FDA Expedited Programs for Cancer Drug Development: Don’t Believe the Doubters

16th August 2019
Intro:  
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Pharmaceutical Patent Term Extension: An Overview

27th March 2019
Pharmaceutical Patent Term Extension: An Overview About the authors: Scott Whittaker is an Alacrita Associate and Robert Johnson is Managing Partner of the firm’s Boston office. Anthony Walker is a...
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Pharmaceutical Probability of Success

19th October 2018
Abstract: Critical strategic decisions are made based on valuation models of pharmaceutical assets. Of the many assumptions that underpin a valuation model, probability of success is a key input, but...
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Leveraging Diagnostics to Realize the Full Potential of Precision Oncology

07th July 2017
As we approach the twentieth anniversary of the approval of Herceptin, the field of precision oncology has never been more exciting or dynamic, and utility seems to be broadly recognized. Precision...
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Commercialization of Cellular Immunotherapies

07th May 2016
Commercialization of Cellular Therapies Biochemical Society Transactions Apr 11, 2016,44(2)329-332; DOI: 10.1042/BST20150240 Abstract Successful commercialization of a cell therapy requires more than...
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What's wrong with NPV valuations?

26th October 2015
Risk-adjusted NPV is Notoriously Fallible Over at least the past decade, risk-adjusted Net Present Value (rNPV) has emerged as the de facto standard for valuing pharmaceutical R&D projects (1,2)....
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Medtech: how to succeed in Europe

20th March 2014
Amidst a currently effervescent biotech scene, medtech is suffering. Sector newsflow is dominated by layoffs, regulatory escalation and a harsh fiscal environment. In this context, it is appealing...
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It is critical for US biotech companies to understand the needs of European payers

17th October 2013
There is increasing divergence between the evidence regulators need for approval, and that needed by payers for reimbursement. Whilst ignoring the needs of European payers before entering Phase 3...
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Is Manufacturing just ‘bad news’?

15th August 2013
Over the past few months one could have been forgiven for thinking that outsourcing supply to Indian manufacturers was a major problem. The recent spate of FDA Warning Letters, and actions, against...
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A genome's got to know it's limitations

28th January 2013
The UK Government has become the latest believer in the genome. In December 2012, the prime minister of the United Kingdom announced an ambitious plan to fully sequence the genomes of 100,000 Britons...
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Biotech in Israel: A Land of Promise

18th May 2012
Israeli medtech is widely regarded as world-class both by investors and the industry at large. Israeli biotech, on the other hand, does not (yet) enjoy similar standing. True, there are some notable...
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FDA Approvals Provide Reason For Cheer

14th March 2012
Both biotech and pharma investors are in despair. KPMG recently concluded that returns on R&D investment among the 30 leading drug companies fell by 50% since 1990. At a 10% rate of return last year,...
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