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Formulation & Development

Anil Kane, Ph.D., MBA

Executive Director, Global Head of Technical & Scientific Affairs

Dr. Kane has more than 25 years of experience in the science and business of taking molecules through the entire drug development process. His extensive knowledge spans early stage development to scale-up and commercial manufacturing, and includes technology transfers between global sites and life cycle management.
Publications
Anticipating the Formulation Challenges of Complex Molecules Phase Appropriate Formulation Process Design
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Softgels

Kaspar van den Dries, Ph.D.

Senior Director Formulation Sciences, Solid Dosage Forms and Softgels

Dr. van den Dries leads the European R&D team in the development of innovative softgel formulations, processes and technologies. He is an expert in the formulation of poorly soluble compounds and self-emulsifying drug delivery systems with experience spanning the entire solid dosage form development cycle.
Publications
Are You Prepared for the Complexity of Pediatric Drug Development?
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API (Small Molecule)

Peter Poechlauer, Ph.D.

Innovation Manager, Small Molecule API

Dr. Poechlauer possesses more than 25 years of experience in biocatalysis and oxidation chemistry. He is an expert in the application of innovative technologies, such as process intensification and microreactor flow chemistry, to small molecule API process development.
Publications
What You Need to Know to Avoid Costly Delays in Your API Scale-Up
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API (Small Molecule)

Michael Cruskie, Ph.D.

Executive Director and General Manager

Dr. Cruskie has more than 20 years of experience working with small molecule APIs, ushering them from early development to scale-up and commercial manufacture. His areas of expertise include supply chain management, technology transfers, project management and business development.
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Formulation & Development

Tony Pidgeon

Director, Business Management

Tony Pidgeon has nearly three decades of experience in the formulation and process development of sterile and solid products, both small molecule and biopharmaceuticals. He is an expert in exploiting the advantages of single-use manufacturing technologies.
Publications
Choosing the Best Sterile Dosage Form for Your Phase I Clinical Supply Needs
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API (Small Molecule)
Formulation & Development

William E. Weiser, Ph.D.

Senior Director, Pharmaceutical Development Services

Dr. Weiser is an expert in analytical method development and validation for APIs and drug products. His expertise includes stability program development, analytical method troubleshooting, preparation of the CMC Section of IND/NDA/CTD submissions, and U.S. agency for European API manufacturers.
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Formulation & Development

Sanjay Konagurthu, Ph.D.

Senior Director, PDS Global Science and Technology

Dr. Konagurthu has more than 17 years of experience managing and assisting in the development of compounds from discovery through clinical and commercial manufacturing. He has extensive experience in oral solid dosage forms including solubility enhancement and modified release.
Publications
Manufacturing Process Scale-up for Phase III: Clear Sailing or Storms Ahead?
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Formulation & Development

Marshall Crew, Ph.D.

GVP, Head of Strategy

Dr. Crew has 18 years of experience in drug delivery, formulation development, process design, solid state characterization and computational modeling. He is a recognized innovator in drug delivery and solubilization, including controlled-release, nanotechnology and solid dispersions.
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Commercial Manufacturing

Mirko Gabriele

Production Director

An expert in scale-up and technology transfers, Mr. Gabriele’s over 10 years of pharmaceutical industry experience includes API bulk production, quality control and research and development.
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Biologics (Large Molecule)

Paul Jorjorian

Head of BioProcess Sciences

Paul Jorjorian is an expert in the purification of biotherapeutic proteins (chromatography, filtration, viral reduction), technology transfers, viral clearance studies and process characterization (QbD/DoE). His current responsibilities include refining the integration of technology transfer processes across our global biologics network.
Publications
Top 5 Considerations When Looking to Outsource to a Biomanufacturing Partner
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Biologics (Large Molecule)

Steve Lam

Senior Vice President, Biologics

Steve brings more than 25 years of leadership experience in biopharmaceutical operations with a focus on manufacturing and commercializing human therapeutics. His deep industry experience has contributed to the growth of companies including Amgen where Steve spent the past 18 years of his professional career. Steve earned a bachelor of arts in chemistry from Knox College in Galesburg, Illinois.
Publications
So Many Choices: What's the Right Biomanufacturing Strategy for Me? Managing Demand Uncertainty in Biologics Production Top Five Risks Facing Your Small Biopharma Clients Today
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Commercial Manufacturing

Eric Jayjock, PhD

Director of Continuous Manufacturing

Eric is focused on developing highly flexible, highly capable continuous manufacturing framework to serve the diverse needs of the pharmaceutical industry. Eric performed his graduate studies at Rutgers University where he was a part of the NSF Center for Structured Organic Particulate (C-SOPS) systems. At Rutgers, his main area of research was the development of scalable manufacturing processes for oral solids dosages.
Publications
Solving the OOS Problem with Continuous Manufacturing

Contact us today to utilize our network of API and biologics experts for your upcoming development or commercial project.