Pharm Industry - Workshop Outline
February 19th 9am – 2pm
TOPIC / PRESENTER / COMMENTS/OUTCOME / Duration(minutes) / Time
Introductions / Vince Quiquero
Shawn Wettig
Owen Van Cauwenberghe
Doug Durham
Kevin McNeill
Rhonda Noll
Agnes Closs / Who am I?
What I do?
How I got here? / 15 / 9:00 - 9:15 am
Introductions / Vince Quiquero / Company introduction and why we are doing this session.
Where we were and how we got here / 15 / 9:15 - 9:30 am
Pharma Industry / Vince Quiquero / Industry perspective, evolution, state of current and future – “one man’s opinion”
History of pharma industry
How it’s changing, start global and then focus on Canadian industry
Contract manufacturing, Big pharma etc.
Intro to Opportunities
Include references / 30
(includes 5 minutes for questions) / 9:30 - 10:00 am
Drug Development / Owen Van Cauwenberghe
Doug Durham / CMC, Control Strategies, Data expectations, burden on proof, functional areas overview
Definition of development
Scientific method (documentation)
Formulation/analytical development
Include references / 30
(includes 5 minutes for questions) / 10:00 - 10:30 am
Break / 15 / 10:30 - 10:45 am
Drug Manufacturing and Validation / Kevin McNeill / Consideration for Commercialization - Validation; Process Design – Establish process parameters, Process Qualification – Confirm your process, Process Verification – Monitor your process (Plan – Execute – Analyze – Report)Understand your process; Process Flow diagram, Break out of key activities – Link to Accucaps (high level) Assess your risk; Unknowns are a risk, Understanding reduces risk – Historical data, study data, procedures Walk through the process; Materials – excipients, APIs, intermediates, Machine – equipment, Method – analytical, procedures, Manpower – knowledge, coordination, training, Measurement – process, parameters, trending, capture, Mother Nature (Environment) – facilities, utilities (Provide examples of each and the link to validation stages is how we can reduce the risk.)
Include references / 30
(includes 5 minutes for questions) / 10:45 - 11:15 pm
Quality and Regulatory / Rhonda Noll / GMPs, GLP, Regulatory Agencies, Risks and Challenges, Governing tools, “Road Map”
Importance of, from development to launch
Importance of documentation
Include references / 30
(includes 5 minutes for questions) / 11:15 - 11:45 pm
Lunch Break / 30 / 11:45 - 12:15 pm
Project Management / Agnes Closs / What is project managements, Duties of a Project Manager, Why is project management important
How are projects managed at Accucaps (Risk Management)
Importance of communication
Voice of the customer vs voice of Accucaps / 30
(includes 5 minutes for questions) / 12:15 - 12:45 pm
Science and Collaboration – Discovery versus Development / Shawn Wettig
Vince Quiquero
Owen Van Cauwenberghe / What each side (academic vs industry) can offer
Discovery is a part of development
IP process
Funding Opportunities
Our “success” story / 15
(includes 5 minutes for questions) / 12:45 - 1:00 pm
Opportunities / Vince Quiquero / Opportunities in industry and at Accucaps / Coop and Internships / 15
(includes 5 minutes for questions) / 1:00 - 1:15 pm
The Future – Round Table discussion – Q/A / Entire Panel / 60 / 1:15 - 2:15 pm