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.
Management Team
Susan Maue, PhD, Regional Managing Director of North America and Global Head of Product Development & Regulatory Solutions
Susan K. Maue is a senior life sciences executive dedicated to helping pharmaceutical, biotechnology, and MedTech companies bring life changing products to patients. As Regional Managing Director of North America and Global Head of Product Development & Regulatory Solutions at ProductLife Group, she leads teams that support clients across the full product lifecycle-from development through regulatory approval and market access.
Her career includes leadership roles at Cencora PharmaLex and AmerisourceBergen, where she guided strategy, operations, data and analytics transformation, M&A integration, and large-scale organizational growth. Earlier roles at Innomar Strategies and Xcenda deepened her expertise in real world evidence, patient access services, pharmacovigilance, and health outcomes research.
Susan holds a PhD in Pharmacy Health Care Administration from the University of Florida and a BS in Industrial Engineering from North Carolina State University. She is known for her patient focused mindset, collaborative leadership, and commitment to strengthening the ecosystem that enables innovative therapies to reach the people who need them most.
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.
Geary Hedrick, VP, Executive Partner
Geary Hedrick is a biopharma solutions architect and industry executive with 8 years of experience supporting drug & biologics development programs from early discovery through regulatory submission and commercialization readiness.
His team advises emerging and mid-size biotech companies on structuring development pathways and aligning the scientific, regulatory, and operational expertise required to advance complex programs. Experience spans early-stage development strategy, pre-IND planning, clinical development, and late-stage regulatory preparation across all aspects of CMC, quality, and clinical operations.
Operating at the intersection of science, development strategy, and execution, Geary and his team architect integrated development solutions that bring together cross-functional expertise around the needs of each program. He works closely with clients, technical leaders, and subject matter experts to ensure development, manufacturing, and regulatory strategies are aligned at each stage of the asset lifecycle.
Known for his ability to see the full development landscape, Geary helps biotech leadership teams translate complex scientific ambition into clear development strategies that move therapies efficiently toward patients.
Frank Perry, Director, Business Development
Frank Perry brings over 15 years of experience in sales, business development, and client engagement across the life sciences, biotechnology, and related industries. He has a proven track record of building lasting client relationships, driving revenue growth, and shaping go-to-market strategies that align with evolving industry needs.
At DSI, Frank leverages his expertise in identifying new opportunities, engaging C-suite executives, and guiding clients through complex decision-making processes to support their drug development and commercialization goals. His background includes senior roles at BioCentury, Mispro, and ChemoMetec USA, where he consistently exceeded sales targets, introduced innovative solutions, and expanded market presence in highly competitive environments.
Before joining the life sciences sector, Frank spent over a decade leading sales strategy in the AdTech space, where he built and managed high-performing teams and supported company growth from startup through expansion. He also proudly served in the United States Marine Corps, earning the Good Conduct Medal, Letters of Appreciation, and a Meritorious Mast for outstanding performance.
Frank studied Business Administration at SUNY Old Westbury and continues to apply his strategic mindset and client-first approach to foster growth and collaboration at DSI.
Josh Moon, Vice President, Head of Sales, North America
Josh brings over a decade of experience in Life Sciences, spanning academic research, pharmaceutical innovation, and commercial strategy. He has led high-performing sales teams and driven growth across clinical trials, medical devices, and post-trial access programs - partnering with both top-five pharma and emerging biotech companies.
Before moving into industry leadership, Josh managed the Neurology Research Institute at The Ohio State University, where he also earned both his Bachelor’s and Master’s degrees in Translational Pharmacology. He later completed a certificate in AI in Healthcare from Stanford Medicine, adding a tech-forward perspective to his strategic approach. Fluent in English, German, and Spanish, Josh brings a truly global outlook to his role.
His appointment marks an important step in strengthening PLG’s presence in North America — connecting client needs with PLG’s global expertise, and fostering growth through collaboration, insight, and innovation.
Bruce Copeland, Senior Director, Business Development
Bruce Copeland has over 17 years of experience in the clinical research and life sciences industry, with a strong focus on delivering strategic solutions across business development, marketing, account management, and service delivery. At Halloran Consulting Group, Bruce leverages his deep expertise in consultative selling, account analysis, and client engagement to help biopharma and medtech organizations navigate complex development challenges. He is known for building lasting client relationships and driving results through lead generation, bid defense preparation, and contract negotiation. With a proven ability to manage the entire sales lifecycle—from initial outreach to contract execution—Bruce plays a key role in connecting clients with the right Halloran expertise to meet their goals.
Prior to joining Halloran, Bruce gained extensive clinical and regulatory experience through key roles at Allucent, WCG Clinical, Cardinal Health Regulatory Sciences, and Vince & Associates Clinical Research. Throughout his career, he has focused on account management, territory expansion, strategic sponsor partnerships, targeted marketing, and new business acquisition. Bruce has successfully developed and managed solutions for a wide range of clients—including biotech startups, mid- to large pharmaceutical companies, medical device manufacturers, and organizations in the animal health sector—demonstrating his versatility and deep industry knowledge.
Bruce holds a Master of Arts in Educational Administration from the University of Missouri–Kansas City and a Bachelor of Science in Speech Communication, Public Relations, and Journalism from Wayne State College.
Kelly Hagen, Director, Business Development
Kelly Hagen serves as Director of Business Development at ProductLife Group (PLG), where she partners with pharmaceutical, biotechnology, and life sciences organizations to support their regulatory, quality, and product development initiatives. With nearly two decades of experience in healthcare and life sciences business development, Kelly is known for helping companies identify strategic opportunities and connect with the expertise needed to successfully navigate complex regulatory and development pathways.
Throughout her career, Kelly has held multiple director-level roles focused on business development, strategic partnerships, and growth within the life sciences sector. She also brings experience in mergers and acquisitions, supporting the identification and evaluation of strategic opportunities that help organizations expand capabilities and strengthen their market position.
At PLG, Kelly works closely with pharmaceutical, biotechnology, and medical device companies to understand their development and regulatory challenges and align them with PLG’s global expertise across regulatory affairs, pharmacovigilance, quality, and clinical development services. Her consultative approach and deep industry knowledge enable her to build trusted relationships with clients while helping them accelerate product development and bring new therapies to market.
Kelly holds a Bachelor’s degree in Communication Sciences from the University of Connecticut.
Heather Kellerman, Associate Director, Business Development
Heather Kellerman is a seasoned professional with over 10 years of experience in sales, marketing, and communications, specializing in the pharmaceutical, biopharmaceutical, and clinical software industries. As an Associate Director of Business Development, Heather leads efforts to identify new business opportunities, foster strong client relationships, and drive sales growth across the healthcare sector. Together, DS Inpharmatics (DSI) and Halloran make up Product Life Group's North American team.
Her expertise encompasses implementing strategic marketing and communication initiatives, managing sales outreach through campaigns and conferences, and enhancing brand awareness through social media. Heather excels in creating business plans, sales pitches, and marketing campaigns, aligning closely with colleagues across departments to execute growth strategies.
Before joining DSI, Heather held key roles at ProPharma, Embedded Solutions, Intrinsic Clinical Systems, and PBA Health, where she demonstrated a strong ability to generate leads, manage sales processes, and collaborate with marketing teams to drive business results. Heather holds a Bachelor of Liberal Arts from the University of Missouri-Kansas City and an Associate in Arts from Metropolitan Community College.
Services Areas
ANALYTICAL SERVICES
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.
REGULATORY SERVICES
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.
