This document describes the consulting services of Pharma & Biotech Innovation to support profitable innovation. The services include strategic advice, project management, and laboratory studies focused on efficient product innovation and manufacturing operations. The consultant has experience developing strategies for commercialization, organizational structures, outsourcing, accessing funds, and navigating regulatory approval pathways. The goal is to help clients translate ideas into products and maximize the profitability of their innovation efforts.
Pharmaceutical Portfolio & Product Life Cycle Managementsbryant89
As product pipelines become thinner, and pressure to get the most out of dwindling resources increases, pharmaceutical portfolio and product lifecycle management becomes an imperative part of a company’s approach to maximizing ROI. Not only must managers carefully strategize in relation to the product’s strengths against competitors and also in such a way to compliment the overall company portfolio, but they must also balance the crucial factors of regulatory change in patent protection, risk mitigation, effective R&D resource allocation in order to achieve an integrated approach to effective portfolio and PLCM.
Now in its 6th year, SMi Groups Pharmaceutical Portfolio & Product Life-Cycle Management is a well established meeting ground for such managers and directors who are faced with the task of managing the pipeline in a way that acknowledges the above mentioned factors and more. In the close up environment that our conferences provide, you can expect to discuss with some of the leading professionals in the field the best way to approach this difficult task. In a showcase of effective approaches from many of the largest pharmaceutical companies, you can be sure to learn much of value to yourself, and to your organization.
Pharmaceutical Portfolio & Product Life Cycle Managementsbryant89
As product pipelines become thinner, and pressure to get the most out of dwindling resources increases, pharmaceutical portfolio and product lifecycle management becomes an imperative part of a company’s approach to maximizing ROI. Not only must managers carefully strategize in relation to the product’s strengths against competitors and also in such a way to compliment the overall company portfolio, but they must also balance the crucial factors of regulatory change in patent protection, risk mitigation, effective R&D resource allocation in order to achieve an integrated approach to effective portfolio and PLCM.
Now in its 6th year, SMi Groups Pharmaceutical Portfolio & Product Life-Cycle Management is a well established meeting ground for such managers and directors who are faced with the task of managing the pipeline in a way that acknowledges the above mentioned factors and more. In the close up environment that our conferences provide, you can expect to discuss with some of the leading professionals in the field the best way to approach this difficult task. In a showcase of effective approaches from many of the largest pharmaceutical companies, you can be sure to learn much of value to yourself, and to your organization.
Beyond Projects: Creating A Winning Product Portfolio by Walter Sun at SVPMA Monthly Event May 2011
Go to link below for notes from this event
http://svpma.org/2011/07/may-2011-event/
Research and Development (R&D) is a process by which a company obtains new knowledge and uses it to improve existing products and introduce new ones to its operations. R&D is a systematic investigation with the objective of introducing innovations to the company’s current product offerings. It achieves this by adding improvements to the current goods and services or introducing a new product offering. Research and Development (R&D) theme Research and development are applied across different industries and sectors
Efficient Indicators to Evaluate the Status of Software Development Effort Es...IJMIT JOURNAL
Development effort is an undeniable part of the project management which considerably influences the
success of project. Inaccurate and unreliable estimation of effort can easily lead to the failure of project.
Due to the special specifications, accurate estimation of effort in the software projects is a vital
management activity that must be carefully done to avoid from the unforeseen results. However numerous
effort estimation methods have been proposed in this field, the accuracy of estimates is not satisfying and
the attempts continue to improve the performance of estimation methods. Prior researches conducted in
this area have focused on numerical and quantitative approaches and there are a few research works that
investigate the root problems and issues behind the inaccurate effort estimation of software development
effort. In this paper, a framework is proposed to evaluate and investigate the situation of an organization in
terms of effort estimation. The proposed framework includes various indicators which cover the critical
issues in field of software development effort estimation. Since the capabilities and shortages of
organizations for effort estimation are not the same, the proposed indicators can lead to have a systematic
approach in which the strengths and weaknesses of organizations in field of effort estimation are
discovered
Technology commercialization strategy for a multidisciplinary R&D institutions such as GRO and CRO under new research and business development (R&BD) paradigm
Research and Development is the most important and functional part of the whole business organization which helps in deciding the considerable objectives, finding ways to accomplish them and taking future decisions for overall business growth.
In 2017, Global Research and Development investment has been maximum in the field of electronics and computing. The present foremost requirement of developing business is innovation and Research and Development is contributing a lot towards it.
Thanks for Reading
Team MakeWebBetter
The Innovation Commercialization Process:A Case StudyCheryl Tulkoff
When people think of innovation, they frequently think of the “big idea” or product while overlooking the fact that innovation is really a process.
They think of innovation solely in the creative sense rather than considering the importance or even existence of an innovation methodology.
Countless examples exist of good inventions that never succeeded in the marketplace or failed to live up to expectations while lesser ones thrived.
Many of these failures could have been eliminated through use of an innovation commercialization process.
This presentation describes the process and demonstrates its application through a case study.
Beyond Projects: Creating A Winning Product Portfolio by Walter Sun at SVPMA Monthly Event May 2011
Go to link below for notes from this event
http://svpma.org/2011/07/may-2011-event/
Research and Development (R&D) is a process by which a company obtains new knowledge and uses it to improve existing products and introduce new ones to its operations. R&D is a systematic investigation with the objective of introducing innovations to the company’s current product offerings. It achieves this by adding improvements to the current goods and services or introducing a new product offering. Research and Development (R&D) theme Research and development are applied across different industries and sectors
Efficient Indicators to Evaluate the Status of Software Development Effort Es...IJMIT JOURNAL
Development effort is an undeniable part of the project management which considerably influences the
success of project. Inaccurate and unreliable estimation of effort can easily lead to the failure of project.
Due to the special specifications, accurate estimation of effort in the software projects is a vital
management activity that must be carefully done to avoid from the unforeseen results. However numerous
effort estimation methods have been proposed in this field, the accuracy of estimates is not satisfying and
the attempts continue to improve the performance of estimation methods. Prior researches conducted in
this area have focused on numerical and quantitative approaches and there are a few research works that
investigate the root problems and issues behind the inaccurate effort estimation of software development
effort. In this paper, a framework is proposed to evaluate and investigate the situation of an organization in
terms of effort estimation. The proposed framework includes various indicators which cover the critical
issues in field of software development effort estimation. Since the capabilities and shortages of
organizations for effort estimation are not the same, the proposed indicators can lead to have a systematic
approach in which the strengths and weaknesses of organizations in field of effort estimation are
discovered
Technology commercialization strategy for a multidisciplinary R&D institutions such as GRO and CRO under new research and business development (R&BD) paradigm
Research and Development is the most important and functional part of the whole business organization which helps in deciding the considerable objectives, finding ways to accomplish them and taking future decisions for overall business growth.
In 2017, Global Research and Development investment has been maximum in the field of electronics and computing. The present foremost requirement of developing business is innovation and Research and Development is contributing a lot towards it.
Thanks for Reading
Team MakeWebBetter
The Innovation Commercialization Process:A Case StudyCheryl Tulkoff
When people think of innovation, they frequently think of the “big idea” or product while overlooking the fact that innovation is really a process.
They think of innovation solely in the creative sense rather than considering the importance or even existence of an innovation methodology.
Countless examples exist of good inventions that never succeeded in the marketplace or failed to live up to expectations while lesser ones thrived.
Many of these failures could have been eliminated through use of an innovation commercialization process.
This presentation describes the process and demonstrates its application through a case study.
What Is It? Product Development vs. Product Management April Bright
This session will focus on the respective roles and responsibilities of the Product Manager vs. the Development Engineer from a product’s inception through its lifecycle maintenance. Attendees will learn how to leverage the cross-functional product team to deliver results, business vs. technical aspects of product development, putting the customer first and navigating the organization in order to get things done.
Healthscape Pharma Marketing Capability Building Program "Building Big Brands"Shailesh Rau
HealthScape is a strategic consulting and business advisory services firm set up in 2012. HealthScape provides data driven strategic insights and helps build both marketing and strategic capabilities in building big brands, product portfolios and new product launches. We aim to be the preferred and trusted partner across all dimensions of product marketing and portfolio management. We also drive high science programs besides product marketing like market shaping/disease shaping initiatives, Preceptorship Programs, CME Accredited Modules etc.
Capability Building Program:
Building Big Brands is a marketing workshop which is delivered over a period of six days, and followed by hand holding of participants over a period of 6-12 months.
Target Audience: Product Managers, Marketing Managers, Medical Affairs Managers and Market Research.
Program revolves over three key pillars which are:
A. Thorough environment scan to develop deeper understanding and value of key insights,
B. The art and science of brand positioning and
C. Conveying this value proposition in a powerful way, so as to build a solid differential over competition.
Each of these pillars is delivered through following workshop modules:
1. Importance of key customer insights
a. Fundamental understanding on insights, importance and value of market research.
b. Tools
c. Templates (A standard process for any organization to bring in a discipline)
d. Case Studies (Both from Pharma and non-pharma)
e. Simulation exercise on company’s own brand
2. Importance of Brand Positioning
a. Fundamental understanding of both science and art of developing brand positioning statement
b. Tools
c. Templates
d. Case Studies (Both from pharma and non pharma)
e. Simulation exercise on company’s own brand.
3. How to develop powerful communication/ Medico-Marketing Programs
a. Fundamental understanding of communication strategy
b. Tools
c. Templates
d. Case Studies (both from pharma and non pharma)
e. Simulation exercise on company’s own brand.
We ensure that this does not get viewed as a mere annual activity, but create a back bone of the functioning and we strongly recommend a simulation of these learnings on one of the company’s own brand.
This method of delivery of this workshop makes it most unique and valuable capability building program.
Mastering the Product Development Process: A Comprehensive Guide to Bringing ...CIO Look Leader
Key Stages of the Product Development Process: 1. Idea Generation 2. Concept Development and Screening 3. Market Research 4. Prototype Development 5. Testing and Validation
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Breadcrumb:Table of ContentsSection 4: Technology and Innovation: ApplicationWeek 7Books and Resources for this WeekWeek 7 Assignment Signature Assignment RubricWeek 7 Assignment Signature Assignment RubricSend to BinderSubmit FeedbackDownload
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YOU
NEED
AN
INNOVATION
STRATEGY
It’s the only way to make sound trade-off
decisions and choose the right practices.
BY GARY P. PISANO
THE BIG IDEA
44 Harvard Business Review June 2015
Gary P. Pisano is the
Harry E. Figgie Professor
of Business Administration
and a member of the U.S.
Competitiveness Project at
Harvard Business School.
G
U
ST
AV
O
B
R
IG
A
N
TE
HBR.ORG
June 2015 Harvard Business Review 45
DESPITE MASSIVE
INVESTMENTS OF
MANAGEMENT
TIME AND MONEY,
INNOVATION
REMAINS A
FRUSTRATING
PURSUIT
IN MANY
COMPANIES.
my more than two decades studying and consulting
for companies in a broad range of industries, I have
found that firms rarely articulate strategies to align
their innovation efforts with their business strategies.
Without an innovation strategy, innovation
improvement efforts can easily become a grab bag
of much-touted best practices: dividing R&D into
decentralized autonomous teams, spawning inter-
nal entrepreneurial ventures, setting up corporate
venture-capital arms, pursuing external alliances,
embracing open innovation and crowdsourcing,
collaborating with customers, and implementing
rapid prototyping, to name just a few. There is noth.
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 pharmaceutical, medical device and
biotechnology companies, government and not for profit organisations
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 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 the Clinical and Regulatory Approval Pathway including
CTN, CTX, IND, ANDA and NDAs
7. Expert Opinion and Witness for Patent Matters
2 Pharma & Biotech Innovation
3. Michael McNamara
Biography
Specialist in management of innovation in pharmaceuticals and 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, 20 years in pharmaceutical and
biotechnology industry
Recent experience with medical device, not for profit, life science, agricultural and
chemical technology projects
Qualified Biochemist/Chemist with postgraduate qualifications in management and drug
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
3 Development of Clinical and Regulatory Strategies involving CTN, CTX, IND ANDA and
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 Preparing an integrated strategy to answering these
and/or technology into product(s)? questions and forming a sound commercialisation
What is your product’s competitive strategy
advantage? Establishing an early development strategy - leads
How will your customers value your to a more focused and efficient development effort*
product?
How do you plan the Product
Preparing a Target Product Profile (TPP) focuses the
Development to add value at each step development team on what is important to the
and deliver products that customers will customer.*
value? Building a TPP and strategy to evolve during
These challenges are common causes development
for innovation failure*
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 the Clinical and
Regulatory Approval Pathway
-including CTN, CTX, IND, ANDA and NDAs
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