1. Pharmaceutical Drug Development & Its Use of Technology
Pharmaceutical drug development communication issues are intimately related to
our healthcare system's poor use of available technology. While working with a
CRO as a marketing associate, I was shocked by the archaic, inefficient
performance of an industry whose purpose was to manage and improve the process
of moving a drug through development. The issues I identified were: 1.
Sending reviewers on-site to obtain FDA required clinical information, when this
information should be electronically available on a secure network that
organizes, analyzes and submits information automatically from the investigative
sites to the pharmaceutical company and the FDA speeding the process of
approval, 2. capturing, screening and retention of patients for clinical
trials is sluggish without the full use of interactive computerized submission
between patient and investigative sites, 3. the lack of a system to qualify or
rate the performance of multiple investigative sites when it is the collective
quality of these site's performance that improves the time between trial and
market launch, 4. poor relationships between CRO, investigative sites and
pharmaceutical company as historically investigative sites dealt directly with
the pharm co. and view CRO's as a subjugate presence. Antagonistic relations
have a direct effect on the cooperative communications necessary for the
realization of mutually beneficial goals. Having identified these issues, I
began to develop a program that would target and resolve these concerns- an
Investigator Relations Program (IRP). 1. Computerize manual data entries
connecting CRO, investigative sites to host pharmacy and FDA, 2. Create online
communication capabilities to connect patients and their treatments/side-
effects/questions to investigative sites improving capture, screening and
retention, 3. Develop a "rating" system to qualify investigative sites and
mentor improvements, 4. Initiate conferences, on-site marketing presence to
address investigator concerns improving reciprocity and collaborative efforts.
Upon exiting the industry to found a comprehensive medical management company, I
realized that the primitive technological state of our hospitals, insurers,
discharge facilities, pharmacies, home health agencies, durable medical equip
and ambulance co were identical to the drug development industry. We are
seeking funding to complete programming and introduce a nationwide, online
network that captures clinical information and utilizes computerized algorithms
to document, organize, analyze and problem-solve. This system can be developed
to achieve the same functions in the Drug Development Industry decreasing
costly, inefficient workforce, dramatically improving the time between drug
trials and market introduction.