Strategy Report- Huntington Ingalls- Newport News Shipbuilding

University of Maryland University College

MGMT 670, Section 9041

Professor Mariana Feld

February 8, 2016

Introduction

CEL-SCI Corporation (my current employer) is a small startup biotech company currently developing several biopharmaceutical products in various stages of development, from the pre-clinical stage to phase III clinical trials. However, CEL-SCI Corporation (CEL-SCI) currently has no products in the market and relies primarily on investors to fund its current operations. CEL-SCI’s a main product, Multikine®, is currently in phase III clinical trials for the treatment of head and neck cancer. CEL-SCI’s other products in development include the LEAPS platform, being developed in pre-clinical trials for rheumatoid arthritis and infectious diseases, as well as other immune tolerogenic products.

This strategic report analyzes whether CEL-SCI Corporation is guided by a strategic management process focusing on a mission based on a vision, guided by a set of core values, committed to accomplishing strategic financial objectives while actively guided by strategies to distinguish itself as an outstanding enterprise

Analysis

The strategic management process, according to Barney & Hesterly, involves a sequential series of analyses which may better position the organization to be able to choose a good strategy leading to a competitive advantage. The strategic management process consists of a mission, objectives, external and internal analyses, strategic choice(s) and strategic implementation, which in turn lead to a competitive advantage (Barney & Hesterly, 2015, p. 5).

Mission and Values

CEL-SCI’s misison, according to its website, is to improve the treatment of cancer and other diseases by empowering the body’s own immune system. CEL-SCI seeks to create value for its shareholders by developing unique immunological therapies to address unmet medical needs.

CEL-SCI’s values include being dedicated to developing creative and novel therapies based on stringent scientific approaches that are data driven. CEL-SCI also strives to be creative and maintain shareholder value while conductiong its businesses in an ethical manner that takes ‘no-shorcuts’ in the drug development process and rewards bold innovation while being economical in the running of the business (CEL-SCI Corporation, 2016a).

Objectives

CEL-SCI’s current objectives include a main current goal to gain market approval from the FDA for Multikine, for head and neck cancer treatment, which is currently being evaluated in a global multicenter phase III clinical trial (ClinicalTrials.gov, 2016). CEL-SCI is also developing the LEAPS platform, being developed in pre-clinical trials for rheumatoid arthritis and infectious diseases, as well as other immune tolerogenic products (CEL-SCI Corporation, 2016b).

External analysis

CEL-SCI is in the pharmaceutical industry which is a very crowded space characterized by intense competiontion. To compete, CEL-SCI currently has patent protection for Multikine (E. Talor, 2003) as well as an orphan status designation, (PR Newswire, 2007). Additionaly, CEL-SCI has other patents including: for rehumatoid arthritis (D. H. Zimmerman et al., 2014), infectious diseases such as influenza (D. Zimmerman, Boonnak, & Talor, 2010), and autoimmune tolerogenic interventions (E. I. Talor, 2007).

Other potential therats for CEL-SCI include the inherent risksthat the product may not be approved and that a better product may be introduced by a competitor at any time.

Internal analysis

CEL-SCI also posseses proprietary quality control testing that would make it dificult for competitor to generate generics even after patent protection, or orphan status, expires. Weakneses may involve the small size of the company and limited resources to further develop propietary testing and technologies.

Business strategy

CEL-SCI’s current main business strategy is to complete phase III clinical trials and receive marketing approval from the FDA (CEL-SCI Corporation, 2016b). A seconcary goal is to continue to develop the pre-clinical LEAPS platform primarily for rheumatoid arthrits but also for infectious diseases suchs as influenza and herpres simplex.

Corporate Strategy

CEL-SCI’s corporate strategy involves positioning itself with several international partners who have purchased local international licesnes throughtout the world that would share on revenues while also sharing on co-development costs. CEL-SCI currently maintains full marketing rights in the US, Europe and Japan, which are considered the main world markets (CEL-SCI Corporation, 2016c).

Strategic implementation

CEL-SCI current strategic implemenataion includes completing and getting approval for its current phase III clinical trial, with help of some partners, and then seeking additional partners in other markets such as the US, Europe and Japan. Marketing approval from the FDA would also lead to higher valuations.

Additonaly, the LEAPS platform, which is currently a secondary priority, could lead to additional partnerships for its currentely patented applications as well as scenarios where competing organizations, with recently developed similar technologies, may potentially infringe on CEL-SCI’s patents, and in turn may be intersted in licensing or acquiring the LEAPS platform.

Emergent strategies

CEL-SCI’s main strategy, as indicated above, is to receive marekting approval for Multikine, currently in phase III clinical trials. However, CEL-SCI is also developing multikine for extended uses in other indications such as for anal warts in HIV/HPV co-infected patients and cervical dysplasia in HIV/HPV co-infected patients (ClinicalTrials.gov, 2014), as well as the LEAPS platform, whicc could potentially lead to evolving strategies in those market segments.

Competitive advantage

CEL-SCI’s competitive advantage relates primarily to patent and orphan designation protections. Additionally, CEL-SCI is also seeking extended use for Multikine, which would involve easier approval timelines as the safety for the product has already been determined. Furthermore, CEL-SCI possess the LEAPS platform, and other immuno-tolerogenic technologies, which gives CEL-SCI additional strategic options going forward.

Conclusion

In conclusion, CEL-SCI competes in the crowded pharmaceutical industry, however CEL-SCI’s strategies of focusing on completing Multikine’s phase III clinical trial, as well as continuing development of the LEAPS platform, contribute to a competitive advantage that provides value to CEL-SCI’s investors.

References

Barney, J. B., & Hesterly, W. S. (2015). Strategic Management and Competitive Advantage: Concepts and Cases (5th ed.). New Jersey: Pearson Education Inc.