Small pharma, including emerging, virtual and small biotechnology companies, navigate a fragmented vendor network on the journey to Phase II trials, often relying on specialty consultants to assist. But managing multiple contract development and manufacturing organizations (CDMO) and independent consultants across disciplines still doesn’t provide a small pharma sponsor with the breadth of expertise and strategic planning needed to address the complexity of early clinical development.
A new paradigm, intelligent drug development, focuses on Phases I and II to achieve proof-of-concept (POC) as efficiently as possible, completing all learning required to plan an effective and complete Phase III program. In this model, small pharma has on-demand access to an aligned and integrated multi-disciplinary team that builds and drives a strategic plan. This strategic team enhances scientific knowledge by maximizing cross-disciplinary interaction, efficiently deploying expert resources and ensuring maximum flexibility, coordination and speed to help small pharma efficiently and effectively execute Phase I and II studies.
This webinar will use case studies and hypothetical scenarios to illustrate how the strategic team works with small pharma sponsors to build the strategic plan, select and coordinate partners from the fragmented vendor space to meet key milestones and help interpret the emerging clinical data to lay the foundations for the next stages of clinical and drug product development.
Join this webinar to discover a new paradigm, intelligent drug development, designed to support small pharma in efficiently navigating early clinical development.
Gary M. Klaich, PhD, Senior Nonclinical Strategy Director, Strategic Development Consulting, PPD, part of Thermo Fisher Scientific
Gary M. Klaich serves as a senior director of strategic development consulting within PPD, the clinical research business at Thermo Fisher Scientific. Gary has nearly 35 years of drug development expertise, with focus areas in toxicology, nonclinical drug development and regulatory affairs. He joined PPD in 2011 as a manager of regulatory affairs, assuming positions of increasing responsibility and joining the strategic development consulting team in 2023. Gary holds a Ph.D. in pharmacology and toxicology from Roswell Park Cancer Institute Division of SUNY at Buffalo and a M.A. in medical microbiology and immunology from the SUNY at Buffalo School of Medicine. He is also a diplomate with the American Board of Toxicology (DABT).
Kevin M. Kane, PhD, CMC Strategy Director, Strategic Development Consulting, PPD, part of Thermo Fisher Scientific
Kevin Kane serves as a chemistry, manufacturing and controls (CMC) Strategy Director within PPD, the clinical research business at Thermo Fisher Scientific. Kevin has more than 25 years of experience in chemical synthesis and drug delivery for early- and late-stage pharmaceutical products. Prior to joining PPD, he worked at various contract development and manufacturing organizations (CDMO) and as an independent consultant on active pharmaceutical ingredient (API) synthesis and formulation manufacturing programs, with a focus on solubilization and modified release of APIs, and the application of adaptive clinical trials to enable drug product optimization.
Who Should Attend?
- VP Development/Outsourcing
- CMO or Clinical VP
- CMC Directors
- Nonclinical & regulatory Directors at virtual, biotech and small pharma companies
- Independent consultants supporting small pharma sponsors
What You Will Learn
Attendees will discover:
- How to effectively engage and partner with a multi-disciplinary strategic team to drive intelligent drug development for small pharma
- How large pharma innovations can be adapted to help small pharma mitigate the complexities of drug development
- What success means for small pharma sponsors and how to build a comprehensive strategy to achieve it
The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, enables customers to accelerate innovation and increase drug development productivity. Utilizing patient-centered strategies and data analytics, its capabilities cover multiple therapeutic areas and include early development, all phases of clinical development, peri- and post-approval, novel approaches to patient recruitment and investigator sites, and comprehensive laboratory services. Recognized as a global industry leader in accelerating promising medicines from early development through regulatory approval and market access, PPD clinical research serves serve pharma, biotech, medical device and government organizations with custom-tailored solutions, including full-service partnerships and functional service partnerships. As a strategic partner in clinical development and analytical services, the business applies cutting-edge technologies, therapeutic expertise and a firm commitment to quality to help customers deliver life-changing therapies.