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Course H120
From Concept to Clinic: Pre-Clinical Project Management
Early Pre-Clinical Stage Drug Development From Inception to First Regulatory Submission
This course will teach you to master:
- Pre-Clinical PM Roles
- Building Pre-Clinical Team Requirements
- Matrix and 360-Degree Management
- Change Control Process Implementation
- Comprehensive Risk Mitigation Plan
- Developing a Gap Analysis Plan
- Initial Regulatory Submission Plan
- Creating RACI Diagrams
- Product Profiles and Draft Labels
- Third Party Contractors
- Strategic Partner/SME Relationships
- Cultural and Remote Issues
- Preparing for Regulatory Filing
For the Drug Development Professional: A Two-Day Workshop To Enable More Successful Development Teams
With the inherent risks associated with early stage life-science development, organizations such as yours face a multitude of challenges. Managing product development with challenging and changing technologies can be high hurdles when trying to advance a project into clinical development.
Project success is vital to your stakeholders and the survival of your business. Good project management can provide a strategic and competitive advantage. Great project management techniques can greatly improve the odds of success amid the high stakes struggle to commercialize products.
This first ever Concept to Clinic: Pre-Clinical Project Management workshop will interactively engage you and immerse you in critical essential skills. You will learn the best practices of project management to assess, modify, deliver and review complex early stage projects, and lead your effort to the initiation of a clinical study. The workshop will focus specifically on the earliest stages of bio-product development and drill down into the nature and discipline of managing early stage projects.
Project Management Techniques That Meet the Needs and Demands of the Competitive Pre-Clinical Environment:
Step by step, you will explore the issues that affect your responsibilities and tasks in the competitive drug development field. As a manager or as a team member, with expert guidance from an industry expert, you will hone your skills and learn to...
- Better and more effectively lead the project team, including remote team members
- Develop a comprehensive project plan with preset milestones and inputs for requisite functional areas, key timeline initiatives, key milestones and deliverables
- Develop thorough documentation and planning techniques - allowing for accurate product profiles, draft labels, a comprehensive gap analysis plan and all processes through First Regulatory Submission
- Implement a communications and management plan for a diverse and remote project group or resources
- Manage relationships, conflict and management issues inherent in drug development and life sciences
- Student Needs Assessment Workshop - A customized workshop will be developed and conducted based on the specific needs and issues of the professionals attending this program
Immediate Benefits of Participating In This Workshop
- Learn to gather only the essential information to build requirements that meet the needs of the pre-clinical team
- Develop solid drug plans with the end in mind: transition to the preparation for the clinical stage of development
- Discover new techniques, tips and tricks for effectively managing cross-functional teams
- Balance the constraints of pre-clinical development including scope, schedule, budget, resources and risk by understanding and using the knowledge areas within the PMBOK©
- Know how to accurately track, report and resolve technical and team issues with confidence
- Develop a model to proactively evaluate all pre-clinical project activities
- Understand how to build contingency plans and execute corrective actions
- Institute a communication plan that provides only necessary information to all project stakeholders
- Learn effective planning techniques to develop comprehensive risk mitigation plans
- Immediately employ effective tools to maximize efficiencies, deliver on targets and milestones, while demonstrating the strategic advantage of the project management function
- Overcome common challenges that are truly germane within the Pre-Clinical Project Managers tasks
- Thoroughly prepare the entire team for the First Regulatory Submission
- Confidently lead your team in developing an initial product label and target profile document
- Gain knowledge from an expert who has been in the trenches in pre-clinical drug development and willing to share his "lessons learned"
- Understand the subtle and more obvious nuances associated with third party contractors and work with them to your advantage
- Discover communication tactics that will create cohesion and unity, preventing costly miscommunication
- Create much more accurate estimates and schedules, saving time and money
- Develop RACI diagrams for projects to track roles and responsibilities
- Effectively work with your team to develop the product profile and characteristics needed for the First Regulatory Submission
- Discover simple cost-saving and time-saving techniques that will not hinder progress or accuracy as they help you thoroughly bring your projects to completion
- Learn the tips and tricks that will better serve you in your tasks and your career
- Balance the constraints of drug development, managing team members and delivering projects to your organization
- Manage team members across the street or around the world while also understanding cultural differences
- Effectively integrate strategic partners and outside subject matter experts into your pre-clinical project
- Track large, complex development projects by better measuring key indicators
Course Outline
I. Concepts for Development: Foundations of Project Management
A. The drug development road from concept to market
B. Leading a team: from discovery to pre-clinical to the First Regulatory Submission
C. Pre-Clinical Development: Navigating the Death Zone
D. Achieving important goals: What needs to be done by when?
E. Adding value as a pre-clinical project manager
II. Defining Pre-Clinical Project Manager Roles and Responsibilities
A. The role of the project manager in pre-clinical drug development
B. Important project manager skills
C. Leading a team: the Good, the Bad, the Ugly!
D. Achieving project benchmarks, decision points, and stage gates
E. Managing subject matter experts
F. Using SWOT analysis to the team's advantage
III. Drug Development Project Roadmap
A. Candidate selection to end stage decision
B. How to transition through the various pre- clinical stages
C. Lead the team in developing the First Regulatory Submission
D. How to lead the team in developing a product profile and draft label
E. Knowledge base: How to develop a lessons learned process
F. Developing and managing the pre-clinical development timeline
G. Project Planning: Developing an effective and integrated project plan to deliver pre-clinical projects
H. Developing a clinical development plan
IV. Project Communications
A. How to develop an effective communications plan
B. Put in a process to bridge the communication gap where everyone is informed
C. Using communication techniques to your advantage
V. Project Governance
A. Implement, monitor, and control life science development projects to assure on-time delivery
B. Matrix Management: How to manage team members and influence without authority
C. Management of Internal stakeholders
D. Management of External stakeholders
E. 360-Degree Management: What can you do?
VI. Project Scope (Requirements)
A. Explore proven tactics for managing scope
B. Understanding project requirements from a business perspective
C. Manage changing requirements across the project lifecycle
D. Deviation management: Change control
1. Implementing a change control process
2. Managing change control
E. Defining measures of success
VII. Virtual Team Project Management
A. How to work with and manage virtual team members
B. How to plan and integrate distanced members into your team
C. Geographic and cultural issues
D. Establishing a working process to assure alignment or project objectives
E. Agreements with distance partners
F. Keys to effective strategic partner relationships
G. Lessons on how to manage meetings
VIII. Project Integration
A. Integrating strategic partners into your pre- clinical project
B. Working with key pre-clinical project stakeholders
1. CMC, regulatory, medical, analytical, biology, safety, and tox
2. Change team thinking: scientific project to company project
C. Developing pre-clinical project roles and responsibilities (RACI): who, what, where, how, when
D. Maintaining a goal-oriented focus
IX. The Soft Skills of Project Management
A. Addressing the drug development culture
B. How to use the communication plan to your advantage
C. What problem solving skills work best?
D. How to step out from the crowd
X. Tips, Tricks and Tools
A. Learn some tools, tips and tricks that will allow you to be one step ahead
B. Develop a set of techniques to deliver value to your organization and team
C. Learn strategies to boost competitiveness
In Class: Case Studies and Group Workshops: Effective and Real-World Experiences for the
Pre-Clinical Project Manager and Team Members!
Informative case studies presented in this program will be followed by group exercises, creating real world solutions for drug development professionals.
- Create a high-level project plan to develop a small molecule, integrating work from functional areas - leading to the Delivery of a Investigational New Drug submission to the Food and Drug Administration.
- Develop a product profile on a recently synthesized molecule.
- Create a communications plan that provides pertinent information to project stakeholders. Included are staff, analysts, managers, leaders, external partners and internal team members.
- Custom exercises will be developed in class, based on the needs of the students in the program.
Who should attend
Develop and put into practice real-world tools and applications that will improve your ability to manage pre-clinical development projects.
By attending this workshop, all professionals involved in the pre-clinical drug development environment will benefit. Those include:
- Project Managers
- Leaders
- Directors
- Program Managers
- Pre-Clinical Scientists
- Clinical Operations members
- Research Directors
- Research Scientists
- Medical Directors
- All team members and regulatory affairs personnel
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