Through the lens of strategic advisory, we assist our clients in first better understanding their end goal(s) and second devising and executing on that vision in an efficient and productive manner.

Developing growth strategies in conjunction with financial/market modeling and operational expertise ensures that our clients are able to capture true value. Along with our partners, we have decades of global experience in financial management, transaction advisory and construction, M&A, market analytics as well as human capital management and coaching.

We are a Founder and Partner lead organization.

BioBridges represents and manages the careers of experienced, highly sought after industry professionals who make an immediate, positive impact on the pharmaceutical, biotech, and medical device programs they serve. For more information, contact Marc Beaver at mbeaver@biobridges.com or 215-681-8330. Learn more.

BioEnsemble is dedicated to providing a comprehensive range of consulting services to meet the strategic and tactical business needs of small and mid-size pharmaceutical, biotechnology and medical technology companies. Key services include (1) development of strategic business plans that take into account product profiles, development phase, R&D and regulatory needs, competitors, market trends, pricing, reimbursement, partnering approaches and company competency; (2) creation of premium deal value and partner selection for in-licensing and out-licensing of assets; (3) development of successful partnerships for licensing, co-development, co-promotion, co-marketing, distribution and manufacturing. Please visit our website www.bioensemble.com and contact us at bioensemble.com.

Founded in 1989, Biotrial is a full-service CRO based in Newark, New Jersey, that provides solutions from in-vivo pharmacology through to proof of concept bringing a wealth of expertise to the study design process. Biotrial’s Phase I studies are conducted in its 110 bed, State-of-the-Art, CPU in Newark. The 5 floor facility boasts a dedicated EEG/Sleep lab to enable high quality data acquisition. Biotrial services include: Non clinical pharmacology; Phase I, specific PD assessments, BA/BE and FIH studies; Project Management & Monitoring of Patient studies; Translational Oncology; Biometrics; Core Lab; and, Regulatory Affairs and Pharmacovigilance.  For more information, please contact William Thomas at wiliam.thomas@biotrial.com or 973-388-2848.

CAI is passionate about helping development-stage companies get their product to market faster. Any misstep on the path to commercialization drains capital, impacts valuation, and delays time to revenue. Most importantly, delays can impact patient access to novel, life-saving therapies. Our experts work with you to understand your product and process, and to help you reach each milestone on the path to commercialization in the most efficient manner.  Our integrated project delivery model enables you to accelerate process validation, tech transfer, manufacturing scale-up, vendor selection, quality system implementation and regulatory affairs from early clinical trials through scale-up to commercial manufacturing.  For more information, please contact Leah Farlow at 317-271-6082.

Crystal Pharmatech, Inc. is a technology-driven contract research organization (CRO) that is specialized on small molecule solid-state research, pre-formulation and formulation development.  We partner with clients to ensure comprehensive solutions and guidance for discovery and selection of the optimal solid phase, process research development, early formulation and formulation development, regulatory support and intellectual property protection.  Founded in 2010, Crystal Pharmatech, Inc. has business relationships with over 700 global pharmaceutical companies. As we continue to grow, Crystal Pharmatech, Inc. will always keep customers our number one priority, will also continue to be at the forefront of new technology innovation.  Please visit www.crystalpharmatech.com for more information.

DZS Clinical Services provides full-service capabilities focused on supporting small to mid-size Pharma/Biotech/Device companies. Integrating seamlessly into operations wherever needed, our core services include clinical development, data analytics, post-marketing studies and pharmacovigilance. Our expertise in implementing e-clinical technology combined with our Insights Platform™ for risk management can streamline clinical trials. We support client projects with high-quality deliverables, strong communication, data transparency, and risk assessment capabilities. Based in the US, with global presence as a subsidiary of WDB Holdings having locations in Finland, Baltics, India and Japan, our position is to be your direct line to maximized efficiencies.  Learn more

Erica Ferry & Associates specializes in creating partnerships between businesses and nonprofit organizations for social good. We design and implement strategic philanthropy and employee engagement programs to achieve maximum benefit for both your company and the constituencies you seek to impact. We also develop and execute strategies to effectively engage your company with stakeholders in your host communities. Do well by doing good! For additional information please contact Erica Ferry at Erica@EricaFerry.com.

Evotec is a drug discovery solutions company providing drug discovery expertise and capabilities to pharmaceutical and biotechnology companies as well as to academic institutions. Drug discovery solutions are provided in form of fee-for-service work, integrated drug discovery alliances, development partnerships, licensing of innovative drug candidates and consulting arrangements. The Company operates worldwide and has leading scientific experts, state-of-the-art technologies as well as key therapeutic expertise in the areas of neuroscience, pain, metabolic diseases, oncology, inflammation and infectious diseases. By leveraging this expertise, Evotec intends to develop best-in-class and first-in-class differentiated therapeutics on its systematic, unbiased and comprehensive infrastructure.

GSG Scientific LLC, located at the Princeton Corporate Plaza Research Center in NJ, provides support for research projects in the food and healthcare industries. We have an expert team of information professionals and scientists to collect and analyze literature and prepare scientific and government agency required reports. Our team provides information for chemistry, pharmaceutical and biotechnology innovation at all stages of product development including chemical searches, animal research alternatives, preclinical research, clinical trials, regulatory landscapes, pharmacovigilance, and toxicology and product safety. In addition, we have a small laboratory for bench scale research services specializing in troubleshooting technical issues. Learn more.

“Finding SolutionsSM” describes what we do.

Hurley Consulting Associates Ltd. has developed and implemented regulatory strategies for the health sciences industry since 1987.

With unique expertise to prepare global regulatory submission documents, datasets, reports, and dossiers, Hurley Consulting performs data analyses as well as integrates nonclinical, clinical, and manufacturing and control evaluations.

For over 30 years Hurley Consulting has supported its domestic and international clients through the entire IND through NDA process. We are recognized within the health sciences industry for our high level of expertise and the excellent quality of our work.   Learn more

Integrated Project Management Company, Inc. (IPM) is a business consulting firm focused on planning and implementing strategically critical initiatives in the life sciences, healthcare, consumer products, and industrial sectors. Since its inception in 1988, IPM has served more than 400 clients and completed more than 4,000 projects. Headquartered in Chicago, IPM has regional offices in Boston, St. Louis, Los Angeles, San Francisco, Minneapolis, and Parsippany. For more information, contact Ralph Bellisano at ralphb@irionline.com or 732-429-1950. Learn more www.ipmcinc.com.

 

McKinsey & Company is a global management consulting firm that seeks to help clients realize their most important goals. In Biopharma, McKinsey provides specialized capabilities that focus on the needs of small and mid-cap companies in clinical and early commercialization stages, including TA and clinical strategy, medical, regulatory, and market access. Learn more.

MMR Consulting is an experienced and dedicated engineering team delivering robust solutions to the Pharma / Biotech industries nationwide. We provide Engineering and Automation Services, Commissioning, Qualification and Validation (CQV), Project Management & Project Controls, Computer Systems Validation (CSV), and Compliance. For more information, please go to www.MMRengineering.com

MSQ Ventures is a New York-based cross-border advisory firm that bridges the healthcare industries globally by offering our deep knowledge, strong network, and local insights into the China market. We provide comprehensive advisory services for our clients’ cross-border projects: market assessment, in/out-licensing, capital raising, joint ventures, and clinical trial management.

MSQ was founded in 2016 by a group of Cross-border industry leaders and biotech veterans with expertise in global healthcare industries. Our platform combines the strengths of a dedicated U.S. based research team, cross-border transaction execution team, and senior advisory team, with the resources of a large Chinese network of industry leaders, KOLs, and government regulatory agencies.

NDA Group is a world leading regulatory, drug development and medical device consultancy. We have a dedicated team of over 150 consultants supported by an expert network and a specialist Advisory Board many of whom are ex- European and US Agency staff.

We support life science companies all over the world and across all phases of development, from pre-clinical to post marketing, to meet the needs and requirements of regulators and payers alike.

Working together with our clients to address key strategic regulatory and reimbursement challenges, our goal is to help streamline drug development to accelerate patient access to important medical therapies. Our scientific expertise covers all major therapeutic areas.

NDA Group supported over 40% of the new medicinal products that were approved in the EU over the last five years. www.ndareg.com

 

Nucleus Network (NN) is Australia’s only multi-site dedicated phase I CRO located in Melbourne (80 beds) and Brisbane (62 beds). The facilities are strategically co-located within the Alfred Hospital in Melbourne and the Royal Brisbane and Women’s Hospital in Brisbane. This provides NN with access to a combined population of 7.5 million people. Since 2004, NN has conducted over 750 studies, with 90% of clients being overseas pharmaceutical and biotech companies. NN runs approximately 70 studies per year, with around 30 of these being true first-in-human studies. For more information, contact Michael Watson, m.watson@nucleusnetwork.com.au.

Since 2001, we have offered an innovative approach to accessing a broad and deep network of expertise to support our clients’ drug development, commercialization, technology & opportunity assessment needs. We help clients moving from discovery to development as well as clients with commercial products but more projects than they can resource, helping them to progress while navigating the challenges of outsourcing to CMOs & CROs. We help management and investors better understand risk and value. Our approach to assembling expert teams helps suppliers better understand their customers’ needs and how to serve them. We address technical issues, help manage programs as well as support strategy & portfolio management. Our approach to provides unique and customized Product Development Planning, Implementation and Issue Resolution, Technical, Operational and “Manufacturability” Due Diligence, Strategy and Operational Improvement, Market Opportunity Assessment, Valuation and Commercialization support for clients in various Life Sciences industries. Learn more.

Expertise in strategic planning, corporate development and sales management with specialization in the life science (pharmaceutical contract manufacturing, nutrition) and personal care industries. Experience in M&A advisory for multiple acquisitions with total value of ~$ 4B. Track record of driving new business growth via the implementation of strategic, customer focused selling processes, including the negotiation of manufacturing and supply agreements with total value in excess of $300M. P&L/operational experience for specialty businesses of ~$70M revenue.

PsychoGenics is a Preclinical CRO with expertise in the CNS and orphan disorders. We are known for our cutting edge translational approach to research, our customized solutions, the breadth and quality of our work, as well as for our ability to identify statistically relevant phenotypic changes, even early and subtle changes, that help our clients quantify the efficacy of their treatments before they move into the clinic. With an extensive portfolio of highly predictive disease models and unparalleled experience performing studies for biopharmaceutical companies of all sizes, PsychoGenics enables clients to deliver superior clinical candidates. The Company’s capabilities include behavioral testing, electrophysiology, translational EEG, quantitative histology, molecular biology, and microdialysis. Complementing its extensive capabilities, PsychoGenics offers a variety of validated mouse models including in-licensed transgenic models that support research in areas such as Alzheimer’s disease, Huntington’s disease, Parkinson’s disease, Autism spectrum disorders, psychosis/schizophrenia, Spinal Muscular Atrophy (SMA), muscular dystrophy and other muscle disorders. Learn more.

Ulteemit Bioprocessing, LLC offers expert consultation in the fields of process development and manufacture of protein therapeutics. With over 30 years’ experience in the biopharmaceutical industry, Dr. Michiel E. Ultee provides both creative insight and a rich perspective into what it takes to turn a protein discovery into a therapeutic. Learn more.

Verve Group Consulting, based in Bedminster, NJ, specializes in providing data privacy, compliance and regulatory consulting services to pre-revenue and other growing life science companies. As a boutique-sized company ourselves, our solutions and pricing are geared specifically for that market. Our clients rely on us to align their data privacy, compliance and regulatory functions with the company’s commercial goals, as well as make those functions due diligence-ready for investment or acquisition. If you have any questions, please contact Larry Samilow, Co-Founder and Managing Director, at (908) 884-0379 or lsamilow@vervegroupconsulting.com. For more information, please visit us at https://vervegroupconsulting.com.

VOZ Advisors (VOZ) is the leading consultant to pharmaceutical, biotech, device, and diagnostic companies around the world in their quest to deliver quality care through innovation and effective partnerships with patient, consumer, and professional advocacy groups.  Having served in leadership positions in advocacy, clinical research, industry, market research, policy, and more, VOZ’s decades of experience enables the firm to offer a customized, strategic, and innovative approach to advance mutual goals between clients and key stakeholders, ensuring a benefit from patient, professional, and consumer perspectives across R&D, clinical trial recruitment and retention, regulatory approval, launch readiness, access, and reimbursement. For more information, please contact Claudia Hirawat at chirawat@vozadvisors.com or 908=294-8399.