PBI Consultancy Services

1. Pharma & Biotech Innovation
Deliver Success through Innovation
Michael McNamara
MSc MRACI C Chem
Pharma & Biotech Innovation
ph 03 94997193 mobile 0407713768
1michael.mcnamara@live.com.au Pharma & Biotech Innovation

2. Pharma & Biotech Innovation
Consultancy Services
Strategic & Hands-on Support for Profitable Innovation
 Clients include small start-up, medium and large companies, government and not for
profit organisations in the pharmaceutical, biotechnology, medical device, life
sciences, biological and chemical technology fields.
 Service offering includes strategic advice and planning, protocol and plan
development, project management and performing plant and laboratory studies
 Service offering focuses in the following areas:
1. Efficient and effective product innovation and manufacturing operations
– Deep experience in product formulation and process development using QbD, multifactorial DOE and lean
six sigma
1. Preparation of Commercialisation and Product Development Strategies for Efficient
Innovation
2. Design and Review of Organisational Structures, Processes and Resources to
effectively Deliver Products to Market
3. Design, Implementation and Execution of Outsourcing/Insourcing Strategies including
Technology Transfer plans
4. Preparation of Business Cases/Business Plans for Funding
5. Accessing Funds through Grants to support your Innovation Strategy
6. Strategies for Navigating Regulatory Approval Pathways
2 7. Expert Opinion and Witness for Patent Matters

3. Michael McNamara
Biography
 Specialist in management of innovation in biotechnology at all phases of product lifecycle
– from research and product concept through to product launch and lifecycle management
 3 years experience as an independent consultant, 25 years in biotechnology and
pharmaceutical industries
 Recent experience with medical device, not for profit, life science, agricultural and
chemical technology projects
 Qualified Biochemist/Chemist with postgraduate qualifications in management and
product regulation
 Senior management roles in R&D, Business Development and Commercial Management at
CSL, Faulding Mayne Pharma and Hospira
 Management of key commercial development and contract manufacturing relationships
worth $30 million AUD including pricing and forecasts to deliver financial targets
 Development of new business relationships based on existing, internally-patented
technology for development and contract manufacture of products with global sales in
excess of $1 billion pa.
 Successful preparation of business cases for commercial funding of innovation worth $30
million pa and grant applications worth up to $10 million
 Managed portfolios of up to 30 development projects from early stage/product concept to
launch/lifecycle management
 Launched products worth $200 million pa in over 70 countries
 Development of Clinical and Regulatory Strategies involving CTN, CTX, IND ANDA and
3 NDA applications for both small molecule pharmaceuticals and biotechnology products

4. Efficient and Effective Innovation
Creating Value from Ideas
The Challenge PBI Supports Efficient Innovation by
 How do you translate your research and/or  Preparing an integrated strategy to answering these
technology into product(s)?
 What is your product’s competitive questions and forming a sound commercialisation
advantage? strategy
 What is the value of your technology and how  Establishing an early development strategy - leads
do you maximise the return? to a more focused and efficient development effort*
 How will your customers value your product?
 How do you plan the Product Development to
 Preparing a Target Product Profile (TPP) focuses the
add value at each step and deliver products development team on what is important to the
that customers will value? customer.*
 These challenges are common causes for
innovation failure*
 Building a TPP and strategy to evolve during
development
Example of PBI Experience
Definition of customer challenges with dosing of an oncology drug lead to strategy to
develop a simpler single vial presentation with a cost effective clinical and regulatory
development path.
* Key indicators of success for innovation see: http://www.stage-gate.net/downloads/working_papers/wp_22.pdf for American Productivity
& Quality Centre report
Recommendation:
“..an experienced product development scientist with a strong management background and a practical approach
4 to problem solving” Ian Nisbet Director, Planning & Coordination, CSL Limited

5. Efficient and Effective Innovation
How to Organise Operations to create value
The Challenge PBI provides leadership in innovation by
 How do you set up innovation  Establishing new or reviewing existing organisation structures;
companies, product development development and portfolio review processes to support best
practice innovation
groups and/or projects for fastest path  Outcomes would include
to profitability?* – Preparing and implementing operational, HR, resource
 How do you balance your portfolio to and capital plans to support delivering value
maximise the profitability of your – Establishing systems to review the portfolio and/or
conducting reviews against milestones and KPIs
innovation effort? including financial performance and profitability
forecasts.
Examples of PBI Experience
1. Conducted strategic review and prepared operational, HR ,financial and capital plan for a not for profit organisation
2. Implemented effective matrix management structure for development groups in MNCs in Australia and EU
3. Lead portfolio review and integration of project and development management process in major merger
4. Excellent track record having delivered over 70 products worth over $200m launched in 70 countries
*A major challenge for innovation companies http://www.stage-gate.net/downloads/working_papers/wp_22.pdf for American Productivity &
Quality Centre report
Recommendation:
• “ (Michael) developed project management, structures and responsibilities.Project management is
now functioning well at Sandoz” Julie Liu Head Development & Regulatory Affairs Sandoz BU
5 Oncology

6. Design and Implementation of Outsourcing
Strategies &Technology Transfer
The Challenge PBI provides leadership in innovation by
 How do you maximise profitability by
 Establishing new or reviewing existing outsourcing strategies,
organisational structures and processes to support
outsourcing non-core products/functions while outsourcing
maintaining control over critical  Establishing new or reviewing existing technology transfer
products/functions? and quality agreements that effectively support delivery of the
 How do you maintain the quality of outsourcing strategy
outsourced development studies and
 Establishing new or reviewing existing detailed outsourcing
and technical transfer plans
outsourced commercial product?  Establishing systems to review performance against
 How do you effectively transfer manufacture milestones and other KPIs including financial indicators
of product to an outsourcing partner?
Examples of PBI Experience
1. Lead major outsourcing initiative for large publicly listed company involving transfer
of product development activities worth $17m pa to 3rd parties with substantial
savings and launch of products worth more than $100 million pa to date
Recommendation:
“Strategic thinking pharmaceutical...leader...covering..developments in Australia, the US
Europe and India.... happy to endorse Michael” Hugh Burrill, Corporate Vice
6 President, Global Pharma R&D, Hospira Inc.

7. Preparation of Business Cases/Business
Plans for Funding
The Challenge PBI supports effectively gaining commercial funding
 How do you present a compelling case  Designing business cases that “press the right
for funding commercial product buttons” with investors
development?  Integrating groups of business cases into a balanced
 How do you integrate a group of business plan for a company that fits within available
business cases for product development funding and demonstrates the viability of a
into a business plan for a company? sustainable business
Examples of PBI Experience
1. Prepared and Integrated business plans into a strategic financial plan for business unit in large publicly listed
company to grow the business 5 fold in 5 years (to $100million pa) with minimal internal funds invested (less
than $200K)
2. Successfully executed plan and gained external funding growing the value of the business from $20 million to
$30 million in 2 years and securing external contract development funding of $6million
3. Prepared financial model and business case for funding for a start-up medical device company demonstrating
rapid profitability of company.
Recommendation:
“Michael saved us many months of internal resource time.. Great to have someone work as
though they were part of our Business Development team” Peter Schembri General Manager,
7 Business Development and Scientific Affairs, Mayne Pharma

8. Accessing Funds through Grants to
support your Innovation Strategy
The Challenge PBI supports effectively gaining grant funding
 Can you use grants to partly fund your  Defining your R&D needs that are applicable for grant funding
development strategy? – which grants to apply for.
 Which grants will best support your strategy  Designing grant applications that address the drivers of
and which ones will not be effective? granting bodies
 How do you best present your grant  Integrating grant application with best practice project and
application for funding? portfolio management to
 How do you improve your chances of
– Increase chances of funding
funding? – Simplify management of grants when awarded
 How do you set up your application so that
Examples of PBI of the grant is simplified
management Experience
1. Revised financial and operational plan for not for profit. Successful in gaining approval of a modified grant ($7.5m).
Managed PIIP, P3 and R&D Tax concession for large publicly listed company
2. Several ARC grant applications successfully prepared and managed.
3. Experience with CRC and Start grant applications/management.
Recommendation:
Grants obtained as lead in application:
• 2004-2009 Pharmaceutical Partnerships Program $10m (Mayne Pharma/Hospira)
• 2002-2004 ARC Linkage Australian Postdoctoral Fellowships (Industry) CSL “Characterisation and Stability of
ISCOM Vaccines”
8 • 1999 Australian Postgraduate Awards (Industry) CSL “Intranasal immunization with ISCOM vaccines”

9. Strategies for Navigating Regulatory
Approval Pathways
The Challenge PBI supports effectively gaining regulatory approval by
 How do you navigate the complex  Defining the requirements for approval
requirements for quality systems and  Defining alternative pathways to approval
documentation for clinical trials and product  Designing IND and NDA/ANDA product development and
approval? clinical strategies that minimise time and cost
 How do you establish product development,  Integrating these strategies with best practice regulatory
regulatory and clinical strategies that affairs, project and portfolio management to speed path to
maximise your chances of approval with least market
time and cost?
Examples of PBI Experience
1. Defined best practice regulatory affairs processes and resources for Sandoz Oncology BU
2. Several First to Market opportunities achieved using minimal preclinical and clinical studies with
NDA and 505b(2) pathway for approval
3. Use of NDA and (505b(2)) pathway for biological products
4. Experience with managing CTN and CTX/IND product development programs
Recommendation:
“Michael .. supported Sandoz Oncology Regulatory Department (in) improvement of business
process efficiency. Reliable, trustworthy and easy to work with” Julie Liu Head Development &
9 Regulatory Affairs Sandoz BU Oncology “

10. Expert Opinion and Witness for Patent
Matters
Examples of Michael McNamara’s IP Experience
• Expert Opinion provided to large publicly listed company on technical aspects of
biopharmaceutical patent formulation and manufacturing process
• Expert Opinions provided to IP legal firm on technical aspects of formulation, biopharmaceutics
and pharmacodynamics in relation to several small molecule drugs
• Holds 3 formulation patents for biopharmaceuticals
• Managed large number of product developments involving patent circumvention
• Trained in giving evidence in patent depositions
Recommendation:
“Michael McNamara assisted me as an expert scientific witness in relation to
pharmaceutical patent litigation. Michael provided first class service both in relation
to the scientific content of his evidence and timeliness of his services”
Ian Pascarl, Partner, Davies Collison Cave Law.
10 Pharma & Biotech Innovation

11. Pharma & Biotech Innovation
Deliver Success through Innovation
Michael McNamara
MSc MRACI C Chem
Pharma & Biotech Innovation
ph 03 94997193 mobile 0407713768
michael.mcnamara@live.com.au
11 Pharma & Biotech Innovation