David Schoneker is president, Black Diamond Regulatory Consulting, LLC

Videos

In part 3 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, talks about the collaboration between the pharma company and the excipient supplier when different routes of administration are considered for an ingredient.

Excipients and Intended Use

Virtual control groups, automation, novel excipients, and sustainability are some of the topics covered by PharmTech this week.

PharmTech Weekly Roundup—May 1, 2026

Avi has 20 years of industry experience in gene therapy, viral vectors, and vaccines. He is currently the President of SK pharmteco Cell and Gene North America managing the business unit. Previously he worked at Novartis Gene Therapies where he supported a pipeline of 15+ gene therapy products in development from preclinical to Phase III development and led the development and implementation of 4 gene therapy manufacturing processes across 4 CGMP and 3 laboratory sites. Prior to his role at SK pharmteco, Avi was the Chief Technical Officer at the Center for Breakthrough Medicines. His prior positions include Head of Technical Development at Novartis Gene Therapies, Director of Manufacturing Science & Technology at Avexis, Inc., and Product lead at Seqirus. Avi holds an MS in Biology from Adelphi University and an MBA from the University of North Carolina Kenan-Flagler Business School.

Avi Nandi, SK Pharmteco, explores the benefits, challenges, and sustainability impact of on-site media and buffer manufacturing for cell & gene therapy.

Avi Nandi on Simplifying Cell & Gene Supply Chains

Senior Director
Education, Outreach, and Digital Experience
Open Biopharma Research and Training Institute

In this episode of Manufacturing Intelligence, we break down digital twin use in pharma, from risk reduction and scale-up modeling to AI integration and virtual inspections.

Manufacturing Intelligence: Unpacking Digital Twin Use in Pharma Manufacturing

Sr. Fellow
Aseptic and Sterile Products
CRB Group

Fellow
Aseptic & Sterile Products
CRB Group

Todd Vaughn and Christa Myers discuss how Robotics are reshaping aseptic pharmaceutical manufacturing by improving efficiency, repeatability, and compliance while demanding new operator skills.

Todd Vaughn and Christa Myers on What Robotics Mean for Pharma Manufacturing

, Associate Director, Product Management, Digital Projects at Charles River.

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Alternative methods to the use of animals in pharmaceutical testing are becoming more used and accepted. Laura Lotfi of Charles River breaks down the basics of virtual control groups in drug development.

Pharma Fundamentals: Using Virtual Control Groups to Reduce Animal Testing in Drug Development

In part 2 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, explains what drives the need for the development of a new excipient and how involved regulators are in the process.

Regulatory Involvement in Excipient Development

Portfolio Manager
Intensified Downstream Systems
Sartorius

Global Technical Product Specialist
Thermo Fisher Scientific

Stuart Tindal and David Chau discuss spectroscopic sensor selection for continuous bioprocessing and how industry collaboration drives shared innovation.

Stuart Tindal and David Chau on Sensors, Standards, and Shared Progress

Rich Sanderson is Regional Operations Director for IPS in Pennsylvania. Rich brings extensive EPCM experience and almost three decades in construction management in the UK and US, including 25 years in US life sciences. For the past 8 years with IPS he has served as an Operations Director leading large, complex EPCM projects and teams for major clients including Merck and GSK. He is recognized for his ability to elevate team performance through Lean practices, collaboration and align stakeholders to deliver outcomes.

Richard Sanderson, IPS, discusses pharma capital project cost pressures, bloated deliverable lists, and making the case for EPCM's end-to-end delivery model.

Richard Sanderson on EPCM vs. Construction Firms

Director 
Life Sciences Global Accounts
Rockwell Automation

Industry Manager - Life Sciences
Endress+Hauser

Director of Digital Solutions
Endress+Hauser

At INTERPHEX 2026, Mel Radford, Bethany Silva, and Jason Pennington explore data trust, cybersecurity, organizational barriers, and KPI-driven thinking in smart pharma manufacturing adoption.

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