Defense & National Security Practice

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A list of Kinexum Newsletters and Featured Articles can be found at the pages below:

Newsletters

From Our Desks

 

 

 

 

 

 

 

Alan Fisher, DrPH

Areas of Expertise:  Biostatistics, Epidemiology, Design and Analysis of Clinical Trials, Outcomes Research. 

Alan Fisher has over 40 years of experience as a Biostatistician focusing primarily on the development and submission of new drugs and biologics.  He has presented and defended the study designs and clinical results of these products to regulatory authorities in the United States, Europe and Canada.  He has also served as an expert witness for legal depositions, participated in due diligence evaluations, analyzed outcomes research (real world evidence) data, and has been a member of several Data Monitoring Committees.

Alan has statistical expertise in the areas of categorical data, analysis of variance and survival analysis.  In addition he has been involved in many successful NDA and BLA submissions to the FDA and is familiar with the current CDISC requirements.  He is also knowledgeable with adaptive designs and sequential analysis.

Alan began his career as a biostatistician at Sandoz with a primary focus on the development and submission of pindolol (Visken®) for the treatment of angina, hypertension and arrhythmia and temazepam (Restoril®).  He then joined Hoechst-Roussel and was lead statistician for cefotaxime (Claforan®), a cephalosporin antibiotic, and  pentoxifylline (Trental®), a hemorheologic  agent for intermittent claudication.  He then joined Knoll Pharmaceuticals and led the statistical analyses and subsequent submission of propafenone (Rhythmol®), an anti-arrhythmic drug.

With the opportunity to take on an increase in level of responsibility, Alan then joined Enzon as Director of Biostatistics and was responsible for the biostatistics, statistical programming and data managements functions.  Under his direction, peg-l-asparaginase (Oncaspar®), for acute lymphoblastic leukemia, and pegadenase (Adagen®), for SCID, were approved by the FDA.

Alan then joined Johnson & Johnson as the Director of Biostatistics at their Immunobiology Research Institute to work on thymopentin for reduction in the risk of progression to AIDS in HIV+ subjects. He then joined the J&J Pharmaceutical Research Institute as a Director of Biostatistics and was also the Clinical Development Team Leader for Women’s Health Products.  In this capacity he led a successful submission of Ortho Tricycle Lo®, an oral contraceptive, and the successful simultaneous submission to the FDA and the EU of Ortho EVRA®, a transdermal contraceptive.  Alan then became Director of Biostatistics for Medical Affairs at Ortho-McNeil and was involved in the analysis of Phase IV studies, line extension submissions and outcomes research (real world evidence) studies.

In 2010 Alan started consulting for both biopharmaceutical companies and non-profit organizations.  This included the role of sole statistician for the successful submission of two products sponsored by BARDA (Biomedical Advanced Research and Development Authority), obiltoximab (Anthim®) for anthrax and tecovirimat (Tpoxx®) for smallpox.  Alan also provided statistical consultation for two contraceptives developed by the Population Council.  In this capacity he met with the Indian Council for Medical Research to defend the study design for one of their products. 

Alan received his BS from Cornell University with a major in Biometry, his MS in Statistics from North Carolina State University, and a DrPH with a concentration in Biostatistics and Epidemiology from the Columbia University School of Public Health.

 

 

Newsletter Winter 2019 - Note from the CEO

Note from the CEO 

Dear Friends of Kinexum, 

Welcome to the Winter 2019 edition of Kinexions, the Kinexum newsletter! 

Featured here are five Kinexum and guest authors on a plethora of topics:  

(i) Sue Manley, Kinexum Project Manager and former Global Head of Regulatory Operations for Novartis, discusses considerations for small to mid-sized companies in planning to file an NDA;

(ii) Dave Bergstrom, PhD, Kinexum strategic formulations and sourcing expert, outlines strategies for approaching CMC, new product development, and sourcing;

(iii) Tom Hedberg, PhD, a Kinexum senior medical writer and Executive Director of the International Medical Crisis Response Alliance (IMCRA), details the emerging silent epidemic of diabetes in China;

(vi) Jennifer Zhao, Kinexum Associate and recent graduate of Dartmouth, recaps Kinexum’s October webinar on the Targeting Aging with MEtformin (TAME) clinical trial that is pioneering a regulatory pathway with FDA for multiple diseases of aging; and

(v) Michael Cobb, software engineer of analytics software startup Navya Network, describes an application of machine learning in healthcare in the form of scalable treatment solutions for cancer diagnoses. 

Please join us for the next Kinexum public webcast on Friday, December 14, 2018, from 11 a.m. to noon, EST, by Tom Hedberg, PhD, on the causes, effects, and global aspects of post-traumatic stress disorder (PTSD) and responses to current treatment failure; you may register here.  

If you missed our previous webinar on the TAME clinical trial, you can find a recording here.

Kinexum will be in San Francisco during the upcoming JP Morgan Healthcare Conference, January 6-10, 2019, including at the RESI conference. If you would like to meet to discuss matters such as regulatory or clinical development strategy or negotiations with or a submission to FDA or another regulatory authority, please email  This email address is being protected from spambots. You need JavaScript enabled to view it.  to make an appointment.  

We are also very excited to announce our Metabesity 2019 congress on October 15-16, 2019 at the Carnegie Institution for Science in Washington, DC. Building on the great success of Metabesity 2017 in London, we are assembling another stellar set of speakers, including Victor Dzau, President of the National Academy of Medicine, Richard Hodes, Director of the National Institute of Aging, and Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research. Updates will appear in future Kinexions issues.

Wishing you a happy, healthy and fulfilling holiday season and 2019! 

 


 [JHZ1]Re-order to reflect layout in newsletter

 

Ramachandra (Ram) G. Naik, M.D.

 

Ramachandra G. Naik, MD

 

Ramachandra (Ram) G. Naik, MD, brings three decades of global institutional experience in patient care and clinical research, in both academic- and private-practice settings, and in drug and device development and medical affairs in the biopharmaceutical industry, with demonstrated clinical, strategic business, and executive leadership skills. He is currently a Professor of Medicine in the Division of Endocrinology, Diabetes, and Metabolism and an Assistant Dean at SUNY Upstate Medical University, Syracuse, NY, and is actively engaged in patient care, clinical research, and administrative activities.

 

Dr. Naik spent more than a decade of his professional career in private practice in Mumbai, India, as a Senior Consultant Endocrinologist at Bombay Hospital. He relocated to the United States in 2007 to join as an Assistant Professor of Medicine and Pediatrics at Barbara Davis Center for Childhood Diabetes at the University of Colorado Denver, where he was involved in patient care and clinical research activities in T1D; he was an investigator in several phase 2/3 clinical trials in the areas of immune interventions in T1D, insulin pumps, continuous glucose monitoring, and newer devices of insulin administration.

 

Dr. Naik transitioned into biopharmaceutical industry in 2009, and since then, has handled roles of progressively increasing responsibilities spanning all phases of clinical development and device development. Initially, as a Director in Global Cardiovascular Metabolism Franchise at Novartis Pharmaceuticals Corporation, he provided clinical leadership to late-stage development programs in diabetes and lipid disorders, was involved in business development and licensing activities, and worked closely with the translational medicine team on early development projects. He drove the initiative of establishing the Novartis “Metabolism Center of Excellence” in Hyderabad, India. Later, as a Therapeutic Area Clinical Director at Merck Research Laboratories, Dr. Naik provided strategic clinical leadership to multiple, global development programs from proof-of-concept through phase 3 registrational studies in diabetes and reproductive endocrinology. He was a core member of the Joint Development Committees of the co-development programs involving external partners (Pfizer and Samsung Bioepis). Subsequently, Dr. Naik worked at Johnson & Johnson Diabetes Care Companiesas the Senior Medical Director of Worldwide Clinical Affairs,with a focus on businesses across three distinct J&J companies providing direct leadership to insulin delivery platform (hybrid closed-loop insulin delivery program and patch insulin delivery system). In addition to providing strategic leadership to regulatory clinical studies for class II and class III devices, he designed and executed real world evidence generation studies, and provided clinical leadership for payer interactions, including value-based contracting, clinical support to digital platform, and franchise medical affairs leadership in the Asia-Pacific region. While pursuing his industry career, Dr. Naik held an academic appointment as an Adjunct Associate Professor at the University of Pennsylvania, and continued to maintain limited patient care activites.

 

Dr. Naik has been an active member of several professional societies, including the ADA and the Endocrine Society. He has served on the Research Grant Review Committee of the ADA. He was a recipient of 2014 Global Corporate Award in “Healthcare and Global Impact.” Dr. Naik has published in the area of autoimmune diabetes, has authored chapters in international textbooks on diabetes (including “Ellenberg & Rifkin's Diabetes Mellitus,” 6th ed., and “Therapy for Diabetes Mellitus and Related Disorders,” 5th ed., American Diabetes Association), and has given invited talks at national and international meetings. He was on the Advisory Boards of several pharmaceutical companies in India and the US prior to joining the biopharmaceutical industry.

 

Dr. Naik completed his post-doctoral training in endocrinology, initially, at All India Institute of Medical Sciences, New Delhi, India, and later, at the University of Washington, Seattle, WA. He was a receipient of the Juvenile Diabetes Research Foundation Postdoctoral Fellowship Award at the University of Washington. Later, Dr. Naik also pursued an executive business education from Kellogg School of Management, Northwestern University, Evanston, IL.

Newsletter Winter 2019 - Susan Manley - Early NDA Planning for Small to Mid-sized Companies

 

Early NDA Planning for Small to Mid-sized Companies

By Susan Manley 

Project Management/Regulatory

This email address is being protected from spambots. You need JavaScript enabled to view it.  

The final phase 3 studies are ongoing with a planned completion in 12 to 18 months. Your board is looking to the submission date with great excitement. Your company has made it this far – is time to relax? No, not yet! Your company has not prepared a US NDA in several years or, even more concerning, has never prepared an NDA. What can you do now to ensure a smooth trip to the submission and beyond?

As a first step, familiarize yourself with eCTD, which is the standard electronic organization and format that is required for a US NDA (see Brandon Jones’s Spring 2018 article for a brief overview). Establish a high-level eCTD timeline, section by section, to identify the critical path to the submission date. List the individual components with the planned completion date, then examine each component/completion date pair to determine dependencies and whether the component completion can be accelerated. This timeline should be used as the basis of a tracking sheet that specifies resources and completion dates. The level of detail needed for the tracking sheet depends on your organization. For example, if you have a robust clinical organization, you may delegate the detail of clinical study completion and report preparation to that group, while you only track the study report completion date. Of course, the items on the critical path will need to be carefully staffed and managed.

In order to complete NDA submission, smaller organizations often need contract staff to deal with the peak workload during the last year before submission. A critical strategy is to bring key contract staff on board early enough so they become familiar with the drug class, planned documents, key scientific and regulatory issues, and internal procedures. If this strategy is not implemented, several setbacks may arise. Too often has the situation occurred in which more medical writers are added at the last minute without proper time and attention to orientation. This rush usually results in senior document reviewer frustration with document content that can involve multiple, time-consuming draft cycles.  

The last item typically finalized is the product labeling. The last components that feed into the labeling are the clinical summaries: the Integrated Summary of Safety, the Integrated Summary of Efficacy, 2.7.3 the Summary of Clinical Efficacy, 2.7.4 the Summary of Clinical Safety, and 2.5 the Clinical Overview (which includes a key discussion of risks and benefits). These final items deserve careful attention and review.  

The NDA submission requires labeling components to be annotated to the source information. A good practice is to prepare and maintain an “emerging package insert” during development, rather than drafting the label at the end of development. This emerging package insert should be annotated with the planned source document and any relevant comments. As work progresses, the emerging package insert will be modified based on development findings.

Careful planning should also apply to the order in which individual modules of the NDA are completed. Module 1 (Administrative Information), Module 2 (Summaries), and Module 5 (Clinical Study Reports) are usually the last sections to be completed. Frequently, Module 3 (Quality) and Module 4 (Nonclinical Study Reports) can be completed and provided to e-publishers days or even months before the completion of the other sections. A best practice is to complete Module 3 and 4 as early as possible. If this practice seems feasible for your company, you should consider discussing a rolling submission with FDA.   

Other topics to be addressed early on include:

·       Timing and content of the pre-NDA meeting. A draft package insert is required for this meeting. The planning and timelines for the NDA preparation should allow flexibility for revisions based on the outcome of this meeting.  

·       Organization of team meetings to communicate the “storyline” and address critical issues based on internal knowledge and FDA communications. 

·       Definition of writing standards, such as product name, document headers, use of templates, and granularity of documents. These standards will facilitate eCTD writing and future updating. 

·       Specification of the process for completing submission components, including quality control, review, sign-off, and storage. Storage should include not only the PDFs for submission, but also the final Word files, for the Word files will be helpful for future NDA amendments or submissions to other health authorities.

All trips to NDA submission have a few traffic humps and even some pot holes. Planning early while keeping these strategies and best practices in mind will help you navigate the journey more easily.