ABOUT US

Steve King

 
Steve King formed 21159 Pharma in 2017 after working for 30 years in Business Development and CMC Drug Development in the Pharmaceutical Industry where he held both Business Development and leadership roles. He has extensive experience in Licensing and Drug Development in small molecules for NDAs (with a focus on Orphan drug development) 505B2s and ANDA products from early stage development through to commercialization. He has a unique combination of practical real-world experience of business and CMC drug development.

He started his career as a retail Pharmacist in the UK then went to Janssen for 3 years. He then joined R P Scherer (Catalent) where he ran the export business for Scandinavia, Middle East and Africa working with NDAs, ANDAs OTC and Nutritional products. During this time the company was awarded the Queen’s Award for Export based on his efforts. In 1995 he came to the USA and joined Pharmaceutics International Inc (Pii) in 1996. During his time at Pii he helped to build the company to over 600 people and was involved in many business roles ranging from developing the CDMO business, licensing and acquisition of Pharmaterials in the U.K. His last position was Senior VP Business Development. In March 2020 in order to help with the COVID-19 pandemic he became COO of ViralClear Pharmaceuticals to develop merimepodib (an oral IMPH inhibitor) through Phase 2 trials.

He graduated from the London School of Pharmacy (University of London).

Steve lives in Baltimore where he enjoys traveling spending time with his daughter, CrossFit and skiing.

Sue Reyer

 
Sue Reyer has over 25 years of public and private company financial and operations experience. She began her career at Ernst & Young and was the Accounting Manager at Mallinckrodt Chemical and Austin Quality Foods (now Kellogg’s) before moving on to provide Controller and CFO services to many early-stage development companies through her own consulting practice which she continues today.

In 2014, she became the Chief Financial Officer at Entegrion where she managed over $60 million of Department of Defense contracts and was a key player in the oversight of their Phase I and Phase II clinical trials for a human biologic as well as the clinical trial for their medical device. Most recently, she was the Director of Accounting and Compliance at Eva Garland Consulting, helping companies navigate various federal agency awards, successfully negotiate indirect rates as well as complete DCAA audits.

Ms. Reyer is operationally minded with the ability to preserve capital, negotiate in a strategic, effective manner with internal and external constituents of various levels and diverse backgrounds while also overseeing the day to day accounting and human resource operations.

Sue graduated from Penn State University and is a licensed Certified Public Accountant in North Carolina.

Dr. Paul Waymack

 
Dr. Waymack was one of the founders of Kitov Pharmaceuticals and has served as the Chairman of the Board of Directors and Chief Medical Officer from July 2013 until retiring in October 2019.

Dr. Waymack has over 20 years of experience in the biopharma field. Dr. Waymack is a former academic transplant surgeon and a former FDA medical officer, with over fifteen years of experience in drug development as a consultant to major pharmaceutical companies, including Pfizer, Roche, Pharmacia, Warner Lambert and Searle. During his 10 years of academic career, Dr. Waymack published over 100 scientific essays, mainly in the fields of prostaglandins and immunology.

In addition, Dr. Waymack volunteered to the U.S. army, where he was commissioned and served as a Major in the Medical Corp. in the position of Chief of Surgical Studies in the U.S. Army’s Institute for Surgical Research.

Dr. Waymack was also an associate professor of surgery at the University of Texas Medical Branch and at the University of Medicine and Dentistry of New Jersey.

Rob Falconer

 
Rob Falconer formed Falcon Pharma LLC in 2018 as a consultancy offering expertise in drug development, regulatory affairs and quality assurance, after 40+ years working at 4 research-based branded pharmaceutical companies, 2 generic drug companies, and 2 previous periods of independent consulting. He has broad experience in the drug development and approval process, as an executive leader for teams producing original and generic formulations, CMC content for INDs, NDAs and ANDAs, recommendations to key business development decisions, and managing all technical activities through FDA approval and launch.

He graduated from the University of Connecticut with a BA degree in biology & chemistry and immediately embarked on a pharmaceutical career spanning Quality Assurance, Regulatory Affairs and Drug Development, including managing IND/NDA/ANDA submissions and acting as primary liaison for numerous on-site FDA inspections. His career included management positions with the Endo division of DuPont Pharmaceuticals, E-Z-EM Inc., Medicopharma Inc., Shire Pharmaceuticals Group, Insmed Inc., and Breckenridge Pharmaceutical, Inc. In the last five full time positions, he was appointed at the Vice President or Sr. Director level, responsible for staffs of up to 75 employees.

He has travelled in over 20 countries for business, working with some 30 partners to achieve US FDA approvals. He has directly participated as a sponsor representative in 3 successful FDA application pre-approval inspections outside the US, as well as several domestic FDA inspections. He has played a key role in achieving FDA approval for 3 NDAs and over 30 ANDAs.

Rob lives with his wife near Richmond, Virginia keeping up with the “development process” of 4 children and 4 grandchildren, and continuing to travel for both work and pleasure.

Stacy Hammonds Nelson

 
Stacy provides project management, regulatory, operational and business development expertise to clients with projects in the late discovery through registration phases of development.

With more than 25 years’ experience, she began her career at Cato Research, Ltd, where she held positions of increasing responsibility, ranging from Project Manager to Director, Drug Development.

She has been an independent consultant for more than 15 years, managing projects ranging from due diligence to FDA interactions for multiple biotechnology and pharmaceutical companies.

She has experience in the initiation and management of multicenter clinical trials in the areas of cardiovascular, neurology, oncology and metabolic diseases.

Stacy also has experience in post-marketing pharmacovigilance and CMC regulatory compliance and has managed the preparation and submission of multiple successful IND and NDAs. She is certified by the Regulatory Affairs Professional Society (RAPS).

Dr. Melisa Barron

 
Melisa holds a B.S. degree in Chemistry and obtained her Ph.D. in Pharmaceutical Sciences at the University of Texas at Austin specializing in drug delivery of biologics and poorly soluble small molecule therapeutics.

Dr. Barron has held key development team and leadership positions at Theravance Inc. and Affinium Pharmaceuticals Inc. responsible for managing technical consultants and contract manufacturing and research organizations to support non-clinical and Phase I/II/III development of novel, small molecule antibiotics. As senior scientist at Theravance, Dr. Barron was principal to the successful NDA submission and approval for marketing and commercialization of the new drug product, VIBATIV™ (Telavancin®) for Injection in September 2009. She is the author of many research articles in peer reviewed scientific journals and has delivered several presentations at scientific conferences in the US and abroad.

Dr. Barron is owner of an independent contract consulting firm providing professional pharmaceutical development consulting services with expertise in drug delivery, manufacture of clinical trial materials and regulatory submissions. As a consultant Dr. Barron has worked with Achaogen Inc. and Athenex Pharmaceuticals Inc. in development of new drug products and assisted in preparation of the NDA submissions in 2017 and 2019.

Recently Dr. Barron worked with ViralClear Pharmaceuticals Inc. on the development of a novel antiviral for the treatment of COVID-19.

Alan Millar

 
Alan has over 28 years experience in API Process Research & Development working for “big Pharma” and, as the founder of Alan Millar CMC Consulting LLC, over three years consulting with the pharmaceutical industry.

With extensive experience in the development and implementation of synthetic processes for the manufacture of API, covering the breadth of the drug development process, from laboratory based manufacture of early clinical supplies, through validation of processes in commercial manufacturing facilities. Using his knowledge of the regulatory environment and experience with early clinical development, he encourages application of a pragmatic (differentiated-development) approach to supporting early phase clinical development; while applying a systematic (quality-by-design) approach to the later phases of the development process. He has extensive experience in writing regulatory documents and in working with the regulatory authorities, including addressing the requirements associated with the ICH M7 guidance on “Assessment and Control of Mutagenic Impurities in Pharmaceuticals’.

Alan received his BS and PhD in Synthetic Organic Chemistry from Heriot-Watt University, Edinburgh, before moving to the US to carry out a Post-Doctoral assignment with Prof. Sidney M. Hecht at the University of Virginia. He started his pharmaceutical career with Parke-Davis Pharmaceutical R&D before joining Glaxo (subsequently GlaxoSmithKline), where he held a variety of domestic and international, Scientific and Leadership roles.