January 7th – 10th
San Francisco, CA
March 19th - 22nd
New York City
April 30th – May 2nd
June 3rd to 6th
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.
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.
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.
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.
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.
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.
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.
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.
Supply Chain and Project Management
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.
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.
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.
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.
Solid Orals Development
Mr. Michailaros is a drug product (DP) subject matter expert in oral DP dosage form (controlled release tablets, parenterals, inhaled products, transdermals, capsules, ointments, creams, liquids and coated tablet formulations.) development and manufacturing specializing in DEA Schedule 2 profile drugs. He has over 20 years of experience supporting CMO selection, due diligence, process validation efforts protocol generation or review and “man in plant” supervising of our client’s production campaigns. He has expertise in technical and compliant validation strategies with all aspects of product validation and supports our client’s product transfer needs including assisting in technical investigations.
Mr. Michailaros holds an MBA in management and an undergraduate chemistry degree from Lehigh University. Prior to consulting for ten years at DSI, he worked in commercial manufacturing for Teva and Johnson & Johnson. He is fluent in Greek.
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.
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.
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.
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.
Regulatory Affairs Submission Authoring
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.
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.
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.
Dr. Torok is a seasoned synthetic organic chemist whose education includes a BS from Bowling Green State University, MS from the University of Arizona and a PhD in Synthetic Organic Chemistry from the University of Iowa as well as a NIH postdoctoral fellowship in microbiology and medicinal chemistry. Dr. Torok has served industry for over 25 years in many aspects of development ranging from synthetic to process development chemistry. Dr. Torok’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. He uses his innovative experience in the conception of practical synthetic routes of chemical processes for the manufacture of APIs and chemical process troubleshooting. He is a hands-on, results-oriented leader of multidisciplinary teams focused on process discovery, process development, cGMP scale-up and transfer and cGMP commercial production. 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. Daniel uses his broad industrial experience to aid in the development of a client’s process, either in assisting as a hands-on bench chemist or as a Group Leader/Project Manager.
Analytical Drug Development
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, but is not limited to, both biologic large and synthetic small molecules, raw material release testing, HPLC, GC, and TOC testing, protein/peptide sequencing, API and Drug substance 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. Whether it’s reviewing, setting and justifying release specifications or determining the most suitable method for an existing product, his hands-on knowledge of methods and experience with contract labs has proven invaluable to clients. As a key CMC support for clients, Colman will assure development reports and data sets are complete and appropriate for a submission. 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).
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.
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 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).
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).
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.
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.