Lifecycle of Drugs/Devices
Name a product or drug that one of our clients has received approval for.
Dojolivi - Ultragenyx - metabolic supplement for treating fatty acid oxidization disorders in adults and children.
Guardant360 CDx - blood test for genomic testing
GentlePro Systems - Candela Medical- aesthetic lasers, skin tightning, tatoo removal, etc.
Who is Stacia's favorite child?
Macie!
The 3 verticals of Digital Prospectors are?
Engineering, IT and Life Sciences.
What does LIMS stand for?
Laboratory Information Management System
Name some of the biggest Biotech/Medical Device hubs in the Country
Boston/Cambridge MA, Bay Area California, Minneapolis Minnesota, RTP/Durham NC, Seattle Washington, etc.
How long does it typically take to get a medical device fully approved by the FDA?
3-7 years. Shorter for Class I
Which team member competed competitive Gymnastics until the age of 12?
What year was DPC founded?
1999.
Name all the main Quality functions you can that we support in our practice
Quality Assurance, Quality Control, QMS, Quality Auditing, Supplier Quality, Quality Engineering, Remediation, Risk Management, etc.
Who is the largest global CDMO in the world?
Lonza
How long does it typically take a drug to get fully approved by the FDA?
10-15 years.
What was the reason behind Carma's most infamous contractor / client experience?
A. Contractor poured themselves a beer at company bar, at beginning of interview.
B. Contractor that was acting manager passed out on lab floor from taking drugs.
C. Contractor showed up for first day in wheelchair with head bandages and cast on leg, arm.
D. All of the above.
D!
What are the two address of our offices?
100 Domain Drive, Exeter NH and 230 Congress Street 3rd Floor, Boston MA
What are the 3 main parts that make up CMC?
Formulation, Analytical Development and Drug Product Development
Name all of the industries that you can that we support under our "Life Science" Umbrella.
Pharmaceutical, Biotechnology, C>, IVD, Precision Medicine, Combo Device, SaMD, Medical Device Class I through III, Medical Equipment Manufactures, CDMO's/CMO's, CRO's.
What type of approval do you need for Medical Devices from the FDA?
PMA, 510K
PMA is only needed for Class III but 510K needed for everything.
Hillary!
Is DPC the best staffing firm to ever work and contract for?
Yes.
What cell therapy has been seeing the biggest uptick in approvals by the FDA and funding most recently?
CAR-T Cell Therapy
Name a client of ours that is in Cell and Gene Therapy.
Name a client of ours that has Class II or III medical devices
Name a client of ours that manufactures devices for government needs.
Tessera, Ultragenyx,
Candela, Abiomed, Laborie
KMC/Elbit and Veranex
How many countries and states has Christie been to?
22 countries and 39 states
According to our website, how many awards/accolades has DPC won over the years?
90
How many classes of devices are there and what are the differences?
Class I through III.
Class I is low/moderate risk, minimal harm.(stethoscope, wheelchair, bedpan, Ventilators)
Class II is moderate/high risk with special controls (CT scanners, Lasers, Catheters, hearing aids, infusion pumps)
Class III is very high risk with premarket approvals (pacemakers, brain simulators)
What has been the biggest M&A deal of 2024?
Gilead acquiring CymaBay Therapeutics for 4.43B. Liver drug.