David Augeri, PhD

EVP Medicinal Chemistry & Drug Discovery

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Dr. Augeri is a senior executive level medicinal chemist and drug discovery leader.  He is the inventor of the now commercialized DPP4 inhibitor, saxagliptin, for type II diabetes, that he developed at Bristol-Myers Squibb.  He is also the inventor of lead molecule of a bcl-2 inhibitor for the venetoclax program at Abbott Labs for B-cell lymphoma & CLL.  At Lexicon pharmaceuticals Dr. Augieri led its team of 16 medicinal chemists, guiding projects through Phase IIb clinical trials for rheumatology indications.  He has supervised the submission to FDA of seven INDs (investigational new drug applications) in oncology, immunology, and metabolic diseases.

 

In a relatively short period of time as an associate professor of drug discovery at Rutgers University, Dr. Augeri had unprecedented success in getting research programs grant funded, including 6 NIH R01s, 1 NIH R21, and 1 DoD funded grant proposal. As a noted expert in medicinal chemistry and drafter of patents, he has close to10 years of advisory experience as a litigation expert consultant and witness for intellectual property cases, where he has written expert witness reports covering topics like obviousness and claims validation. He has 104 peer reviewed scientific publications and a number of issued patents.
 

 

Brian E. Cain, MBA
Chief Strategy Officer

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Brian is a visionary leader and senior healthcare executive who specializes in delivering results through strategic planning, implementing best practices, and building high performing teams. He is a veteran of senior management roles in JNJ, BMS, Celgene, Merck, Schering, Pfizer, Pharmacia, and GSK. Brian has over 25 years of experience in strategically and cost-effectively growing key pharmaceutical brands through best-in-class market research (domestic and global), business intelligence, customer insight mining, data strategy, forecasting, and commercial analytics.

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Brian’s significant experience has been in both small start-ups, and also in eight of the largest global pharmaceutical organizations. He has proven success in strategic positioning for multi-billion-dollar products, working in dynamic, demanding environments, while remaining pragmatic and focused. Brian thinks broadly and always rolls ups his sleeves to get the job done.

 

Valerie Darling, MBA

Chief Business Officer

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Valerie is a senior global biotechnology and pharmaceutical executive adept at scaling start-up organizations in preparation for the commercial stage of development. She has extensive deal and business development experience with devices and drugs in a variety of therapeutic categories. Valerie is a proven transformational healthcare leader in both public and private companies: Her experience is with Fortune 100s and early-stage start-ups, M&A integrations, and VC & PE-backed portfolio companies. 

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A strategic entrepreneur and subject matter expert in a highly regulated industry, Valerie is known for exceeding KPIs for: Revenue growth, profit margin, market share, product interaction, cost reduction, diverse talent development & retention, and compliance. She is Hispanic who is bilingual Spanish, and also speaks French, German, and other languages. She has had award winning performances and recognition during her career senior positions at JNJ, BMS, Cardinal Health, Endo, Sanofi Genzyme, and AstraZeneca.

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Sara Obregon, PMP
VP Project Management

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Sara is a project management executive who has been recruited to become a founding member of a number of pharmaceutical start-ups due to her skill at organizing programs and initiatives for brand new companies.  She is known as a professional who can drive nearly all aspects of operational success that leads to a successful small company IPO or M&A exit sale of the company after expedited achievement of project milestones.  Prior to her work at BalinBac Therapeutics, Inc., Sara coordinated activities of 7 C-level executives to develop the antibiotic, Solosec (secnidazole), for FDA approval within 4.5 years.

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At BalinBac Therapeutics, Sara has organized and planned start-up related projects for a new, microbiome focused, drug-development company with projects related to respiratory pandemic pathogens, including COVID-19,  and gastro-intestinal maladies in humans, as well as infectious disease medical countermeasures in animal health & nutrition for companion animal and livestock species.

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Sara began her career at Pfizer Pharmaceuticals in New Product Development and is certified in project management with a PMP.

Bruce Nemlich, MBA

EVP Analytics & Planning

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Bruce has worked across a wide range of pharmaceutical commercial strategy, analysis, and implementation over the past 30 years at Pfizer, McKinsey, and in his own consulting practice.  At Pfizer, he led the Management Science Group and the Resource Allocation Group where besides supporting sales and marketing optimization, he worked with Business Development and Commercial Development developing potential product strategy and stress-testing forecasts.
 
Bruce played key roles on various co-promotion deals including Lipitor, Celebrex, Spiriva, and Eliquis, especially negotiating promotion resource levels.  His insights gave Pfizer the confidence to pursue the co-promotion deal with Warner-Lambert for atorvastatin.  He supported the initial and on-going co-promotion negotiations of what eventually became Lipitor. 
 
On Spiriva, Bruce created the US Sales Capabilities Presentation to initiate the deal, negotiated ongoing promotion levels and standards, and later consulted to Boehringer-Ingelheim on a peri-LOE strategy for Spiriva and re-launch of Stiolto, leveraging their new respiratory delivery device.
Bruce holds an MBA from the University of Chicago in Marketing, Econometrics, and Finance, and Bachelor of Science in Transportation, Urban Planning, and Behavioral Science from the Massachusetts Institute of Technology.

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Steve Bartle, PhD

Director of Animal Research and Development

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Dr. Bartle has a M.S., Ph.D., and postdoctoral experience in Ruminant Nutrition, with an emphasis on beef cattle nutrition and management. Dr. Bartle spent 10 years as a research scientist at Texas Tech University working primarily with feedlot cattle.  He then spent 18 years in the feed industry, primarily as a Research Manager for a major feed company, but also in technical service and division management.  Dr. Bartle then accepted an opportunity to return to a university setting with a position as Director of Research for the Beef Cattle Institute at Kansas State University.  Dr. Bartle retired from this position in 2016.  He credits his passion for animal nutrition with having grown up on a farm in North Dakota.

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Andrew Koopman, MS, CLP

EVP – Licensing/Tech Transfer

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Andrew is an entrepreneur and scientist who is an expert in business development, licensing, and technology transfer.  His extensive experience in these settings in academia were at New York University where he had oversight of the technology transfer and new venture offices in the medical life-science sector.  Andrew supervised portfolio and spinout companies in various incubators and made the critical connections to enable these start-ups to commercialize numerous nascent technologies, and to ensure the building of successful ventures. The years of experience in doing university joint ventures and spinouts has provided Andrew with a valuable network and unique insights, tools, and expertise to design deals and carry out new venture due diligence (technical, IP, market, scaling).  The usual scope of projects overseen include technology searches, opportunity evaluation, market assessment, technology transfer negotiation, startup acceleration advisory work, and fundraising.  Andrew developed his product development industry experience at Roche Molecular Systems prior to working in Academia in tech transfer at NYU, followed by consulting and Board of Directors work at a variety of start-up biotech companies.

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Jeffrey Marquis, CPA, CFA, PMP, Masters of Management, IT

Consultant - Finance & Financial Controls

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Jeffrey is a senior-level professional with experience as President, COO and CFO of private companies in the consumer, travel and hospitality industries.  He is a proven team builder, leader and motivator who has previously managed a high performing organization with 4,000 professionals throughout the U.S.  As a CFO his reputation has been one of a creative, yet highly analytical decision maker with track record of successful investments, partnerships and corporate finance and development strategies.  Jeffrey achieved these accomplishments by leveraging his background and certifications after earning his CPA, CFA, PMP, Masters of Management in IT, and Executive MBA through Harvard Business School’s AMP program. 

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Jeffrey’s industry experience includes Government Contracts, Investment Analysis, Big 4 Accounting, Hospitality Services, Online Travel, Hotel & Casino Operations, and Portfolio Management. His key finance skills include: Senior financial management, revenue & cost optimization, strategic growth plans & scalability, multi-year & long-range planning, high-value negotiations, partnership development, budget leadership & planning, business development, financial analysis & reporting, and treasury management.
 

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William R. Zimmermann, MD, MBA
Consultant – Clinical Development

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Dr. Zimmermann is an accomplished clinician, entrepreneur, and business executive.  He began is career running his family tool and die manufacturing company while obtaining his medical degree and doing post-graduate training in anesthesiology, sub-specializing in cardiac anesthesiology.  While on the faculty of the University of Chicago’s anesthesiology department, Dr. Zimmermann earned his MBA from UChicago’s Graduate School of Business and graduated at the top of his class. Dr. Zimmermann founded MedTrials China, one of the first clinical research organizations (CROs) in that country, before returning to clinical practices in Nevada and Illinois, where he further developed his expertise in delivery of inhaled respiratory drugs and expert consulting to drug development companies.
 

 

Paul Jeffrey, MBA

Consultant – Early Commercial Development & New Product Planning

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Paul began his career as an organic chemist at Schering, then Merck. After several years he joined Pfizer in US Marketing. For nearly 30 years where his last position was VP, Early Commercial Development, he was responsible for Pfizer’s Primary Care Division pipeline products and business development deals.
 
Over the years Paul contributed to Pfizer’s new product commercialization, business development, and global marketing across many therapeutic areas including infectious disease, allergy, respiratory, neuroscience, and pain. As well as many of Pfizer’s successful licensing and acquisition deals. Later in his career, he led Pfizer’s cardiovascular franchise, including new product and global marketing. Many of Paul’s products became billion-dollar sellers including Zyrtec, Aricept, Diflucan, Chantix, Geodon, Norvasc, and Lipitor. Just before leaving Pfizer Paul was co-leader on Eliquis, now one of Pfizer’s most successful products, selling over $5 billion/year with partner BMS. 
 
Paul now uses his pharmaceutical development and deal-making experience to help biotechs maximize their product or company value to potential investors or pharma partners.
He aided Excaliard in achieving acquisition by Pfizer. He has consulted for Aralez, Oligomerix, Saniona, and MAPS Public Benefit Corp. As a partner in BusStim, he is an advisor to Shifa Biomedical and 4 other biotechs. He is on the Board of Directors for Arkay Therapeutics.

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Michelle Higgin, PhD

Consultant – Toxicology/Clinical Pharmacology

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Dr. Michelle Higgin leads a top preclinical consulting company, PharmaDirections.  She provides consulting and executional preclinical services (including subcontractor project management) in the fields of toxicology and safety pharmacology, and also directs chemistry, manufacturing and controls (CMC) programs for pharmaceutical clients that enables them to expedite their Investigational New Drug (IND) status enabling studies. 

Dr. Higgin obtained her PhD in Biochemistry from the University of Wisconsin, Madison and did her postdoctoral work at the National Institutes of Health.  Following her entry into the CRO/CDMO industry, she has led project management for preclinical programs for dozens of companies at PharmaDirections for more than a decade and a half.  These programs have resulted in client companies getting granted IND status for their drug development programs, a number of which ultimately have received approvals of their New Drug Applications (NDAs) at FDA.

 

Steve King, RPh

Consultant – CMC, QA/QC

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Steve King is an experienced consultant and senior manager with a demonstrated history of success working in the pharmaceutical industry directing a leading contract drug product development manufacturing organization (CDMO). He developed strong professional skills in business development, alliance management, licensing, CMC outsourcing, and direction of manufacturing activities in the pharmaceutical industry from working at Pharmaceutics International, Inc. (PII), Catalent, R. P. Scherer, and the COVID-19 therapeutics company, ViraClear.

Mr. King has directed a network of pharmaceutical professionals that provides technical and business development support for pharmaceutical development programs including API sourcing, drug product formulation, and general product development activities for quality and regulatory compliance.

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During his long tenure at manufacturing company, Pii, Mr. King built the business from under 20, to more than 500 employees (over $50 million in revenues). His experience at Pii provided expert understanding of the drug development process for NDA and ANDA products, in multiple dosage forms, as well as all aspects of running a CDMO business and performing services for CDMO clients.

 

Sitaram Velaga, PhD

Consultant – Respiratory Delivery & Regulatory Affairs

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Sitaram Velaga is a pharmaceutical entrepreneur and expert in respiratory drug delivery systems. He specializes in consulting and development services for projects for respiratory drug repurposing and repositioning, i.e., finding new uses for old drugs. A particular focus is nasal and inhaled administration, which offers significant opportunities for high value and clinically important repurposing/repositioning of existing drugs to treat local diseases in the lungs or systemic conditions.

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Dr. Velaga’s company, Kenox, has proven experience in the development and approval of nasal and inhaled products (using 505 (b)(1), (b)(2), and ANDAs pathways) as well as traditional regulatory device and drug pathways based on a wide range of device technologies including dry powder and soft mist inhalers.
 

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Edgar Asebey, JD

Consultant – Regulatory Law & Requirements for Respiratory Delivery

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Edgar Asebey is a partner at Keller Asebey Life Science Law PLLC and brings over two decades of experience in government regulation of pharmaceutical, biotechnology, medical device, food, dietary supplement, cosmetics and most recently hemp/CBD and cannabis companies. With experience within government, as in-house counsel and as a CEO of a life science company, he brings a wealth of knowledge to clients who require novel solutions to complex issues, such as companies in the Rx respiratory medical device, tobacco, hemp/CBD and cannabis/THC sectors.

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Edgar provides services to the life science and food industries with FDA regulatory, venture finance and associated transactional services. His practice focuses on the areas of drugs, biotech, medical devices for drug delivery, food, dietary supplements, Cannabis and cosmetics. Edgar advises clients in these industries on regulatory, registration, importation, and enforcement matters. He also counsels clients on premarket approval submissions and on compliance issues associated with the development, manufacture, marketing, and sale of FDA-regulated products and provides support in licensing and transactional matters to FDA-regulated companies.

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Edgar is a member of the American Bar Association (Section on Administrative Law & Regulatory Practice: Food and Drug Committee and International Committee), Food & Drug Law Institute (FDLI), Dade County Bar Association, and BioFlorida.
 

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