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21159 Pharma: The Origin of the Name

Many people have asked how the name 21159 Pharma came about, and while a few do guess correctly, many do not. Over the past 10 years 21159 Pharma Founder Steve King has been active in CrossFit and enjoyed the constantly varied workouts and tough challenges on the mind and body. There is a lot of perseverance, hard work, thinking and strategy involved in Crossfit, and this mindset is transferred into the company when we do our daily work. In Crossfit, 21-15-9 is a common rep scheme (Fran, a benchmark CrossFit workout, for example), which is how the name came about.

Our Team

Click to read team member bios

Steve King

President

Sue Reyer

Chief Financial Officer

Dr. Paul Waymack

Chief Scientific / Medical Officer

Rob Falconer

CMC / Quality Assurance

Stacy Hammonds Nelson

Clinical Program Lead

Dr. Melisa K. Barron

Formulation Consultant

Martin Osterhout, PhD

API Process R&D

Robert K. Schultz, PhD

Drug Device Combinations

Silvia Chang

Project Management

Alexis Nahama

Animal Health

Our team of independent contractors can work together as a team or individually as required

Steve King
President

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, golf, pickleball and skiing.

Sue Reyer
Chief Financial Officer

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
Chief Scientific / Medical Officer

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. He 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
CMC / Quality Assurance

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
Clinical Program Lead

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 K. Barron
Formulation Consultant

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.

Martin Osterhout, PhD
API Process R&D

Martin’s expertise is focused on the development and implementation of short-, mid-, and long-range small molecule drug product development strategies that ensure scientific best practices in the understanding and overall scope/vision of registering and approval of a drug candidate. Over 25 years, Martin has proven leadership skills, is able to manage processes, peer groups, and senior leadership across an R&D organization. Martin has experience managing multiple assignments in parallel, calling on effective team coordination abilities in cross-functional environments.

Martin believes in having a hands on/man-in-plant approach to solving chemistry and process technical issues.  This approach ensures that small molecule drug substance and drug product processes developed are robust, rigorous, and reproducible.

Martin has a Ph.D. in synthetic organic chemistry from Indiana University-Bloomington and a B.S. in Chemistry from Duke University. He completed a post-doctoral assignment at Emory University.

Martin lives in Raleigh NC USA.

Examples of projects contributed to:

  • Provide development strategy for both small molecule assets including driving decisions on intravenous drug product development for a diabetes drug candidate.
  • Managing the manufacture of 2.1 Metric tonnes of a diabetes drug candidate & tablets/placebo for Phase 3 clinical studies.
  • Development of small molecule CMC regulatory strategy and regulatory writing for key regulatory interactions (Pre-IND, EOP2 and Type C meetings, etc) for multiple programs.
  • Managed the small molecule CMC portfolio for a small biotech; oversaw the topical formulation development of several drug candidates and managed the manufacture and package/labeling of Phase 2 clinical trial material for both assets; managed the GMP manufacture of Phase 2 drug substance supplies
  • Author Requests for Proposals and follow through the CDMO selection process leading to selection of CDMO/CRO for the requested work packages.
  • Provide appropriate due diligence small molecule CMC support to Business Development group for the scientific evaluation of drug candidates during in-licensing opportunities.
  • Served as team leader in the technical transfer of epilepsy drug candidates to a global manufacturing site utilizing Design For Manufacturing tools (Britest and FMEA, etc.) through registration, validation, Pre-Approval Inspection and launch.
  • Author and/or review synthetic development and validation reports and synthetic sections of CMC modules in regulatory documents including IND, NDA, SNDA, MAA submissions, briefing books, DMF, and other regulatory documents and updates.
Robert K. Schultz, PhD
Drug Device Combinations

Dr. Schultz has over 30 years of experience developing and commercializing drug-device combination products. His consulting practice focuses on In vivo/in vitro correlation and dissolution testing, preclinical safety and drug delivery assessment, CMC, and extractable and leachables testing. His hands-on approach to experimental design and analysis and technical and regulatory writing skills provide a significant resource for smaller companies looking to augment their development team’s capabilities.

Silvia Chang
Project Management

Silvia brings over 25 years of experience managing projects in the biotechnology/pharma space. She has successfully managed projects in a variety of areas including therapeutic products in early research stage to late clinical stage, diagnostic products, capital improvement projects, animal health products, and supply chain.

Having begun her career in the lab, Silvia moved to Project/Program Management after receiving her MBA. She brings a unique perspective to her clients in that she can understand the technical issues while ensuring that their business case is considered and aligned with. Her leadership in projects from research to preclinical and clinical studies to process development and manufacturing (both in-house and externally) has given her a solid view of the entire drug development process. Additionally, she has successfully introduced and set up project management systems in companies including Nestle Health Sciences.

Silvia received a BA in Human Biology and an MS in Biology from Stanford University and an MBA from the Darden School at the University of Virginia. She also holds a PMP certificate.

Alexis Nahama
Animal Health

Alexis Nahama is an experienced life sciences executive with a comprehensive background spanning both animal and human health sectors. Trained as a veterinarian at the Maisons-Alfort Veterinary School in Paris, France, Alexis transitioned  into the pharmaceutical industry, initially focusing on research and development (R&D) before assuming progressively senior roles in business strategy and operations.

He has over two decades of experience in pharmaceutical and biotech R&D, diagnostics, medical data systems, and marketing strategies. His career encompasses a broad spectrum of responsibilities, including drug development, business development and marketing in both animal health and human health domains.

In animal health, Alexis has extensive experience in global product and service marketing, targeting both professionals and consumers. Notably, he spearheaded direct-to-consumer initiatives, reaching millions of pet owners with acquisition and retention programs. His tenure as head of marketing for VCA, a publicly traded operator of veterinary facilities, saw him navigate through challenging economic periods, demonstrating his resilience and strategic acumen. Most recently he has helped start-ups in animal health develop their assets, prepare for financial raises or exit through strategic M&A.

On the human health front, Alexis brings a wealth of knowledge as senior executive and leader of the RTX Pain Business Unit at Sorrento Therapeutics, Inc. (Nasdaq: SRNE). There, he successfully managed the program from its inception through preclinical studies, investigational new drug (IND) application, and phase 1 and phase 2 clinical trials targeting osteoarthritis of the knee pain. He was able to comple the phase 2 clinical program, including overseeing complex Good Manufacturing Practice (GMP) manufacturing of highly potent toxins, in a timeframe of less than five years.

Furthermore, Alexis introduced an innovative multi-species approach to clinical development. Through initiatives like the RTX program, he demonstrated that human drug development processes could be significantly expedited by leveraging naturally occurring diseases in companion animals. This approach not only accelerated human drug development timelines but also the approach to bridge the gap between human and animal health.

Beyond his corporate endeavors, Alexis remains deeply engaged in the broader community, serving on the boards of non-profit organizations dedicated to advancing veterinary care and education. His contributions to organizations like the Catalyst Council and Ethos Discovery reflect his passion for improving healthcare outcomes across species boundaries.

Notably, Alexis’s eclectic interests extend beyond the boardroom. With a penchant for high intensity pursuits, he has logged over 800 skydives and now channels his passion into aerobatic competitions, piloting his plane in front of judges that score both skill and precision.