Scot Faulkner, MPA

David Reinhold Brill, Ph.D

 

David is a research biochemist and pharmacologist by academic training and since earning his Ph.D. degree, has accumulated well over 35 years of pharmaceutical regulatory strategic and project leadership experience from the early R&D development stage through all Phases of clinical development leading to successful NDA submissions / approvals across multiple therapeutic areas, with a focus on CNS-related disorders (specifically forms / types of schizophrenia and Alzheimer's disease), Metabolism (specifically Type I and Type II diabetes) and Cardiovascular disease therapeutic targets (specifically primary and secondary stroke prevention and hypertension) in the United States, Europe and other regulatory jurisdictions.

David's expertise and "comfort zone" is in the very hands on development and implementation of regulatory strategies and accompanying documentation that support the conduct of pharmaceutical development programs leading to optimized product profiles / labels that benefit the patient.  The development / submission / approval of a product including such an optimized product profile is only possible based upon establishing a strong relationship with the relevant health authorities based on solid data-driven strategies and documents.  David has a long and successful track record with FDA and EMA in ensuring that this is an essential component of all programs under his responsibility.  Over his more than 35-years of pharmaceutical industry regulatory experience, David has led and been principally responsible for the successful conduct of an extraordinary number of project specific FDA interactions (e.g. all Type A, B, and C interactions via face-to-face or teleconference) on complex, multidisciplinary project issues.  David has led his company and project development team through the preparation and successful conduct of three FDA Advisory Committee meetings.

David has a long history of establishing internal company policies and procedures relating to the specific clinical and CM&C development of NCE's, NBE's, and biosimilars.  He has led and been responsible for leading successful development teams including critical clinical and cGMP compliance issues as well as project teams responsible for the development of product profile / CFR compliant labeling and the associated promotional / commercial messaging and advertising.

On a personal note, David is an FAA licensed private pilot, a certified scuba diver, and maintains dual citizenship in the US and the EU, with established residencies in both New York and Vienna, Austria.

 

 

 

Jennifer Zhao

 

Jennifer Zhao joined Kinexum as an Associate in 2018 after graduating magna cum laude from Dartmouth College, where she studied Biological Chemistry and Chinese Language and Literature. She conducted research throughout her undergraduate career, culminating in a chemistry thesis investigating the synthesis of pyrroloindole ring systems. At Dartmouth, she has programmed events for the pre-health society, tutored students in Chemistry, and co-founded a Living Learning Community to support students in STEM fields. Jennifer interned at Close Concerns, a healthcare informatics company specialized in diabetes and obesity. She is particularly interested in the pharmaceutical industry.

 

Brandon Jones

Brandon is skilled in preparing electronic regulatory submissions, medical writing, regulatory intelligence and contract administration.

Brandon has worked in the Pharmaceutical/Clinical Research field for the past 17years providing services for both Sponsors and CROs. 

Prior to pursuing a consulting career Brandon provided eCTD submission expertise (including IND, MAA, ANDA, SPL) and regulatory document production at CRO leader QuintilesIMS (now IQVIA).  He is skilled in eCTD submissions and communications with the FDA, Health Canada and other regulatory agencies worldwide.  Further, Brandon provided leadership and training for regulatory intelligence, medical writing, and managed the Corporate Standards Database for the Quality Assurance Compliance and Standards Department at Biogen Idec.  Previously, he was the Risk Management Coordinator at Ashfield Pharmacovigilance where he chaired the Safety Executive Committee (SEC) meetings, reported safety decisions, medical safety discussions and tracked Events of Interest (EOI).  He has served as a Contract Administrator, negotiating complex legal language and budgets, at QuintilesIMS (now IQVIA), PharmalinkFHI (now Novella), Inveresk Research and local law firms. 

Brandon has a degree in Business Administration and attended University of North Carolina at Chapel Hill for Journalism and Mass Communications.

Anand Khedkar, Ph.D

 

Anand Khedkar has over 20 years experience spanning various functions in research and development.  He began his career as process development scientist at Biocon Limited, transitioning to formulation development and analytics for biological molecules.

Anand was instrumental in setting up a world class protein formulation and protein analytics group at Biocon R&D. He has led CMC development of several biosimilars (monoclonal antibodies, Insulin analogues) and novel molecules as per the requirements of US FDA, Health Canada, and MPA. He has successfully defended regulatory applications. His expertise includes process development and scale up, technology transfer, troubleshooting formulation development and protein analytical development and characterization, and CQA identification.

He was the innovator for oral insulin (Insulin Tregopil) at Biocon and led the program from lab to advanced clinical development, leading a large cross-functional team and engaging with a Clinical Advisory Board and Key Opinion Leader. He has additionally been involved in several joint development programs for novel molecules, including serving on joint development and steering committees. He is very passionate about development of alternative delivery systems for protein and peptides.

At Apobiologix, Anand was involved in mentoring a team of scientists engaged in biosimilar development; developing a strategy for biosimilars, antibody drug conjugates, and high concentration formulation of monoclonal antibodies; evaluating CROs and CDMOs; and performing due diligence of biosimilar products for in-licensing. He was also involved in developing an oncology product on a 505( b)(2) pathway.

Anand has a Ph.D in protein formulation and characterization from Deakin University, Australia, a Masters Degree from the Institute of Chemical Technology, India in Bioprocess Development, and a Bachelor’s degree in Pharmaceutical Sciences.

 

 

 

 

Joyce Reyes

Joyce Reyes is an expert in Chemistry, Manufacturing and Controls, Regulatory Affairs and Quality Assurance, particularly in large molecules and cell, tissue and gene therapy, with two decades of experience in various roles at both small and large biotechnology and pharmaceutical companies. She has extensive experience in small molecules, recombinant protein (fermentation and cell culture, monoclonal antibodies, enzymes, peptibodies, and biosimilars), cell/gene therapy and viral production processes.

Prior affiliations include Vice President of Regulatory Affairs and Quality at Pacific-Link Consulting, and roles in manufacturing and CMC at Somaxon Pharmaceuticals (supporting the approval of Silenor), Jennerex Biotherapeutics (supporting development of a novel vaccinia-based oncolytic virus), Geron (supporting filing of the first ever human embryonic stem cell therapy to the FDA), Cell Genesys, InterMune, Xoma, Invitrogen and Baxter.

Joyce received a Bachelor of Arts degree from St. Mary's College of California, Moraga and a Masters in Health Law from The University of California, San Diego/California Western School of Law, and is RAC-certified.

 

 

 

Leadership List

Officers

G. Alexander Fleming, MD
Executive Chairman

Thomas Seoh
President and Chief Executive Officer

 

Clinical Development

G. Alexander Fleming, MD

Arthur Santora, MD, Ph.D

Brian E. Harvey, MD, Ph.D

Charles Alexander, MD

Giora Davidai, MD

Gordon B. Cutler, Jr., M.D.

Grant Williams, MD

Guenther Karmann, Ph.D

John K. Whisnant, Jr, MD

Michael Trautmann, MD

Peter Damsbo, MD

Rob Walsh, MD

Simon Bruce, MD

Theo Gana, MD, Ph.D

Todd J. Lorenz, MD

 

Regulatory Affairs

G. Alexander Fleming, MD

Arthur Santora, MD, Ph.D

Asoke Mukherjee, Ph.D

Brian E. Harvey, MD, Ph.D

Catherine Bernard, Ph.D

David Reinhold Brill, Ph.D

Dia Hill

Doug Muchmore, MD

Frances Mielach, Ph.D, RP.h

Gabrielle Wiederkehr, MSc

Grant Williams, MD

Joshua Sharlin, Ph.D

Joyce Reyes

Lana Pauls, MPH

Michael Sharp, Ph.D

Scot Faulkner, MPA

 

EU Regulatory

Catherine Bernard, Ph.D

Michael Trautmann, MD

 

Clinical Operations/Project Management

Chris Yun

Gabrielle Wiederkehr, MSc

Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.

Lana Pauls, MPH

Lynn Schaich

Susan Manley

 

Pre-Clinical

Asoke Mukherjee, Ph.D

Dave Edwards, Ph.D

Frances Mielach, Ph.D, RP.h

Joy Cavagnaro, Ph.D

Marijke Adams PharmD, Ph.D

Monalisa Chatterji,Ph.D

Virgil Whitehurst, Ph.D

 

CMC, Formulation/Process Development & Sourcing

Anand Khedkar, Ph.D

David Bergstrom, Ph.D

Joyce Reyes

Knut Zellerhoff, Ph.D

Robert Kaster, RPh., ASQ-CQA

 

Medical Device

Michael Sharp, Ph.D

Rob Walsh, MD

 

 QA/QC

Joshua Sharlin, Ph.D

Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.

Lynn Schaich

Robert Kaster, RPh., ASQ-CQA

 

Medical Writing/Electronic Submissions

Brandon Jones

Dahlia Sperling

Sandor Bernath, Ph.D, MBA

 

Process & Innovation Management

Elizabeth Whalley Buono, BSN, RN, MBA, JD

Scot Faulkner, MPA

 

Defense & National Security Practice

Dean E.Calcagni, MD

 

Commercializing and Business & Corporate Strategy

Lisa Jansa, MBA

Martin Lafontaine

Stephen Casey, MBA

Thomas Seoh

 

Kinexum Associate

Jennifer Zhao

 

Founders

G. Alexander Fleming, MD

Lisa Jansa, MBA