Learn how CRO/CDMOs successfully address operational and regulatory challenges for pharmaceutical and biotechnology clients; and how this can make the difference between study success or failure.

In this webinar we will reveal the inner workings of the manufacturing and pharmacy department of a CRO/CDMO, so you understand the different regulatory and operational considerations faced by a clinical research pharmacy.

You will learn about inherent challenges, and the appropriate mitigation measures and optimization solutions that deliver the most effective results and outcomes.

What will you learn?

• Study planning, including quantity calculation, and how to minimize deviations

• Safely and successfully working with Schedule I products

• Packaging and labeling requirements for different countries and jurisdictions

• Shipping and importation logistics during the COVID-19 era

Who may this interest?

• Small pharmaceutical startups

• Pharmaceutical companies

• University research department heads

Featured Speakers

Ben W. Reed

Vice President, Manufacturing

Ben has more than 15 years' experience in the pharmaceutical industry. He has had management roles in all areas of analytical chemistry, including raw material release, stability and method development. He was the EMS/EHS Manager responsible for ISO14001 certification of a 130,000-square-foot CDMO facility. He has extensive background in manufacturing various dosage forms, from formulation development through clinical manufacturing, and process validation for commercial manufacturing. Additionally, Ben is well experienced in sourcing, purchasing and qualifying new manufacturing equipment, and the design and operation of cGMP manufacturing suites. He also has experience as a Process Engineer focusing on process transfer and process improvement while at PMRS and TEVA. He is a graduate of Cedarville University (BS).

Kevin Kirkcaldy

Pharmacy Manager

Dr. Kevin M. Kirkcaldy, MBA, Pharm.D, is a pharmacist and pharmacy manager responsible for overseeing all activities related to the management of investigational products used in Phase I to IV clinical trials. He has expertise in study planning, protocol reviews, SOP writing, randomization management, cleanroom preparation, dispensing, and HR management. After completing his bachelor's degree in Pharmacy, he owned multiple pharmacies with different banners over the years. He currently owns a Brunet pharmacy, which he has managed for over eight years. He also has experience as a senior product manager in the IT healthcare field. Kevin holds a master’s degree in Business Administration in Pharmaceutical Management from Laval University and a Doctor of Pharmacy from the University of Montreal. He is currently working on a degree in Pharmaceutical Product Development.

Todd Janssen

Director, Pharmacy

Todd Janssen, RPH, is a graduate of the University of Kansas School of Pharmacy, and has been a practicing pharmacist for 27 years. Todd spent the first 20 years of his career as a Pharmacist in the retail sector. In 2012, he transitioned to pharmacy management in the clinical research setting. He has experience with sterile preparations and extemporaneous compounding in all types of early phase clinical studies. Many of the studies that he has worked on require a comprehensive, multi-step procedure to deliver product for administration in trial subjects.

Dennis A. DiBiagio

VP, Business Development

Dennis is a registered pharmacist with more than 36 years’ experience in the pharmaceutical industry. He has an extensive background in pharmaceutical contract manufacturing and operations management of GMP manufacturing facilities. He has collaborated with multidisciplinary teams to develop multiple dosage forms to support all phases of drug development from pre-IND clinical supply through commercial scale manufacturing. Dennis was a founding partner of Pharmaceutical Manufacturing Research Services, Inc. and was Director, Manufacturing Services, responsible for product development, clinical supply manufacturing, commercial manufacturing and facility operations. Dennis has also held various support and leadership positions in product development, manufacturing services and facility management while working at Greenwich Pharmaceuticals and William H. Rorer. Dennis is a graduate of Duquesne University School of Pharmacy (BS).

Ingrid Holmes

Ingrid Holmes, Vice President
Global Clinical Operations

Ingrid Holmes joined Altasciences in 2011 as Vice President of Clinical Operations for Altasciences' Montreal site. Now, as Vice President, Global Clinical Operations, Ingrid's responsibilities include oversight of all Altasciences’ clinical pharmacology units, with 400 early phase beds, a dedicated driving simulator unit with 10 simulators on-site, and purpose-built inhalation facilities. Additionally, Ingrid is responsible for the harmonization of clinical processes across Altasciences’ sites, and acts as Global Compliance Lead within the Quality Management System. Ingrid started her career in clinical research in 1995 at LAB Pharmacological Research. Over the years, Ingrid has held various management roles in early stage clinical operations, progressing to become Director of Business Operations and Continuous Improvement, overseeing the financial and quality performance of five international clinical sites. In her various roles, she has gained extensive experience in the conduct of early phase trials, international regulatory requirements, business operations, quality management systems, and Lean Six Sigma.