Archive for the ‘Milesahead’ Category

Gartner Supply Chain Leaders Conference – What will be Hot?

Published May 20th, 2014 by Trevor Miles @milesahead 0 Comments

My friend and colleague CJ Wehlage has weighed in on what he believes will happen on the Gartner Top 25.

CJ is most certainly being bold and I cannot fault his analysis beyond the usual carping that the Top 25 generates. Instead I want to focus on what seem to me to be major trends that are maybe below the surface but will inform a lot of the discussion. I go to and speak at a lot of conferences so I hear a mixture of over stated claims, future initiatives, and concerns about the state of Supply Chain Management.

Over the past 3-4 years Sales & Operations Planning (S&OP) has seen a resurgence in interest, including the many variants such as Integrated Business Planning (IBP) and SIOP. More recently there has been a lot of discussion, including from Christian Titze, Ray Barger, and others at Gartner on Visibility, usually coupled with the term end-to-end. What I have been hearing more and more recently, let us say late 2013and early 2014, is end-to-end planning. Kinaxis led the charge in this space first calling this a Control Tower in 2012-2013, but that was quite confusing because the 3PLs were already calling their capabilities Logistics Control Towers. Which got even more confusing when Visibility became more popular because how is that different from a Logistics Control Tower?

To me this is all semantics. At the core what people are trying to do, whether during execution or within operational, tactical, or strategic planning is to bring in a wider set of data so that they can investigate more alternatives during the planning phases and get early warning of things not going to plan during the execution phase. Perhaps even more importantly it is about getting different functions within the organization and even across organizations to work together to resolve issues, which is of course the essence of S&OP:

Sales and operations planning (S&OP) is an integrated business management process developed in the 1980s by Oliver Wight through which the executive/leadership team continually achieves focus, alignment and synchronization among all functions of the organization.

Substitute the words “executive/leadership” for any other group and you have what I am hearing over and over as End-to-End Visibility and End-to-End Planning. It is about lowering the walls between functions and organizations so that we can finally replace inventory with information.

But this isn’t what is in the core of the bubbling cauldron. End-to-End Planning and Visibility are driving a core need for a rethink of the entire supply chain data layer. Gartner went through this rethink a few years ago, and, as much as I hate to admit it, they were ahead of me. This is when Gartner moved from a 4 stage demand-driven maturity model to a 5 stage model in March 2013 by inserting a stage in the middle called Integrate. (Introducing the Five-Stage Demand-Driven Maturity Model for Supply Chain Leaders, 26 March 2013, Noha Tohamy, Matthew Davis)

Gartner states that what is required to achieve this stage of Integrated DDVN are

Technologies to support end-to-end supply chain processes; improved data rationalization and integration capability.
Cross-functional decision making across internal supply chain; process-focused COEs to enable the business.

I bring out these description of technology and process needs because they show the dependency of the process on the technology. They also show that my statements above are totally consistent with Gartner’s perspective.

But the elephant in the room is the technology. In fact it is really the data. Many companies have several instances of ERP, each deployed differently. Despite many moving to a single instance of ERP there are still many ‘shadow IT’ required to do what the core ERP solution cannot. And then there is the planning layer, which is even less harmonized or standardized. Most business people consider this an IT problem. Guess what? It isn’t going away until the business makes solving the data issue their issue. And it isn’t about consolidating down to a single ERP system. Even though consolidating down to one ERP instance is a step forward, with manufacturing outsourcing accelerating in many industries, heterogeneous data sources are here to stay. The question is what will the future data layer look like?

As Josh Greenbaum states in a blog published just today and titled “Security, Privacy, Big Data, and Informatica: Making Data Safe at the Point of Use

Our data warehouse legacy treats data like water, and models data management on the central utility model that delivers potable water to our communities: Centralize all the sources of water into a single water treatment plant, treat the water according to the most rigorous drinking water standard, and send it out to our homes and businesses. There it would move through a single set of pipes to the sinks, tubs, dishwashers, scrubbers, irrigation systems, and the like, where it would be used once and sent on down the drain.
But data isn’t like water in so many ways.

My bold prediction is that the data layer isn’t going to be ERP centric as it is now. And we are not going to repeat the marketplace craziness of the late 1990s. Unless cloud native ERPs such as Kenandy, which is based on SalesForce, emerge with built-in semantics to absorb meta-data from many sources and pull data in when needed. But I predict we will see a whole new breed of data providers emerge, possibly out of the wreckage that is the EAI space, that will capture this space and serve up data for analytics and business purposes.

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Posted in Milesahead, Response Management, Supply chain collaboration, Supply chain management


Part 3: My thoughts on Gartner’s Magic Quadrant for Supply Chain Planning System of Record

Published April 22nd, 2014 by Trevor Miles @milesahead 0 Comments

I was recently asked three questions on Gartner’s Magic Quadrant for Supply Chain Planning System of Record. As I said earlier, I want to share these videos with our readers…

The three questions I was asked were:

  1. What do you think of the Gartner Magic Quadrant for supply chain planning system of record?
  2. In your opinion, how does RapidResponse differentiate itself as a supply chain planning system of record?
  3. From your experience, what is the level of understanding of planning systems of record in the market?

Here’s my response to question #3. If you haven’t checked out my response to question #1 and question #2, you may want to view them first. Enjoy!

The report positions vendors based on completeness of vision in the supply chain planning system of record market and on their ability to execute to that vision. If you’re interested in reading the full report, the Gartner document is available upon request at http://kinax.is/Gartner.

Posted in Control tower, Demand management, Milesahead, Sales and operations planning (S&OP), Supply chain collaboration


Part 2: My thoughts on Gartner’s Magic Quadrant for Supply Chain Planning System of Record

Published April 17th, 2014 by Trevor Miles @milesahead 0 Comments

I was recently asked three questions on Gartner’s Magic Quadrant for Supply Chain Planning System of Record. As I said last week, I want to share these videos with our readers.

The three questions I was asked were:

  1. What do you think of the Gartner Magic Quadrant for supply chain planning system of record?
  2. In your opinion, how does RapidResponse differentiate itself as a supply chain planning system of record?
  3. From your experience, what is the level of understanding of planning systems of record in the market?

Here’s my response to question #2 (if you haven’t checked out my response to question #1, you may want to view that first).

Hope you enjoy!

In your opinion, how does RapidResponse differentiate itself as a supply chain planning System of Record?


 

You can also check out my responses to question #3 as well:

 
The report positions vendors based on completeness of vision in the supply chain planning system of record market and on their ability to execute to that vision. If you’re interested in reading the full report, the Gartner document is available upon request at http://kinax.is/Gartner.

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Posted in Demand management, Milesahead, Sales and operations planning (S&OP), Supply chain collaboration, Supply chain management


My thoughts on Gartner’s Magic Quadrant for Supply Chain Planning System of Record – A video blog

Published April 11th, 2014 by Trevor Miles @milesahead 0 Comments

I was recently asked three questions on Gartner’s Magic Quadrant for Supply Chain Planning System of Record. The three questions I was asked were:

  1. What do you think of the Gartner Magic Quadrant for Supply Chain Planning System of Record?
  2. In your opinion, how does RapidResponse differentiate itself as a supply chain planning System of Record?
  3. From your experience, what is the level of understanding of planning systems of record in the market?

My answers were recorded and I thought I would share these videos with our readers… here is the first one. Hope you enjoy!

What do you think of the Gartner Magic Quadrant for Supply Chain Planning System of Record?

You can check out my responses to question 2 and 3 as well:

The report positions vendors based on completeness of vision in the supply chain planning system of record market and on their ability to execute to that vision. If you’re interested in reading the full report, the Gartner document is available upon request at http://kinax.is/Gartner.

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Posted in Milesahead, Supply chain management


‘Know Sooner, Act Faster’: A Supply-Chain Mantra | Kinexions

Published April 9th, 2014 by Melissa Clow 2 Comments

SupplyChainBrain attended our annual Kinexions user conference, and while there, they completed a number of video interviews with customers, analysts, and Kinaxis executives. And, we’d like to share them!

In this interview, hear C.J. Wehlage, vice president of high-tech solutions with Kinaxis, detail industry’s major supply-chain management challenges in particular, the difficulty of obtaining full visibility of supply and demand, and dealing with the volatility of markets. Know sooner, act faster  is the mantra offered by Wehlage as a key strategy for dealing with growing market volatility. I run into supply chain practitioners who don’t know as much as they think they do, he says.  It’s about responsiveness, and how much you know about your supply chain.

 

Previously, we featured interviews with:

 

‘Know Sooner, Act Faster’: A Supply-Chain Mantra – Interview summary

CJ wehlageIn seeking upstream visibility, many companies don’t look beyond their first-tier suppliers. As a result, crises often devolve into firefighting, rather than being averted through proper oversight of all suppliers, third-party logistics providers and even the retail store.

It’s tough to put a value on the prevention of a crisis that never happens. Still, says Wehlage, that necessary level of responsiveness is the core of supply chain.  It’s the key to how managers can influence the reporting structure within their organizations. Being able to make informed decisions, and acting on them, provides executives with a level of power that isn’t reachable through traditional methods.

Responsiveness isn’t just a tool for managing supply-chain execution; it also bears a strategic element. Decisions can be driven at the C-level, rather than occurring exclusively in the trenches.

A key competency that many companies are missing today is leadership. There has to be somebody asking the end-to-end questions, says Wehlage. What’s my profitability across this?

Yet another key element of modern-day supply-chain management is obtaining the right talent. It used to be sufficient for employees to possess functional expertise. Now, end-to-end skills are critical.

Posted in Demand management, Inventory management, Milesahead, Sales and operations planning (S&OP), Supply chain collaboration


7 Life Sciences Supply Chain Processes That Require an Integrated Approach

Published April 7th, 2014 by Trevor Miles @milesahead 0 Comments

The emerging or intensifying industry dynamics that I discussed in an earlier blog post, along with significant shifts in strategy, are having a direct and material impact on the way Life Sciences supply chains must operate. The compounded effect of a host of complexity drivers is creating the need for supply chain transformation. By satisfying the following seven supply chain processes in an integrated manner, Life Sciences teams will be better equipped for success in today’s new, complex world.

  1. Collaborative launch management – clinical, regulatory and commercial
  2. Jurisdictional control to respect regulatory needs during planning
  3. Consensus demand planning across affiliates and countries
  4. Risk evaluation and recovery to deal with shortages and FDA shutdowns
  5. Shortage analysis and reporting for FDASIA compliance
  6. Supply and capacity planning to balance demand across regions
  7. Expiry management to balance long supply lead times and shifting demand

Let’s take a look at each of these in more detail.

Coordinated Launches

The effective launch of a new product is critically important in any industry, but it is of particular importance in the Life Sciences industry given the long time it takes to bring a new drug to market from discovery through clinical trials and commercialization, with regulatory oversight and conformance throughout the process. When the ‘long tail’ trend is coupled with shorter patent protection, the margin and market captured during the early launch period will be crucial to the recovery of the R&D investment, and thus the pressure to streamline and coordinate clinical trials and the regulatory process with the commercial launch has become intense.

Revenue Trends throughout the Product Life Cycle

phamacutical supply chain graph

Jurisdictional Control

In addition, mandates by regulatory bodies require jurisdictional control of demand satisfaction to account for third country sourcing, validation, and shelf life requirements, amongst others. This requires sophisticated attribute based planning to link demand characteristics to supply characteristics while simultaneously analyzing and reducing expiry risk, especially when inventory postponement strategies are used.

Consensus Demand Planning

For tax, legal, and regulatory reasons, many Life Sciences companies establish semi-independent sales affiliates or subsidiaries in some jurisdictions or sell through third parties. Creating a consensus demand plan across all the affiliates and subsidiaries is not a trivial task. Often, each demand region will forecast in different units (doses, standard packs, grams of API, etc.); almost always in different currencies; at a different cadence (quarterly, monthly, weekly); and over different time horizons. However, manufacturing needs to create a single forecast using a consistent unit of measure so that they can net the demand against available supply and determine future manufacturing capacity needs. To make matters worse, the affiliates are often less than fully transparent about their on-hand inventory.

Risk Evaluation and Recovery (including Shortage Analysis and Reporting)

Current technical architectures do not provide the capabilities needed to address new requirements under FDASIA ̶ reporting obligations for drug shortage issues and more active inspection of production facilities for instance. Information flow is typically limited to EDI exchanges with little or no ability to understand, for example, the impact of an API supply de-commit on future treatment —drug or device— availability in a regulatory region. To do this, Life Sciences companies will require much greater visibility and what-if scenario capabilities to both inspect and affect the global supply chain across Third Party Operators and into the supply base.

Tender Analysis and Management

Many manufacturers lack the required process standardization in manufacturing, inventory and expiry management, and other core business disciplines to make the required trade-offs during tender analysis between demand satisfaction, expiry risk, and constrained capacity utilization, ultimately leading to effective supply and capacity planning to balance demand across regions. Collaboration across the players in the supply chain is often insufficient and inefficient to achieve these tradeoffs. Given the harsh penalties imposed for non-conformance, being able to make the trade-offs to maintain profitability span the life cycle of the tender, not simply the tender acquisition phase.

Expiry Management

Streamlining manufacturing and distribution processes in order to satisfy demand while reducing unit cost is therefore becoming increasingly important in order to maintain profitability, reduce inventories and enhancing competitiveness within the industry. This is especially true given the long manufacturing lead times, often as long as 12-18 months in bio-pharmaceuticals, which lead to the need for expiry risk and stop sell analysis capabilities to balance effective demand satisfaction with efficient capacity utilization.

A New Technology Paradigm for a New World

phamacutical supply chain graph #5Legacy demand planning and supply chain planning systems were not designed for today’s complexities, and consequently don’t meet the many challenges that have emerged. As a result, Life Sciences companies are adopting process improvements and new technologies targeted at removing business “silos,” improving collaboration, and increasing productivity.

For a true breakthrough, you need an integrated solution. People must be able to leverage a single system with one set of data, supported by comprehensive analysis and decision-making capabilities, no matter what the process or the problem.

To keep a finger on the pulse of the supply chain, today’s solutions must:

  • Embrace the reality that today’s supply chains are multi-enterprise in nature and, thus, must provide comprehensive visibility into the extended supply chain to regain an understanding of the manufacturing commitments and inventory positions throughout the supply network. Visibility is an essential pre-requisite for effective orchestration of the business.
  • Proactively bring to light major variances to plan, identifying not only specific events, but also identifying and quantifying the consequences to customer service, revenue, margin, and a number of other financial and operations metrics, and thereby flagging those that could do most harm to the business.
  • Arm decision-makers with scenario simulation capabilities for risk trade-off and response, to model and compare situations quickly and appropriately to ensure a profitable response is put into action. And it must facilitate and incorporate human judgment, since many of the decision requirements are extremely difficult, if not impossible, to capture in a mathematical model — the foundation of an optimization system.
  • Foster collaboration for team-based decisions that tap the collective insight of the right people in the organization — those that understand the potential impact of any event and proposed action alternatives.

 

Posted in Best practices, Demand management, Milesahead, Pharma and life sciences supply chain management, Supply chain management


5 Drivers of Supply Chain Complexity in the Life Sciences Industry

Published March 31st, 2014 by Trevor Miles @milesahead 0 Comments

I’ve attended several Life Sciences events recently (including Biomanufacturing Summit) and it’s quite clear that these supply chain teams are working in a new, complex world. Not only do they need to meet diverse customer expectations, but they need to do so while coordinating an extended supply chain, in an environment that is constantly changing. Additionally, they’re faced with a set of five industry trends that are driving complexity even further.

1.       Exceedingly Distinct Markets

Through accidents of history and industrial capabilities, the Life Sciences industry has developed to satisfy principally the diseases of the affluent West, such as cardiovascular disease, diabetes, respiratory disease, and obesity, while paying less attention to the diseases prevalent in the developing world, such as malnutrition, malaria, HIV/AIDS, and TB. This has led to a drug market segmented by geography and demographics, with companies in the emerging markets focused on satisfying the ‘local’ diseases. But in recent years, with the rapid expansion of the middle class in many emerging economies, many of the ‘Western’ diseases are increasing rapidly in the middle classes of the emerging markets – for example diabetes in India – stretching local healthcare provision while opening opportunities for expansion into these countries. While at the same time innovations by companies in emerging markets are challenging the market leadership of well-established Life Sciences companies in the West.

2.       Increased Outsourcing

With tremendous opportunities for growth in emerging markets, many manufacturers have executed aggressive globalization and outsourcing strategies, while relying increasingly on Third Party Operators (TPOs) in India and China for Active Pharmaceutical Ingredient (API) supply and subcomponents, or even the manufacturing of complete devices. Coming along with these shifts is an increase in business complexity and supply chain risks given the varying regulations across global supply chains and longer and riskier supply chains.

3.       New Regulations

With this rapid increase in the use of TPOs has come added risks to quality and of counterfeiting, leading the US Food and Drug Administration (FDA) to push for the passage of the Safety and Innovation Act (FDASIA), which focuses on the risks inherent in an increasingly global Life Sciences supply chain. Much of the public comment has been on the two user fee reauthorizations, as well as two new user fee programs, and the reauthorization for pediatric research. But buried deep in the text are provisions for supply chain validation – in both domestic and off-shore plants – and drug shortages that will have a profound impact on outsourced and global supply chains.

Stefanie Johns, Ph.D., Program Manager, Xavier Health Initiatives, commenting on conference sessions at Xavier University, states that:

“The new powers from FDASIA will level the playing field between foreign and domestic sites, enhance transparency and collaboration with foreign regulators, and shift focus “away from the border to a global safety net.” FDASIA also provides the FDA with new tools to destroy counterfeit products, misbrand products on the basis of inspection refusal, and deliver criminal penalties for intentional adulteration. In order to streamline resources, the FDA will be moving towards a risk-based inspection system and will work with foreign regulatory counterparts.”

In summary, the impact of FDASIA on the Life Sciences supply chain will come from provisions for:

  • reporting of drug shortage issues, and the penalties associated with not informing the FDA;
  • and more active inspections of production facilities, including sites in other countries, including those belonging to Third Party Operators.

 

Outsourcing in the Pharmaceutical Industry

phamacutical supply chain graph #1Source: Frost and Sullivan Global Bio-Pharma CMO Market Report,“ May 2010

 

4. Shift in Treatment Focus

One side effect of FDASIA is the fast-tracking of approval for treatments that address an ever narrower spectrum of diseases. Of particular importance to rare disease patients, and likely to help encourage further investment, is the Breakthrough Therapies Act addressing the need to provide expedited development and evaluation of potential therapies that show promise early in the research process; and the Therapeutics for Rare and Neglected Diseases which aims to encourage and speed up the development of new drugs for rare and neglected diseases.

Included in the Breakthrough Therapies Act is a voucher system that allows companies developing rare pediatric diseases to obtain a transferable voucher which they can use for the expedited approval of another treatment, whether that treatment satisfies the requirements for priority review or not.

The trend to ever more targeted products is widespread across most industries whether Life Sciences, High-Tech/Electronics, or Consumer Goods. In the past, the limited markets coupled with the fact that many of the patients were in less affluent areas of the world, were a disincentive to major Life Sciences companies that were addressing a large set of diseases with broad spectrum therapeutics. However, with many of the major disease categories covered effectively by existing treatments, combined with the fact that a) many treatments are reaching the end of their patent protection period, b) growing competition from generics, and c) increasing scrutiny from regulatory bodies have all led to a rapid shift in focus of research, as well as mergers and acquisition activity toward rare diseases. (While there isn’t a universally accepted definition of a rare disease, the US government defines a rare disease as one afflicting fewer than 200,000 Americans, while the European Union defines a rare disease as one afflicting fewer than 1 in 2,000 people.)

 

Innovation versus Cost

phamacutical supply chain graph #2

 

A report released by the Pharmaceutical Research and Manufacturers of America (PhRMA) in 2011 emphasized the extent of this shift away from broad spectrum drug research focused on diseases with large patient bodies to narrow spectrum drugs focused on rare diseases. According to the PhRMA report there were a record 460 medicines for rare diseases either in clinical trials or awaiting FDA review at the time the report was published.

To overcome the economic barriers associated with the discovery and development of diagnostic equipment, drugs and devices to treat rare disease, big Life Sciences companies have been pursuing collaborations, acquisitions, and joint ventures, often with companies in India and China.

This search for ‘long tail’ drugs will mean that Life Sciences must also deal with increasingly complex demand patterns. They have to simultaneously deal with predictable patterns for mid-life cycle products and highly unpredictable patterns for new introductions. They typically have to manage both low volume, high mix products that require quick response for clinical trials and high volume products that require ramped production and global delivery capabilities. phamacutical supply chain graph #3

5.       Shorter Patent Protection

An aging product portfolio, along with a future of shorter patent periods in general, with limited opportunities for patent extensions (as demonstrated by the recent challenge by the Indian government of patent extensions based upon reformulation), only serves to reinforce the critical requirement for supply chain efficiency and effectiveness, in order to capitalize fully on the opportunities while they exist.

These industry trends are having a significant impact on the way supply chains must operate. And unfortunately, there is growing evidence that existing technology architectures are not satisfying the capability needs for this new, complex world. In an upcoming blog post, I’ll be looking at seven supply chain processes (including jurisdictional control, expiry management, supply and capacity planning) that require an integrated approach to overcome these complexity drivers.

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Posted in Inventory management, Milesahead, Pharma and life sciences supply chain management, Sales and operations planning (S&OP), Supply chain management


On the road again! LogiPharma Europe – April 8-9, 2014

Published March 25th, 2014 by Alissa Hurley 0 Comments
_Trevor Miles

Trevor Miles, vice president of thought leadership and industry principle, life sciences

We’re excited to be participating in LogiPharma Europe 2014 in Basel, Switzerland!

This year’s conference is focused on Supply Chain as a Customer Centric Function.

Join us for a roundtable discussion on April 8th on how to leverage the cloud to achieve true innovation in supply chain management. And, on April 9th, Trevor Miles is leading a session entitled Continuous S&OP – Breaking the Mold. In this session, he will discuss how business and technology has changed tremendously in the thirty years since S&OP was first defined, enabling much more proficient and integrated S&OP processes. Trevor will describe how companies are breaking the traditional S&OP mold from both a process and technology perspective.

During the conference follow hashtag #LogiPharma  and stop by the Kinaxis booth #21 to meet with the team and learn more about how Kinaxis has helped life science companies adopt process improvements and technology targeted at removing business “silos,” improving collaboration, and achieving significant operations performance breakthroughs. Find out more about RapidResponse for life sciences at: http://kinax.is/pharm.

More about the conference:
LogiPharma is the ONLY VP-level, end-to-end supply chain event for life science professionals, focusing on strategic and tactical improvements for Europe & the rest of the world. It caters to professionals from across the spectrum of innovative pharma, generics, animal health as well as bio tech companies, tackling the most relevant, pressing challenges and opportunities present in the industry

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Posted in General News, Milesahead, Pharma and life sciences supply chain management, Sales and operations planning (S&OP), Supply chain collaboration, Supply chain management