BUSINESS DEVELOPMENT - Founder's Syndrome
John Bermingham says Founder’s Syndrome is defined as a situation that occurs when an organization operates according to the personality of a dominate person within the organization, usually the founder. This syndrome normally occurs when an organization begins to achieve revenue growth at a level that requires a change in management style and how things get done, and this type of problem can be very difficult to deal with.
REGULATORY REVIEW - Regulators Make Intentions Clear on Transparency & Harmonization
Erick Gaussens says that continued emphasis on data transparency and on streamlining of the submission process – to the benefit of both regulatory agencies and pharma companies – create both opportunities and challenges for companies.
BIOSIMILARS - The US Biosimilar Approval Pathway: Policy Precedes Science
David Shoemaker, PhD, says the origin of the BPCIA had its roots in the Drug Price Competition and Patent Restoration Act of 1984 championed by Senators Waxman and Hatch, which has provided low-cost generic alternatives to prescription brand-name drugs for the three subsequent decades. What Congress failed to appreciate at the time was the current state of protein characterization science and consequently whether interchangeability could in fact be obtained or what level of biosimilarity was acceptable.
SPECIAL FEATURE - Patients & Physicians Desire Transdermal, Topical & Subcutaneous Delivery
Contributor Cindy H. Dubin recently interviewed several topical, transdermal, and subcutaneous product manufacturers to find out how they are working with patients and physicians to develop delivery systems that meet their needs for comfort, compliance, and more effective delivery.
MARKET BRIEF - Sequestration Haunts Life Science Research Tool Market Into 2014
Christi Bird, Senior Industry Analyst, Frost & Sullivan, believes the bleakest outlook provided for the life sciences industry is one without a clear light at the end of the tunnel, and successful companies will buckle down to determine long-term strategies for beating the lackluster numbers expected from a sustained austerity policy.
MANAGEMENT INSIGHT - The Secret to Successful Global Expansion is to Bring Your RATs & CATs Together
Derek Hennecke shares his strategy for getting ahead in the global race by following the RAT/CAT virtuous cycle approach to creating and sustaining global advantage developed by Donald Lessard, Rafael Lucea, and Luis Vives in “Building Your Company’s Capabilities Through Global Expansion,” MIT Sloan Management Review.
BIOAVAILABIITY ENHANCEMENT - Innovators & Corporate Cultures: Symbiotic Relationships
Marshall Crew, PhD, explores some of the key features of people and organizations that lead to the innovations and products, and hopes that by example, insights can be acquired that will be useful in his colleagues respective organizations and that might ultimately lead to more innovation in the industry.
Rexam Healthcare Devices Becomes Nemera; Renews Commitment
It was announced today that the healthcare business formerly known as Rexam Healthcare Devices has become Nemera. This name change follows the May 2, 2014,…
IDENTITY HUB - Leveraging Identity Hubs to Speed the Drug Development & Delivery Process & Maximize Revenue Opportunities
Vijay Takanti, MS, MBA, believes the Exostar Life Sciences Identity Hub is a proven implementation of the identity hub concept that provides the trust necessary for enterprises and individuals to collaborate with confidence.
THERAPEUTIC FOCUS - Addressing HPV-Related Cancers in HIV/HPV Co-Infected Population
Eyal Talor, PhD, believes the goal of HIV care is empowering people to live well (long and productive lives) with the virus. When it comes to the risk of developing HPV-related cancers, HIV positive individuals need expanded arsenals that will be able to address their specific needs.
ADAPTIVE FOCUSED ACOUSTICS - Scalability of AFA in Nanoemulsions: From Microliters to Continuous Flow
Laura E. Forte and Srikanth Kakumanu, PhD, conduct a study demonstrating that Covaris’ AFA can quickly and easily produce nanoemulsions on sample scales varying from 300 microliters to continuous flow.
PEPTIDES & ANTIBODIES - Peptides in Antibody & Peptide Drug Conjugates
Archana Gangakhedkar, MS, and Jyothi Thundimadathil, PhD, indicate peptide-based linkers are promising counterparts in ADCs, providing tumor-specific cleavable and stable circulating linkers, and a new emerging class of PDCs is proving to be useful toward a broad spectrum of indications when compared to ADCs.
EXECUTIVE INTERVIEW - 3M Drug Delivery Systems Division: A Partner to Tackle Market Complexities
Drug Development Executive: Cindy R. Kent, VP & General Manager of 3M DDSD, discusses her vision for the company and how developing trends are impacting the players in the pharmaceutical industry.
EXECUTIVE INTERVIEW - Parexel: Simplifying the Journey to Market
Drug Development Executive: Carol Collins, Corporate Vice President, Strategic Partnerships, PAREXEL, clarifies how Strategic Partnerships differ from other outsourcing approaches – and what makes them more effective.
MARKETING MATTERS - Increasing Your Reach & Frequency
David F. Scelba is the Founder & Chairman of SGW Integrated Marketing & Communications and is a Partner at LifeSciencePR. He is responsible for the development of the company’s new interactive products and services and plays a key role as senior strategist for developing clients’ integrated marketing communications programs. He is also involved in researching and investigating acquisition opportunities and for initiating negotiations on behalf of the company. His diversified B2B, consumer, and retail experience encompasses industries such as: automotive; biochemical; broadcast; education; healthcare; hospitals; life sciences; microwave; pharmaceutical (research/drug delivery); political; professional video/audio; medical; telecommunications; and more. He is a keynote motivational speaker whose audiences include marketing professionals, college professors, MBA graduate students, and undergraduates seeking careers in the marketing- and communications-related industries. He also mentors business and government leaders on the use of technologically innovative tools for better communication with their targeted audiences.
COLON-SPECIFIC DELIVERY - Toward Reliable Colon-Specific Drug Delivery
Wilfried Andrä, PhD, Pieter Saupe, and Matthias E. Bellemann, PhD, indicate the greatest obstacle on the road to targeted drug delivery in the GI tract was, until now, the lack of a practicable method to localize the capsule.
ADVANCED DELIVERY DEVICES - Incorporating Patient-Centric Design Into a Novel Anti-Needlestick Safety Device
Sarah Baer, MBA, says the market for biotechnology drugs continues to grow, and there is a need for pharmaceutical companies to offer injection devices that support both the complex properties of the biologic as well as the needs of the end-user who will be performing the injection.
BIOAVAILABILITY ENHANCEMENT - Diffusion of Innovation & the Adoption of Solubilization Technologies: Observations of Trends & Catalysts
Marshall Crew, PhD, says that although diffusion processes of innovative products and services have been studied extensively for nearly 45 years, it seems reasonable that we might learn from others’ observations, and the frameworks they’ve developed to model diffusion of technology for the adoption of bioavailability platforms.
EXCIPIENT UPDATE - Elution of Dexamethasone Acetate Into Buffered Saline Solution Through a Silicone Elastomer Using Excipients
Brian Reilly, Mustafa Al-Azzam, and Robert Kivlin measure the elution rate of DMA from a cured silicone matrix into a physiological environment with the goal of understanding the influence of load level and the use of excipients in DMA delivery through a cured silicone matrix.
MANAGEMENT INSIGHT - Antifragile: Nassim Taleb on the Evils of Modern Medicine
Derek Hennecke reviews the latest book by Black Swan author Nassim Taleb, indicating it is a thoroughly maddening book. And whether or not you enjoy this type of mental gymnastics, and if it gains anything like the notoriety of his previous books, you’re going to hear about it.
