Tomorrow s Project Manager: Evolving Competencies for Biopharmaceutical Professionals

Transcription

1 Tomorrow s Project Manager: Evolving Competencies for Biopharmaceutical Professionals Pre-conference Tutorials: October 25, 2010 Conference: October 26-27, 2010 DoubleTree Hotel and Executive Meeting Center Bethesda, MD, USA Co-located with Ensuring Quality and Balancing Risks for Multiregional Clinical Trials: Statistical, Clinical, Regulatory, and Ethical Factors October 26-27, (See page 5 for details.) Address leading issues for the project management community, engage in discussions with leading project management experts, and discover competency model elements suitable for best practices. PROGRAM CHAIRPERSON ; Pete Harpum Managing Director Harpum Consulting Limited PROGRAM COMMITTEE Richard Heaslip, PhD President and Founder Programmatic Sciences Cris Howard, MBA, MEd, PMP Senior Clinical Project Manager, Product Development Emergent BioSolutions Andreas Scherer, PhD General Manager ProChain Solutions, Inc. Steve Wake Founder and Chairman Association for Project Management Earned Value SIG (EVA Specialist) Senior Consultant, Harpum Consulting Limited Where do you think pharmaceutical project management is headed? What do you think should be on the radar for pharmaceutical project management of tomorrow? Project management in the pharmaceutical industry is evolving to meet the ever-changing environment. Advances continue in project management skills and technology. This project management workshop will provide an opportunity to discuss the evolving role of the project manager and stimulate an interactive environment in a series of workshops that will focus on the key project management competencies including: Leadership, Process and Scientific/Technical skills to prepare for the changing landscape of the biopharmaceutical industry. WHO SHOULD ATTEND Discovery and development portfolio managers and planning staff Program and project managers Global product/project directors Drug development functional leaders Executives and general managers responsible for drug development TABLETOP EXHIBIT OPPORTUNITY See page 6 for contact information. Worldwide Headquarters Drug Information Association, Inc. 800 Enterprise Road, Suite 200 Horsham, PA 19044, USA Regional Offices Basel, Switzerland Tokyo, Japan Mumbai, India Beijing, China

2 2 CONTINUING EDUCATION CREDITS Drug Information Association has been approved as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 8405 Greensboro Drive, Suite 800, McLean, VA 22102; (703) Drug Information Association is authorized by IACET to offer 1.6 CEUs for this program. The Drug Information Association has been reviewed and approved as a provider of project management training by the Project Management Institute (PMI). This program offers a maximum of professional development units (PDUs). Continuing Education Credit Allocation: Conference: 12 PDUs (PMI: ); 1.2 CEUs Tutorial: Effectively Leading Virtual Drug Development Teams: 3.75 PDUs (PMI: );.4 CEUs If you would like to receive a statement of credit, you must attend the program and tutorial, if applicable, sign-in at the DIA registration desk each day of the program, and complete the on-line credit request process through My Transcript at Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on November 3, Please Note: If you do not scan your badge at each session you attend, you will not be able to request continuing education credits for that portion of the program. Disclosure Policy It is Drug Information Association policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Faculty disclosures will be included in the course materials. LEARNING OBJECTIVES At the conclusion of this meeting, participants should be able to: Explain project management competencies of today and tomorrow Describe how to use project management competencies to drive a professional development plan Discuss what project management competencies are, how they can be/should be used, why they are important, and how they factor into a project management development plan DAY 1 MONDAY, OCTOBER 25, :00-5:00 PM PRE-CONFERENCE TUTORIAL Effectively Leading Virtual Drug Development Teams: A Real Challenge for Today s Project Manager TUTORIAL INSTRUCTOR Douglas W. Call, PhD, PMP Senior Consultant, Harpum Consulting Limited and Adjunct Professor, Campbell University School of Pharmacy and Health Science Drug development teams today are becoming increasingly virtual, global, and multi-cultural. Leading these international project teams requires the project manager to employ a wider range of skills in leadership, communication, trust building, technology and time management as well as cultural intelligence than ever before. Are you up to this challenge? Are you leading your virtual team as effectively as you should? This tutorial will present proven techniques to combat the traditional enemies of virtual teams: Geography, Isolation, Trust and Cultural Differences. The session will also include ways to efficiently exploit communication and information technologies to make your global team as effective as one that works in the same team room every day. Using a combination of an interactive lecture, group discussions of case studies, directed team activities and readily available references, the instructor will guide participants towards a greater awareness of ways to increase their individual capabilities to lead virtual teams. LEARNING OBJECTIVES Recognize the traditional enemies of virtual teams and proven ways to combat them Describe leadership techniques that allow members of a virtual project team to identify strongly with the group, win and keep their trust and commitment, manage conflict, augment cooperation, improve communication and increase productivity Employ communication and information technologies to manage both the synchronous and asynchronous nature of virtual team operations

3 3 DAY 2 TUESDAY, OCTOBER 26, :30-8:30 AM CONFERENCE REGISTRATION AND CONTINENTAL BREAKFAST 8:30-9:00 AM WELCOME AND OPENING REMARKS 9:00-10:30 AM KEYNOTE PLENARY SESSION Carlos Garner, PhD Senior Director, Project Management 10:30-11:00 AM MORNING REFRESHMENT BREAK 11:00-11:45 AM SESSION 2 Comparison of the Various Project Management Competency Models Douglas W. Call, PhD, PMP Senior Consultant, Harpum Consulting, Limited and Adjunct Professor, Campbell University School of Pharmacy and Health Sciences Several international project management professional organizations have developed and published project management competence frameworks. These models are designed to outline the key dimensions of project management and to identify the competencies that can be used to predict project manager performance.this presentation will compare these varied competency models and propose ways to apply the most useful aspects of their frameworks to developing a practical competence framework for project managers in the pharmaceutical industry. 11:45-12:00 PM Framework for Interactive Sessions 12:00-1:30 PM NETWORKING LUNCHEON OPPORTUNITY 1:30-4:45 PM SESSION 3 The Relative Importance of Scientific and Technical Skills to the Biopharmaceutical Project Management Professional of the Future SESSION CHAIRPERSON Most would agree that developing drugs for the future will be more technically and scientifi cally complex than developing them in the past. However, what is not clear is whether the increased complexity will put pressure on project management professionals to seek more advanced scientifi c and technical training. In this session, the potential impact of scientifi c and technical uncertainty on the roles of project manager and project leader will be explored. 1:30-2:15 PM KEYNOTE SPEAKER Richard Heaslip, PhD Affi liated Faculty, Organizational Dynamics University of Pennsylvania President Programmatic Sciences 2:15-3:45 PM BREAKOUT GROUP DISCUSSION ON THE FOLLOWING TOPICS: Topic 1: The future of the Project Leader and the Project Manager roles: How will the evolution of these roles aff ect their need for scientifi c and technical skills? Topic 2: The impact of specialization on the role of project manager: How important will it be for project managers to develop a more advanced understanding of the therapeutic- or disease-area in which they manage? Topic 3: A look into the crystal ball: What scientifi c or technical skills will be most important to pharmaceutical project managers, and how should they acquire them? Topic 4: Understanding the scientifi c and technical side of operations: Will it be important for project managers to acquire more advanced skills in operational science, such as performance management, resource management, product valuation, and portfolio management? 2:45-3:15 PM REFRESHMENT BREAK 3:45-4:45 PM REPORT OF OUTPUTS FROM BREAKOUT GROUPS, WITH COMMENTARY, Q&A, AND FEEDBACK FROM SPEAKERS PANEL MEMBERS SPEAKERS PANEL MEMBERS Richard Heaslip, PhD Affi liated Faculty, Organizational Dynamics University of Pennsylvania President Programmatic Sciences Mark Lane, PhD Senior Director, Product Development Team Leadership MedImmune 4:45-5:45 PM NETWORKING OPPORTUNITY DAY 3 WEDNESDAY, OCTOBER 27, :30-8:30 AM CONFERENCE REGISTRATION AND CONTINENTAL BREAKFAST 8:30-9:30 AM SESSION 4 Developing the Competent Project Management Process Skills for Tomorrow s Biopharmaceutical Organizations SESSION CHAIRPERSON Cris Howard, MBA, MEd, PMP Emergent BioSolutions Senior Clinical Project Manager Product Development-Gaithersburg MD Darcy Christianson Senior Principle Training and Development Specialist Medtronic, Inc The biopharmaceutical environment is changing rapidly. Drug developers are confronted with a daunting number of changes and challenges. These include changing regulatory expectations, expediential cost increase, as well as decreasing probability of technical success. The project managers not only need to be

4 4 cognizant of these changes, but must confront these in their day-to-day leadership of drug development teams. To deal eff ectively and effi ciently with these challenges, the project manager must continue to enhance and grow their project management competency. The big question is how to do this when corporate resources are constrained, and then how to access the overall eff ectiveness of their eff orts which must be undertaken by both the project manager as well as the organization that they work in. 8:30-9:30 AM KEYNOTE SPEAKERS Rick Milter Professor, Carey Business School John s Hopkins University Ajoy Chakrabarti, PhD, MBA Senior Director/Project Manager Anthrax Immune Globulin Program Emergent BioSolutions 9:30-10:30 AM BREAKOUT GROUP DISCUSSION ON THE FOLLOWING TOPICS: Topic 1: Who s responsible for developing project management process skills: the employee or the company? What are employees in your organization doing to sharpen their own skills? What is your organization doing to sharpen your PMs skills? Topic 2: In selecting job candidates, should organizations require the PMP certifi cation as demonstration of mastery of PM Process Skills? Why or why not? If not, what alternative methods can be used to evaluate and select the best job candidates? Topic 3: How does your organization currently evaluate PM Process Skill performance? How SHOULD organizations evaluate PM Process Skill performance? 10:30-10:45 AM REFRESHMENT BREAK 10:45-11:50 AM REPORT OF OUTPUTS FROM BREAKOUT GROUPS, WITH COMMENTARY, Q&A, AND FEEDBACK FROM SPEAKERS PANEL MEMBERS 11:50 AM-12:00 PM WRAP-UP 12:00-1:00 PM NETWORKING LUNCH 1:00-4:15 PM SESSION 5 Interactive Session on Leadership and Personal Skills SESSION CHAIRPERSON Dr. Andreas Scherer General Manager ProChain Solutions, Inc. Jesse Conard Associate Director, Project Management Centocor R&D Project managers are responsible for project delivery and consequently are uniquely placed to make a positive or negative impact. Whilst understanding project management methodologies, tools and techniques is important, the critical test is being able to apply them in practice. This is where leadership skills and behaviors become critical as the project manager leads the project team to meet the objectives. In this session we discuss critically important elements of leadership in the context of leading teams in the biopharma industry. 1:10-2:00 PM KEYNOTE SPEAKER T. Andrew Finn, MA, PhD Associate Professor, Department of Communication George Mason University 2:00-3:00 PM INTERACTIVE SESSIONS Topic 1: Goal setting and planning: Reviews the processes leaders use to set goals and develop plans to achieve these goals. Topic 2: Motivating People: This module examines how to be sensitive to your team members needs and create an environment that will motivate them. Topic 3: Resolving Confl ict: This module provides concepts that will help the presenter and the participants learn confl ict resolution skills. FACILITATORS: Jesse Conard Associate Director, Project Management Centocor R&D T. Andrew Finn, MA, PhD Associate Professor, Department of Communication George Mason University 3:00-3:20 PM AFTERNOON REFRESHMENT BREAK 3:20-4:15 PM REPORT OF OUTPUTS FROM BREAKOUT GROUPS, WITH COMMENTARY, Q&A AND FEEDBACK FROM Speakers Panel Members 4:15 PM CLOSING REMARKS 4:30 PM WORKSHOP ADJOURNED Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinion and not necessarily that of the organization they represent, or that of the Drug Information Association. Speakers and agenda are subject to change without notice. Recording of any DIA tutorial/workshop information in any type of media, is prohibited without prior written consent from DIA.

5 Co-located with Tomorrow s Project Manager: Evolving Competencies for Biopharmaceutical Professionals Ensuring Quality and Balancing Risks for Multiregional Clinical Trials: April Clinical, 19-21, Regulatory, 2010 Tutorials: and Ethical April 18, Factors 2010 Marriott Bethesda North Hotel & Conference Center, Bethesda, MD, USA October 26-27, 2010 DoubleTree Hotel and Executive Meeting Center Bethesda, MD, US Join Industry and International Regulatory Leaders to Address Multi regional Clinical Trial Opportunities and Risks from a Global Perspective The identification of important challenges that drew together representatives from the pharmaceutical industry, CRO, global regulators, academia and allied working groups to collaborate in the continuum discussion FDA/PhRMA Workshop: Challenges and Opportunities of Multiregional Clinical Trials held in October 29-30, 2007, has continued to evolve to now bring forth the highly-anticipated symposium for key stakeholders and global regulators to address the progression of clinical design and study conduct for multiregional clinical trials (MRCTs). This conference will serve as a platform for the advancement of best practices and standardization of multiregional clinical trials that take place throughout the world, including trials that take place in Asia (India, China, South East Asia), South Africa and Latin America, from lessons learned through the path forward to align regionally for global harmonization. Partner with industry and regulatory leaders who are experts in successfully navigating the challenges of clinical trials across multiple regions including emerging markets and learn how to proactively plan for clinical trial success. Hear innovative case studies from industry leaders that will give you valuable tools to understand intellectual property protection, implement ethical clinical trial practices for at-risk populations, and successfully recognize and gain insights into heterogeneous regulatory environments. A pharmaceutical industry MRCT - Key Issues Team will provide updates on the current work relative to forthcoming white papers including trial quality, assessment of consistency of results across regions, points to con sider when defining a region, and exploring and addressing international regulatory obstacles when planning unified MRCTs. KEYNOTE SPEAKER Robert M. Califf, MD Vice Chancellor for Clinical Research; Director of the Duke Translational Medicine Institute (DTMI) and Professor of Medicine in the Division of Cardiology at the Duke University Medical Center in Durham, North Carolina; Co-chair person of the Clinical Trials Transformation Institute (CTTI) EVENT INFORMATION Contact Constance Burnett, Program Developer Phone Fax Constance.Burnett@diahome.org, or visit WHO SHOULD ATTEND Experienced industry clinical research professionals with drug development experience seeking current knowledge of more advanced topics involving issues with the design, implementation, maintenance, analysis, and registration of multiregional clinical trials. This includes: Statisticians Mid- senior-level project managers/decision makers Regulatory affairs professionals Medical affairs professionals Site directors Investigator site managers Research and strategic development professionals Contract research organizations Public policy and law (including intellectual property) professionals PROGRAM CHAIRPERSONS Bruce Binkowitz, PhD, MA Senior Director, Clinical Biostatistics, Merck & Co., Inc. Ekopimo Okon Ibia, MD, MPH Director and US Regulatory Policy Lead, Global Regulatory Strategy, Policy, and Safety, Merck & Co., Inc. Renée E. Moore, PhD President, Corporate and Strategic Development, Encorium PROGRAM COMMITTEE Brent Burger Director, Statistics, Cytel, Inc. Richard Kotz Team Leader, Division of Biostatistics, Office of Surveillance and Biometrics, CDRH, FDA Andy Lee Senior Vice President, Global Clinical Research Operations, Genzyme Corporation Yi Tsong, PhD Deputy Division Director, Office of Biostatistics, Division of Biometrics, CDER, FDA Sue-Jane Wang, PhD Associate Director for Adaptive Design and Pharmaco genomics, Office of Biostatistics, Office of Translational Sciences, CDER, FDA Mike Ward Manager, International Programs Division, Therapeutic Products Division, Health Canada

6 REGISTRATION FORM Register online or fax this page to Tomorrow s Project Manager: Evolving Competencies for Biopharmaceutical Professionals Event #10028 October 26-27, 2010 DoubleTree Hotel and Executive Meeting Center, Bethesda, MD, USA Registration Fees If DIA cannot verify your membership, you will be charged the nonmember fee. Registration fee includes refreshment breaks, luncheons, and reception (if applicable), and will be accepted by mail, fax, or online. Member Early-bird Opportunity On or before After Available on nondiscount member fee only OCT. 4, 2010 OCT. 4, 2010 Member Fee US $1310 US $1460 Join DIA now to qualify for the early-bird member fee! MEMBERSHIP US $140 To qualify for the early-bird discount, registration form and accompanying payment must be received by the date above. Does not apply to government/academia/nonprofit members. Nonmember Fee US $1600 A one-year membership to DIA is available to those paying a nonmember registration fee. 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