Andrew D. Skibo
The threat of lower profit margins and decreasing revenue streams
is creating intense pressure for many pharmaceutical and
biopharmaceutical companies. Patent expirations loom for major
brands, average drug development costs continue to rise, while research
and development productivity is declining. The overall success rate for
drugs moving through clinical trials to approval in the United States has
dropped by 50 percent for small molecules [1]. The reimbursement
picture is equally challenging. Even when a drug can traverse the
regulatory hurdles, reimbursement is no longer guaranteed.
Markus Hartmann, Ph.D., MDRA
The coincident issue of two quality-risk-management-driven
draft guidance documents by the United States Food and Drug
Administration (FDA) and the European Medicines Agency (EMA)
in August 2011 has been considered by many stakeholders and observers
as a paradigm shift in clinical quality risk management (CQRM). Both
documents, FDA’s guidance entitled 'Oversight of Clinical Investigations
- A Risk-Based Approach to Monitoring,‘ which was finalized in August
2013 [1], and EMA’s draft ‘Reflection Paper on Risk-Based Quality
Management in Clinical Trials’ [2], have triggered a myriad of blogs,
discussions, webinars and conference presentations focusing on the
modernization of clinical trial operations and conduct.
C. Ray Goff
Distribution networks and professionals are faced with more
challenges now than ever. Networks are being asked to plan a
four-fold expansion and are simultaneously asked to plan for
closure. This article will lay out the internal factors of the market and the
external factors that influence distribution. These factors are harbingers of
tight cash flow, scarce resources, increasing cost and growing demand.
The growing number of medicines, patients and clinical trials awaits our
attention in the immediate future.
William Downey, MBA
Over the past decade, pharmaceutical and biotechnology
companies have increased their use of contractors for
biopharmaceutical production. This includes both the production
of drug substances as well as drug products. Over the next few years,
this trend will continue as drug developers project a greater proportion
of their manufacturing budgets will be devoted to outsource production.
While virtual biotechnology companies have always relied on contract
manufacturing organizations (CMOs) for their production needs, HighTech
Business Decisions’ studies show large pharmaceutical and biotechnology
companies will also spend a greater proportion of their manufacturing
budget on outsourcing. For large biotechnology and pharmaceutical
companies, moving production to CMOs presents challenges with regards
to cost savings, controls, quality, and flexibility. Biotechnology companies
want lower costs, but they also want a collaborative relationship. While
partnership arrangements are being sought, many pharmaceutical and
biotechnology companies continue to view the market for contract filland-
finish services as a commodity, whereby price continues to be a factor
for choosing a CMO.
Dr. Hoss A. Dowlat
The current state of prefilled syringes (PFS), including reusable
autoinjectors, passive retractor devices, and dual-chamber prefilled
syringes for freeze-dried products, is discussed. Prefilled syringes
allow customization of dose, dose accuracy, patient self-treatment,
convenience, compliance, fast administration, functionality, and reliability.
These devices additionally spare expensive biologics by reducing waste,
avoiding secondary contamination, and decreasing human error.
Chitra Lele, Ph.D.
Increase in patent expiries and competition in market expansion opportunities has led to
substantial penetration of generic medicinal products in both developed as well as emerging
markets. It is estimated that generic competition eroded $67 billion from top drug companies’
annual sales in the United States between 2007 and 2012, with more than three dozen drugs
losing patent protection during this period.
May Wattie Singh
Just in Time labeling does not have to be stressful. A better understanding can make it less daunting.
You have poured over the plans again and again. There is no way around it. Your drug product is
either limited or expensive. Perhaps it is utilized in pooled supply, short-dated, or there is limited
stability data. In any of these scenarios, you will need the most efficient and flexible clinical
packaging process possible. You will need Just in Time (JiT) labeling.
Mark S. Jensen, Ph.D.
In collaboration with Anacor and the Drugs for Neglected Diseases Initiative (DNDi), SCYNEXIS
recently discovered SCYX-7158 (1), a novel representative of the oxaborole class of compounds
with excellent activity against Human African Trypanosomiasis (HAT) or “sleeping sickness”. HAT
is a devastating disease that threatens more than 60 million people in sub-Saharan Africa [1].
The discovery eff orts leading to 1 have been well documented [2] and describe the attractive
biological, pharmacokinetic and pharmacodynamic properties this unique molecule off ers.
Abhijit Gokhale, Ph.D., Thomas Williams, Ph.D., Jason Vaughn, Ph.D.
Pharmaceutical research increasingly focuses on the delivery systems that enhance desirable
therapeutic objectives while minimizing side effects. In recent pharmaceutical applications involving
pulsatile delivery, multiparticulate dosage forms gain favor over monolithic forms due to their
potential benefits.