Events and Presentations
Events Archives
Life Sciences Supply Chain Working Group
International Attitudes about Risk Management: MIT Survey Results
Bruce Arntzen, Director, MIT Global SCALE Risk Initiative
Wednesday, July 28, 2010
Life Science companies are often leaders in risk prevention and mitigation. But those programs often need active participation by diverse trading partners to really be successful. Trading partners from different regions, cultures, and industries may not share their beliefs, priorities, and enthusiasm for risk prevention programs. Forewarned is forearmed.
Bruce presented the results of a recent global survey about risk attitudes and management practices in which 1500 people responded from over 70 countries. In this meeting attendees had the chance to take the brief survey themselves and find out how they compared to each other and the world. Following was a discussion about how supply chain and risk managers here in New England could take advantage of these findings in their own companies.
In this Working Group, supply chain and related professionals from area pharmaceutical, biotech, and medical device companies come together to discuss important current topics and network with their peers.
Life Science Financial Executives Working Group
Enterprise Risk Management: A Systematic Approach to Identifying, Assessing and Mitigating Risks in Life Science Operations
Scott Chizzo, President & CEO, Maxiom Group
Thursday, July 22, 2010
Risk is a given in Life Science organizations, however, many companies do not address this topic head-on. Boards, investors and regulators are all increasing their scrutiny and expecting key executives, especially financial executives, to identify and take steps to mitigate business and operational risks in a more comprehensive way. Recent, high profile failures associated with patient outcomes, product integrity and quality and operations processes are exacerbating these pressures.
The following topics were discussed in Scott's presentation:
- Definition and perspective on Enterprise Risk Management
- Why an Enterprise Risk Management Program is necessary and brings business value
- The Enterprise Risk Management Life Cycle
- Examples/Application of Enterprise Risk Management in Life Science operations
Following the presentation, the breakout groups explored:
- Current risk management approaches and results in participants' organizations
- Applicability of the Enterprise Risk Management Life Cycle
- Role of the Financial Executive in introducing and sustaining Enterprise Risk Management
- Lessons Learned/Best Practices for Risk Management
- Call to Action: What can participants do immediately to implement new ideas
This Working Group is an ongoing series of meetings that provide a forum for senior finance executives to explore and discuss the operating issues and challenges facing Life Science companies, the financial impacts of those challenges, and the new ideas, best practices and specific techniques that they can utilize to address them.
A Life Sciences Webinar
What Early Stage Companies Need to Know About Quality Management:
Lessons Learned from Industry Leaders
Wednesday, June 23, 2010
Life sciences companies are trying to cope with the mounting challenges of managing and maintaining quality systems while facing increased compliance risks. Clinical trials are becoming more complex and the FDA is scrutinizing data to a higher degree. This is leading to increased demands on quality organizations, and many are drowning in paper-based systems while struggling to maintain compliance.
As a result, life sciences organizations are looking to invest in quality management solutions (QMS) earlier in the company's life cycle. This webinar addressed key questions about QMS including:
- The business value of QMS for life sciences firms
- When is the right time to invest in QMS?
- What are the triggers?
- The benefits of QMS for an fast-growing firms
- How to integrate your QMS with other enterprise applications
A panel of industry professionals shared, through a facilitated discussion, their experiences with deploying and realizing the benefits of QMS. They discussed best practices they have implemented and lessons they have learned.
A Life Sciences Seminar
Pharmaceutical Risk Management
Featuring Genzyme and Genentech
Thursday, May 27, 2010
Maxiom Group participated in a panel seminar and workshop with speakers from Genzyme and Genentech – A Member of Roche Group for VP and Director-level professionals working in the following functions: Risk Management, Quality or Quality Systems, Operational Excellence, Operations, Manufacturing, Supply Chain.
Attendees learned how leading pharmaceutical organizations manage quality risk across their entire supply chain and how Dyadem is helping the global pharmaceutical community strengthen their Quality Risk Management initiatives. They discovered how to easily identify, measure, mitigate and communicate risk across multiple production sites, simplify regulatory compliance and gain transparency throughout the entire lifecycle of your products. This event was sponsored by Dyadem.
The presentation tracks:
- John Gallardo, Project Manager/Principal Quality Engineer, Genentech
"Risk Management Challenges and Opportunities for Pharmaceuticals"
- Lisa Robertson, Director, Global Design, Risk Management and Change Control
Genzyme Corporation
"Building the Vision for Enterprise Risk Management"
- Stewart Baillie, Director of Product Management, Dyadem
"QRM as an ICH Q10 enabler"
- Todd Applebaum, Vice President, Strategy & Operations, Maxiom Group
"Mitigating Supply Chain Risk & Addressing Business Continuity Across the Enterprise”
- Dr. Todd Davidson, Ph.D., DABT, Toxicologist, Safebridge Consultants, Inc.
"Regulatory and Operational Topics in Occupational Health and Safety"
- Jeffrey Fetterman, President & CEO, ParagonRx
"Designing Risk Management Programs Using Evidence-Based Systems"
Life Science Financial Executives Working Group
Planning and Managing the Costs of Clinical Trials:
Challenges, Issues and Best Practices for CFOs
Scott Chizzo, President & CEO, Maxiom Group
Thursday, April 8, 2010
Maxiom Group kicked-off New England's first Financial Executives Working Group focused on life science issues. At Maxiom Group, a consulting firm focused on life science companies, several of our client CFOs have asked us to facilitate the creation of this group in order to provide a forum for them to learn about and discuss operating issues and challenges with significant financial impact. As a result, Maxiom Group was pleased to sponsor this inaugural meeting with our clients Ed Fitzgerald, CFO at ARIAD Pharmaceuticals, Bill Waters, CFO at Pharmalucence and Fred Driscoll, CFO at Novavax.
Maxiom Group works with emerging and established Life Science companies to plan and execute the development and commercial launch of their products. Planning, budgeting, monitoring, and controlling clinical trials has become more complex and difficult as clinical trials become more complex, global, and regulated. The issues and questions the group explored included:
- What metrics should CFOs be using?
- What are the management techniques CFOs are using or not using?
- What part do CROs play in controlling or not controlling costs?
- What role should the CFO play?
The purpose of this working session was to discuss the issues and share lessons learned for better understanding the drivers of costs in clinical trials, setting the budget right up-front, and better monitoring and predicting the final costs.
Life Sciences Supply Chain Working Group
3PL Strategies in Life Sciences: Critical Factors in Selecting a Partner
Vin Kosewski, Vice President, Supply Chain Operations, Sepracor Inc.
Thursday, April 1, 2010
Small or medium sized pharmaceutical or biotech companies typically do not operate their own distribution centers. Most of these companies partner with third party logistics providers (3PL's) to meet their warehousing and distribution needs. Vin discussed the vital aspects of evaluating and selecting a partner including:
- Which capabilities and services to consider
- Network strategy
- The benefits of QMS for an emerging firm
- Different partnership structures
- Partner selection
- Critical success factors
A Life Sciences Workshop
Improve Quality. Reduce Risk.
Exploring QMS Earlier in the Development Lifecycle
Thursday, March 4, 2010
This workshop addressed the following key questions about QMS:
- When is the right time to invest in QMS?
- What are the "triggers" that cause the need?
- The benefits of QMS for an emerging firm
- How to integrate your QMS with other enterprise applications
- What are the business values to life sciences firms?
A panel of industry professionals including experts from Alkermes, Shire HGT and MannKind shared, through a facilitated discussion, their experiences with deploying and realizing the benefits of QMS. They discussed best practices they have implemented and lessons they have learned.
INTERPHEX 2009 Presentations
March 17-19, 2009
Go Beyond Pedigree for Maximum Brand Security
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