GPRD PM Lunch & Learn Year in Review

GPT Product Transitions to GSS

100

2 of the 8 transition criteria that are evaluated to determine whether significant development support is required [i.e., whether product(s) should be transitioned to GSS]

What is ... (must name 2)? (1) No ongoing clinical trial activity (except IIS or affilite-run studies) and no new clinical indications or claims planned (2) No outstanding regulatory commitments or major submissions (3) No significant product quality issue under investigation (4) No significant safety issue (including regulatory inquiries or PV signals) (5) No unresolved material supply issues (e.g., API source, packaging components, etc.) (6) No significant legal / contractual issues (7) No significant US Medical / Regulatory activities (until GSS is prepared to support US activities) (8) No capacity constraints in GSS

200

The average number of months it takes between the time a product is approved for transition until the official product transition date

What is ... 3-4 months? Note: while GSS becomes the primary contact for the product on the official product transition date, the GPT is still involved in closing out open issues for a 3-month period post transition. After that time, GSS will contact the GPT only on an ad-hoc basis.

300

These are 2 of the 8 Major Process Steps in managing a product transition to GSS

What are ... (must name 2)? (1) Begin transition possibility discussions (2) Go / No-Go Decision (3) Overview Meeting: GPT and GSS (4) Information Evaluation (5) Decide & Communicate Project Timelines (6) Knowledge, Information, and Document Transfer (7) Finalize and Officially Transfer Responsibilities (8) Lessons Learned & Project Close-out

400

The number of products that were transitioned to GSS in 2008 & 2009

What is ... 16? In chronological order... 2008 Simdax & Calcijex Synthroid (ex-US) Cefdinir, Clarithromycin, Erythromycin 2009 Tarka, Goptin, Isoptin, Clivarine, Rythmol, Cardizem LA, Teveten, Teveten HCT, Betapace, Regulaton

500

The responsibilities of the GPT PM (DDPM) transition to either of these people in the GSS organization (only need to name 1 individual)

Who are either Ute Raschke or Jochen Drewelies? (either person is correct)?

Finance -- OR-- Development Sciences Timelines & Costs

100

This is an example of a topside adjustment.

What is ... any information / data that comes in after the typical PBR process yet is financially material enough where we want to adjust the LBE for it (ie a plane carrying $5MM of Abbott drug supply crashes, so we will not take receipt next Month)?

200

The three Development Sciences functions that make up a large portion of the critical path from before Milestone A to the First in Human dose

What are... Process R&D, Preclinical Safety, and DMPK-BA (must state all 3)?

300

This is what happens to approved money for a study when there is favorability because the study was cheaper than budgeted for or it was cancelled.

What is... it is redeployed to fund the next item on the prioritized project list per the heatmap process?

400

These are 2 examples of the primary role of the functional Operations Manager

What are... (must name 2)? (1) Communicate key information to functional estimators, department management, and senior management. (2) Assist with strategic design or establishing strategic planning for global operations activities, and tactical execution to achieve departmental strategies, goals, and objectives. (3) Accountability to ensure that the functional area operates within the current budget by tracking actuals, forecasting headcount, developing Latest Best Estimates, and explaining variance in collaboration with others (i.e. Directors, Function Heads, Department Managers, or GPRD Finance).

500

These are the three financial "target setting" opportunity types for GPRD (often referred to as "cycles"). Note - "portfolio" not included.

What are ... Plan, Update, and LBE (must state all 3)?

GPT Health Checks -- OR-- A PM's Role: Leading Through Change

100

These are two of the actions a PM can take with a GPT to help the team raise issues & conflicts within the GPT and/or subteams.

What are ... (must share 2 - not necessarily these)? (1) monitor & help ensure GPT culture environment is conducive to openness, etc. (2) run more efficient meetings by ensuring opportunities exist in meeting to raise issues/conflicts (e.g., expected outcomes)

200

These are 2 of the 7 steps of the Leading Change Model.... 7 Steps to Success

What are ... (must name 2)? (1) Define the change (2) Develop Sponsorship (3) Assess Change Readiness (4) Create Change Plan (5) Implement the Change (6) Evaluate (7) Sustain

300

What are some of the best practices / resources that can be applied by a PM to help ensure a GPT is functioning according to the GPT Model?

What are ... (must name 2 - not necessarily these)? (1) Conduct GPT Health Checks and act on findings where appropriate (2) Follow effective meeting guidelines and consider using metrics to measure baseline and progress (3) Consider / use Peer Recognition (4) Utilize GPT Master Schedule and Prioritization (5) Partner with HR Learning & Development, if appropriate

400

These are the definitions of 2 of the Leading Change Model ... 7 Steps to Success

What are (must correctly define 2)? (1) Define the change - develop the business case for change (2) Develop sponsorship - Identify those with the power to legitimize and sanction the change (3) Assess Change Readiness - Get key people on board (4) Create Change Plan - Document how to implement the change (5) Implement the Change - Introduce tangible aspects of chnage into the work environment (6) Evaluate - Determine how the change will be evaluated (7) Sustain - Achieve long term outcome of change

500

These are 2 of the actions the Synagis & Motavizumab GPT implemented to ensure meeting effectiveness was practiced.

What are ... (must name 2 - not necessarily these)? (1) draft agenda drafted w/PD and issued 2 weeks prior. Agenda has appropriate details (expected outcome, time, etc.) (2) Presentation slides in eRoom 2 days before. Team asked to review in advance of meeting. (3) Worked w/team members ahead of meeting to ensure appropriate meeting materials. (4) Good meeting management - e.g., monitored time, correct level of detail in meeting, etc. (5) Minutes published in timely manner, and action items followed up.

Partnerships -- OR-- HUMIRA Next Generation Delivery Device

100

2 examples of existing TYPES of partnerships (not partner names) in GPRD that are being supported by GPRMD Project management

What are ... (must name 2)? (1) product specific (2) program specific: - Development only - Discovery and Development - Development and Commercial (3) multi indication

200

The group whose support can be enlisted to help a team develop a Life Cycle Management (LCM) strategy (and whose was enlisted for the HUMIRA Next Generation Delivery Device project)

What is ... DSG?

300

Some of the unique considerations when working with small partnerships.

What are ...? (1) Corporate financial stability (2) Resource capacity (skill sets, total available resources) (3) Less mature processes, systems and control (4) Relative importance of partner product pipeline / Corporate value

400

An example of assessment activities that were conducted (outside the Portfolio process) on the HUMIRA Next Generation Delivery Device project to support the team's Life Cycle Management effort.

What are... activities such as ... (must name 1)? (1) identifying key drivers of value (2) capturing key parameters influencing patient preference (not proven to have direct sales impact) (3) identification and quantification of factors influencing cost, risk, timing, and value (4) determining estimate of expected value of each device category (5) Offsetting time, cost, and likelihood of launch against commercial value (6) Analysis of the sensitivity of the results to the key input variables (7) Assessment of the market impact and relative value / key uncertainties for each device type

500

Some key considerations when working with academia as a partner

What are ...? (1) Differences in processes between academia and industry (2) Bureaucracy (Contracts, IP) (3) Publications

GPT eRoom Coordinator Training

100

These are 2 individual(s) who could be contacted for support with GPT and/or GPRD PM function eRooms

Who are ... (name any 2)? (1) IT Help Desk (for IT issues such as logging on, plug in, etc.) (2) Darren Kolasinski (setting up GPT eRooms, sign up for eRoom technical training, etc.) (3) Hrishi Nayar or Paul Ramirez (taking over for Hrishi) (4) Kimberly Kotlar

200

The most important reason for using the PENCIL icon in eRoom to check out a file for editing

What is ... to "lock" or "check out" the file so only one person can edit it at a time?

300

The first thing to check if your eRoom edit capabilities are not functioning correctly

What is ... the eRoom plug in?

400

The levels at which access control can be managed in an eRoom (name at least 2)

What are ...? (1) eRoom (2) Folder (3) Document

500

The action item that was given to all DDPMs to complete with their project teams by the end of January 2010 --- AND --- the number of GPTs that remain to have this completed (according to the tracking spreadsheet in the eRoom) .... you get a 200 point bonus for the 2nd part of this question!

What is ... present eRoom training for GPT members (recommendation is to present this to the entire GPT, not just Core team) either at a quarterly communications meeting or calling a special ad hoc training meeting? As of December 14th, 22 GPTs need to either complete the training (or have it logged as "NA" in the tracking spreadsheet)