Get More DONE.
Cross-Functional Team of Experts.
Our integrated approach enables us to serve as a trusted extension of your team, guiding clients through the complex landscape of drug development and commercialization with solutions tailored to specific requirements.
Evan Edwards
As an expert in the pharmaceutical and medical device industries, Evan Edwards serves as CEO for Kymanox. He was the cofounder of kaléo Inc. and co-inventor of the AUVI-Q (epinephrine injection, USP) and kaléo’s drug delivery device technologies. He has extensive experience in drug device combination products and is named on over 200 patents, issued and pending, both domestically and abroad.
Edwards is a subject matter expert in Usability Engineering, Design Controls, Combination Products, Operations, Industrialization, Quality Systems, Executive Leadership, Pre-Approval Inspection Readiness, Human Factors, Intellectual Property Strategy and Invention and Design. Edwards holds a B.S. in Mechanical Engineering from University of Virginia and an M.S. in Systems Engineering from University of Virginia with a concentration on Human Factors Engineering.
Nicholas Ciccarelli, PE
Nick is the Chief Operating Officer and leads the device design and innovation group at Kymanox, which focuses on combination product and medical device product design and development.
Nick has spent his career working to bring cutting edge medical technologies to patients and providers. He encourages his engineering team to consider manufacturing, assembly, and testing early in the development cycle, because inadequate device design can lead to costly changes later on. Nick has led and worked within cross-functional engineering teams that span the US, Europe, and China. His experience includes individual component design (e.g., plastic injection molding, stamping, glass forming, rubber compression molding), sub-assembly layout, and top-level system integration of complex electromechanical devices. He has been heavily involved in Design Verification activities, in vivo study design and execution, and the preparation of regulatory submissions.
He received a Bachelor of Science degree in Bioengineering from the University of Maryland, College Park and is a licensed Professional Engineer in Pennsylvania.
Andrea Johnson
Andrea leads Human Resources for Kymanox including development of organizational strategy and oversight of talent acquisition, management, and development for full time employees and the growing network of Kymanox contractors. She is responsible for revolutionizing the employee experience for Kymanox as the company grows rapidly. This includes management of all human resource functions including compensation, benefits, leave, performance management, employee satisfactions survey management, onboarding, and compliance with all existing governmental and labor reporting requirements
Prior to joining Kymanox, Andrea held various Human Resources positions at Hyatt Hotels, TicketsNow.com, Vibes Media, Level 10, Novan, and MAS Acme. She earned her Bachelor of Arts in International Studies from Miami University (Ohio).
Kevin C. Brown
Kevin Brown has been closely involved with Kymanox since it was founded in 2004. As a certified Project Management Professional (PMP), he brings over twenty years of project management, technology, and systems integration experience to the company, including extensive expertise in the development of large-scale, on-demand applications. Having identified, developed, and launched multiple web–based commercial applications for the pharmaceutical and biotechnology industries, Kevin is an expert in the Software Development Life Cycle (SDLC), quality systems, and GAMP5. His experience with GMP Software and Computer System Validation helps clients achieve FDA approval on software and equipment used as medical devices. Kevin has supported the approval of various biologics and medical devices by leading teams that provide commissioning, qualification, and validation (CQV) of software and equipment. He has managed Development and Quality Assurance teams and also has extensive experience with equipment and facility construction.
Prior to joining Kymanox, Kevin worked in advertising, software development, and systems consulting. He also has extensive experience working with Enterprise Resource Planning (ERP) systems, including SAP, Oracle, NetSuite, Sage and others. At various stages of his career, Kevin has been involved in the development of desktop applications, databases, and internet applications. He has also managed technical resources in a variety of roles, supporting GxP Quality Systems and audits by regulators.
Kevin graduated with honors from the University of Notre Dame with a Bachelor of Business Administration in Management.
Michelle Frakes, PhD
With over 15 years of experience in both the technical and business sides of the life science industry, Dr. Frakes leads the Business Solutions and Marketing efforts for Kymanox. On the business front, her responsibilities include proposal and CRM management as well as supporting the development of sales processes and procedures. On the marketing front, she is responsible for brand management, digital and print marketing, trade events and shows, sponsorships, and corporate communications. Dr. Frakes also provides project management support for both internal and external projects.
Prior to joining Kymanox, Dr. Frakes worked as the Director of Project Management at Flexcell International Corporation. She earned her PhD in Biomedical Engineering from the University of North Carolina, Chapel Hill and her Bachelor of Science in Engineering Science from the University of Tennessee, Knoxville.
Nathan Blazei, RAC, ASQ-CQA
Nathan Blazei has nearly two decades of life science industry experience and is skilled in various quality management system tools, regulatory strategy and filings, product and process development, process validation, continuous improvement methods, auditing and gap assessments, risk management, and regulatory inspection preparation, facilitation, and remediation. Nathan applies his engineering background to quality and regulatory compliance projects for clients to ensure that solutions are technically sound and compliant with current regulations.
Outside of Kymanox, Nathan worked for Liquidia, Novartis Vaccines & Diagnostics, Grifols and its predecessor Talecris Biotherapeutics, ev3 (now Covidien), and Boston Scientific. Nathan received a Bachelor of Science degree in Chemical Engineering from the University of Notre Dame and a Master of Engineering degree in Bioengineering from the University of California, San Diego. Nathan is a member of the Regulatory Affairs Professionals Society (RAPS). He is a Certified Quality Auditor (CQA) through the American Society for Quality (ASQ) and holds a Regulatory Affairs Certification (RAC-US) through RAPS. He has presented at domestic and international industry events on various topics relevant to the life sciences.
Ryan M. Doxey
With over 16 years of experience, Ryan leads the Chemistry, Manufacturing, and Controls (CMC) Services & Analytical Sciences Practice for Kymanox. He is a seasoned, strategic leader in the areas of CMC Regulatory and Pharmaceutical Development.
Ryan’s expertise includes program and portfolio management, global CMC regulatory requirements and strategy, CDMO/CMO selection and management, product development (including formulation, process, and analytical), technology transfer (pre- and post-approval), and clinical supply manufacturing and distribution. He has a passion for identifying, developing, and delivering practical and innovative solutions for complex, non-conventional product formulations and drug delivery systems throughout a product’s lifecycle. Ryan also has extensive experience in the areas of Technical Operations and Quality Management for manufacturing, release, and distribution of pharmaceutical and combination products.
Before joining Kymanox, Ryan worked at Novan, Steiefel, and DSM Pharmaceuticals. Ryan holds a Bachelor of Science in Biochemistry from the University of North Carolina in Chapel Hill and has completed 2 years of coursework toward a Ph.D. in Molecular Pharmaceutics from East Carolina University.
Izi Bruker, PhD, MPH, ASQ
Dr. Bruker has more than 25 years of experience in product development, quality and compliance, and regulatory and clinical affairs. His expertise encompasses compliance with US and EU regulations for medical devices and combination products, development of guidelines for evidence-based medicine, technology landscape analysis, strategic planning, due diligence, auditing, and project management.
Dr. Bruker is an experienced CGxP auditor for CMC, Clinical, and Laboratory, supporting products that contain devices, drugs or biologics. He has served as a member of Pharmacovigilance groups at Fortune 500 companies evaluating complaint and adverse event data for further action. Dr. Bruker has implemented and optimized R&D processes for medical device development in order to cut down the cycle time and increase productivity. He has designed and implemented design control processes in compliance with FDA and ISO requirements. He has been an advisor and trainer to large-cap pharmaceutical companies in combination product regulations, Quality System Regulation (QSR) and benefit-risk analysis. He has been a key member of the Quality Councils responsible for the operational integrity of the QSR and decisions on product recalls.
Dr. Bruker has written Clinical Evaluation Reports (CERs) in accordance with the latest EU medical device guidelines and participated in reviews and symposiums with Notified Bodies on the changes to EU regulations for medical devices. Dr. Bruker was a member of the Medical Device Innovation Consortium (MDIC), a collaborative effort between the US FDA and industry focused on Regulatory Science. In the orthopedic space, Dr. Bruker has designed and commercialized a multitude of products. He was a pioneer in the development of novel bio-resorbable polymer-based products in the sports medicine field in general and their application to joint preservation in particular.
He has collaborated with major teaching hospitals in the development of test methods and novel carrier systems for healing and regeneration. Dr. Bruker was a member of the Osteoarthritis Research Society International (OARSI) committee tasked by the FDA to critically evaluate the guidelines on “clinical development programs for the treatment and prevention of osteoarthritis.”
In the Ophthalmology space, Dr. Bruker has been involved in process development for contact lens manufacturing, intraocular lens design, testing, and development through commercialization. In general surgery, Dr. Bruker was involved in design and materials development for hernia repair, lung resection, and mesh development for pelvic organ prolapse.
Dr. Bruker holds a Ph.D., Chemical Engineering from the University of Wisconsin, Madison and a M.P.H., Comparative Effectiveness from Harvard School of Public Health. He received a B.S., Chemical Engineering from Rensselaer Polytechnic Institute and was named to the Whitney Gallery of Technical Achievers by GE Corporate R&D.
Alexis Dechelette, PhD
Alexis is the senior Director of Design and Innovation for the device design and innovation group at Kymanox, which focuses on combination product and medical device product design and development.
Alexis has been working in the medical device space his entire career. He first held research and development positions at an innovative dental device startup in California and then product development and manufacturing engineering positions at a drug delivery device company in Pennsylvania. Throughout his career, Alexis has worked on global projects across multiple continents involving several technical teams from vendors and clients. Through his project engagements and responsibilities, Alexis has developed a clear understanding of the key success factors for complex medical device projects that he shares passionately with his team and his clients. Alexis’ expertise is in out-of-the-box thinking and ideation, low pressure and high-pressure fluid delivery systems, pharmaceutical primary packaging, and low volume manufacturing. His interest is in taking innovative ideas to scalable concepts by applying sound engineering fundamentals and rapid prototyping.
Alexis holds an undergraduate engineering degree from the Ecole des Mines de Nancy in France and both a MS and PhD in Mechanical Engineering from Purdue University.
David Dlugo
Jason Merryman
With over 25 years of experience in Technical Operations and Engineering in the life science industry, Jason Merryman leads the Automation, Controls, and Utilities function (Automation Engineering) for Kymanox. Automation Engineering provides life science companies a full-range of Technical Operations support from technical strategy at the C-suite level to hands-on engineering support at the shop floor level. We help our clients identify long-term technical operations strategy including capacity expansion, facility utilities and systems, automation, and process specification. Additionally, we help our clients with implementation and adoption of new automated processes, commissioning, qualification, and validation of processes or equipment, computer system validation, and other shop-floor level support like change control management, creating or amending standard operating procedures, technical and operations personnel training, and continuous improvement. Automation Engineering provides solutions for the entire spectrum of Technical Operations and Engineering issues.
Prior to joining Kymanox, Jason worked as Vice President of Engineering at PharMEDium, a 503B compounder and division of AmerisourceBergen. Additionally, Jason has held leadership positions in Class I and Class III medical device companies. Jason earned both a M.S. degree in Engineering Management and B.S. degree in Mechanical Engineering from Missouri University of Science and Technology.
Katy Rommel, PhD
With over 10 years of professional experience, Katy Rommel is the Senior Director, Product Development & Commercialization group at Kymanox. Katy has interdisciplinary interests and a broad skill set which allows her to effectively bridge gaps between technical teams and business initiatives.
Katy’s experience is focused on early-phase development of combination products and in-vitro diagnostics. She is especially skilled at starting up new projects, building teams, and guiding them down the right path. She is a critical thinker and is not afraid to ask challenging questions to achieve aggressive goals.
Prior to joining Kymanox, Katy worked to build structure and processes to support technology development at Theranos. She earned a PhD in Chemistry from the Georgia Institute of Technology as well as bachelor’s degrees in Biology and Chemistry from the University of North Carolina, Wilmington.
Taras Seniuch
Taras Seniuch is a passionate and collaborative leader with over 20 years of industry experience in small molecule, injectable, and combination products. He has held various roles in product/packaging design and development, combination product development, operations, international supply chain, and business development, all of which provided him with the opportunity to launch multiple global commercial programs, including Enbrel, Sensipar/Mimpara, Incivek, Kalydeco, and Orkambi to name a few. Taras is committed to working with teams and partners to bring products through the development process and into commercial launch with quality and speed. Having held positions in the U.S. and internationally, Taras’ cultural awareness and understanding can provide unique perspectives on projects, programs, and services that can help organizations reach their most important goal of delivering product(s) to patients.
Prior to joining Kymanox, Taras graduated with a BS Science in Packaging from Michigan State University, attended company sponsored training at Wharton School, University of Pennsylvania, and held various roles at Aventis (Sanofi), Amgen, Vertex Pharmaceuticals, and SHL-Medical. He has also been an author and contributor to industry publications and hosted/presented at industry conference events/webinars.
QuynhNhu Nguyen, MS
With over 17 years of experience in both consulting and FDA regulatory review evaluations, QuynhNhu Nguyen is the Senior Director of Human Factors and Regulatory Strategy at Kymanox.
QuynhNhu has over 15 years of FDA regulatory science and evaluation experience with human factors, medication errors, and product design and development, reviewing 900+ medical products (devices, drugs, biologics, and combination products) that covered all therapeutic areas from various phases starting with investigational product applications to marketing applications to post approval supplements.
QuynhNhu has supported 45+ projects serving small, medium, and large pharmaceutical companies in ensuring comprehensive HF program executions with data-driven regulatory strategies and “Right First Time” submissions.
QuynhNhu earned a Master of Science Degree in Systems Engineering from Johns Hopkins University and a Bachelor’s degree in Biomedical Engineering from George Washington University.
Akshay Nadkarni, MS
Akshay Nadkarni is the Director of CMC at Kymanox. With over 10 years of experience in implementing risk-based approaches to drug product, medical device, and combination product development, Akshay leads projects in the areas of GMP manufacturing process and analytical method development, scale-up, and technology transfer for clinical and commercial-stage products. Akshay also has experience authoring CMC modules for multiple IND and NDA filings with the FDA. .
Apart from working at Kymanox, Akshay has held positions in the product development groups at Nicox Ophthalmics and Envisia Therapeutics. Akshay earned his Master of Science in Biomanufacturing from North Carolina State University, and his Bachelor of Science in Biomedical Engineering from Duke University.
Chris Adkins
Chris Adkins has 14 years of industry experience, spanning biologics drug substance and drug product manufacturing at both clinical and commercial phases, drug substance process development, single use technology, parenteral primary packaging, and comprehensive product development. Chris is passionate about operational readiness and product development initiatives, especially those that meet unmet medical needs.
Prior to joining Kymanox, Chris graduated with a BS in Mechanical Engineering from North Carolina State University and held various roles at Novartis, CSL Seqirus, SaniSure, and Datwyler. Chris also serves as the host of Kymanox’s Life Science Solutions podcast, interviewing industry leaders about developments across drug and device development and manufacturing.
Brandon Patterson
Brandon leads Kymanox’s MS&T group and brings over 20 years of experience in the pharmaceutical, 503B compounding, and medical device industries. As a leader at Kymanox, he enjoys working with and mentoring very talented engineers that have the same passion for helping our clients as he does. His team of Process Engineers have the tools and capability to deliver on any project. Brandon is also a working manager and has had the pleasure of leading large capital projects for our clients.
Prior to joining Kymanox, Brandon worked as the Sr. Director of Engineering at PharMEDium, a 503B compounding company. He earned his Bachelor of Science in Chemical Engineering from Purdue University.
Nicole Bridgers, MS
Nicole Bridgers, Director, Biologics and Advanced Medicinal Therapeutic Products at Kymanox, brings a wealth of expertise in gene therapy, biologics, and process development. With over a decade of experience, Nicole has led efforts in viral vaccines, cell and gene therapy, and biologic manufacturing. Her background includes bio process development, scale-up, and technology transfer, with a keen focus on integrating upstream, downstream, and fill-finish processes. Nicole’s leadership at Kymanox involves guiding teams through the complexities of biologic drug development, ensuring seamless transitions from small to large-scale manufacturing while maintaining regulatory compliance. Nicole’s technical depth, including her past roles at CSL Seqirus and FUJIFILM Diosynth, make her an expert in delivering patient-centric solutions for next-generation biologics.
Rachel Ward, PhD
Rachel Ward is the Director of Emerging Enterprise at Kymanox, leveraging her expertise in regulatory strategy, quality compliance, and product development for medical devices, pharmaceuticals, biologics, and combination products. Previously, as Associate Director of Regulatory Affairs, she led health authority interactions, authored FDA and Notified Body submissions, and guided development across therapeutic areas such as rare diseases, oncology, and dermatology. Rachel also applies her scientific background to business development, client engagement, and strategic planning, particularly for early-stage products. A former researcher in mitochondrial diseases, she has successfully submitted Orphan Drug Designation applications and implemented clinical bridging strategies.
Rachel holds a Ph.D. in Biochemistry from Duke University and graduated summa cum laude with dual Bachelor of Science degrees from Rose-Hulman Institute of Technology.
Ryan Agard
As Director of Product Development & Commercialization at Kymanox, Ryan leads the development of innovative medical devices, driving the design and integration of cutting-edge technologies. Prior to this, he served as Associate Director of Product Development at Kymanox, where he contributed to the company’s growth and success in product development.
Before joining Kymanox, Ryan held various roles at Teva Pharmaceuticals, including Associate Director of Combination Product and Device R&D, where he played a key role in the research and development of combination products. His earlier career includes significant contributions as Principal Product Development Engineer at Neuma LLC and Senior Product Development Engineer at Unilife Corporation. Ryan began his career as an Associate Product Development Engineer at Globus Medical.
Ryan holds a BS in Mechanical Engineering from Lehigh University.
Shaun Devitt
Shaun Devitt is a Director of Sterilization Technology and brings over 10 years of expertise in product and process development of drug delivery devices and combination products. He has contributed to the development of novel parenteral packaging, including reconstitution systems and wearable injectors. This work has extended to a focus on sterilization and sterility assurance process development, especially for new forms of products and packages where traditional approaches are not feasible. Shaun has innovated across the range of sterilization modes (irradiation, heat, and gas) for several clients with multiple patents pending. He and his team have also worked within and innovated in the critical related fields of Container Closure Integrity and terminally sterilized package integrity testing.
Shaun has a Bachelor’s of Engineering from The Cooper Union.
Thierry Jomini, MBA
Thierry is the Director of Business Development for Kymanox EU team. He has more than 12 years of experience in injection devices and combination products for various application such as diabetes, Parkinson disease, and hormone therapies. He has a focus on managing device development projects and taking care of business development activities. In the past, Thierry was in charge of product development, industrialization, and marketing of different products for biotech firms all around the world, especially in Europe and in Asia. He has also a strong engineering experience in building biotech production facilities.
If he is not busy working, Thierry loves being outside in the beautiful Swiss Alps, hiking in the summer or skiing in the winter. He is also a passionate saxophonist
Rahel von Rohr, MSc
Rahel von Rohr is a highly skilled leader in medical device development with over a decade of experience in project management and product development within the medical and biomedical engineering sectors. She currently leads the Kymanox Europe, where she drives the design and development of innovative medical devices, ensuring projects are delivered with precision and efficiency.
Prior to joining Kymanox, Rahel gained extensive experience in the medical device industry, holding key roles at Ypsomed AG and Sensirion. At Ypsomed AG, she served as both Product & Account Manager and Product Manager, where she was responsible for managing product lines and client accounts, driving strategic growth, and ensuring customer satisfaction. At Sensirion, Rahel excelled as a Key Account/Product Manager, focusing on medical products and fostering strong relationships with key clients.
Rahel holds a Master of Science (M.Sc.) in Biomedical Engineering from the renowned Eidgenössische Technische Hochschule Zürich
Gerry Farrell, PhD
Gerry has over 25 years of experience leading Biologics, Vaccine, and Viral Vector development and manufacturing operations in the CDMO arena. He has taken customer products from multiple platforms through development, tech transfer, validation, and GMP commercial manufacturing. Most recently Gerry was the COO for FUJIFILM Diosynth Biotechnologies facility in College Station, Texas where he was responsible for the construction and start-up of its state of the art antibody and viral vector manufacturing facilities and drove tenfold organizational growth over 9 years.
Gerry holds a B.Sc. and Ph.D. in Chemistry from Dublin City University.
Howard Drake
Mathias Romacker, MEcon
Mathias joined Kymanox as an Executive Advisor in October 2022, and will continue his support as our Ambassador. In this role, he will be part of a team of seasoned former executives who will share their experiences and insights with pharmaceutical and medical device companies. Prior to joining Kymanox, he was the Principal of Romacker Injection Device Strategy, LLC. He brings over 30 years of industry experience on the supplier and pharma side to the table.
Mathias retired from corporate life in December 2019. He stayed connected to the industry through speaking engagements and in advisory roles. Furthermore, he joined the PDA Board of Directors in January 2020. Mathias was last Senior Director, Device Strategy at Pfizer HQ in New York City. He joined Pfizer in March 2015. In this role within Pfizer Global Supply, he focused on the front end of device technology. He worked with multiple functions and sites across the organization to develop a device strategy for Pfizer pipeline and inline products.
Paul Jansen
Paul Jansen is currently working as a Drug Device Development Consultant. He is also on the Board of Directors at Subcuject and sits on the Advisory Boards of Evoleen, Windgap, and Kymanox.
He was formerly Associate Vice President, Medical Device Development, Sanofi until his retirement in January 2017. Jansen is a Professional Engineer with more than 30 years of experience in medical devices. He completed his degree in mechanical engineering and has completed graduate work in biomedical engineering at the University of Toronto.
Jansen has extensive experience in the design, development, manufacturing, and lifecycle management of medical devices. Jansen has multiple patents to his name and has deep experience in the creation and management of intellectual property portfolios. He has successfully led teams that have developed and launched several award-winning devices, including Lantus SoloStar, the world’s most popular insulin pen injection device. In addition, he has expertise in the design and development of injection molding systems and electronic components.
Jansen has been a long-time member of the International Standards Organization serving as Working Group Convenor and Expert on many work groups responsible for standards related to injection devices. Until January 2022, he was the Chair of Technical Committee 84, Devices for the administration of Medicinal Products and Catheters.
Jansen and his wife live in Boston, Massachusetts. He has two adult children and three grandchildren.
Roger Lias, PhD
Roger Lias, PhD is a global biopharmaceutical executive with more than 30 years of experience across biologics development, manufacturing, and commercial leadership. He has led and advised CDMOs, biopharma innovators, and biomanufacturing platforms, guiding complex biologics programs from early development through commercial execution worldwide.
Roger has held multiple C-suite and senior leadership roles, including President, CEO, and board member of Avid Bioservices; President and COO of Wheeler Bio; CEO of Stelis Biopharma; and Chief Commercial Officer at Vibalogics and Aurigene Pharmaceutical Services. He is a recognized business development leader with deep expertise across monoclonal antibodies, recombinant proteins, vaccines, and advanced modalities, and a proven track record at organizations including Lonza Biologics, KBI BioPharma, Diosynth, Allergan, Cytovance Biologics, and Eden Biodesign.
At Kymanox, Roger brings broad expertise across biologics development, tech transfer, scale-up, commercial manufacturing, and CDMO strategy. His global perspective and deep understanding of the biologics outsourcing landscape enable him to align technical, operational, and commercial objectives, supporting successful partnerships and sustainable manufacturing growth.
Roger holds a BS in Physiology and Biochemistry from the University of Southampton and a PhD in Biotechnology from the University of Cambridge.
William (Bill) Monteith
William (Bill) Monteith joined Kymanox as an Executive Advisor in May 2024, bringing over 40 years of experience in pharmaceutical and biotech operations. In this role, he will leverage his extensive expertise to support clients with strategic planning, regulatory compliance and remediation, facility management and buildout, and supply chain optimization across both small and large molecule manufacturing.
Throughout his career, Bill has held several executive positions in prominent companies within the industry. Most recently, he served as Chief Operating Officer at StrideBio, Inc., where he led the transformation from a pre-clinical to a clinical research organization. His experience also includes executive roles at Cellectis, Hitachi Chemical Advanced Therapeutics Solutions, Dendreon, Sandoz, Shire, and Wyeth Pharmaceuticals. These positions have given Bill comprehensive knowledge in managing large-scale pharmaceutical manufacturing operations, quality assurance, and strategic planning.
Bill’s expertise spans various areas of pharmaceutical and biotech operations, including gene therapy, cellular immunotherapy, and traditional pharmaceutical manufacturing. He has a strong track record in overseeing facility buildouts, launch preparations, and site readiness for commercialization. With his strategic insights and broad industry experience, Bill is well-positioned to advise Kymanox clients on complex operational challenges and process improvements in the rapidly evolving pharmaceutical and biotech landscape.
Bill holds a B.S. in Chemistry from St. Lawrence University.