As companies move more toward outsourcing various components of a drug’s development program in order to manage internal resources, they have an increased need to develop robust skills in managing vendors.
Few pharmaceutical and biotech companies provide their employees with direct training in vendor management, and indeed, they often relegate this to associates, hoping that the vendors will manage themselves. This is a very risky strategy to take, as a company can lose control of timelines, allow vendors to get away with shoddy practices that jeopardize critical data, and spend financial resources on unnecessary or over-priced services.
Vendor management can be taught, and is best done so by experts with many years of experience. In this webinar, Swiftwater Group will discuss what works and what doesn’t in dealing with vendors, whether the vendors are CROs, CMOs, Quality Assurance/Control Consultants, or Bioanalytical vendors.
Topics covered in this webinar include:
- Identifying potential vendors (e.g., large vs. small, broad vs. specific services)
- Writing an RFP to best communicate your needs
- Performing a Comparative Bid Analysis, especially when bids are extremely different
- Identifying how to cut out “upsell” where vendors try to include services you don’t need
- What to include in a final contract to protect your investment (e.g., payment terms, responsibility for issues)
- How to maintain control by kicking off the project on the right foot
- Tips on managing the vendor to ensure they stick to timelines
- When to address issues in the quality of services performed
- Negotiating follow-on contracts
For each topic, we will discuss memorable case studies that will “bring home” the important messages and which will allow you to use this information in your day-to-day work.
Tom Fritz, Managing Partner, Swiftwater Group LLC
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.
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.
Chris Seifarth, Associate Partner, Swiftwater Group LLC
Chris has nearly 20 years of experience in healthcare and clinical research. Chris has collaborated with development strategy teams for most of the top 20 global pharmaceutical companies to optimize the translational medicine paradigm for design, implementation, and management of clinical trials. He has a diverse background in global regulatory affairs and extensive experience writing and reviewing study protocols, clinical study reports, SOPs, CRFs, training materials, and clinical development strategies, ensuring compliance with FDA and ICH-GCP regulations.
Chris has designed, developed, and managed Phase I – IV clinical trials in many therapeutic areas including cardiology, respiratory therapy, infectious disease, dermatology, and neurology. He is also a Certified Clinical Research Associate (CCRA-ACRP) and Certified Auditor (SQA) and has had extensive training in project management, clinical trial monitoring, and conducting vendor and investigator/clinical site audits.
Chris holds a BS in Health Studies from Charter Oak State College, and an MS in Regulatory Affairs and Quality Assurance at Temple University School of Pharmacy in Philadelphia.
Who Should Attend?
- Managers and above in established Small to Mid-size Pharma and Biotechnology companies and emerging start ups
- Senior Management in Pharma/Biotech-focused Venture Capital Firms
Functional areas include Pre-Clinical Development, Clinical Pharmacology, Clinical Research/Development, Clinical Operations, Drug Development, CMC, Regulatory Affairs, Quality Assurance and Quality Control, Outsourcing
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.
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 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.
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.
For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email email@example.com