The application you submit to get approval for a biologic in US
What is BLA or Biologics License Application?
The three main tenets of project management
What are scope/quality, time and cost?
What is 5?
A bar chart that illustrates a project schedule
What is a Gantt chart?
How many sheepadoodles does Michael Henderson own?
What is 3?
The Apogee governing body for development decisions and milestone approvals
What is PPRC?
A series of dependent tasks where delay in any one delays the end goal day for day
What is the critical path?
The number of states that Program Management team represents
What is 3?
Stakeholder management and conflict resolution fall under this category of program management skills
What are soft skills?
Apogee went public on this date
What is July 13, 2023?
The UK drug regulatory authority
What is MHRA?
The timeline task whose completion drives the timing of another task
What is predecessor?
The combined years of PM experience in the Apogee Program Management team
What is 45 years?
The process of weighing pros and cons of various approaches in a systematic way
What is scenario planning?
The number of Apogee full time employees as of today
What is 195?
A law that allows the FDA to collect fees from pharma/biotech to help fund its drug approval process
What is PDUFA or Prescription Drug User Fee Act?
When the parameters of a project expand in an unplanned way
What is scope creep?
The fastest Apogee time from internal Development Candidate or DC selection to FPI in a HV study (in months)
What is X months?
Without this exercise, teams can be caught off guard when programs don't go according to plan
What is risk identification and mitigation planning?
The number of Apogee Board members
What is 9?
A quantifiable metric that measures an organization's progress toward its goals
What is KPI?
The system of breaking down projects into smaller, more manageable components or tasks
What is WBS or Work Breakdown Structure?
The number of lines in Apogee Smartsheet master timeline (for all programs) as of December 4th, 2024
What is 3445 (or 3500)?
A Japanese business practice that involves consulting with key stakeholders to gain support and feedback for a proposed change or project, BEFORE a formal announcement or meeting
What is "nemawashi"?
The headquarters for Apogee Therapeutics is in this city
What is Waltham, MA?