News & Insights
RxC actively researches and publishes its point of view on key issues impacting the pharma and biotech industries. We welcome your input on our pieces. To be notified when we publish something new, please sign up for our updates newsletter.
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January 7, 2018
RxC International has evaluated the Luxturna clinical story and its market opportunity, including critical questions regarding this highly-watched commercial launch. Here's what you need to know.
January 2, 2018
This month, the most noteworthy gene therapy stories include:
- First Mover Advantage? Gilead Blazes Trail for Competition
Newly-Published Yescarta Study Raises Safety Concerns
Results from Hemophilia Gene Therapy Studies Prompt Pricing Questions...Again
Read about these developments and our commercial insights into the ongoing evolution of the gene therapy market.
December 6, 2017
November saw some important moments in gene therapy. We have summarized the most noteworthy and included the remaining in our news and updates sections.
December 5, 2017
Existing pharma co-promotions face challenges that can threaten their success and longevity if not addressed. Learn about the these challenges and methods our expert co-promotion team has applied to remedy them.
November 9, 2017
October was a landmark month for gene therapies with the approval of the second-ever gene therapy in the US, Yescarta (axicabtagene ciloleucel) from Kite and Gilead. The prior approval of Novartis’ Kymriah is more proof that gene therapies are set to shake up the pharma industry. Gene therapies saw other wins as Luxturna, Spark’s treatment for Leber congenital amaurosis, received the FDA’s recommendation for approval and Bluebird Bio’s interim data report for its gene therapy Lenti-D to treat cerebral adrenoleukodystrophy showed promising results.
Effective Pharmaceutical Life Cycle Management Planning: Optimizing Product Value over a Drug's Lifespan
November 9, 2017
Developing an effective drug life cycle management plan is critical for maximizing the value of a pharma product over the course of its commercial lifespan. Drawing from our deep expertise of pharmaceutical product lifecycle management, RxC International has identified key success factors and industry best practices as well as common pitfalls to avoid when developing and implementing LCM plans.
October 31, 2017
Pharmaceutical companies with effective Life Cycle Management (LCM) planning typically work with outside partners to develop and execute LCM plans. Working with a third-party partner adds outside thinking and best practices to an organization. “When you can [bring] in the experience that you need, you’ll benefit from the hard work that others have done, shorten your time to market for new products, and introduce new talent to your company,” writes Madeline Bennett of The Telegraph.
September 27, 2017
Understanding the critical success factors of Life Cycle Management (LCM) planning helps pharmaceutical companies avoid common life cycle pitfalls that can lead to sub-optimal life cycle plans or ineffective implementations. Companies that don’t optimize the life cycle management process and develop innovative strategies to meet the demands of today’s pharmaceutical landscape generally experience lower returns than their more proactive counterparts.
September 14, 2017
Successfully optimizing co-promotional agreements relies upon governance, brand management, and performance management. Yet, despite good intentions from each party, challenges can arise in a co-promotional agreement that threaten its longevity and overall success. In our experience, preventing or overcoming challenges in existing co-promotions usually requires assistance from a third party like RxC International. Below are the nine most common challenges we have encountered during our extensive experience with co-promotion programs.
How to Avoid Pharmaceutical Value Erosion: 5 Critical Components of a Highly Effective Life Cycle Management Process
September 7, 2017
A comprehensive Life Cycle Management (LCM) process is essential to developing pharmaceutical life cycle plans that deliver maximum value over the life of pipeline and marketed products. Ensuring that the life cycle process is objectively and consistently executed enables organizations to fully explore all potential concepts, foster collaborative thinking, and uncover more innovative opportunities. Life sciences companies with multiple products across several therapeutic areas can benefit from a consistent approach that allows management to make effective comparisons across the organizational portfolio and allocate resources accordingly.
September 6, 2017
MORRISTOWN, NJ, RxC International, a premier life sciences management consulting firm, announced today that Bradley K. Kozar has joined the firm as a Strategy Partner. Brad is a payer strategy and market access consulting executive with significant consulting/agency and pharmaceutical industry experience. “Brad is a leading expert in managed markets - he has led many successful biopharma product launches and has been instrumental in helping his clients achieve more favorable market access through better formulary placement and reimbursement. We are excited to have Brad joining us to provide our clients with a more integrated offering by addressing market access within our core services of corporate strategy, new product strategy and commercial excellence,” said Subbarao Jayanthi, Managing Partner of RxC International.
August 1, 2017
Companies must implement effective Life Cycle Management (LCM) strategies to build more value into products while they are still in development. LCM includes identifying and prioritizing multiple potential indications and formulations while strategically planning their development and launch timing and sequence. Competitive companies must also direct sufficient resources to a strong LCM process for their pipeline and marketed products.
June 28, 2017
As the complexity and investment for successfully marketing a prescription drug or biologic rises, many companies seek to de-risk their commercialization effort by joining forces with a partner biopharma company. Co-promotions, or the formal relationship established between two companies to combine resources for a more effective promotion of a product, are becoming increasingly common in the biopharma industry. While co-promotions are structured with the right intent, these agreements require careful consideration of several key strategic and operational issues in order to achieve optimal effectiveness.
Philip Vorhies to Bring Added New Product Strategy and Commercial Expertise to RxC International as Strategy Partner
June 22, 2017
MORRISTOWN, NJ, RxC International, a premier life sciences management consulting firm, announced today that Philip Vorhies has joined the firm as a Strategy Partner. Philip is an experienced strategy and operations consulting executive with over 20 years of biopharmaceutical industry experience. “Philip has an excellent track record of value creation for life sciences clients. He is truly passionate about helping his clients succeed. He has led several successful pharma and biotech product launches and been instrumental in building highly productive consulting teams. We are excited to have Philip on board as we continue to strengthen our management team,” said Subbarao Jayanthi, Managing Partner of RxC International.
June 1, 2017
Gene therapies are poised to enter the US healthcare system within the next 1-2 years as viable treatment options for a variety of diseases. In response to this burgeoning opportunity, the Institute for Clinical and Economic Review (ICER) convened a policy summit and recently released a report on the potential value and challenges of gene therapy treatments
Key Drivers Shaping the BioPharma Industry Today
May 18, 2017
Regulatory Dynamics: The BioPharma industry is highly regulated. The FDA is armed with strict federal legislations that are implemented to tightly regulate the drug approval procedure and subsequent commercialization of these drugs. The sole focus of FDA for such stringent regulatory measures is to offer safer and effective medicines to the consumers.
Different Types of Drug Design in BioPharma
May 4, 2017
Traditional methods of drug discovery rely on in vitro and in vivo trial-and-error testing of chemical substances on cultured cells or animals, and extrapolating the observed effects to potential treatment regimens. Compounds are initially screened to narrow in on the ones that have some degree of activity. If these compounds share common chemical features, one or more pharmacophores are then developed. At this point, medicinal chemists attempt to use structure-activity relationships to improve certain features (activity against the chosen target, reduce activity against unrelated subjects) of the lead compound to make it more effective and safe.
Evidence-Based Vs. Value-Based Medicines
April 25, 2017
A clinical trial or clinical study is defined as any investigation in human subjects intended to discover or verify the clinical, pharmacological, and/or other pharmacodynamic effects of an investigational product, and/or to identify any adverse reactions to an investigational product, and/or to study absorption, distribution, metabolism, and excretion of an investigational product with the objective of ascertaining its safety and/or efficacy. While the major questions answered are those of clinical value in all three phases, economic end-points and strategic end-points like quality of life (QoL) are introduced during Phases II and III. It is not uncommon that these economic and strategic end-points are introduced in earlier phases as well.
Product Pricing Strategy in BioPharma
April 20, 2017
In order to develop pricing strategy, it is imperative to understand the demand-supply drivers combined with drivers that positively and negatively affect pricing decisions. Equally important is the understanding of the key elements of Value-Based Pricing (VBP) along with what it takes to develop and refine the VBP using stakeholder (payers, providers, patients, and policy makers) input. Finally, the optimal pricing derived through this process needs to be applied in the marketplace to ensure product success.
Product Manufacturing--Life Cycle Phases
April 5, 2017
There are four stages in product manufacturing life cycle that include designing and developing the product, transferring technology to commercial-scale production, undertaking commercial manufacturing, and dealing with product discontinuation.
Payer Decision-Making Process
March 16, 2017
Whether it is a new or existing product, the fundamental issues that affect payer positioning are similar and must be discretely understood in each therapeutic area. The primary drivers that the payer looks for in the product are clinical evidence, comparative clinical differentiation and economic competitiveness compared to other existing products. Besides clinical value, other aspects that are equivalently important are the ability to keep patients compliant and reach their intended treatment goal, which leads to reduced costs and increased quality of care. Payers also seek competitive pricing and contracting terms that benefit their business and financials. Payers are increasingly looking for creative ways such as linking product access and price to health outcomes with the goal of better managing care and associated costs. This is an essential part of value-based pricing and the product that offers the best value in terms of treatment outcomes usually commands the best price.
Patient Protection and Affordable Care Act (PPACA) and its Impact on BioPharma Companies
March 2, 2017
PPACA is one of the most important healthcare legislation approved recently. The public and private stakeholders listed above have all actively participated in shaping up this legislation. Some of the highlights of this legislation and the direct impacts to the BioPharma companies are highlighted below.
BioPharma Product Life Cycle Management Strategies
February 16, 2017
LCM strategies range from new indications to end of life cycle Rx-to-OTC switching strategies. The evidence supporting these strategies is typically generated through phase IIIb, phase IV, and research studies and the outcomes require regulatory approval prior to commercializing these opportunities. Multivariate strategies can be adopted depending on the life cycle stage of the product and the availability of resources. LCM strategies, if successful, can offer new solutions, create switching costs, and increase the lifetime value of the product. The following are the most common LCM strategies to create incremental value for the product.
Common BioPharma Business Models and Strategic Choices
February 2, 2017
The following are the most common business models that have evolved over the last two decades as the industry structure has gone through significant transformation.
Investment Framework to Spot Attractive BioPharma Opportunities
January 19, 2017
Investing in the BioPharma industry comes with its own share of challenges and uncertainties. The research methodologies employed by the companies are geared towards product discovery and development, but may not always lead to successful outcomes in clinical and real world settings. Perhaps the most important thing to cope up with is the unpredictability of results involved in medical research—each positive result comes after a lot of experimentation which costs considerably to a company’s exchequer. Moreover, a BioPharma company has to successfully navigate through the domestic and international regulatory pathways to make the product commercially successful in the domestic and international markets. The following is a general framework that investors could use to identify opportunities in the BioPharma industry. Note that the BioPharma companies also leverage a similar framework to identify product investment opportunities and to create value for their stakeholders and shareholders.
Common Investment Transactions in the Current BioPharma Environment
January 5, 2017
Since the BioPharma industry has been going through a significant transformation, the investment environment has been fairly dynamic and the following five different transactions are fairly noticeable.
RxC International’s Richard J. Tinsley to Present at PBIRG Annual General Meeting
MORRISTOWN, New Jersey – May 14, 2015 – RxC International today announced that Richard J. Tinsley, MBA, MEd, a senior partner in the firm, will present at this year’s PBIRG Annual General Meeting, which will take place May 17-20, 2015, in New Orleans. Tinsley will participate in a panel to discuss the future of healthcare. This year’s PBIRG Annual General Meeting will cover a wide range of topics on the future of healthcare.
Richard J. Tinsley Joins RxC International as a Senior Partner
MORRISTOWN, New Jersey – February 25, 2015 – RxC International today announced that Richard J. Tinsley, MBA, MEd, has joined the firm as a senior partner. RxC International is a life sciences management consulting firm specializing in corporate strategy, new product development, and commercialization.
RxCommercial Research International Launches its 2nd Edition of its Successful book on Commercialization of BioPharmaceutical Products in the USA
Morris Plains, New Jersey—RxCommercial Research International has announced the release of the second edition of its successful Practical Guide on commercializing pharmaceutical products in the USA. Pharmaceutical and Biotechnology companies produce innovative life-saving and life-enhancing medicines for patients. The discovery, development, manufacturing, distribution, and commercialization of a biopharmaceutical product are highly complex processes and they get further compounded due to the regulatory nature of the industry. This book not only offers insights into all areas of the product value chain but also shows strategic choices that companies have to deal with at each and every stage of the commercialization process.