PDA Metro Chapter: Annual Chapter Day

Featured Presenters

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  James P. Agalloco, BEChE, MSChE, MBA

  Agalloco & Associates Inc.

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  James P. Agalloco, BEChE, MSChE, MBA

  Agalloco & Associates Inc.

  James Agalloco is President of Agalloco & Associates, a technical service firm to the pharmaceutical and biotechnology industry.  Since the formation of Agalloco & Associates in 1991, Jim has assisted more than 200 health care firms in a wide range of validation, automation and compliance areas.  Jim has over 45 years of industry experience and has worked in organic synthesis, pharmaceutical formulation, pharmaceutical production, project and process engineering, validation and process automation during his career at Merck, Pfizer, Squibb and Bristol-Myers Squibb.  He received his BS in Chemical Engineering from Pratt Institute in 1968 and his MS, also in Chemical Engineering from Polytechnic Institute of New York in 1979.  He received his MBA in Pharmaceutical Studies from Fairleigh Dickinson University in 1983.  He is a past President of the Parenteral Drug Association and served as an Officer or Director from 1982 to 1993.  He is a member of USP’s Microbiology Expert Committee for 2005-2020.  He serves on the Editorial Advisory Boards of Pharmaceutical Technology and Pharmaceutical Manufacturing.  Jim serves on the scientific advisory boards of MEDInstill and Eniware.  He is a frequent author and lecturer on the subject of sterilization, aseptic processing and process validation.

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  Matt Campagna

  Associate Director, Bristol Myers Squibb

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  Matt Campagna

  Bristol Myers Squibb

  With over 8 years of experience in regulatory affairs CMC, I am passionate about supporting the development and global commercialization of innovative cell and gene therapies that can transform patients' lives. My core competencies include developing and implementing successful CMC strategies, preparing and filing global regulatory submissions, and managing and facilitating agency interactions. I am currently an Associate Director, Global Regulatory Affairs CMC Cell Therapy at Bristol Myers Squibb, where I work with a diverse and collaborative team of experts to advance BMS's pipeline of cell and gene therapies.
  
  In my current role, I leverage my skills in bioassay, cell biology, and protein purification to support the CMC aspects of BMS's cell and gene therapy programs, including CAR-T and gene editing products. I am responsible for preparing and filing CMC submissions (including initial IND/IMPD, BLA, post approval variations), as well as responding to CMC questions from global health authorities. I also coordinate and provide strategic input for agency meetings and interactions, ensuring that BMS's CMC positions are aligned with the regulatory requirements and expectations. Prior to joining BMS, I supported the global commercialization of Daiichi Sankyo's ADC pipeline, primarily focused on datopotamab deruxtecan, a novel antibody-drug conjugate for the treatment of various cancers.
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  Thomas Corizzi

  Manager, Digital Capability Managment, Quality Systems, Bristol Myers Squibb

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  Glenn Corrington

  Director, Quality Assurance and Quality Systems, Nevakar LLC

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  Rebecca D. Jordan

  Associate Director, GMSAT, Bristol Myers Squibb

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  Rebecca D. Jordan

  Bristol Myers Squibb

  Rebecca Jordan is Associate Director, GMSAT at Bristol Myers Squibb. She has over 10 years’ experience in industry as a QC Microbiologist, where she has supported both large and small manufacturing firms, commercial facility start-up, development through licensure of parenteral drugs, facility and utilities monitoring, APS, CAPA, and quality risk management to name a few. She has also successfully navigated global regulatory audits, developed and implemented aseptic training programs, established EM trend and disinfectant efficacy programs, and consulted on new facility design projects for CAR-T therapy manufacturing. She is a keen investigator whose curiosity and dedication has led to a diverse and rewarding career. She holds a B.S. in Biology from Fitchburg State University.

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  Carly Krystopik

  Principal Scientist, Bristol Myers Squibb

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  Carly Krystopik

  Bristol Myers Squibb

  Carly is a microbiologist with over ten years of experience, specializing in review of GMP testing and documentation. Ensures current practices are in compliance with industry guidelines and regulatory expectations. Experienced in review of Bacterial Endotoxin (Gel Clot and Kinetic) Routine and Validation, TOC, Conductivity, HPC, Microbial Identification, Bioburden, MLT, Growth Promotion, Antibiotic testing, and AET. Also, skilled in review of autoclave qualifications, Biological Indicator verification and release, and numerous equipment calibrations. Proficient in creation, review and revision of procedures, protocols, reports and forms.
  
  She performs in-process bioburden testing of parenteral products and in-use hold time studies of final products to define commercial labelling requirements.
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  Jennifer Metch

  Plant Microbiologist, Janssen CAR-T

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  Jennifer Metch

  Plant Microbiologist, Janssen CAR-T

  Jennifer is the Plant Microbiologist within the Janssen CAR-T Advanced Therapies Supply Chain and has been with Johnson & Johnson for 26 years. Her areas of focus include collaboration with Process Development team, Quality and Operations organization to successfully transfer process to cGMP facility to manufacture products, define specific aseptic techniques to be performed for crucial process steps and provide input to processing operations, ensure microbiological control strategy is consistent with cGMP and Janssen requirements , design, maintain and deliver aseptic technique and microbiology awareness training program, maintain, re-evaluate and communicate KPIs to site environmental monitoring program, support process microbiological investigations, identify risks and opportunities in relation to contamination control on the manufacturing floor and drive follow-up initiatives for improvement in cooperation with operators, QC and operations management. Jennifer has a B.S in Biology from Stockton University.
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  Ryan Pachuchki

  Principal Scientist, Bristol Myers Squibb

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  Ryan Pachuchki

  Bristol Myers Squibb

  I use my passion and skills at BMS in the Microbiology Center of Excellence. I help support the network with my expertise in validating novel technology and molecular biology. I lead validation and qualification of new technology. My main goal is to help get life saving medicine to patients faster with the highest level of excellence by using my scientific expertise and the validation of novel assays.
  
  I have worked at the New Jersey Department of Health in molecular virology section. My main task was to sequence SARs-CoV2. We sequenced about 200 samples a week and publish those results to GISAID. We were able to detect the first omicron variant in NJ. I have helped validate new assays and I was the main sequencer at the laboratory bench. I am skilled in validating new assays.
  
  My dissertation work was focused on how bacterial infections can increase the severity of the Lupus. I developed a novel ELISA to detect antibodies against bacterial biofilms. I demonstrated these antibodies correlate with disease flares. My passion for science comes from my mother Eileen and Aunt Kas passing away from Lupus and other autoimmune complications. I made a promise to never forget them. May my work be proof of my dedication to that promise and determination to continue to fight against diseases that can cut short the most cherished things in life.
  
  As a result, I am willing to use my talents to serve the community for a larger accomplishment than my own endeavors to increase human health quality.

  
  
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  Alicia Riesgo

  Compliance, Sr. Regional Director, IPS

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  Robert D. Seltzer

  Principal Consultant, Worldwide GMP Compliance Professional