issues

March 2014

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COVER

BIOAVAILABILITY ENHANCEMENT – Analysis of the Historical Use of Solubilization Technologies

Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., continues his multiple-part series discussing today’s most challenging issues in solubility.

FEATURES

CELL THERAPIES – The Challenges & Possible Solutions for Transferring Cell Therapy From the Bench to the Industry

Lior Raviv, MMedSc, and Ohad Karnieli, PhD, discuss the significant emerging challenges in downstream processing of cell therapies focused mostly on allogeneic therapies.

ADVANCED DELIVERY DEVICES – New Drug Delivery & Stabilization Platforms Gaining Global Interest

Sam de Costa, PhD, believes the launch of two stabilization and drug delivery platforms that have the potential to revolutionize the delivery of vaccines, therapeutics, and diagnostics, while significantly cutting costs, has attracted sharp interest from pharmaceutical and biotech companies around the world.

FIXED-DOSE COMBINATIONS – Fixed-Dose Combination Products – A Review (Part 1 – Introduction)

Tugrul T. Kararli, PhD, MBA; Kurt Sedo; and Josef Bossart, PhD; believe the pharmaceutical industry has been paying increasing attention to the potential of Fixed-Dose Combination products, and in a series of three articles, examine the past, present, and future of these products with the intent of understanding their whats and whys.

EXECUTIVE INTERVIEW – Hermes Pharma: User-Friendly Dosage Forms, a Win-Win Situation for Patients & Pharma

Drug Development Executive: Dr. Thomas Hein, Director, Sales & Business Development at Hermes Pharma, discusses how user-friendly dosage forms help put patients first, their advantages for patients and pharmaceutical companies, as well as the challenges associated with their development and production.

SPECIAL FEATURE- Analytical Testing of Biologics & Biosimilars

Contributor Cindy H. Dubin talks with some of the leading experts in the industry about the importance of outsourcing analytical testing in the biologic/biosimilar space, the associated challenges, and how to ensure products get to market safely and quickly.

BUSINESS DEVELOPMENT – The Compensation Paradox

John A. Bermingham is currently the COO of 1st Light Energy & Conservation Lighting. He was previously Co-President and COO of AgraTech, a biotech enterprise focused on chitosan, a biomaterial processed from crustacean shells (shrimp, crawfish, crab, etc), as well as President & CEO of Cord Crafts, LLC, a leading manufacturer and marketer of permanent botanicals. Prior to Cord Crafts, he was President & CEO of Alco Consumer Products, Inc., an importer of house ware, home goods, pet, and safety products under the Alco brand name and through licenses from the ASPCA and Red Cross. He successfully turned around the company in 60 days and sold Alco to a strategic buyer. Mr. Bermingham was previously the President & CEO of Lang Holdings, Inc. (an innovative leader in the social sentiment and home décor industries) and President, Chairman, and CEO of Ampad (a leading manufacturer and distributor of office products). With more than 20 years of turnaround experience, he also held the positions of Chairman, President, and CEO of Centis, Inc., Smith Corona Corporation, and Rolodex Corporation. He turned around several business units of AT&T Consumer Products Group and served as the EVP of the Electronics Group and President of the Magnetic Products Group, Sony Corporation of America. Mr. Bermingham served 3 years in the U.S. Army Signal Corps with responsibility for Top Secret Cryptographic Codes and Top Secret Nuclear Release Codes, earned his BA in Business Administration from Saint Leo University, and completed the Harvard University Graduate School of Business Advanced Management Program.

THERAPEUTIC FOCUS – Repurposing Drugs to Transform Lives

Roger Garceau, MD, FAAP, presents a drug that might have slipped into obscurity if the team at NPS Pharmaceuticals had accepted defeat, but instead, the medicine has received an extraordinary second chance to address a different, and significant, unmet medical need.

BIOAVAILABILITY ENHANCEMENT – Analysis of the Historical Use of Solubilization Technologies

Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., continues his multiple-part series discussing today’s most challenging issues in solubility.

MARKET BRIEF – Latin America Next-Generation Biosimilars Market: Opportunities & Future Growth

Lucila Rocca, Healthcare Industry Analyst, Frost & Sullivan, indicates the Latin American Biosimilars market will grow at a significant rate in the next 5 years, and the importance of establishing rigorous regulation will stimulate this market growth.

EXECUTIVE INTERVIEW – Gerresheimer: Understanding Customer Requirements

Drug Development Executive: Andreas Schütte, Member of the Management Board, Plastics & Devices Division, discusses his important role in Gerresheimer’s divisional restructuring process, and how he is convinced the new structure better reflects customer requirements.

MANAGEMENT INSIGHT – In Pursuit of Ethics: Reflections On Why We Do What We Do

In January, the FDA banned imports from a fourth Ranbaxy plant in India after an unscheduled inspection revealed a lab littered with flies, a leaking refrigerator for drug samples, and..