Sikora Strategic and Clinical Consultants
Building biotechnology start-ups from inception to liquidity
Building biotechnology start-ups from inception to liquidity
We are excited to share that, starting February 1, 2025, Sikora Consultants will officially join forces with Phase Bridge, a leading biotechnology consulting agency. Phase Bridge specializes in guiding therapeutic start-ups through the journey from early preclinical development to the clinical stage.
This partnership marks an exciting new chapter, and we are committed to ensuring a seamless transition for our valued clients. By combining our expertise with Phase Bridge's, we will offer an expanded range of services designed to accelerate the development of therapeutic innovations from early-stage concepts to industry-ready proof of concept.
To learn more about Phase Bridge and the enhanced capabilities now available to you, please visit www.phase-bridge.com.
We are looking forward to continuing to support your success with our expanded resources and expertise.
Are you the CEO of a therapeutic start-up with outstanding pre-clinical or Phase I data but insufficient financial resources to conduct a full Phase II study? Sikora Consultants is here to help. We specialize in partnering with underfunded therapeutic start-ups, guiding them toward clinical efficacy proof of concept at premier US institutions.
At Sikora Consultants, our mission is to bridge the gap between promising early-stage therapeutics and the compelling proof-of-concept data needed to secure strategic partnerships with larger pharmaceutical companies.
To bridge your company clinical program to the PoC and subsequent strategic partnership, we design and deliver customized clinical studies tailored to your budget, without compromising on the highest pharma standards.
Our approach is laser-focused on answering the single most critical question for your asset: Is it efficacious in the indication of interest? By prioritizing this goal, we streamline proof-of-concept studies to deliver clear, actionable results that meet industry expectations. Our forte lies in designing cost-effective, bespoke clinical trials conducted at our trusted partner institutions. The result? A robust data package that positions your asset for success in strategic collaborations.
What sets Sikora Consultants apart is our expertise in medical, clinical, and statistical analysis. We ensure that every trial we design is optimized for success, prioritizing endpoints and enrollment criteria that align with your therapeutic goals and the standards of pharmaceutical evaluation. From GAP analysis and protocol development to clinical advisory board formation, we provide a comprehensive roadmap to bridge your early-stage program to proof of concept seamlessly.
By leveraging a success-based model, we enable you to navigate the clinical development journey strategically and efficiently. Our commitment to cost-conscious execution ensures that your resources are maximized while delivering the data needed to drive meaningful partnerships.Let Sikora Consultants be your partner in transforming innovative science into impactful therapies. Together, we’ll navigate the path from early-stage innovation to industry-ready proof of concept, empowering your start-up to achieve its full potential.
Our TAs of expertise:·
Oncology
Neurology and neurodegenerative, including Alzheimer’s and ALS
I&I: immunology, rheumatology, and infectious diseases
Rare diseases
Pediatric diseases
Cardiovascular
Women's Health
- Comprehensive Business Plan Development:
- Expertise in developing VC-friendly business plans starting with in-depth technology evaluations.
- Intimate knowledge of what traditional and corporate venture capital firms seek, ensuring a complete investment package.
- Deliverables include company teasers, investor PowerPoint presentations, comprehensive valuations, business model development, and competitive evaluations.
- Investor Presentations: Skilled in presenting business plans and investment opportunities to potential investors, effectively communicating value propositions and strategic vision.
- Comprehensive R&D Plan Development:
- Starts with thorough technology evaluations and up-to-date pre-clinical data analysis.
- Focused on creating robust R&D strategies that align with the latest industry trends and scientific advancements.
- Clinical Plan Development:
- Involves recruiting top Key Opinion Leaders (KOLs) from top-tier academic medical centers in the relevant therapeutic areas (TAs).
- Collaboration with KOLs to identify lead indications, develop inclusion/exclusion criteria, define end-points, and determine patient numbers based on comprehensive evaluations of the latest clinical studies in the TA of interest.
- Scientific and Clinical Advisory Board Structuring:
- Structured multiple Scientific and Clinical Advisory Boards with top KOLs from leading academic medical centers in the U.S., EU, Switzerland, Japan, and other regions.
- Expertise includes assembling boards in diverse fields such as cardiovascular, oncology, neurodegenerative diseases, pain, ophthalmology, dermatology, rheumatology, and autoimmune disorders.
- Lead indication identification
- Clinical Advisory Boards: Identified and recruited members for Clinical Advisory Boards, Clinical Trial Steering Committees, and Data Safety Monitoring Boards (DSMBs), comprising top Key Opinion Leaders from relevant therapeutic areas.
- Clinical Trial Protocol Development: Skilled in developing comprehensive clinical trial protocols to ensure scientific rigor and regulatory compliance.
- Top-Tier Clinical Trial Site Recruitment: Identified and recruited leading academic clinical trial sites to enhance the quality and reach of clinical research.
- Clinical Trial Execution:
- Possesses proprietary expertise in accelerating clinical trial enrollment to meet project timelines and objectives.
- Managed amendments to clinical trial protocols based on real-time enrollment rates and data.
- Investigator-Initiated Trials: Experience in facilitating investigator-initiated trials at top-tier academic medical centers, ensuring robust study design and execution, yet at 25% of the cost as compared to the traditional trial mechanism.
- Clinical Trial Design and Results Presentation:
- Significant experience in designing clinical trials and presenting results at late-breaking trial sessions at major congresses.
- End-to-End Partnership Expertise: Specialized in forming strategic alliances and partnerships from initial concept through post-transactional integration.
- 18 Years of Experience: A seasoned professional with 18 years of corporate and business development experience.
- Diverse Partnership Execution: Successfully executed a variety of partnerships, including strategic corporate investments, licensing agreements, and outright acquisitions.
- Therapeutic Space Focus: Extensive experience in establishing strategic partnerships and alliances within the therapeutic sector.
- Pharmaceutical Industry Connections: Strong relationships with Business Development & Licensing (BD&L) teams across major pharmaceutical companies.
- Customized Partnership Packages: Skilled in developing tailored strategic partnership packages to align with specific business goals.
- Targeted Partner Outreach: Expertise in identifying and engaging with potential strategic partners.
- Due Diligence Support: Comprehensive assistance with due diligence processes to ensure informed decision-making.
- Post-Transaction Integration: Proven track record in ensuring smooth and effective integration following partnership agreements.
Engagement Details
Objective
Milestone-Based Compensation
Deliverables
Thorough evaluation of therapeutic technologies, consistent with corporate and traditional venture capital technology evaluation.
- Expertise in almost all therapeutic areas, with an exception of psychiatry.
Identification and recruitment of top scientific and clinical key opinion leaders in any therapeutic area from top-tier institutions in US, EU, Switzerland, and Japan.
Sergey Sikora, MBA, PhD is a Strategic and Clinical Consultant, specializing in providing strategic, M&A, transactions, and clinical development support to pharmaceutical and biopharmaceutical start-ups to mid-size companies and traditional biotechnology and pharmaceutical venture capital firms. He left Releviate Therapeutics in the mid-2024 (company developing non-addictive, antibody-based, disease-modifying neuropathic pain therapy) as the Chief Executive Officer and a Member of the Board of Directors. Sergey's 20 years of experience in the biotechnology industry spans the spectrum of pharmaceutical, biopharmaceutical, and diagnostic industries. Before Releviate, Sergey founded and managed CardioCell, cell therapy company focusing on cardiovascular diseases. During his tenure at CardioCell he took the company from inception to Phase III. Sergey's expertise spans cardiovascular, neurodegenerative, neuropathic pain, ophthalmology, dermatology, autoimmune, rheumatology, and rare diseases, such as Duchenne's muscular dystrophy, ALS. During his tenure as the CEO of CardioCell he served on the FDA discussion panel for heart failure, along with top KOLs in heart failure and heart failure industry leaders from AstraZeneca and Bayer, resulting in the position paper. Sergey is also recognized as Top 20 Most Notable UCSD Alumni in the Business World, according to the Money, Inc. Sergey earned a B.S. in Biochemistry at UCLA, a Ph.D. in Molecular Biology from UCLA , and an M.B.A from the Rady School of Management, UCSD. He has multiple patents and multiple clinical peer-reviewed publications.
LinkedIn: https://www.linkedin.com/in/sergey-sikora-6952192/
Sergey Sikora has been an indispensable force behind the success of Cer Tek Bio Corp. As both Chief Medical Officer and Chief Executive Officer, Sergey has brought unparalleled expertise and dedication to our mission. His strategic vision and leadership have been essential in transforming Cer Tek Bio Corp into a viable and thriving company. With Sergey at the helm, the complex challenge of developing a groundbreaking vaccine platform to prevent future pandemics is not only possible but within our grasp. Thank you, Sergey, for your tireless hard work and unwavering commitment. Your contributions have been nothing short of extraordinary!
As a former client, I could endorse Sergey more strongly. Very sharp, experienced, and personable. Congrats on the growth of your company, Sergey!
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