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Indication Sequencing for a New Molecular Entity with Multiple Potential Oncology Indications

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Abstract

In this chapter, we address portfolio optimization at a sub-portfolio level. Even a “mini” portfolio—such as a single molecule with numerous indication opportunities—can pose a significant challenge to an organization; there are many interdependencies, correlations, and synergies to consider, weigh, and trade off. Here we present a case study that considers the challenge of optimizing this sub-portfolio by determining the best sequence of three potential indications. The same methods can be applied to a molecule with even more indication opportunities, a group of related molecules, or an entire portfolio.

An erratum to this chapter can be found at http://dx.doi.org/10.1007/978-3-319-09075-7_12

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Abbreviations

BC:

Metastatic breast cancer

DPL:

Decision programming language by syncopation

eNPV:

Expected NPV, a probability weighted average of all possible NPV outcomes, including technical risk

G-BA:

Gemeinsamer Bundesausschuss (Federal Joint Committee, the supreme decision-making body of the healthcare system in Germany)

IP:

Intellectual property

IQWiG:

Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (scientific unit that assess effectiveness, quality, and efficiency of diagnostic and therapeutic methods and pharmaceuticals in Germany)

MM:

Multiple myeloma

MODA:

Multiple objective decision analysis

NPV:

Net present value, a sum of discounted cash flows over a defined time horizon using an agreed upon discount rate

NSCLC:

Non-small-cell lung cancer

PC:

Prostate cancer

PD:

Pharmacodynamics

PK:

Pharmacokinetics

POS:

Probability of success (technical success for a phase)

PTD:

Patient treatment day

PTRS:

Probability of technical and regulatory success (combined POS for all phases)

PV:

Present value

RA:

Rheumatoid arthritis

R & D:

Research and development

References

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Correspondence to Jack Kloeber Jr. Ph.D. .

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About KROMITE

KROMITE is a leading strategic advisory firm that specializes in the application of decision science to help clients make strategic decisions, manage risk, and create value. KROMITE was founded in 2003 to provide independent and unbiased support for tough decisions in the life science industry.

Our team, headquartered in New Jersey and located throughout North America and Europe, possesses unparalleled expertise in decision analysis and decision making. From years of working for pharmaceutical, biotech, medical device, and agricultural companies, our team commands intimate knowledge of tools, terminologies, organizational roles and responsibilities, R & D processes, common deal term structures, and organizational decision making processes, which allows our clients to rely on us as a partner and external expert.

For more information about KROMITE, please call us at +1 (267) 983 6305, email us at info@KROMITE.com, or visit our Web site at www.KROMITE.com.

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Kloeber, J., Stojanovic, A., Kim, C.K. (2015). Indication Sequencing for a New Molecular Entity with Multiple Potential Oncology Indications. In: Antonijevic, Z. (eds) Optimization of Pharmaceutical R&D Programs and Portfolios. Springer, Cham. https://doi.org/10.1007/978-3-319-09075-7_8

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