Pharmtech
FDASmart

Upcoming Pharmaceutical Technology /
FDASmart Webinar  - Miller/Rees – March 24th , 2010, 2-3 PM EST

Transforming Today’s Pharma Supply Chain to a  More Collaborative & R&D  Friendly Model

How to Transform today’s disjointed Pharma supply chain to Achieve the ultimate goals for  Patient Value & Investment Return

Speakers:

Jennifer Miller-Executive Director,Global R & D, Pfizer Inc

Hedley Rees—Managing Director, Biotech PharmaFlow Ltd, UK

Webinar Highlights Description:
In this webinar, Miller and Rees will dissect the typical drug industry’s accepted working model and point out flaws and weaknesses it generates as the various sectors work in silos and isolation.  The webinar will highlight how R&D and other early stages of the  pharma business operations can independently impact  the entire supply chain without realization of delays or damage they are bound to cause.

The speakers will trace how today’s pharma R&D has evolved, its driving missions and constraints plus biases which left isolated to continue  with their “walls” can negatively  affect  pharma supply chain efficiency &  operations  thus ultimately diminishing patient value and  even pharmaceutical investment returns.

Several real-world case studies will be presented tracing what was done wrong to crystallize root cause and then present possible alternative best practices  and solutions that can be applied to eliminate these breakdowns.  Outdated science/technology practices and mis-steps during the early R&D, clinical trial design stages will be discussed highlighting how they led to the delays and  failures and in the marketing and manufacturing aspects of the supply chain.

Background:
Given the tectonic changes in today’s pharmaceutical industry including the impending patent cliff, reduced revenues from the threat of generic drugs, the transformation from a monolithic giant to operating leaner with  more nimble and collaborative partnerships, thrust  for growth not in the West but at emerging regions- the  drug companies have awakened and are eager to change.

The pharma supply chain is under siege from external factors that include the threat of sub-standard drugs, adulterated APIs or downright counterfeits. With other matters however, the pharnaceutcial industry itself is to blame. The industry has been slow to adopt  new manufacturing technologies and best practices, continue to operate  R&D in disjointed fashion or silos with no clear & cohesive  move-forward strategy leading up to later stages of the drug supply chain. Outsourcing and global clinical trials add to the complexity.

Clearly, a new drug development paradigm and business model  is needed. It’s not how fast one runs but who gets to the finish FIRST that marks the winner in a race. Great discovery science or potential blockbuster  in-licensed drugs will  FAIL in the end if  later stages of the supply chain are not “embedded” into the early stages and framework of  the pharmaceutical R&D. To achieve ultimate patient value and investment returns, the pharma industry needs to transform its entire supply chain.

What you will learn:

-- Why R&D in the pharma industry operates as it does and has been doing for decades

--Flaws and weak links in R&D  plus the rest of the early pharma supply chain and how they    negatively impact patient value and investment returns when left disjointed and operating    within their own silos

--Why the Clinical Trial Supply Chain is stuck in the 60’s – has not transformed like other    industries.

-- New ways of thinking and new skill sets required for the transformation from  today’s R&D    silo to a more  manufacturing-friendly  and end-to-end supply chain

--How the drug development process is constrained by regulators – why that could be the    root cause, & how it can be overcome to achieve a more cohesive pharma supply chain

--Why there is little transparency into financial and customer (patient) needs and how they    can be changed

-- How can other flexible options can be built into drug development plan.

Speakers:

Jennifer Miller, B.S., MBA, CPA
Executive Director, Global R&D, Pfizer Inc.

Jennifer Miller
Jennifer Miller leads the business operations group within Pharmaceutical Sciences for Pfizer’s Global Research & Development Division.  In this position she has been responsible for improving the performance of the organization which includes its clinical trial supply chain.  Several new business models have been introduced along with improved processes, Lean Six Sigma and more innovative approaches which have led to significant year over year efficiencies.
Prior to her role in operations, Jennifer held roles within the Finance and Controllers organizations at Pfizer Inc.  Before joining Pfizer in 1996, Jennifer spent five years with KPMG Peat Marwick in the healthcare assurance practice in New York and prior to that served as an officer in the US Military in South Korea and the US.
 

Mr.  Hedley Rees, B. Eng (Hons), MBA, MCIPS
Managing Director, Biotech PharmaFlow

Hedley Rees
Hedley Rees is the Managing Director for Biotech PharmaFlow, a UK based consulting & training company that helps emerging and established companies build, manage and continuously improve their clinical trial and commercial supply chains
Biotech PharmaFlow specializes in  virtual supply chain networks for companies with aspirations to develop and commercialize new drugs. He has carried out assignments for many companies including Sandoz, Novartis, Kowa Pharmaceuticals Europe, Otsuka Pharmaceuticals Europe, Apex Heathcare Consulting, Neuropharm, Chroma Therapeutics and CSS Informatics (Division of PPD).

His specific interest is in driving industry improvements through the regulatory modernization frameworks of FDAs 21st Century Modernisation and ICH Q8 – Q10.
Prior to this, Hedley held senior supply chain positions at Bayer, British Biotech, Vernalis, Johnson & Johnson and OSI Pharmaceuticals.
Hedley also speaks at International conferences and has articles published in both US and EU journals. He has signed with J. Wiley & Sons, New Jersey to write a book for publication later this year entitled “Supply Chain Management in Pharmaceuticals: Delivering Patient Value”

 
Who Should Attend:
    • Pharmaceutical R&D staff and managers
    • Pre-Clinical Development
    • Clinical Development
    • Regulatory Affairs
    • Quality Assurance
    • Chemistry, Manufacturing and Controls (CMC)
    • Finance
    • Marketing
    • Informatics and Information Systems
    • Business Development
    • Licensing,
    • General Management
    • Procurement
    • Supply Management
    • Operations
    • Production Management
    • Inventory Management & Control
    • Production & Material Planning
    • Demand Planning
    • Logistics

     

Click here to Register