Dr. Teresa Ceseña

Dr. Teresa Ceseña has over 10 years of pharmaceutical writing experience, and now leads the medical writing department as Senior manager of medical and regulatory writing since 2009.  The medical writing team has grown significantly, and one of her key responsibilities has been to ensure that onboarding, training and mentoring continue to maintain high levels of quality. Before coming to MMS, she had also taught at the university level.

As one of her key responsibilities is training of new medical writing colleagues, Dr. Cesena is responsible for implementing and maintaining processes and training programs. This includes establishing training exercises, other training material, and the development and training of mentors. Other responsibilities include developing training material for clients.

In addition, she has successfully led multiple and complex regulatory writing documents, and that experience has been applied in the MMS training programs. Her document repertoire includes, but is not limited to:

• Large, complex submissions, including safety and efficacy documents
• Clinical Study Protocols
• Clinical Study Reports
• Lay summaries
• Briefing Documents
• Writing and submitting grants, including facilitating grant writing workshops

 

Dr. Alan Hammer

Dr. Alan Hammer has nearly 10 years of research experience in which he collected, analyzed, and interpreted scientific data.  He spent 6 years working in preclinical research, developing an innovative method for detecting metastatic potential in breast cancer and identifying novel drug targets for cancer therapy.  During this time, Dr. Hammer authored, reviewed and edited multiple peer-reviewed manuscripts and published a book chapter on the role of the hormone prolactin in breast cancer progression.

Since joining MMS Holdings Inc. as a medical writer, Dr. Hammer has been lead writer on several types of clinical documents, including clinical study reports (CSRs) and various regulatory submission documents (including integrated summary of safety [ISS], summary of clinical safety [SCS], and summary of biopharmaceutics and associated analytical methods).  Dr. Hammer has authored clinical documents that span across several therapeutic areas, including pain management, cardiovascular disease, and acid reflux disease.  Further, he serves as a point of contact for medical and regulatory writing issues within MMS Holdings Inc.

Dr. Hammer holds a doctorate in Cell and Molecular Biology from the University of Toledo and is a member of the American Medical Writers Association.

 

Joe Archer

Mr. Joe Archer is the Associate Director, Trial Disclosure Services, and instrumental in the launch and growth of the clinical trial disclosure business at MMS. Mr. Archer has over 25 years of experience in clinical research and is a Subject Matter Expert of processes and systems related to the reporting of clinical trial information to ClinicalTrials.gov, EudraCT, and additional registries globally. Prior to holding this role, Mr. Archer was Senior Manager, Clinical Trial Disclosures at GlaxoSmithKline from 2007 to 2011 where he led the development and oversight of systems, processes, quality controls and compliance of clinical disclosure reporting of the company’s protocol and results summary information. He has also held various positions of increasing responsibility in the Regulatory Quality Control and Strategic Operations divisions of INC Research, Pfizer, and Parke-Davis. Mr. Archer earned a Bachelor of Science degree in Health Care Administration from Eastern Michigan University.

 

Chris Hurley

Chris Hurley has worked in the industry since 1990, starting as a contract SAS programmer in the Clinical Data Management department at Warner Lambert/Parke-Davis, which later was acquired by Pfizer.  At Pfizer, Chris moved to Clinical Reporting Systems where he worked on statistical programming and data standards projects.

In 2007, Chris started working on the CRO side of the business where he spent three years at i3 Statprobe, in Ann Arbor.  Since 2010, Chris has been manager of Clinical Programming and Biostatisticians at MMS Holdings Inc., Canton, Michigan, USA. Chris has supported many statistical programming projects at major pharmaceutical companies.  Chris has also provided leadership support as was evident when he was assigned to help develop a data anonymization solution for a major pharma company.   Together, with a small team from the sponsor and MMS Holdings, Chris helped develop global standards, SOPs, software and validation for this important initiative.

Chris started volunteering for PhUSE in 2013 as a co-chair for a Single Day Event (SDE). In 2014, Chris stepped up to contribute as US Events Project Co-Lead where he helped plan and organize all US PhUSE SDEs.  In 2015, Chris was added to the PhUSE Board as Director of US Events. In 2016, Chris assumed more responsibilities on the board in his current role as PhUSE US Director.

 

Dr. Sandra Drake

Dr. Sandra Drake has over 20 years of pharmaceutical industry experience and currently serves as the MMS Associate Director of Pharmacovigilance and Operations.  Before joining MMS, Dr. Drake has held Director positions at Esperion Therapeutics, and Somanetics Corporation; held a Vice President position at Summit Health; and has also taught at the university level. Dr. Drake provides oversight and guidance to Pharmacovigilance and Project Management teams regarding Adverse Event Case Management, Regulatory Reporting, and Risk Management activities for clinical studies. Dr. Drake holds a Bachelor of Science in Medical Technology from University of Michigan-Flint, an MPH in Laboratory Practice in Epidemiology from University of Michigan, and a PhD in Pathobiology from the University of Minnesota.

 

Dr. Kulin Kalpesh Mehta

Dr. Kulin Kalpesh Mehta has over 9 years of experience supporting the pharmaceutical and research industries.  Dr. Kulin holds the title of Senior Medical Reviewer at MMS. Since joining MMS, Dr. Kulin has been a lead medical monitor, has successfully written various safety reports, including Safety Management Plans, Safety Narratives, and Post Marketing Risk Management activities.  Dr. Kulin has served as a mentor to Pharmacovigilance team members based across the globe during his time at MMS.  In addition, Dr. Kulin is a Certified MeDRA Coder and has successfully performed coding of Adverse Events, Medical History and Concomitant Medications for many key client projects.  Dr. Kulin holds a Doctorate of Medicine (MBBS) from the Maharashtra University of Health Sciences, and a Masters of Public Health in Epidemiology from Indiana University, School of Medicine.

 

Dr. Amanda Beaster

Dr. Amanda Beaster has over 5 years pharmaceutical writing experience and holds the title of Technical Manager of Medical and Regulatory Writing for MMS. Since joining MMS, Dr. Beaster has been a lead writer on several types of clinical documents, such as Clinical Study Reports, (CSRs), Clinical  Study Protocols, (CSPs), Manuscripts and Patient Narratives. Dr. Beaster has also authored various complex NDA Module documents, including Module 2.4 (Nonclinical Overview), Module 2.5 (Clinical Overview), Module 2.6 (Nonclinical Written and Tabulated Summaries), Module 2.7 (Clinical Summary Documents), and Module 5.3.5.3 (Integrated Summary of Efficacy).  Dr. Beaster holds a PhD in Basic Medical Science (Microbiology) from the University of South Alabama College of Medicine, and a Bachelor of Science in Biology from Pensacola Christian College.

 

Dr. Ranjana Sundara

Dr. Ranjana Sundara has nearly 5 years of clinical experience and 3 years of technical writing experience, including experience as a medical writing lead for clinical NDA submission documents.  She has successfully written complex regulatory writing documents, including Clinical Study Protocols and Phase 2 and Phase 3 Clinical Study Reports.  In addition, Dr. Sundara has several years of academic clinical experience in Obstetrics and Gynecology, Family Medicine, and Internal Medicine.  Dr. Sundara holds a Doctorate of Medicine from Avalon University School of Medicine, and a Bachelor of Science in Physiology from Michigan State University.  Dr. Sundara is also a member of the American Medical Writers Association.

 

Kelly Williams

Kelly Williams has over 11 years of experience supporting the pharmaceutical industry as both a Biostatistician and a Programming Project Leader. Kelly is currently holds the title Clinical Principal Programmer for MMS.  Throughout her career she has performed extensive SAS programming activities to support both study and submission level tasks, including utilization and application of SDTM and ADaM CDISC standards.  Kelly has developed programming standards to maximize efficiencies, which included the development of global macros.  Kelly has also supported safety activities at the integrated level across a portfolio of compounds.  Kelly holds a Master of Science in Applied Statistics from Western Michigan University.