Pharmaceutical Executive Podcasts

Product Development Using the NDA 505(B)(2) Pathway
By: Camargo

A 505(b)(2) application is a new drug application that contains full safety and effectiveness reports, but allows at least some of the information required for approval to come from studies not conducted by or for the applicant. This approach can lead to approval in a fraction of the time and cost required by traditional paths. For 505(b)(2) in particular, early assessment and preparation are key to identifying needs and avoiding redundancies to set the path to a profitable product. Pre-investigational new drug (PIND) meetings serve as a prudent step in this process and can guide development strategies that reduce time to market and can all but eliminate the possibility of clinical holds.

Avoiding Rescue Situations: Addressing the 505(b)(2) Product Development Challenges Before They Become Problems
By: Camargo

Executing an effective strategy for development of a 505(b)(2) product is challenging for companies that are new to the 505(b)(2) approval pathway. Guidelines for developing products via the 505(b)(2) pathway have been in place in the U.S. for more than a decade,1 yet many companies that have historically developed new drugs through the new drug application (NDA) pathway (505(b)(1)) or generic medicines through the abbreviated NDA pathway (505(j) ANDA) may not be familiar with the specific processes and requirements of 505(b)(2). Companies and their consultants who rely only on published guidance risk making mistakes in the process that can cost significant time and money, and even derail a project altogether.

The Emergence of Medical Affairs in Biopharma
By: Pharmaceutical Executive Editors

The role of medical affairs within biopharma organizations is evolving, with these functions providing increasing patient and physician-centered services as part of a new business model aimed at delivering value in healthcare. Pharm Exec spoke with Honorio Silva, MD, President-Elect of the International Federation of Associations of Pharmaceutical Physicians (IFAPP) and VP of ACRES, the Alliance for Clinical Research Excellence and Safety, about the key factors driving growth in the medical affairs field, the challenges for teams in providing true value-added services, and the new expectations medical affairs personnel must meet amid and the growing demand for data transparency.

Breakthrough Drugs vs Breaking the Bank
By: Pharmaceutical Executive Editors

As overall healthcare costs continue to rise, biopharma companies are under increasing pressure to demonstrate the economic value of their products and justify prices. This has resulted in competing demands for innovative breakthrough medicines and healthcare cost containment. Ken Kaitin, PhD, Professor and Director, Tufts Center for the Study of Drug Development, joined Pharm Exec to discuss how this conundrum, and the continuing spike in R&D costs, are impacting drugmakers.

The Regulatory Pulse for Advanced Therapies
By: Pharmaceutical Executive Editors

Advanced therapies such as cell and gene therapies and regenerative medicine offer ground-breaking treatment for many diseases that could not be adequately treated previously. Regulations governing these products, however, vary greatly by health authorities across the globe. Gopalan Narayanan, MD, Biologics and Advanced Therapies Expert at NDA Group, recently shared his thoughts with Pharm Exec on the regulatory environment today in Europe and elsewhere for advanced therapies, as well as the unique classification issues specific to these products.

The Emerging 505(b)(2) Marketplace Provides Opportunities for Generic Companies Seeking New Revenue Streams in the U.S.
Sponsored By: Camargo Pharmaceutical Services

CEOs of generic companies report they are considering a spectrum of solutions to bridge the revenue gap, but perhaps none are more valid than the U.S. FDA’s 505(b)(2) approval pathway, which can offer accelerated approval, reduced development costs, lower risk and, in certain cases, market exclusivity. In this podcast, readers will get an understanding of 505(b)(2), why developers are choosing it, how products are identified and models for development.

Finding Feasibility: A Digital Discussion on Identifying Viable Products
Sponsored By:Camargo Pharmaceutical Services

To maximize profitability, a pharmaceutical company must pursue products that are likely to provide a return. Pharmaceutical Executive talked with Ken Phelps, president and CEO of Camargo Pharmaceutical Services, to learn how to find the most viable products.
Click here to check out our corresponding whitepaper

Asset Accuracy: Know What You Have and What It’s Worth
Sponsored By EquipNet
Pharm Tech interviews Christopher Kinzie, the Director of Appraisal and Valuation Services for EquipNet, Inc. Chris outlines how pharmaceutical companies use appraisal and valuation services to capitalize on their assets and reduce the risk of liability.

Emerging Leader Podcast Series 2011
Sponsored By Cegedim Relationship Management
Meet this year’s Emerging Pharma Leaders. Can these trendsetters build competitive scale from scarcity? Listen in as 10 of our winners discuss their thoughts on managing in the era of lean.

Trends in Assessing Internal and Outsourced Clinical Trial Costs and Resource Demand
Sponsored By ClearTrial
Join Reid Paul, Editor in Chief of Pharmaceutical Representative, Ken Getz, Senior Research Fellow at the Tufts Center for the Study of Drug Development, and Andy Grygiel, Vice President of Marketing and Product Management at ClearTrial, for Parts 1 and 2 of this podcast series as we discuss recent Tufts research on assessing clinical trial costs and resource demand. In Part 3 of the series, Molly Blake-Michaels, Director, Clinical Services at ClearTrial, will examines the pros and cons of the most widely used clinical trial forecasting and budgeting methods in use today by biopharmaceutical and medical device companies.

Emerging Pharma Leadership Awards 2010
Sponsored By Cegedim Relationship Management
Pharm Exec’s third annual Emerging Pharma Leadership Awards podcast series addresses a key issue facing the biopharma industry today and asks the hard question of what are the attributes of effective leadership in organizations that have no choice but to adapt to a changing market environment? Join us as ten winners discuss their thoughts on leadership today.

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