Sikora Strategic and M&A Consultants
Building biotechnology start-ups from inception to liquidity
Services For Therapeutic Start-ups
M&A and Strategic Partnerships
M&A and Strategic Partnerships
M&A and Strategic Partnerships
- 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.
Technology Evaluation
M&A and Strategic Partnerships
M&A and Strategic Partnerships
- Gap Identification: Skilled in identifying gaps in pre-clinical and clinical data or programs that may impact the success of therapeutic technologies
- Strategic Gap Closure Plans: Development of comprehensive plans to address and close identified gaps, ensuring robust and viable technology programs.
- Extensive Evaluation Experience: Successfully evaluated over 3,000 therapeutic technologies in the last three years.
Licensing
M&A and Strategic Partnerships
Portfolio Strategy Development
- Technology Search and Evaluation: Offering comprehensive search and evaluation services to identify promising technologies within the industry.
- In-Licensing Expertise:
- Shelved Products: Specializing in identifying and in-licensing shelved products with untapped market potential.
- Academic Technologies: Extensive experience in sourcing and in-licensing innovative technologies from universities and research institutes.
- Out-Licensing Proficiency: Demonstrated success in out-licensing technologies, maximizing value, and expanding market reach.
- 18+ Years of Licensing Experience: Over 18 years of in-depth experience in both in-licensing and out-licensing, with a strong understanding of industry dynamics.
- Academic Licensing Knowledge: Deep familiarity with the academic licensing process, ensuring smooth, effective, and strategic negotiations.
Portfolio Strategy Development
Scientific and Clinical Advisory Boards
Portfolio Strategy Development
- Technology Portfolio Comprehensive Evaluation and Vetting: Expertise in conducting thorough evaluations and vetting of technology portfolios to ensure strategic alignment and potential for success.
- Patenting Decisions: Skilled in making informed patenting decisions to protect intellectual property and enhance market value.
- Gap Identification and Out-Licensing Package Preparation:
- Identified gaps in out-licensing packages and developed strategic plans to close these gaps.
- Prepared comprehensive out-licensing packages to facilitate successful licensing transactions.
- Search, Evaluation, and Licensing of Technologies Worldwide: Extensive experience in searching for, evaluating, and licensing technologies globally, ensuring access to cutting-edge innovations.
- Extensive Biotechnology Evaluation Experience: Evaluated over 3,000 biotechnologies, providing deep insights and assessments to support strategic decision-making.
Strategic Development Plan
Scientific and Clinical Advisory Boards
Scientific and Clinical Advisory Boards
- 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 Boards
Scientific and Clinical Advisory Boards
Scientific and Clinical Advisory Boards
- 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.
Clinical Trials
Review and Related Modifications of Clinical Programs
Review and Related Modifications of Clinical Programs
- 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.
Review and Related Modifications of Clinical Programs
Review and Related Modifications of Clinical Programs
Review and Related Modifications of Clinical Programs
Frequently, lagging patient enrollment can be easily fixed through program evaluation.
- Thorough evaluation of clinical programs: amended multiple clinical programs in the fields of cardiovascular, Immunology, Immune-oncology, vaccines, pain, neurodegenerative diseases to boost/accelerate enrollment.
The process includes:
- Current Status: Review of trial protocols, safety data, and efficacy results.
- Challenges Identified: Potential issues with patient recruitment, retention, or protocol adherence.
- Recommendations: Adjustments to inclusion/exclusion criteria, enhanced patient monitoring, or revised study endpoints.
- Comprehensive Evaluation of Ongoing Enrollment:
Data Analysis: Assess current enrollment figures against targets. This includes visits to clinical trial sites and comprehensive evaluation of patient population at each site.
- Trend Identification: Examine trends and patterns in enrollment data.
- Identification of Reasons for Lagging Enrollment:
- Eligibility Criteria: Can protocol be amended to relax some inclusion/exclusion criteria to enhance enrollment.
- Study Endpoints: Are they clear, relevant, and achievable?
- Site Performance: Are there issues with site engagement or performance?
- Patient Awareness: Is there sufficient awareness of the study among potential participants?
- Development of Recommendations
- Amending Enrollment Criteria: Adjust criteria to broaden the patient pool while maintaining scientific rigor.
- Revising Endpoints: Ensure endpoints are feasible and relevant to patient outcomes.
- Boosting Enrollment:
- Site Optimization: Improve site performance through additional training or resources for trial coordinators.
- Enhanced Outreach: Implement targeted recruitment strategies, including digital marketing or partnerships with patient advocacy groups.
Acting CEO, COO, CBO
Review and Related Modifications of Clinical Programs
Acting CEO, COO, CBO
Within last three years I was asked to serve as Acting Chief Executive, Chief Operating, and Chief Business Officer for various therapeutic start-ups. Also serve as advisor to a CEO.
Services for Investors
Technology Evaluation
Technology Evaluation
Technology Evaluation
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.
Key Opinion Leaders
Technology Evaluation
Technology Evaluation
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.
Acting CEO, COO, CBO
Technology Evaluation
Acting CEO, COO, CBO
Within last three years I was asked to serve as Acting Chief Executive, Chief Operating, and Chief Business Officer for various therapeutic start-ups. Also serve as advisor to a CEO.
Services for Academia and Research Institutes
Technology Portfolio Evaluation
Technology Portfolio Evaluation
Technology Portfolio Evaluation
- Thorough technology portfolio review and vetting.
- Technology vetting: selecting technologies that are ready for out-licensing.
Evaluate Technology Readiness
- Ready-to-be-Licensed: Assess the maturity of the technology, including completed R&D, validated proof-of-concept, and strong intellectual property (IP) protection.
- Almost Ready: Determine the specific additional data or development required to bring the technology to a licensable state. Evaluate the feasibility and cost of obtaining this additional data.
- Less Likely to be Licensed: Analyze the potential challenges, market demand, and technological gaps that make these technologies less attractive for licensing.
Gap Analysis and Gap Closure
Technology Portfolio Evaluation
Technology Portfolio Evaluation
More often than not technologies need relatively inexpensive additional development work. The key is what needs to be done to have outstanding out-licensing package.
- Gap Identification: Skilled in identifying gaps in pre-clinical and clinical data or programs that may impact the success of therapeutic technologies.
- Strategic Gap Closure Plans: Development of comprehensive plans to address and close identified gaps, ensuring robust and viable technology programs.
- Extensive Evaluation Experience: Successfully evaluated over 3,000 therapeutic technologies in the last three years.
Out-licensing Package Formation
Out-licensing Package Formation
Out-licensing Package Formation
Formation of out-licensing package, consistent with the pharmaceutical licensees' requirements. With our extensive experience and related deal sheet in strategic partnerships, we know exactly what is needed in successful out-licensing to the pharmaceutical industry.
Technology Marketing
Out-licensing Package Formation
Out-licensing Package Formation
- Extensive connections in the start-up, mid-size, and big pharmaceutical ecosystem.
- Up-to-date knowledge of each pharmaceutical company focus at each stage of drug development: early development, late development, and commercialization.
Our Lead Consultant
Sergey Sikora, PhD, MBA
Sergey Sikora, MBA, PhD is a strategic and M&A 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/
Our Consulting Team
Under Construction
Recent Client Testimonies
Most recent Client: CER TEK BIO
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!
Most recent Client: Secretome Therapeutics
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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