1) Capacity planning is difficult in biopharmaceutical manufacturing due to high uncertainty in drug development success, risk averseness to capacity shortages given life-saving drugs, and high costs to build new capacity.
2) The document examines key metrics for capacity decisions and argues the need for integrated models of both supply and demand that account for uncertainty.
3) Accurately modeling demand involves understanding probability of drug approval success and variability in potential patient usage, while modeling supply requires detailed analysis of facility production capabilities and resource constraints.
Advances and investment in digital health is growing at an incredible rate and Contract Manufacturing Organizations and Contract Development and Manufacturing Organizations are becoming an essential part of the new pharma value chain. From wearables, to apps, to digital platforms, the data and efficiencies generated by these innovations are opening up important avenues across the pharma ecosystem. As pressure on improving drug development heats up, data, digital and technological innovations are critical to delivering the desired business and patient outcomes, promoting significantly more networking and outsourcing strategies. CMOs are evolving from service providers to strategic partners. CMOs now cover the entire value chain of pharma production, including specialized services such as R&D.
A brief introduction of the outsourcing methods in Pharma Supply Chain, Types of Outsourcing, Framework to decide correct outsourcing partner, factors to consider while selecting a partner, Process of outsourcing and Outsourcing models.
Thinking Beyond Compliance Medical Device WhitepaperJenna Dudevoir
This white paper is based on a research study with leading medical device companies - from startups to multibillion dollar enterprises - to explore how they are balancing new product development with compliance requirements.
The Innovation Gap in Pharmaceutical Drug Discovery and New Models for R&D Su...Michael Hu
Whitepaper exploring the root causes behind Pharma Industry's widening Innovation Gap and discusses several R&D innovation models for addressing the productivity conundrum.
Fostering the Quality Based CMO-Sponsor RelationshipAjinomoto Althea
Althea Technologies' Sr. VP of Quality and Regulatory, EJ Brandreth, talks about life in the CMO world from the quality perspective. In this presentation, he discusses the regulations involved in biologics manufacturing and fill finish operations, and the importance of establishing a quality based partnership between CMOs and sponsors.
Making Key Decisions in New Product Planning When “Perfect” Information is No...Anthony Russell
Presentation given at New Product Planning Summit 2021.
Learning Objectives:
* Review the types of decisions typically made in New Product Planning
* Discuss the nature of information available to support decision-making in New Product Planning
* Review the impact and context of decision-making in New Product Planning
* Review potential approaches to assist in New Product Planning decision-making
Advances and investment in digital health is growing at an incredible rate and Contract Manufacturing Organizations and Contract Development and Manufacturing Organizations are becoming an essential part of the new pharma value chain. From wearables, to apps, to digital platforms, the data and efficiencies generated by these innovations are opening up important avenues across the pharma ecosystem. As pressure on improving drug development heats up, data, digital and technological innovations are critical to delivering the desired business and patient outcomes, promoting significantly more networking and outsourcing strategies. CMOs are evolving from service providers to strategic partners. CMOs now cover the entire value chain of pharma production, including specialized services such as R&D.
A brief introduction of the outsourcing methods in Pharma Supply Chain, Types of Outsourcing, Framework to decide correct outsourcing partner, factors to consider while selecting a partner, Process of outsourcing and Outsourcing models.
Thinking Beyond Compliance Medical Device WhitepaperJenna Dudevoir
This white paper is based on a research study with leading medical device companies - from startups to multibillion dollar enterprises - to explore how they are balancing new product development with compliance requirements.
The Innovation Gap in Pharmaceutical Drug Discovery and New Models for R&D Su...Michael Hu
Whitepaper exploring the root causes behind Pharma Industry's widening Innovation Gap and discusses several R&D innovation models for addressing the productivity conundrum.
Fostering the Quality Based CMO-Sponsor RelationshipAjinomoto Althea
Althea Technologies' Sr. VP of Quality and Regulatory, EJ Brandreth, talks about life in the CMO world from the quality perspective. In this presentation, he discusses the regulations involved in biologics manufacturing and fill finish operations, and the importance of establishing a quality based partnership between CMOs and sponsors.
Making Key Decisions in New Product Planning When “Perfect” Information is No...Anthony Russell
Presentation given at New Product Planning Summit 2021.
Learning Objectives:
* Review the types of decisions typically made in New Product Planning
* Discuss the nature of information available to support decision-making in New Product Planning
* Review the impact and context of decision-making in New Product Planning
* Review potential approaches to assist in New Product Planning decision-making
Performing Competitive Intelligence in a Pharmaceutical CompanyAnthony Russell
Workshop presented in the Competitive Intelligence and Pricing course as part of the University of Southern California Master of Science in Healthcare Decision Analysis program. Presented on Nov 4, 2018 at USC. The workshop gives an overview of what competitive intelligence is and how it is done in pharmaceutical companies. The workshop includes a couple of non-pharmaceutical exercises to help students learn how to write key intelligence questions and to work through a market simulation exercise. The workshop ends with a discussion on the various career pathways available within the competitive intelligence field.
How and When to Kill a Program in New Product PlanningAnthony Russell
Presented at the 4th New Product Planning Summit in Boston (Dec 2 -3 , 2019). Presentation covers why weak programs should be cut from pharmaceutical and biotech pipelines, what defines a "weak" program, and describes objective methods to evaluate programs to help prioritize assets.
Lifecycle Management in the Pharmaceutical IndustryAnthony Russell
Presented to students in the Drug Development and Product Management program at UC San Diego. Covers the rationale for lifecycle management is important. Includes case studies of successful implementation of lifecycle management. Presentation date: 2/5/2019.
How to Work Effectively with Research Teams in New Product PlanningAnthony Russell
Presented at the 3rd New Product Planning Summit. The presentation was designed to help professionals in New Product Planning to present a case for why commercial strategy input is needed early in the process of developing new therapeutics. The presentation also includes suggested approaches and tools to help with effective engagement with Research teams.
Building a Business Case for New Product Planning in a Small Company EnvironmentAnthony Russell
Presented at the 2nd New Product Planning Summit by ExL Events in Boston (Dec 8, 2017). An overview of why commercial strategy is needed early in product development. As pressures continue to mount in drug development (crowded markets, payer and access issues, etc.), it is becoming critical to focus on the early stages of drug development. Working early with research and development teams to evaluate the commercial viability of programs will benefit companies of all sizes to maximize their portfolio of therapeutic candidates.
A workshop presentation for Medical Affairs Strategic Summit West held in San Diego on September 23, 2019. The workshop covered the following learning objectives:
* Understand the factors involved in selecting and prioritizing indications
* Understand the importance of strategic market segmentation
* Understand how Medical Affairs can be involved in the process of new product planning
Future Pharma Trends - Long-term opportunities tempered by short-term challengesscottosur
An overview of the key trends shaping the pharmaceutical industry today, and those that are set to play a central role in the future, as companies transition towards a new business model: Pharma 2.0.
Provides key strategies and trends shaping the future of the pharmaceutical industry. Examines the impact of the Obama administration on US healthcare, and the implications for Pharma. Assesses the implications of the current economic and financial situation on healthcare. Analyzes key growth drivers and resistors set to shape Pharma\'s future.
Contact me at sosur@datamonitor.com to learn more!
This presentation was made in Pharmasource Munich 2012 and covers the aspects of Pharma API and Intermediate sourcing. The presentation covers the following sub topics
1. How the changing structure of the Pharma industry is affecting ingredients sourcing
2. Are India and China still the places to go ( and for how long) – does the Cost - Benefit stack –up?
3. Supplier Innovation and Potential gains
4. Analyzing the Asian Pharma market –
a generics hub with a competitive skill base
i may be contacted at gurmeetsingh144@hotmail.com
McKinsey Sağlık Tedarik Zinciriyle, FMCG Tedarik Zinciri karşılaştırıyor. Sağlık Tedarik Zincirindeki iyileştirme fırsatına ve toplumsal boyutuna dikkat çekiyor.
Performing Competitive Intelligence in a Pharmaceutical CompanyAnthony Russell
Workshop presented in the Competitive Intelligence and Pricing course as part of the University of Southern California Master of Science in Healthcare Decision Analysis program. Presented on Nov 4, 2018 at USC. The workshop gives an overview of what competitive intelligence is and how it is done in pharmaceutical companies. The workshop includes a couple of non-pharmaceutical exercises to help students learn how to write key intelligence questions and to work through a market simulation exercise. The workshop ends with a discussion on the various career pathways available within the competitive intelligence field.
How and When to Kill a Program in New Product PlanningAnthony Russell
Presented at the 4th New Product Planning Summit in Boston (Dec 2 -3 , 2019). Presentation covers why weak programs should be cut from pharmaceutical and biotech pipelines, what defines a "weak" program, and describes objective methods to evaluate programs to help prioritize assets.
Lifecycle Management in the Pharmaceutical IndustryAnthony Russell
Presented to students in the Drug Development and Product Management program at UC San Diego. Covers the rationale for lifecycle management is important. Includes case studies of successful implementation of lifecycle management. Presentation date: 2/5/2019.
How to Work Effectively with Research Teams in New Product PlanningAnthony Russell
Presented at the 3rd New Product Planning Summit. The presentation was designed to help professionals in New Product Planning to present a case for why commercial strategy input is needed early in the process of developing new therapeutics. The presentation also includes suggested approaches and tools to help with effective engagement with Research teams.
Building a Business Case for New Product Planning in a Small Company EnvironmentAnthony Russell
Presented at the 2nd New Product Planning Summit by ExL Events in Boston (Dec 8, 2017). An overview of why commercial strategy is needed early in product development. As pressures continue to mount in drug development (crowded markets, payer and access issues, etc.), it is becoming critical to focus on the early stages of drug development. Working early with research and development teams to evaluate the commercial viability of programs will benefit companies of all sizes to maximize their portfolio of therapeutic candidates.
A workshop presentation for Medical Affairs Strategic Summit West held in San Diego on September 23, 2019. The workshop covered the following learning objectives:
* Understand the factors involved in selecting and prioritizing indications
* Understand the importance of strategic market segmentation
* Understand how Medical Affairs can be involved in the process of new product planning
Future Pharma Trends - Long-term opportunities tempered by short-term challengesscottosur
An overview of the key trends shaping the pharmaceutical industry today, and those that are set to play a central role in the future, as companies transition towards a new business model: Pharma 2.0.
Provides key strategies and trends shaping the future of the pharmaceutical industry. Examines the impact of the Obama administration on US healthcare, and the implications for Pharma. Assesses the implications of the current economic and financial situation on healthcare. Analyzes key growth drivers and resistors set to shape Pharma\'s future.
Contact me at sosur@datamonitor.com to learn more!
This presentation was made in Pharmasource Munich 2012 and covers the aspects of Pharma API and Intermediate sourcing. The presentation covers the following sub topics
1. How the changing structure of the Pharma industry is affecting ingredients sourcing
2. Are India and China still the places to go ( and for how long) – does the Cost - Benefit stack –up?
3. Supplier Innovation and Potential gains
4. Analyzing the Asian Pharma market –
a generics hub with a competitive skill base
i may be contacted at gurmeetsingh144@hotmail.com
McKinsey Sağlık Tedarik Zinciriyle, FMCG Tedarik Zinciri karşılaştırıyor. Sağlık Tedarik Zincirindeki iyileştirme fırsatına ve toplumsal boyutuna dikkat çekiyor.
BUDGET1Operating BudgetMonica AyresHCA 311 Health Ca.docxhartrobert670
BUDGET
1
Operating Budget
Monica Ayres
HCA 311: Health Care Financing and Information Systems
Kevin Hayes
July 13, 2015
Operating Budget
Before the manager or board accept the proposal for capital investment, there are a number of factors they should consider. The first factor to consider is the community need requirements (Herkimer, 1986). The health care needs of the community must be identified an then the capital investments selected which will best serve this need. In fact there is no use in internally selecting a capital project which management thinks the community needs, then trying to convince the citizenry that they need.
From the case provided, it is apparent that the move to expand the operations of the company is motivated by the fact that the company has not embarked on any serious capital investment plan for a period spanning over 6 years. This is a weak factor because it clearly indicates that the community need is not the main issue. The case further indicates that the company is facing severe competition from its rival in the Health Care market. This implies that the products are available from different and that there community members can still get products if they want from the competitors. Expanding is not a solution to this issue. In fact, if competition is what is forcing the company to seek plans to expand, then the manager or the board is less likely to accept the proposal.
Another factor to consider is marketability of the proposal (Herkimer, 1986). Based on the case provided, it is clear that there are many competitors in the market. Interestingly, the proposal intends to expand the enterprise so that the number of products produced increases. This is ridiculous because there is no need to increase the amount of products produced when it is clear that there are many competitors in the market. In fact, what the company should have done instead was to invest on technology to reduce the cost of production and hence lower the prices. This could enable the company compete well with competitors. Consequently, as far as marketability of proposed changes is concerned, the proposal is not strong.
The last factor to consider is urgency (Herkimer, 1986). Based on the case, there is no argument made to show that there is urgency or that the community needs the changes to be implemented urgently. This means that as far as urgency is concerned, the capital investment is not viable.
Reference
Top of Form
Herkimer, A. G. (1986). Understanding hospital financial management. Rockville, Md: Aspen Publishers.
Bottom of Form
CAPITAL INVESTMENT
1
Capital Investment Plan
Monica Ayres
HCA 311: Health Care Financing & Information Systems
Kevin Hayes
July 6, 2015
Capital Investment Plan
Abble Inc. is planning to undertake an expansionary Capital Investment process that will see the company’s operations and proceeds double hence cushioning the company’s going concern basis. The move to expand the operations of the company is ...
Increasing costs and new competitors from growth markets are challenging the industry. The consequences are the obligation to increase efficiency and a growing relocation and concentration process. But what is the benchmark for top performance in manufacturing chemical and pharmaceutical products? The ConMoto project study confirms: a Value oriented Maintenance and Asset Management is the key to sustainably increase production efficiency of the chemical and pharmaceutical industry.
Chemometrics Pharmacometrics Econometrics of QbD Swiss Pharma-6 2012Ajaz Hussain
The notion ‘by design’, in the phrase ‘Quality by
Design’, conveys an intention to deliver a product
or service with a pre-defined ‘quality’ so as to satisfy
intended customers. When the quality of a medicinal
product is considered, customer satisfaction
is often not easily measured. Therefore, regulatory
approval is important, and, it may be viewed as a
surrogate for confidence and satisfaction patients
and their physicians perceive.
This SWISS PHARMA presentation by
the author on 25 May 2012, in Basel, explored the
potential role of mathematical modeling tools, categorized
as Chemometrics, Pharmacometrics and
Econometrics, in improving regulatory communications
on ‘quality by design’. This article provides a
summary of arguments outlined during this presentation.
Market Access - Getting ready for Personalized Medicine!executiveinsight
A presentation outlining the potential gains, pitfalls and strategies needed to realize the value in Personalized Medicine (Companion Diagnostics, Therapies).
Whitepaper: New concept opportunities in personal careSagentia
Innovation in the personal care, health and beauty industry has traditionally been dominated by R&D in formulation chemistry and huge marketing budgets. In recent years, however, a new frontier has emerged: the area of devices. This paper outlines the device opportunity, market drivers and key enablers. This is followed by specialist perspectives on the technology and diagnostics viewpoints written by experts in each field.
http://www.sagentia.com/personal-care
ER Publication,
IJETR, IJMCTR,
Journals,
International Journals,
High Impact Journals,
Monthly Journal,
Good quality Journals,
Research,
Research Papers,
Research Article,
Free Journals, Open access Journals,
erpublication.org,
Engineering Journal,
Science Journals,
The Global Supply Chain Ups the Ante for Risk ManagementLora Cecere
Executive Summary
Unfortunately, supply chain disruptions are a fact of life for today’s global multinational company. The reasons are many. A risk management event can be triggered by natural events, geopolitical shifts, economic uncertainty and demand/supply volatility.
Historically, the roots and genesis of risk management programs were based on attempts to reduce insurance costs. Today it is much, much more. The focus is on prevention, early sensing, and the execution of well-orchestrated plans to mitigate the impact of a disruption. Global supply chain leaders understand that designing and implementing a robust risk management practice is essential and fundamental to running a global business. The size of the bubble in Figure 2 indicates the relative level of risk today, and the colors correspond to the level of risk.
Figure 2. Comparison of Risk Drivers for the Past Five Years and Future Five Years
While product quality and supply chain visibility are declining but still important, the areas of operations complexity and the definition of globalization infrastructure is increasing. The areas of economic uncertainty, supplier reliability, along with demand volatility, are continued risk factors.
Over time, as supply chains morphed from regional to global multinational organizations, globalization and regulatory compliance increased. As a result, procurement has shifted from traditional programs focused solely on contract management, price and term negotiations, and supplier scorecards to include the evolution of supplier development, to manage product quality and multi-tier supplier relationships, in and across value chain relationships.
Today is a less certain world than a decade ago. Geopolitical shifts, economic uncertainty and demand/supply volatility are rising. In addition, to spur growth companies are quick to add products to the item master, but slow to rationalize the portfolio. The rising complexity of items sold decreases the organization’s ability to forecast, and the longer lead times across multiple tiers of sourcing and supply increases the Bullwhip Effect’s impact (distortion of the demand signal across multiple tiers of the value network). As a result, there is a greater need for supplier development and supplier sensing to reduce supply risk. Inventory management and supplier financial sensing grow in importance with the increase in uncertainty.
Risk management is no longer narrowly focused: a technology, a response to a natural disaster, or improving supply chain visibility. Instead, it is more holistic with a focus on managing demand and supply variability cross-functionally and improving outcomes in an uncertain world.
In this report, we share insights on the current state of risk management programs while providing recommendations on what defines excellence.
Ibm The Supply Chain Of The Future BilcareBilcareltd
In the course of our research for IBM’s inaugural Global Chief Supply Chain Officer Study, we conducted face-to-face interviews with nearly 400 senior supply chain executives from 25 countries and 29 different industries.
Here, we focus on the responses of the 23 supply chain executives from the Life Sciences industry (see sidebar, Survey sample).
In the course of our research for IBM’s inaugural Global Chief Supply Chain
Officer Study, we conducted face-to-face interviews with nearly 400 senior
supply chain executives from 25 countries and 29 different industries.1
Here, we focus on the responses of the 23 supply chain executives from
the Life Sciences industry (see sidebar, Survey sample).
Similar to Capacity planning in biomanufacturing (20)