Program Management and GANTT Chart Products

Bettina Kaplan

Quality Assurance

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.

Susan Fasso

Quality Assurance

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.

Anil Raghani, Ph.D.

Senior Analytical Science

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.

• Developed several analytical methods with universal set of analytical conditions that provided a unified approach for the implementation across multiple products
• Authored analytical sections of (INDs, BLA and MAA) and numerous RTQs
• Experienced in 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.

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.

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.

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.

David Blasingame

Drug Substance Development

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.

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.

Catherine Bernard, Ph.D.

Regulatory Affairs Strategy

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.

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.

James Mencel, Ph.D.

Drug Substance Development

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 with a focus on lab-to-plant transfer for GMP clinical supply and commercial manufacturing and on inter-site technology transfer. This includes API synthesis design and Phase 1 Formulation sourcing support for our clients. He 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. Dr. Mencel joined us at DSI in 2015 as an expert process chemist who’s 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.

Bob Gaffney

Talent Acquisition

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.

Meranda Parascandola

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.

Jason Bender

Project Management

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).

Brian Lihou

Project Management and 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).