A DEEPER DEPARTMENT

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

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.

Kyriakos Michailaros

Solid Orals Development

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 transdermals.

Mr. Michailaros has helped author regulatory submissions in the EU as well as in the US and has worked extensively with international vendors. He has extensive experience in project 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.

• Led Product Launch teams for time sensitive milestones,
• Authored development protocols, reports, and CMC sections for regulatory filings,
• Experience in regulatory CMC strategy for drug development,
• Production troubleshooting of pharmaceutical oral solid dosage forms.

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.

Daniel W. Frank

Senior Regulatory Affairs Consultant

Mr. Frank has strong knowledge of regulatory and compliance for all phases of drug development, investigational and marketing applications, post-approval changes and GMP. He brings a manufacturing and compliance perspective to his writing with his career spanning from API to finished product manufacturing.

He provides expertise in all aspects of CMC including API requirements, formulation development, scale-up, manufacturing, submission/change requirements and validation for oral, topical, and injectable dosage forms.

Timothy Lloyd Trapp

Senior Project Management Consultant

Mr Trapp is an experienced CMC and pharmaceutical project management professional with extensive knowledge in development, pilot, clinical, and commercial pharmaceutical operations. Over the course of his 39+ year career, he has gained extensive technology transfer, design/scoping, commissioning, qualification, validation, and construction management experience for FDA regulated facilities.

Mr. Trapp is also RAC certified with extensive Module 3 submissions in support of IND, NDA, BLA, PMA, and IMPD submissions.

Ambareen Sheriff

Senior Regulatory Affairs Consultant

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.

David Blasingame

Senior Project Management Consultant

Mr. Blasingame has over 20 years of practical hands on experience in API drug substance manufacture. David has worked closely with the most API CMO’s in the US, Europe and Asia. David coordinates and leads manufacturing efforts by directly involving himself in all aspects of development and manufacture. This includes the research and development of small molecules, API synthetic routes and impurity control. David contributed to the manufacturing tech transfer and commercial launch activities for the Kuvan Oral Powder and the Cerliponase Alfa products at BioMarin as well as Neratinib at Puma Biotechnology. David assists our clients with COGs, CMO selection and product transfers, validation and launch and can assume the role of project lead for CMC activities on behalf of a client. In addition, he serves as a target subject matter expert in areas such as due-diligence, working with regulatory on commercial processes, or supported legal defending patents. His current roles for clients include project management, review and generation of technical documentation, supplier identification, sourcing and the analysis of cost of goods. David applies phase appropriate strategy to all aspects of a products development. David’s technical competence and manufacturing background provides clients with an onsite decision-making capability to suit their needs.

Susan Fasso

Senior Quality Assurance Consultant

Ms. Fasso has worked in industry holding various Quality Control and Quality Assurance roles for over 30 years. She received her BS in Chemistry at Drexel University before going on to earn her M.S in Regulatory Affairs/Quality Assurance at Temple University. Susan has held increasing roles of responsibility in Quality Assurance throughout her career at Wyeth, Flour Daniel, GW Labs Iroko and GPC Biotech amongst others.

Susan provides our clients with a depth of relevant experience that she readily shares. Susan is routinely asked to advise on phase appropriate solutions to a client’s needs. This includes a global understanding of compliance standards. In this capacity Susan has provided our clients with comprehensive gap analysis reports that they can then go on and use as resource justifications or to map out their Quality Systems.

Susan has planned and performed PAI and BIMO Inspection activities, provided input to filing IND’s, CTA’s, and MA submissions for small molecule and biologics products, managed lot release activities on behalf of clients, as well as managed client vendor audit responsibilities. Susan can work independently on behalf of a client or within any existing infrastructure a client may have in place which makes her an essential member of our team.

Daniel Torok, Ph.D.

Senior Drug Substance Consultant

Dr. Torok is a seasoned synthetic organic chemist who has been with DSI since shortly after its inception. Dan has served industry for over 30 years in many aspects of development ranging from synthetic to process development chemistry. He is a hands-on, results-oriented focused on process development, cGMP scale-up and transfer and cGMP commercial production.

Dan manages and oversees projects ranging from pre-IND chemistry development to pre-launch validation and material sourcing for late-stage clinical trials. Prior to joining DSI in 2008, he was with Lonza and Hovione for 17 years, where he honed his skills and expertise in API tech transfer, process validation and sourcing strategies. Dan uses his broad industrial experience to aid in the development of a client’s process, either in assisting as man in plant or as a project manager. Dan’s familiarity with most major worldwide CMO’s has made him invaluable to clients in support of existing API operations and sourcing new sites for production needs.

• Oversees project management, API synthesis design and API/Formulation sourcing support to our clients
• Assists clients in providing timely technical assistance as both an author and strategic advisor

Dan received his MS from the University of Arizona, his PhD in Synthetic Organic Chemistry from University of Iowa and performed his post-doctoral fellowship in microbiology and medicinal chemistry at the NIH.

Robbi Freisem

Senior Quality Assurance Consultant

Ms. Freisem is a subject matter expert in GXP Quality Assurance providing our clients with an effective CMC quality system management through drafting individual standard operating procedures. Her technical background is in drug substance manufacturing, small molecule and biologic API’s, sterile manufacturing, plant design, and technology transfer. She is a proficient negotiator of Quality Agreement and coordinating regulatory interactions with a CMO. Her capabilities include investigation remediation, lot release oversight, inspection preparation assistance, and site inspections providing extensive knowledge of ISO and cGMP requirements.

• Established and conducted GMP audit procedures
• Established quality systems and clinical quality assurance programs for start-up company
• Established supplier / vendor qualification program for GMP, GLP, and GCP contractors, CROs and CMOs

Ms. Freisem holds an undergraduate degree in biology serving in industry as a Quality department head with over 30 years at Wyeth, Centocor and Cardiokine.

Eileen Jacobs

Senior Project Management Consultant

A Drexel University trained mechanical engineer, Ms. Jacobs has over 23 years of global Pharmaceutical industry experience in engineering and product launch leadership roles in companies such as Wyeth, RPR and SKB. Using her sound technical abilities, Eileen serves our clients in effectively planning strategies for product launch, release, and distribution to markets worldwide.

Having served as the key contact for multiple major pharmaceutical company’s product launch to the EMEA markets, Eileen is aware of the challenges of coordinating Manufacturing needs with that of Supply Chain. Through effective and transparent project management tools, she routinely serves our clients in the areas of accumulating ready for launch product stock in anticipation of new product approvals. By understanding the many aspects of production and their relationship to support functions, Eileen can manage those relationships on behalf of clients or within a client’s existing infrastructure.

Eileen provides for our clients is around product transfer up to and including process validation. Often as client’s grow out of or require a site change to a new CMO, they must rely solely on the guidance of that CMO. Eileen creates overall project tracking tools (GANNT) that provide our clients with a snap shot of critical milestones and potential choke points throughout a project.

Amy McCord, Ph.D., RAC

Senior Regulatory Affairs Consultant

With a BS in Microbiology and Cell Sciences and a Ph.D. in Biomedical Sciences from the University of Florida and University of South Florida respectively, Dr. McCord brings over 10 years of technical industry knowledge to her Regulatory background.

With her knowledge of cell based therapies, recombinant proteins, gene therapies, small molecules, vaccines, device and device drug combination products, Amy brings a broad technical experience to her regulatory capabilities. Dr. McCord began her career working on submissions for multiple products at Accentia Bio and Cardinal Health. Amy earned her RAC Certification and is experienced in drafting Module 3 and QOS Module 2 submission content.

Amy provides our clients with authoring capabilities for their submission needs which includes, CMC content, briefing book drafting, submission amendments, and a variety of agency responses. Amy is often asked to provide regulatory affairs risk based guidance in the areas of submission content and strategy. She can drive focused meetings with our internal team and/or a client’s existing infrastructure to meet submission deadlines. Given Dr. McCord’s technical background, she also supports our clients by providing valuable insight and feedback as a Subject Matter Expert on critical development reports or milestones to meet a company’s objectives.

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.

Paul E. Long

Project Management Consultant

Mr. Long has supervised government regulated pharmaceutical and related industries with clear business processes for over 20 years. He manages the interdependencies of manufacturing and regulatory teams to drive the drug development process.

Mr. Long directs cross functional teams by matching desired technical expertise to execute the work plan and meet project timelines. He prioritizes the importance of meeting budgets, scope of work and end points by targeting the client’s strategic goals to understand where projects fit into the client’s portfolio. He monitors the impact of the changes on the risks and minimizes the impact to the project scope in order to make the project more successful.

Nancy J. Harper, Ph.d.

Senior Drug Product Consultant

With over 30 years of industry experience, Dr. Harper is an accomplished pharmaceutical product development scientist with emphasis on development of parenteral, oral liquid and inhalation products. She possesses a unique talent for merging scientific rigor, regulatory expertise, and pragmatism into drug product development while ensuring that customer needs are met.

As an expert in commercial drug product design and development (formulation and manufacturing process), she applies Quality by Design (QbD) concepts, CMC regulatory strategy/authorship, echnical risk assessment and problem solving. Nancy is a key contributor to clients as formulator or pharmaceutical expert in the development and successful commercialization of new drug products. She possesses experience with NCE’s (human and veterinary), product enhancements, and generic products for developed and emerging markets.

Bettina Kaplan

Senior Quality Assurance Consultant

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, Bio-Pharmaceuticals, 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, Softgels, Film Strips, Topicals, Liquids, Creams, Ointment, Gels, Suspensions, Sterile, Biopharmaceuticals, Aseptic products, Powders, Inhalers, Nutritionals, Aerosols and Combination Products.

Accomplishments include developing an active Quality & Compliance Organization to monitor all activities for R & D and Manufacturing Operations, implementation of best practices for Quality Systems to maintain compliance through effective Change Management. Creation of FDA readiness programs to assure effective and inspection management.

Jason Bender

Head of Supply Chain Services

Jason has a well-rounded Project Management background that includes a wide variety of aspects in Commercial Supply Chain, Clinical Supplies, Technology Transfers and Analytical Method Transfers. Jason is well versed in leading domestic and international cross-functional teams through challenging projects including initial Phase I/II drug supply needs, longer term Phase III forecasting/manufacturing, pre- & post-approval launch activities and manufacturing site changes.

Jason’s experience 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.

Jason received a BS in Chemical Engineering from Rensselaer Polytechnic Institute. Jason has held positions at Endo Pharmaceuticals, Merck Research Laboratories and Wyeth Pharmaceuticals (Pfizer).

Dennis H. Roberts

Senior Project Management Consultant

Mr. Roberts is a Pharmaceutical Development leader with proven proficiency gained through 30+ years’ experience guiding teams to successfully bring products to USP/EP/JP markets and maintain them. He has extensive experience with international GMP regulations for development, testing, manufacturing and commercialization, API, sterile injectable (liquid and lyophilized) and solid oral product development, testing and manufacturing. Coordinates with internal/external teams and vendors as well as negotiates with global regulatory bodies. He serves as a key client contact for assigned project responsibilities, establishing working relationships with client project teams which result in client satisfaction and operational excellence.

• Analytical Laboratory Management
• Drug Product Development
• Regulatory and Industry Compliance

Before joining DSI, Mr. Roberts served as Executive Director, Product Development at Xeris Pharmaceuticals. He holds a degree in Chemistry from Washington State University.

James Klancke

Senior Analytical Development Consultant

Mr. Klancke is an Analytical Executive with over 30 years of industry expertise in analytical method development and validation, analysis, and stability of pharmaceuticals in a GMP environment. He has expertise in all phases from drug concept through commercialization and has demonstrated leadership and management of large laboratory and technical teams. He also has experience in the development and validation of dissolution methods.

Jim has a proven ability to work effectively and meet or exceed expectations of internal and external customers leading to the launch of numerous products.

He applies a high level of proficiency in experimental design, data assessments, specification development, and risk assessment and mitigation in facilitating successful product development.
 

Johanna Hunt Karas

Senior Supply Chain Consultant

Ms. Karas has over twenty-eight years of experience in providing clinical supplies for investigational studies worldwide. Experience includes packaging and labeling, understanding of label requirements for multiple countries, import/export requirements, development of IVR specifications and monitoring systems for duration of clinical studies.

She has coordinated packaging/labeling, monitor repass dates, forecast and review/write packaging section of clinical protocols. Diligently worked with international counterparts to establish international shipping, depots, customs and processes.

A leader for developing and implementing of IRT for all phases of clinical trials including clinical trial designs that affect patient supply. She provides a variety of study experience including open label, blinded and double dummy studies, as well as complex drug packaging such as titration studies. Also, functioned as unblinded pharmacist for large Phase III studies by monitoring randomization of patients and ensuring drug availability.

Ms. Karas is a licensed pharmacist with a B.S. degree from the University of North Carolina at Chapel Hill. She has served in a clinical supply role at PRA, Gilead Sciences and as an independent consultant.

Michael Carroll

Senior Consultant, Microbiologist

Mr. Carroll is an accredited Microbiologist with over 35 years of product development, quality control and GMP manufacturing experience in the pharmaceutical, biotechnology and medical device industries. He is experienced in all phases of development, PAI, regulatory approval and product launch. He provides experimental analyses and applies knowledge to resolve quality issues.

Mr. Carroll provides technical guidance reviewing analytical methodology, assuring compliance with regulatory GMP guidelines, and initiating Quality Control laboratory process improvements.

• Developing scale-up, environmental and maintenance monitoring programs,
• Created accurate low-cost LAL test: Firm was using an unreliable LAL test on a lipid-containing product. Created and validated a new LAL test with higher accuracy rate and virtually no false positives. Reduced lot turnaround times and decreased costs 60%,
• Oversaw validation and implementation of new test globally. Firm needed ‘Harmonized’ Compendial Microbial Limits test validated and implemented in 140+ sites,
• Managed multiple (8) successful aseptic processing facility start-ups,
• Developing and validating microbiological test methods and specifications,
• Designing, qualifying and implementing new products/processes.

Mr. Carroll earned a BS in Biology/Pre-Med from the University of California at San Diego and a Medical Technology certification from Pennsylvania Hospital. He is ASCP Certified and a member of the Parenteral Drug Association (PDA).

Prasad Gullapalli, Ph.D.

Senior Drug Product Consultant

Dr. Gullapalli is skilled in the development and execution of CMC strategies for New Chemical Entities (NCEs) and for product line-extensions of existing molecules using patentable novel drug delivery technologies. He has over 20 years of experience developing strategies to respond to agency drug product inquires and representing clients during Preapproval Inspections (PAI), conducting investigations on Quality Events (QEs), and implementing Corrective and Preventive Actions (CAPAs).

• Built in-house oral dosage formulation and process development capabilities and personnel expertise (drug substance (DS) characterization, pre-formulation, analytical, and clinical & preclinical formulations) to complement the outsourcing model of early to late-stage product development and cGMP manufacturing at CROs & CDMOs,
• Expertise in immediate/Controlled Release (IR/CR) Tablets & Capsules, liquid-filled soft gel & hard capsules (SEDDS/SMEDDS/aqueous & nonaqueous solubilized dosage forms), and nanocrystal dispersions (NCD),
• Hands-on experience in both Biotech/Pharma and Contract Research Development & Manufacturing Organization (CRO & CDMO) sides of drug product (DP) development, selecting CROs & CDMOs, negotiating timelines and logistics and providing oversight (person-in-plant) of all supply chain management activities for clinical programs.

Before joining DSI, Dr. Gullapalli served as Head of Formulations at Dart Neuroscience and similar roles with Elan, Chiron and Purdue Pharma. He is RAC certified and earned his Ph.D. in Pharmaceutics from the University of Tennessee. He has eleven Patents/Applications and over 30 Publications/ Presentations.

Amanda B. Goodman

Supply Chain Consultant

Ms. Goodman is an accomplished clinical trials material manager with experience running domestic and international drug development programs for clinical trial phases 1through 3. The clinical trial programs included management of CMC manufacturing of drug substance, drug product, labeling and packaging of clinical supplies and clinical supply distribution.

She has led the developing and implementing of IRT for all phases of clinical trials including development of randomization and stratification criteria, review and development of specifications and user acceptance testing. She is knowledgeable of cGMPs and relevant FDA regulations.

Expertise includes developing detailed electronic diary for use in phase 2 and phase 3 clinical trials for orphan disease working with vendors to develop specifications, specification review, testing script development, conducting and managing testing of the diary and assisting in trouble shooting as issues arose during the clinical trial.

• Established and maintained clinical supply chain to ensure appropriate material delivery in a timely manner for multiple clinical trials,
• Maintain appropriate supplies for clinical sites based on expiry period including management of short expiry periods and limited IMP supply,
• Worked with clinical and CMC to develop robust strategies to ensure clinical trial needs are met,
• Responsible for all IMP labeling activities including development of label content for multiple regulatory agencies and management of translations,
• Establish and modified trial specific distribution agreements,
• Lead person managing vendors and coordination between multiple sites (domestic and international) to ensure project success including managing budgets, contracts, invoices and statements of work,
• Lead person developing and implementing IRT for all phases of clinical trials including development of randomization and stratification criteria, review and development of specifications and user acceptance testing,
• Collaborate with CMC and clinical project teams to develop CTM supply requirements based on materials on hand and clinical needs,
• Manage shipments of materials to depots throughout the world, work with depots to get materials through customs and have materials delivered as sites in a timely manner.

Maria Arakil

Quality Assurance Consultant

Ms. Arakil has expertise in phase-appropriate quality oversight for biologics and small molecules with experience in API/drug substance, drug product, and fill/finish operations from early phase development to commercial manufacturing. She has served as process owner and trainer for change control, deviations, CAPAs, material review board and product complaints (eQMS). She has also provided quality support to quality control, supply chain, clinical operations and facilities.

Catherine Bernard, Ph.D.

Senior Regulatory Affairs Consultant

Dr. Bernard directs our regulatory efforts and is a key strategist working closely with our client’s submission team. At DSI, Catherine oversees the regulatory aspects of API synthesis, delivery of clinical trial materials (CTM) (formulation, manufacturing, analytical testing, packaging, stability) and the coordination of chemistry, manufacturing and controls (CMC) information into regulatory filings. She has more than 25 years of experience in the pharmaceutical industry, with an extensive background in defining regulatory strategies to achieve corporate goals and moving early stage drug development programs to global regulatory submission and commercial launch. Dr. Bernard is a subject matter expert for submission life cycle management including both large and small molecule in all dose formulations. Before joining DSI, Catherine held the position of vice president of research and process development at VALORUM. She holds a Ph.D. in Biochemistry and Cell Biology from Université Paul Sabatier Toulouse III. She leads the CRO’s FDA and EMEA filing strategies in the UK. On behalf of our clients, she has successfully negotiated with agencies, submitting briefing books and in-person meeting attendance. Catherine is well versed in the many aspects of authoring in the electronic CTD format. In her time in industry, Catherine has supported multiple dosage forms at various stages of development.

James Mencel, Ph.D.

Senior Drug Substance Consultant

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. As a DSI subject matter expert, Jim assists our clients in providing timely technical assistance as both an author and advisor. Jim began his career in Discovery Chemistry and progressed to peptide and small molecule API chemical process R&D at Rhone Poulenc Rorer, and then Johnson Matthey with a focus on lab-to-plant transfer for cGMP clinical supply and commercial manufacturing and on inter-site technology transfer. Jim oversaw process & analytical development for API process scale-up; oversaw formulations R&D; and was responsible for GMP API & drug product manufacturing. 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.

• Oversees 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

Jim influences and oversees projects ranging from pre-IND chemistry development to pre-launch validation and material sourcing for late-stage clinical trials. In this capacity, he has proven indispensable.

Anil Raghani, Ph.D.

Senior Analytical Development Consultant

Dr. Raghani is a seasoned pharmaceutical professional with area of expertise in analytical chemistry related to Chemistry, Manufacturing, Controls (CMC) Module 3/Quality, technical writing for regulatory submissions, analytical method development, validation, technology transfer and control strategy development. An accomplished Consultant with in-depth understanding of manufacturing process development of small molecule therapeutics as well as biologics, formulation development, raw material control, regulatory requirements and ICH guidelines. Dr. Raghani is highly experienced in reviewing scientific information from laboratory data, technical reports, quality and manufacturing documents to assess technical merits and suitability of scientific rationale to ensure information presented in the regulatory submission is presented clearly and conclusions are supported by the scientific data.

• Develops analytical methods with universal set of analytical conditions that provide a unified approach for the implementation across multiple products
• Authors analytical sections of (INDs, BLA and MAA) and numerous RTQs
• Experienced in Biologics; protein characterization, analytical comparability and biosimilarity

Dr. Raghani received his Ph.D. in analytical chemistry for the University of Florida. Prior to joining DSI, he served as Director CMC Strategy at Coherus BioSciences.

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 provides oversight to other internal analytical team members, he directly supports clients in all the stages of development. Using his technical ability in conjunction with his knowledge of submission requirements, he not only supports 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.

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.

Randall Lis, Ph.D.

Chemistry Development and Regulatory Affairs

Dr. Lis serves as our CMC consultant with industry experience in the development of new drugs and therapeutic agents. He is responsible for setting the long-term strategy and vision for the regulatory function by providing global CMC regulatory management. He has filed over one hundred IND’s, NDA’s and other market product applications.

• Provides critical review of documentation supporting regulatory applications,
• Provides status of global regulatory affairs strategies and tactics, procedures and practices,
• Articulates complex regulatory CMC issues supporting global development and commercialization of early and late state products.

Dr. Lis received a B.A. in Chemistry from Rutgers University in New Brunswick, NJ and a Ph.D. in Organic Chemistry from Indiana University in Bloomington, Indiana.

Alpaslan Yaman, Ph.D.

Senior Drug Product Consultant

Dr. Yaman has expertise in sterile and non-sterile formulation development, process development (including automation) and scale-up, validation, technology transfer and technical services. He has scaled up and validated more than 40 products ranging from sterile powders to lyophilized reconstituted products. His expertise includes both traditional and biotech (peptides, proteins and nucleotide) drugs.

• Gamma irradiation of macromolecules and microwave sterilization,
• Third party manufacturers and service providers in the arena of technical
  support and quality/compliance,
• Novel delivery systems such as liposomes, microspheres and drug/device
  combination products.

Dr. Yaman earned his Ph.D. in Pharmaceutical Sciences with a major in Industrial Pharmaceutics and minor in Physical Chemistry. Prior to consulting, he served as Vice President, Technical Operations and Manufacturing at Edge Therapeutics and as Executive Director, Process Engineering, Worldwide Technical Operations at Johnson & Johnson.

Les D. 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.

His Consultant experience 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

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.

Meranda Parascandola

Head of Business Development 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.

Brian Lihou

Head of Operations

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).

Rick J. Offerman Ph.D

Senior Project Management Consultant

Dr. Offerman is an experienced API and drug substance professional with manufacturing practical experience. He has supported client’s Project Management, API and CMO support services in a variety of roles ranging from technical support to marketing and business development activities. Rick’s breadth of experience ranges from person in plant coverage, drug substance process oversight to negotiating manufacturing services agreements (MSAs)

Prior to joining DSI, Dr. Offerman was an Independent Consultant at a CMO specializing in small molecule and highly potent APIs and controlled substances. As an industrial chemist he held roles in laboratory development and scale up of small molecules as well as a process engineers on a manufacturing staff for several years.

Edward Narke, MS, RAC

Principal, Regulatory Affairs

A 25 year career in the pharmaceutical industry that is characterized by its breadth and extensive experience in all phases of drug development, from pre-clinical to post-marketing, with biologics and drugs. With hands-on experience in manufacturing process development, his expertise has been within CMC and Regulatory Sciences.

Ed has served as an advisor to emerging start-up and established pharmaceutical companies on development of in-line and pipeline products and opportunities. Starting in process development and technology transfer at Lonza to his years with Pfizer, Inc. he managed the preparation of IND, NDA and the BLA amendments for Enbrel® and Rapamune®, as well as regulatory strategy and submission preparation for the development programs for several biologics. After that, he was in drug regulatory affairs with numerous emerging biotech firms.

In 2007 Ed co-founded DSI. Ed holds a BS in chemistry from the University of Pittsburgh and an MA in organic chemistry from Villanova University. He is a co-instructor for several courses on the CTD Module 3 at several major conferences and offers customized in-house training programs on authoring CTD submissions. He is a member of RAPS and AAPS and has chaired the AAPS CMC Focus Group, the RAPS Philadelphia Chapter and the Regulatory Sciences Section Content Advisory Committee for AAPS magazine.

Christopher Brookes

Senior Drug Substance Consultant

Chris has 40 years of diverse management and business experience in API, fine chemical manufacturing, and contract custom synthesis. Principle responsibilities have included operations and project management, product introduction, product costing, regulatory compliance, and the achievement of financial and strategic targets. Product introduction ran the gamut from process development chemistry through large scale manufacturing. His hands-on and analytical approach has led to the successful commercialization of several API’s, chemical process optimization, and improved site operations, including plant utilization.

• CMC NDA submission including authoring, QA checking and editing of drug substance and drug product module 3 CMC sections,
• Directed the cGMP manufacture of bulk API’s and developed SOPs, batch records, policies and technology transfer documentation,
• Directed the activities of a 17 reactor cGMP pilot plant (30 to 750 gallon scale), four kilo labs.

Prior to joining DSI, Dr. Brookes served has as Technical and Operations Director for three bulk API manufacturing facilities. He holds a Ph.D. in Chemistry from the University of Birmingham.

Anthony Durning

Principal

Head of CMC Drug Development and consulting services practice. Tony has 30 years of senior management experience in drug development, cGMP manufacturing and commercialization; including hands-on plant management, budgeting and strategic planning. His experience spans a broad range of small molecule and biologic dosage forms and all aspects of technical and manufacturing operations from active pharmaceutical ingredient (API) through fill and finishing operations for clinical and commercial launch; including: Synercid®, Abelcet®, Myocet®, Taxotere®, Nasacort®, Lovenox®, Thymitaq®, lixivaptan, and rM-CSF.

Anthony has held positions of increasing responsibility at CardioKine Inc, Eximias Pharmaceuticals, Rhone Poulenc Rorer, Bristol Myers Squibb, Aventis, The Liposome Company and Enzo BiochemInc. Tony is an inventor on numerous patents and a founder of DSI. He received a BS in Biology from Rutgers 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.

David Adams

Senior Drug Substance Consultant

Mr. Adams is a perceptive chemist/engineer with over 30 years’ experience problem-solving in pharmaceutical manufacturing and process development with a history of making significant improvements. Experienced with fractional distillation, hydrogenations, catalysis, Grignard reactions, extractions, filtrations, hazardous reagents. Experienced with GMP’s, lean sigma, statistical-process-control, hazard analyses, environmental controls & treatment, DEA, OSHA & FDA regs.

• Managed approximately 6 production campaigns
• Improved operation and provided accountability for $15-million process recovery streams.
• Developed an improved crystallization for 6-ACP reducing processing time 50%.

Before joining DSI, Mr. Adams served has Production Team Leader for Lonza and Senior Process Engineer at Johnson Matthey.

Rose Zhao, Ph.D.

Regulatory Affairs Strategy

Dr. Zhao has led regulatory affairs groups in the US and China. She has authored entire CMC sections for IND, ANDA, NDA, MAA and medical device submission. An expert in CMC, generic and combo product strategy with a background in pharmaceutical development, Dr. Zhao has a successful track record gaining FDA and EU approvals. She has served as agency point of contact and led agency meetings providing both strategy and briefing books. She helps clients build internal structure to develop and author using eCTD guidance.

• Skill regulatory CMC strategist at preparing responses to health authority’s questions.
• Expert negotiator of inspection strategies and meetings with agencies
• International Agent for US and Canadian submissions

Before joining DSI, she was the Director of Regulatory CMC at Ironwood Pharma and team CMC lead at Johnson & Johnson. Dr. Zhao holds a Ph.D. in analytical chemistry from the University of Georgia and is a certified Regulatory Affairs Professional. She is fluent in Mandarin.

Gopi Vudathala, Ph.D.

Regulatory Affairs Strategy

Dr. Vudathala, serves as our Senior Vice President of Scientific and Regulatory Affairs with more than 20 years of experience in the development of new drugs and therapeutic agents. He has extensive experience in the management of global development projects, CMC regulatory management and regulatory strategy. He has led more than 100 FDA regulatory meetings in his career and continues to lead numerous meetings. He has authored more than 30 abstracts/publications and is frequently requested as a speaker both nationally and internationally. Dr. Vudathala is a seasoned regulatory negotiator conducting numerous interactions with the FDA, HC and EMA. He is proficient in developing regulatory starting materials strategies. A hands-on Executive with experience in small molecules, biologics, vaccines and drug-device combination products. He has contributed to the global approval of over twenty new drugs and biologics submissions. A highly motivated leader, technically competent and strategic thinker driven by performance and results. Dr. Vudathala holds a Ph.D. in Pharmaceutics from the University of Alberta. He began his career as a CMC reviewer for Health Canada. He was formerly Head of Quality Advocacy at GSK Vaccines and Global Head of Regulatory CMC at Novartis Vaccines and Associate Vice President of Regulatory Affairs CMC at Sanofi-Aventis.

Sanjay Sharma

Formulation Development

Mr. Sharma manages the development of NDA and ANDA products from formulation research through late stage development and commercial manufacturing. He has expertise in due-diligence of products and organizations for in-licensing. His formulation development knowledge includes solid, oral, liquid, topical, control release, transdermal, aerosol and combo devices. He has authored CMC sections of IND, NDA, and ANDA filings.

• Developed DPI formulation with 15% better-emitted dose than commercial formulation.
• Tech transfer external site integration of research activities from scale up to commercial.
• Define project tasks and timelines, critical path and track project progress using MS-Project.

Mr. Sharma earned a master’s degree in chemical engineering from the University of Utah and an MBA from Brigham Young University. He is a member of the American Association of Pharmaceutical Scientists. He has over twenty years of formulation experience at Watson Labs and Zar Pharmaceutical.

Royden Coe

Formulation Development

Royden is a scientist with more than 44 years of experience in the development and optimization of formulation, process, and product development of parenteral and solid dosage forms. Roy has worked with a range of formulation technologies; including, but not limited to sterile dosage forms; solution, liposomal, lyophilized, and solid dosage forms; hot melt hard gelatin capsules. He has extensive experience in the design (design of experiments and response surface modeling) and execution of experiments for process development, optimization, and process scale up. He has performed technical transfer from the lab to GMP manufacturing and process scale up studies on over 20 products, many of which later received market approval. Roy has been responsible for ensuring cGMP compliance for finished dosage for the manufacture of clinical batches and has written numerous drug product (P.3.2) sections for NDA and IND’s for solid and parenteral drug products. Roy has been employed by Cardiokine, Inc., Discovery Laboratories, Inc., Élan Pharmaceuticals, The Liposome Company, Steris Laboratories, Elkins-Sinn, Inc., and has been a consultant for DSI since 2008.

Rachel Ozer, Ph.D.

Biological Drug Substance Development

Dr. Ozer is a Harvard educated Chemist with a Ph.D. in Chemistry and Cell Biology from The Scripps Research Institute. With over 25 years of industry experience, Ms. Ozer is our most senior DSI bioprocess development and manufacturing consultant. Throughout her career, Rachel has led efforts in pharmaceutical bioprocessing and manufacturing, statistical process design and control, industrial filtration, chromatography and separations science, process economics, bioorganic chemistry, and analytical biochemistry. This includes direct experience while at the Ontario Institute for Cancer Research Biopharmaceutics for the design and implementation of strategy for clinical manufacturing, production of clinical supply drug substance for international Phase II studies, process development studies and transfer to manufacturing suite, manufacturing management and oversight, process demonstration, leadership in compliance requirements for clinical production, bioanalytical regulatory support studies for clinical development. In addition to the areas, Rachel has used the experience from her time at Bristol-Myers Squibb Co. and Shire to support our client’s existing pharmaceutical products with clinical development, technical analysis and composition of drug master files, evaluation of process controls, specifications and risk management. This has allowed clients to supplement their existing capabilities and serve as justification for additional resources to a given program.

Robert Michalik, J.D.

Medical Device and Combination Products

Dr. Michalik is a biochemist and subject matter expert for medical device and 510K product registration. He has prepared over 50 regulatory submissions including E.U. Technical Files, “510(k)” Premarket Notifications, Investigational Device Exemptions, Premarket Approvals applications., etc. He has specialty expertise in electromechanical devices, intravascular catheters, orthopedic implantable devices, glucose monitoring systems, wearable “smart” devices and sterile injectable products. He has authored several BLA, NDA and EU MAA submissions.

Dr. Michalik currently serves as adjunct facility in regulatory science at Johns Hopkins University. He earned his undergraduate degree in biochemistry from the University of Massachusetts and his Doctor of Jurisprudence at Suffolk Law Center. He has over twenty years of biochemistry and regulatory field experience at Merck/Serono, Berlex and Bioheart.

Beth Brown, Ph.D

Pharmaceutical Drug Delivery

Dr. Brown brings formulation, process development, pharma, biotech, drug device and drug delivery technology expertise to our clients including development of biologics from toxicology studies, through IND enabling studies, Clinical Phase studies, draft provisional patents and the marketing technical and business assessment for commercial dosage forms. Her career roles focused on novel science, revolutionary and evolutionary next generation products and the establishment of business processes. She has developed first-in-the-world oral bacterial capsule therapy platform including product and manufacturing processing.

• Utilized novel applications of bioprocessing, lyophilization, pharmaceutical encapsulation and packaging technologies.
• Authored regulatory submissions and two provisional patents for oral bacterial capsule therapy platform.
• Bioanalytical test method development and validation, PMA-qPCR, gene sequencing.

Dr Brown is experienced in later phase BLA submission activities and has worked directly with Quality and Manufacturing Directors to set up commercial manufacturing suites and quality control laboratories. Prior to joining DSI, Dr. Brown served as Director Research and Development for Rebiotix, a clinical stage biotechnology company founded to revolutionize the treatment of debilitating diseases by harnessing the power of the human microbiome. She is past editorial board member for Drug Delivery Technology and hold a Six Sigma Black Belt.

Judith Gallant, Ph.D

Regulatory Submission Authoring

Dr. Gallant is a highly skilled submissions content author. Judith provides expertise in CMC regulatory content authoring and review for monoclonals, various therapeutic proteins as well as small molecules. Judith provides strong project management for submissions and supports the client to publisher relationship. Judith has extensive global regulatory experience both NDA and BLA filings, as well as CTA and MAA variations, IMPD/IND CTD Modules 2 & 3 content and amendments.

• Authors and reviews the chemistry, manufacturing, and controls sections of regulatory dossiers including DMFs, INDs, ANDAs, NDAs, BLAs, and post-approval annual reports for various products
• Provides guidance for CMC-related aspects of drug development, including gap analyses for submissions, manufacturing process development, analytical method validations, and batch data analysis
• Prepared briefing packages, presentation material, and led a scientific advice meeting with an EU health authority, seeking input on variation strategy for numerous of DS and DP manufacturing changes for a therapeutic protein.

Prior to joining DSI, Dr. Gallant served various industry roles in strategy and technical authoring including Associate Director, CMC Regulatory for Ispen and Regulatory CMC Writer at Shire. She is fluent (read, write, converse and speak) in French and English.