Business Unit Leadership
Regulatory Operations: ePublishing/Submissions
Regulatory Project Management
Norman W. Baylor, PhDPresident & Chief Executive Officer
Dr. Baylor joined Biologics Consulting after 20 years with the Food and Drug Administration (FDA), most recently as the director of the Office of Vaccines Research and Review (OVRR).
In his prior position at the FDA’s Center for Biologics Evaluation and Research, Dr. Baylor was responsible for planning, developing, and administering CBER’s broad national and international programs and operational activities involving vaccines and related products. He has also served as the FDA’s liaison to CDC’s Advisory Committee on Immunization Practices, and the DHHS National Vaccine Advisory Committee. Dr. Baylor continues to serve as an expert advisor to the World Health Organization in addition to providing strategic consulting to Biologics Consulting clients in the areas of vaccines and vaccine-related products.
PhD, Molecular Microbiology, University of Kentucky (1985)
MS, Microbial Genetics, University of Kentucky (1981)
BS, Medical Microbiology, University of Wisconsin-Madison (1978)
Ken Guito, MBAChief Operating Officer
Kenneth Guito, MBA was hired as Chief Operating Officer (COO) of Biologics Consulting Group, Inc. in 2019, following a 35-year career in the Biotech/Biopharmaceutical Industry. Prior to joining Biologics Consulting, Mr. Guito was with Sanofi Pasteur Inc. (1990-2015), most recently serving as General Manager, Sanofi-Topaz, Inc., a subsidiary company. In this role he was responsible for all operational activities for the company. Prior to this, he held senior level positions in Corporate and Business Development where he was responsible for executing the strategic directive for the organization’s continued growth; the evaluation of in-licensing and acquisition opportunities and execution of transactions. He began his professional career in pharmaceutical development where he held senior leadership positions in Product Development, Clinical Affairs, and Regulatory Affairs for Sanofi-Pasteur Inc. and Schering Corporation. During his tenure, he was a principal force in bringing nine, small and large molecule products through development to commercial success. Mr. Guito has served on the Board of Directors for Ben Franklin Technology Partners since 2012; Board of Directors for Life Sciences PA 2006 – 2013; and the PA Academy of Science, Advisory Board 2006 – 2008. In his role as COO of Biologics Consulting Mr. Guito is responsible for developing and implementing the operational objectives and supporting the strategic direction of the company.
Michael J. Grace, PhDBusiness Unit Lead – CMC
Dr. Michael Grace joined Biologics Consulting in June 2020 as Head of the CMC Business Unit. Dr. Grace has over 30 years CMC experience as a Senior Executive encompassing CMC from analytical development and drug substance/product development, to drug substance and product manufacturing, fill-finish, QC testing and release, packaging and labelling, and supply management and distribution. As a Senior Executive in the BioPharma industry, he has had responsibility for both Development Operations and Technical Operations/Manufacturing and experience in working capacity and capability from all-internal to pure-play external as well as hybrid internal/external models. His CMC experience ranges from pre-clinical/Phase 1-entry programs through Phase 3 registration and licensing programs. He has both supervisory and hands-on experience with Module 3 dossier writing, compilation and review, and has had numerous successful interactions with FDA, EMA, and other ROW RHAs, that have resulted in helping to place nine commercial products (interferon, fusion-proteins, IO mAbs, and therapeutic peptides) on the market.
As Vice President of Technical Operations & Manufacturing at Advaxis Inc., Dr. Grace led a rapid Phase 3 analytical and process development program, followed by validation and technical transfer to an EU CDMO for the MAA registration submission for an IO vaccine product. He also led the de novo establishment of an internal cGMP facility for Phase 1 manufacture of patient-specific IO vaccines. He lead and supervised the Module 3 activities for the MAA as well as several initial and updated INDs and IMPDs.
Prior to Advaxis, Dr. Grace lead Analytical Development/Technical Operations at NPS Pharmaceuticals. His leadership and subject matter expertise helped resolve drug product process and manufacturing issues that resulted in the successful FDA approval of Natpara (rhPTH (1-84)). He lead and supervised Module 3 activities for the Natpara BLA and MAA, Natpara INDs and IMPDs, and worked with FDA and EMA to address review questions and RFIs. He also lead the analytical and process review for the commercial transfer of Gattex (teduglitide) from Takeda to NPS Pharmaceuticals.
As an Executive Director in Biologics Process & Product Development at Bristol-Myers Squibb, Dr. Grace lead Phase 3 CMC bioanalytical development and validations for Orencia (abatacept) and Orencia SC, Nulojix (belatacept), and Yervoy (ipilimumab), as well as Phase 2 bioanalytical development for Opdivo (nivolumab). Dr. Grace lead the BLA, sBLA, and MAA Module 3 analytical sections authoring, compilation and review activities, and was responsible for pre- and post-approval world-wide RHA interactions for Orencia, Nulojix and Yervoy.
Dr. Grace began his career at Schering-Plough Corporation where he started as a bench-scientist leading a bioassay development laboratory. At Schering-Plough, he had increasing responsibilities in technical and managerial scope within bioanalytical and biophysical development in Biotechnology Development at the Schering Plough Research Institute.
Dr. Grace received his Ph.D. in Biochemistry from the University of Nebraska, in the laboratory of Dr. Naba Gupta while working on mammalian protein synthesis. He received his B.S. in Chemistry cum laude, from the University of Nebraska.
Calley A. HardinBusiness Unit Lead – Medical Devices
Calley A. Hardin joined Biologics Consulting as a Consultant (Medical Devices) in February 2009.
Calley came to Biologics Consulting with over 8 years of experience in various technical engineering roles, including 3 years of experience as a Biomedical reviewer at FDA in the Office of Device Evaluation, Division of General, Restorative and Neurological Devices, General Surgery Devices Branch. At FDA, Calley was involved in the review process for 510(k)s, IDEs and as lead reviewer for PMAs. Calley’s combination of industry and FDA experience positions her to provide clients with a specialized understanding of regulatory processes and the challenges they may encounter when interacting with the agency.
Calley holds a BS in Biomedical and Electrical Engineering from Vanderbilt University.
Calley served as a Consultant / Senior Consultant on the Medical Device Team for 12 years. As the Business Unit Lead for the Biologics Consulting Medical Device Team, Calley is responsible for:
• Business development including new client intake, client satisfaction and ensuring that we remain a consulting firm of choice by reputation in the medical device community.
• Managing the current device team members, recruit new talent, and improve all team processes.
BE, Biomedical and Electrical Engineering, Vanderbilt University, Nashville, TN (2000)
Kris Kraihanzel, MBA, MABusiness Development Lead
Mr. Kraihanzel joined Biologics Consulting in July 2021 and has over 20 years of experience in multiple corporate roles within both profit and non-profit industries which adds to his depth and breadth of skills and insight. Most recently, he has direct business development experience providing GXP consulting solutions to various sizes of pharmaceutical companies internationally. Mr. Kraihanzel also has wide range of business development coaching, business growth strategy, and relationship management expertise which directly impacts and supports life science clients with quality and value-add assistance.
Kris previously worked for Advarra Consulting as Director of Business Development for nine years and assisted over seventy-five clients with repeated GXP engagement support. In addition, he helped mentor younger business development professionals to be useful at client-engagement processes which advanced life science research and life-saving solutions to patients globally.
David J. Pepperl, PhDBusiness Unit Lead – Nonclinical Development
David Pepperl, PhD, is a pharmacologist and toxicologist with experience in the early stage development of biologic products. Prior to joining Biologics Consulting, David served as toxicologist and preclinical development scientist at TherImmune Research Corporation, where he drafted nonclinical development plans, authored nonclinical sections of regulatory submissions and managed preclinical development programs for clients.
Dr. Pepperl’s early work focused on in vitro and cell biological models of drug action, safety and signaling. During his tenure at Biologics Consulting, he has designed and overseen numerous nonclinical development programs for a variety of biologic products, including cell and gene therapies, vaccines, blood products, monoclonal antibodies and protein therapeutics as well as small molecules. In addition to protocol and study report reviews, Dr. Pepperl routinely performs nonclinical safety assessments, and both authors and reviews development plans for a diverse array of drugs and biologic products. He has written numerous nonclinical sections of pre-INDs, INDs and CTDs behalf of clients, and routinely assists sponsors with FDA meetings and other interactions with regulatory interactions. Dr. Pepperl has also worked closely with sponsors to source and manage bot non-GLP and GLP safety studies at contract research organizations (CROs) and routinely performs GLP compliance inspections of behalf of clients.
David received his BS in Biochemistry from Michigan State University in 1988, and his PhD in Pharmacology & Toxicology from the University of Arizona in 1994 with an emphasis on the pharmacology and signaling of G-protein coupled adrenergic receptors. He completed post-doctoral work at Pharmacia and Parke-Davis Pharmaceuticals. Dr. Pepperl joined Biologics Consulting as a Senior Consultant in January of 2004 and has served as Pharm/Tox team leader since 2015. He currently resides with his family in Montgomery Village, Maryland, and enjoys cycling, fitness and hiking.
PhD, Pharmacology and Toxicology, University of Arizona, Tucson, AZ (1994)
BS, Biochemistry, Michigan State University, East Lansing, MI (1988)
HeeSun SmaldoreBusiness Unit Lead – Project Management
Ms. Smaldore joined Biologics Consulting in May 2016 with over nine years of regulatory affairs experience. She supports Sponsors with product development related to INDs, BLA/NDAs, Orphan Drug Designations and amendments and supplements as needed. She serves as the U.S. Agent Representative for Sponsors and interfaces with the FDA on a consistent basis and attends FDA-Sponsor meetings. She is familiar with FDA regulations and guidance, as well as policies and procedures at CBER, CDER, and OOPD.
Ms. Smaldore provides regulatory guidance, project management and submission support for original applications and lifecycle management. She has extensive submission experience in legacy, CTD and eCTD formatted applications. Her experience in electronic publishing allows her to advise Sponsors with the best practices to implement during writing efforts in order to support compliant electronic submissions and lifecycle management of an application.
Most recently, Ms. Smaldore was the Regulatory Affairs Manager at Aclairo Pharmaceutical Development Group, Inc. where she managed the regulatory services, including regulatory strategy and operations, project management and ongoing application maintenance. She served as U.S. Agent for foreign Sponsors as well as Authorized Representative for U.S. based companies needing regulatory support. In addition, Ms. Smaldore attended many FDA meetings, performed literature searches, assisted in writing and QC of nonclinical 2.6 sections and regulatory documents (briefing documents, IBs, annual reports, FDA waivers, regulatory strategy memos and position papers).
Prior to Aclairo Pharmaceutical Development Group, Inc. she was at Parexel as a document specialist where she gained experience in electronic publishing and managed regulatory submissions for various regulatory authorities. At CROfessionals, Ms. Smaldore was a regulatory affairs associate where she gained project management, regulatory writing and clinical trial experience.
BS, Biology, George Mason University, Fairfax, VA
Benjamin H. WimmerDirector/Business Unit Lead – Regulatory Operations: Publishing/Electronic Submissions
Benjamin Wimmer joined Biologics Consulting in November 2009 and leads the Regulatory Operations: Publishing/Electronic Submissions team.
Prior to joining Biologics Consulting, Mr. Wimmer worked for the Electronic Publishing team at Pharmaceutical Product Development (PPD), a global contract research organization, and as an Editor’s Assistant for the Journal of Geophysical Research at the American Geophysical Union.
His expertise lies in US-Regional eCTD publishing, validation, and submission of electronic applications (Pre-INDs, INDs, BLAs, NDAs, DMFs, ANDAs) and lifecycle maintenance to the FDA via the Electronic Submissions Gateway. He also has experience in eCTD and NeeS regulatory submissions to Health Canada and the EU.
BA, English (Professional Writing), University of North Carolina Wilmington, Wilmington, NC (2006)
Kerin L. Ablashi, MSConsultant
Ms. Ablashi has been working in the biotech industry since 1990 and joined Biologics Consulting in 2005. As a CMC Technical Writer at Biologics Consulting, Ms. Ablashi utilizes her GMP manufacturing, quality, and project management experience to assist clients with the preparation of CMC portions of their regulatory submissions to the FDA, EMA, and other regulatory bodies. Specifically, Ms. Ablashi writes and reviews the Quality Overall Summary (QOS, CTD Section 2.3) and CTD Module 3 sections of pre-IND, IND, BLA, NDA, PAS, and Master Files in accordance with ICH M4Q. To do this, she interacts directly with each client’s SMEs and regulatory experts. Ms. Ablashi also prepares and reviews worksheets, white papers, and SOPs. Since joining Biologics Consulting, Ms. Ablashi has also reviewed completed batch records and laboratory notebooks, assisted with the preparation of an Investigator’s Brochure for an early-phase clinical project, performed review of the Tables, Listings, and Figures of clinical data for an MAA / BLA submission, mapped the contents of a traditional “Section 7” CMC Section to a CTD Module 3 section. She has also served as a regulatory project manager for Biologics Consulting clients, which involves coordinating the preparation of regulatory submissions and serving as the point of contact with FDA Regulatory Project Managers. Her clients range from academia to industry, with projects in all phases of clinical development, from Pre-IND to post-marketing.
Ms. Ablashi received a BS in General Biological Sciences at the University of Maryland, College Park, in 1989 and earned a MS in Environmental Biology from Hood College in 2000. After completing her undergraduate education, she went on to work with HIV and other infectious viruses at Universal Biotechnologies (1990 – 1991) and then at Microbiological Associates (now BioReliance) (1991 – 2001). At BioReliance, she worked first in a GLP testing environment and then in the cGMP manufacturing facility, producing and supervising the production of gene therapy and cell-associated products for clinical use. She also supervised the cGMP Cell Banking suite before moving into technology transfer / process development group. In 2000, Ms. Ablashi became a Project Manager specializing in GMP Manufacturing. From there, she moved to become a Project Manager handling the CROs and CTOs for manufacturing and preclinical testing at Biosynexus Incorporated, a biopharmaceutical company specializing in anti-staphylococcal agents.
MS, Environmental Biology, Hood College, Frederick, MD (2000)
BS, General Biological Science, Emphasis in Zoology, The University of Maryland, College Park, MD (1989)
Debra Barngrover, PhDSenior Consultant
Debra came to Biologics Consulting with over 25 years of experience in the biopharmaceutical industry. Prior to joining Biologics Consulting, she was Vice President, Technology, at Genzyme Corporation. During her tenure at Genzyme, she led the process development team for a recombinant protein from initial product concept through approval to market launch in over 40 countries, and managed the Technology Development group responsible for development of more than 15 small molecule, protein and viral vector products, including seven commercial products. She provided managerial leadership to process development, analytical, formulation development, project management, manufacturing package and label engineering and risk management functions. She has authored and reviewed several CMC BLA submissions and participated in agency meetings and plant inspections. She was responsible for developing a Supply Chain Risk Management program, which monitored the risks and mitigation strategies for the commercial supply chains, many involving Contract Manufacturing Organizations around the world. Additionally, she has experience in designing packaging and logistics solutions for cold chain products to multiple markets. She has taught courses in regulatory strategy, mammalian cell culture, supply chain and recombinant protein development for RAPS, ISPE, ASME and other organizations. She holds a B.S. from Colorado State University and a Ph.D. degree in Biochemical Nutrition from Cornell University.
As a Senior Consultant in Regulatory / Manufacturing at Biologics Consulting with 4 years of experience, Debra utilizes her broad technical and project management expertise to assist clients in the following areas:
- Gap analysis for regulatory filings
- Preparing and reviewing CMC sections of regulatory filings (pre-INDs, INDs, BLAs, sBLAs)
- Protein, cell therapy and viral vector process development, technology transfer and scale-up
- Product development planning, program and alliance management
- Strategic capacity planning, make/buy decisions, CMO selection and management
- Temperature sensitive distribution strategy development and packaging design
- Biosimilar development
- Risk analysis, FMEA workshops and determination of process control strategies
- Preparing for facility inspections
PhD, Nutritional Biochemistry, Cornell University, Ithaca, NY
BS, Colorado State University, Fort Collins, CO
Diana M. Colleluori, PhD, MBASenior Consultant
20 years of domestic and global experience in analytical methods, quality control, CMC regulatory affairs, and strategic planning in both start-up and growth organizations focused on biotechnology products, including cell and gene therapy products. Key technical experience includes potency assays, release and characterization assays, stability, specifications, raw materials, and all associated quality documentation. Direct experience authoring IND/IMPD and BLA/MAA sections and briefing documents.
Christopher Bussineau, PhDSenior Consultant
Chris joined BC as a Senior Consultant in 2015 after two years as an independent CMC consultant and more than 25 years of experience in the development, manufacturing, and quality control of clinical and commercial biopharmaceutical products, as well as IVDs. 14 of those years were in plant management with primary responsibility for operational success and maintaining regulatory licenses. Since 1994 Chris has been leading teams in process improvement, technology transfer, quality improvement, facility design, and validation. He has supported no less than 40 large-molecules (antibodies, vaccines, and peptides), 6 gene therapy products, 5 live biotherapeutic products, and 10 small molecule APIs bridging Pre-clinical development to Post-approval lifecycle management. His authoring at BC alone includes 22 IND/IMPDs, 8 BLAs, 2 Type V Master Files, a 510(k), and 12 formal FDA meeting background packages.
Prior roles include VP of Operations at One Lambda, Inc., VP of Pharmaceutical Operations at BioVascular, Inc., Vice President and General Manager of Cambrex BioScience Baltimore, Inc., and Senior Director of Technical Operations at Chiron Corporation. He holds a PhD in Chemical Engineering from William Marsh Rice University and a BA in Chemistry from the University of California at San Diego. Active with the Parenteral Drug Association since 2001, he contributed to Technical Reports #42, #14, and #15, and was on the Biotechnology Advisory Board.
His expertise and interests include technology transfer; facility and process engineering design; process development; technical troubleshooting; cell substrate, drug substance, and drug product characterization; annual production reviews; due diligence; supply chain analysis; microbiology support; manufacturing oversight (man-in-plant); quality systems support; risk management; FMEA; training; operations strategy; operational excellence; validation of cleaning, equipment, process, and software; vendor qualification and audits; regulatory submissions support for your Annual Report, IND, NDA, ANDA, BLA, IMPD, MAA, and 510K; formal FDA meeting requests and briefing documents; supplier and GMP audits; mock pre-approval inspection auditing; CAPA and deviation investigation and resolution; vaccines; blood products; cell and gene therapy; recombinant proteins; monoclonal antibodies; live biotherapeutic products; oligonucleotide products, small molecule APIs; and human microbiome products.
PhD, Chemical Engineering, Rice University, Houston, TX (1986)
BA, Chemistry (Biochemistry emphasis), University of California, San Diego, CA (1977)
Hitendra (Vijay) Jethwa, PhD, MBASenior Consultant
Vijay Jethwa, PhD joined Biologics Consulting as a Senior Consultant (Analytical/CMC) in 2013. Vijay comes to Biologics Consulting with over 25 years of industry experience in the development, validation, and routine performance of potency assays, cell-based bioassays, and immunoassays for diagnostics, PK/PD studies, drug substance & drug product characterization, lot release, and stability, as well as immunogenicity assessments.
Most recently, he started up the new GMP Bioanalytical Laboratories at the Merck Vaccines Facility in Durham, NC. His group developed and transferred analytical methods for the characterization and release of live virus vaccines. Prior to joining Merck, Vijay was at Biogen Idec for over 12 years in various capacities including leading all CMC activities related to biosimilar development and serving as the site-head of the cGMP Bioassay, Microbiology, and Virology QC Laboratories. He established GLP testing laboratories at Biogen, including laboratory design, equipment sourcing and validation, supporting antibody and PK/PD testing for various GLP/GCP studies.
Vijay prepared and presented Quality sections for Regulatory advice meetings and has authored, reviewed, and approved sections of several regulatory submissions (IND, IMPD, BLA, etc.) Vijay has presented on bioanalytical topics at several national and international scientific symposia.
As a Senior Consultant with Biologics Consulting, Vijay will utilize his broad technical expertise to assist clients in the following areas:
- Development and Validation of Bioassays and Immunoassays for potency and immunogenicity
- CMC Analytical support
- QA/QC support
- GLP and GMP auditing, including focused data integrity audits
- Regulatory submission gap analyses, writing and review (IND, IMPD, BLA, etc.)
Areas of Expertise
- 25+ years of experience in the development, validation, and routine performance of bioassays and immunoassays for potency, host cell protein assays, host cell DNA assays, PCR-based mycoplasma testing, rapid microbiology assays, and immunogenicity assessments.
- Biologics pre-IND through post-marketing CMC Analytical support including strategy and execution (Technical and Regulatory)
- Laboratory Quality Systems development and implementation
- Global GLP/GMP auditing, including PAI-preparedness and Data Integrity Auditing
- Development of Biosimilars
- PhD Molecular & Cellular Pathology; MBA Leadership & Strategy
MBA, Kenan-Flagler Business School, University of North Carolina, Chapel Hill, NC (2012)
PhD, Molecular and Cellular Pathology, University of North Carolina, Chapel Hill, NC (1998)
BS, Medical Technology, University of North Carolina, Chapel Hill, NC (1992)
BS, Biology, University of North Carolina, Chapel Hill, NC (1987)
Vincent J. Narbut, MBASenior Consultant
Vincent Narbut, MBA joined Biologics Consulting as a Senior Consultant (Biopharmaceutical Products) in February 2011. Vince has over 30 years of experience in the biopharmaceutical industry including technical expertise and management experience in process development, manufacturing, engineering, IT and quality assurance. Since joining Biologics Consulting, his work has included: Establish quality systems and develop simulation models for raw material distributor. Develop cleaning and process validation master plans and perform process risk assessments. cGMP manufacturing facility (DS/DP/Cell Therapy; Client and CMO), quality system, drug depot, raw material/component and computerized system vendor audits. CMC regulatory submission gap analysis, drafting and reviews (32S, 32P, 32A manufacturing and development sections). QbD assessments and review of process validation documents. Cell culture and purification process troubleshooting. Facility design reviews (drug substance, drug product, cell therapy facilities). Quality Engineering oversight for new biopharmaceutical manufacturing facility design, construction, commissioning and validation. Due diligence assessments for products and corporate capabilities. Drug substance and drug product process validation support (including development of procedures for Process Design using QbD, Process Performance Qualification, Continued Process Verification).
Vince worked for over 25 years at Biogen in Cambridge, MA and Research Triangle Park, NC. As Director of Quality Technical Systems at Biogen, Vince was responsible for cGMP oversight of corporate IT systems and automation as well as the strategic direction of the IT platforms used to support the Global Quality organization (LIMS, Training management, Deviation/CAPA/Change control management, Product Complaints and Document management. Prior to this role, Vince served as Director of QA Validation with responsibility for developing and consolidating all facility/equipment, cleaning, automation, computerized system, analytical method, process, and shipping validation approaches used in the company into a comprehensive global program. Prior to joining the Quality organization at Biogen, Vince spent several years in the Global Engineering organization as Manufacturing Technology Principal. He was instrumental in the design and startup of the company’s 15,000 L scale manufacturing facilities in RTP, NC and Hillerod, Denmark. He also worked on the engineering design of two Aseptic Fill/Finish facilities in Europe. Vince spent the first 15 years of his career at Biogen in clinical and commercial product manufacturing, managing the operation of the company’s 2,000 L scale facilities in Cambridge, MA and RTP. These efforts culminated with the successful global regulatory agency inspections of both facilities for commercial licensure of Avonex, the company’s first commercial product.
Vince has made numerous presentations at technical forums including PDA, Interphex, ISPE, CASSS, Waterside Biotechnology Conference and NC Biotechnology Center Investor forum. He holds a BA in Biochemistry from Cornell University and a Master of Business Administration from Babson College.
MBA, Babson College, Babson Park, MA
BA, Biochemistry, Cornell University, Ithaca, NY
Fluent in French
Nanda K. Subbarao, PhDSenior Consultant, Analytical Development
Dr. Subbarao has been a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems since 2007. Prior to that, she was with Sandoz and Pfizer. Her consulting areas include FDA regulatory submission preparation and review, GMP systems design and implementation, data integrity and equipment. She has assisted pharma and biotech organizations in evaluation of analytical methods and method validation for a wide range of products from pre-clinical phase to commercial phases. Some specific technical areas include small molecule pharmaceuticals, well characterized proteins including biosimilars and vaccines.
Nanda has co-authored numerous scientific publications and is frequently an invited speaker at Industry Meetings. She serves on the AAPS Stability Community and AAPS Data Storage Working Group. She currently serves as an Editorial Advisor for BioProcess International.
Her areas of expertise include
- FDA regulatory submission preparation and review
- Well Characterized Proteins including Biosimilars, Gene Therapy Products, Cell Therapy Products, Nanotechnology products, PET products, Conventional drugs
- Products ranging from pre-Clinical tox phase to Clinical Phase III and commercial
- GMP systems design and implementation and Data Integrity
- Audit of Laboratory GMP/GLP systems and Advice on upgrade of GMP/GLP systems
- PAI readiness
- Investigations and root cause analysis
- Client training course development
PhD, Bio-organic Chemistry, Indian Institute of Technology, Bombay (1985)
MS, Chemistry, Indian Institute of Technology, Bombay (1980)
Obtained training in subjects such as Certified Quality Auditor, Audit Preparation, cGMP Compliance, Project Management and Negotiation skills
Robert KutnerSenior Consultant
Mr. Kutner joined Biologics Consulting in May 2022 and has over 22 years of cell and gene therapy expertise, including 12 years of industry experience at platform-based biotech companies. He has direct experience in discovery, process and analytical development, vendor development, process characterization/validation, and authoring regulatory submissions. Mr. Kutner also has experience in nonclinical and clinical assay development. He supports process and analytical development for cell or vector products (Pre-IND through Phase III), developing functionality and genetic transfer assays for potency or mobilization of inserted vector, comparability study design and CMC regulatory filings as needed.
Robert previously worked for Avrobio as Head of Process and Analytical Development where he reverse tech-transferred external manufacturing for multiple ex-vivo gene therapy products. In addition, he established the comparability strategy for translating Investigator Sponsored Trials into the Avrobio Plato™ platform.
Prior to Avrobio, he worked for Rocket Pharmaceuticals as Head of Human Gene Therapy. In this role, he managed the establishment of CDMOs to support drug substance and drug product for multiple gene therapeutics.
Before Rocket, Robert worked for bluebird bio where he first gained his industry experience. As Head of Process Development, he was responsible for developing and scaling-up the rLV platform process to support multiple ex-vivo gene therapeuitics. His efforts followed through characterization and validation of these drug substances and included development of clinical and non-clinical assays. His procedures are currently in use for commercial production or testing of lentiviral vectors in multiple regions.
Prior to bluebird, he worked for LSU Medical School where he spent a decade researching scaleable processes and testing methods for viral vectors and vaccines. As Director of the Vector Core for the Gene Therapy Program, Robert gained his experiences on pDNA, rAd, rAAV, rLV, alphavirus, fowl-pox, and modified vaccinia platforms. Including the various typing and expression cassettes, he worked on well over 250 constructs and designed several production platforms.
Mr. Kutner has extensive experience in industrial scale production for cell and gene therapy. He is trained in GMP and can advise on best practices to implement during development of drug substances or drug products.
Mr Kutner received his B.S. in Chemistry from the University of Oklahoma in 1999.
Christina Vessely, PhDSenior Consultant
Christina Vessely, PhD comes to Biologics Consulting with over 18 years of experience in analytical and formulation development within the biotechnology industry. Her experience ranges from early stage research and development for small and start-up firms through late stage development and commercialization for mid-sized and large pharmaceutical companies. She has been involved in priority review and/ fast track programs, she has participated in Pre-approval inspections (PAI) and PAI enabling activities such as design and execution of validation studies and evaluation of GMP systems, as well as authoring and editing of analytical sections for multiple filings in both the U.S. and in the EU (IND/IMPD, BLA/MAA).
In the analytical arena, Christina’s areas of expertise have included analytical method development and validation, development of reference standards and other critical reagents, stability strategy and evaluation, and establishment of comparability and/or similarity. Her product experience includes vaccines, insulin analogs, cytokines, monoclonal antibodies, and other therapeutic proteins. She has been involved in the development and execution of CMC/Regulatory strategy for both novel and biosimilar products.
Christina earned her PhD at the University of Colorado Health Sciences Center (now CU Denver). She studied in the laboratory of Dr. John Carpenter, where she utilized various biophysical and biochemical techniques for the characterization of proteins. Through various projects within the biotechnology industry she has expanded her formulation development experience to include therapeutic proteins (including monoclonal antibodies), both liquid and lyophilized, for both traditional and non-traditional delivery systems. She additionally has worked with vaccines and with peptide based therapies. In addition to her PhD, she holds a MS in Chemistry from CU Denver and a BS in Chemical Engineering from the Colorado School of Mines in Golden, CO.
As a Senior Consultant in Analytical and Formulation, Christina will utilize her expertise to assist clients in the following areas:
- Development, Qualification and validation of analytical methods for raw materials, In-process testing, Lot release, Stability, and assessment of comparability and similarity
- Application of Biophysical and Biochemical techniques for extended characterization of products and to further demonstrate comparability and biosimilarity. Techniques include various spectroscopic techniques, evaluation of thermal properties, and evaluation of sub-visible particles
- The development and characterization of critical reagents including product specific reference standards, assay specific reagents, and strategy to demonstrate continuity of standards across the life span of the program
- Formulation strategy and development including the design of preliminary and later stage screening studies, application of biophysical techniques to evaluate formulation stability for short term studies, evaluation of stability profiles for lead candidate formulations in longer term studies, and evaluation of container/closure systems for drug substance and drug product
PhD, Pharmaceutical Sciences University of Colorado Health Sciences Center, Denver, CO (2006)
MS, Chemistry, University of Colorado, Denver, CO (2002)
BS, Chemical Engineering, Colorado School of Mines, Golden, CO (1996)
Jenny XiradakisSenior Consultant
Jenny comes to Biologics Consulting with over 23 years of global pharmaceutical industry experience. She has a wealth of experienced as outlined below:
Former FDA NE Region District Drug Expert
Domestic and International FDA GMP/GXP Inspections of Human and Animal Drugs
Global Compliance for Regulatory Inspections
Regulatory Compliance Review
Preparation for Regulatory Audits
PADE Inspections & Global Pharmacovigilance Requirements
Data Integrity for Batch Manufacturing Records and Laboratory Software
Process Validation & Process Capability Evaluations
Equipment Qualification Requirements for Pharmaceutical Processes
Contract Development / Negotiations
Compliance with GMP, GxP, 21 CFR Part 211
503A/503B Pharmacy Compounding
Education & Credentials
Coursework for Master’s Degree in Drug Regulatory Affairs, Temple University
B.Sc. in Pharmacy, Arnold & Marie Schwartz’s College of Pharmacy, Long Island University (Six Year Program)
Licensed Pharmacist, State of New York, since 1997, #045129-1; State of New Jersey, since 1996, #RI24650
Joshua Crist, MSESenior Consultant
Mr. Crist joined Biologics Consulting in 2018 with 7 years of experience as a biomedical engineer and lead reviewer at the FDA in the Office of Device Evaluation (ODE), Division of Surgical Devices (DSD), where he evaluated a wide variety of device and submission types. His experience includes review of IDEs, 510k(s), De Novos, PMAs, HDEs, Q-Submissions (Pre-Submissions), and Expedited Access Pathway (EAP) submissions. Examples of his device expertise include biosurgery products, surgical hemostats, surgical sealants, adhesion barriers, wound dressings, aesthetic and reconstructive implants, dermal fillers, surgical mesh, surgical staplers, as well as software based devices such as lipoplasty systems, negative pressure wound therapy devices, and robotically-assisted surgery devices.
While at the FDA, Mr. Crist served as a member of the Additive Manufacturing Working Group and has experience evaluating 3D-printed medical devices. He also led the Hemostatic Trauma Devices Working Group, and has experience in CFR 50.24 clinical studies with exception from informed consent for emergency research. In his review of biosurgery and polymer-based devices, he has dealt with complex biocompatibility testing to support in-situ polymerizing devices and chemical characterization to support polymer equivalency.
Prior to joining the FDA, Mr. Crist conducted 4 years of cell and tissue engineering laboratory research under Dr. Elisseeff at Johns Hopkins University’s Translation Tissue Engineering Center (TTEC). His research focused on mesenchymal stem cells and biopolymer tissue adhesives for cartilage repair, in-vitro models of osteoarthritis and osteoporosis, and the interactions of glycoengineering with stem cell behavior.
Mr. Crist received both his B.S. and M.S.E. in Biomedical Engineering from Johns Hopkins University with highest honors, in 2010 and 2011, respectively.
As a Consultant for Medical Devices with Biologics Consulting, Mr. Crist utilizes his scientific and regulatory expertise to assist clients in the following areas:
• Preparation of device submissions (Q-Sub, 510k, PMA, IDE, etc.)
• Short and long term regulatory strategy for medical devices and combination products
• Product development and preclinical testing strategies
• Animal study and clinical trial development to achieve regulatory success
• Crafting responses to FDA deficiencies and communicating with FDA on behalf of clients
M.S.E. Biomedical Engineering, Johns Hopkins University, Baltimore, MD (2011)
B.S. Biomedical Engineering, Highest Honors, Johns Hopkins University, Baltimore, MD (2010)
Becky Ditty, MSConsultant
Becky Ditty joined Biologics Consulting in the spring of 2017 with over 14 years of industry experience in medical device regulatory affairs. Prior to joining Biologics Consulting, Becky integrated regulatory strategy throughout the product lifecycle supporting the creation of new product development including labeling, risk management, premarket submissions, and change control. Becky supported a diverse product portfolio, including bone cements, computer assisted surgery systems, vertebral balloon systems, and radiofrequency generators; along with the integration of acquired products. Becky was an active participate in the AdvaMed software work group, which collaborated with FDA to develop the new software-focused guidance document “Deciding When to Submit a 510(k) for a Software Change to an Existing Device”.
From a post-market compliance perspective, Becky supported post-market surveillance activities including managing medical device reports (MDR) filings and device recalls. Additionally, Becky led the internal audit program and regularly assisted in third party audits.
Furthermore, Becky was an account manager for division-wide regulatory affairs and quality (RA/QA) projects. As the account manager, Becky was the liaison between the regulatory and quality departments and the IT department. Becky managed the implementation of new IT solutions and the modifications to existing systems to better meet the RA/QA department needs.
Becky earned a bachelor of science in management information systems and marketing from Oakland University. She later earned a master of science in Orthopedics Regulatory and Clinical Affairs from Grace College and Seminary.
BS, Management Information Systems, Marketing, Oakland University, Rochester, MI (1999)
MS, Orthopedic Regulatory and Clinical Affairs, Grace College and Seminary, Winona Lake, IN (2013)
Christy Foreman, MBESenior Consultant
Ms. Foreman comes to Biologics Consulting in 2018 with over 28 years of federal service. She has 22 years of experience with the Food and Drug Administration (FDA), 18 of those years spent in the Center for Devices and Radiological Health. She has extensive experience with premarket regulatory programs (PMAs, 510(k)s, de novo applications, IDEs and pre-submissions) and well as good manufacturing practices including the Quality System Regulation and postmarket enforcement issues such as recalls, warning letters, seizures and injunctions for a wide variety of medical devices.
Christy began her career at the FDA in 1996 as a reviewer in the anesthesiology and defibrillator devices branch in the Office of Device Evaluation (ODE) where she also began serving as an FDA representative on several voluntary consensus standards for medical devices. She entered management as the Branch Chief for orthopedic, physical medicine and anesthesiology devices in the Office of Compliance. She went on to become the deputy division director in the Office of Compliance for the division responsible for orthopedic, physical medicine, anesthesiology, cardiovascular, neurology and radiology devices. She then returned to ODE where she served as the deputy office director from 2008 – 2010 and the director of ODE from 2010-2014. She was instrumental in the development and implementation of the 510(k) plan of action, implementation of new legislation such as FDASIA and user fee negotiations within industry.
In 2014 Ms. Foreman joined the Center for Tobacco Products as the Associate Director for Regulatory Programs in the Office of Compliance and Enforcement where she developed new regulatory programs and regulations, including manufacturing regulations, in the newest Center in the FDA.
Christy received her BBE in Biomedical Engineering in 1993 and her MBE in Biomedical Engineering in 2000, both from The Catholic University of America.
M.B.E. Biomedical Engineering, The Catholic University of America, Washington, DC (2000)
B.B.E. Biomedical Engineering, The Catholic University of America, Washington, DC (1993)
Neva TaingProject Coordinator & Contracts Specialist
Matthew KruegerSenior Consultant
Mr. Krueger joined Biologics Consulting in April 2020, after more than 15 years with the U.S. Food and Drug Administration (FDA) in the Center for Devices and Radiological Health (CDRH). His experience includes over 6 years in pre-market submissions including PMAs, HDEs, 510(k)s, IDEs, 513(g)s, and de novo submissions and over 11 years reviewing and supervising the review of manufacturing information and compliance actions, including Quality Systems, PMA and HDE manufacturing information, recalls, allegations, injunctions, seizures, civil money penalties, and warning letters. His experience involves a variety of devices areas including cardiovascular, orthopedic, neurology, physical medicine, and dental devices. He has also worked on combination products with CDRH, CDER, and CBER as the lead reviewing centers.
Before joining Biologics Consulting, Mr. Krueger worked as an Assistant Director overseeing the Neurosurgical Team in the Office of Product Evaluation and Quality’s Office of Neurology and Physical Medicine Devices. As the Assistant Director, he was involved in all aspects of pre-market and post-market review of neurosurgical devices. Mr. Krueger joined the Office of Product Evaluation and Quality and the Office of Neurology and Physical Medicine Devices as part of 2018 reorganization of CDRH.
Prior to joining the Office of Product Evaluation and Quality, Mr. Krueger worked in the CDRH Office of Compliance where he started as a Biomedical Engineer and reviewer in the Vascular and Circulatory Support Branch. He went on to be the Branch Chief of the Orthopedic and Physical Medicine Devices Branch in the Division of Enforcement B and then following a reorganization, the Physical Medicine, Orthopedics, Neurology, and Dental Devices Branch in the Division of Manufacturing and Quality. As the branch chief, he was responsible for overseeing the review work of staff who reviewed regulatory actions such as injunctions, seizures, civil money penalties, and warning letters, as well as establishment inspection reports, recalls, allegations, promotion and advertising, and PMA and HDE manufacturing information for original and site change supplements. In 2017, Mr. Krueger completed a detail serving as the Acting Division Director for the Division of International Compliance Operations (DICO) where he managed branches responsible for foreign enforcement, imports, exports, and the Medical Device Single Audit Program (MDSAP) giving him experience and insight into each of these regulatory programs.
In his first position with the FDA and prior to working in the Office of Compliance, Mr. Krueger was a Mechanical Engineer and reviewer in the Office of Device Evaluation’s Division of Cardiovascular Devices, working in the Peripheral Vascular Devices Branch. As a Mechanical Engineer, he served as both a lead reviewer and a consulting reviewer for Mechanical Engineering testing on a variety of vascular devices including peripheral and coronary stents, IVC filters, endovascular stent grafts, endovascular catheters and delivery systems.
Mr. Krueger received his BS in Mechanical Engineering from Southern Methodist University, and MS in Bioengineering from the University of Pennsylvania.
Jennifer Moyer joined Biologics Consulting in January 2021 and has 24 years of experience in standards development across multiple regulated industries.
Jennifer most recently worked at the Association for the Advancement of Medical Instrumentation (AAMI) as a Senior Director in the Standards Department. During her 12 years there, Jennifer worked with a large and diverse portfolio of standards committees to publish essential performance and basic safety standards for medical devices. Jennifer has worked closely with many of the stakeholders in the medical device arena: clinicians, FDA, academic, and industry. She also was team lead for all the device standards under AAMI’s purview, currently over 500 projects and publications
MS Regulatory Affairs for Drugs, Biologics, and Medical Devices, Northeastern University (2020)
MA Management and Leadership, Webster University (2014)
BA English Literature (major), History (minor), Drew University (1986)
Ms. O’Kelly joined Biologics Consulting in April 2019 and has 8 years of experience in multiple engineering, quality, and leadership roles for medical device companies.
Prior to joining Biologics Consulting, Ms. O’Kelly was the Quality Systems Manager at Terumo Medical Corporation where she led the redesign of the change management system, managed the document control and records management team, and led the Change Review Board while overseeing the multi-site change management process in alignment with 21 CFR Part 820, ISO 13485 and other global medical device regulations.
Prior to that role, Ms. O’Kelly utilized her strong background in medical devices, quality systems and compliance to develop a quality integration process for medical device product and company acquisitions. She later used this process to lead multiple multi-million-dollar acquisitions through various stages from due diligence to integration completion.
Ms. O’Kelly also has deep technical experience supporting a variety of products with Johnson & Johnson and W.L. Gore & Associates as a Sr. Quality Engineer, New Product Development Engineer, and Manufacturing Engineer.
As a Consultant at Biologics Consulting, Ms. O’Kelly utilizes her technical and quality systems expertise to assist clients in the following areas:
• Quality system design, organization and development
• Quality system documentation review and preparation
• Due diligence support, including gap analyses of design history files and quality systems and development of quality integration strategies
• Technical support and review of bench testing, design documentation, risk analyses and device technical specifications for regulatory submissions
• Preparing and assisting in the preparation of all types of regulatory submissions for medical devices
BS, Bioengineering, The Schreyer Honors College At The Pennsylvania State University, University Park, PA (2011)
BS, International Studies, The Schreyer Honors College At The Pennsylvania State University, University Park, PA (2011)
James Seiler joined Biologics Consulting in February 2022. Mr. Seiler comes to us with over 35 years of FDA review experience in medical devices. His extensive experience provides valuable insight into what FDA expects in all types of regulatory submissions, including investigational device exemption (IDE), premarket notification (510(k)), premarket approval (PMA) submissions, and Q Submissions (Q Sub).
His review experience includes FDA regulatory submission review of non-clinical bench tests (device performance, electrical safety, electromagnetic compatibility, and device software), as well as multi disciplinary team reviews of clinical study results, and progress and annual reports for IDE and PMA submissions.
He also comes with experience as an acting device review manager at the agency for insight into preferred submission content for an efficient review of your regulatory submissions. Additionally, Mr. Seiler’s experience in the Office of Combination Products (OCP) helps him to work with you to determine the timing and content for early and continued involvement of OCP for those devices needing input from the Center for Drug Evaluation and Research (CDER) and/or the Center for Biologics Evaluation and Research (CBER).
Mr. Seiler has a Master’s degree in Electrical Engineering from George Washington University in Washington, D.C., and a Bachelor’s degree in Electrical Engineering from Penn State University in University Park, Pennsylvania.
Donna-Bea Tillman, PhD, MPASenior Consultant
Dr. Tillman came to Biologics Consulting in 2012 with over 17 years of medical device experience with the Food and Drug Administration (FDA), Center for Devices and Radiological Health.
Donna-Bea began her career at the FDA in 1994 as a reviewer in the Ob/Gyn devices branch, and entered management as the Branch Chief for Pacing and Electrophysiology Devices. She went on to become the Deputy Division Director for Cardiovascular Devices, and then served as director of the Office of Device Evaluation from 2004-2010. Although Donna-Bea has experience with many different types of medical devices, her area of special expertise is regulation of medical device software. During her early years at FDA, she performed numerous software reviews, and was a key member of the teams that wrote most of the FDA guidance document on software review. In 2000, she took over leadership of the FDA Software Policy Working Group, and over the next ten years, emerged as the FDA expert in the regulation of medical device software.
In 2010 Dr. Tillman joined Microsoft’s Health Solutions Group as the Director of Regulations and Policy, where she was responsible for obtaining the appropriate global premarket registrations and managing Microsoft’s post-market safety programs. Over the nearly two years that she was at Microsoft, her team established a medical device quality system and obtained ISO 13485 certification.
Donna-Bea received her BSE in Engineering from Tulane University, her PhD in Biomedical Engineering from the Johns Hopkins University, and her Master’s in Public Administration from the American University.
As a Senior Consultant for Medical Devices at Biologics Consulting, Donna-Bea utilizes her broad technical and regulatory expertise to assist clients in the following areas:
- Advising clients on the regulatory requirements that may apply to software used in a medical environment
- Short and long term regulatory strategy for medical device technologies and combination products
- Assisting clients with strategy and development of preclinical testing and other product development issues
- Assisting clients in preparing for FDA meetings and FDA Advisory Panel meetings
- Preparing and assisting in the preparation of RFDs, Pre-IDEs, IDEs, 510(k)s and PMAs
- Providing clients with a comprehensive “FDA style” review of submissions
MPA, American University, Washington, DC (2005)
PhD, Biomedical Engineering, Johns Hopkins University, Baltimore, MD (1991)
BSE, Engineering and Biology, Tulane University, New Orleans, LA (1985)
Laurie Iciek, PhD, RACSenior Consultant
Laurie has over 17 years of experience as a Toxicologist, with a current role as Sr. Nonclinical Consultant for Biologics Consulting, and previous roles as a Lead Toxicologist in the pharmaceutical industry. Her academic training in cellular and molecular immunology has served as a strong foundation for Laurie’s work in biologic drug development, including issues that arise during the development of monoclonal antibodies (mAbs), fusion proteins, vaccines, and immuno-oncology therapeutics. Her industry experience includes the development of biologics and small molecules for MedImmune, Abbott Laboratories (currently AbbVie), and Bristol-Myers Squibb (BMS).
She has received numerous industry awards including Bronze and Silver awards from MedImmune, a CEO team award from AstraZeneca, a 3Rs Honorable Mention award from AstraZeneca, and a President’s award from Abbott. Laurie’s experience as a Lead Toxicologist includes: 1) conducting target safety risk assessments (literature reviews) for potential targets in multiple therapeutic areas; 2) designing, executing, and defending preclinical safety assessment packages to support the worldwide development of both biologics and small molecule drugs for oncology, immunology, and infectious disease indications; 3) authoring toxicology and pharmacokinetics sections for discovery transition documents/co-development packages, clinical documents, and worldwide regulatory submissions (e.g., IND, IMPD, BLA, MAA. 505(b) 2 NDA); 4) Study Director, Study Monitor, and/or Study Sponsor for GLP toxicity studies in multiple species; 5) authoring Standard Operating Procedures and IACUC protocols; 6) training/mentoring direct reports and students; and 7) educating others through internal and external seminars and mentorship programs. Laurie’s biologics experience includes mAbs, bi-specifics, combinations, antibody drug conjugates (ADCs), immuno-oncology drugs, fusion proteins, vaccines, and immunotherapeutics.
Laurie also has experience in the development of safety risk assessment strategies for process impurities, extractables and leachables, and excipients. To broaden her knowledge of the entire drug development process, Laurie obtained her Regulatory Affairs Certification (RAC, USA) in 2014.
PhD, Immunology, Michigan State University, East Lansing, MI (1994)
BS, Biology, Central Michigan University, Mount Pleasant, MI (1988)
Pauline McEwan, PhDSenior Consultant
Dr. McEwan joined Biologics Consulting as a Senior Consultant in April, 2017 with more than 12 years of consulting experience in drugs, biologics, devices and combination product development. Prior to joining Biologics Consulting, she served as a senior consultant toxicologist at Aclairo PDG and IND Consulting where she was involved in all aspects of nonclinical development of gene and cell therapies, small molecule, biosimilars, and viral therapeutics, as well as drug and device development and safety programs. The nonclinical development activities included writing and submissions of eCTD’s, IND’s, 505b(2), BLA’s, NDA’s, IDE’s, position papers and toxicological safety assessments for impurities, leachables and extractables.
Dr. McEwan has also worked closely with sponsors to outsource GLP and non-clinical GLP studies to nonclinical CRO’s and is involved closely with nonclinical study design, implementation, monitoring and auditing of GLP study facilities.
Dr. McEwan works with clients/sponsors to provide regulatory strategy and to assist in FDA meetings on behalf of clients for combination (drug-drug, drug-device, biologics-device) products at CBER, CDER and CDRH divisions.
For several years, Pauline served as Principal Consultant to Celladon Corporation and was responsible for the nonclinical development of a gene therapy program for congestive heart failure, working in conjunction with FDA on developing guidance documents for industry.
Prior to her consulting career, Pauline held industry positions as senior manager and director of research and development at Miravant Medical Technologies for cardiovascular drug/device combinations and served as a Steering Committee Member at Guidant Corporation.
Pauline’s early career was sponsored by British Heart Foundation and Wellcome Trust initiatives. Pauline received her Ph.D. in experimental pathology from the University of Glasgow Department of Pathology and MRC Blood Pressure Unit. Her thesis focused on the role of growth factors in the pathophysiology of endocrine and cardiovascular disease. She held post-doctoral fellowships in pharmacology and cardiovascular genetics at Edinburgh and Harvard Medical School, respectively. Her work has culminated in several publications in peer-reviewed journals and book chapters.
L. Bruce Pearce, PhDSenior Consultant
L. Bruce Pearce, PhD joined Biologics Consulting as a Senior Consultant in July 2010. Bruce is a pharmacologist who brings 20-plus years of academic and industry experience encompassing many aspects of biologics development including: design, development, analysis, oversight and regulatory reporting of pharmacology, toxicology, pharmacokinetic, safety pharmacology, physiologic research and Phase I-III clinical trials. He also has expertise in non-clinical and clinical pharmacology/toxicology, program strategic/technical design, quantitative outcomes analysis, and benefit-risk balance assessment. Therapeutic areas include: treatment of anemia due to surgery, trauma, chemotherapy, emergency research under exception to informed consent (21 CFR 50.24) including in/pre-hospital resuscitation from hemorrhagic shock due to trauma. Additionally, Dr. Pearce has experience in the treatment of cardiac, cerebral and peripheral ischemia as well as the therapeutic use of botulinum toxin.
Bruce began his career as a faculty member within the Department of Pharmacology at Boston University School of Medicine with his research interests leading to participation as a principal in founding a biotechnology start-up focusing on the development of therapeutic botulinum toxin. He has directed the non-clinical research and formulation development, participated in the development and design of clinical trials supporting IND, clinical trials, and meetings with FDA. He defined a unit of biologic activity for clinical formulations of botulinum toxin and filed a patent describing the unique efficacy of mixtures of botulinum toxin serotypes. During Dr. Pearce’s tenure at Biopure Corporation, his activities evolved from Manager to Director including responsibility for oversight of nonclinical program development and nonclinical research efforts with CROs, universities, military organizations and foundations, including negotiation of contracts and licensing agreements. He has contributed to design and execution of study protocols, presentation of proposals and study results to regulatory agencies and managed the non-clinical sections of regulatory filings through BLA. Additionally, he has designed, developed and managed pharmacology, pharmacokinetics, teratology, genotox, cardiotox and general toxicology protocols.
Dr. Pearce was the principal investigator directing all studies performed under DoD grants and development of in-hospital Phase II safety protocol to study hemorrhagic shock patients. In this role, he had oversight of nonclinical research in support of the trauma program, including protocol design, data analysis, and authoring reports and publications. He established and chaired an oversight committee of clinical/non-clinical experts in trauma and emergency medicine. Dr. Pearce has designed and authored Phase II protocol with medical scientists and held project management accountability for all functions supporting clinical trials. Dr. Pearce has authored and negotiated cooperative research and development agreement (CRADA) with the US Naval Medical Research Center for new product development and clinical trials in trauma. Co-principal investigator of a Phase II/III protocol for investigating product use in the treatment of hemorrhagic shock proposed under waiver of informed consent for emergency research in the out-of-hospital setting. Led product development as adjunct to radiation therapy in glioblastoma. He is the primary author of the clinical protocol for treatment of life-threatening, severe anemia due to acute myeloid leukemia in Jehovah Witness patients; functioned as project team leader and regulatory affairs representative. In collaboration with internal and external scientists, he led efforts to define and understand safety issues associated with the use of blood substitutes in the treatment of surgical anemia. He has proposed relative efficacy theory identifying issues with the current generation of blood substitutes limiting efficacy compared to standard of care, packed red blood cells. Dr. Pearce has administered and coauthored submissions to FDA, addressing, database, nonclinical and clinical efficacy, safety and risk/benefit profile issues and participated in Advisory Committee meetings.
More recently, Dr. Pearce served as an independent consultant with his research efforts focused on outcomes analysis, the interdependence of safety and efficacy, and risk-benefit balance assessment as it relates to decision making in drug development and regulatory approval. Co-developed methods to provide blinded quantitative assessment of safety and benefit-risk balance at all phases of clinical development in support of regulatory requirements. Established a website (http://www.SIBRA.org) dedicated to promoting the development of quantitative methods for outcome analysis and benefit-risk balance assessment in clinical trials.
Bruce received his undergraduate training in Chemistry and Biology at the University of Massachusetts and graduated magna cum laude and doctoral training in Pharmacology as a graduate fellow at the State University of New York. He completed his postdoctoral training in pharmacology as an NIH postdoctoral fellow within the Departments of Pharmacology at Yale School of Medicine and Harvard Medical School. Dr. Pearce was distinguished as recipient of an Alfred P. Sloan Foundation Fellowship and Glaxo Drug Discovery Grant/Award, has authored more than 70 publications and more than 50 study reports.
Postdoctoral Pharmacology, Harvard University, Cambridge, MA (1985-1987)
Postdoctoral Pharmacology, Yale University, New Haven, CT (1983-1985)
PhD, Pharmacology, State University of New York, NY (1984)
BA, Chemistry/Biology, University of Massachusetts, MA (1978)
Emily Place, PhD, MPHSenior Consultant
Emily joined Biologics Consulting in 2022 after working as a pharmacology/toxicology reviewer at the FDA in CDER’s Office of Oncologic Diseases for over 8 years. For the first four years of her time, she worked on a team that supported a division reviewing applications in benign heme and hematological malignancies and the last 4 years she reviewed applications in solid tumors. During her time at the FDA Emily reviewed over 150 pre-INDs, 250 commercial INDs and 100 NDAs, BLAs and/or supplements. She co-chaired a Pharmacology/Toxicology Subcommittee for Oligonucleotide Therapeutics for 7 years, and performed consults, provided education, developed internal practice, and oversaw the safety and activity of drug applications for Oligonucleotide Therapeutics in all of the therapeutic divisions across the Office of New Drugs. She has extensive regulatory experience in all aspects of nonclinical pharmacology, toxicology and safety pharmacology assessments for small molecules, biologics (monoclonal antibodies, fusion proteins, antibody drug conjugates, bi-specifics, tri-specifics, immune- activating products) and oligonucleotide therapeutics and an expertise in the treatment of oncologic diseases. She also served as a member of the Biologics Subcommittee which oversees biologic products in the Office of New Drugs; the Pediatric Subcommittee which oversees juvenile animal studies in the Office of New Drugs; and the Emerging Technology Subcommittee which collects incoming studies in the Office of New Drugs and explores new methodologies to improve predictivity and potentially replace, reduce, and/or refine animal testing.
Emily received a bachelor’s in science in Biology from State University of New York at Binghamton in 2001. She received her PhD in Cell Biology from University of Connecticut in 2006 and completed an MPH in Epidemiology at the University of California at Berkeley 2012. Following her PhD, she was an Associate Investigator at San Francisco VA Medical Center from 2007-2009 where her research focused on miRNA dysregulation in prostate cancer. She completed a post-doctoral fellowship at Stanford School of Medicine testing chemotherapeutics in a translational model of NHL and was a Cancer Prevention Fellow at the National Cancer Institute in the Laboratory of Human Carcinogenesis where her research involved examining the role of extracellular plant small RNA communication in human carcinogenesis. Her research has culminated in several publications in peer-reviewed journals and book chapters. She is currently Faculty at the University of California at Berkeley, School of Public Health, in the Division of Biostatistics and teaches Biostatistics in the master’s in public program.
Christopher M. Scull, PhDSenior Consultant
Christopher Scull, PhD, is a drug development professional whose experience has spanned research, discovery, preclinical development, and regulatory affairs. Dr. Scull’s expertise includes product development strategy, design and management of pharmacology and toxicology studies, writing and reviewing FDA submissions, and achieving GLP compliance.
Prior to joining Biologics Consulting, Chris served as Global Director, Discovery Sciences, at Innovimmune Biotherapeutics, where he managed development of a portfolio of pre-IND drug candidates. In addition to being the site-head for the Brooklyn-based research team, Chris was responsible for preclinical development planning and management of nonclinical studies.
Dr. Scull also served in multiple roles at Memorial Sloan Kettering Cancer Center (MSKCC). As a member of the Investigational Products team, he co-authored and reviewed IND applications and assisted investigators with FDA compliance during the design and conduct of pharmacology and toxicology studies. In a subsequent role at MSKCC, Chris led the establishment of a new testing facility for GLP-compliant nonclinical studies which included the design of laboratory and animal facilities, installation and validation of new equipment, authoring of SOPs, and training of personnel for GLP compliance.
While completing his doctoral studies at the University of North Carolina at Chapel Hill, Chris assisted the biotech startup Entegrion with preparation and analysis of test articles for nonclinical studies and pre-approval testing of a new trauma bandage.
Chris received his BS in Chemistry from UNC Chapel Hill in 2003 and his PhD in Cellular and Molecular Pathology from UNC Chapel Hill in 2009. He is also PMP certified by the Project Management Institute and holds the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society. Chris joined Biologics Consulting in 2017 and currently resides with his family in Silver Spring, Maryland.
Mark Thornton, MD, MPH, PhDSenior Clinical Consultant
Mark O. Thornton, MD, MPH, PhD brings over 20 years of experience in the biologics development arena, including six years at FDA CBER, 14 years in the biotechnology and pharmaceutical industries, and more than two years at Biologics Consulting. As an industry physician, Dr. Thornton’s most recent positions were Chief Medical Officer and Chief Development Officer at biotechnology companies developing cutting edge products, primarily in the oncology setting. In these roles, he developed a wide breadth of experience leading Phase 1-3 clinical trials in numerous oncology settings and in many classes of drugs and biologics, including small molecules, monoclonal antibodies, gene and cell therapy and cancer vaccines. Outside the cancer arena, Dr. Thornton has also led or helped lead the development teams responsible for the FDA approval of two Biologics License Applications, one each for an immunologic agent and a preventive vaccine.
As a Medical Officer in the FDA CBER Division of Clinical Trial Design and Analysis, Dr. Thornton’s focus was on biologics therapeutics, mostly in oncology, infectious disease and inflammatory disease settings. While serving at the FDA, Dr. Thornton led or helped lead the FDA review teams responsible for the successful licensure of two Biologics License Applications, one each in an oncology and infectious disease indication.
Dr. Thornton has also provided guidance to investment and venture capital firms, as well other stakeholders interested in due diligence of clinical, safety and/or regulatory programs of biotechnology and pharmaceutical companies. Dr. Thornton also has developed expertise in FDA regulatory policy, and has published five Op-Eds in the Wall Street Journal since 2007 on issues covering the span of drug development policy. Dr. Thornton is a member of the American Society of Clinical Oncology and the Johns Hopkins Medical and Surgical Society.
Areas of Expertise
Drug Development and Licensing Strategy: Optimizing and streamlining clinical development programs through use of tools such as adaptive clinical trial designs; Shortening the critical path to market by optimizing regulatory development strategies through the use of tools such as surrogate endpoints.
Clinical Trials: Assist in protocol design; Medical / Safety monitoring of ongoing clinical studies; Assist in clinical and safety data analysis Assist in writing of Clinical Study Reports.
Regulatory Affairs: Assist in preparation for FDA meetings: pre-IND, end-of-phase 2, pre-NDA/BLA, etc.; Assist in writing of regulatory submissions: briefing documents, clinical sections of INDs, BLA/NDAs, Orphan Product, Breakthrough Therapy Designation, etc.
Due Diligence and Drug Policy: Determining the status of the clinical and regulatory programs of pharmaceutical and biotechnology companies of interest, e.g.  likelihood of clinical trial success,  probable time to data,  critique and evaluate regulatory communications; Advise on the possible impact of the ongoing regulatory policy changes (PDUFA, etc.) on product development plans.
MPH, (Masters in Public Health) Johns Hopkins School of Public Health, Baltimore, MD (2000)
Clinical Pharmacology Research Fellowship, Johns Hopkins School of Medicine, Baltimore, MD (1994-1995)
Internal Medicine Internship, Bethesda Naval Hospital, Bethesda, MD (1987-1988)
MD, West Virginia University, Morgantown, WV (1987)
PhD, Pharmacology and Toxicology, West Virginia University, Morgantown, WV (1983)
Nolan CligrowElectronic Publishing Specialist
Mr. Cligrow joined Biologics Consulting in June 2021 and has experience working in the drug/medical device industry, including a year working as an electronic publishing specialist. He worked with publishing tools to submit electronic submissions to the FDA via cloud software. Mr. Cligrow also has experience working in a laboratory setting including working in a parasitology lab to examine mammalian samples to determine the existence of parasites or other harmful bacteria.
Nolan previously worked for Hikma Pharmaceuticals as a regulatory affairs publishing specialist to submit original ANDA and NDA applications for approval to the FDA. In addition to original applications, submissions such as annual reports, PADERS, labeling, CBE-0 and CBE-30, as well as amendments were processed and compiled before sending to the FDA.
Prior to Hikma, he worked for IDEXX laboratories as an assistant lab technician in order to analyze and process samples from veterinarian clinics for the existence of parasites and harmful bacteria.
Mr. Cligrow has experience in reviewing eCTD-formatted applications as well as electronic publishing requirements and can compile various types of applications to be sent to the FDA for approval.
Mr. Cligrow received his B.S. in Biochemistry from The Ohio State university in 2017 and obtained his M.S. degree in Bioinformatics from Jonhs Hopkins in 2019 where he studied genomic databases and how to process and parse them using various software and command-line tools such as Python, Java, and SQL.
Tuan DinhElectronic Publishing Specialist
Tuan Dinh joined Biologics Consulting in June 2014 and provides electronic submissions assistance. Tuan comes to Biologics Consulting with 2 years of hands on experience in the regulatory industry with Octagon Research Solution/Accenture.
Prior to working in the regulatory industry Tuan served 8 years in the United States Marine Corps as a Motor Transport Mechanic. During his time in service he served 1 combat tour to Iraq, and 1 combat tour to Afghanistan.
BA, Marketing, Villanova University, Villanova, PA (2008)
Tamara DuboisSenior Electronic Publishing Specialist
Tamara DuBois, BS joined Biologics Consulting as an Electronic Publishing Specialist in September 2019.
Tamara comes to Biologics Consulting with over 4 years of submission experience. Recently, she was an Electronic Publishing Specialist at PPD. She is experienced in publishing CRFs and submission documents.
Tamara holds a BS in Anthropology with a minor in Forensics from University of North Carolina at Wilmington.
David IjehElectronic Publishing Specialist
David Ijeh, BS joined Biologics Consulting as an Electronic Publishing Specialist in February 2021.
David comes to Biologics Consulting with over 3 years of regulatory submission experience. Recently, he was a Regulatory Specialist at Technical Resources International. He is experienced in the process of publishing, validation, submission and life-cycling of regulatory documents in eCTD format
He holds his BS in Biology from Salisbury University.
Meagan GerbigElectronic Publishing Coordinator
Meagan comes to Biologics Consulting with over 7 years of experience working for pharmaceutical companies. Most recently, she worked for Regeneron Pharmaceuticals as a Regulatory Systems Specialist. In that role, she supported various regulatory computer systems, providing training and technical support to users company-wide. Prior to Regeneron, Meagan worked in Regulatory Operations at Array BioPharma. At Array, Meagan was responsible for all document publishing, hyperlinking, bookmarking, and submission compilation.
As a Project Manager/E-publishing Associate at Biologics Consulting, Meagan will utilize her technical and regulatory expertise to assist clients in the following:
- Providing Project Management and Electronic Publishing submission support, with respect to original INDs, BLAs, ANDAs, and Master Files in both legacy and eCTD format and maintenance of those submissions
- Perform quality control review of published submissions
- Create and finalize SOPs
- Provide assistance with authoring, managing, and overseeing proposal development for multi-disciplinary projects
- Miscellaneous administrative duties as necessary
BS, Biomolecular Science, Clarkson University, Potsdam, NY (2005)
Drug Information Association Annual Conference (2008, 2013)
ShareFEST – The SharePoint Conference for Life Sciences (2012)
Leveraging Global eCTD Efficiencies (2010)
Preparing Compliant eCTD Submissions (2007)
Regulatory Affairs Professionals Society
Regulatory Affairs Professional Society Annual Conference (2007)
Preparation of FDA Submissions and Communicating with the FDA (2007)
Center for Professional Innovation & Education
Mckenzie OrchowskiAssociate Director Regulatory Operations: Publishing/Electronic Submissions
Ms. Orchowski comes to Biologics Consulting with over 5 years of regulatory submission experience. She is proficient in managing the assembly of complex clinical trial authorizations and marketing applications for submission to the FDA for drugs, biologics, and medical devices.
Mckenzie previously worked for Translational Drug Development (TD2), an oncology contract research organization, and gained experience working with cross-functional teams to plan and track the preparation of initial IND applications. She also assisted with content compilation and Word formatting of Type B meeting requests and briefing packages, as well as orphan drug designations and annual reports.
Prior to TD2, she worked for Arivis (formerly known as Mission3) as their Regulatory Operations Manager. In this role, she managed the publication and validation of all client eCTD submissions using a home-grown publishing software solution. Mckenzie directly contributed to the enhancement of this system by interfacing with the software development team to compose test-driven user requirements.
Ms. Orchowski gained extensive experience as a Senior Publishing Specialist at Medicis Pharmaceuticals, where she acted as primary liaison to coordinate the outsourcing of large eCTD submissions, including an original 505(b)(1) NDA. Mckenzie also published an initial IND application and an original 505(b)(2) NDA and prepared lifecycle submissions for over 27 products (in paper, eCopy, and eCTD format), including supplements, amendments, periodic safety updates, and promotional material submissions for INDs, NDAs, BLAs, ANDAs, IDEs, and PMAs.
Ms. Orchowski received her B.S. in Molecular Bioscience and Biotechnology from Arizona State University in 2007 and her M.S. in Biotechnology Management from Southern Illinois University Edwardsville in 2010.
MS, Biotechnology Management, Southern Illinois University Edwardsville, Edwardsville, IL (2010)
BS, Molecular Bioscience & Biotechnology, Arizona State University, Tempe, AZ (2007)
Shannon RueckerSenior Electronic Publishing Specialist
Shannon Ruecker joined Biologics Consulting as an Electronic Publishing Specialist in May 2018.
Shannon comes to Biologics Consulting with over 3 years of regulatory submission experience. She previously worked for PAREXEL International as an Associate in the Regulatory Outsourcing Services group, assembling eCTD submissions primarily for the EU. In this role, she also gained experience assembling and validating eCTD submissions for Australia, New Zealand, Saudi Arabia, and Switzerland.
Prior to PAREXEL, Shannon worked for Arivis producing eCTD submissions in accordance with FDA requirements, and was the primary contributor to the publishing of original IND applications and master files. She is well-versed in eCTD guidance documents and was responsible for interpreting FDA and ICH specifications to produce business user requirements for the development of home-grown publishing software.
Shannon graduated summa cum laude from the University of California, Santa Cruz with a BA in Environmental Studies.
B.A. Environmental Studies, summa cum laude, University of California, Santa Cruz, CA (2010)
James C. TaylorSenior Electronic Publishing Specialist
James C. Taylor joined Biologics Consulting in April 2015, as an Electronic Publishing Specialist.
James comes to Biologics Consulting with over 14 years of experience in the medical research industry at Pharmaceutical Product Development. Most recently, James was Senior Publishing Specialist responsible for leading a number of eCTD publishing projects, including large-scale case report form projects.
Prior to that, James was the lead specialist for publishing standard operating procedures and working practice documents for PPD’s Clinical Quality Assurance.
James holds a Bachelor of Arts degree from the University of Akron.
BA, English, University of Akron, Akron, OH (1985)
Mallory AlerElectronic Publishing Specialist
Mallory R. Aler joined Biologics Consulting as an Electronic Publishing Specialist in April 2022.
Mallory comes to Biologics Consulting with over 6 years of regulatory submission experience. She previously worked for Aquila Solutions as a Senior Regulatory Publisher in the Regulatory Affairs services, assembling eCTD submissions primarily for the CA, EU and US applications. In this role, she also gained experience assembling and validating eCTD submissions for the EMA as well as the CTA and FDA.
Prior to Aquila, Mallory worked as a professional administrative assistant for Sacred Heart Catholic School, and as a free-lance translator. She is well-versed in eCTD construction and harmonization to the guidelines of the FDA and ICH.
Mallory graduated with honors from the Wittenberg University with a BA in Foreign Language and Literature, as well as from Georgia State University with a MA in Applied Linguistics.
Aleese Hopkins, MSRegulatory Project Manager
Aleese Hopkins joined Biologics Consulting as a Regulatory Associate in October 2017 and has over 5 years of regulatory affairs experience. She provides project management and submission support for original applications and life cycle management, including INDs, BLA/NDAs, Orphan Drug Designations, and amendments and supplements as needed. She serves as a U.S. Agent Representative for foreign groups as well as a primary regulatory contact for U.S. based companies. In this capacity she facilitates communication between FDA and the sponsor and ensures requirements and timelines are adequately met. Ms. Hopkins has experience in eCTD formatting and is trained in electronic publishing, allowing her to advise Sponsors regarding best practices to implement during the writing process in order to support compliant electronic submissions of their application.
Prior to joining Biologics Consulting Group, Aleese was the Research and QA Associate for Aclairo Pharmaceutical Development Group, Inc. Here she gained experience in formatting, quality control, and technical writing. She is also trained in quality assurance and helped develop and run the QA department at Aclairo in order to perform TK analyses in accordance with GLP regulations.
Aleese holds a BS in Biology from Florida State University and a MS in Regulatory Affairs in Drugs, Biologics, and Medical Devices from George Washington University.
|B.S.||Biology, Florida State University, Tallahassee, FL (2011)|
Ji-Hyun Lee, MSRegulatory Associate
Ms. Lee joined Biologics Consulting in April 2022. She has worked with The Goudy Lab – Children’s Hospital of Atlanta/ Emory University in collaboration with Northeastern University to evaluate regulatory pathway of a repurposed FDA approved generic drug that is incorporated in a nanofiber scaffold.
Ji-Hyun previously worked for GSK as a Scientist contractor from PPD, part of Thermo Fisher Scientific. She worked in the Immunology and Cellular Analytics group in Analytical R&D department and performed cell-based potency bioassays to test stability, lot release, and characterize mRNA vaccine. She supported in house and GMP sample testing and developed cell-based assays for characterization and assay release. She collaborated with Drug Substance and Drug Product to support process development, formulation development, and high throughput sample testing.
Prior to GSK, Ji-Hyun worked for Pfizer as a Senior Associate Scientist. She was in Viral Vaccine R&D and was involved in many projects, including COVID-19, Influenza, and RSV. She was involved in assay development for ELISPOT and serological assays, such as HA/HAI and micro-neutralization assays. She produced virus, cultured RSV clinical isolates, and titrated for assay use for different projects in the pipeline.
Prior to Pfizer, she worked for U.S. Military HIV Research Program under Henry M. Jackson Foundation at Walter Reed Army Institute of Research as a Research Assistant. She supported novel vaccine strategies to increase efficacy of RV144 using flow cytometry-based assay to explore effector function and to measure cytotoxicity and phagocytosis.
She received her B.S. in Biology from Virginia Tech in 2015, M.S. in Infectious Disease/ Microbiology from George Mason in 2017, and M.S. in Regulatory Affairs from Northeastern University in 2022.
Kelly H. Reich, MS, RACRegulatory Project Manager
Ms. Reich joined Biologics Consulting in July 2001 and has 15+ years of experience advising sponsors on CBER and CDER regulatory requirements and providing application directed project guidance. This includes driving projects by educating first-time Sponsors and inexperienced teams regarding FDA regulations and expectations as well as integrating with a Sponsor’s existing infrastructure to manage global, multi-disciplinary teams working on applications for submission to FDA.
Supported applications include INTERACT, preIND, IND, BLA, NDA, ANDA, OD, DMF and related meetings. Ms. Reich coordinates and participates in writing, review, regulatory strategy discussions, generation and maintenance of project timelines, publishing and application life cycle maintenance activities (annual reports, fast track designation requests, protocol amendments, responses to FDA queries, etc.). She outlines typical application activities and milestones keeping in mind opportunities for accelerated pathways including fast track, breakthrough and regenerative medicine designations. And Ms. Reich provides perspective on best practices to manage availability of information, resources, corporate pressures, and publishing time to put together a quality application.
Ms. Reich has extensive experience serving as a regulatory contact or US Agent representative liaising with FDA on behalf of Sponsors. In this role she is in contact with FDA Regulatory Project Managers across various CDER and CBER offices on a daily basis following up on submission reviews, managing responses to information requests, and coordinating and participating in FDA meetings and associated rehearsals and de-briefing sessions.
Ms. Reich completed a MS in biotechnology and regulatory affairs at Johns Hopkins University in 2007 and achieved her Regulatory Affairs Certification (RAC) in 2010.
MS, Biotechnology & Regulatory Affairs, Johns Hopkins University, Baltimore, MD (2007)
BS, Biotechnology, James Madison University’s College of Integrated Science and Technology, Harrisonburg, VA (2001)
Regulatory Affairs Certification (RAC) (2010)
Samira ShirwaRegulatory Project Manager
Samira Shirwa joined Biologics Consulting in April of 2021 and has experience working on managing multiple projects through their life cycle. She comes with both a patient and sponsor centric understanding of clinical research and has had the opportunity to lead data analysis and research design of dozens of research projects simultaneously.
Ms. Shirwa previously worked as Clinical Research Lead at Vitreous Retina Macula Consultants of New York and gained experience drafting and executing protocols for new diagnostic and therapeutic strategies. She worked very closely with regulatory agencies to ensure compliance of study protocols and FDA standards. She has also created and negotiated intricate budgets with sponsors and directors, and acted as primary liaison between all outside vendors.
Prior to Vitreous Retina Macula Consultants of New York, Ms. Shirwa worked for Tricenna as a Clinical Research Coordinator and coordinated 40 research trials annually to ensure compliance with protocols, GCP and FDA standards. She managed the workflow of all team members, managed IRB submissions and completed all IRB requirements in conjunction with regulatory policies, and authored Standard Operating Procedures. She worked closely with sponsors to escalate any major issues or adverse events and communicated global regulation requirements.
Ms. Shirwa received her B.S. in Biomedical Engineering from Syracuse University where she engaged in multiple Research and Development and Clinical Research projects.Ms. Shirwa received her B.S. in Biomedical Engineering from Syracuse University where she engaged in multiple Research and Development and Clinical Research projects.
Holli S. Vaughan, MS, RACRegulatory Project Manager
Holli joined Biologics Consulting in March 2000 with 12+ years of regulatory affairs/project management experience in the biopharmaceutical industry. Prior to joining Biologics Consulting, she was the sole US Regulatory Affairs representative for an Australian-based biotech startup and held regulatory affairs positions in both small and mid-size companies.
Holli provides clients with regulatory project management and submission support for a variety of CBER and CDER regulated products. She works with multi-disciplinary teams in managing and preparing original INDs (Phase 1 through Phase 3), BLAs, NDAs, MFs, and Orphan Drug Designation requests; as well as providing FDA meeting support (INTERACT and Types A, B, C and D); ongoing maintenance support for regulatory applications/submissions; establishment registration/listing and document QC.
Holli also serves as the U.S. Agent/Regulatory Contact for foreign and U.S. based companies. She regularly interacts with FDA Regulatory Project Managers in this role. Her experience supporting different types of development programs has allowed her to build a positive rapport with numerous FDA Regulatory Project Managers across Center Offices and Divisions
MS, Interdisciplinary Scientific Studies, Biology, John Hopkins University, MD
BS, Biology, University of Mary Washington, VA
Regulatory Affairs Certification (RAC-US) 2001 – Present
Yelena Vaydman, MSRegulatory Project Manager
Yelena Vaydman joined Biologics Consulting in April 2015. She provides regulatory support and project management for a variety of regulatory applications. Yelena has experience with original applications as well as application maintenance (amendments and supplements). She has worked with preparing, submitting and maintaining both paper and electronic submissions, as well as converting paper document submissions to electronic format. She serves as a US Agent representative and regularly liaises with FDA.
MS, Regulatory Affairs for Drugs, Biologics, and Medical Devices, Northeastern University (2016)
BS, Biology, University of Massachusetts at Amherst, Amherst, MA (2009)
Minor in Music Performance (Piano), University of Massachusetts at Amherst, Amherst, MA (2009)
Member of the Commonwealth College, University of Massachusetts at Amherst, Amherst, MA (2009)
Rita M. Wilson, MSRegulatory Project Manager
Rita joined Biologics Consulting on June 1, 2022, and has fourteen years of industry experience, including seven years in clinical operations and seven years in regulatory affairs in Phase 1-3 global clinical studies and post-marketing product life cycle management. Her experiences include small and large molecules (including vaccines) in various therapeutic indications, including Oncology, Pain Management, HIV, CNS, CVS, Rare Diseases, Endocrine, Women’s Healthcare & Fertility products.
Rita’s experience with biopharmaceutical companies and CROs complemented with a medical background equip her with a unique mix of skills and expertise for providing broad guidance, strong leadership, efficient project management, and effective communication with executive management, health agencies, and stakeholders for regulatory strategy and execution; collaborating the review and submission of regulatory documents (CTD modules 1 to 5) for IND/CTA, BLA/NDA/MAA and post-approval variations in the US and ROW
Rita previously worked for Halozyme Therapeutics Inc. as Senior Manager in Regulatory Affairs (clinical) and led the regulatory activities for partnership development programs. Her primary responsibilities included developing and executing regulatory strategy; and collaboration efforts for reviewing the regulatory documents for Pre-IND, IND/INDa, C.T.A., BLA /sBLA/NDA, Orphan Drug Designation, and PIP applications. Before Halozyme, Rita worked as a consultant at ACADIA Pharmaceuticals and contributed to the regulatory strategy and execution for the two ACADIA products. Before ACADIA, Rita was the regulatory submission planner for the Asia-Pacific region for MSD (a subsidiary of Merck Co. Inc., USA). She led the regulatory strategy execution for the MAA of the three M.S.D. products in seventeen AP countries. She also served as a regulatory liaison and led MAA of three vaccines in India and neighboring markets.
Rita serves as the US Agent Representative for the sponsors. She interfaces with CBER and CDER and is familiar with US FDA regulations and guidance.
Rita has her bachelor’s degree in general dental surgery (BDS) and master’s degree in Clinical Research (MSCR) from India. In addition, she has an advanced certification in Regulatory Affairs and pursuing her master’s in Regulatory Science from San Diego State University.