The Rutgers Mini-MBA™: BioPharma Innovation features focused learning experiences and case studies on vital subject areas in today’s rapidly changing industry environment. Ten sessions are delivered in three-hour modules. Topics may include:
The process of developing and launching a new therapy, device or drug is complex and involves many steps. This module will explore the entire process, highlighting milestones in R&D, regulatory processes, market development, and post-marketing requirements. We will also cover establishing readiness to launch a new product in terms of salesforce, payers, and patient services.
- The life cycle of a new drug, device or therapy
- How life science companies prepare to launch a new product, drawing on resources across the organization
The FDA & the Regulatory Process
The ability to negotiate within the constraints of established FDA regulatory procedures can determine the success or failure of any drug product – and, in the case of small companies, the success or failure of the company. Chronic diseases such as Type II diabetes will serve as examples to emphasize specific points in drug development/ drug approval process.
- Distinctions between the regulatory procedures for small molecule drugs and biopharmaceuticals
- Regulations governing pharmaceutical marketing
- Steps toward marketing approval for drugs in US development
Emerging from Disruption
In order to keep up with the constant change that takes place in healthcare, leaders in the pharmaceutical industry need to develop strategies that address current market drivers and prepare for an uncertain future. Strategically addressing specific market drivers will improve biopharma innovation. The “Emerging from Disruption” presentation explores the critical aspects of the Affordable Care Act to which pharma must respond, including the impact of the legislation on the pharmaceutical industry and our payer and provider customers, including commercial managed care organizations, Medicare, Medicaid, and Accountable Care Organizations, among others.
- Update on regulatory changes
- How healthcare delivery is changing in the face of the ACA
- How these changes in the healthcare system affect drug discovery, development and distribution
Modeling the Return in Investment in Research and Development
Pharmaceutical firms make critical high-risk investment decisions on R&D in an environment where most will fail and any financial returns may be 10 to 15 years into the future. In this module, participants will learn how those decisions are made. Financial models and methods will be introduced an applied in a real-world case study. You will consider whether a firm should in-license a compound that might or might not become a marketable drug fifteen years later – after the Phase I, II, and III trials have been completed.
- Discounted cash flow models
- Net Present Value (NPV) and Internal Rate of Return (IRR)
- Decision trees
- Monte Carlo simulations
Supply Chain Development
Supply chain is a critical part of all business operations, including drug discovery, production and distribution. Participants will investigate the diverse aspects of supply chain development in this module including a drug’s suitability for manufacturing, and considerations that impact the manufacturing of pharmaceutical products.
- Evaluating a drug’s suitability for manufacturing, factoring in such as physical properties required for safe and convenient dosing of patients and manufacturing requirements for synthesis, scale- up, packaging, and shelf-life
- Considerations that impact the manufacturing of pharmaceutical products (e.g. COGS, QC, regulatory guidelines, special handling for biologics, etc.)
- Specific considerations for production and storage of biological products such as recombinant insulin
- Identifying Go/No Go decision points for supply chain
Strategic Alliances and Acquisitions
This module will analyze the role of partnering and mergers from a strategic perspective, including the financial and managerial challenges posed by the inherent technological, institutional, and market uncertainties in drug discovery and development. Participants will develop a framework for understanding partnerships as strategic options and be challenged to arrive at new and creative ways of bringing together organizations with complementary capabilities to create synergies in the drug discovery and development process.
- The industry value chain
- The role of key players in the discovery process
- How alliances and partnering help in moving ideas to the marketplace
As new drugs are developed and brought to maket, understanding intellectual property rights (both inside and outside the U.S.) is key. Scientists, business managers, and everybody in the industry is better protected and positioned when the ownership of IP is clearly understood. Participants will also discuss FTC/anti-trust laws, patent reform and challenges to exclusivity, technology licensing, and identifying critical Go/No Go decision points for IP.
- Clear definitions and understanding of patents, copyrights, and trademarks
- In– and out– licensing, materials transfers
- Cross licensing and technology management; and enforcement
Ethics and Strategy in Life Sciences
This session will use strategic frameworks (i.e., Porter’s 5 forces, value-based strategy) to understand critical issues—both from an ethical but also business perspective--for pharmaceutical firms. The strategic decisions hinge on understanding both the industry structure (i.e., barriers to entry, bargaining power of customers, etc.) and competition. The ethical considerations and dilemmas stem from pharmaceutical firms balancing shareholder pressure to maximize value-capture, while protecting the industry structure that gives them a built-in advantage relative to other industries.
- Life sciences companies face unique ethical challenges due to the nature of the products and business model
- Strategy is about making difﬁcult choices that increase the Willingness to Pay or lower costs relative to other ﬁrms.
- CSR is about doing the right thing, but also about shaping the external environment in a more favorable way
Market Access, Demonstrating Value
As payer and provider customers look to reduce costs and increase quality, demonstrating value is becoming increasingly important for pharmaceutical manufacturers to obtain favorable access for their branded drugs. This presentation explores the effectiveness of pricing strategy, prescription drug reimbursement, and contracting principles in the evolving healthcare market. Through interactive discussion and hands on workshops, participants will explore opportunities to adopt innovative approaches in response to marketplace opportunities.
- Strategic considerations necessary to position a new product to maximize access and utilization through pricing decisions
- How a new drug comes to market
- An overall understanding of the reimbursement environment
Innovation in the Pharmaceutical and Biotechnology Industries
There are many stakeholders who influence pharmaceutical decision-making. This module examines how these disparate stakeholders can positively or negatively impact pharmaceutical innovation. They will also discuss the effects of funding reductions on pharmaceutical R&D and relate all of these topics to the example of Type II diabetes.
- Psychology of decision making related to innovation
- Role of organizational culture in innovation
- Changing existing culture to effectively drive innovation and promote inclusiveness and stakeholder buy-in
Capstone Session: Business Analysis of Future Business Models: Problem Solving with Interdisciplinary Teams
This capstone module will be a dynamic, interactive workshop that ties together all of the topics covered in the course to create a comprehensive, insightful vision of the pharmaceutical industry’s future role in the management of Type II diabetes. By proposing their own innovative business models for sustainable disease management, participants will set the stage for conducting SWOT (strengths, weaknesses, opportunities, threats) analyses to assess the viability of each proposed model. This exercise will culminate in the selection of business models for managing Type II diabetes and recommendations for leveraging cross-functional teams in the assessment, introduction, and implementation of new business opportunities.
For an overview of our Mini-MBA: BioPharma Innovation program plus program benefits and outcomes, please click here.