G. Alexander Fleming, MD

Brian Oscherwitz, MBA, PMP

 

Areas of expertise: Project Management; Clinical, Regulatory, and Commercial Product Development; SOP Development 

 

Brian Oscherwitz has over 20 years of experience working alongside executive leadership to direct cross-functional teams of subject matter experts. He has led teams in the completion of a wide range of projects, including new product development, commercial launch programs, global regulatory filings, process improvement initiatives, and portfolio and corporate integrations.

 

Brian’s project management expertise spans several areas, including directing the clinical operations of several pharmaceutical companies. As a member of Shire Pharmaceuticals’ Clinical Operational Excellence & Support team, Brian led a novel Risk Management & Clinical Trial Oversight model designed to transform global Clinical Operations while enhancing comprehensive project quality and ICH E6 R2 compliance. Brian also led generic clinical development programs for Biovail Technologies, Inc., and for development/clinical-stage companies Reata Pharmaceuticals and Constellation Pharmaceuticals.

 

Brian has also demonstrated a breadth of regulatory and commercial product development leadership. He managed the planning and timelines for global regulatory filings for high priority cancer therapies with Genentech Inc. He led Global Expansion teams at Hospira/Pfizer to make domestically approved injectable products available to patients in Canada, EMEA, LATAM, MENA, APAC, and CEE. During his tenure at Galderma Laboratories, a joint venture between Nestle, Switzerland, and L’Oreal, Paris, Brian introduced and propagated the organization’s North American project management office. He established the policies, processes, enterprise-wide tools, and training needed to optimize the management and execution of projects ranging from co-development initiatives to M&A projects.

 

Brian’s organizational management also includes identifying process improvement opportunities. He led the Global Supply Chain improvement initiative at Astellas Pharma US, Inc., as well as the Clinical Operations and Promotional Material review process refinement projects at Galderma Laboratories LP.

 

To immerse himself more deeply in every dimension of biopharmaceutical endeavors, Brian spent 10 years in the CRO sector supporting clinical trials in project management, investigator relations, and bids & contracts roles at Pharmaceutical Product Development (PPD). He also developed expertise in the Patient Recruitment and Retention discipline with D. Anderson & Company.

 

Brian provides Kinexum with insight gained from his experience leading teams of contributors with roles ranging from Clinical Research Associate to CEO; and representing a multitude of operational disciplines worldwide. Brian’s experience in developing and leading project initiatives – from pre-clinical to launch – for clients across the CRO, patient recruitment/retention, consumer product, pharmaceutical, and biotech sectors also spans from startup to big pharma.

 

Brian received his MBA with a concentration in the Management of Technology from The University of Texas at San Antonio, and his BA in Microbiology with an emphasis on Immunology from The University of Texas at Austin. Brian is also PMP-certified through the Project Management Institute (PMI).

 

 

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.

 

 

 

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.

 

 

 

 

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.

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

Brian Oscherwitz, MBA, PMP

Chris Yun

Gabrielle Wiederkehr, MSc

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

Lana Pauls, MPH

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