issues

July/August 2014

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COVER

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.

FEATURES

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.

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.

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.

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.

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.

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.

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.

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.

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.