Our Professional Consulting Staff Provides Smart and Efficient Solutions
Established in 2007 by Anthony Durning and Edward Narke, DSI was founded on the idea of providing clients with targeted and specific services within the CMC, Regulatory, and Operations arena. This type of support was imagined to be value added and timely to meet clients’ needs as they arise for as long as they are required. This philosophy continues to be what drives our organization today.
Fast forward to 2021 and DSI is now part of the ProductLife Group’s worldwide consulting team, specializing in outsourcing and consulting services that support the global life sciences industry across the product development and marketing life cycle. Whether advocating a complete CMC regulatory strategy, directing CMC operations, or developing CMC submission content that represent the best interests of emerging biotech, DSI remains focused on the critical CMC and Regulatory issues and build programs that enhance development. We are scientific and regulatory program management professionals who work closely with our clients to manage risk and drive development and product registration projects forward as quickly and efficiently as possible.
Brian Lihou, General Manager
Brian has in-depth experience with aseptic processing equipment trains, freeze drying bulk and sterile filling applications, including vial and ampule filling of suspensions, proteins, and powders. He has also managed support groups such as Technical Support, Instrumentation and Maintenance.
He has spearheaded performance improvement measures across departments and the optimization of plant procedure revisions and lot failure investigations for both clinical and commercial operations. Brian has participated in many domestic and international Regulatory inspections in support of Manufacturing Operations.
Brian has held positions in managing new facility start up, existing facility expansion and new product launch campaigns on a variety of scales for both clinical and marketed commercial products. Brian received a BS in Management from Almeda University. Brian has held positions of increasing responsibility at Endo Pharmaceuticals, Skyepharma Inc. (formerly DepoTech), Alkermes Inc., Genentech Inc., The Liposome Company and Johnson & Johnson (Ortho Biotech).
Meranda Parascandola, Head of BD and Marketing
Meranda started her career as a Legal Assistant at a litigation law firm in NYC while attending College of Staten Island. After graduating with an Associate’s degree, she landed an Administrative Assistant position at a pharmaceutical company in New Jersey. With her ability to recognize, learn and adapt to the needs of the growing business she quickly earned the role of Regulatory Affairs Specialist.
Her experiences with drug labeling, FDA communications and submissions made her a good fit for DSI industry experienced team. Meranda has over 10 years of experience in the Pharmaceutical/Biotechnology industry. Expertise includes leadership in business development, sales promotion, analytics, co-promotions, partnerships and collaborations. An effective leader with a proven track record of sales growth and generating revenue.
Most recently she provided strategic communication services for pharmaceutical, biotech and device companies preparing for FDA Advisory Committee meetings. She joined DSI in 2017 as Executive Director Business Development. In this role she utilizes her experience on both the regulatory and regulatory operations of product development working within all phases of a product’s lifecycle.
Thomas Hoy, Head of Project Management
With over 35 years of industry experience, Tom brings a well-rounded and diverse background in biotech, pharmaceutical, medical device, and supply chain operations to our DSI Team. His extensive experience with both small start-up as well as mid to large sized companies provides him a firm understanding of a client’s needs as the relate to CMC Operations. Having an in depth understanding of a broad range of products ranging from bulk biologics through finished goods packaging enables Tom to best target a client’s needs and responsibilities for their products.
Tom brings a history of managing multiple facilities throughout his career while consistently reducing cost and maintaining outstanding compliance profiles and customer service. His collaborative leadership style, with an emphasis on creating long-term internal and external relationships with stakeholders, makes Tom an essential part of the DSI Leadership team.
Tom received his BS, Pharmacy from the Philadelphia College of Pharmacy and Science and his MBA in Operations Management from Drexel University.
Anne Carr, Head of Finance & Administration
Anne Carr is the Head of Finance and Administration at DSI, where she manages all aspects of this continually growing company’s finances. Her responsibilities include all financial bookkeeping, the development and management of budgets, and the analysis and preparation of financial statements, as well as payroll and human resources functions. Anne develops and maintains internal controls and helps provide financial clarity while reporting on the company’s financial health to the principals and management team.
Anne joined DSI in 2010 and has been with the company every step of the way during its growth. She has seen the size of the company more than tripled from 15 associates in 2010, to its current count of 49 consulting and support personnel.
Before joining DSI, Anne spent ten years developing herself in the field of accounting and finance. Prior to that, she worked for Prudential Insurance for 14 years in accounting, group underwriting, and small group compliance.
Anne holds a Bachelor of Business Administration, as well as an MBA in General & Strategic Management from Temple University’s Fox School of Business.
Bob Gaffney, Head of Recruitment Operations
Bob Gaffney leads all talent acquisition and employee retention efforts for DSI. Bob oversees executive search and non-executive recruiting services, as well as recruitment process outsourcing, compensation analysis and employee satisfaction survey services.
After founding Remedy Solutions in 2005, Bob led the firm to become the top recruiting and executive search entity for the small emerging biotech industry, serving clients across the U.S. and placing more than 150 professionals in 12 years of operation. Bob has spent his entire professional career in the healthcare area, staffing and executive search industry — with the bulk of that time spent solely on CMC Regulatory. Bob is passionate in his goal of surpassing expectations and assisting with talent acquisition and employee retention strategies.
Colman Byrne, Head of Analytical Services
With over 30 years of industry experience, Mr. Byrne is our most senior Analytical Services expert at DSI. Colman is technically proficient in all aspects of analytical services having spent years managing both contract laboratories and AR&D groups at pharma and biopharma companies. This includes both biologic large and synthetic small molecules, raw material release testing, HPLC, GC, and TOC testing, protein/peptide sequencing, API manufacturing processes, lipid-based product testing, and various forms of drug product testing, and support of combination products.
Colman received his education from Trinity College Dublin. Prior to joining DSI, Colman has worked at Charles River Labs, Eximias, Cardiokine in increasingly responsible analytical development, regulatory, quality and operations roles. At CRL Colman was responsible for a lab of over 10 people managing cGMP laboratory testing including chemistry, microbiology, cell culture, particulate counting and identification, biocompatibility testing and animal facilities.
The Analytical Team consists of professionals who can provide oversight to a client's analytical program through direct, hands on, support in all the stages of development. Using their technical ability in conjunction with industry knowledge of submission requirements, they not only can support an initial filing effort but also the technical defense of a submission (information requests, in person Regulatory Agency meetings, and annual report updates).
- Expert reviewer, setting and justifying release specifications or determining the most suitable method for an existing product
- Deep hands-on knowledge of methods and experience with contract labs and proven invaluable to clients.
DRUG SUBSTANCE SERVICES
James Mencel, Ph.D., Head of Drug Substance Services
A Yale educated chemist, Dr. Mencel has served the pharmaceutical industry for over 30 years with practical experience in all aspects of synthetic chemistry and API development as well as early drug product formulation. In this capacity, Jim is technically proficient in several languages which serves his work with the global CMO community.
Jim joined DSI in 2015 from Galleon as an expert process chemist whose career focus has evolved toward applying principles of quality risk assessment and sound science to provide CMC guidance to all aspects of his area of drug substance.
The Drug Substance Team assists our clients in providing timely technical assistance as both an author and advisor. Ranging from discovery chemistry to peptide and small molecule API chemical process R&D. Services include lab-to-plant transfer for cGMP clinical supply and commercial manufacturing and on inter-site technology transfer. Our Team can oversee your process & analytical development for API process scale-up; formulation R&D; and GMP API & drug product manufacturing.
- We can oversee API synthesis design and process transfer and API/Formulation sourcing support
- Assists clients in providing timely technical assistance as both an author and strategic advisor
Regardless of scope, we can help with projects ranging from pre-IND chemistry development to pre-launch validation and material sourcing for late-stage clinical trials.
DRUG PRODUCT SERVICES
Kyriakos Michailaros, Head of Drug Product Services
Mr. Michailaros provides over 21 years of drug product expertise with both oral and solid processes, and product development and manufacturing. He specializes in difficult technical formulation and manufacturing challenges and products with unique requirements, including controlled release, zero-order release, abuse deterrence, pediatric formulations, oral disintegration. In addition, he has developed, and optimized products including controlled release tablets, abuse deterred capsules, pediatric formulations, solid and liquid filled capsules, suspensions, inhaled products, and transdermal.
Before joining DSI, Mr. Michailaros was Senior Engineer, Validation and Commercial Technical Services at Teva Pharmaceuticals as well as Johnson & Johnson. He has served DSI clients for over ten years. He earned a chemical engineering degree from Lehigh University and a mini-MBA in Management Essentials from Rutgers University.
The Drug Product Team has helped author regulatory submissions in the EU as well as in the US and has worked extensively with international vendors. They have extensive experience in program management, scale-up, tech transfer and validation, lean manufacturing, six sigma/process excellence, design of experiments (DOE), chemistry manufacturing and controls (CMC) regulatory submission authoring, capital projects and third-party manufacturing management.
- We can lead your Product Launch teams for time sensitive milestones,
- Assist in authoring development protocols, reports, and CMC sections for regulatory filings,
- Provide expertise to your regulatory CMC strategy for drug development,
- Add value to your production troubleshooting of pharmaceutical steriles, oral solid dosage forms, transdermal, and a host of dosage form formulations.
Ambareen Sheriff, Head of Regulatory Services
Ms. Sheriff has lead U.S. EMEA, HC and ROW regulatory and quality strategies supporting development and preparation of drug products, investigational studies, and marketing authorization. She has received FDA and EMEA approval for over 50 products for numerous INDs, ANDAs, NDAs, and Supplements, and has extensive working knowledge of 21 CFR, DDMAC, cGMPs, ISO, ICH, EMA and USP regulations.
With more than 32 years of experience, Ms. Sheriff is an expert in regulatory strategies for orphan drug designation, exclusivity, controlled correspondences, briefing books, etc. In addition to the different types of applications for the FDA, she has submitted drug applications to EMA, Health Canada and Scientific advice packages to MHRA, EMA and Brazil as part of global regulatory strategy. She has strong international experience of product registrations to regulatory authorities such as EMA, CE mark, TGA & TPD.
The DSI Regulatory Services team offers the experience and knowledge to guide the regulatory aspect of drug development from initial investigational submissions (IND, IMPD) through the final marketing application (NDA, MAA) process. DSI's experts are adept at the strategic aspects of the regulatory process as well as being "hands-on" resources for drafting and publication of the submissions. In addition, we offer the following services and much more:
- Provide Subject Matter Experts to review content for technical accuracy
- Provide GAP assessments for submissions and provide solutions to issues found during development and agency review and offer remediation solutions.
- Provide data integrity reviews between submission and source documents.
- Pre-IND or NDA meeting preparation including strategic guidance, drafting and reviews of briefing packages, and implementation of agency responses.
QUALITY ASSURANCE SERVICES
Bettina Kaplan, Head of Quality Assurance Services
Bettina is a seasoned Pharmaceutical Quality Assurance and Compliance professional with a BS in Chemistry from Steven's Institute of Technology and various industry certifications in Quality Assurance and Compliance Practices. Bettina has over 30 years of experience in Quality Control, Quality Assurance (R & D, Manufacturing, Quality Systems, Supplier Management, Quality Management and Corporate Quality) and Compliance with expertise in remediating and building robust and effective Quality Systems that are fit for the organization's size and scope.
Her experience has been in Pharma, OTC, Nutritional, Combination Products, Biopharmaceuticals, Contract Manufacturing and Packaging and APIs. Bettina has held positions of increasing responsibility at Schering-Plough, Thompson Medical Company, Hoffman-LaRoche, Purdue, Sharp Packaging, and Sandoz. Bettina has worked with a wide variety of dosage forms as follows: Oral Solid Dosage Forms - Tablets, Capsules, Soft gels, Film Strips, Topicals, Liquids, Creams, Ointment, Gels, Suspensions, Sterile, Biopharmaceuticals, Aseptic products, Powders, Inhalers, Nutritional, Aerosols and Combination Products.
The DSI Quality Assurance team can assist you in developing an active Quality & Compliance Organization for your program. By bringing a phase appropriate perspective to Quality, the team will implement a best practices approach to Quality Systems in order to maintain compliance through effective Change Management. Whether the scope is the complete management of your Quality system or adding support to your audit team, our team will provide the experience necessary to get the job done.
CELL & GENE THERAPY SERVICES
Paul J. Voronko, Senior Large Molecule Consultant
Mr. Voronko has over 30 years’ experience in the manufacture of large molecules. He has worked on the technical transfer and scale-up of multiple products ranging from antibiotics and monoclonal antibodies to cell and gene therapies. Paul has managed large-scale commercial production facilities and has worked with a network of CMOs for early phase clinical production. He is familiar with perfusion and fed-batch processes used for adherent and suspension cell lines.
Mr. Voronko has been intricately involved with the design, scale-up, and start-up of drug substance production facilities. He has directed the execution of PPQ studies, authored the manufacturing section of regulatory submissions and directly interacted with the FDA and EMA during PAI inspections. He has also been a member of due diligence teams with responsibility for assessing product manufacturability and potential suppliers.
As a facility GM and serving on serval Leadership Teams, Paul also has significant management experience for setting strategic goals, developing capital plans, budget management, and staff development.
BIOLOGICS & MICROBIOLOGY SERVICES
Les Mintzmyer, Senior Biologics Manufacturing Consultant
Mr. Mintzmyer is our hands-on expert for managing and directing biologics contract manufacturing organizations (CMO). He has led the commercial manufacturing operations for a multi-product facility directing materials management, inoculum, cell culture, purification, facilities, engineering and strategic support.
He successfully prepared a full service 6x20kL biologics facility for an FDA PAI, ultimately receiving biologic product manufacturing approval. The Operation grew from 60 to over 225+ employees in under 2 years. Prior to joining DSI, Mr. Mintzmyer served as Vice President, Manufacturing Operations for Jazz and Celetor Pharmaceuticals. Additionally, he served in a VP role for two CMOs; Avid Bioservices and Laureate Biopharmaceutical Services.
Our Biologics Services team support includes:
- Technical interface with Contract Manufacturing Organizations assisting in their preparation of proposals for consideration as a second manufacturing site for a client product
- Provided process knowledge input and experimental design guidance for obtaining data leading to process improvements and manufacturing robustness securing drug product supply to market
- Collaborated with client’s internal team to bring a new product and technology to manufacturing site
SUPPLY CHAIN SERVICES
Joseph P. Ivan, Head of Supply Chain Services
Mr. Ivan has over 20 years of experience in the pharmaceutical industry, 8 years in manufacturing and 12 years in supply chain. He has designed, implemented, and managed both clinical and commercial supply organizations for various sized companies.
Joe’s experience includes protocol development and review, forecasting, label management, inventory management, IRT management, ancillary supply management and global logistics management for all clinical phases, protocol types (blinded, open) and world regions. His specialties include North America, Asia Pacific, the European Union, Eastern Europe, and Latin America. In particular, he is a subject matter expert for importing clinical drug into China. He has authored and managed site and subject facing materials such as Pharmacy Manuals and Dose Card instructions. He is International Trade Compliance Certified (ITCC) for Import/Export in the US.
As a leader for bioanalytical laboratory testing, his experience includes assay development, validation and execution for clinical laboratory operations supporting clinical operations.
Our Supply Chain Services team has experience that spreads across branded and generic pharmaceuticals with a focus on Contract Manufacturing Organizations while it also includes scheduling, logistics, forecasting, API & excipient sourcing, comparator sourcing and Contract Packaging & Labeling Organizations.
MEDICAL DEVICE SERVICES
Vikki M. O'Connor, Senior Regulatory Affairs Consultant
Ms. O'Connor has more than 32 years of experience leading U.S. EMEA and ROW regulatory and quality strategies supporting development of medical devices, investigational studies, and marketing authorizations. She has received FDA and Notified Body / Competent Authority market approval on over 50 products via numerous 510(k)'s, IDEs, PMAs, Supplements and Amendments. She has written a dozen MDR Submissions (TUV, BSI and DQS) and has extensive working knowledge of 21 CFR, cGMPs, cGCPs, ISO, ICH, MDCG and applicable USP device regulations.
Ms. O'Connor is an expert in regulatory strategies for all classes of devices including active devices, active implantable devices, devices with software, hardware, and electronic components. In addition to the different types of applications for the FDA, she has submitted MDR Submissions to the EMA, Health Canada, Australia, Brazil, China, and Japan as part of global regulatory strategy. She has strong international experience of product registrations to EMA, Health Canada, TGA, ANVISA, CFDA and PMDA.
EARLY PROGRAM SERVICES
Judy Magruder, Senior Program Development Consultant
Judy Magruder has served as an advisor to emerging start-up and established pharmaceutical companies on development of in-line and pipeline products and opportunities with deep experience in key disciplines of drug development, facilitating effective program management to define, track, troubleshoot and meet business goals. Successfully developed small molecules, biologics, drug-device combinations, oral dosage forms, injectables, implants, transdermal and microneedle patches and a track record of building successful cross-functional teams especially at early stage innovators and significantly impacting achievement of project goals.
Judy received an MBA from Santa Clara University and a BS in Animal Science from the University of California Davis. Prior to joining DSI, Judy was an Independent Consultant and has held noteworthy roles in Program management and operations on the west coast at Zosano Pharma, Signature Therapeutics, DURECT Corporation and ALZA Corporation.