5th BSCA Conference – Foster City, 2012

“Advance Biopharma Industy for Strategic Sourcing, Operational Efficiency,

Global Supply Chain Integrity & Federal Compliance “

 
 

Business and academic leaders will address the strategic and tactical management of global sourcing, entry into the emerging markets, information transfer from R&D to clinical trials to commercialization, manufacturing excellence, environmentally controlled distribution, risk mitigation, sustainability and SCM talent and career development, while ensuring compliance with expanding government regulations.

BSMA 5th ANNUAL CONFERENCE PROGRAM

PRELIMINARY – Please note this program is likely to change

 

Monday, October 8, 2012

9:00am

REGISTRATION OPEN

11:00am – 12:00pm

“STUMP THE CHUMP”: OPEN FORUM FOR FREE CONSULTING & EXCHANGE OF SOLUTIONS.  Get answers to your questions regarding Supply Chain Regulations:

 
 
  • ePedigree
  • Serialization
  • Track and Trace
  • Strategic Sourcing
  • Clinical Operations
  • Cold Chain
  • Emerging Markets
  • Information Technology
  • Other subjects

Moderators: 

  • Mark Ginestro, Clarkston Consulting
  • Bill Coakley, BSMA
  • Shankar Suryanarayanan, BSMA
  • Ron Bone, McKesson
  • Others – TBA

12:00pm-6:00pm

PLENARY SESSIONS 

12:00PM-12:30PM

LUNCHEON NETWORK

12:30pm-12:40pm

WELCOME ADDRESS

 
  • Devendra Mishra, Executive Director, BSMA

12:40pm-1:15pm

 Biotech Building the Biotech Supply Chain:  Adolescence to Maturity:  What Does it Take?” 

The Biotech industry has grown up in the last 30 years from wild ideas to business success.  Many best practices have been established in the development of molecules from research to commercialization – but the desire to retain creativity and innovation has often stifled the shift to full industrial maturity.  Pressure continues in the healthcare sector to drive efficiency – how can we deliver this while retaining innovation?  This presentation will cover case studies of successful implementation of efficiency improvements while enhancing creativity and innovation, and offer some provocative ideas of where supply chain in our industry could go in the future.  

  • Susanne Somerville, Vice President, Supply Chain North America, Genentech-Roche

1:15pm-1:45pm

 Biotech Supply Chain Vision: Meeting the Global Transformational Challenge” 

Business is entering a new economic era where volatility will be the new normal. Unanticipated events can be expected to occur at ever-accelerating rates of speed, leaving scant margin for errors in judgment or preparation. This global transformation is prompting executives to re-think supply chain operations to better align with corporate strategies for growth and profitability.  End-to-end supply chain integration, with an understanding of where value can be unleashed, will no longer be a “nice-to-have” but a fundamental requirement of supply chain strategy.  There is a huge opportunity for today’s life sciences supply chain executives to quantify how net profitability – or “costs-to-serve” – can be maximized to achieve corporate goals.  

  • Wayne McDonnell, Director of Advisory, PwC
1:45pm-2:30pm

PANEL:  “Industry 360° – Advancing the Efficacy and Integrity of the Global Supply Chain

The subjects of supplier relations development, contract manufacturing and clinical trials management, governmental compliance, collaboration for efficiency, cold chain technology challenges, IT deployment, Big Data and analytics, social media and . integrity in the global supply chain, emerging markets and best practices from other industries will be discussed to generate solutions for the young biotech industry.

Panelists:

 
  • Chris Horan, Vice President, Supply Chain, Region North America, Genentech
  • Kevin Pegels, Vice President – Global supply Chain, BayerHealthcare – Biotech
  • Mark Buck, Global Supply Chain and Procurement Leader, Bio-Rad
  • Rayne Waller, Vice President, Corporate Manufacturing, Amgen
  • Rob Tenerowicz, Vice President, Supply Chain Management, Bio-Marin
Moderator:
  • Wayne McDonnell, Director of Advisory, PwC

2:30pm-3:00pm 

 “Sourcing Suppliers from Emerging Market: Leveraging for Competitive Edge

The case study of a global manufacturing company will address the total cost of acquisition, supplier qualification, metrics for success and strategic sourcing’s role in life cycle management.

  • Paul Anderson, Vice President, Life Technologies
3:00pm-3:30pm

 ““Sustainability: The Profitable & Responsible Business Imperative for Biopharma!”

Presentation will cover the success achieved in the area of corporate social responsibility, reduction of carbon footprint, recycling, packaging reduction, cold chain enhancements, renewable energy proposals, and recycling to safeguard the sustainability of the environment. Life Technologies, recognized by the Dow Jones Sustainability and Bloomberg-Maplecroft Climate Innovation indexes, has achieved a 20 percent drop in the company’s energy use and a 41 percent cut in its hazardous wastes from 2008 to 2011 through their four-phase Evolution Model. Technologies’ initiatives have included fostering new partnerships in the value chain; transitioning the company from a linear (take-make-waste) to a closed-loop business model; and introducing innovative concepts such as low-carbon delivery, reverse logistics, and product take-back for reuse, recycling, and refurbishment.

 
  • Cristina Amorim, Chief Sustainability Officer, Life Technologies
  • Shelley Murasko, Director, Environmental Sustainability, Life Technologies

3:30pm-4:00pm

NETWORK BREAK

4:00pm-4:30pm

 ““Clinical Supply Chain Landscape” – Results & Reactions

Tufts Center for the Study of Drug Development has just completed a first-ever of its type survey and review of the biggest challenges faced by senior-level supply chain leaders from major pharmaceutical companies. This study examines several critical areas, including clinical supply chain infrastructure, capacity, forecasting, use of technology, outsourcing and strategic partnerships, and management practices. Learn about the results of this study as well as the key strategies survey responders identified to address these issues.

 
  • Mary Jo Lamberti, PhD, Senior Project Manager, Tufts Center for the Study of Drug Development

4:30pm-5:00pm 

“Discovery to Commercialization of a Drug: The IT Holy Grail and Enabler of the Supply Chain”

 

Demonstrated solutions in the areas of R&D, Laboratory Management, Clinical Operations, Sourcing, Planning, Manufacturing, Distribution, Cold Chain, B2B Connectivity, Patient Healthcare Management and Governmental Regulations compliance.

  • David Wiggin, Program Director, Healthcare and Life Sciences, Teradata

5:00pm-5:30pm 

“Logistics for Life-Saving Drugs Globally without Borders: Ensuring Quality, Reliability, Safety and Govt. Compliance”

The presentation uncovers the critical transportation network, information and knowledge systems, track and trace capability, distributed facilities, cold chain technologies and customer service deployed to deliver life-saving drugs to the major as well as emerging markets of the world with focus on lead time optimization and sustainability while meeting individual governmental regulations.

 
  • Speaker to be annouced

5:30pm-6:00pm 

Good Distribution Practices Regulation – USP Chapter 1083

Understand the new standards proposed in USP Chapter 1083 Good Distribution Practices and how they offer best practices to help ensure supply chain integrity, and reduce risks of counterfeit or mishandled medicines.  Supply chain integrity involves minimizing risks from the sourcing of the biopharma raw materials to the manufacture of the medicinal ingredients, and also to the finished dosage form (medicine) itself in its packaging and its distribution to a patient or consumer. The goal of good distribution practices is to encourage sound business practices that help deter interference and manipulation by bad actors and also to provide effective means to detect adulterated drug components and drug products to prevent them from entering the supply chain.

 
  • Speaker to be announced

6:00pm- 7:00pm

COCKTAIL RECEPTION 

 

 

Tuesday, October 9, 2012

 

Plenary Session

8:30am-8:45am 

WELCOME ADDRESS
 
  • Bill Coakley, Vice President, Strategic Alliances, BSMA

8:45am-9:15am

Supply Chain Management Talent & Career Development: A Road Map

  • Speaker to be announced

9:15am-9:45am

Planning for Supply Chain Efficiency and Patient Care: Meeting the Crying Need S&OP in the biotech industry, unlike mature industries, has yet to become the engine that drives and aligns the functional segments of an enterprise for overall cost-effectiveness, responsiveness and capacity optimization. Taken for granted, it has not attained top management support and become a discipline within organizations. A blueprint will be presented to align clinical and commercial planning, use ERP for CMO Planning and Forecasting; establish MDM best practices; and, achieve management support for S&OP.

  • Kevin Pegels, Vice President – Global Supply Chain Management, BayerHealthcare – Biotech

9:45am-10:15am

NETWORK BREAK

 

TRACK 1

10:15am-11:00am

PANEL: Strategic Management of Suppliers:  Maintaining Efficient Manufacturing Operations In the emerging global market place of the biotech industry, focus on suppliers and their suppliers has become a formidable challenge as their impact on manufacturing and delivery to patients can sometimes be onerous. The capabilities and actual performance of suppliers as well as the characteristics of the supplied ingredients not only impacts manufacturing operations, but also determine the quality of the final finished product to be consumed by a patient. As a result, identifying, monitoring and controlling the suppliers’ process variables and the raw material specifications are essential to ensure excellence in manufacturing operations. In this context, limited resources in an enterprise make the task of managing suppliers in a proactive and value-adding manner very difficult.

  • Ken Duval, Associate Director, Supply Chain, Shire Pharmaceuticals

  • Mary Kachinsky, Sr. Director, Strategic Sourcing, Cubist Pharmaceuticals

  • Mike Mayo, Director, Materials & Procurement, Olympus Biotech

11:00am-11:30am

Life Cycle of a Supplier

  • Jim Latimer, Sr. Director, Purchasing and Supply Management, Elan Pharmaceuticals

  • Isaac Young, Sr. Director Supply Chain Operations, BioMarin Pharmaceuticals

  • Mark Buck, Global Supply Chain Leader, Bio-Rad Laboratories

11:30am-12:00pm

“Contract Manufacturing Outsourcing: Ensuring A Successful Partnership! “

  • Mark Buck, Global Supply Chain Leader, Bio-Rad Laboratories

12:30pm-1:30pm

LUNCH NETWORK

1:30pm-2:00pm

“Implementing Sustainability Programs: Case Studies from the Field” To operate sustainably, more businesses are beginning to look beyond their walls and engage their suppliers and customers in sustainable business practices. This discussion will provide examples of collaborative initiatives and the successes, failures, and practical realities to implementing sustainability along your supply chain.  Examples will include perceived product trade-offs between cost and sustainability, the challenges of alternative delivery methods (carts/ totes), and facilitating packaging reductions with suppliers to help customers reduce waste.

  • Megan Maltenfort, Sustainability Manager, VWR International

2:00pm-2:30pm

“Opportunities & Challenges for Sourcing from China & India” A comparative evaluation of the realities of the market opportunities, mode of navigation and measures for overcoming impediments will be made based on personal experience, information and knowledge of the two major emerging nations in biotech.

  • Shankar Suryanarayanan, Vice President – International, BSMA

  • Yingming Yue, Associate Director, Supply Management, Nektar Therapeutics

2:30pm-3:00pm

“Singapore Economic Development Showcase: Outsourcing Resources for Biotech”   Singapore is a leading international biomedical sciences cluster to impact global health by achieving excellence and synergies across R&D, manufacturing and headquarter activities. More than 50 companies are carrying out biomedical sciences R&D that includes drug discovery, translational and clinical research in order to improve R&D productivity and address unmet healthcare needs in fast-growing regions. Learn how to tap into these resources as well as explore the market opportunities for your products.

  • Neeraj Kumar, Center Director-Americas, Singapore Economic Development Board

3:00pm-3:45pm

“Best Practices in Master Supply Agreements with CMO’s”

Supply Agreements with Contract Manufacturers have unique challenges. Hear industry experts explain how they deal with performance provisions, licensing rights, IP, price increases, sole sources and other situations commonly encountered when dealing with CMO’s. 

 

  • Jake Handy, Attorney, Fenwick & West

  • Vincent Garnier, Head of Contract Manufacturing Operations, Genentech

  • Tim Jordan, Associate Director Supply Chain, MAP Pharmaceuticals

  • Yingming Yue, Associate Director, Supply Management, Nektar Therapeutics

Moderator:

 
  • Bill Coakley, Vice President, Strategic Alliances, BSMA

3:45pm-4:15pm

“California Transparency in Supply Chains Act, SB 657” In 2010, several non-governmental organizations in California drew up the– the first act of its kind in the U.S. to link business to the issue of human trafficking.  According to the act, retail sellers and manufacturers with annual worldwide gross receipts over $100 Million doing business in the state of California must publicly disclose their efforts to eradicate slavery and human trafficking from their direct supply chain by the end of 2011. Learn how this bill impacts life science companies and supply chain professionals.

  • David Gonzalez, Attorney, DLA Piper  

 

TRACK 2

10:15am-11:00am

 

11:00am-11:30am

“Disaster Prevention and Business Recovery: Are You Ready?” Whether the business is small or large, an emergency response to a disaster and the subsequent impact on business continuity can be a daunting task. The extent of the impact will vary depending on the characteristics of the disaster, time of year, specific areas of the company impacted, and duration, among other things. Business continuity plans should go beyond simple evacuation plans. These plans should be specific, tailored to the operations and encompass all facets of the business. Development of these plans is also a proactive way to prevent an occurrence from becoming a catastrophe.

  • Russell Owens, Sr. Business Continuity Specialist, Chubb Insurance Company

11:30am-12:00pm

“S&OP Execution to Dynamically & Optimally Respond to Volatility in a Global Supply Network” Alignment of sales, operations and financial plans has been successfully realized with the help of systems, tools, best practices and organizational structures in major enterprises.  However the supply chain executives continue to identify S&OP execution to be a formidable challenge.  Demand volatility in the global marketplace, disruptions in the supply chain, recognition of commitments made, constraints in capacity, outsourcing, tools of optimization and lack of integrated systems make it harder for companies to effectively execute their plans undergoing continuous revision.  A proven solution will be presented with dynamic, optimal replanning in order to respond to execution changes which integrate all the necessary segments of supply, manufacturing and delivery to maximize customer service.  Synchronization of demand with supply across the global supply chain is a unique characteristic of the solution where iterations of the plan are executed with unprecedented speed.

 

  • Jan Aggerbeck, CEO, icon-sc

12:00pm-12:30pm

“Supply Chain Risk Evaluation & Management (SCREAM)” SCREAM: We all need to do it!   Implementing a supply chain risk assessment program in a small start-up pharmaceutical business can be difficult, and can be even more difficult when looking out beyond the next phase of a product lifecycle (INDA, clinical studies, NDA).  This is a “lessons learned” presentation about the Speaker’s attempt to implement SCREAM at a small pharmaceutical company, and some of the lessons learned before and after the implementation of a risk evaluation program.pan>

  • Tim Jordan, Manager of Supplier Engineering, Intuitive Surgical

12:30pm-1:30pm

LUNCH NETWORK

1:30pm-2:00pm

“Solving the Missing Link between Forecasting & ERP in Clinical Supply Optimization”  Due to tight study timelines and budgets, industry demands to minimize waste and risk in the supply chain are growing every day.  This presentation will cover how to incorporate a forecast output as demand in an ERP system to provide the manufacturing plan.  We will discuss integration of IVRS data to automatically update forecasts to provide visibility for proactive supply chain management.  Attendees will discover the importance of combining technology and knowledgeable supply chain managers to bridge the gaps for a supply plan that is efficient, reliable and gives you the ability to react to unplanned events.

  • Michelle Foust, PharmD, Director of New Product Development, Almac Clinical Services

2:00pm-2:30pm

“Leveraging Technology to Transform the Clinical Supply Chain” Despite multiple success stories drawn from across various industries, the biopharmaceutical sector has been slow to adopt transformational technology to service the clinical supply chain. This session will focus on what other industries are doing; the potential available through “big data” and some suggestions on ways to think differently about how we currently operate. In addition, the facilitators will discuss how clinical supply chain professionals can improve the support and flexibility provided to clinical development and ultimately help serve as a launching point for commercial success.

  • Leon Wyszkowki, VP of North America Operations, Fisher Clinical Services

  • David Northrup, Vice President, Accenture Life Sciences

2:30pm-3:00pm

“There is More Project at the End of the Money” (Building & Managing a Clinical Supply Budget) Building and managing a clinical supply study budget is a demanding task, and with the increasing complexity of clinical trials, along with internal finance pressures, this task is more important than ever before.  This presentation will outline strategies for working with your vendors, managing internal expectations, dealing with sponsor / CRO / CMO relationships, and will give real-life examples of studies running over an estimated budget and outline strategies to identify and mitigate this situation early in the trial.

  • Matt Blume, General Manager, Catalent Pharma Solutions

  • Brian Keesee, Head of Project Management, Catalent Pharma Solutions

3:00pm-3:45pm

“Clinical Suuply Chain Best Practices” – A Town Hall Meeting Learn and share with your peers solutions and best practices to common challenges encountered in clinical supply chain.  Hear how the experts perform forecasting, determine safety stock levels, manage inventory, reduce costs and lead times, satisfy labeling, packaging and cold chain requirements, and handle shipments to emerging markets. 

Moderator:  

  • Bill Coakley, Chairman, Strategic Sourcing and Clinical Operations Committees, and Vice President, Strategic Alliances, BSMA

   
 
 

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