Articles in Trade Journals
Keys to Mitigating Risk in Adaptive Trials
Phase III trials, the last before a drug is submitted to a regulatory agency for approval, cost about $20 million. The fact that about 50% of them fail is a big problem. Sy Pretorius, Chief Scientific Officer of PAREXEL, a leading global pharmaceutical consulting firm, believes this high rate of failure is caused by traditionally rigid trial designs. He argues that designs that enable trials to change as new data is collected can reduce failures. We helped Pretorius publish his article, “Three Keys to Mitigating Risk in Adapative Trials,” in Life Science Leader.
How to De-Risk Complex Molecule Formulation
If formulation problems surface late in the process of turning active pharmaceutical ingredients (APIs) into beneficial drugs, developers may have to change their API production processes, or even redo Phase I and Phase II trials. In “Anticipating the Formulation Challenges of Complex Molecules,” an article we helped Anil Kane, Global Head of Formulation Sciences at Patheon, publish in BioProcess Online, he explains how developers can avoid that nightmare.
Speeding Drugs to Market
The FDA is creating new pathways to shorten the time it takes for new medicines to receive regulatory approval. However, meeting FDA requirements for these pathways can be a tricky business. PAREXEL is a leading international drug consulting firm, and Bloom Group helped PAREXEL Vice President Barry Farrimond, Network for Excellence in Health Innovation President Jonathan Fleming, and PAREXEL expert Mark Mathieu place their article “FDA’s Accelerated Pathways Are the New Normal” in DIA, the publication of the Drug Information Association.
Waste-Not Want-Not Formulation and Process Design
Developers must make important decisions about product formulation and process design to move a drug from preclinical through Phase II trials as quickly as possible. Over-engineering a Phase I or Phase II drug that ultimately fails in the clinic wastes resources. But neglecting sound science during early stages can result in a promising product that may not have a scalable or commercially manufacturing process.
Asian Supply Chain Mysteries
An Oregon woman opens a box of Halloween decorations she bought at her local K-Mart and out falls a note pleading for help, written by a man in a Chinese prison camp. How does this happen? According to FTI Consulting Forensic & Litigation Consulting Senior Director Greg Hallahan, Western companies that outsource manufacturing to Asia do a pretty good job vetting their suppliers, but not such a good job checking to see if their suppliers are subcontracting the work out. We helped Hallahan repurpose his article in FTI Journal, for Thomson Reuters News and for Supply & Demand Chain Executive.
Fighting Pharma Demand Forecast Fails
Given the long road drugs must travel to get to market, developers have to predict demand, and line up production capacity, years before a new product launches. If they guess too low, they won’t have enough to meet demand (causing reputational damage and the loss of potential revenue). If they guess too high, they’re stuck with product they can’t sell. And because forecasts are always off, James Mullen, CEO of Patheon, a global contract manufacturing firm, has a solution: flexible and scalable manufacturing capabilities.
Fighting Bribery and Fraud in Emerging Markets
Matías Mora Simoes is a Senior Managing Director in the FTI Consulting Forensic and Litigation Consulting practice and is the head of the FTI Consulting Panama and FTI Consulting Mexico offices. We helped him place his article, “What Companies Do Right (and Wrong) Fighting Bribery and Fraud in Emerging Markets,” based on FTI Consulting research, in Corporate Compliance Insights. You can read the article, here.
Converging Risks in Emerging Markets
Eighty-three percent of 150 respondents to an FTI Consulting survey reported suffering significant losses in emerging markets. Based on this research, Arun Shukla, Senior Managing Director in the Corporate Finance practice of FTI Consulting, and Andrew Klemm, a senior consultant in the same practice, wrote “Risks Converge in Emerging Markets,” which we helped them place on CFO.com. You can read the article, here.
The How and Why of Telemedicine
The use of telemedicine is on the rise; it’s benefits are obvious to patients and providers, but there remain social and regulatory hurdles to surmount. We helped FTI Consulting Senior Managing Director Wayne Gibson, and FTI Consulting Health Solutions Managing Director Jeffrey Bessette suggest ways to leap those hurdles in “The How and Why of Telemedicine,” published in Health Management Technology.
Oil and Gas Industry Gets Social Media Wrong
Steve Everley is a Senior Director at FTI Consulting, advising clients in a broad range of industries, including coal, refining and LNG exports. Everley published an article in FTI Journal, “Drilling for a Social Media Strategy,” here, about how social media, which can target small groups and communicate with them in an intimate manner, is a better communication channel for the oil and gas industry than the national marketing efforts it has heretofore focused upon. The industry has left social media to its activist opponents. It can do so no longer.
In December, we helped Everley publish a version of his FTI Journal article in industry publication OGI, here.
Comments are closed.