  Organiza)onal infra-‐structure

development •  New commercial model

development

•  Our commercializa)on strategy is based on a deep understanding of the scien)fic plaWorm and its resul)ng posi)oning in the treatment paradigm

•  We have a network of industry experts in the areas of market research, business strategy development, real life data, payer exper)se, global expansion that can be involved as the situa)on requires.

Our Goal

•  Provide a rigorous scien+fic approach towards commercializa+on

•  Develop new commercial approaches that are effec+ve and efficient while adhering to GPP

•  Provide experienced business leadership in the life sciences to develop a sustainable growth plan for our clients

•  Serve as a Fully Integrated Business Network to provide answers to any commercializa+on ques+ons on a +mely basis

•  Develop insights in a +mely manner to make decisions with the right informa+on at the appropriate +me

•  Allow every company to maximize their efficiency in the u+liza+on of scarce resources


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Our Competencies

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Our Clients

Our Case Studies

AGENDA

Preclinical R&D Clinical Development Regulatory

Submission Post-‐Approval

Leveraging integrated strategies to answer increasingly complex set of ques+ons drives program value through efficiency, faster market uptake, and higher peak sales

Developing an Asset is a Complex Process

Performance Op+miza+on Go-‐to-‐Market Strategy

Evidence Plan Op+miza+on Asset Strategy

Who are the stakeholders, what are their levers, and how do they influence the market?

What will the market look like when we launch?

What evidence will we need to prove our product's value at launch?

What endpoints to measure?

Which clinical trial design?

Which popula)on to study?

What is the overall launch strategy?

What is our market development strategy?

What is our lifecycle strategy?

Strategic Development Approach

Development Timeline

Ongoing KOL Interac)on

Ini+al Data Analysis and Research

Full Gap Analysis

Product Dev. Plan

Execu+on and Delivery

Assessment Monitoring & Repor)ng

Adapta)on

Target Product Profile

Drug Dev. Strategy

Ac)ons to date •  Assessed high-‐level landscape

•  Ini+al KOL discussions

Planned steps •  Engage KOLs, outside experts

•  Comp. analysis •  POC/PC review

Process •  Select indica+on(s), create TTP, develop strategy, create PDP, and manage program execu+on

•  Con+nually review data and apart plans

Protocols

Ongoing Risk Assessment

Example process flow highlights an integrated delivery process

1 2 3 4

The Strategic Planning Framework

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What are we gebng into?

Where do we want to be and how do we

get there?

What ac)on do we need to take when?

What does success look like?

Stage 1: Environmental

Context

Phase 2: Strategy

Development

Phase 3: Implementa+on

Phase 4: Results /

Performance Measurement

•  Environmental / Compe++ve Assessments

•  Pa+ent profiling •  HC stakeholder analysis •  Scenario Planning •  Opportunity Analysis •  Archetype Projec+on

•  Mission •  Vision •  Strategic Intent •  Goals, metrics, targets •  Capabili+es and key rela+onships

•  Cri+cal Success Factors •  Poten+al Product Posi+oning

•  Processes •  Resources •  Implementa+on Plan and Timing

•  Budgets •  Forecasts

•  Data tracking, collec+on and repor+ng

•  Feedback mechanisms for improvement

•  Balanced Scorecard

Key Que

s+on

s:

Areas to Explore

Objec+ve: Implementable strategies specific to the client’s organiza+on

Key Components of a Successful Product Launch

•  Serve as a Center of Excellence for Business Solu+ons to life-‐sciences companies and the Investment Community.

Thoughjul Strategic Plan

Focused Execu+on

High Performing

Team Success

Due Diligence Mindset

Our Competencies

• Business Strategy/Planning and Development • Commercializa+on Planning/new model development • Government and Key stakeholder strategies • Product Development strategies

Business Strategy

• Organiza+onal Effec+veness/Quality/Processes. • Developing High Performance Teams • Leadership Development

Implementation

• CEO/COO/CMO Services • Board of Director Services • Commercializa+on Planning/New Commercial Models • Clinical/commercial convergence

Operational Excellence

• Scien+fic and commercial evalua+on • Opportunity Analysis • Pre-‐investment assessment • Post-‐investment organiza+onal consul+ng

Due Diligence


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Our Competencies

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Our Clients

Our Case Studies

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Our Customers

•  Start-‐up life sciences companies focusing on the Rx or OTC market.

•  Universi+es, especially offices of technology transfers •  Venture Firms who seek help in providing due diligence or

oversight in their investment •  Private and state offices promo+ng the commercializa+on of

life sciences. •  Companies who need to improve their opera+ng efficiency

and leadership training •  Companies seeking new commercial approaches/models


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Our Competencies

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Our Clients

Our Case Studies

AGENDA

Due Diligence of Investment

Case Study: Venture Capital

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  Background

Company: Venture Firms Situa)on: A group of Venture Firms needed an independent assessment of one of their investments (breast cancer diagnos+c) as it was not progressing to plan Objec)ve of the project: •  Perform due diligence to determine

the progress of the diagnos+c development

•  Report on the +meline to commercializa+on

•  Assess data gaps •  Develop a +meline and to ac+vi+es

to commercializa+on •  Recommenda+on next steps

  Ac)on

Approach •  Performed secondary research to

understand the scien+fic plajorm •  Primary interviews to assess the

strength of the commercial process •  Company documents around

regulatory and customer feedback •  Company Dynamics and capability

Assessment

  Outcome

•  Our recommenda+ons were accepted •  The science did not support the theory •  Company ceased opera+ons in 2011

  Recommenda)on

Board Report •  Address scien+fic gaps through NIH

fund rather than Investment capital •  Revisit the regulatory route and

gain feedback to the design of the registra+on studies

•  Place commercial experts on the Board

•  Outsource the automa+on of the staining procedure

•  Replace the CEO with a strong leader who can change the team dynamics and company culture

Launch Budget Development

Case Study: Medium Pharmaceutical Company

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  Background

Company: Medium-‐sized pharma company Situa)on: •  The company requested to assess

the cost of a good launch •  Help develop a launch budget Objec)ve of the project: •  Analyze launch successes and

launch failures •  Based on the available internal data

and external assessment, build a launch budget segmented by pre-‐approval, post-‐approval/ before launch and post-‐launch

  Ac)on

Approach •  We performed secondary and

primary analysis of successful and failed launches

•  Determined the product archetype to assess its compe++ve posi+oning

•  Aligned the CSF and stakeholder interac+ons with the archetype

•  Established +meline for execu+on around key stakeholders

•  Develop the budget by stakeholder group along the execu+on +meline

  Outcome

•  The posi+oning as well as the budget were accepted and used for implementa+on •  The product is in full pre-‐launch implementa+on •  One medical person called it the best consul+ng group they had ever worked with.

  Recommenda)on

•  The client was advised to develop a

strategy more like a specialty/oncology product.

•  Heavy emphasis on Thought Leader educa+on.

•  Developed a tac+cal implementa+on plan iden+fying the number of required touch points with key stakeholder.

•  Developed the budget aligned with the requested +me segments

Building the Architecture of a Reimbursement and Access Organiza+on

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  Background

Company: Medium-‐sized pharma company Situa)on: •  The company wanted to improve

their reimbursement and access(R&A) capabili+es

Objec)ve of the project: •  Assess Best in Class reimbursement

organiza+ons, their coverage, pa+ent processes as well as internal versus outsourcing components

•  Develop an architecture and footprint including internal capability development and appropriate outsourcing model

  Ac)on

Approach •  We studied 12 R&A programs

through secondary and primary research.

•  We assessed internal capabili+es and performed a gap analysis versus Best in Class organiza+ons

•  Assessed various Hub organiza+ons fill the capability gaps.

•  Developed the final architecture including the linkages between internal oversight and external vendors to look like one team in front of the customer.

  Outcome

•  The implementa+on of the recommenda+on is on-‐going

  Recommenda)on

•  The recommenda+on was to keep many of the customer-‐facing front-‐end ac+vi+es in-‐house but outsource all the back-‐end ac+vi+es such as pa+ent eligibility considera+ons and implementa+on around co-‐pay assistance and Pa+ent Assistance programs.

•  U+lized the exper+se of Hub providers to develop a turn-‐key, scalable back-‐office.

•  Also highlighted the importance of differen+a+on through non-‐financial, pa+ent focused programs, which required the company to get back and assess their knowledge of the target pa+ents.

Case Study: Medium Pharmaceutical Company

Transforming an Organiza+on into a High Performing Team

Case Study: Medical Communication Organization

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  Background

Company: Small communica+ons organiza+on Situa)on: •  The organiza+on was trying to

reverse its declining business(NNB, revenue and Profits)

Objec)ve of the project: •  The Medical Communica+ons

organiza+on was targeted for poten+al sale or shut-‐down.

•  The goal was to assess whether the value of this organiza+on could be improved.

  Ac)on

Approach •  Assessed the Business Development

func+on and clearly defined roles and responsibili+es for the leadership team

•  Assessed the financial performance to iden+fy the reasons for the declining profitability

•  Ini+ated a change agenda to redirect the team to focus on profitability.

•  Developed quarterly expense targets +ed to revenue.

  Outcome

•  The organiza+on set a new record in NNB, revenue and profit. •  Achieved double digit New Business, Revenue growth and triple digit profit growth versus the previous year. Contribu+on

margin and Profit improved by 6 and 8 percentage points respec+vely.

  Recommenda)on

•  Re-‐organized the leadership from a regional to a global structure

•  Increased the percentage of billable hours by elimina+ng unnecessary mee+ngs

•  Segmented the business and developed specific BD targets for each segment.

•  Developed metric to track performance

•  Communicated on a monthly basis to the whole team progress and celebrated successes

Developing a Client Services Organiza+on

Case Study: Nurse Educator Service Provider

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  Background

Company: •  Small organiza+on providing nurse

educator services Situa)on: •  Organiza+on struggled financially

and called me to make an independent assessment of the root-‐cause

Objec)ve of the project: •  Assess GAPS •  Recommend and implement

changes

  Ac)on

Approach •  Performed overall company

assessment, processes, outputs •  Assessed the compe++ve landscape

regarding services offered, promo+onal approach, adver+sing focus

•  Made recommenda+on regarding services offered, customer interac+on approach, impact demonstra+on

•  Focused heavily on Account Management

  Outcome

•  The organiza+on has a more resona+ng pitch deck thanks to a heavier focus on data to demonstrate impact •  Have a proac+ve and focused measurement plan in place for every RFP •  Expanded the contact network with accounts •  Developed a pipeline of future opportuni+es and signed ~ > $1M of new Brands so far in 2015.

  Recommenda)on

•  Currently leading the Client Services Group as well as the Analy+cs and Insights effort.

•  Developed measurement plan along the pa+ent journey and analyzed all the 2014 data to demonstrate impact of client’s nursing services

•  Developed an Account Management Process that focused on maximizing revenue/client, defined roles and responsibili+es between Client Services and Client Opera+ons

We have a Network of Experts

Magnatas, LLC Legal

Global Assessment

Finance

IP Strategy

Market Research

Regulatory

Pricing/Reimbursement/

Access

IT Solu)ons

Global Assessment

As a Fully Integrated Business Net Provider, MAGNATAS, LLC can help answer any commercializa+on ques+ons

The Team •  Dr. Michael Ackermann is the prac+ce leader

–  Over thirty years of healthcare experience from basic research to commercial product launches and General Management

–  NIH Research, pharmaceu+cals, healthcare services –  Strategic development, opera+ons, and sales & marke+ng

•  Depending on the scope and need, Mike will assemble and lead a team of experts from the consor+um

–  Right people, right +me, right insights

Selected accomplishments:   Guided Lilly’s largest Business Unit from flat performance to

19% growth

  Build, developed and led high performance teams in the areas of sales, Business Units and strategic groups in the pharmaceu+cal product as well as services industry

  Launched two highly successful products with Cymbalta and Stra\era

  Developed a new commercial strategy around clinical/commercial convergence that contributed $100M in NNB.

  Achieved a complete turnaround of a Medical Communica+ons Company

  Guest lecturer on healthcare topics at Indiana’s Kelly School of Business

  Fogarty Interna+onal Fellow at NIH/NIEHS

  Authored 32 scien+fic research ar+cles and abstracts in the areas of immunology and immunotoxicology

Educa)on   PH.D. Immunology, Drexel School of Medicine

  MBA, The Kenan-‐Flagler School of Business at the University of North Carolina at Chapel Hill

  B.S. Hampden-‐Sydney College in Virginia

  Bilingual (German and English)

Next Steps

•  For addi+onal informa+on, please contact

Dr. Michael F. Ackermann macker1156#@sbcglobal.net

919-‐279-‐5475 Thank You

Documents

MAGNATAS AUGUST 2015