Tim Kachmar

Tim Kachmar has 24 years of experience in Regulatory Affairs and has held various positions as a Senior Regulatory Affairs professional with significant FDA, EMA, MHRA, MPA, MEB and BfArM liaison experience.  Tim specializes in CMC, global clinical trial initiation and submission project management.  Tim’s therapeutic categories include oncology, cardiovascular, antibiotics and medical imaging.  Tim is Assistant Vice President  in Regulatory Affairs and Quality Assurance for Regenacy Pharmaceuticals.  Tim previously worked at Acetylon Pharmaceuticals as an Associate Vice President of Regulatory Affairs where he led the regulatory affairs team and provided regulatory leadership in the development of novel HDAC compounds. He also served as Senior Director of Regulatory Affairs and Quality Assurance at Verastem, Radius Health, Inc., and Mersana Therapeutics. Tim received his undergraduate degree and M.S. in Biology from the University of Massachusetts at Lowell.

Karen H. Noh, R.Ph., Pharm.D.

Dr. Noh is a regulatory leader with experience in developing and implementing regulatory strategies for both drug and biologic products in all phases of drug development, including marketed products. She has served as the US regulatory lead for various development programs and has been involved in INDs, and NDA/BLA filings including major efficacy supplements. Her experience includes developing global strategic regulatory development plans, labeling analysis, pediatric programs, as well as leading Health Authority meetings. In addition to development programs, Karen has broad expertise with marketed products, including critical issues management, safety related labeling changes, drug shortages, Dear Healthcare Professional letters, and formulation withdrawals and risk management programs. She has also provided regulatory leadership on the development and review of promotional campaigns, including DTC and initial product launch campaigns. She has managed FDA advisory committee meeting preparations by developing and implementing regulatory strategies, assisting in the preparation of briefing packages, as well as identifying key issues and responses. Karen has led development of US and global publication plans for marketed products and has expertise in researching, and interpreting regulatory intelligence information to shape regulatory strategies. Previously, Karen worked for Hoffmann-La Roche where she held positions in regulatory affairs, medical information, and publication management She is currently an employee of MBO Partners and is a sub-contractor for Advyzom. Karen received her Bachelor of Science and Doctor of Pharmacy degrees from the Philadelphia College of Pharmacy and Science and completed a drug information residency at Roche Laboratories Inc.

Lisa Drucker, PharmD, MBA

Dr. Lisa Drucker has over 20 years of experience in Regulatory Affairs with focused expertise in ensuring medical products meet FDA requirements related to Advertising & Promotion and Labeling.  She has extensive experience in interacting with the FDA Office of Prescription Drug Promotion (OPDP). She has built and optimized efficient business processes in electronic document management systems, especially for the Promotional and Medical Review Committees and Labeling Review Committee processes. Dr. Drucker has specific industry experience in hematology/oncology, supportive care, rare diseases, endocrinology, neurosciences, cardiovascular, anti-infectives, urology, women’s health and pain management. She has supported over 15 product launches and advised US and Global Marketing teams on the development of strategic messaging that are competitive and compliant with FDA regulations.  Dr. Drucker is an expert on FDA’s Consistent with FDA Labeling Guidance and use of data in promotion that is not in FDA-approved labeling.  She also has proficient expertise on FDAMA 114 regulations, 21^st Century Cures Act, and FDA’s Payer Guidance.  Dr. Drucker held various positions in Regulatory Affairs at Celgene, Daiichi Sankyo, Novartis, Sanofi-Aventis and Johnson & Johnson.  Dr. Drucker received her Doctor of Pharmacy degree with a Business Minor from University of Rhode Island, College of Pharmacy and her Masters in Business Administration from Rutgers Business School.  She completed a Medical Information Post-Doctoral Fellowship with Rutgers University at Ortho-McNeil Pharmaceutical.

Catherine Wheeler, M.D.

Catherine Wheeler is a hematologist and oncologist with over 20 years of industry experience in Clinical Development. She has held senior level positions in Pharma and Biotech in early and late clinical development for both small molecule and biologic therapeutics and has particular expertise in new molecule projects going from Discovery into Phase 1. She has been responsible for medical strategy for compounds in clinical development as well as functional and cross-functional team leadership. Most recently she has been a consultant in pharmaceutical development for numerous companies and projects. Catherine was Chief Medical Officer and Senior Vice President for Clinical Development at Acetylon Pharmaceuticals Prior to Acetylon, Catherine was Site Head for Oncology Translational Medicine at Roche Pharmaceuticals. Prior to Roche, Catherine was Vice President for Strategic Planning and Business Development within the Oncology and Infection Therapeutic Area for AstraZeneca. Catherine received her Bachelor of Science Degree from Bennington College and her Medical Degree from the University of Illinois Medical Center. Her Residency in Medicine was at Beth Israel Hospital and she was on the staff of Beth Israel Deaconess, Dana-Farber Cancer Institute, and Harvard Medical School.

Stephanie Krumholz, Pharm.D./Dr. rer. medic

Dr. Stephanie Krumholz is Founder and CEO of therainnova AG, Switzerland. Dr. Krumholz is an entrepreneur and a regulatory leader with about 20 years of experience in developing and implementing regulatory strategies focusing on EU, Switzerland and certain ROW countries. She supports companies in shaping the regulatory environment across therapeutic areas from early development through filing submissions and up to providing post-marketing support in those markets. Dr. Krumholz has served as EU regulatory lead, US regulatory lead, and Global Regulatory Leader in various NDA /BLA / MAA submissions across several jurisdictions. Her experience includes providing international strategic development plans, labelling analysis, paediatric programs, as well as leading Health Authority meetings with EU, Swiss, US and certain ROW Health Authorities including managing two FDA Advisory Committees and several EU Scientific Advise meetings. In addition, Dr. Krumholz has successfully managed critical issues and safety related changes across a variety of projects. She supports companies in Switzerland to gain marketing approvals through identifying the most optimal filing pathway while within Switzerland, in parallel, advising the clients in the local requirement (QMS) when acting as Swiss Marketing Authorisation Holder.   Read full bio >>

Dr. Aaron Bernstein has over 25 years of experience in the pharmaceutical industry leading the strategic planning of new drug applications to global health authorities. Aaron has played a lead role as the Project Manager of several New Drug Applications, Supplemental New Drug Applications, Investigational New Drug Applications. He has been the lead author on many Clinical Study Reports (Phases 1‑4), Integrated Summaries of Efficacy, Integrated Summaries of Safety, Summaries of Clinical Efficacy, Summaries of Clinical Safety, Protocols, Benefit/Risk Summaries, Investigator Brochures, and Health Authority Briefing Documents. The work of Aaron spans many therapeutic areas, most notably metabolic diseases, Hepatitis C, HIV/AIDS, cardiovascular disorders, infectious diseases, oncology, women’s health, and type II diabetes mellitus. Aaron is a founding member and past president of the European Medical Writers Association. He is an active member of the American Medical Writers Association, where he frequently presents on topics of medical writing standards and processes, as well as, drug regulation and drug development. Aaron is a primary contributor in the development and publication of CORE Reference tool, a detailed companion to the ICH E3 guideline on Clinical Study Reports.  Aaron received his Ph.D. in Human Anatomy and Cell Biology from the University of Maryland, Baltimore, MD.

Mary Clark has over 30 years of experience in medical and scientific writing focused on pharmaceutical regulatory documents or scientific/medical manuscripts for peer-reviewed journals. Mary has expertise in a number of therapeutic areas including pulmonary, oncology, cardiovascular, gastroenterology, immunology, pain management, CNS, orthopedics, infectious disease, and women’s health. She also has a strong background in scientific research and statistics, having conducted studies in biological oceanography at the Smithsonian Institution while holding a doctoral fellowship. Mary earned her Master’s Degree in Technical and Scientific Communication from Miami University of Ohio and a Bachelor’s Degree in Biology from the University of Delaware.

Deana Kaye has over 13 years of medical writing experience.  She was responsible for medical writing services for regulatory submissions, including INDs, NDAs developing protocols, Investigator Brochures, and briefing packages.  Deana has experience across a range of therapeutic areas, including cardiovascular, dermatology, endocrinology, hematology, infectious diseases, musculoskeletal, neurology, ophthalmology, oncology, psychiatry, respiratory and urology.  Deana has received her MS in Biomedical Writing from the University of the Sciences in Philadelphia..

Laura Lufrano has over 30 years of professional experience in the pharmaceutical industry.   Prior to joining Advyzom, Laura worked for Johnson & Johnson Consumer Health Care and Pharmaceuticals leading Research and Development Operations within North America and globally.    In various senior leadership positions, Laura drove research and delivery of new products and established J&J’s first global Medical Writing Department responsible for clinical study reports, investigator brochures and regulatory submission documents for all therapeutic areas.

Laura is a Doctoral candidate in Pharmacology/Toxicology at Rutgers University.  Laura earned her Master of Science in Pharmacology/Toxicology from Arnold and Marie Schwartz College of Pharmacy of Long Island University and a Bachelor of Science in Pharmacy from Rutgers College of Pharmacy.

Dr. Janet Merritt has 30 years of experience in the pharmaceutical industry, with over 15 years of medical writing experience. Janet is based in the UK, near London, and works with clients in the UK, US and Europe. Janet offers a broad range of writing services to support drug development and approval. She has extensive experience in writing nonclinical and clinical documents, including (but not limited to) Investigational New Drug applications, New Drug Applications, Briefing Documents, Investigator’s Brochures, protocols, study reports, and publications. Janet has experience in many disease areas, including (but not limited to) oncology, metabolic diseases, viral diseases, inflammation and auto-immune diseases, respiratory, cardiovascular, and gastrointestinal diseases. She has experience with new chemical entities, biologics and literature-based submissions. Janet has a broad area of scientific knowledge and the ability to make balanced scientific judgments, enabling a flexible approach and the ability to acquire rapid understanding of new areas. Janet is the author of over 50 full papers in peer-reviewed journals; she has completed a 5-year term on the Editorial Board of the Biochemical Journal; and has completed the Professional Development program of the European Medical Writers Association. She has a MA in biochemistry from Oxford University, UK; a PhD in cellular pharmacology from Sheffield University, UK; and postdoctoral experience in cellular pharmacology at the Medical College of Virginia, USA. This was followed by experience leading research groups in cellular pharmacology at two large pharmaceutical companies in the UK. client standards.

Tracey Spampinato has over 20 years of experience within the pharmaceutical research industry. Tracey has prepared documents in all phases of clinical development and have included clinical protocols, study reports, NDA sections, summary sections, IBs, literature summaries, and clinical narratives. Tracey’s writing experience includes extensive pharmacokinetic and pharmacodynamic data interpretation and a wide variety of therapeutic indications, including epilepsy, Crohn’s disease, Progressive Supranuclear Palsy, Oncology, hepatorenal syndrome, uterine fibroid disease, hemoglobinuria, Alzheimer’s disease, irritable bowel syndrome, Type 2 diabetes, disorders of reduced GI motility, chemotherapy-induced nausea and vomiting, pain and spasticity, cardiomyopathy, chronic renal failure/kidney disease, Parkinson’s disease, depression/SSRIs, schizophrenia, and gastroesophageal reflux disease. Tracey graduated from the University of Wisconsin with her Bachelor of Science in Nutritional Science and has a Master’s Degree in Adult Education from North Carolina State University.

Lana Rutitskaya has over 10 years of experience in Regulatory Submissions in the Pharmaceutical area.  Lana worked at DSI Pharmaceuticals as a Lead Dossier Specialist in Regulatory Operations.   Lana was responsible for preparing and publishing a variety of submissions for IND’s/NDA’s, Annual Reports, Briefing Packages, CMC supplements, Protocol and Information Amendments and CSR’s.  She is proficient in publishing eCTD submissions using Lorenz DocuBridge, Octagon Viewpoint, MS Office Suite, Adobe Orifessional and ISI Toolbox, as well as preparing paper submissions.  Lana has a BS in Electrical Engineering and a Certificate in Computer Programming and Design Technique.

Sharon has over 25 years of combined Regulatory Document and Submission Publishing in the pharmaceutical industry.  Sharon has worked as a Lead Dossier Specialist in Regulatory Operations/Submissions where she performed and oversaw preparation of submissions to the FDA in both electronic and paper format for IND’s/NDA’s such as initial INDs, Annual Reports, Briefing Packages, CMC supplements, Protocol and Information Amendments, CSRs and OPDP.  She is proficient in publishing eCTD submissions using Lorenz docuBridge, MS Word, and Adobe Acrobat Professional with ISI Toolbox. Sharon is highly focused on the client and can provide pre-submission document publishing and submission support offering frequent communication and close collaboration to meet needs and timelines.

Prior to joining Advyzom as a consultant in Regulatory Operations and submissions, Sharon held positions within Regulatory Operations at Mallinckrodt Pharmaceuticals, Daiichi Sankyo, Inc., and Hoffmann-La Roche Inc. /Genentech.