If you want to go fast - go alone. If you want to go far - go together.
- African proverb -
Our team of senior advisors brings together areas of deep expertise to help take our clients to new heights. Combined with many years in our respective fields, a team-oriented mindset, and a proven methodology, we can help you achieve your goals effectively AND quickly.
Optimization, Project Leadership, Management Consulting
"Improving Performance." Whether it is as a strategy consultant and executive for top and specialist advisory companies, as head of R&D project or resource management, or as a subject matter expert for a technology company, this has been Tobias' mantra for over 30 years. It drives what he does, whether it is an operating strategy, process optimization program, project / development team management, or using technologies and data as disruptors.
He has helped clients to
- increase R&D performance through innovation and process reinvention, optimize functions (e.g. clinical development, regulatory affairs and drug safety), develop new business models (e.g. precision medicine), and use real world evidence data to enhance development planning
- make better strategic asset-based decisions by bringing together appropriate specialist skills (e.g. clinical, regulatory, scientific)
- explore and implement ways to use technology as a disruptor and to improve business performance (e.g. with the right cognitive and AI capabilities)
As a native English and German speaker, he has held international leadership positions:
- Global head of project and resource management function in R&D
- High Performance Clinical Development Service Line Lead in Austria, Switzerland and Germany
- Executive of three global, specialist life science consultancies, responsible for establishing and growing a US presence.
Eckart Schwarz, MD
Risk Management, Compliance, Regulatory and Medical Governance, Organizational Development / Labor Arbitrage
Dr Eckart Schwarz is a seasoned senior pharmaceutical executive with an impressive 30+ year track record of leading global strategic initiatives and building/managing large teams & budgets transnationally. A long-term Senior Vice President in various pivotal roles in major blue-chip pharma, he has been recognized for his transformational leadership in designing and building global strategic and operational solutions and teams, in most of the disciplines involved in drug development. Trained as a physician / anesthesiologist in the UK, Eckart has an impeccable academic pedigree which includes Honorary Fellowship of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians (London, England). His stance is resolutely global, having worked and lived in Europe, the UK, Singapore, India and the US, where he is now based in the greater Philadelphia area. He is a dynamic leader with exceptional analytical capabilities, deep and broad experience and expertise, strategic visionary outlook, high personal energy and compelling communication skills, yet at the same time is humble, approachable and pragmatic. Drawing on his broad experiences as a senior trans-enterprise leader in “big pharma” Dr Schwarz is now focusing on providing bespoke consultancy, both in terms of overall strategic advice, but also in specific disciplines of Life Sciences and Drug Development, where he has a track record of major transformational delivery, namely in (but not limited to) the areas of:
global organizational development and modelling
labor arbitrage and building offshoring / outsourcing platforms and solutions
regulatory information management (RIM) and data curation
drug development process optimization
regulatory operations and life cycle management
risk management design and strategies
quality and compliance approaches and implementation
medical and regulatory governance
CMO capability building and strategies
Undine Schachtschabel, PhD
Undine Schachtschabel has over fifteen years of experience in all phases of clinical development, marketing authorization of small-molecule drugs and biologics, and corresponding international regulatory strategies. Trained at the Max-Planck-Institute in Germany, she has in-depth experience in advanced research, innovative product development and post-licensing efforts across different therapeutic areas including immunology/oncology, infectious diseases, cardiovascular diseases, and endocrinology. She has developed regulatory strategies for the US, Europe, and emerging markets, prepared CTD dossiers for INDs and MAAs and provided critical assessments for approval - key quality documents, advanced therapy medicinal products (ATMPs), pediatric investigation plans (PIPs/PSPs), and joint product licensing and registrations across US-American and European markets. She also supported post-authorization and license maintenance activities in due course. Undine has liaised and successfully negotiated with US- and European Agencies, managed Scientific Advice-/Agency meetings, and worked within US and European corporate matrix teams as the regulatory point of contact for biotechnology- and pharmaceutical companies.
Chemistry, Manufacturing and Controls
Steve Pondell is a Managing Director at IBTSolutions. He is a CMC expert in the manufacturing, compliance and regulatory aspects of product development from clinical manufacturing, through global clinical regulatory approvals and into commercial production. Asan expert consultant, Steve has served a variety of small to medium sized pharma and biotech companies with projects that include GMP Gap Analyses, IND/IMPD compilations, Phase I product development programs, cGMP compliance and supplier audits, and businessdevelopment activities for a global logistics provider. He has experience at working with small biotech companies as well as multi-national pharmaceutical companies. He has served as a contract manufacturer and as a virtual manufacturing outsourcing manager. His particularspecialty is assisting companies work across the sponsor/contract manufacturing relationship, creating high performing partnerships on a global basis.
Jo Ann Horowitz, MD
Dr. Jo Ann Horowitz is a hematologist and oncologist with senior pharmaceutical expertise in both small and large Pharma over ~30 years. Jo Ann's successes include leading global strategic initiatives and building/managing teams covering both novel early and late stage hematology and oncology programs. Her drug development experience has included gene therapy, immunotherapy, targeted therapies and traditional drug development. Jo Ann has succeeded in leading clinical filings for US and ex-US Health Authorities, worked to prepare her team and other teams for meetings with Health Authorities including Oncology Drug Advisory Committee and Joint Scientific Advice preparation and participation. Jo Ann has worked on new product acquisition teams resulting in regulatory approval. Following a successful career in pharmaceutical drug development for ~ 30 years Jo Ann has been consulting for over 2 years.
Anke Hoppe knows what it takes to run a successful clinical trial. She has over 30 years of clinical operations experience in major international pharmaceutical and biopharmaceutical companies and various clinical research organizations. Her experience ranges from working as clinical research associate for nine years to project and program management lead at several of the leading CROs to head of clinical operations for biotechs.
She has been involved in the development of medicines (phase 1-3) targeted at osteoporosis, hypoparathyroidism, schizophrenia, hepatitis C (including pediatric and 3b studies), Parkinson’s Disease, cystic fibrosis, osteoarthritis, hematology, biologicals (vaccines), HIV, severe chronic pain, urge incontinence, chronic constipation, liver cirrhosis, diabetes, gastric and duodenal ulcers and cellulitis.
Bill Scuba is an innovative and accomplished data scientist with extensive experience in natural language processing, environmental science, and a broad range of artificial intelligence techniques. His two decades of work have included projects at a range of institutions including the Scripps Institution of Oceanography, Novartis Pharmaceuticals, the University of Utah Department of Bioinformatics, the United States Department of Defense, and BAE Systems. He has also published a number of research papers including a novel algorithm for working with data that has a large number erroneous values.
Finance, Corporate Development
John has extensive experience working with companies stressed or distressed.by loss of profitability, liquidity, or support from their existing capital providers. John has a unique blend of experience as business advisor, interim executive, and debt/equity investor. He acutely understands the significant challenges that confront owners and executives who suddenly find themselves having to navigate often hostile negotiations with vendors, landlords and lenders and the myriad of advisory firms seeking to profit from expensive in-court insolvency processes. As the company’s trusted advocate, John distills hostility by seeking creative, cost-efficient operational, financial, and capital solutions to stabilize the company and restore it to health.
John has worked with hundreds of companies across a wide range of industries, with specific focus on middle market companies in the consumer/retail, SAAS/technology, and business services sectors. His current engagements include serving as fractional CFO for a healthcare technology company, M&A leader for a pharmaceutical services company, and active board member for a business services company.
David Onks is an executive and leadership coach who helps individuals who are experiencing or desire a pivot point in their career. He also coaches teams or groups that may not be performing at their best. David brings over 23 years of global corporate leadership to help individuals and teams see an increase in:
David has a shared empathy for his clients and his approach allows them to define/refine their vision, provide clarity in the direction they want to go, and allow them to form specific actions to help them get there. His clients experience a renewed passion and energy about their next steps and how it aligns to their vision. David understands the pressures of a fast-paced organization focused on quality delivery. He formed Sparked Coaching to provide both qualitative and quantitative value for both the company and the individual. He is passionate about providing clients with the whole picture to ensure work/life balance.