November 16, 2011

Developing Biosimilars in the US – The Dawn of a New Era?

Developing Biosimilars in the US – The Dawn of a New Era?

An abbreviated drug approval pathway, available in the US since the 1980s, paved the way for generic medicine development and price competition. Similar legislation for biopharmaceuticals will pioneer the way for biosimilars, products which are highly similar to previously approved innovator products. However, because research and development has progressed faster than regulations and guidance documents, there is significant confusion among developers regarding the path for development and the future of biosimilars.

With the FDA currently creating guidance documents to clarify its expectations for developers, the industry is at a crossroads. Some believe that biosimilars are inherently doomed to failure – that the science will never hold up. However, experts at Swiftwater Group have evaluated and applied regulations for biosimilars development for both European and US marketing authorizations, and believe that biosimilars indeed change the marketplace. In this webinar, Swiftwater Group will discuss how an integrated drug development perspective will allow biopharmaceutical developers to bring biosimilars to market quickly.

Topics covered in this webinar include:

• Understanding how regulatory agencies and industry define biosimilars
• How to differentiate among Substitutability, Interchangeability, and Therapeutic Equivalence
• Reviewing the precedent and current regulatory landscape around development of biosimilars
• How biosimilars development will differ from generics development
• Understanding the CMC, toxicology, and clinical complexities of biosimilars development
• What biosimilars approval and data packages will likely consist of
• What we expect FDA Guidances to Define
• Integrated Drug Development – How Timing is Key

• Managers and above in established Small to Large Pharma and Biotechnology companies as well as start ups
• Senior Management in pharma/biotech-focused Venture Capital Funds

Functional areas include Pre-Clinical Development, Clinical Pharmacology, Clinical Research/Development, Clinical Operations, Drug Development, CMC, Regulatory Affairs, Quality Assurance and Quality Control

Background
Tom is a recognized expert in pharmaceutical development. He has spent more than 20 years working with companies both as an executive and as a consultant. He has developed and managed company-wide drug development programs and has been directly responsible for the successful completion of numerous clinical trials and regulatory submissions. He has deep expertise in pharmaceutical operations management, clinical and regulatory strategy, technical and operational due diligence, and operational set-up and restructuring. He also has an extensive background in both small and large molecule manufacturing and personally led the manufacturing function of a growing biopharmaceutical company. Tom has widespread drug development experience, having worked on successful product registrations in the United States, Europe, and Japan.

Before joining Swiftwater Group, Tom was co-founder of the biotechnology company ImaRx, and directed the company’s first two products through NDA approval and a third to an NDA submission. Tom also led and managed efforts for product out-licensing to corporate partners such as BMS, DuPont Pharmaceuticals, and Yamanouchi Pharmaceutical in Japan. This portfolio development led to the acquisition of ImaRx by DuPont in 1998. Since that time, Tom has been helping other companies bring outstanding products to market through focus, creativity, deliberation, and planning.

Education
Tom has an MS in veterinary physiology from South Dakota State University and a BS in animal science from Texas Tech University. He has also completed all of his studies for a PhD in metabolic biochemistry with a minor in pharmacology at the University of Arizona Cancer Center.

Background
Tom focuses on all phases of pharmaceutical drug development. With his background in pharmacology, scientific writing, and business development, Tom serves an instrumental role in evaluating and planning integrated drug development programs and in preparing regulatory documents for global submission. Tom’s substantial experience in project management contributes to the organization, preparation, and critical quality review of documentation necessary for the regulatory review process. Tom has worked with both leading pharmaceutical companies and innovative biotechnology firms to develop and implement comprehensive CMC, nonclinical, clinical, and regulatory strategies for new chemical entities, 505(b)(2) pathway reformulations, and recombinant protein therapeutics, including a follow-on biologic. In addition to traditional CMC platforms, Tom also has experience working on multiple drug programs for therapeutics derived from plant sources.

Education
Tom earned both his PhD in Pharmacology and MBA, with a concentration in Intellectual Property Management, from the Pennsylvania State University. He completed a post-doctoral fellowship at the University of Pennsylvania, where he focused on novel drug delivery therapeutics. He also holds a BS in Biology from Washington and Lee University.

Swiftwater Group was founded in 1998 by a small group of seasoned pharmaceutical consultants and industry veterans with the express purpose of taking a fresh approach to helping clients succeed. Our vision was – and remains today – to approach each client problem, challenge, or opportunity with customized, industry-specific solutions delivered by true life sciences experts.

Integration

We believe that the problems, challenges and opportunities that our clients wrestle with must almost always be tackled from multiple directions. Major decisions need to be based on a thorough understanding of the implications of non-clinical evaluation, clinical study design, manufacturing process and control, and how regulatory bodies will view the work. This is especially important when planning and coordinating projects to meet global objectives.

At Swiftwater Group, we cross-train our consultants so they understand the integrated relationship of pharmaceutical and biotechnology development disciplines; our consultants with clinical expertise also know how to anticipate and identify process and regulatory issues that are likely to arise, while our CMC experts can identify cost-effectiveness issues and other challenges that can emerge during non-clinical studies. Ensuring our team has this full-spectrum development expertise across functional areas is a key to our – and your – success.

Business Savvy

Every client and client problem is unique. Some clients depend on outsourcing every aspect of development, from pre-clinical studies through Phase III trials. Other clients have expertise in Phase III Clinical Trials, but have had less experience doing "First in Man" studies. Others may have a deep pipeline and as a result are resource-constrained and need help managing the development of a growing a portfolio, or assistance with a specific therapeutic area or functional area.

With extensive experience on the business side of pharmaceuticals, Swiftwater Group understands the tradeoff between time, money, and resources. Whether you are trying to meet investment milestones, beat competitors to the market, or create superior data, you can rely on Swiftwater Group to provide expert advice and service – on time and on budget.