505(b) (2) - A smart pathway to differentiate from competitive, low margin environment of generics

2021 ◽  
pp. 174113432098786
Author(s):  
Pooja Rathee ◽  
Swagat Tripathy ◽  
Sahil Khatter ◽  
BP Patra ◽  
PN Murthy ◽  
...  
Keyword(s):  
Clinical Studies ◽  
Lower Cost ◽  
Development Program ◽  
New Product ◽  
Potential Productivity ◽  
Defense Strategies ◽  
Market Launch ◽  
Regulatory Strategy ◽  
Limited Change ◽  
Early Market

Purpose 505(b) (2) application is one of the advantageous ways of regulatory submission. This submission approach can lead to fast-track approval for wide-ranging products, exclusively for those that exemplify a limited change from formerly approved drug. Safety and efficacy evidence in terms of non-clinical and clinical portion of the Reference Listed Drug (RLD), are trusted upon. Additionally, supplementary data essentially required to establish comparability with the RLD, are presented in the dossier. Methods This retrospective analysis is to understand the FDA's expectations and avoid errors in terms of data support approval for a new product submitted under the 505 (b) (2) route. The current script is an analysis on how to architect 505(b) (2) regulatory strategy by developing a different set of documents/information. Results The ultimate goal of this review is to allow drug developers to easily navigate through various 505 (b) (2) submissions and defense strategies for registration processes available to the new drug manufacturers and to understand an effective, safer filing route by facilitating early market launch with a prospect of lower cost. Conclusion Before considering option 505 (b) (2), general companies should have a good understanding of product’s potential productivity, scalability, patent infringement, expensive clinical studies and/or non-clinical studies to appropriately strategize scientific and commercial opportunities. This leverage will potentially quicken the development program and will definitely lower the clinical and regulatory risk of new product entrants.

scholarly journals Metronomic Chemotherapy: A Systematic Review of the Literature and Clinical Experience

2019 ◽  
Vol 2019 ◽  
pp. 1-31 ◽  
Author(s):  
Cem Simsek ◽  
Ece Esin ◽  
Suayib Yalcin
Keyword(s):  
Clinical Studies ◽  
Lower Cost ◽  
Metronomic Chemotherapy ◽  
Maximum Tolerated Dose ◽  
Cancer Management ◽  
The Past ◽  
Promising Therapeutic Approach ◽  
Treatment Models ◽  
Dose Dense ◽  
Preclinical And Clinical Studies

Metronomic chemotherapy, continuous and dose-dense administration of chemotherapeutic drugs with lowered doses, is being evaluated for substituting, augmenting, or appending conventional maximum tolerated dose regimens, with preclinical and clinical studies for the past few decades. To date, the principle mechanisms of its action include impeding tumoral angiogenesis and modulation of hosts’ immune system, affecting directly tumor cells, their progenitors, and neighboring stromal cells. Its better toxicity profile, lower cost, and easier use are main advantages over conventional therapies. The evidence of metronomic chemotherapy for personalized medicine is growing, starting with unfit elderly patients and also for palliative treatment. The literature reviewed in this article mainly demonstrates that metronomic chemotherapy is advantageous for selected patients and for certain types of malignancies, which make it a promising therapeutic approach for filling in the gaps. More clinical studies are needed to establish a solidified role for metronomic chemotherapy with other treatment models in modern cancer management.

scholarly journals Regulatory hurdles in bringing an in vitro diagnostic device to market

1996 ◽  
Vol 42 (9) ◽  
pp. 1556-1557 ◽  
Author(s):  
K M Smith ◽  
J A Kates
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
New Products ◽  
New Product ◽  
Diagnostic Device ◽  
Regulatory Strategy ◽  
The Us ◽  
In Vitro Diagnostic ◽  
Medical Device Regulation

Abstract We discuss the hurdles that developers and manufacturers of in vitro diagnostic devices face in obtaining regulatory approval to market their products in the US. A thorough understanding of medical device regulation and the early planning of a clinical and regulatory strategy are imperative in assuring successful and timely launches of new products. Finally, it is critical for manufacturers to establish a working partnership with the Food and Drug Administration to expedite their new product applications.

THE TREND TOWARD OUTSOURCING IN NEW PRODUCT DEVELOPMENT: CASE STUDIES IN SIX FIRMS

2003 ◽  
Vol 07 (01) ◽  
pp. 51-66 ◽  
Author(s):  
YUSHAN ZHAO ◽  
ROGER J. CALANTONE
Keyword(s):  
Product Development ◽  
Case Studies ◽  
Transaction Cost ◽  
New Product Development ◽  
Lower Cost ◽  
New Product ◽  
Transaction Cost Theory ◽  
Routine Administration ◽  
Strategic Role ◽  
Resources And Capabilities

In the constant drive for higher quality, lower cost, and faster-to-market products, many firms have begun to learn "how not to make things" — how to give some tasks to other firms who could make more efficiently. Examples from industries highlight the trend. Case studies were conducted in six firms and many insightful comments from prominent managers are incorporated. The case studies reveal a trend toward outsourcing some tasks in new product development. We use the transaction cost theory and the resource-based theory to explain the trend of outsourcing. This kind of outsourcing allows the firm to focus on core tasks and access resources and capabilities not available or not easily developed internally. NPD program performance can be greatly enhanced, and the R&D department can move away from routine administration toward a more strategic role. Many implications for managers are offered, and theoretical contributions are discussed.

scholarly journals Shifting Innovation to Users via Toolkits

2002 ◽  
Vol 48 (7) ◽  
pp. 821-833 ◽  
Author(s):  
Eric von Hippel ◽  
Ralph Katz
Keyword(s):  
New Product Development ◽  
Development Process ◽  
Lower Cost ◽  
Traditional Approach ◽  
New Product ◽  
Product Development Process ◽  
Service Development ◽  
User Needs ◽  
User Innovation ◽  
Alternative Approach

In the traditional new product development process, manufacturers first explore user needs and then develop responsive products. Developing an accurate understanding of a user need is not simple or fast or cheap, however. As a result, the traditional approach is coming under increasing strain as user needs change more rapidly, and as firms increasingly seek to serve “markets of one.” Toolkits for user innovation is an emerging alternative approach in which manufacturers actually abandon the attempt to understand user needs in detail in favor of transferring need-related aspects of product and service development to users. Experience in fields where the toolkit approach has been pioneered show custom products being developed much more quickly and at a lower cost. In this paper we explore toolkits for user innovation and explain why and how they work.

scholarly journals Incumbent defense strategies against new product entry

1997 ◽  
Vol 14 (2) ◽  
pp. 163-176 ◽  
Author(s):  
Hubert Gatignon ◽  
Thomas S. Robertson ◽  
Adam J. Fein
Keyword(s):  
New Product ◽  
Defense Strategies ◽  
Product Entry

scholarly journals Defining a General Collective Intelligence Based Renewable Energy Solution Development Program

2021 ◽  
Author(s):  
Andy E Williams
Keyword(s):  
Renewable Energy ◽  
Environmental Sustainability ◽  
Lower Cost ◽  
Collective Intelligence ◽  
Development Program ◽  
Solution Space ◽  
Functional Modeling ◽  
Functional Models ◽  
Development Processes ◽  
Sustainable Renewable Energy

The choice of which problem renewable energy programs target is one that might benefit from greater General Collective Intelligence or GCI. Where a collective intelligence uses the intelligence of crowds to maximize impact on a given problem, a GCI is defined as having the capacity for general problem solving ability, and therefore the capacity to increase outcomes by choosing the optimal problem to solve. Collectively intelligent development aims to solve the problems required to create the ability for groups to reliably explore all of the currently possible solution space and to reliably converge on the best available solution in that space, so that developing solutions which facilitate a significantly improved impact on targeted outcomes as compared to other development processes is reliably achievable. Where conventional development processes have known cognitive or other biases that may prevent certain categories of solutions from being selected by groups even where optimal, collectively intelligent development aims to create the capacity to reliably converge on the optimal overall solution. A proposed Collective Intelligence Based Renewable Energy Program aims to leverage human-centric functional modeling to provide groups with a common model of the problem being solved. This proposed program then leverages a newly developed model of General Collective Intelligence to collectively reason in terms of those common functional models as required to develop a solution that optimizes impact on the targeted problem, such as the problem of achieving a significantly lower cost of access to sustainable renewable energy, or achieving a significant increase in environmental sustainability of that renewable energy, as defined by metrics that might be related to carbon emissions.

Cross-Functional Integration and New Product Success: An Empirical Investigation of the Findings

2008 ◽  
Vol 72 (6) ◽  
pp. 132-146 ◽  
Author(s):  
Lisa C. Troy ◽  
Tanawat Hirunyawipada ◽  
Audhesh K. Paswan
Keyword(s):  
New Product Development ◽  
Empirical Investigation ◽  
Meta Analysis ◽  
Functional Integration ◽  
Development Program ◽  
New Product ◽  
New Product Success ◽  
Analysis Techniques ◽  
Product Success ◽  
The Impact

Although cross-functional integration is often considered an important element in a successful new product development program, a great deal of variance exists in extant literature regarding how integration is defined and implemented and how relevant studies are conducted. The authors attempt to bring clarity to a diverse set of 25 studies that investigate cross-functional integration by empirically analyzing 146 correlations between integration and aspects of new product success. The authors examine the impact of 12 potential moderators that affect the integration–success link using meta-analysis techniques. The findings indicate that though cross-functional integration may indeed have a direct impact on success, the combination of integration with other variables may be of greater importance. Furthermore, because most of the nine variables that significantly affect the integration–success relationship are either managerially controlled or industry specific, the findings imply that firms should design cross-functional structures to maximize their effectiveness. Other variables that affect the integration–success relationship reflect researchers’ methodological decisions, suggesting that care should be taken when designing and interpreting the results of such studies. The authors discuss the implications of these findings and directions for further research.

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