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Outsourcing Best Practices Panel

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Contributors

  • Corey Nehls

    Corey Nehls is Senior Vice President of PPD’s Bioanalytical Laboratories located in Richmond, Virginia and Middleton, Wisconsin. He is a graduate of the University of Wisconsin – Madison. Over the past 31 years, he has held increasing levels of responsibility at PPD, from his beginnings as a bench scientist to his current position as Senior Vice President with over 700 staff. During his career, Corey, and his management team have provided bioanalytical support for thousands of preclinical and clinical trials. At PPD, Corey has led nineteen successful on-site regulatory inspections, sixteen FDA and three ANVISA. He is a graduate of PPD’s executive leadership development program and has served as a laboratories representative on a special advisory committee to the CEO.

  • Mario Rocci, Jr., Ph.D., FCP, FFIP

    Dr. Rocci currently serves as Chairman of the Board of Directors of Solvias AG and as an Executive Advisor to IMA Clinical Research. He has previously served in various executive roles including President of ICON Development Solutions, and Chief Executive Officer of Prevalere Life Sciences, Inc. Dr. Rocci began his professional career with academic appointments at the Philadelphia College of Pharmacy and Science and the Division of Clinical Pharmacology in the Department of Medicine at Jefferson Medical College.

    Dr. Rocci currently serves as the Chairman of the Dean’s Advisory Committee for the School of Pharmacy and Pharmaceutical Sciences at the University at Buffalo, SUNY, and as a Member of the Industrial Advisory Committee in the School of Pharmacy at the University of Kentucky. Previous professional service includes Chairman of the Product Quality Research Institute, President of the American Association of Pharmaceutical Scientists (AAPS) and President of the American Society for Clinical Pharmacology and Therapeutics (ASCPT).

    Dr. Rocci has one patent and over 140 publications to his credit, including a book on regulated bioanalysis in drug development. He currently serves as an Associate Editor of The AAPS Journal.

    Dr. Rocci is a Fellow of the American College of Clinical Pharmacology (ACCP) and the International Pharmaceutical Federation (FIP). He has received the Distinguished Service Award from AAPS, the Willis G. Gregory Memorial Award from the School of Pharmacy and Pharmaceutical Sciences at the University at Buffalo, SUNY and the Henry W. Elliott Award from ASCPT.

  • Robyn Rourick

    Robyn A. Rourick is a Director in Bioanalytical Sciences at Genentech, Inc. where she oversees bioanalytical outsourcing strategies for PK, ADA and biomarker analysis in support of clinical sample analysis. She is particularly keen on aligning with CRO partners on industry advances in analytical technologies creating benefits in patient care. For 4 years prior, Robyn was a Sr. Manager in Nonclinical Study Operations where she oversaw GLP and non-GLP outsourced non-clinical studies in support of pre and post IND programs. She served as a liaison between cross functional groups for study related requirements as well as developed strategies to address operational efficiencies and process gaps in study execution. Prior to Genentech she held the position of Director, Pharmaceutical Sciences, at Kalypsys, Inc. Her primary responsibilities involved analytical and pharmaceutical development activities in support of early phase clinical programs. Prior to Kalypsys, Robyn was Associate Director of DuPont Pharmaceuticals Research Labs and previous to that was Group Leader, Analytical Technologies at CombiChem, Inc. where she was involved in building an ensemble of analytical assays to assess performance of discovery compounds against the development milestones faced by a pharmaceutical agent. Prior to CombiChem, Robyn held positions of increasing responsibility over the course of 10 years at Bristol-Myers Squibb. During this time, she championed the integration of LC/MS in different phases of drug development.

    Robyn A. Rourick received her B.S. in Chemistry from Fairfield University and her MS in Forensic Chemistry under the direction of Dr. Henry Lee at the University of New Haven. Robyn is a Board Member of the Pharmaceutical & BioScience Society (PBSS) and chairs the San Diego Chapter. She is a founding member of the Clinical & Pharmaceutical Solutions through Analysis (CPSA) Charitable Foundation and an organizing committee member for CPSA USA.

  • Danièle Schott

    Danièle Schott is Head of the Business Unit Specialized Expert Analytical Solutions (S.E.A.S.), Site Head and a member of the Executive Committee of the Solvias Group.

    Based in Switzerland, Solvias is a global laboratory services platform that specializes in developing, analyzing, and testing a wide range of biological and chemical substances and products for life science companies. Solvias also offers one of the largest proprietary ligand portfolios for catalytic transformations and a suite of related custom synthesis and catalysis technology services.

    After her PhD in chemistry and a couple of years in research in academy, Danièle started her industrial career at Solvias in 2007, as a business development manager and soon developed a passion for fostering customer relations, developing market growth strategy, in combination with the dynamic landscape of the Health Care industry with the ultimate aim of serving the patient needs. She then took a role as Key Account Manager where the concept of partnership in the customer supplier relation became even more of an evidence. In 2013 she joined the Lonza group, where she lead teams of Key Account Managers in Europe and globally within the Biosciences business unit. She and her team eventually move on to play a key role in the strategic market share development and positioning for Cell and Gene Therapy media at a global level. In 2018, she rejoined the Solvias Group as the Business unit Head S.E.A.S.

    Her passion for finding solutions together with the customers to accelerate the access to treatments for patients, while encompassing regulatory, scientific, supply, business imperatives has only grown over the years. In her different roles, she aims at transmitting her passion to the people working with her.

  • Andrew Vick, Ph.D.

    Dr. Andrew Vick has 23 years of experience working within the biotechnology and pharmaceutical industry in the fields of toxicology, nonclinical and clinical pharmacology, and drug disposition (PK/PD). Most recently, he has held senior leadership roles with Contract Research Organizations where he has provided strategic counsel to the biopharmaceutical industry.

    Currently, Dr. Vick is responsible for financial, operational, and scientific oversight of all Midwest sites within Charles River’s North American Safety Assessment business. In this role, Dr. Vick oversees a biomedical staff of >3,000 who are involved in diverse aspects of nonclinical (toxicology, pharmacology, reproductive toxicology, laboratory sciences, etc.) and clinical (bioanalysis, PK/PD data analysis, etc.) development. These services include a full range of in vivo and in vitro testing capabilities that comply with global regulatory requirements in support of pharmaceuticals, animal health products, and agrochemical products. He also serves as the Executive Sponsor to several global pharmaceutical companies, where he provides strategic advice, customized program and study designs, regulatory advice, and risk mitigation tactics.

    Prior to joining Charles River, Dr. Vick was Vice President, Analytical Services for WIL Research, overseeing scientific and operational aspects of the analytical, formulations, bioanalytical, metabolism, and pharmacokinetic services for the sites in the US. Prior to WIL Research, he was Executive Vice President and Senior Director of Pharmacokinetics, Dynamics, and Metabolism at Seventh Wave Laboratories. Previous roles have included: Scientific Director of the BioPharma Services Division of Millipore, Principal Scientist within the Drug Disposition and Toxicology department of Eli Lilly and Company, and a preclinical scientist at Biogen. In these roles, Dr. Vick contributed to the design, conduct, and interpretation of preclinical and clinical testing strategies for both small organic and biotherapeutic molecules across a variety of therapeutic indications and stages of development.

    Dr. Vick earned his B.S. in Zoology and Ph.D. in Pharmaceutical Chemistry from The Ohio State University. He has continued his support of the University through service on the Dean’s Corporate Council for the College of Pharmacy, and he recently joined the Division of Pharmaceutical Chemistry as an Adjunct Professor. Dr. Vick also serves in the role of President for the American Association of Pharmaceutical Scientists.

April 28, 2021
Wed 1:00 PM EDT

Duration 1H 30M

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