PharmaceuticalsBiopharmaceuticals Industry Examples

Pharmaceuticals/Biopharmaceuticals Industry Examples

Research and development in the pharmaceuticals and biopharmaceuticals sector plays a strong role in revolutionizing the way illnesses are prevented, diagnosed, treated, and cured. Contributors to these efforts are found throughout the sector's major segments, which include brand-name drug manufacturers, generic drug manufacturers, firms developing biopharmaceutical products, nonprescription drug manufacturers, and firms undertaking research on a contract basis. Universities, hospitals, and research centers also play a pivotal role in the research and development activities of this sector.

Most of the organizations within the industry choose to group their portfolio of projects based on the following criteria:

• Project Phase

• Project by Core Technologies

• Projects by Emerging Biopharmaceuticals

• Projects by Core Support Area

• Resource Distribution of Medical and Clinical Staff

• Resources by Skill Set

Project Phase

To ensure proper balance of the project pipeline and its synchronization with financial, material, and human resources, portfolio managers would need to see the portfolio of projects grouped by their respective phase. Due to high costs and long development cycles associated with the development of new drugs, it is imperative that portfolio managers understand exactly how many projects are in each phase at any given time. Following is a example of portfolio grouping of projects by their phase:

• Lead Identification

• Pre-Clinical

• One Trial

• Two Trial

• Final Trial

• Submission/Launch

• Commercial Program

Projects by Core Technologies

The biotechnology industry is characterized by certain core technologies around which the major projects are undertaken. Organizations may find it useful to group their portfolio of projects by their core technologies. Following is an example of portfolio grouping of projects by core technologies:

• Genomics

• Combinatorial Chemistry

• High Throughput Screening

• Bioinformatics

Projects by Emerging Biopharmaceuticals

Pharmaceutical companies usually employ leading-edge technologies in development of their products, and with that the amount of financial, material, and human resources needed for those projects is significantly high. To properly synchronize the project pipeline with resources available, portfolio managers may need to view certain projects grouped by underlying technology, as presented in the following example:

• Mimetics and peptidomimetics

• Glycotherapeutics

• Fully Human Monoclonal Antibodies

• Antigen Vaccines

• Vector Vaccines

• Gene Therapy

Projects by Core Support Area

A significant view that may be created for portfolio managers is to group projects by their core support area. It provides significant information about the number of projects active or not in various core areas and hence portfolio managers can ensure that their portfolio of projects is balanced and addresses all business needs. Following is an example of grouping projects by their core support area:

• Discovery

• TOX/ADME

• Medical

• Clinical Pharmacy

• CM & C

• Marketing & Sales

• Regulatory

• Legal

Resource Distribution of Medical and Clinical Staff

Resource managers and portfolio managers must identify the skill sets available to them for project work and the organizational distribution of those skills throughout the company. As such, most common skill sets and occupational areas are described as follows:

• Pharmacokinetic

• Pharmacodynamic

• Dose Ranging

• Dose Safety and Efficacy

• Drug Interaction

• Renal Effects

• Hepatic Effects

• Bioequivalency

Resources by Skill Set

Synchronizing the portfolio of a project with resources available in the organization is most of the time a fine act of balancing skill sets with tasks required for the projects. To assist project and resource managers in finding the appropriate resource for any given task, the organization may find it useful to identify and group available resources by skill set. It is worth mentioning here that the deploying organization must decide what skill sets are relevant to the business to ensure that the list of available skills does not grow to unmanageable proportions. The list of skills must be meaningful and relevant to the business of the organization. It must be developed as an aid in identifying the proper resources and not necessarily as a repository of all available skills in the organization. The following is an example of how resources could be grouped by their skill set:

• Scientist

• Bioinformatics

• Biostatistics/Mathematical Modeling

• Pharamacogenomics

• Immunology

• Integrative Genomics & Viral Host Cell

• Project Manager

• Chemoinformatics

• DART Neurogenomics

• Peptide Synthesis

• Product Manager

• Product Support Engineer

• Quality Systems Engineer

• Principal Pharmaceutical Scientist

• Analytical Method Development

• Research Scientist