From Our Desks

From Our Desks

Newsletter Spring 2020 From Kinexum Founder, Zan Fleming

Newsletter Spring 2020 Note from CEO, Thomas Seoh

Newsletter Spring 2020 NASH Update—March 2020 by Brian Harvey

Newsletter Spring 2020 Potomac Fever and a Life of Stories by Steven Grossman

Newsletter Spring 2020 THE TARGET PRODUCT PROFILE by Albert Yehaskel

Newsletter Spring 2020 Wow or Yeow!? FDA's 2019 Review and 2020 Outlook Webinar Highlights by Jennifer Zhao

Newsletter Winter 2020 - James Carroll_Why Photobiomodulation Might be the Answer to the Opioid Crisis

Newsletter Winter 2020 note from the CEO

Newsletter Winter 2020 - Thomas Seoh Another Immigrant’s Tale

Newsletter Winter 2020 - Michael Zemel_Reflections on Targeting Metabesity 2019

Newsletter Winter 2020 - Founder, Dr. Zan Fleming

Newsletter Winter 2020 - Faiez Zannad_Interview with Professor Faiez Zannad on the Cardiovascular Clinical Trialists Forum (CVCT)

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 Winter 2019 - Jennifer Zhao, Kinexum Webcast Recap: Using Metformin to Target Aging

Newsletter Fall 2018 - Dean E. Calcagni, M.D. on Beyond the NIH - Other Federal Medical R&D

Newsletter Fall 2018 - Brian E. Harvey, MD, Ph.D, A Perspective on the Development of the Treatment of Our Next Epidemic

Newsletter Fall 2018 - Grant Williams, MD on Evidentiary Standards in the Accelerated Approval of Cancer Drugs

Newsletter Fall 2018 - Michael Sharp, Ph.D on A Crash Course on 510(k) Clearances

Newsletter Fall 2018 - 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