James J. Sarene
Managing Director & Founder
Jared Byer, MBA
Jared Byer, MBA has nearly 20 years of professional writing, marketing and corporate development experience. As Managing Director at BioAlliance Strategies, Jared helps companies build market share by communicating the values that differentiate their organization from competitors. Prior to joining BioAlliance Strategies, while working for leading global clinical research organizations (CROs), Jared wrote proposals that resulted in approximately $500 million in awarded contracts.
The skills Jared developed at global clinical research companies support the goals of nonprofit organizations who face the same competitive pressures as their for-profit counterparts. Jared’s writing ability is the result of his experience in a range of professional settings, including daily newspapers, public sector research, environmental risk management, proposal development, marketing, and business owner. He wrote for the Kansas City Times while earning an undergraduate degree at the University of Kansas. He earned his MBA at Pfeiffer University. He is an honorably discharged veteran of the US Coast Guard. During his four-year enlistment, he served aboard the USCGC Glacier, an icebreaker based in Long Beach, CA. He spent two years in New Orleans, where he was assigned to a construction team supporting Coast Guard stations in the Gulf Coast region.
Jack J. Luchese, BA, MBA
Advisor: Finance, M&A, Corporate Development
Advisor: M&A, Licensing, Capital Raising, Turnarounds, Interim Executive/Board Support
Author: The Life Science Entrepreneur: A Practical Guide to Forming, Financing, Building, and Exiting a Life Science Company
As a seasoned CEO of several companies that executed numerous alliances and fund raising activities, Jack brings a broad prospective to your business.
Jack understands the realities of getting commercial and financial deals done and brings the tenacity and focus needed to make them happen. He will advise you as to the appropriate process needed, the internal and external resources that will be required, and establish a realistic timetable to enable the transaction to succeed. All such transactions first require the proper big picture strategy and must have the detailed tactical support plan to be successful.
Johnson & Johnson
Controller Functions and Key Financial management responsibilities
Business Development – In and Out-Licensing of technology and products and Product Acquisitions
Rorer Group (acquired by Rhone-Poulenc)
VP, Corporate Development – Mergers & Acquisitions, Divestitures, Product Acquisitions
Division CEO – International Pharma/Biologics Business – turnaround, product launches, downsizing, expansion
Public Biotech Company – CEO
Executed key technology deals with Glaxo and Merk
Significant, multiple fund raising activities
Founded three subsidiaries
Medical Device Start-Up
Life Sciences Consulting
Richard M. Hahn
Senior Marketing and Creative Director
As owner and creative director, he took the company in a new direction the early 1990s through the addition of a full-service marketing and public relations division, providing clients an extensive range of marketing and branding strategies including logo development, print, website creation, audio and video production, as well as strategic planning and consulting services.
As a highly successful marketing and branding consultant, Richard has developed and implemented strategies for such regional and national companies as Mercy Health, Syncro Medical Innovations, CurrentSAFE, Western Reserve Health Care System, Allegheny Financial Group, Gasser Chair Company and EXAL Corporation.
Patrick R. Ayd, BSN, MBA
Advisor: Clinical Sites
Through working with many of the leading names in the clinical research industry, Patrick came to know that modernizing and standardizing processes was critical for the future effectiveness of the entire clinical drug development process. In the course of his work, Patrick has designed and created the operations for several large successful “state of the art” Clinical Pharmacology inpatient facilities and has helped many late phase clinical research sites re-evaluate their operations and implement new processes.
From this foundation, Patrick provides client his experience in clinical trial research including early Phase clinical research (I-II) and late Phase clinical research (III-IV) to help clinical research sites improve operational processes by creating Standard Operating Procedures (SOPs) and independent Quality Assurance (QA) processes to address the most critical aspects of conducting clinical research trials.
Leo J. Adalbert, MBA
Advisor: Integrated Strategic Commercialization Planning
An insightful, collaborative, and creative leader, Leo carries more than 25 years of deep cross-functional commercial and clinical development experience across both biologics and small molecules. He has built and shaped brands across multiple therapeutic areas, with particular expertise in specialty and rare disease/Orphan Drug markets across all phases of the product lifecycle.
His proven record of success spans global marketing, business development, negotiations, and alliance capability building and leadership. This unique cross-functional perspective enables Leo to look at challenges holistically and to critically assess the major market drivers, strategies, and tactics vital to building an enduring competitive advantage. And, his science-driven, market-led, patient-focused approach maximizes product value to patients, clinicians, and payers through its lifecycle.
Leo is founder of StraNexa BioPharm Commercialization Consultancy, where he provides insight-driven strategic and tactical expertise to the biopharmaceutical industry to help create and sustain competitive advantage. Prior to StraNexa, Leo held various leadership roles across marketing, business development, and alliance leadership at leading firms such as AstraZeneca, Merck, Astra Merck, and Regeneron. Leo earned an MBA from Harvard Business School (fellowship), a BS in Business Administration from West Virginia University (summa cum laude), and executive leadership certifications from Northwestern University (Kellogg) and University of Pennsylvania (Wharton). He has also recently completed extensive coursework in biological sciences, earning high honors (Phi Theta Kappa distinction). He also is an expert instructor for Biotech Primer, facilitating a course he created covering important concepts within strategic commercialization in biopharma.
Romano Robusto, LLB, B.CL., B.Sc.
Advisor: Medical Devices
Mr. Robusto’s most rewarding accomplishment, however, was discovering and providing initial ﬁnancing for a start-up Ohio-based company that developed a Breast Cancer computer-aided detection (CAD) technology, which culminated with FDA approval of the Second Look CAD system for Mammography. Another key career accomplishment involved his contribution to the growth of Biochem ImmunoSystems Inc. Speciﬁcally, from 1988-1996 the diagnostic revenues grew from $5 Million to $125 Million USD and the business grew from 40 people to 600 worldwide mainly through strategic partnerships and acquisitions, including two Italian companies in 1991 and that of Serono Diagnostics in 1994. It was after this latter acquisition that Mr. Robusto was given operational and sales/business development responsibility for the entire Paciﬁc Rim, including President of the Japanese and Singapore subsidiaries.
Mr. Robusto also spent 5 years with Diagnocure Inc., a company specializing in the development and sales of molecular cancer diagnostic tests. He recently completed a mandate as General Manager for a UK subsidiary of a medical device manufacturer and is presently acting as a consultant to the diagnostic/device sector. Complementing Mr. Robusto’s extensive corporate experience, he also worked with the life sciences division of the SGF, the economic development arm of the Quebec Government, responsible for investing development capital into companies that had achieved commercial viability. In addition to the Medmira board mandate, he has also served as Chairman of the Board and Interim CEO for Radient Technologies Inc., a privately-owned pharmaceutical processing company where shortly after being nominated as Chairman of the Board of Directors, was asked to step in as Interim CEO to restructure and raise the requisite capital to fuel the scale-up of their research and development activities, their pilot manufacturing plant capabilities and the overall growth of the company. Radient specialized in Microwave-Assisted Natural Product Extraction, Puriﬁcation and Isolation services of compounds from plant-based sources destined for pharmaceutical, nutraceutical and cosmetic applications.
After having successfully closed a $5.6 Million ﬁnancing, the company moved its main processing facilities to Edmonton, Alberta. More recently, he completed his 4-year mandate as Director for MCN Bioproducts, a private Canadian Agro-Bio company which was successfully sold to a major multinational player within the sector. Mr. Robusto holds degrees in Common and Civil law from McGill University, a B.Sc. in Physical Therapy from McGill University and majored in Biochemistry at Concordia University.
Patrick D. Mize, Ph.D
Advisor: Product Development / Regulatory Services
Clear Design Goals also aid in many Business Development activities. Knowing the complete Design Goals allow for better interactions with potential business partners by accurately defining organizational needs and those elements, which a business partner can provide during the commercialization process.
Dr. Mize has over 30 years of Regulatory and Product Development experience in In Vitro Diagnostic [IVD], Medical and Surgical Devices. His expertise includes: regulatory strategy; preparation and support of submissions to the FDA and third parties; design and implementation of QMS, cGMP, or ISO systems [ISO 13485]; and design control training and implementation. Dr. Mize has further experience with 483 mitigations, compliant handling, and CAPA systems.
Dr. Mize has directed the Regulatory and Product Development process for multiple diagnostic tests, their transfer into manufacturing, and the subsequent launch activities. He began his diagnostics career developing early POC assays for respiratory and sexually transmitted diseases. He subsequently developed and helped commercialize environmental immunoassays for priority pollutants in soil and ground water. Dr Mize also has developed and commercialized several POC coagulation assays and some of the first companion diagnostics for novel anticoagulants.
Dr. Mize was a founding member and served as Chief Scientific Officer for two medical device companies, LAAM Sciences and Nirvana Sciences, based in North Carolina. He has served in positions of increasing responsibility at Becton Dickinson, Pharmanetics, Inverness Medical Innovations [Alere], and Atherotech Diagnostic Labs.
Dr Mize also has extensive consulting experience in blood typing reagents and optimization of manufacturing processes, development of molecular tests for cancer diagnostics, 483 mitigations in POC and instrumented immunoassays, and 510(k) submissions for both Diagnostic and Medical Devices.
Dr. Mize obtained a BA in Chemistry at Florida Atlantic University and a Ph.D. in Organic Synthetic Chemistry at Duke University.
Imen Jelassi, PharmD, MSc
Advisor: EU Director, Strategic Relations
She has significant experience in business development for both products and services and has initiated prospection activities in Europe and also in LATAM and Russia for her clients. She has performed Business Development activities for both human and veterinary products. Due to her skills and experience, she is able to target the right prospects for her clients based on her deep knowledge of the market and a focus on her client’s needs.
Imen has worked as a CRA and have a good understanding of the GCP, the conduct of clinical trials, the regulation and feasibility studies in Europe but also in the MENA region.
Imen also holds a master degree in health marketing and has the right competencies for conducting market studies, market intelligence, market access, competitor analysis, increasing brand exposure and multichannel marketing.
Imen is based in Paris, France and speaks 4 languages: English, French, German and Arabic.
David Dworaczyk, Ph.D.
Advisor: Research & Development
During his career, Dr. Dworaczyk has been directly engaged in start-up companies, product and company acquisitions/integration and has been actively involved in raising funds for various initiatives. He has also gained expertise in Decision and Risk Analysis, has done extensive research in strategic planning, R&D portfolio management. He has also built, developed and implemented various IT/enabling technologies for use across the pharmaceutical development continuum.
Dr. Dworaczyk earned his undergraduate degree in Biology at Daemen College, his Master’s degree in Cell and Molecular Biology from the State University of New York at Buffalo and his Doctorate in Leadership and Business Administration from the University of Delaware.
Manager, Business Development & Marketing
As a thought leader in her services, Carol specializes in social media marketing. She works with businesses to develop and manage online campaigns and effectively drives brand awareness, engagement and traffic to our client’s social media pages. Carol understands the creative process required to engage a client, educate them on critical marketing strategies and execute those strategies to increase market penetration.
Carol utilizes her extensive knowledge to build social media calendars that align with client annual activities, highlight their key opinion leaders and showcase their general capabilities. These efforts keep clients on track and ever present in their target market. She understands and stresses the importance of making people come together as one in a social media-built community.
Alexander V. Sarene
Associate Manager, IT Support / Product Development