Selected Publications

March 22 2019 Kinexum Webcast Prevention of T2DM

Prevention of T2DM

Webinars

Below please find links to videos of webinars from Kinexum members and honored guest speakers:

Catalyzing the Transition from Bench to Bedside: Early Partnering with Patient Organizations - Featuring James Valentine and Larry Bauer. To view the slide presentation, click Here.

China: Reshaping the Global Clinical Development Landscape - Featuring George Baeder, SVP, Strategy and Business Development, dMed Biopharmaceuticals. To view the slide presentation, click Here.

Precision Medicine Approach to Cancer Care and Prevention - by Drs. Brian Leyland-Jones and Jeff Bockman. To view the slide presentation, click here.

Targeting Metabesity: Prospects and Pathways for Extending Healthy Lifespan and Saving Trillions - by Dr. Nir Barzilai, Joseph Cook and Dr. Alexander Fleming. To view the slide presentation, click Here.

Prevention of T2DM - by Dr. Ralph LaFronzo. To view the slides for the presentation, please click here.

PTSD - Associated Pathologies in the World of 2018 - 12.14.2018 Thomas Hedberg, MSc, Ph.D., Executive Director International Medical Crisis Response Alliance, on causes, effects and treatment failure of PTSD

Using Metformin to Target Aging - 10.26.2018 Dr. Kritchevsky, Sticht Center for Healthy Aging and Alzheimer’s Prevention Wake Forest School of Medicine and Dr. Barzilai, Albert Einstein College of Medicine 

An Inside View of the European Regulatory Framework: Cooperation Works - 07.13.2018 Prof. Bart Van der Schueren, University of Leuven, Belgian Representative on EMA

Opportunities for the Development and Approval of Regenerative Medical Products in Japan - 06.08.2018 Rob Claar, CEO of HekaBio K.K.

Targeting Metabolism to Attack Obesity, NASH, CVD and Aging Itself - 05.11.2018 Dr. Zemel, Chief scientific Officer, Nusirt Biopharma.

From Big Hammers toLasers: Lessons being learned from targeting the immune system to reverse or prevent disease - 03.23.2018 Dr. Larry Steinman, Professor of Neurology, Neurological Sciences and Pediatrics, stanford University, as interviewed by Dr. Zan Fleming 

From Our Desks

Newsletter Fall 2019 - Founder, Dr. Zan Fleming

Newsletter Fall 2019 note from the CEO

Newsletter Fall 2019 - M Prasad Palthur, Ph.D. - Artificial Pancreas Device Systems (ADPS) – Directions for Future Developmentt

Newsletter Fall 2019 - Mustafa Noor, MD - My Journey as a Recently Arrived Refugee to America

Newsletter Summer 2019 - Webcast Recap: Dr. Ralph DeFronzo on Type 2 Diabetes

Newsletter Summer 2019 - Alan Fisher, Experiences as a Data Monitoring Committee Biostatistician

Newsletter Summer 2019 - M Prasad Palthur, Artificial Pancreas Device Systems (ADPS) – General Product Development and Regulatory Pathways

Newsletter Summer 2019 - Bill Hoover, Issues with Product Development Traceability

Newsletter Summer 2019 - CEO, Thomas Seoh

Newsletter Summer 2019 - Founder, Dr. Zan Fleming

Newsletter Summer 2019 - George Baeder - How China is Changing the Clinical Development Landscape 

Newsletter Spring 2019 - Founder, Dr. Zan Fleming

Newsletter Spring 2019 - note from the CEO Thomas Seoh

Newsletter Spring 2019 - John Kucharczyk, Can Blockchain and Artificial Intelligence Transform the Management of Healthcare?

Newsletter Spring 2019 - Brian Oscherwitz, Perspective on How the Kinexum Advantage Benefits Its Consultants and Clients

Newsletter Spring 2019 - Jennifer Zhao, Perspectives as a Kinexum Associate  

Newsletter Spring 2019 - Prasad Palthur, Artificial Pancreas Device Systems – An Evolving Approach and Research Pathway

Newsletter Winter 2019 - Tom Hedberg The Silent Epidemic of Diabetes in china

Newsletter Winter 2019 - David Bergstrom - Strategies to Approaching CMC New Product Development and Manufacturing Outsourcing Resources

Newsletter Winter 2019 - Michael Cobb - Applications of Machine LEarning in Healthcare: Scalable Treatment Solutions for Cancer Patients

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

Newsletter Winter 2019 From Kinexum Founder: Staying on the NDA Learning Curve

Newsletter Winter 2019 - Note from the CEO

Newsletter Summer 2018 - Lana Pauls, MPH, My Career Trajectory – Themes & Contrasts

Newsletter Summer 2018 - Rob Claar on Fast-Track Opportunities in Japan for Regenerative Medical Products

Newsletter Summer 2018 - Bart Van der Schueren on The European Regulatory Framework: Personal Perspective 

Newsletter Summer 2018 - Lutz on Biosimilar Insulin - Current Status

Newsletter Summer 2018 - note from the CEO

Newsletter Spring 2018 - Brandon Jones on Electronic Submissions to Regulatory Authorities

Newsletter Summer 2018 - from Kinexum Founder - A tale of Two Different Scientific worlds

Newsletter Winter 2018 - note from the CEO Thomas Seoh

Marketing Added Value Arthur Santora MD, Ph.D

Beyond Hemoglobin A1C Consensus Conference - July 21, 2017 Charles M. Alexander, MD, FACP, FACE

Early on Commercial Planning Investments within the R&D Process: The Business Case Martin Lafontaine

Newsletter Fall 2017 - note from the CEO Thomas Seoh

From Kinexum Founder - Ties that Bind - People and Nations Zan Fleming, MD

Read More about Asoke Mukherjee Asoke Mukherjee, Ph.D

Thomas Seoh Interview in July 2017 Issue of World Korean Medical Journal

The Opioid Epidemic: A Perfect Storm Elizabeth Whalley Buono, BSN, RN, MBA, JD     

Two Minus One: 2017 ADA Annual Meeting Lawrence Steinman, MD

Challenges of Early Clinical Development Simon Bruce, MD

Metabesity 2017

A Milestone for Kinexum Zan Fleming, MD

Targeting Metabesity - 4/28/2017 Webinar

Could Time to Approval be Secondary? Giora Davidai, MD

Quality with Good Intent Julie Waltz Gerlach, B.S.N., M.P.H., R.C.A.

Innovation Steve Casey &  Elizabeth Whalley Buono, BSN, RN, MBA, JD     

Presentation - Ed Allera, Esq. and Barbara Binzak Blumenfeld, Ph.D., M.A., Esq.

Hypoglycemia Evaluation and Reporting in Diabetes: Importance for the Development of New Therapies

Round Table Discussion - Friday 1/20/17

Keys to Regulatory Operations Success

FDA E-Submission

Regulatory Perspectives From FDA Staff

The need for Faster Insulin: Dr. Muchmore

Metformin - Associated Lactic Acidosis

Risk and Effectiveness Information in Promotional Labeling and Marketing Claims Julie Waltz Gerlach, B.S.N., M.P.H., R.C.A.

More About Asoke Mukherjee

Consensus Conference

Tyrosine kinase inhibitors: their on-target toxicities as potential indicators of efficacy

Shah DR, Shah RR, Morganroth J.

Source

Rashmi Shah Consultancy Ltd, Birchdale, Gerrards Cross, Buckinghamshire SL9 7JA, UK.

Abstract

Tyrosine kinase inhibitors (TKIs) have revolutionized the treatment of certain forms of cancers, raising hopes for many patients with otherwise unresponsive tumours. While these agents are generally well tolerated, clinical experience with them has highlighted their unexpected association with serious toxic effects on various organs such as the heart, lungs, liver, kidneys, thyroid, skin, blood coagulation, gastrointestinal tract and nervous system. Many of these toxic effects result from downstream inhibition of vascular endothelial growth factor or epidermal growth factor signalling in cells of normal organs. Many of these undesirable effects such as hypertension, hypothyroidism, skin reactions and possibly proteinuria are on-target effects. Since tyrosine kinases are widely distributed with specific functional roles in different organs, this association is not too surprising. Various studies suggest that the development of these on-target effects indicates clinically desirable and effective inhibition of the corresponding ligand-mediated receptor linked with oncogenesis. This is reflected as improved efficacy in the subgroup of patients who develop these on-target adverse effects compared with those who do not. Inevitably, issues arise with respect to the regulatory assessment of efficacy and risk/benefit of the TKIs as well as the clinical approach to managing patients who develop these effects. Routine subgroup analysis of efficacy data from clinical trials (patients with and without on-target toxicity) may enable more effective clinical use of TKIs since (i) discontinuing or reducing the dose of the TKI has a negative impact if the tumour is TKI-responsive; and (ii) it is usually possible to manage these undesirable on-target effects with conventional clinical approaches. Prospective studies are needed to investigate this proposition further.

Link